US20160174829A1 - Balloon access device for endoscope - Google Patents
Balloon access device for endoscope Download PDFInfo
- Publication number
- US20160174829A1 US20160174829A1 US14/978,275 US201514978275A US2016174829A1 US 20160174829 A1 US20160174829 A1 US 20160174829A1 US 201514978275 A US201514978275 A US 201514978275A US 2016174829 A1 US2016174829 A1 US 2016174829A1
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- United States
- Prior art keywords
- balloon
- endoscope
- distal
- gastrointestinal
- cap
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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
- A61B1/00089—Hoods
-
- 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
- A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
-
- 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
- A61B1/00064—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
- A61B1/00101—Insertion part of the endoscope body characterised by distal tip features the distal tip features being detachable
-
- 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
- A61B1/00137—End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
-
- 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
- A61B1/012—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 characterised by internal passages or accessories therefor
- A61B1/018—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 characterised by internal passages or accessories therefor for receiving instruments
-
- 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
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- 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
- A61M25/1009—Balloons anchored to a disc or plate
Definitions
- insufflation gas administered to the lower GI tract can induce abdominal discomfort, and this has led to the common practice of using professional anesthesia providers to induce anesthesia to “knock-out” the patient. Additionally, insufflation gas may cause lengthening of anatomy and spontaneous perforation. Post surgical recovery times are provided to allow the patient to purge insufflation gas and to awaken from the anesthesia.
- CO2 gas control systems, CO2 tanks, and CO2 gas heaters have found their way into the operating room to provide CO2 as a insufflation gas. The CO2 gas is more readily absorbed through the patient's intestinal wall to reduce the post operative recovery time.
- the balloon access device includes a balloon expandable from a deflated shape to an inflated shape, the balloon having a proximal end and a distal end, wherein a dome portion is formed on the distal end of the balloon, and a cap having a proximal end configured to be coupled to a distal end of an endoscope and a distal end for sealing with the proximal end of the balloon when the balloon is expanded.
- the proximal end of the balloon includes a proximal collar configured to couple to a distal end of a catheter and a sealing surface configured to seal with the cap.
- the cap includes an endoscope receptacle extending into the cap through the proximal end of the cap for receiving the distal end of the endoscope.
- the cap includes a balloon sealing portion proximate the distal end of the cap, the balloon sealing portion including a circular groove that retains and seals with a circular rib of the balloon.
- the balloon is a transparent hollow balloon.
- the balloon access device includes a lock mechanism for securing a catheter relative to the endoscope to maintain a sealing contact between the balloon and the cap.
- the balloon access device includes a lock mechanism including a balloon insertion tube for receiving the balloon when the balloon is in the deflated state, the tube having a length greater than a y-portion of an operative channel within the endoscope to guide the balloon into and beyond the y-portion, and a clamp for securing a catheter relative to the endoscope to maintain a sealing contact between the balloon and the cap.
- the balloon access device includes a balloon insertion tube for receiving the balloon when the balloon is in the deflated state, the balloon insertion tube having a length greater than a y-portion of an operative channel within the endoscope to guide the balloon into and beyond the y-portion.
- the balloon access device is in combination with an endoscope, wherein the proximal end of the cap is coupled to the distal end of the endoscope.
- FIG. 4 is an isometric view of the balloon access device with the balloon shown collapsed by drawing a vacuum prior to being inserted into an adjacent balloon insertion tube.
- FIG. 11 shows an exploded cross sectional view of an embodiment of the balloon and balloon seal cap.
- the dish shaped portion can be configured to seal against at least a distalmost surface 48 of the cap 40 .
- the distal collar 67 of balloon 60 extends distally from the dome 64 and is configured to seal with the distal tip 62 .
- the proximal collar 68 extends proximally from the at least one sealing surface 66 and is configured to seal with the hollow cannula 70 (see FIGS. 2 and 3 ).
- the embodiment of FIG. 10 comprises a balloon 60 b and a seal cap 40 b and uses a peg- in-hole arrangement for sealing.
- the balloon 60 b is sized to have about the same radial diameter as the distal end 106 of the endoscope and the balloon 60 b nests and seals with a receptacle of a cylindrical balloon sealing portion 44 a .
- Mushroom shaped balloon 60 a comprises a distal dome 64 with at least one sealing surface 66 a that is substantially flat and circular.
