US20220175221A1 - Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same - Google Patents
Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same Download PDFInfo
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- US20220175221A1 US20220175221A1 US17/392,897 US202117392897A US2022175221A1 US 20220175221 A1 US20220175221 A1 US 20220175221A1 US 202117392897 A US202117392897 A US 202117392897A US 2022175221 A1 US2022175221 A1 US 2022175221A1
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- balloon
- sleeve
- fore balloon
- endoscope
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/00071—Insertion part of the endoscope body
- A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
- A61B1/00082—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00131—Accessories for endoscopes
- A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/31—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1015—Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
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- Engineering & Computer Science (AREA)
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- Optics & Photonics (AREA)
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- Pulmonology (AREA)
- Anesthesiology (AREA)
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- Endoscopes (AREA)
Abstract
Apparatus comprising: a sleeve adapted to be slid over the exterior of an endoscope; an aft balloon secured to the sleeve; an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the aft balloon; a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein; and a fore balloon secured to the distal ends of the pair of hollow push tubes, the interior of the fore balloon being in fluid communication with the interiors of the pair of hollow push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the fore balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the fore balloon is in its inflated condition, the axial opening is closed down.
Description
- This patent application:
- (1) is a continuation-in-part of pending prior U.S. patent application Ser. No. 14/619,845, filed Feb. 11, 2015 by Cornell University and John Frederick Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-34), which patent application:
-
- (A) is a continuation-in-part of pending prior U.S. patent application Ser. No. 14/540,355, filed Nov. 13, 2014 by Cornell University and Jeffrey Milsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-17 CON), which patent application:
- (i) is a continuation of prior U.S. patent application Ser. No. 12/969,059, filed Dec. 15, 2010 by Jeffrey Milsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-17), which patent application:
- (a) claims benefit of prior U.S. Provisional Patent Application Ser. No. 61/284,215, filed Dec. 15, 2009 by Jeffrey Milsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE BODY LUMEN OR BODY CAVITY, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-17 PROV); and
- (i) is a continuation of prior U.S. patent application Ser. No. 12/969,059, filed Dec. 15, 2010 by Jeffrey Milsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-17), which patent application:
- (B) claims benefit of prior U.S. Provisional Patent Application Ser. No. 61/938,446, filed Feb. 11, 2014 by Cornell University and John Frederick Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-34 PROV);
- (A) is a continuation-in-part of pending prior U.S. patent application Ser. No. 14/540,355, filed Nov. 13, 2014 by Cornell University and Jeffrey Milsom et al. for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. CORN-17 CON), which patent application:
- (2) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/170,476, filed Jun. 3, 2015 by Lumendi Ltd. and John Frederick Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. LUMENDI-1 PROV);
- (3) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/170,497, filed Jun. 3, 2015 by Lumendi Ltd. and Stephen Evans et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. LUMENDI-2 PROV);
- (4) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/244,008, filed Oct. 20, 2015 by Lumendi Ltd. and Alan Fortunate et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. LUMENDI-3 PROV);
- (5) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/244,214, filed Oct. 21, 2015 by Lumendi Ltd. and Audrey Bell et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME (Attorney's Docket No. LUMENDI-4 PROV);
- (6) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/305,773, filed Mar. 9, 2016 by Lumendi Ltd. and Alan Fortunate for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, INCLUDING VENTING OF BALLOONS THROUGH PACKAGING DESIGN (Attorney's Docket No. LUMENDI-7 PROV);
- (7) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/305,797, filed Mar. 9, 2016 by Lumendi Ltd. and Brian David Chouinard for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, INCLUDING IMPROVED AFT BALLOON THERMAL BONDING USING INSERT MATERIAL (Attorney's Docket No. LUMENDI-9 PROV); and
- (8) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/305,804, filed Mar. 9, 2016 by Lumendi Ltd. and Brian David Chouinard et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, INCLUDING IMPROVED FORE BALLOON CONSTRUCTION (Attorney's Docket No. LUMENDI-10 PROV);
- The twelve (12) above-identified patent applications are hereby incorporated herein by reference.
- This invention relates to surgical methods and apparatus in general, and more particularly to surgical methods and apparatus for manipulating the side wall of a body lumen and/or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same.
- The human body comprises many different body lumens and body cavities. By way of example but not limitation, the human body comprises body lumens such as the gastrointestinal (GI) tract, blood vessels, lymphatic vessels, the urinary tract, fallopian tubes, bronchi, bile ducts, etc. By way of further example but not limitation, the human body comprises body cavities such as the head, chest, abdomen, nasal sinuses, bladder, cavities within organs, etc.
- In many cases it may be desirable to endoscopically examine and/or treat a disease process or abnormality which is located within, or on the side wall of, a body lumen and/or body cavity. By way of example but not limitation, it may be desirable to examine the side wall of the gastrointestinal tract for lesions and, if a lesion is found, to biopsy, remove and/or otherwise treat the lesion.
- The endoscopic examination and/or treatment of the side wall of a body lumen and/or body cavity can be complicated by the anatomic configuration (both regional and local) of the side wall of the body lumen and/or body cavity, and/or by the consistency of the tissue making up the side wall of the body lumen and/or body cavity, and/or by the tethering of the side wall of the body lumen and/or body cavity to other anatomical structures.
- By way of example but not limitation, the intestine is an elongated tubular organ having an inner lumen and is characterized by frequent turns (i.e., the regional anatomic configuration of the intestine), and comprises a side wall characterized by numerous folds (i.e., the local anatomic configuration of the intestine), with the side wall tissue having a relatively soft, pliable consistency, and with the colon in particular being tethered to the abdomen and/or other abdominal structures via soft tissue. It can be difficult to fully visualize the side wall of the intestine, and/or to treat a lesion formed on the side wall of the intestine, due to this varying side wall anatomic configuration (both regional and local), its relatively soft, pliable consistency, and its tethering to other anatomical structures via soft tissue. By way of example but not limitation, in the case of colonoscopies, it has been found that approximately 5-40% of patients have an anatomic configuration (regional and/or local) of the side wall, and/or a tissue consistency, and/or colon tethering to other anatomical structures, which makes it difficult to fully visualize the anatomy (including pathologic conditions of that anatomy, such as polyps or tumors) using conventional endoscopes, and/or to fully access the anatomy using instruments introduced through conventional endoscopes.
- In addition to the foregoing, it has also been found that some body lumens and/or body cavities can spasm and/or contract. This spasming and/or contraction can occur spontaneously, but it is particularly common when an endoscope or other instrument is inserted into the body lumen and/or body cavity. This spasming and/or contraction can cause the body lumen and/or body cavity to constrict and/or otherwise move and/or change its configuration, which can further complicate and/or compromise endoscopic visualization of the anatomy, and/or further complicate and/or compromise access to the anatomy using instruments introduced through conventional, flexible endoscopes. In addition, during examination of the colon, which is typically conducted while both advancing and withdrawing the endoscope through the colon, the endoscope may grip and/or otherwise gather the colon during advancement and/or withdrawal and then suddenly slip and release the colon. This gripping and then sudden release of the colon can result in the endoscope moving quickly past significant lengths of the colon, thereby making accurate examination of the colon challenging.
- It would, therefore, be highly advantageous to provide novel apparatus capable of manipulating the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.
- It would also be highly advantageous to provide novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted into a body lumen and/or body cavity with respect to the side wall of the body lumen and/or body cavity, whereby to facilitate the precision use of those instruments.
- Among other things, it would be highly advantageous to provide novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of endoscopes (and hence also steadying and/or stabilizing the distal tips and/or working ends of other instruments inserted through the working channels of those endoscopes, such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.).
- And it would be highly advantageous to provide novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to the surgical site by means other than through the working channels of endoscopes.
- It would also be highly advantageous to be able to straighten bends, “iron out” inner luminal surface folds and create a substantially static or stable side wall of the body lumen and/or body cavity, whereby to enable more precise visual examination (including visualization of areas which may be initially hidden from view or outside the field of view) and/or therapeutic intervention.
- The present invention comprises the provision and use of novel apparatus for manipulating the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.
- The present invention also comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted into a body lumen and/or body cavity with respect to the side wall of the body lumen and/or body cavity, whereby to facilitate the precision use of those instruments.
- Among other things, the present invention comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of endoscopes (and hence also steadying and/or stabilizing the distal tips and/or working ends of other instruments inserted through the working channels of those endoscopes, such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.).
- And the present invention comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to the surgical site by means other than through the working channels of endoscopes.
- And the present invention comprises the provision and use of novel apparatus capable of straightening bends, “ironing out” folds and creating a substantially static or stable side wall of the body lumen and/or body cavity which enables more precise visual examination (including visualization of areas which may be initially hidden from view or outside the field of view) and/or therapeutic intervention.
- In one preferred form of the present invention, there is provided apparatus comprising:
-
- a sleeve adapted to be slid over the exterior of an endoscope;
- an aft balloon secured to the sleeve;
- an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the aft balloon;
- a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endo scope therein; and a fore balloon secured to the distal ends of the pair of hollow push tubes, the interior of the fore balloon being in fluid communication with the interiors of the pair of hollow push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the fore balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the fore balloon is in its inflated condition, the axial opening is closed down.
- In another preferred form of the present invention, there is provided a method for performing a procedure in a body lumen and/or body cavity, the method comprising:
- providing apparatus comprising:
-
- a sleeve adapted to be slid over the exterior of an endoscope;
- an aft balloon secured to the sleeve;
- an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the aft balloon;
- a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endo scope therein; and
- a fore balloon secured to the distal ends of the pair of hollow push tubes, the interior of the fore balloon being in fluid communication with the interiors of the pair of hollow push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the fore balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the fore balloon is in its inflated condition, the axial opening is closed down;
- positioning an endoscope in the sleeve so that the endoscope nests in the push tube bridge;
- positioning the apparatus in the body lumen and/or body cavity;
- inflating the aft balloon;
- advancing the pair of push tubes distally;
- inflating the fore balloon; and
- performing the procedure.
- These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:
-
FIG. 1 is a schematic view showing novel apparatus formed in accordance with the present invention, wherein the novel apparatus comprises, among other things, a sleeve for disposition over the end of an endoscope, an aft balloon mounted to the sleeve, a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein, a fore balloon mounted to the distal end of the hollow push tubes, and a push tube handle mounted to the proximal ends of the hollow push tubes; -
FIGS. 2-4 are schematic views showing various dispositions of the fore balloon relative to the aft balloon; -
FIG. 5 is a schematic view showing further details of the distal end of the apparatus shown inFIG. 1 ; -
FIG. 6 is a section view taken along line 6-6 ofFIG. 5 ; -
FIGS. 7 and 8 are schematic views showing a pair of hollow push tubes, a raised push tube bridge, and the fore balloon; -
FIGS. 9-11 are schematic views showing a pair of hollow push tubes and a raised push tube bridge formed in accordance with the present invention; -
FIG. 12 is a schematic view showing another pair of hollow push tubes and a raised push tube bridge formed in accordance with the present invention; -
FIG. 13 is a schematic view showing another pair of hollow push tubes and a raised push tube bridge formed in accordance with the present invention; -
FIG. 14 is a schematic view showing another pair of hollow push tubes and a raised push tube bridge formed in accordance with the present invention; -
FIGS. 15 and 16 are schematic views showing further details of the fore balloon; -
FIG. 17 is a schematic view showing the push tube handle; -
FIGS. 18 and 19 are schematic views showing construction details of the fore balloon; -
FIGS. 20-34 are schematic views showing another form of the handle mechanism for the novel apparatus of the present invention; -
FIG. 35 is a schematic view showing one form of inflation mechanism provided in accordance with the present invention; -
FIG. 36 is a schematic view showing another form of inflation mechanism provided in accordance with the present invention; -
FIGS. 37 and 38 are schematic views showing another form of inflation mechanism provided in accordance with the present invention; -
FIGS. 39-58 are schematic views showing another form of inflation mechanism provided in accordance with the present invention; -
FIG. 59 is a schematic view showing relief valves which may be used to ensure that the pressure within the fore balloon and/or aft balloon does not exceed a predetermined level; -
FIG. 60 is a schematic view showing a retraction system which may be used to take up slack in a flexible tube of the apparatus shown inFIG. 1 ; -
FIGS. 61-82 are schematic views showing novel apparatus for inflating and deflating balloons; -
FIG. 83 is a schematic view showing the novel apparatus of the present invention sealed within a novel package formed in accordance with the present invention; -
FIG. 84 is a schematic view showing details of a novel inflation mechanism formed in accordance with the present invention; -
FIG. 85-88 are schematic views showing further details of the novel package ofFIG. 83 and further details of the novel inflation mechanism ofFIG. 84 ; -
FIGS. 89-107 are schematic views showing preferred ways of using the apparatus ofFIG. 1 ; -
FIG. 108 is a cross-sectional schematic view showing how gaps are created between (i) the sleeve, (ii) the push rod lumens, and (iii) the aft balloon inflation lumen of the apparatus ofFIGS. 1-106 ; -
FIG. 109 is a cross-sectional schematic view similar toFIG. 108 , showing a plurality of novel extruded inserts filling the aforementioned gaps between the sleeve, the push rod lumens and the aft balloon inflation lumen, whereby to facilitate airtight bonding of the aft balloon to the assembly; -
FIGS. 110, 111 and 112 are schematic views showing novel extruded inserts formed in accordance with the present invention; -
FIGS. 113 and 114 are schematic views showing the novel extruded inserts ofFIGS. 110, 111 and 112 disposed along the sheath of the apparatus ofFIGS. 1-106 so as to fill the gaps between the sleeve, the push rod lumens and aft balloon inflation lumen; -
FIGS. 115-122 are schematic views showing an alternative construction for the fore balloon; -
FIG. 123 is a schematic view showing another alternative construction for the fore balloon; -
FIGS. 124 and 125 are schematic views showing an alternative construction for the aft balloon; -
FIG. 126 is a schematic view showing an alternative construction for the hollow push tubes and push tube handle of the present invention; -
FIG. 127 is a schematic view showing another form of the sleeve, wherein the sleeve comprises additional lumens for receiving instruments; -
FIGS. 128-131 are schematic views showing how instruments may be advanced through the additional lumens of the sleeve; and -
FIG. 132 is a schematic view showing instrument guide tubes which may be disposed in the additional lumens of the sleeve, wherein instruments may be advanced through the instrument guide tubes. - The present invention comprises the provision and use of novel apparatus for manipulating the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas initially hidden or outside the field of view) for examination and/or treatment during an endoscopic procedure.
- (As used herein, the term “endoscopic procedure” is intended to mean substantially any minimally-invasive or limited access procedure, diagnostic and/or therapeutic and/or surgical, for accessing, endoluminally or transluminally or otherwise, the interior of a body lumen and/or body cavity for the purposes of viewing, biopsying and/or treating tissue, including removing a lesion and/or resecting tissue, etc.)
- The present invention also comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted into a body lumen and/or body cavity with respect to the side wall of the body lumen and/or body cavity, whereby to facilitate the precision use of those instruments.
- Among other things, the present invention comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of endoscopes (and hence also steadying and/or stabilizing the distal tips and/or working ends of other instruments inserted through the working channels of those endoscopes, such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.).
- And the present invention comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to the surgical site by means other than through the working channels of endoscopes.
- And the present invention comprises the provision and use of novel apparatus capable of straightening bends, “ironing out” folds and creating a substantially static or stable side wall of the body lumen and/or body cavity which enables more precise visual examination (including visualization of areas which may be initially hidden from view or outside the field of view) and/or therapeutic intervention.