- Balloon 60 b is configured to fit snugly in the cylindrical balloon sealing portion 44 a and to seal the at least one sealing surface 66 a against a rib 45 b .
- the distal guide tip 62 can be used with any balloon embodiments such as 60 , 60 a , 60 b , and 60 c .
- the distal guide tip 62 can include the stepped proximal post 69 which is configured to fit within the distal collar 67 , 67 a , 67 b, or 67 c to create a smooth exterior when mated with the balloon 60 , 60 a , 60 b , or 60 c (see at least FIGS. 1&2 ).
- the guide tip 66 and cannula 70 can be adhered to the balloon 60 , 60 a , 60 b , or 60 c with adhesives such as but not limited to polyurethanes or cyanoacrylates.
- alternate fastening techniques can be used with distal guide tip 62 and cannula 70 such as but not limited to heat staking, ultrasonically welding, or laser welding. Whereas these fastening techniques are described for the attachment of the distal guide tip 62 , they can be used for all other embodiments of the apparatus such as elements of the handle portion 50 or attachment of the proximal collar 68 to the cannula 80 .
- FIG. 13 shows balloon 60 c in a normal un-inflated normal shape wherein the inner air pressure is the same as the outside atmospheric pressure and the balloon 60 c has assumed the “as manufactured” mushroom shape.
- the normal shape of balloon 60 c is substantially mushroom shaped, and comprises the distal dome 64 c attached to the proximal at least one sealing surface 66 c .
- the at least one sealing surface 66 c is substantially flat and has been pulled back (via catheter 70 ) to seal against a ring of contact with the ring shaped distalrnost surface 48 c of the seal cap 40 .
- FIG. 14 is another side view of the access device 30 on the endoscope 30 where about 2.5 ml of air have been placed into the balloon 60 c and cannula 70 .
- the distal dome 64 c maintained substantially the same shape, but the at least one sealing surface 66 c domed slightly and pushed the distal dome 64 c and guide tip 62 in the distal direction. This increased the sum of longitudinal lengths A 1 and A 2 to about 11.7 mm without an appreciable change in D 2 . It is visually seen that the majority of the 0.7 mm balloon longitudinal length change occurred in the doming of the at least one sealing surface 66 c which increased dimension B 2 .
- the hollow catheter 70 extends longitudinally along the instrument channel 102 and is attached to the balloon 60 which is inflated (via the catheter 70 ) an amount that substantially restricts the embedding of the guide tip 62 into the balloon as described previously.
- the cap 40 is sealed against the endoscope and the balloon 60 is sealed within the cap 40 to seal the front face 104 of the endoscope 100 from fluids, mucous, and residual natural materials normally found within the luminal structure.
- ring 61 of the balloon is embedded in the groove 41 in the seal cap 40 to create a seal.
- FIG. 19 is a view through the lens 105 of the camera of the endoscope 100 looking at collapsed tissue through the transparent balloon 60 and guide tip 62 .
- the surgeon has steered the guide tip 62 of the balloon 60 to a centered position of the collapsed tissue opening 204 of the tissue 200 . Since the tissue guide 200 is transparent, tissue 200 can be seen therethrough.
- the surgeon is confident that the balloon access device 30 and endoscope 100 are aimed at the center of the collapsed lumen, and that the balloon access device 30 and endoscope 100 can now be pushed down a center of the lumen such as the large intestine.
- several of the medical professional operators were surprised at the depth of penetration of the balloon access device 30 equipped endoscope 100 in such a short time.
- FIG. 20 is a cross sectional view of a blow molding dies that is configured to make the balloon of FIG. 12 .
- the blow molding die 210 has a piece of expandable polyethylene tubing 220 placed along a longitudinal axis of the balloon shape of the die 210 .
- warm compressed air can be blown to expand the polyethylene tubing 220 against the cooler inner walls of the mold 210 which can be held slightly below the melting temperature of the polyethylene tubing 220 .
- the tubing 220 has expanded against the walls of the mold 210 and sets in the net or normal “as manufactured” shape. Then the molded balloon 60 can be extracted by opening the die 210 to release the balloon 60 .
Abstract
Provided is a balloon access device having a cap coupleable to an endoscope and a balloon for sealing with the cap when expanded. The balloon access device allows a physician to both separate collapsed tissue and visualize the path of the endoscope without administering insufflation gas to the collapsed area of a patient.