- In accordance with the present invention, and looking now at
FIG. 1 , there is shownnovel apparatus 5 which is capable of manipulating (e.g., stabilizing, straightening, expanding and/or flattening, etc.) the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure using an endoscope 10 (e.g., an articulating endoscope), and/or for stabilizing the distal end ofendoscope 10 and/or the distal tips and/or working ends of other instruments (e.g., graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc., not shown inFIG. 1 ). - More particularly,
apparatus 5 generally comprises asleeve 15 adapted to be slid over the exterior of the shaft ofendoscope 10, a proximal (or “aft”) balloon 20 (the terms “proximal” and “aft” will hereinafter be used interchangeably) secured tosleeve 15 near the distal end of the sleeve, and a base 25 secured tosleeve 15 at the proximal end of the sleeve.Apparatus 5 also comprises a pair ofhollow push tubes 30 slidably mounted tosleeve 15 as will hereinafter be discussed, the pair of hollow push tubes being connected to one another at their distal ends with a raisedpush tube bridge 31, the raisedpush tube bridge 31 being configured to nest an endoscope therein, and a distal (or “fore”) balloon 35 (the terms “distal” and “fore” will hereinafter be used interchangeably) secured to the distal ends ofhollow push tubes 30, such that the spacing betweenaft balloon 20 andfore balloon 35 can be adjusted by the physician (or other operator or user) by movinghollow push tubes 30 relative to sleeve 15 (e.g., by advancing the two hollow push tubes simultaneously atpush tube handle 37, see below). SeeFIGS. 1 and 2-4 .Apparatus 5 also comprises an associated inflation mechanism 40 (FIG. 1 ) for enabling selective inflation/deflation of one or both ofaft balloon 20 andfore balloon 35 by the physician (or other operator or user). - The Sleeve Looking now at
FIGS. 1-6 ,sleeve 15 generally comprises an elongated, thin-walled tube configured to be slid over the exterior of the shaft of endo scope 10 (e.g., retrograde from the distal tip of the endoscope) so as to make a close fit therewith, with the sleeve being sized and constructed so that it will slide easily back over the endoscope during mounting thereon (preferably with the scope “dry”) but will have sufficient residual friction (when gripped by the hand of the physician or other operator or user) with the outer surface of the endoscope such that the sleeve will remain in place to allow torqueing (i.e., rotational turning) and pushing/pulling of the endoscope during use (e.g., within the colon of a patient). In one preferred form of the invention,sleeve 15 can move circumferentially to some extent about endoscope 10 (and when gripped securely by the hand of the physician or other operator or user, can rotate in conjunction with the shaft of the endoscope); butsleeve 15 can only move nominally in an axial direction relative toendoscope 10.Sleeve 15 is sized so that when its distal end is substantially aligned with the distal end ofendoscope 10, sleeve 15 (in conjunction with base 25) will substantially cover the shaft of the endoscope. In any case,sleeve 15 is sized so that when it is mounted toendoscope 10 andendoscope 10 is inserted into a patient,sleeve 15 extends out of the body of the patient. In one preferred form of the invention,apparatus 5 is provided according to the particular endoscope with which it is intended to be used, withapparatus 5 being sized so that whenbase 25 is in engagement with the handle of the endoscope, the distal end ofsleeve 15 will be appropriately positioned at the distal end of the endoscope, i.e., substantially aligned with the distal end of the endoscope or slightly proximal to the distal end of the endoscope. - If desired, the distal end of
sleeve 15 may be provided with a radially-inwardly-extending stop (not shown) to positively engage the distal end surface ofendoscope 10, whereby to prevent the distal end ofsleeve 15 from moving proximally beyond the distal end surface ofendoscope 10. Such a radially-inwardly-extending stop can also assist in preventing “torque slip” ofsleeve 15 relative toendoscope 10 during torqueing (i.e., rotational turning) of the endoscope while within the colon, and/or “thrust slip” ofsleeve 15 relative toendoscope 10 during forward pushing of the endoscope while within the colon. -
Sleeve 15 preferably has a smooth outer surface so as to be non-traumatic to tissue, and is preferably made of a highly flexible material such that the sleeve will not inhibit bending of the endoscope during use. In one preferred form of the invention,sleeve 15 comprises polyurethane, polyethylene, poly(vinyl chloride) (PVC), polytetrafluoroethylene (PTFE), etc., and is preferably transparent (or at least translucent) so as to allow distance markings onendoscope 10 to be visualized throughsleeve 15. And in one preferred form of the invention,sleeve 15 preferably has nominal hoop strength, so that the physician (or other operator or user) can gripendoscope 10 throughsleeve 15, e.g., so as to torque the scope. If desired,sleeve 15 can include a lubricious coating (e.g., a liquid such as perfluoropolyether synthetic oil, a powder, etc.) on some or all of its interior and/or exterior surfaces, so as to facilitate disposition of the sleeve over the endoscope and/or movement ofapparatus 5 through a body lumen and/or body cavity. Alternatively,sleeve 15 may be formed of a material which is itself lubricious, e.g., polytetrafluoroethylene (PTFE), etc. It should be appreciated that the inside surface ofsleeve 15 may include features (e.g., ribs) to prevent the sleeve from rotating relative to the endoscope during use. - If desired, a vacuum may be “pulled” between
sleeve 15 andendoscope 10, whereby to securesleeve 15 toendoscope 10 and minimize the profile ofsleeve 15. By way of example but not limitation, a vacuum may be introduced at the proximal end of sleeve 15 (i.e., at base 25) or a vacuum may be introduced at a pointintermediate sleeve 15. By way of further example but not limitation, it should also be appreciated that removal ofsleeve 15 from endoscope 10 (e.g., at the conclusion of a procedure) may be facilitated by introducing a fluid (e.g., air or a liquid lubricant) into the space betweensleeve 15 andendoscope 10, e.g., at the proximal end of sleeve 15 (i.e., at base 25) orintermediate sleeve 15. - Still looking now at
FIGS. 1-6 ,aft balloon 20 is secured tosleeve 15 just proximal to the articulating joint of the endoscope near to, but spaced from, the distal end of the sleeve.Aft balloon 20 is disposed concentrically aboutsleeve 15, and hence concentrically about anendoscope 10 disposed withinsleeve 15. Thus,aft balloon 20 has a generally toroidal shape.Aft balloon 20 may be selectively inflated/deflated by means of a proximal inflation/deflation tube 45 which has its distal end in fluid communication with the interior ofaft balloon 20, and which has its proximal end in fluid communication with a fitting 46 mounted tobase 25. Fitting 46 is configured for connection to the aforementioned associatedinflation mechanism 40. Fitting 46 is preferably a luer-activated valve, allowinginflation mechanism 40 to be disconnected from fitting 46 without losing pressure inaft balloon 20. Inflation/deflation tube 45 may be secured to the exterior surface ofsleeve 15 or, more preferably, inflation/deflation tube 45 may be contained within alumen 47 formed withinsleeve 15. - Preferably
aft balloon 20 is disposed a short distance back from the distal end ofsleeve 15, i.e., by a distance which is approximately the same as the length of the articulating portion of asteerable endoscope 10, such that the articulating portion of the steerable endoscope will be disposed distal toaft balloon 20 when the steerable endoscope is disposed insleeve 15. This construction allows the flexible portion of the steerable endoscope to be articulated even whenaft balloon 20 has been inflated in the anatomy so as to stabilize the adjacent non-articulating portion of the endoscope relative to the anatomy, as will hereinafter be discussed in further detail. Thus, when inflated,aft balloon 20 provides a secure platform within the anatomy for maintainingendoscope 10 in a stable position within a body lumen or body cavity, withendoscope 10 centered within the body lumen or body cavity. As a result,endoscope 10 can provide improved visualization of the anatomy. Furthermore, inasmuch asendoscope 10 is securely maintained within the body lumen or body cavity by the inflated aftballoon 20, instruments advanced through the internal lumens (sometimes referred to as the “working channel” or “working channels”) ofendoscope 10 will also be provided with a secure platform for supporting those instruments within the body lumen or body cavity. - When aft
balloon 20 is appropriately inflated, the aft balloon can atraumatically engage and form a sealing relationship with the side wall of a body lumen within whichapparatus 5 is disposed. - In one preferred form of the invention,
aft balloon 20 is formed out of polyurethane. -
Base 25 is secured to the proximal end ofsleeve 15.Base 25 engagesendoscope 10 and helps secure the entire assembly (i.e., apparatus 5) toendoscope 10.Base 25 preferably comprises a substantially rigid or semi-rigid structure which may be gripped by the physician (or other operator or user) and pulled proximally, whereby to allow the physician (or other operator or user) to pullsleeve 15 over the distal end ofendoscope 10 and then proximally back along the length ofendoscope 10, whereby to mountsleeve 15 to the outer surface of the shaft of the endoscope. In one preferred form of the invention,base 25 is pulled proximally along the endoscope untilbase 25 seats against the handle of the endoscope, thereby prohibiting further proximal movement of base 25 (and hence thereby prohibiting further proximal movement of sleeve 15). In one preferred form of the invention,base 25 makes a sealing engagement withendoscope 10. - The pair of
hollow push tubes 30 are slidably mounted tosleeve 15, whereby the distal ends of the hollow push tubes (and the raisedpush tube bridge 31 connecting the distal ends of the pair of hollow push tubes 30) can be extended and/or retracted relative to sleeve 15 (e.g., by advancing or withdrawing the hollow push tubes viapush tube handle 37, see below), and hence extended and/or retracted relative to the distal end ofendoscope 10 which is disposed insleeve 15. Preferably,hollow push tubes 30 are slidably disposed insupport tubes 50 which are secured to the outer surface ofsleeve 15 or, more preferably, are contained withinlumens 52 formed withinsleeve 15.Support tubes 50 are preferably formed out of a low friction material (e.g., polytetrafluoroethylene, also known as “PTFE”) so as to minimize resistance to movement ofhollow push tubes 30 relative to support tubes 50 (and hence minimize resistance to movement ofhollow push tubes 30 relative to sleeve 15). In this respect it should be appreciated that minimizing resistance to the movement ofhollow push tubes 30 relative to supporttubes 50 improves tactile feedback to the user whenhollow push tubes 30 are being used to manipulatefore balloon 35. In one form of the invention,support tubes 50 are flexible (so as to permitendoscope 10, and particularly the articulating portion ofsteerable endoscope 10, to flex as needed during the procedure); however,support tubes 50 also provide some column strength. Thus, whensupport tubes 50 are mounted withinlumens 52 formed insleeve 15, the assembly ofsleeve 15 andhollow support tubes 50 is flexible yet has a degree of column strength (whereassleeve 15 alone is flexible but has substantially no column strength). In the event that hollowpush tubes 30 are contained withinlumens 52 formed insleeve 15, and in the event that supporttubes 50 are not disposed betweenhollow push tubes 30 andlumens 52,lumens 52 are preferably lubricated so as to minimize friction betweenhollow push tubes 30 andlumens 52. - The distal ends of the pair of
hollow push tubes 30 are connected together with a raised push tube bridge 31 (FIG. 7 ). Raisedpush tube bridge 31 provides a rounded structure at the distal ends ofhollow push tubes 30 which simultaneously serves to (i) connect the distal ends ofhollow push tubes 30 together, and (ii) eliminate abrupt ends at the distal end ofhollow push tubes 30 which could cause trauma to tissue, e.g., during distal advancement ofhollow push tubes 30. Raisedpush tube bridge 31 is configured to nest an endoscope therein (FIG. 8 ). - In one preferred form of the invention, raised
push tube bridge 31 is also hollow. In this form of the invention, the hollow raisedpush tube bridge 31 may be formed integral withhollow push tubes 30, i.e., thehollow push tubes 30 and the hollow raisedpush tube bridge 31 may form one continuous tube (FIGS. 9-11 ). Or, in this form of the invention, the hollow raisedpush tube bridge 31 may be formed separately fromhollow push tubes 30 and the hollow raisedpush tube bridge 31 may be joined tohollow push tubes 30 during manufacturing (FIG. 12 ). - In one preferred form of the invention, raised
push tube bridge 31 may be substantially solid and is connected withhollow push tubes 30 during manufacture. - If desired, raised
push tube bridge 31 may be inclined distally, e.g., in the manner shown inFIGS. 7-12 . - Alternatively, if desired, raised
push tube bridge 31 may be set substantially perpendicular to the longitudinal axes ofhollow push tubes 30, e.g., in the manner shown inFIG. 13 . - Furthermore, if desired, raised
push tube bridge 31 may be in the form of a ring, withendoscope 10 nesting within the interior of the ring, e.g., in the manner shown inFIG. 14 . - The proximal ends of
hollow push tubes 30 are connected to pushtube handle 37. As a result of this construction, pushing distally on push tube handle 37 causes the distal ends ofhollow push tubes 30 to move distally (at the same rate) relative to sleeve 15 (whereby to movefore balloon 35 distally relative to aft balloon 20) and pulling proximally on push tube handle 37 causes the distal ends ofhollow push tubes 30 to retract proximally (at the same rate) relative to sleeve 15 (whereby to movefore balloon 35 proximally relative to aft balloon 20). Note that by movinghollow push tubes 30 distally or proximally at the same rate, the distal ends of the hollow push tubes are maintained parallel to each other. A clamp 53 (FIGS. 37 and 60 ) is provided atbase 25 for holdinghollow push tubes 30 in a selected disposition relative to base 25 (and hence in a selected disposition relative to sleeve 15). -
Hollow push tubes 30 and raisedpush tube bridge 31 are preferably formed out of a relatively flexible material which provides good column strength, e.g., a thermoplastic polyethylene resin such as Isoplast™ (available from The Lubrizol Corporation of Wickliffe, Ohio), polyethylene, polypropylene, nylon, etc. It should be appreciated thathollow push tubes 30 and raisedpush tube bridge 31 can comprise a single material or a plurality of materials, and that the stiffness ofhollow push tubes 30 and raisedpush tube bridge 31 can vary along their length. By way of example but not limitation, the distal-most portion ofhollow push tubes 30 and raisedpush tube bridge 31 can be formed of the same material as the remainder of the hollow push tubes but have a lower modulus so as to be more flexible than the remainder of the hollow push tubes, or the distal-most portion ofhollow push tubes 30 and raisedpush tube bridge 31 can comprise a different, more resilient flexible material. By way of example but not limitation, the distal-most portion ofhollow push tubes 30 and raisedpush tube bridge 31 can comprise Nitinol. By way of further example but not limitation, the distal-most portion ofhollow push tubes 30 and raisedpush tube bridge 31 can comprise a stainless steel coil covered with an outer jacket of polytetrafluoroethylene (PTFE), with the distal-most jacket/more-proximal tubing together providing a sealed lumen for inflating/deflatingfore balloon 35. By forminghollow push tubes 30 and raisedpush tube bridge 31 with distal ends which are more flexible than the remainder of the hollow push tubes, thehollow push tubes 30, raisedpush tube bridge 31 andfore balloon 35 can together function as a lead (with a soft atraumatic tip) forapparatus 5 andendoscope 10, as discussed further below. - In one preferred form of the invention,
hollow push tubes 30 are configured to maintain a parallel disposition when they are in an unbiased state, i.e., when no force is being applied tohollow push tubes 30. This is true regardless of the state of inflation or deflation offore balloon 35. The provision of raisedpush tube bridge 31 can help maintain the parallel disposition ofhollow push tubes 30. - The distal-most portion of
hollow push tubes 30 can be configured to bend inwardly or outwardly if desired e.g., via their connection to raisedpush tube bridge 31. With such a configuration, when the distal ends ofhollow push tubes 30 are held longitudinally stationary (e.g., by an inflated fore balloon, as will hereinafter be discussed) and a sufficient distally-directed force is applied tohollow push tubes 30, the middle portions of hollow push tubes 30 (i.e., the portions between theinflated fore balloon 35 and sleeve 15) can bend or bow outwardly, whereby to push outwardly on the side wall of the body lumen whichapparatus 5 is disposed in, thereby providing a “tenting” effect on the side wall of the body lumen and/or body cavity in the space betweenaft balloon 20 andfore balloon 35. This “tenting” effect can significantly enhance visibility and/or tissue stability in the area distal toendoscope 10, by pushing outwardly on the side wall of the body lumen and/or body cavity in whichapparatus 5 is disposed. - It should also be appreciated that by forming
hollow push tubes 30 out of a flexible material, it is possible to manually adjust their position during use (e.g., by using a separate tool, by torqueing the apparatus, etc.) so as to prevent thehollow push tubes 30 from interfering with visualization of the patient's anatomy and/or interfering with diagnostic or therapeutic tools introduced into the space between the fore and aft balloons 35, 20. By way of example but not limitation, ifapparatus 5 is disposed in the anatomy in such a way that ahollow push tube 30 blocks visual or physical access to a target region of the anatomy, the flexible hollow push tube(s) may be moved out of the way by using a separate tool or instrument, or by rotating the apparatus with a torqueing motion so as to move the flexible hollow push tube(s) out of the way, etc. By way of further example but not limitation, by constructinghollow push tubes 30 so that they are circular and flexible and of a diameter significantly smaller than the round circumference ofendoscope 10, the movement of the round endoscope, when articulated, can simply push the hollow push tubes out of the way and provides a unobstructed visual path to the tissue of interest. - It should also be appreciated that, if desired,
hollow push tubes 30 can be marked with an indicator including distance markers (not shown in the figures), e.g., colored indicators or radiopaque indicators, so that a physician (or other operator or user) observing the surgical site viaendoscope 10 or by radiological guidance (e.g., X-ray fluoroscopy) can ascertain the relative disposition ofhollow push tubes 30 at the surgical site both longitudinally and/or circumferentially with respect to the side wall of the body lumen and/or other body cavity. -
Hollow push tubes 30 have their internal lumens (i) in fluid communication with the interior of fore balloon 35 (FIGS. 1-5, 15 and 16 ), e.g., via a plurality ofopenings 32, and (ii) in fluid communication with a fitting 56 mounted tobase 25. Fitting 56 is configured for connection to the aforementioned associatedinflation mechanism 40, in order thatfore balloon 35 may be selectively inflated/deflated with air or other fluids (including liquids). Fitting 56 is preferably a luer-activated valve, allowinginflation mechanism 40 to be disconnected from fitting 56 without losing pressure infore balloon 35. - More particularly, in one preferred form of the present invention, and looking now at
FIG. 17 , push tube handle 37 comprises ahollow interior 57.Hollow push tubes 30 are mounted to push tube handle 37 so thathollow push tubes 30 will move in conjunction withpush tube handle 37, and so that the hollow interiors ofhollow push tubes 30 are in fluid communication with thehollow interior 57 ofpush tube handle 37. Push tube handle 37 also comprises a fitting 58 which is in fluid communication withhollow interior 57 ofpush tube handle 37. Aflexible tube 59 connects fitting 58 with an internal chamber (not shown) inbase 25, with this internal chamber inbase 25 being in fluid communication with theaforementioned fitting 56. As a result of this construction, when push tube handle 37 is moved distally,hollow push tubes 30 are moved distally, and hencefore balloon 35 is moved distally; and when push tube handle 37 is moved proximally,hollow push tubes 30 are moved proximally, and hencefore balloon 35 is moved proximally. Furthermore, when positive fluid pressure is applied to fitting 56 inbase 25, positive fluid pressure is applied to the internal lumens ofhollow push tubes 30, and hence to the interior of fore balloon 35 (i.e., via openings 32), whereby to inflatefore balloon 35; and when negative fluid pressure is applied to fitting 56 inbase 25, negative fluid pressure is applied to the internal lumen ofhollow push tubes 30, and hence to the interior of fore balloon 35 (i.e., via openings 32), whereby to deflatefore balloon 35. - It should be appreciated that the provision of a pair of
hollow push tubes 30, connected together at their distal ends by a raisedpush tube bridge 31, provides numerous advantages. By way of example but not limitation, the provision of a pair ofhollow push tubes 30, connected together at their distal ends by a raisedpush tube bridge 31, provides a symmetric force tofore balloon 35 when the fore balloon is advanced distally into a body lumen, as will hereinafter be discussed. Furthermore, the provision of a pair ofhollow push tubes 30, connected together at their distal ends by a raisedpush tube bridge 31, provides equal outward forces against the adjacent anatomy when the pair of hollow push tubes are employed to straighten out the anatomy in the area proximate the distal end ofendoscope 10, thereby enhancing visualization of, and/or access to, the anatomy, as will hereinafter be discussed. In addition, the provision of a pair ofhollow push tubes 30, connected together at their distal ends by a raisedpush tube bridge 31, ensures thatfore balloon 35 remains centered onendoscope 10, thereby facilitating un-docking offore balloon 35 fromendoscope 10 and re-docking offore balloon 35 overendoscope 10, as will hereinafter be discussed. In addition, the provision of a pair ofhollow push tubes 30, connected together at their distal ends by a raisedpush tube bridge 31, helps ensure thatfore balloon 35 is stable relative to the tip of the endoscope, minimizing rotational movement of the fore balloon when inflated. Furthermore, the provision of a pair of hollow push tubes, connected together at their distal ends by a raisedpush tube bridge 31, provides a redundant air transfer system for inflating or deflatingfore balloon 35. And the provision of a pair ofhollow push tubes 30, connected together a their distal ends by a raisedpush tube bridge 31, presents a rounded, blunt distal end forhollow push tubes 30, thereby ensuring atraumatic advancement offore balloon 35 within the anatomy. -
Fore balloon 35 is secured to the distal ends ofhollow push tubes 30, with raisedpush tube bridge 31 being disposed within the interior offore balloon 35, whereby the spacing betweenaft balloon 20 andfore balloon 35 can be adjusted by movinghollow push tubes 30 relative tosleeve 15, i.e., by moving push tube handle 37 relative tosleeve 15. Furthermore,hollow push tubes 30 provide a conduit between the interior offore balloon 35 and fitting 56, whereby to permit selective inflation/deflation offore balloon 35 via fitting 56. - Significantly,
fore balloon 35 is configured so that (i) when it is deflated (or partially deflated) and it is in its “retracted” position relative to sleeve 15 (FIG. 2 ),fore balloon 35 provides an axial opening 63 (FIGS. 15, 16 and 19 ) sufficient to accommodatesleeve 15 and the shaft ofendoscope 10 therein, with raisedpush tube bridge 31 extending concentrically aboutaxial opening 63, wherebyfore balloon 35 can be “docked” oversleeve 15 andendoscope 10, and (ii) whenfore balloon 35 is in its “extended” position relative tosleeve 15 and is appropriately inflated (FIG. 4 ),axial opening 63 is closed down (and preferably completely closed off). At the same time, when appropriately inflated, the fore balloon can atraumatically engage and form a sealing relationship with the side wall of a body lumen and/or body cavity within whichapparatus 5 is disposed. Thus, whenfore balloon 35 is appropriately inflated, the fore balloon can effectively seal the body lumen and/or body cavity distal tofore balloon 35, by closing downaxial opening 63 and forming a sealing relationship with the side wall of the body lumen and/or body cavity within whichapparatus 5 is disposed. In this way, whenhollow push tubes 30 are advanced distally so as to separatefore balloon 35 fromaft balloon 20, and whenfore balloon 35 andaft balloon 20 are appropriately inflated, the two balloons will create a sealed zone therebetween (sometimes hereinafter referred to as “the therapeutic zone”). - It will be appreciated that, when
fore balloon 35 is reconfigured from its deflated condition to its inflated condition,fore balloon 35 expands radially inwardly (so as to close down axial opening 63) as well as radially outwardly (so as to engage the surrounding tissue). Note thathollow push tubes 30 and raisedpush tube bridge 31 are disposed withinfore balloon 35 in such a way that their presence within the fore balloon does not physically interfere with inflation or deflation offore balloon 35. - Thus it will be seen that
fore balloon 35 has a “torus” shape when deflated (to allow it to seat over the distal end of the endoscope) and a substantially “solid” shape when inflated (to allow it to close off a body lumen or body cavity). - To this end, and looking now at
FIGS. 18 and 19 ,fore balloon 35 is preferably manufactured as a single construct comprising abody 67 having aproximal opening 69 and adistal opening 71, aproximal extension 73 having a “key-shaped”cross-section comprising lobes 74, and adistal extension 76 having a circular cross-section. Note thatlobes 74 are disposed onproximal extension 73 with a configuration which matches the configuration of hollow push tubes 30 (i.e., whereapparatus 5 comprises twohollow push tubes 30 diametrically opposed to one another,proximal extension 73 will comprise twolobes 74 diametrically opposed to one another—for the purposes of the present invention,proximal extension 73 and lobe(s) 74 may be collectively referred to as having a “key-shaped” cross-section). During assembly,proximal extension 73 is everted into the interior ofbody 67,hollow push tubes 30 are seated inlobes 74 ofproximal extension 73, (with the interiors ofhollow push tubes 30 being in fluid communication with the interior ofbody 67 and with raisedpush tube bridge 31 disposed within the interior of body 67), and thendistal extension 76 is everted into the interior ofproximal extension 73, whereby to provide afore balloon 35 havingaxial opening 63 extending therethrough, withhollow push tubes 30 being secured tofore balloon 35 and communicating with the interior offore balloon 35, and with raisedpush tube bridge 31 being disposed concentrically aboutaxial opening 63. Significantly,axial opening 63 is sized to receive the distal end ofendoscope 10 therein, and raisedpush tube bridge 31 is sized to nestendoscope 10 in the area beneath the raisedpush tube bridge 31. Also significantly, the formation offore balloon 35 by the aforementioned process of evertingproximal extension 73 into the interior ofbody 67, and then evertingdistal extension 76 into the interior ofproximal extension 73, provides multiple layers of balloon material aroundhollow push tubes 30, thereby providing a more robust balloon construction. Among other things, providing multiple layers of balloon material aroundhollow push tubes 30 adds cushioning to the distal ends ofhollow push tubes 30, thereby providing an even more atraumatic distal tip to hollowpush tubes 30 and further ensuring that the distal tips ofhollow push tubes 30 do not damage the adjacent tissue. - In one preferred form of the invention,
fore balloon 35 is formed out of polyurethane. - It should be appreciated that when
fore balloon 35 is in its deflated condition, the material offore balloon 35 substantially encompasses the distal ends ofhollow push tubes 30 and raised push tube bridge 31 (while still allowinghollow push tubes 30 to be in fluid communication with the interior offore balloon 35, i.e., via openings 32), thereby providing an atraumatic tip for advancingfore balloon 35 distally through a body lumen. Furthermore,hollow push tubes 30, raisedpush tube bridge 31 and the deflatedfore balloon 35 can, together, essentially function as a soft-tipped lead forapparatus 5 andendoscope 10, as discussed further below (FIG. 93 ). - If desired, one or both of
aft balloon 20 andfore balloon 35 can be marked with an indicator (e.g., a color indicator or a radiopaque indicator) so that a physician (or other operator or user) observing the surgical site viaendoscope 10 or radiological guidance (e.g., X-ray fluoroscopy) can ascertain the disposition of one or both of the balloons at the surgical site. - As noted above, and as shown in
FIG. 1 ,apparatus 5 comprises a base 25 which is secured tosleeve 15 at the proximal end of the sleeve and which carriesfittings aft balloon 20 and/orfore balloon 35, respectively.Apparatus 5 also comprises a push tube handle 37 which hashollow push tubes 30 mounted thereto, withhollow push tubes 30 physically supporting (and providing fluid communication to) the interior offore balloon 35. As also noted above, proximal inflation/deflation tube 45 provides fluid communication between fitting 46 ofbase 25 and the interior ofaft balloon 20; and aflexible tube 59 provides (with other elements) fluid communication between fitting 56 ofbase 25 and the interior of hollow push tubes 30 (and hence the interior of fore balloon 35). - With the construction shown in
FIG. 1 ,base 25 supports and guideshollow push tubes 30 as they are advanced distally or retracted proximally, butbase 25 does not directly support and guide push tube handle 37 as it is advanced distally or retracted proximally. - To that end, if desired, and looking now at
FIGS. 20-25 ,apparatus 5 may comprise a similar but somewhat different base (i.e., thebase 25A) and a similar but somewhat different push tube handle (i.e., thepush tube handle 37A).Base 25A comprises anextension 205 which has theaforementioned fittings Extension 205 comprises acenter slot 210 and a pair ofside slots 215. Push tube handle 37A comprises a C-shapedbody 220 havinghollow push tubes 30 mounted thereto, and having acenter locking element 225 and a pair of finger grips 230 mounted thereto. Lockingelement 225 preferably comprises ascrew shaft 235 and ascrew knob 240, such thatscrew knob 240 can be advanced towards or away frombody 220 by turning the screw knob. - Push tube handle 37A is mounted within
extension 205 ofbase 25A so thatscrew shaft 235 is slidably received incenter slot 210 and so that finger grips 230 are slidably received inside slots 215, whereby to provide support and guidance to push tube handle 37A. - As a result of this construction, push tube handle 37A can be moved distally or proximally by moving
screw shaft 235 and finger grips 230 distally or proximally, whereby to movefore balloon 35 distally or proximally; and push tube handle 37A can be locked in position relative tobody 25A by turningscrew knob 240 so that it securely engages the outer surface ofextension 205, whereby to lockfore balloon 35 in position relative tobody 25A. Note that torsion can be applied tofore balloon 35 by applying torsion to finger grips 230, e.g., by moving oneside wing 230 distally while pulling theother side wing 230 proximally. -
FIGS. 26-30 show different configurations forscrew knob 240. - If desired,
lubricious washers 245 may be added to the assembly to reduce friction (FIG. 31 ), or texture may be added to surfaces (e.g., the underside ofscrew knob 240 as shown inFIG. 32 ) so as to increase friction. Furthermore, finger grips 230 may be shaped differently than those illustrated inFIGS. 20-30 , or moved to a different portion of the assembly. See, for example,FIG. 33 , which shows finger grips 230 formed as part of asecond knob 250 which keys to the slider assembly. - It should also be appreciated that, if desired, push tube handle 37A may comprise a generally C-shaped body having a different configuration from the C-shaped
body 220 shown inFIGS. 23, 25, 31 and 33 . By way of example but not limitation, and looking now atFIG. 34 , C-shapedbody 220 may comprise a pair of downwardly extendinglegs 255 connected by alinkage 260. -
Inflation mechanism 40 provides a means to selectively inflateaft balloon 20 and/orfore balloon 35. - In one preferred form of the present invention, and looking now at
FIGS. 1 and 35 ,inflation mechanism 40 comprises a single-line syringe inserter 140 comprising abody 145 and aplunger 150. Preferably aspring 153 is provided inbody 145 to automatically return plunger 150 at the end of its stroke.Syringe inserter 140 is connected to one or the other offittings line 155. Thus, with this construction, when single-line syringe inserter 140 is to be used to inflateaft balloon 20,syringe inserter 140 is connected to fitting 46 vialine 155 so that the output of single-line syringe inserter 140 is directed to aft balloon 20 (i.e., via proximal inflation/deflation tube 45). Correspondingly, when single-line syringe inserter 140 is to be used to inflatefore balloon 35,syringe inserter 140 is connected to fitting 56 vialine 155 so that the output of single-line syringe inserter 140 is directed to fore balloon 35 (i.e., viaflexible tube 59 and the interiors ofhollow push tubes 30 and out of openings 32). - In another preferred form of the present invention, and looking now at