Description
- This application claims the benefit of U.S. Provisional Application No. 61/471,957 filed Apr. 5, 2011 and International Application No. PCT/US2012/032248 filed Apr. 5, 2012, which are hereby incorporated herein by reference.
- The present apparatus embodied relates, in general, to medical devices and in particular, to access balloons used in combination with endoscopes.
- Endoscopes are well-known in the art and are flexible devices that are inserted into a natural body orifice such as the mouth or anus to provide visual and surgical access to portions of the upper and lower Gastro Intestinal (GI) tract. Endoscope accessible portions of the lower GI tract extend from the anus to the small intestine, and during this journey, the flexible endoscope must traverse a torturous convoluted path through the anus, the rectum, and through the large intestine to the ileocecal opening of the small intestine. The torturous path includes an “S” shaped passage through the rectosigmoid junction and the sigmoid colon, and around several larger than right angled bends of the splenic flexure and hepatic flexure. Additionally, in small bowel enteroscopy, an endoscope must traverse a large torturous convoluted path having multiple “S” shaped passages.
- Before insertion of the endoscope, the patient is given drugs to purge fecal matter from the lower GI tract. Once emptied, the tubular walls of the large intestine can flatten or collapse together into a flattened tubular configuration. The collapsed intestines may inhibit passage of the flat face of the distal end of the endoscope, and the collapsed tissue can inhibit visualization by pressing against or near to a camera mounted within the flat face. To enhance the passage of the endoscope through the collapsed lower GI tract and to improve visualization, insufflation gas is routinely pumped into the patient's lower GI tract to expand and distend the collapsed tubular tissues. The expanded walls may improve visualization and reduce tissue contact with the flat face of the endoscope as it is pushed farther and farther into the insufflated lower GI tract. The distal portion of the endoscope is steerable, and the insufflated tissue can provide room for the surgeon to visually steer the endoscope through the path ahead.
- The administration of insufflation gas to the lower GI tract can induce abdominal discomfort, and this has led to the common practice of using professional anesthesia providers to induce anesthesia to “knock-out” the patient. Additionally, insufflation gas may cause lengthening of anatomy and spontaneous perforation. Post surgical recovery times are provided to allow the patient to purge insufflation gas and to awaken from the anesthesia. CO2 gas control systems, CO2 tanks, and CO2 gas heaters have found their way into the operating room to provide CO2 as a insufflation gas. The CO2 gas is more readily absorbed through the patient's intestinal wall to reduce the post operative recovery time.
- The present invention provides a balloon access device having a cap coupleable to an endoscope and a balloon for sealing along with the cap when expanded. The balloon access device allows a physician to both separate collapsed tissue and visualize the path of the endoscope without administering insufflation gas to the collapsed area of a patient.
- In one embodiment, the balloon access device includes a balloon expandable from a deflated shape to an inflated shape, the balloon having a proximal end and a distal end, wherein a dome portion is formed on the distal end of the balloon, and a cap having a proximal end configured to be coupled to a distal end of an endoscope and a distal end for sealing with the proximal end of the balloon when the balloon is expanded.
- In another embodiment, the 1 the inflated shape includes a non-pressurized shape and a fully inflated shape.
- In still another embodiment, the proximal end of the balloon includes a proximal collar configured to couple to a distal end of a catheter and a sealing surface configured to seal with the cap.
- In yet another embodiment, the cap includes an endoscope receptacle extending into the cap through the proximal end of the cap for receiving the distal end of the endoscope.
- In a further embodiment, the cap includes a stop that engages a front face of the endoscope when the endoscope is received within the cap, and wherein an opening is provided through the stop to distally expose at least one of a light, opening, optics or operative channel on the front face of the endoscope.
- In another embodiment, the cap includes a balloon sealing portion proximate the distal end of the cap, the balloon sealing portion including a circular groove that retains and seals with a circular rib of the balloon.
- In still another embodiment, the cap includes an outwardly flaring balloon sealing portion that is flexible outwardly relative to a body of the cap to create a seal with the balloon.
- In yet another embodiment, the outwardly flaring balloon sealing portion prevents the balloon from being unseated from the cap.
- In a further embodiment, the cap includes a rib on an interior portion of the cap, and wherein the sealing surface of the balloon nests and seals with a receptacle of a balloon sealing portion and the rib.
- In another embodiment, the dome portion is hemispherical or ellipsoidal in shape.
- In still another embodiment, the balloon is non-concentrically disposed relative to the endoscope.