FIG. 36 ,inflation mechanism 40 comprises anelastic bulb 156 having afirst port 157 and asecond port 158. A one-way valve 159 (e.g., a check valve) is disposed infirst port 157 so that air can only pass throughfirst port 157 when traveling in an outward direction. Another one-way valve 159 (e.g., a check valve) is disposed insecond port 158 so that air can only pass throughsecond port 158 when traveling in an inward direction. Whenelastic bulb 156 is compressed (e.g., by hand), air within the interior ofelastic bulb 156 is forced outfirst port 157; and whenelastic bulb 156 is thereafter released, air is drawn back into the interior ofelastic bulb 156 throughsecond port 158. - As a result of this construction, when
elastic bulb 156 is to be used to inflateaft balloon 20,first port 157 is connected to fitting 46 vialine 155 so that the positive pressure output ofelastic bulb 156 is directed toaft balloon 20.Elastic bulb 156 may thereafter be used to deflateaft balloon 20, i.e., by connectingsecond port 158 to fitting 46 vialine 155 so that the suction ofelastic bulb 156 is directed toaft balloon 20. Correspondingly, whenelastic bulb 156 is to be used to inflatefore balloon 35,first port 157 is connected to fitting 56 vialine 155 so that the positive pressure output ofelastic bulb 156 is directed tofore balloon 35.Elastic bulb 156 may thereafter be used to deflatefore balloon 35, i.e., by connectingsecond port 158 to fitting 56 vialine 155 so that the suction ofelastic bulb 156 is directed tofore balloon 35. - Alternatively, and looking now at
FIGS. 37 and 38 , asyringe 160 may be used to inflateaft balloon 20 and/orfore balloon 35.Inflation mechanism 160 comprises abody 161 and aplunger 162. Preferably a spring (not shown) is provided inbody 161 to automatically return plunger 162 at the end of its power stroke.Syringe 160 is connected tofittings line 163. With this construction,syringe 160 comprises avalve 165 for connectingsyringe 160 tofore balloon 35 oraft balloon 20, and avalve 170 for selecting inflation or deflation of the connected-to balloon. - Thus, with this construction, when
syringe 160 is to be used to inflateaft balloon 20, valve 165 (a two-position valve that connectsvalve 170 to either the fore balloon or the aft balloon) is set so that thesyringe 160 is connected through fitting 46 toaft balloon 20, and valve 170 (a 2-way crossover valve which allows the one-way valves to be arranged to inflate in one configuration and deflate in the other configuration) is set so thatsyringe 160 is providing inflation pressure. Thereafter, whenaft balloon 20 is to be deflated,valve 170 is set to its deflate position. - Correspondingly, when
syringe 160 is to be used to inflatefore balloon 35,valve 165 is set so thatsyringe 160 is connected through fitting 56 tofore balloon 35, andvalve 170 is set so thatsyringe 160 is providing inflation pressure. Thereafter, whenfore balloon 35 is to be deflated,valve 170 is set to its deflate position. - In another preferred form of the present invention, and looking now at
FIGS. 39-58 ,inflation mechanism 40 comprises ahand inflator 300 also formed in accordance with the present invention.Hand inflator 300 generally comprises ahousing 305 carrying a bulb or “pump” 310, an aft balloon inflation line 315 (for connection to fitting 46 ofapparatus 5, seeFIG. 1 ), a fore balloon inflation line 320 (for connection to fitting 56 ofapparatus 5, seeFIG. 1 ), and internal pneumatic apparatus 325 (FIG. 42 ) for directing air betweenpump 310 and aftballoon inflation line 315 and fore balloon inflation line 320 (and for venting air from aftballoon inflation line 315 and fore balloon inflation line 320), all as will hereinafter be discussed. - As seen in
FIGS. 42 and 43 , internalpneumatic apparatus 325 comprises acheck valve 330, acheck valve 335, acheck valve 340, amulti-way valve 345, afore balloon indicator 350, anaft balloon indicator 355, acheck valve 360, acheck valve 365, an “air in”port 367 and an “air out”port 368. A selector knob 370 (FIGS. 39, 40 and 41 ) is attached tomulti-way valve 345 so as to allow the user to setmulti-way valve 345 as desired, andopenings 375, 380 (FIG. 40 ) are formed inhousing 305 so as to exposefore balloon indicator 350 andaft balloon indicator 355, respectively, to the view of the user. - Looking now at
FIGS. 44 through 47 , internalpneumatic apparatus 325 is configured so that (i) aftballoon 20 can be selectively inflated bypump 310, (ii) aftballoon 20 can be selectively deflated bypump 310, (iii)fore balloon 35 can be selectively inflated bypump 310, and (iv)fore balloon 35 can be selectively deflated bypump 310. - More particularly, when
aft balloon 20 is to be inflated, and looking now atFIG. 44 ,selector knob 370 is set so thatmulti-way valve 345 creates a fluid line connecting “air in”port 367,check valve 340,check valve 335, pump 310,check valve 330,aft balloon indicator 355,check valve 365, aftballoon inflation line 315 andaft balloon 20, so that repeated compressions ofpump 310 inflatesaft balloon 20, with the pressure withinaft balloon 20 being indicated byaft balloon indicator 355. - When aft
balloon 20 is to be deflated, and looking now atFIG. 45 ,selector knob 370 is set so thatmulti-way valve 345 creates a fluid line connectingaft balloon 20, aftballoon inflation line 315,check valve 365,aft balloon indicator 355,check valve 340,check valve 335, pump 310,check valve 330 and “air out”port 368, so that repeated compressions ofpump 310 deflatesaft balloon 20, with the pressure withinaft balloon 20 being indicated byaft balloon indicator 355. - When
fore balloon 35 is to be inflated, and looking now atFIG. 46 ,selector knob 370 is set so thatmulti-way valve 345 creates a fluid line connecting “air in”port 367,check valve 340,check valve 335, pump 310,check valve 330,fore balloon indicator 350,check valve 360, foreballoon inflation line 320 andfore balloon 35, so that repeated compressions ofpump 310 inflatesfore balloon 35, with the pressure withinfore balloon 35 being indicated byfore balloon indicator 350. - When
fore balloon 35 is to be deflated, and looking now atFIG. 47 ,selector knob 370 is set so thatmulti-way valve 345 creates a fluid line connectingfore balloon 35, foreballoon inflation line 320,check valve 360,fore balloon indicator 350,check valve 340,check valve 335, pump 310,check valve 330 and “air out”port 368, so that repeated compressions ofpump 310 deflatesfore balloon 35, with the pressure withinfore balloon 35 being indicated byfore balloon indicator 350. - In one preferred form of the invention, and looking now at
FIGS. 48 and 13K ,fore balloon indicator 350 andaft balloon indicator 355 each comprise apiston 385.Piston 385 is created by attaching twoend caps pliable extrusion 400.End cap 390 is securely mounted tohousing 305 and is pneumatically connected by atube 405 to the system pressure which is to be measured (i.e., to a balloon, either thefore balloon 35 or theaft balloon 20, depending on whetherpiston 385 is employed infore balloon indicator 350 or aft balloon indicator 355).End cap 395 rides alongtube 405 and abuts aspring 410 which engages awall 415 ofhousing 305.End cap 395 includes analignment feature 420 which is slidably disposed in a guide (not shown) inhousing 305, and acolor pressure indicator 425 which is visible through one or the other of theaforementioned openings 375, 380 (depending on whetherpiston 385 is employed infore balloon indicator 350 or aft balloon indicator 355).End cap 395 acts as the pressure indicator, inasmuch as the longitudinal position ofsecond end cap 395 along tube 405 (relative to wall 415) is an indicator of system pressure. In essence, the twoend caps extrusion 400 effectively constitute a piston (i.e., piston 385) which expands and contracts as the system pressure changes, with system pressure being reflected by the disposition ofcolor pressure indicator 425 relative to one or the other of theaforementioned openings - When there is no pressure in the system (i.e., when the fore balloon or the aft balloon is entirely deflated), the indicator remains in the position shown in
FIG. 50 . In this position,extrusion 400 is collapsed and folded upon itself. When pressure is introduced into the system (and hence, into tube 405) and a balloon (i.e.,fore balloon 35 or aft balloon 20) begins to inflate,end cap 395 begins to move relative totube 405, compressingspring 410. The distance that endcap 395 moves depends on the pressure in the system (i.e., the pressure within tube 405), the diameter of the extrusion, and the bias force of the spring.FIG. 51 showspiston 385 andextrusion 400 fully extended (i.e., indicating maximum pressure within the system or, to put it another way, complete inflation of eitherfore balloon 35 or aft balloon 20). Ideally, the fully-extended position ofcolor pressure indicator 425 relative toopenings housing 305 correlates to the maximum allowable pressure offore balloon 35 oraft balloon 20. - It should be appreciated that since the position of a
color pressure indicator 425 relative to anopening housing 305 is reflective of the pressure within the system (i.e., the pressure within eitherfore balloon 35 or aft balloon 20), in one preferred form of the present invention, various colors (e.g., green, yellow and red) are used to correspond to various predetermined pressures within the system. - Thus, the design shown in
FIGS. 48-53 comprises a colored indicator (i.e., color pressure indicator 425) attached to the “dynamic” (i.e., moving)end cap 395 ofpiston 385. The color scheme on each indicator alerts the user as to how “full” (i.e., how inflated) each of the balloons (i.e.,fore balloon 35 or aft balloon 20) is. However, it should also be appreciated that, if desired, the indicator could comprise numeric pressure values instead of colors. Alternatively, the pressure level could be indicated by a strip of colors (or numbers) fixed to the housing (i.e.,adjacent openings end cap 395 comprises a pointer which extends out of opening 375 or 380 and, as the piston expands (i.e., aspliable extrusion 400 expands andend cap 395 moves towardwall 415 against the power of spring 410) and contracts (i.e., aspliable extrusion 400 contracts andend cap 395 moves away fromwall 415 under the power of spring 410), the pointer points to the appropriate pressure indication mark onhousing 305. - The design shown in
FIGS. 48-53 illustrates the twoend caps piston 385 being separated by a tubularpliable extrusion 400. However, it should also be appreciated that, if desired,pliable extrusion 400 may be replaced by a balloon 430 (FIG. 54 ).Balloon 430 is preferably spherical (FIG. 54 ), although it may also comprise other shapes if desired (see, for example,FIG. 55 , which shows a generally diamond-shapedballoon 430, andFIG. 56 which shows a generally tubular balloon 430). Or, if desired,balloon 430 may be used to push a flag upward, i.e., perpendicular to the axis of the balloon, instead of expanding a piston along its axis. SeeFIGS. 57 and 58 . - In yet another form of the invention,
inflation mechanism 40 may comprise an automated source of fluid pressure (either positive or negative), e.g., an electric pump. - If desired, and looking now at
FIG. 59 , arelief valve 175 can be connected to the inflation/deflation line which connects tofore balloon 35 so as to ensure that the pressure withinfore balloon 35 does not exceed a predetermined level. Similarly, and still looking now atFIG. 59 , arelief valve 180 can be connected to the inflation/deflation line which connects toaft balloon 20 so as to ensure that the pressure withinaft balloon 20 does not exceed a predetermined level. - Alternatively, and/or additionally, one or more pressure gauges 182 (
FIG. 1 orFIG. 38 ) may be incorporated into the fluid line connected toaft balloon 20, and/or the fluid line connected tofore balloon 35, whereby to provide the physician (or other operator or user) with information relating to the pressure insideaft balloon 20 and/orfore balloon 35 so as to avoid over inflation and/or to help the physician (or other operator or user) ascertain the inflation state of a balloon during a procedure. - Furthermore, it will be appreciated that as
fore balloon 35 moves between its “retracted” position (FIG. 2 ) and its “extended” position (FIG. 4 ), theflexible tube 59 connectingpush tubes 30 to base 25 (and hence to fitting 56) may gather aboutbase 25, potentially interfering with the physician's (or other operator's or user's) actions. Accordingly, if desired, and looking now atFIG. 60 , a flexibletube retraction system 185 may be provided (e.g., within base 25) to take up slack inflexible tube 59 whenfore balloon 35 is extended. - As discussed above, in one preferred form of the invention,
inflation mechanism 40 comprises a hand inflator 300 (FIGS. 39-58 ) for selectively inflating/deflating a selected one offore balloon 35 andaft balloon 20.Hand inflator 300 generally comprises a manual pump (e.g., bulb 310) for providing an air pressure/suction source, and amulti-way valve 345 for directing the flow of air from/tobulb 310 to/from a selected one offore balloon 35 andaft balloon 20. - In one form of the present invention, and looking first at
FIGS. 61 and 62 ,multi-way valve 345 preferably takes the form of anovel manifold 500 disposed withinhousing 305 ofhand inflator 300.Manifold 500 generally comprises abottom plate 505 fluidically connected tobulb 310, a rotatablemiddle plate 510, and atop plate 515 fluidically connected tofore balloon 35,aft balloon 20,fore balloon indicator 350 andaft balloon indicator 355. Ashaft 520 passes through, and connects together,top plate 515,middle plate 510 andbottom plate 505, as will hereinafter be discussed in further detail. Looking next atFIG. 63 ,bottom plate 505 generally comprises abody 525 having acavity 530 formed therein.Bottom plate 505 also comprises aninflation port 535 configured to be fluidically connected to an air pressure source (e.g., bulb 310) and adeflation port 540 configured to be fluidically connected to an air suction source (e.g., bulb 310).Inflation port 535 anddeflation port 540 are fluidically connected tocavity 530, as will hereinafter be discussed in further detail. -
Cavity 530 ofbottom plate 505 comprises (i) acentral opening 545 which passes throughbody 525 ofbottom plate 505 for rotatably receivingshaft 520 therein, and (ii) a plurality of O-rings 550 which are disposed incavity 530 and arranged concentrically aboutcentral opening 545. O-rings 550 define two ring-shaped zones which are disposed coaxially relative to one another and which can be fluidically isolated from one another (i.e., whenmiddle plate 510 is mounted on top ofbottom plate 505 and coverscavity 530, as will hereinafter be discussed). More particularly, O-rings 550 define aninner deflation zone 555 and anouter inflation zone 560 disposed coaxially aboutinner deflation zone 555.Inner deflation zone 555 comprises anopening 565 which is fluidically connected todeflation port 540, andouter inflation zone 560 comprises anopening 570 which is fluidically connected toinflation port 535. In one preferred form of the invention,bottom plate 505 also comprises acheck valve 575 fluidically connected todeflation port 540 for allowingbulb 310 to “re-form” (i.e., draw air through check valve 575) when it is not possible to draw air from atmosphere through inner deflation zone 555 (it will be appreciated thatcheck valve 575 is functionally equivalent to thecheck valve 340 shown inFIG. 65 ). - Looking next at
FIG. 64 ,middle plate 510 comprises abody 580 having asmooth bottom surface 585 for sealingly engaging O-rings 550 disposed incavity 530 of bottom plate 505 (whereby to fluidically sealinner deflation zone 555 and outer inflation zone 560), and a smoothtop surface 590 for sealingly engagingtop plate 515, as will hereinafter be discussed in further detail.Body 580 ofmiddle plate 510 comprises acentral opening 595 which passes throughbody 580 ofmiddle plate 510 and is configured to engage shaft 520 (e.g.,central opening 595 may comprise a non-circular cross-section which mates with a portion ofshaft 520 having a corresponding non-circular cross-section) such that rotation ofshaft 520 causes corresponding rotation ofmiddle plate 510.Middle plate 510 also comprises aninner hole 600 and anouter hole 605 which are disposed on a common radius and which pass throughbody 580 ofmiddle plate 510.Inner hole 600 is disposed so as to be in common orbit with, and fluidically connected to,inner deflation zone 555 ofbottom plate 505 whenmiddle plate 510 is mounted overbottom plate 505.Outer hole 605 is disposed so as to be in common orbit with, and fluidically connected to,outer inflation zone 560 ofbottom plate 505 whenmiddle plate 510 is mounted overbottom plate 505. - Looking next at
FIGS. 65-67 ,top plate 515 comprises abody 610 having abottom surface 615, atop surface 620 and acentral opening 625 passing throughbody 610 for rotatably receivingshaft 520.Top plate 515 also comprises an aftballoon connection port 630 for fluidically connectingaft balloon 20 tomanifold 500, an aftballoon indicator port 635 for fluidically connectingaft balloon indicator 355 tomanifold 500, anaft balloon channel 640 extending between aftballoon connection port 630 and aftballoon indicator port 635, a foreballoon connection port 645 for fluidically connectingfore balloon 35 tomanifold 500, a foreballoon indicator port 650 for fluidically connectingfore balloon indicator 350 tomanifold 500 and afore balloon channel 655 extending between foreballoon connection port 645 and foreballoon indicator port 650. -