- In yet another embodiment, the balloon includes a distally located guide tip on a distal portion of the dome portion for guiding an operator in parting and spreading non-insufflated gastrointestinal tissue during operation.
- In a further embodiment, the balloon is a transparent hollow balloon.
- In another embodiment, the balloon access device includes a lock mechanism for securing a catheter relative to the endoscope to maintain a sealing contact between the balloon and the cap.
- In still another embodiment, the lock mechanism includes a releasably lockable clamp mechanism that contacts and grips the catheter.
- In yet another embodiment, the balloon access device includes a lock mechanism including a balloon insertion tube for receiving the balloon when the balloon is in the deflated state, the tube having a length greater than a y-portion of an operative channel within the endoscope to guide the balloon into and beyond the y-portion, and a clamp for securing a catheter relative to the endoscope to maintain a sealing contact between the balloon and the cap.
- In a further embodiment, the balloon access device includes a balloon insertion tube for receiving the balloon when the balloon is in the deflated state, the balloon insertion tube having a length greater than a y-portion of an operative channel within the endoscope to guide the balloon into and beyond the y-portion.
- In another embodiment, the balloon access device is in combination with a catheter, wherein the proximal end of the balloon is coupled to a distal end of the catheter.
- In still another embodiment, the balloon access device is in combination with an endoscope, wherein the proximal end of the cap is coupled to the distal end of the endoscope.
- In yet another embodiment, the cap is integral with the endoscope.
- According to another aspect of the invention, a balloon access device for use with an endoscope is provided. The device includes a balloon expandable from a deflated shape to an inflated shape, the balloon having a proximal end and a distal end, wherein a dome portion is formed on the distal end of the balloon, a cap having a proximal end configured to be coupled to a distal end of an endoscope and a distal end for sealing with the proximal end of the balloon when the balloon is passed through the cap and expanded to the inflated shape, and a balloon insertion tube for receiving the balloon when the balloon is in the deflated state, the balloon insertion tube having a length greater than a y-portion of an operative channel within the endoscope to guide the balloon into and beyond the y-portion.
- According to still another aspect of the invention, a method of creating a seal between a balloon and a cap is provided, the balloon having a proximal end having a sealing surface and proximal collar coupled to a distal end of a catheter, and the cap having a proximal end coupled to a distal end of an endoscope, the method including advancing the catheter and balloon through an operative channel of the endoscope until the balloon is positioned distal the distal end of the cap, expanding the balloon from a deflated shape to at least a partially inflated shape, and moving the balloon proximally towards the cap so that the sealing surface (66) abuts a distal end of the cap to create a seal between the cap and the balloon.
- According to yet another aspect of the invention, a method of performing a gastrointestinal procedure on a patient having gastrointestinal tissue in a non-insufflated state using an endoscope and balloon access device installed upon the endoscope is provided, the balloon access device including a cap coupled to a distal end of the endoscope and an at least partially inflated balloon coupled to a distal end of a catheter received in an operative channel of the endoscope, the method including advance the endoscope through the gastrointestinal tissue, guiding the endoscope using a camera on a distal end of the endoscope and a guide tip on a distal end of the balloon, and spreading the tissue using a body of the balloon and the guide tip, wherein the balloon is transparent so that an operator can view the tissue through the balloon using the camera and the operator can center the guide tip in a gastrointestinal tract.
- In one embodiment, the method includes retracting the endoscope from the gastrointestinal tissue, wherein during the retracting a balloon sealing portion of the cap flattens a luminal fold in the tissue.
- The foregoing and other features of the invention are hereinafter described in greater detail with reference to the accompanying drawings.