Bottom surface 615 ofbody 610 comprises an aftballoon inflation port 660 and an aftballoon deflation port 665 which open onbottom surface 615 and which are fluidically connected toaft balloon channel 640.Bottom surface 615 ofbody 610 also comprises a foreballoon inflation port 670 and a foreballoon deflation port 675 which open onbottom surface 615 and which are fluidically connected tofore balloon channel 655. A plurality of O-rings 680 are disposed aboutports ports top surface 590 ofmiddle plate 510 as will hereinafter be discussed in further detail. In one preferred form of the present invention,bottom surface 615 ofbody 610 also comprises a balance O-ring 685 for helping to maintain sealing engagement of O-rings 680 withtop surface 590 ofmiddle plate 510, as will hereinafter be discussed in further detail. - In one preferred form of the invention,
top plate 515 also comprises an aft balloonchannel check valve 690 disposed in top plate 515 (it will be appreciated thatcheck valve 690 is functionally equivalent to thecheck valve 365 shown inFIG. 65 ). Aftballoon check valve 690 is in fluid communication withaft balloon channel 640 and prevents over-inflation ofaft balloon 20 by releasing air to atmosphere when the air pressure within aft balloon channel 640 (which is the same as the air pressure within aft balloon 20) exceeds a predetermined threshold. In one preferred form of the invention,top plate 515 also comprises a fore balloonchannel check valve 695 disposed in top plate 515 (it will be appreciated thatcheck valve 695 is functionally equivalent to thecheck valve 360 shown inFIG. 43 ). Fore ballooncheck channel valve 695 is in fluid communication withfore balloon channel 655 and prevents over-inflation offore balloon 35 by releasing air to atmosphere when the air pressure within fore balloon channel 655 (which is the same as the air pressure within fore balloon 35) exceeds a predetermined threshold. - Looking next at
FIGS. 68 and 69 ,manifold 500 is assembled such thatmiddle plate 510 is rotatably disposed betweenbottom plate 505 andtop plate 515, withshaft 520 passing throughcentral opening 625 oftop plate 515, throughcentral opening 595 ofmiddle plate 510 and throughcentral opening 545 ofbottom plate 505. More particularly, the distal end ofshaft 520 comprises adistal bearing 700 which is secured toshaft 520 by aretainer clip 705. The proximal end ofshaft 520 comprises aproximal bearing 710 which is secured to the proximal end ofshaft 520, with aspring 715 being disposed betweenproximal bearing 710 andtop surface 620 oftop plate 515. Aselector knob 720 is fixedly mounted to the proximal end ofshaft 520 such that rotation ofselector knob 720 causes corresponding rotation of shaft 520 (and hence corresponding rotation of middle plate 510).Shaft 520 is able to rotate freely withincentral opening 625 oftop plate 515 andcentral opening 545 ofbottom plate 505, and to also rotate freely withinproximal bearing 710 anddistal bearing 700. However,shaft 520 engagescentral opening 595 ofmiddle plate 510 such that rotation ofshaft 520 causes corresponding rotation ofmiddle plate 510, whereby to permit a user to selectively rotate middle plate 510 (i.e., by rotatingselector knob 720, which, in turn, rotates middle plate 510). - It will be appreciated that when the various components are assembled on
shaft 520,bottom plate 505,middle plate 510 andtop plate 515 are “sandwiched” betweendistal bearing 700 andproximal bearing 710 under compression provided byspring 715, whereby to maintain constant contact (i) betweenbottom surface 585 ofmiddle plate 510 and O-rings 550 ofbottom plate 505, (ii) betweentop surface 590 ofmiddle plate 510 and O-rings 680 of top plate 515 (i.e., betweentop surface 590 ofmiddle plate 510 and aftballoon inflation port 660, aftballoon deflation port 665, foreballoon inflation port 670 and fore balloon deflation port 675), and (iii) betweentop surface 590 ofmiddle plate 510 and balance O-ring 685 oftop plate 515. - As a result, an air-tight air pathway is maintained through
manifold 500 between a selected one of (i)inflation port 535 ordeflation port 540, and (ii) a selected one offore balloon 35 oraft balloon 20, such thatbulb 310 may be used to selectively inflate or deflate a selected one offore balloon 35 oraft balloon 20, as will hereinafter be discussed in further detail. - More particularly, it will be appreciated that rotating
selector knob 720 causesshaft 520 to rotate, thereby causingmiddle plate 510 to rotate. When this occurs,inner hole 600 andouter hole 605 ofmiddle plate 510 also rotate relative tobottom plate 505 andtop plate 515. Sinceinner hole 600 ofmiddle plate 510 is aligned in common orbit withinner deflation zone 555 ofbottom plate 505,inner hole 600 is always aligned withinner deflation zone 555, regardless of the rotational position of middle plate 510 (and hence,inner hole 600 is always fluidically connected todeflation port 540, i.e., vis-à-visopening 565 in inner deflation zone 555). Similarly, sinceouter hole 605 ofmiddle plate 510 is aligned in common orbit withouter inflation zone 560 ofbottom plate 505,outer hole 605 is always aligned with outer inflation zone 560 (and hence,outer hole 605 is always fluidically connected toinflation port 535 vis-à-visopening 570 in outer inflation zone 560). - It will also be appreciated that when
middle plate 510 is rotated (i.e., by rotating selector knob 720),inner hole 600 ofmiddle plate 510 may be positioned so that it is (i) aligned with aftballoon deflation port 665, or (ii) aligned with foreballoon deflation port 675, or (iii) unaligned with aport 665, 675 (and hence open to atmosphere). Similarly,outer hole 605 ofmiddle plate 510 may be positioned so that it is (i) aligned with aftballoon inflation port 660, or (ii) aligned with foreballoon inflation port 670, or (iii) unaligned with aport 660, 670 (and hence open to atmosphere). In this respect it will be appreciated that the provision of O-rings 680 and balance O-ring 685 creates a small gap betweenbottom surface 615 oftop plate 515 andtop surface 590 ofmiddle plate 510, such that when either (or both) ofinner hole 600 and/orouter hole 605 ofmiddle plate 510 are unaligned with aport inner hole 600 and/orouter hole 605 are connected with atmosphere. - As a result of this construction, it will be appreciated that middle plate 510 can be selectively rotated so as to occupy one of five states: (1) an aft balloon inflation state, wherein outer hole 605 of middle plate 510 is aligned with aft balloon inflation port 660 of top plate 515 and inner hole 600 of middle plate 510 is open to atmosphere (“State 1”); (2) an aft balloon deflation state wherein outer hole 605 of middle plate 510 is open to atmosphere and inner hole 600 of middle plate 510 is aligned with aft balloon deflation port 665 of top plate 515 (“State 2”); (3) a fore balloon inflation state wherein outer hole 605 of middle plate 510 is aligned with fore balloon inflation port 670 of top plate 515 and inner hole 600 of middle plate 510 is open to atmosphere (“State 3”); (4) a fore balloon deflation state wherein outer hole 605 of middle plate 510 is open to atmosphere and inner hole 600 of middle plate 510 is aligned with fore balloon deflation port 675 (“State 4”); or (5) an inactive state wherein neither outer hole 605 nor inner hole 600 of middle plate 510 is aligned with a port 660, 665, 670, 675 in top plate 515, i.e., wherein both outer hole 605 and inner hole 600 are open to atmosphere and with ports 660, 665, 670, 675 of top plate 515 being fluidically sealed against top surface 590 of middle plate 510 (“State 5”).
- Thus it will be seen that the relative positions of aft
balloon inflation port 660, aftballoon deflation port 665, foreballoon inflation port 670 and foreballoon deflation port 675 withinbottom surface 615 oftop plate 515 can be arranged such that rotation ofmiddle plate 510 causes selective switching between theStates - By way of example but not limitation, in one preferred form of the present invention,
State 1 is effected whenknob 720 is in the “8 o'clock” position,State 2 is effected whenknob 720 is in the “4 o'clock” position,State 3 is effected whenknob 720 is in the “10 o'clock” position, andState 4 is effected whenknob 720 is in the “2 o'clock” position. In this form of the invention,State 5 is effected wheneverknob 720 is rotated to a position intermediate the aforementioned positions. - 1. Aft Balloon Inflation. Looking now at
FIGS. 70-72 , there is shown the path that air travels throughmanifold 500 whenmiddle plate 510 is inState 1 discussed above for effecting aft balloon inflation (i.e., whenmiddle plate 510 is rotated such thatouter hole 605 ofmiddle plate 510 is aligned with aftballoon inflation port 660 oftop plate 515 andinner hole 600 ofmiddle plate 510 is open to atmosphere). InState 1, whenbulb 310 is squeezed and released, free air from atmosphere is drawn intoinner hole 600 ofmiddle plate 510, passes intoinner deflation zone 555 ofbottom plate 505, throughopening 565 ininner deflation zone 565, throughdeflation port 540, intobulb 310 and then back out ofbulb 310, intoinflation port 535, throughopening 570, intoouter inflation zone 560, throughouter hole 605 ofmiddle plate 510, into aftballoon inflation port 660, throughaft balloon channel 640, out of aftballoon connection port 630 and intoaft balloon 20. It should be appreciated that as this occurs, and looking now atFIG. 72 , aftballoon deflation port 665, foreballoon inflation port 670 and foreballoon deflation port 675 are all fluidically sealed againsttop surface 590 ofmiddle plate 510 so that air cannot enter or leave viaports manifold 500 is inState 1, inflation ofaft balloon 20 does not have any effect onfore balloon 35. - 2. Aft Balloon Deflation. Looking next at
FIGS. 73 and 74 , there is shown the path that air travels throughmanifold 500 whenmiddle plate 510 is inState 2 discussed above for effecting aft balloon deflation (i.e., whenmiddle plate 510 is rotated such thatouter hole 605 ofmiddle plate 510 is open to atmosphere andinner hole 600 ofmiddle plate 510 is aligned with aft balloon deflation port 665). InState 2, whenbulb 310 is squeezed and released, air fromaft balloon 20 is drawn into aftballoon connection port 630, throughaft balloon channel 640, out aftballoon deflation port 665, throughinner hole 600 ofmiddle plate 510, intoinner deflation zone 555, throughopening 565, outdeflation port 540, intobulb 310, back out ofbulb 310, intoinflation port 535, throughopening 570 inouter inflation zone 560, intoouter inflation zone 560, throughouter hole 605 ofmiddle plate 510 and out to atmosphere. It should be appreciated that as this occurs, aftballoon inflation port 660, foreballoon inflation port 670 and foreballoon deflation port 675 are all fluidically sealed againsttop surface 620 ofmiddle plate 510 so that air cannot enter or leave viaports manifold 500 is inState 2, deflation ofaft balloon 20 does not have any effect onfore balloon 35. - 3. Fore Balloon Inflation. Looking next at
FIGS. 75 and 76 , there is shown the path that air travels throughmanifold 500 whenmiddle plate 510 is inState 3 discussed above for effecting fore balloon inflation (i.e., whenmiddle plate 510 is rotated such thatouter hole 605 ofmiddle plate 510 is aligned with foreballoon inflation port 670 oftop plate 515 andinner hole 600 ofmiddle plate 510 is open to atmosphere). InState 3, whenbulb 310 is squeezed and released, free air from atmosphere is drawn intoinner hole 600 ofmiddle plate 510, passes intoinner deflation zone 555 ofbottom plate 505, throughopening 565 ininner deflation zone 565, throughdeflation port 540, intobulb 310 and then back out ofbulb 310, intoinflation port 535, throughopening 570, intoouter inflation zone 560, throughouter hole 605 ofmiddle plate 510, into foreballoon inflation port 670, throughfore balloon channel 655, out of foreballoon connection port 645 and intofore balloon 35. It should be appreciated that as this occurs, aftballoon deflation port 665, aftballoon inflation port 660 and foreballoon deflation port 675 are all fluidically sealed againsttop surface 590 ofmiddle plate 510 so that air cannot enter or leave viaports manifold 500 is inState 3, inflation offore balloon 35 does not have any effect onaft balloon 20. - 4. Fore Balloon Deflation. Looking next at
FIGS. 77 and 78 , there is shown the path that air travels throughmanifold 500 whenmiddle plate 510 is inState 4 discussed above for effecting fore balloon deflation (i.e., whenmiddle plate 510 is rotated such thatouter hole 605 ofmiddle plate 510 is open to atmosphere andinner hole 600 ofmiddle plate 510 is aligned with fore balloon deflation port 675). InState 4, whenbulb 310 is squeezed and released, air fromfore balloon 35 is drawn into foreballoon connection port 645, throughfore balloon channel 655, through foreballoon deflation port 675, throughinner hole 600 ofmiddle plate 510, intoinner deflation zone 555, throughopening 565, throughdeflation port 540, intobulb 310, back out ofbulb 310 intoinflation port 535, throughopening 570 inouter inflation zone 560, intoouter inflation zone 560, and throughouter hole 605 ofmiddle plate 510 and into atmosphere. It should be appreciated that as this occurs, aftballoon inflation port 660, aftballoon deflation port 665 and foreballoon inflation port 670 are all fluidically sealed againsttop surface 590 ofmiddle plate 510 so that air cannot enter or leaveports manifold 500 is inState 4, deflation offore balloon 35 does not have any effect onaft balloon 20. - 5. Fore Balloon And Aft Balloon Sealed Against Inflation/Deflation. When
middle plate 510 is disposed inState 5 discussed above (i.e., whenmiddle plate 510 is rotated such thatinner hole 600 andouter hole 605 are both open to atmosphere), aftballoon inflation port 660, aftballoon deflation port 665, foreballoon inflation port 670 and foreballoon deflation port 675 are all sealed againsttop surface 590 ofmiddle plate 510. InState 5, squeezing and releasing ofbulb 310 has no effect on eitherfore balloon 35 or aft balloon 20 (inasmuch as air is drawn intoinner hole 600 ofmiddle plate 510, entersinner deflation zone 555, passes throughopening 565, passes outdeflation port 540 and intobulb 310, and is then passed frombulb 310, intoinflation port 535, throughopening 570 and intoouter inflation zone 560, and then out throughouter hole 605 to atmosphere). - It should be appreciated that other manifolds may be utilized in
inflation mechanism 40 in place of thenovel manifold 500 discussed above. - By way of example but not limitation, and looking now at
FIG. 79 , there is shown anothernovel manifold 500A for selectively inflating or deflating a selected one ofaft balloon 20 andfore balloon 35.Manifold 500A serves the same function asmanifold 500 discussed above (i.e., manifold 500A selectively controls a plurality of airway paths in order to permit a user to selectively inflate or deflate a selected one ofaft balloon 20 andfore balloon 35 using a single user interface), however, manifold 500A employs a somewhat different construction thanmanifold 500. - Looking now at
FIG. 80 , manifold 500A generally comprises a rotatable control dial and a plurality of tubes (labelled 1-6 inFIG. 80 ), with the control dial being configured to selectively close-off one or more of the plurality of tubes and to selectively open one or more of the plurality of tubes as the rotatable control dial is rotated. More particularly, and still looking atFIG. 80 , there is shown arotatable control dial 800 comprising abody 805.Body 805 comprises afirst groove 810 having afirst cutout section 815 and asecond cutout section 820, asecond groove 825 having afirst cutout section 830 and asecond cutout section 835, athird groove 840 having acutout section 845, afourth groove 850 having acutout section 855, afifth groove 860 having acutout section 865 and asixth groove 870 having acutout section 875. - The plurality of tubes discussed above are fixed in place relative to
rotatable control dial 800 and each of the plurality of tubes passes through one offirst groove 810,second groove 825,third groove 840,fourth groove 850,fifth groove 860 andsixth groove 870. More particularly, afirst tube 880 in fluid connection withbulb 310 and atmosphere passes throughfirst groove 810, asecond tube 885 in fluid connection withbulb 310 and atmosphere passes throughsecond groove 825, athird tube 890 in fluid connection withaft balloon 20 andbulb 310 passes throughthird groove 840, afourth tube 895 in fluid connection withaft balloon 20 andbulb 310 passes throughfourth groove 850, afifth tube 900 in fluid connection withfore balloon 35 andbulb 310 passes throughfifth groove 860, and asixth tube 905 in fluid connection withfore balloon 35 andbulb 310 passes throughsixth groove 870. -
First groove 810,second groove 825,third groove 840,fourth groove 850,fifth groove 860 andsixth groove 870 are sized such thatfirst tube 880,second tube 885,third tube 890,fourth tube 895,fifth tube 900 andsixth tube 905 are “pinched off” such that air cannot flow throw the tube whenever the tube is disposed in a section of itsrespective groove tube - More particularly,
first tube 880 only permits passage of air through the tube when it is disposed in eithercutout section 815 orcutout section 820 offirst groove 810,second tube 885 only permits passage of air through the tube when it is disposed in eithercutout section 830 orcutout section 835,third tube 890 only permits passage of air through the tube when it is disposed incutout section 845, etc. Sincetubes dial 800, whencontrol dial 800 is selectively rotated by a user,cutout sections tubes cutout sections body 805 ofcontrol dial 800, it is possible to control which of thetubes cutout section control dial 800 is rotated to a given position. Thus it is possible to control the flow of air to and frombulb 310, and to simultaneously control the flow of air to and from a selected one ofaft balloon 20 andfore balloon 35, by selectively moving control dial 800 to a specific position. Further details regarding the flow of air throughmanifold 500A are provided inFIGS. 81 and 82 . - In one preferred form of the present invention, and looking now at
FIG. 83 ,novel apparatus 5 is sealed within asterile package 1000 untilnovel apparatus 5 is to be used.Package 1000 is typically provided in the form of abottom tray 1005 which is sized to holdnovel apparatus 5, and acover 1010 for mating to, and sealing off,bottom tray 1005.Fore balloon 35 andaft balloon 20 are in their deflated condition whennovel apparatus 5 is sealed withinsterile package 1000. - While
fore balloon 35 andaft balloon 20 are stored withinpackage 1000 in their deflated condition, it has been found that it is sometimes possible for a small amount of residual air to remain withinfore balloon 35 and/oraft balloon 20 and/or the various fluid pathways leading tofore balloon 35 and/or aft balloon 20 (e.g.,hollow push tubes 30,push tube bridge 31, proximal inflation/deflation tube 45, etc.). As a result, when novel apparatus 5 (sealed within package 1000) is thereafter shipped to a recipient via a means of transportation wherepackage 1000 is exposed to a substantial change in air pressure (e.g., whennovel apparatus 5 is shipped to a recipient via an airplane), the change in air pressure can cause the residual air remaining withinfore balloon 35 and/or aft balloon 20 (and/or the various fluid pathways leading tofore balloon 35 and/or aft balloon 20) to expand. Such expansion whilenovel apparatus 5 is sealed withinpackage 1000 can cause damage tofore balloon 35,aft balloon 20 and/or other components ofnovel apparatus 5. - One possible solution to the foregoing problem is to fully evacuate all of the air from
fore balloon 35,aft balloon 20 and all of the pathways, leading tofore balloon 35 andaft balloon 20 beforenovel apparatus 5 is sealed withinpackage 1000. However, it has been found that it can be challenging to evacuate all of the air fromfore balloon 35,aft balloon 20 and the pathways leading tofore balloon 35 andaft balloon 20. In addition, it has also been found that it can be challenging to ensure that no air is thereafter able to leak back into any of the evacuated components ofnovel apparatus 5. - Another possible solution is to allow the air within the interior of
package 1000 to freely enter and exit the components ofnovel apparatus 5, e.g., by leaving one or both offittings novel apparatus 5. It is possible that a recipient may inadvertently leave a valve open that should be closed prior to usingnovel apparatus 5, thereby causing malfunction ofnovel apparatus 5. - Thus there is a need for a new and improved way to maintain a free exchange of air between the interior of
package 1000 andfore balloon 35 andaft balloon 20, while automatically sealing off that free exchange of air when the user removesnovel apparatus 5 frompackage 1000. - To this end, and looking now at
FIG. 84 , a fore balloon ventingcheck valve 1015 and an aft balloon ventingcheck valve 1015A are provided inhand inflator 300, with fore balloon ventingcheck valve 1015 being disposed in foreballoon inflation line 320 and with aft balloon ventingcheck valve 1015A being disposed in aftballoon inflation line 315. For clarity of illustration, only fore balloon ventingcheck valve 1015 is shown inFIGS. 85-88 and discussed in detail hereinbelow, however, it should be appreciated that aft balloon ventingcheck valve 1015A is identical in construction and function to fore balloon venting check valve 1015 (although aft balloon ventingcheck valve 1015A is disposed in aftballoon inflation line 315 rather than in fore balloon inflation line 320). - Looking now at
FIGS. 85-88 , fore balloon ventingcheck valve 1015 and aft balloon ventingcheck valve 1015A are disposed in the bottom surface ofhousing 305 ofhand inflator 300, such that they are in fluid communication with foreballoon inflation line 320 and aftballoon inflation line 315, respectively, and hence in fluid communication withfore balloon 35 andaft balloon 20, respectively. More particularly, fore balloon ventingcheck valve 1015 comprises alumen 1020 having a first end in fluid communication with foreballoon inflation line 320 and a second end having anopening 1025 formed in the outer surface ofhousing 305. A ball (e.g., a rubber ball) 1030 is movably disposed withinlumen 1020 and is biased againstopening 1025 by aspring 1035. Whenball 1030 is biased againstopening 1025, air cannot pass throughopening 1025 and into (or out of) foreballoon inflation line 320, i.e.,fore balloon 35 is sealed off against the free passage of air into (or out of)fore balloon 35. -
Bottom tray 505 comprises an upwardly-extendingfinger 1040 which is sized and positioned such thatfinger 1040 is received withinopening 1025 ofhousing 305 when novel apparatus 5 (and, more specifically, hand inflator 300) is disposed withinbottom tray 1005 ofpackage 1000.Finger 1040 is sized such that when it is received withinopening 1025, afinger 1040 engagesball 1030 and drivesball 1030 against the power ofspring 1035, whereby to unseatball 1030 from opening 1025. At the same time, a gap remains betweenfinger 1040 and the sides ofopening 1025, whereby to allow air to pass from the interior ofpackage 1000 through fore balloon ventingcheck valve 1015, through foreballoon inflation line 320 and intofore balloon 35, and vice versa (FIG. 87 ). -
Bottom tray 1005 comprises asimilar finger 1040A for forcingcheck valve 1015A open whenhand inflator 300 is seated inbottom tray 1005 ofpackage 1000. - If desired, an upwardly-extending stop (not shown) may also be provided on
bottom tray 1005 ofpackage 1000 for engaging the bottom surface ofhousing 305 ofhand inflator 300 whenhand inflator 300 is disposed withinbottom tray 1005 ofpackage 1000, whereby to ensure that an air gap is maintained between the bottom surface ofhand inflator 300 and the bottom surface ofbottom tray 1005, and hence ensure that air is free to flow throughcheck valves hand inflator 300 is seated inbottom tray 1005 ofpackage 1000. - As a result of this construction, when
novel apparatus 5 is disposed inbottom tray 1005,fingers check valve 1015 and aft balloon ventingcheck valve 1015A, respectively, so that air is permitted to freely enter into, and exit out of,fore balloon 35 andaft balloon 20 via fore balloon ventingcheck valve 1015 and aft balloon ventingcheck valve 1015A, respectively. This eliminates the aforementioned problems associated with exposingpackage 1000 to substantial changes in air pressure (e.g., during shipping) and prevents damage toapparatus 5 during shipping. - When
apparatus 5 is to be used,cover 1010 is removed frompackage 1000 andnovel apparatus 5 is removed frombottom tray 1005. When this occurs,fingers check valve 1015 and aft balloon ventingcheck valve 1015A, respectively, thereby allowing these check valves to return to their “closed” positions. - Thus it will be seen that fore balloon venting
check valve 1015 and aft balloon ventingcheck valve 1015A act to protectnovel apparatus 5 from exposure to air pressure differentials during shipping/storage and does so in a passive fashion that does not require the recipient to close any valves. -
Apparatus 5 may be used to manipulate, (e.g., stabilize, straighten, expand and/or flatten, etc.) the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopicprocedure using endoscope 10, and/or to stabilize the distal tips and/or working ends of instruments (e.g., graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.), e.g., advanced into the therapeutic zone. - More particularly, in use,
sleeve 15 is first mounted to endoscope 10 (FIG. 1 ). This may be accomplished by pullingbase 25 proximally over the distal end ofendoscope 10 and then pulling proximally along the length ofendoscope 10 until the distal end ofsleeve 15 is substantially aligned with the distal tip ofendoscope 10. At this point,aft balloon 20 is deflated,fore balloon 35 is deflated, andfore balloon 35 is docked over the distal end ofendoscope 10, withendoscope 10 nesting in the area beneath raisedpush tube bridge 31.Endoscope 10 andapparatus 5 are ready to be inserted as a unit into the patient. - Looking next at
FIG. 89 ,endoscope 10 andapparatus 5 are inserted as a unit into a body lumen and/or body cavity of the patient. By way of example but not limitation,endoscope 10 andapparatus 5 are inserted as a unit into the gastrointestinal (GI) tract of the patient.Endoscope 10 andapparatus 5 are advanced along the body lumen and/or body cavity to a desired location within the patient (FIGS. 90 and 91 ). - When
apparatus 5 is to be used (e.g., to manipulate the side wall of the gastrointestinal tract so as to provide increased visualization of the same and/or increase access to the same, and/or for stabilizing instruments relative to the same),aft balloon 20 is inflated so as to stabilize apparatus 5 (and hence endoscope 10) within the body lumen and/or body cavity. SeeFIG. 92 . This may be done using the aforementioned associatedinflation mechanism 40. - In this respect it will be appreciated that inasmuch as the articulating portion of the endoscope resides distal to
aft balloon 20, the endoscope will be able to articulate distal toaft balloon 20 so as to facilitate visualization of the anatomy even after aftballoon 20 is inflated. Significantly, such visualization is enhanced, inasmuch asaft balloon 20 stabilizesendoscope 10 within the gastrointestinal tract and distends the colon and increases the colon to a fixed diameter directly adjacent toaft balloon 20. - Next,
hollow push tubes 30 are advanced distally in the body lumen and/or body cavity (i.e., so as to movefore balloon 35 further ahead of aft balloon 20) by pushing distally onpush tube handle 37. Thus,hollow push tubes 30, and hencefore balloon 35, move distally relative to endoscope 10 (which is stabilized in position within the gastrointestinal tract by the inflated aft balloon 20). Note that raisedpush tube bridge 31 provides an atraumatic tip for the distal ends ofhollow push tubes 30, thereby ensuring atraumatic advancement offore balloon 35. Note that the deflatedfore balloon 35 covers the distal ends ofhollow push tubes 30 and raisedpush tube bridge 31 during such distal advancement offore balloon 35, thereby ensuring atraumatic advancement offore balloon 35. Note that atraumatic advancement offore balloon 35 may be further enhanced by forming the distal ends ofhollow push tubes 30 and raisedpush tube bridge 31 out of a more resilient material. - When
hollow push tubes 30 have advancedfore balloon 35 to the desired position distal toendoscope 10,fore balloon 35 is inflated (FIG. 93 ) so as to securefore balloon 35 to the anatomy. Again, this may be done using the aforementioned associatedinflation mechanism 40. Asfore balloon 35 is inflated, theinflated fore balloon 35, the inflatedaft balloon 20, andhollow push tubes 30 will all complement one another so as to stabilize, straighten, expand and/or flatten the side wall of the body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopicprocedure using endoscope 10. In this respect it will be appreciated that theinflated fore balloon 35 and the inflatedaft balloon 20 will together expand and tension the side wall of the body lumen and/or body cavity, andhollow push tubes 30 will tend to straighten the anatomy between the two inflated balloons when the fore balloon is extended distally from the aft balloon. In this respect it will also be appreciated that onceaft balloon 20 andfore balloon 35 have both been inflated,fore balloon 35 will create a substantially full-diameter seal across the body lumen and/or body cavity (because the inflated fore balloon closes down theaxial opening 63 extending through the fore balloon when the fore balloon is in its deflated state), andaft balloon 20 will cooperate withsleeve 15 andendoscope 10 to create another substantially full-diameter barrier across the body lumen and/or body cavity. Thus, theinflated fore balloon 35 and the inflatedaft balloon 20 will together define a substantially closed region along the body lumen and/or body cavity (i.e., an isolated therapeutic zone which prevents the passage of fluid and/or other liquids by virtue of the air-tight seals established by theinflated fore balloon 35 and aft balloon 20). The side wall of the body lumen and/or body cavity will be tensioned by inflation offore balloon 35 andaft balloon 20, whereby to better present the side wall of the body lumen and/or body cavity for viewing throughendoscope 10. - It should be appreciated that the expansion and tensioning of the side wall of the body lumen and/or body cavity effected by the
inflated fore balloon 35, the inflatedaft balloon 20, andhollow push tubes 30, can be further enhanced by advancing the fore balloon when it is inflated and gripping the side wall of the body lumen and/or body cavity, whereby to further tension the side wall of the body lumen and/or body cavity. - Significantly, inasmuch as the
inflated fore balloon 35 and the inflatedaft balloon 20 together define a substantially closed region along the body lumen and/or body cavity (i.e., an isolated therapeutic zone), this region can then be inflated (FIG. 24 ) with a fluid (e.g., air, CO2, etc.) so as to further tension the side wall of the body lumen and/or body cavity, whereby to better present the side wall of the body lumen and/or body cavity for viewing throughendoscope 10 and stabilize the side wall so as to facilitate more precise therapeutic interventions. If desired,fore balloon 35 can be retracted toward aft balloon 20 (i.e., by pulling push tube handle 37 proximally), while remaining inflated (and hence maintaining a grip on the side wall of the body lumen and/or body cavity), so as to move the visible mucosa and further improve visualization and access (seeFIG. 95 ), e.g., so as to position a particular target area on the side wall of the body lumen and/or body cavity at a convenient angle relative to the endoscope and endoscopic tools. - Alternatively, if desired, once
aft balloon 35 has been inflated,hollow push tubes 30 may be advanced distally a portion—but only a portion—of their full distal stroke, thenfore balloon 35 may be inflated so as to grip the side wall of the body lumen and/or body cavity, and thenhollow push tubes 30 may be further advanced distally. This action will cause flexiblehollow push tubes 30 to bow outwardly (seeFIGS. 96-99 ), contacting the side wall of the body lumen and/or body cavity and pushing the side wall of the body lumen and/or body cavity outwardly, e.g., in a “tenting” fashion, whereby to further enhance visualization of the side wall of the body lumen and/or body cavity byendoscope 10. - If desired, instruments 190 (
FIG. 100 ) may be advanced through working channels ofendoscope 10 so as to biopsy and/or treat pathologic conditions (e.g., excise pathological anatomy). It will be appreciated that such instruments will extend through the distal end of the endoscope, which is effectively stabilized relative to the anatomy viaaft balloon 20, so that the working ends ofinstruments 190 will also be highly stabilized relative to the anatomy. This is a significant advantage over the prior art practice of advancing instruments out of the non-stabilized end of an endo scope. Preferablyinstruments 190 include articulating instruments having a full range of motion, whereby to better access target anatomy. - Furthermore, if bleeding were to obscure a tissue site, or if bleeding were to occur and the surgeon is unable to identify the source of the bleeding, the isolated therapeutic zone permits rapid flushing of the anatomic segment in which the therapeutic zone lies (e.g., with a liquid such as saline) with rapid subsequent removal of the flushing liquid (see
FIGS. 101-103 ). - Also, if desired,
fore balloon 35 can be directed with high precision to a bleeding site, whereuponfore balloon 35 may be used (e.g., inflated) to apply local pressure to the bleeding site in order to enhance bleeding control (seeFIG. 104 ). This can be done under the visualization provided byendoscope 10. - If it is desired to reposition
endoscope 10 within the anatomy with minimal interference fromapparatus 5,fore balloon 35 is returned to its torus configuration (i.e., partially deflated), the fore balloon is retracted proximally and “re-docked” on the distal end of endoscope 10 (withendoscope 10 nesting in the area beneath raised push tube bridge 31),aft balloon 20 is deflated, and then endoscope 10 (withapparatus 5 carried thereon) is repositioned within the anatomy. Note that wherefore balloon 35 is to be re-docked on the distal end ofendoscope 10,fore balloon 35 is preferably only partially deflated untilfore balloon 35 is re-docked on the distal end of the endoscope, since partial inflation offore balloon 35 can leavefore balloon 35 with enough “body” to facilitate the re-docking process. Thereafter,fore balloon 35 may be fully deflated if desired, e.g., so as to positively grip the distal end ofendoscope 10. - Alternatively, if desired,
fore balloon 35 may be used as a drag brake to control retrograde motion of the endoscope. More particularly, in this form of the invention,endoscope 10 andapparatus 5 are first advanced as a unit into the body lumen and/or body cavity until the tip of the endo scope is at the proper location. Next,aft balloon 20 is inflated,hollow push tubes 30 are advanced distally, and thenfore balloon 35 is inflated (FIG. 105 ). Visualization and, optionally, therapeutic treatment may then be effected at that location. When the apparatus is to be moved retrograde,aft balloon 20 is deflated,fore balloon 35 is partially deflated, and then the endoscope is withdrawn proximally, dragging the semi-inflatedfore balloon 35 along the body lumen and/or body cavity (FIG. 106 ), withfore balloon 35 acting as something of a brake as the endoscope is pulled proximally, thereby enabling more controlled retrograde movement of the endoscope and hence better visualization of the anatomy. If at some point it is desired,aft balloon 20 andfore balloon 35 can be re-inflated, as shown inFIG. 107 , with or without introduction of a fluid into the “isolated therapeutic zone” established between the two balloons, so as to stabilize, straighten, expand and/or flatten the anatomy. - It is also possible to use
aft balloon 20 as a brake when withdrawing the endoscope (and hence apparatus 5) from the anatomy, either alone or in combination with the aforementioned braking action fromfore balloon 35. - At the conclusion of the procedure,
endoscope 10 andapparatus 5 are withdrawn from the anatomy. Preferably this is done by deflating (or partially deflating)fore balloon 35, retractinghollow push tubes 30 so thatfore balloon 35 is “re-docked” onto the distal end of endoscope 10 (withendoscope 10 nesting in the area beneath raised push tube bridge 31), fully deflatingfore balloon 35 so that it grips the distal end of the endoscope, deflating aft balloon 20 (if it is not yet deflated), and then withdrawingendoscope 10 andapparatus 5 as a unit from the anatomy. - It should be appreciated that
apparatus 5 may also be used advantageously in various ways other than those disclosed above. By way of example but not limitation, when endoscope 10 (and apparatus 5) is to be advanced within the colon, it may be desirable to firstproject fore balloon 35 distally under visual guidance of the endoscope so thatfore balloon 35 leads the distal end of the endoscope. As a result, when the endoscope is advanced distally, withfore balloon 35 being deflated (or partially deflated), the fore balloon and flexible hollow push tubes 30 (and raised push tube bridge 31) may act as an atraumatic lead (guiding structure) for the endoscope as the endoscope advances through the colon. Significantly, inasmuch as the distal ends ofhollow push tubes 30 are preferably highly flexible, as the advancingfore balloon 35 encounters the colon wall (e.g., at a turn of the colon), the flexible hollow push tubes can deflect so that the fore balloon tracks the path of the colon, thereby aiding atraumatic advancement of the endo scope along the colon. It should also be appreciated thatapparatus 5 may also be used advantageously in other ways to facilitate further examinations of the luminal surface otherwise difficult to be performed currently. Such an example is endoscopic ultrasound examination of the lumen which would be facilitated by the fluid-filled inflated fore balloon and ultrasound probe examination. -
Aft balloon 20 is bonded tosleeve 15 along at least the distal edge ofaft balloon 20 and the proximal edge of aft balloon 20 (i.e., the distal and proximal edges whereaft balloon 20 meets sleeve 15), such that an airtight seal is created betweenaft balloon 20 andsleeve 15.Pushrod lumens 52 and aftballoon inflation lumen 47 are disposed in contact with, and parallel to,sleeve 15, withpushrod lumens 52 passing entirely through aft balloon 20 (i.e., through both the proximal and distal edges ofaft balloon 20 whereaft balloon 20 meets sleeve 15) and with aftballoon inflation lumen 47 passing through the proximal edge ofaft balloon 20 and extending into the interior ofaft balloon 20. As a result,aft balloon 20 must be sealingly bonded tosleeve 15 about a series of components (i.e.,pushrod lumens 52 and aft balloon inflation lumen 47) which collectively present a non-circular cross-sectional profile at the bonding sites. - In practice, it has been found that it is challenging to effect airtight thermal bonding of
aft balloon 20 tosleeve 15, inasmuch as the presence ofpushrod lumens 52 and aftballoon inflation lumen 47 create open wedges (or corners) which the material ofaft balloon 20 must fill in order to ensure airtight bonding ofaft balloon 20 tosleeve 15. - More particularly, and looking now at
FIG. 108 ,gaps 1100 exist in the space betweenpushrod lumens 52 andsleeve 15,gap 1105 exists in the space between aftballoon inflation lumen 47 andsleeve 15, andgaps 1110 exist in the space between apushrod lumen 52 and aftballoon inflation lumen 47. The presence ofgaps aft balloon 20, and the presence ofgaps 1100 at the distal edge ofaft balloon 20, compromise the airtight sealing ofaft balloon 20 tosleeve 15, since it is difficult to make the material ofaft balloon 20 adhere to the irregular perimeter defined bypushrod lumens 52 and aftballoon inflation lumen 47. Stated another way, it can be challenging to make the material ofaft balloon 20 enter intogaps - Thus it would be desirable to provide a new and improved means to fill
gaps aft balloon 20 can be thermally bonded tosleeve 15 in an airtight sealing engagement. - To that end, and looking now at
FIGS. 109, 110, 111, 112, 113 and 114 , there are provided novel extruded inserts 1115 which have a cross-sectional profile matching theaforementioned gaps 1100. Extruded inserts 1115 are sized to fillgaps 1100 at the location where the proximal edge ofaft balloon 20 and the distal edge ofaft balloon 20 are bonded tosleeve 15 aroundpushrod lumens 52. Extruded inserts 1110 are preferably flexible and may be of any desired length (e.g., extrudedinserts 1115 may extend along substantially the entire length ofsleeve 15, orextruded inserts 1115 may extend only along a portion ofsleeve 15 whereaft balloon 20 is bonded tosleeve 15, or a plurality ofextruded inserts 1115 may extend along a plurality of interrupted sections ofsleeve 15, etc.). In one preferred form of the invention, extrudedinserts 1115 extend from a location just distal toaft balloon 20 to a location just proximal toaft balloon 20. - There is also provided a
novel extruded insert 1120 having a cross-sectional profile matching theaforementioned gap 1105. Extrudedinsert 1120 is sized to fillgap 1105 at the location where the proximal edge ofaft balloon 20 and the distal edge ofaft balloon 20 are bonded tosleeve 15 around aftballoon inflation lumen 47. Extrudedinsert 1120 is preferably flexible and may be of any desired length (e.g., extrudedinserts 1120 may extend along substantially the entire length ofsleeve 15, orextruded inserts 1120 may extend only along a portion ofsleeve 15 whereaft balloon 20 is bonded tosleeve 15, or a plurality ofextruded inserts 1120 may extend along a plurality of interrupted sections ofsleeve 15, etc.). In one preferred form of the invention, extrudedinsert 1120 extends from a location at the distal end of aftballoon inflation lumen 47 to a location just proximal toaft balloon 20. - There are also provided novel extruded inserts 1125 having a cross-sectional profile matching the
aforementioned gaps 1110. Extruded inserts 1125 are sized to fillgaps 1110 at the location where the proximal edge ofaft balloon 20 and the distal edge ofaft balloon 20 are bonded tosleeve 15 around aftballoon inflation lumen 47 and apushrod lumen 52. Extruded inserts 1125 are preferably flexible and may be of any desired length (e.g., extrudedinserts 1125 may extend along substantially the entire length ofsleeve 15, orextruded inserts 1125 may extend only along a portion ofsleeve 15 whereaft balloon 20 is bonded tosleeve 15, or a plurality ofextruded inserts 1125 may extend along a plurality of interrupted sections ofsleeve 15, etc.). In one preferred form of the invention, extrudedinsert 1125 extends from a location at the distal end of aftballoon inflation lumen 47 to a location just proximal toaft balloon 20. -
Inserts sleeve 15, (ii)pushrod lumens 52, (iii) aftballoon inflation lumen 47, and (iv) aftballoon 20, whereby to facilitate the airtight bonding ofaft balloon 20 tosleeve 15,pushrod lumen 52 and aftballoon inflation lumen 47. - It should be appreciated that where additional components/lumens (e.g., working channels) are disposed coaxially about
sleeve 15, additionalextruded inserts - With the “double eversion” fore balloon construction discussed above,
fore balloon 35 is formed as ahollow balloon body 67 having two extensions (i.e.,proximal extension 73 and distal extension 76) which are both everted inwardly (i.e., the proximal extension is everted first, the distal extension is everted second) into the interior ofbody 67 and thermally bonded together to formfore balloon 35. With this approach,fore balloon 35 comprises a torus, whereby to facilitate docking offore balloon 35 over the distal end of sleeve 15 (i.e., the distal end of endoscope 10) whenfore balloon 35 is in its deflated condition. At the same time,fore balloon 35 can provide a full-diameter barrier across an anatomical passageway whenfore balloon 35 is in its inflated condition. - However, it has been found that it can be challenging to effect good thermal bonding between inwardly-everted
proximal extension 73 and inwardly-everteddistal extension 76, inasmuch as bothproximal extension 73 anddistal extension 76 are located within theinterior body 67 offore balloon 35 during bonding, and therefore can be difficult to access during component bonding. - One solution to this problem, and looking now at
FIGS. 115-119 , is the provision of analternative fore balloon 35A.Fore balloon 35A is manufactured as a single construct comprising abody 67A having aproximal opening 69A and adistal opening 71A, aproximal extension 73A having a “key-shaped”cross-section comprising lobes 74A, and adistal extension 76A having a circular cross-section. Note thatlobes 74A ofproximal extension 73A have a configuration that matches the configuration of hollow push tubes 30 (i.e., whereapparatus 5 comprises twohollow push tubes 30 diametrically opposed to one another,proximal extension 73A comprises twolobes 74A diametrically opposed to one another—for the purposes of the present invention,proximal extension 73A and lobe(s) 74A may be collectively referred to as having a “key-shaped” cross-section).Proximal extension 73A is relatively short and is preferably flared outwardly at its proximal end, whereby to facilitate docking offore balloon 35A oversleeve 15 and/orendoscope 10 as will hereinafter be discussed in greater detail. Furthermore,proximal extension 73A preferably comprises a proximally-extendingtongue 77 for facilitating docking offore balloon 35A over the proximal end of sleeve 15 (and/or the proximal end of endoscope 10). - Thus it will be appreciated that
fore balloon 35A is formed in a manner generally similar to theaforementioned fore balloon 35, except thatproximal extension 73A offore balloon 35A differs from the aforementionedproximal extension 73 of fore balloon 73 (i.e., by being formed with a shorter length, a flared proximal end and a tongue 77). -
Fore balloon 35A is also assembled in a somewhat different manner than theaforementioned fore balloon 35, as will hereinafter be discussed in greater detail. More particularly, and looking now atFIGS. 120-122 ,hollow push tubes 30 are seated inlobes 74A ofproximal extension 73A, withproximal extension 73A extending proximally away fromfore balloon 35A and withdistal extension 76 extending distally away fromfore balloon 35A.Hollow push tubes 30 are advanced distally into the interior ofbody 67A offore balloon 35A such that the interiors ofhollow push tubes 30 are in fluid communication with the interior ofbody 67A and with raisedpush tube bridge 31 disposed within the interior ofbody 67A. If desired, an assembly mandrel M may be used during assembly in order to provide support for the components during insertion ofhollow push tubes 30 intofore balloon 35A offore balloon 35A (seeFIG. 120 ). - Next, processing mandrel M is removed (if one is used), and
distal extension 76A is everted into the interior ofbody 67A offore balloon 35A and passed proximally throughbody 67A, and through the interior ofproximal extension 73A, untildistal extension 76A extends to the proximal opening ofproximal extension 73A. As a result of this construction,proximal extension 76A extends throughbody 67A, and bothproximal extension 73A anddistal extension 76A extend proximally away frombody 67A offore balloon 35A, and pushtubes 30 are disposed betweenproximal extension 73A anddistal extension 76A proximal tobody 67A offore balloon 35A. Thus, in this form of the invention,proximal extension 73A is not everted into the interior offore balloon 35A, rather,proximal extension 73A remains extending proximally away fromfore balloon 35. -
Proximal extension 73A anddistal extension 76A are then bonded together at their proximal ends, withpush tubes 30 being sealed therebetween, such that airtight thermal bonding is effected. - As a result of the foregoing,
fore balloon 35A has a toroidal configuration, comprising aboy 67 having a center opening formed by (i)proximal extension 73A/everteddistal extension 76A on the proximal side ofbody 67A, and (ii) everteddistal extension 76A within the interior ofbody 67A. - Significantly, this form of the invention results in
fore balloon 35A having a toroidal shape which does not require thermal bonding to be carried out within the interior ofbody 67A offore balloon 35A, thereby simplifying assembly. Furthermore, by formingproximal extension 73A as a relatively short structure having an outwardly flared proximal end, and by providingtongue 77 on the proximal edge ofproximal extension 73A,proximal extension 73A can facilitate docking offore balloon 35A oversleeve 15 and/orendoscope 10. - If desired, and looking now at
FIG. 123 , novel extruded inserts 1130 may be provided alongsidehollow push tubes 30 so as to facilitate bondinghollow push tubes 30 toproximal extension 73A and to the everteddistal extension 76A. - Furthermore, if desired, additional material and/or extrusions may be provided along either (or both of)
proximal extension 73A anddistal extension 76A, and/or around the proximal opening ofproximal extension 73A, so as to provide increased rigidity to those portions offore balloon 35A. - If desired,
aft balloon 20 may be formed with an everted construction. More particularly, and looking now atFIGS. 124 and 125 , there is shown anaft balloon 20A which generally comprises adistal extension 1135 and aproximal extension 1140. During construction,distal extension 1135 is everted back through the center ofaft balloon 20A so as to form a generally toroidal balloon structure which is secured tosleeve 15. In this form of the invention, atube 1145 has itsdistal end 1150 disposed exterior to the everteddistal extension 1135, and interior to the outside wall ofaft balloon 20A, and itsproximal end 1155 connected to the aforementioned proximal inflation/deflation tube 45, so that air (or another fluid) can be introduced intoaft balloon 20A and removed fromaft balloon 20A. - If desired,
apparatus 5 may be constructed so thathollow push tubes 30 may be advanced or retracted, to a limited extent, independently of one another, as well as in conjunction with one another—such limited independent advancement or retraction ofhollow push tubes 30 can aid in steering the partially- or fully-deflatedfore balloon 35 through the body lumen and/or body cavity, whereby to facilitate advancement or retraction ofendoscope 10 through the body lumen and/or body cavity, and/or such independent advancement or retraction ofhollow push tubes 30 can facilitate applying a “turning force” to the anatomy with aninflated fore balloon 35, whereby to better present the anatomy for visualization and/or treatment. - By way of example but not limitation, in this form of the invention, and looking now at
FIG. 126 ,hollow push tubes 30 are each independently slidably mounted to push tube handle 37 so thathollow push tubes 30 can move, to some extent, independently of push tube handle 37 and each other.Stops 191 limit distal movement ofhollow push tubes 30 relative to push tube handle 37 so that a hollow push tube cannot be moved completely out ofpush tube handle 37. As a result of this construction, whenfore balloon 35 is to be moved distally,hollow push tubes 30 are moved distally, either together or, to the extent allowed by raisedpush tube bridge 31, independently of one another. And whenfore balloon 35 is to be moved proximally,hollow push tubes 30 are moved proximally, either together or independently of one another, to the extent allowed by raisedpush tube bridge 31. At any point in a procedure,hollow push tubes 30 can be moved, to the extent allowed by raisedpush tube bridge 31, independently of one another so as to “turn” the fore balloon, e.g., such as whenfore balloon 35 is inflated and engaging the anatomy, whereby to apply a “turning force” to the anatomy, or wherefore balloon 35 is partially inflated and is being used as an atraumatic tip for the advancing assembly, whereby to help “steer” the assembly through the anatomy. Note that raisedpush tube bridge 31 at the distal ends ofhollow push tubes 30 provides a limiting mechanism to limit the extent to whichhollow push tubes 30 may be moved, longitudinally, independently of one another, in order to prevent excessive turning offore balloon 35, and/or hollow push tube cross-over, and/or hollow push tube entanglement, and/or hollow push tube misalignment, etc. Note also thathollow push tubes 30 may be held in a particular disposition by mountinghollow push tubes 30 in the aforementioned clamp 53 (FIGS. 37 and 60 ). - It should also be appreciated that it is possible to modify the construction of
sleeve 15 so as to support instruments (or hollow instrument guide tubes) external toendoscope 10. More particularly, looking again atFIGS. 5 and 6 , it will be seen that in the construction shown inFIGS. 5 and 6 ,sleeve 15 comprises alumen 47 for receiving inflation/deflation tube 45 for inflating/deflatingaft balloon 20, and a pair oflumens 52 for receivingsupport tubes 50 which receivepush tubes 30 for manipulating and inflating/deflatingfore balloon 35. However, if desired,sleeve 15 may include additional lumens for supporting instruments (or hollow instrument guide tubes) external toendoscope 10. - More particularly, and looking now at
FIG. 127 , there is shown an end view of another form ofsleeve 15 which includes a plurality oflumens 195 for slidably receivinginstruments 190 therein. Note that, when inflated,aft balloon 20 provides a secure platform for maintainingendoscope 10 andsleeve 15 within a body lumen or body cavity, withendoscope 10 andsleeve 15 centered within the body lumen or body cavity. As a result, the distal ends oflumens 195 ofsleeve 15 will also be securely maintained within the body lumen or body cavity so as to provide a secure support for instruments advanced throughlumens 195 ofsleeve 15. - The proximal ends of
lumens 195 may extend to, and through,base 25, in which case instruments may be inserted intolumens 195 atbase 25, or the proximal ends oflumens 195 may terminate proximal to base 25 (but still outside the body of the patient), in which case instruments may be inserted intolumens 195intermediate sleeve 15. By way of example but not limitation, whereendoscope 10 is 180 cm in length andinstruments 190 are 60 cm in length, it can be advantageous to insertinstruments 190 intolumens 195 at a point closer toballoons 20, 35 (rather than at base 25). Note that inFIG. 127 , thelumen 47 for receiving inflation/deflation tube 45 and inflation/deflation tube 45 for inflating/deflatingaft balloon 20 are not visible, since the view is distal-facing and is taken at a location distal to wherelumen 47 and inflation/deflation tube 45 terminate onsleeve 15. -
FIGS. 128-131 showvarious instruments 190 extending out oflumens 195. Note thatinstruments 190 preferably comprise articulating instruments, e.g., graspers 190A inFIGS. 128-131 , acauterizing device 190B inFIGS. 128-129 ,scissors 190C inFIGS. 130 and 131 , and asuction device 190D inFIGS. 128-131 . - It should be appreciated that where
sleeve 15 comprises its central passageway for receivingendoscope 10,lumen 47 for receiving inflation/deflation tube 45,lumens 52 for receivingsupport tubes 50 which receivehollow push tubes 30, and/orlumens 195 for slidably receivinginstruments 190 therein,sleeve 15 is preferably formed by an extrusion process. - In one preferred form of the invention,
lumen 47 for receiving inflation/deflation tube 45,lumens 52 for receivingsupport tubes 50 which receivehollow push tubes 30, and/orlumens 195 for slidably receivinginstruments 190 may have a fixed configuration (i.e., a fixed diameter), so thatsleeve 15 has a fixed outer profile. - In another preferred form of the invention,
lumen 47 for receiving inflation/deflation tube 45,lumens 52 for receivingsupport tubes 50 which receivehollow push tubes 30, and/orlumens 195 for slidably receivinginstruments 190 may have an expandable configuration (i.e., they may have a minimal profile when empty and expand diametrically as needed when filled), so that the overall profile ofsleeve 15 is minimized. - It should also be appreciated that where
sleeve 15 comprises a plurality oflumens 195 for slidably receivinginstruments 190 therein, it can be desirable to provide greater structural integrity to the distal ends oflumens 195 so as to provide improved support for theinstruments 190 received withinlumens 195. To this end, a support ring may be provided at the distal end ofsleeve 15, wherein the support ring provides openings for the passage ofhollow push tubes 30 and openings for the passage ofinstruments 190. Note that the openings in such a support ring for the passage ofinstruments 190 preferably make a close fit with the instruments so as to provide excellent instrument support at the distal end ofsleeve 15. - Alternatively and/or additionally,
lumens 195 may accommodate hollow instrument guide tubes which themselves accommodate instruments therein. Such hollow instrument guide tubes can provide greater structural integrity to the distal ends oflumens 195 so as to provide improved support for theinstruments 190 received withinlumens 195. - And such hollow instrument guide tubes may be of fixed geometry or of bendable or articulating geometry. See, for example,
FIG. 132 , which shows hollowinstrument guide tubes 200 extending out oflumens 195 and receivinginstruments 190 therein. Note that hollowinstrument guide tubes 200 may be independently movable relative to one another (and independently movable relative to sleeve 15). Note also thatinstruments 190 preferably make a close fit with hollowinstrument guide tubes 200 so as to provide excellent instrument support at the distal end ofsleeve 15. - In another form of the present invention, the toroidal construction of
fore balloon 35 may be replaced by a “conventional” balloon construction, i.e., by a balloon having a substantially uniform, full-diameter cross-section. In this form of the invention, the deflated fore balloon is not “docked” over the endoscope during insertion—instead, the deflated fore balloon resides alongside the endoscope during insertion; and in this form of the invention, the fore balloon is not “re-docked” back over the endoscope during withdrawal—instead, the balloon resides distal to the endoscope (or alongside the endoscope) during withdrawal. It will be appreciated that, in this form of the invention, the raisedpush tube bridge 31 can help retain the deflated fore balloon alongside the endoscope. - Thus it will be seen that the present invention comprises the provision and use of novel apparatus for manipulating the side wall of a body lumen and/or body cavity so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure, e.g., to straighten bends, “iron out” inner luminal surface folds and create a substantially static or stable side wall of the body lumen and/or body cavity which enables more precise visual examination (including visualization of areas which may be initially hidden from view or outside the field of view) and/or therapeutic intervention. By way of example but not limitation, the novel apparatus can be used to stabilize, straighten, expand and/or flatten bends and/or curves and/or folds in the side wall of the intestine so as to better present the side wall tissue (including visualization of areas which may be initially hidden from view or outside the field of view) for examination and/or treatment during an endoscopic procedure.
- The present invention also comprises the provision and use of novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (e.g., endoscopes, articulating and/or non-articulating devices such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) inserted into a body lumen and/or body cavity during an endoscopic procedure with respect to the side wall of the body lumen and/or body cavity, whereby to facilitate the precision use of those instruments.
- By way of example but not limitation, the present apparatus can provide a stable platform (i.e., a stable endoscope, stable therapeutic tools and a stable colon wall, all stable with respect to one another) for the performance of numerous minimally-invasive procedures within a body lumen and/or body cavity, including the stabilization of an endoscope and/or other surgical instruments (e.g., graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) within the body lumen and/or body cavity, e.g., during a lesion biopsy and/or lesion removal procedure, an organ resection procedure, endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR), etc., while at the same time stabilizing the colon (including decreasing deformation of the colon wall) so as to enable more precise visualization, intervention and/or surgery.
- Significantly, the present invention provides novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of endoscopes (and hence also steadying and/or stabilizing the distal tips and/or working ends of other instruments inserted through the working channels of those endoscopes, such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) with respect to the side wall of the body lumen and/or body cavity, and stabilizing the side wall of the body lumen and/or body cavity relative to these instruments.
- And the present invention provides novel apparatus capable of steadying and/or stabilizing the distal tips and/or working ends of instruments (such as graspers, cutters or dissectors, cauterizing tools, ultrasound probes, etc.) advanced to the surgical site by means other than through the working channels of endoscopes.
- The novel apparatus of the present invention can be used in substantially any endoscopic procedure to facilitate the alignment and presentation of tissue during an endoscopic procedure and/or to stabilize the working end of an endoscope (and/or other instruments advanced through the endoscope) relative to tissue or to assist in the advancement of the endoscope during such a procedure.
- The present invention is believed to have widest applications with respect to the gastrointestinal (GI) tract (e.g., large and small intestines, esophagus, stomach, etc.), which is generally characterized by frequent turns and which has a side wall characterized by numerous folds and disease processes located on and between these folds. However, the methods and apparatus of the present invention may also be used inside other body lumens (e.g., blood vessels, lymphatic vessels, the urinary tract, fallopian tubes, bronchi, bile ducts, etc.) and/or inside other body cavities (e.g., the head, chest, abdomen, nasal sinuses, bladder, cavities within organs, etc.).
- While the present invention has been described in terms of certain exemplary preferred embodiments, it will be readily understood and appreciated by those skilled in the art that it is not so limited, and that many additions, deletions and modifications may be made to the preferred embodiments discussed above while remaining within the scope of the present invention.
Claims (21)
1.-40. (canceled)
41. Apparatus comprising:
a sleeve adapted to be slid over an exterior of an endoscope, the sleeve comprising a proximal end and a distal end;
a pair of push tubes slidably mounted to the sleeve, the pair of push tubes each comprising a proximal end and a distal end;
a fore balloon secured to the distal ends of the pair of push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition; and
a push tube handle secured to the proximal ends of the pair of push tubes for moving the pair of push tubes relative to the sleeve.
42. Apparatus according to claim 41 further comprising a base secured to the sleeve at the proximal end of the sleeve, wherein the base is configured to support and guide the push tube handle as the push tube handle moves the pair of push tubes relative to the sleeve.
43. Apparatus according to claim 42 wherein the base comprises an extension having a center slot and a pair of side slots, and further wherein the extension comprises at least one fitting for inflating/deflating the fore balloon.
44. Apparatus according to claim 43 wherein the push tube handle comprises a C-shaped body having a center locking element and a pair of finger grips mounted thereto such that the push tube handle can be (i) locked in position relative to the extension by the center locking element, whereby to lock the fore balloon in position, and (ii) moved distally or proximally relative to the extension, whereby to move the fore balloon distally or proximally.
45. Apparatus according to claim 44 wherein the center locking element comprises a screw shaft and a screw knob, and further wherein the push tube handle is mounted within the extension of the base so that the screw shaft is slidably received in the center slot of the extension and so that the finger grips are slidably received in the pair of side slots in the extension.
46. Apparatus according to claim 45 wherein the push tube handle is locked to the extension by turning the screw knob until the screw knob engages an outer surface of the extension.
47. Apparatus according to claim 45 wherein torsion can be applied to the fore balloon by applying torsion to the finger grips.
48. Apparatus according to claim 41 further comprising an aft balloon secured to the sleeve.
49. Apparatus according to claim 41 wherein the endoscope comprises a proximal end and a distal end, wherein the proximal end of the endoscope comprises a handle, and further wherein the sleeve is sized so as to substantially cover the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.
50. Apparatus according to claim 41 further comprising an inflation/deflation tube formed integral with the sleeve.
51. Apparatus according to claim 41 wherein the sleeve comprises a pair of passageways for receiving the pair of push tubes.
52. Apparatus according to claim 51 wherein the pair of passageways are formed integral with the sleeve.
53. Apparatus according to claim 51 wherein each of the pair of passageways receives a support tube which receives a push tube.
54. Apparatus according to claim 41 wherein the sleeve comprises a lumen for receiving an instrument.
55. Apparatus according to claim 54 wherein the lumen is formed integral with the sleeve.
56. Apparatus according to claim 48 wherein the aft balloon comprises a body having a proximal opening and a distal opening, a distal extension extending distally from the body, a proximal extension extending proximally from the body, and further wherein the aft balloon is formed by everting the distal extension into an interior of the body and into an interior of the proximal extension.
57. Apparatus according to claim 48 wherein at least one of the sleeve, the aft balloon, the pair of push tubes and the fore balloon comprises a visualizable marker.
58. Apparatus according to claim 41 further comprising an inflation mechanism for selectively inflating/deflating the fore balloon.
59. Apparatus according to claim 41 wherein the pair of push tubes are connected to one another at their distal ends by a raised push tube bridge, and further wherein the raised push tube bridge is configured to nest an endoscope therein.
60. Apparatus according to claim 59 wherein the raised push tube bridge is in the form of a ring.
Priority Applications (2)
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US17/392,897 US20220175221A1 (en) | 2009-12-15 | 2021-08-03 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US17/685,213 US20220183540A1 (en) | 2009-12-15 | 2022-03-02 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
Applications Claiming Priority (15)
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US28421509P | 2009-12-15 | 2009-12-15 | |
US12/969,059 US8979884B2 (en) | 2009-12-15 | 2010-12-15 | Method and apparatus for stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US201461938446P | 2014-02-11 | 2014-02-11 | |
US14/540,355 US9924853B2 (en) | 2009-12-15 | 2014-11-13 | Method and apparatus for stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US14/619,845 US9986893B2 (en) | 2009-12-15 | 2015-02-11 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US201562170497P | 2015-06-03 | 2015-06-03 | |
US201562170476P | 2015-06-03 | 2015-06-03 | |
US201562244008P | 2015-10-20 | 2015-10-20 | |
US201562244214P | 2015-10-21 | 2015-10-21 | |
US201662305804P | 2016-03-09 | 2016-03-09 | |
US201662305773P | 2016-03-09 | 2016-03-09 | |
US201662305797P | 2016-03-09 | 2016-03-09 | |
US15/172,385 US10149601B2 (en) | 2009-12-15 | 2016-06-03 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US16/215,843 US11076743B2 (en) | 2009-12-15 | 2018-12-11 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
US17/392,897 US20220175221A1 (en) | 2009-12-15 | 2021-08-03 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
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US17/685,213 Continuation-In-Part US20220183540A1 (en) | 2009-12-15 | 2022-03-02 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
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US16/215,843 Active US11076743B2 (en) | 2009-12-15 | 2018-12-11 | Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same |
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US10149601B2 (en) | 2018-12-11 |
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US11076743B2 (en) | 2021-08-03 |
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