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FIG. 1 is an isometric view of an embodiment of a transparent balloon access device deployed on an endoscope. -
FIG. 2 is an isometric view of the balloon access device with the transparent balloon shown in a normal unexpanded dome shape. -
FIG. 3 is an isometric exploded view of the balloon access device -
FIG. 4 is an isometric view of the balloon access device with the balloon shown collapsed by drawing a vacuum prior to being inserted into an adjacent balloon insertion tube. -
FIG. 5 is an isometric view of the balloon access device with a balloon seal cap placed on a distal end of the scope and with a dashed line illustrating a path where the balloon access device can enter an open instrument channel which exits within the attached balloon seal cap. -
FIG. 6 is a side section view of the flexible shaft of the endoscope with an un-inflated balloon being pushed longitudinally along an instrument passage of the endoscope. -
FIG. 7 is a side view showing the balloon after emerging from a distal end of the endoscope. -
FIG. 8 is a side view showing the balloon inflated after emerging from a distal end of the endoscope. -
FIG. 9 shows an exploded cross sectional view of an embodiment of the balloon and balloon seal cap. -
FIG. 10 shows an exploded cross sectional view of an embodiment of the balloon and balloon seal cap. -
FIG. 11 shows an exploded cross sectional view of an embodiment of the balloon and balloon seal cap. -
FIG. 12 shows an exploded cross sectional view of an embodiment of the balloon and balloon seal cap. -
FIG. 13 shows the balloon ofFIG. 12 in a normal un-inflated shape wherein the inner air pressure is the same as the outside atmospheric pressure. -
FIG. 14 shows the balloon ofFIG. 12 in an inflated shape where about 2.5 ml of air have been placed into the balloon and cannula. -
FIG. 15 shows the balloon ofFIG. 12 in an inflated shape where about 3.5 ml of air have been placed into the balloon and cannula. -
FIG. 16 shows the balloon ofFIG. 12 in an inflated shape where about 5 ml of air have been placed into the balloon and cannula. -
FIG. 17 is a side cross sectional view of the balloon access device installed upon an endoscope as the balloon access device spreads tissue to burrow through non-insufflated and collapsed luminal tissue. -
FIG. 18 is an enlarged side cross sectional view of the balloon access device ofFIG. 17 showing spreading forces on the collapsed luminal tissue. -
FIG. 19 is a view through the camera lens of the endoscope showing a guide tip of the balloon moved to a centered position in a collapsed tissue lumen opening to ensure passage of the balloon and endoscope down a center of the lumen. -
FIG. 20 is a cross sectional view of a blow molding dies that is configured to make the balloon ofFIG. 12 . -
FIG. 21 is an isometric view of a clamp mechanism to clamp or lock the tensioned cannula relative to the endoscope to maintain a sealing contact between balloon and seal cap. -
FIG. 22 is an alternate a clamp mechanism. -
FIG. 23 is a front view of a distal end of an endoscope. - The following description of certain examples of the medical apparatus should not be used to limit the scope of the medical apparatus. Other examples, features, aspects, embodiments, and advantages of the medical apparatus will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the medical apparatus. As will be realized, the medical apparatus is capable of other different and obvious aspects, all without departing from the spirit of the medical apparatus. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
- It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
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FIG. 1 is an isometric view of one embodiment of aballoon access device 30 installed upon anendoscope 100. Theballoon access device 30 is configured to fit within anoperative channel 102 of theendoscope 100 when undeployed, and to deploy a transparenthollow balloon 60 across adistal face 104 of theendoscope 100. Theballoon 60 is transparent so that scope optics can view GI tissue there through, andballoon 60 can be dome shaped on at least a distal end. A distally locatedguide tip 62 is supported solely on a distal end of the dome shape by amembrane wall 65 of theballoon 60. The configuration of the deployedguide tip 62 andballoon 60 on theendoscope 100 is such that non-insufflated GI tissue can be parted and spread with thetip 62 and theballoon 60 in response to pushing with theendoscope 100. Theballoon access device 30 andendoscope 100 as configured can rapidly burrow along a non-insufflated and at least partially pinched GI tract such as the non-insufflated lower GI tract, or can pass through an expanded or insufflated portion of the GI tract. As will be described in detail later, the deployedtransparent guide tip 62 can be visually aimed at a center of the collapsed lumen of the non-insufflated GI tract by articulating adistal end 106 of theendoscope 100. When theguide tip 62 is aimed, pushing theendoscope 100 initiates the spreading and parting of the collapsed tissue walls with theballoon access device 30, thereby enabling passage of theendoscope 100 along a center of the non-insufflated lumen of the GI tract. - As shown in
FIG. 1 , theballoon access device 30 is shown inserted into anoperative channel 102 of theendoscope 100 and comprises aproximal handle portion 50 extending from a proximal opening of theinstrument channel 102. Abiopsy valve 108 is provided on the proximal opening of theinstrument channel 102 and ahollow cannula 70 extends from theproximal handle portion 50, through thebiopsy valve 108, and into theinstrument channel 102. A distal end of thecannula 70 is secured to a proximal end of thetransparent balloon 60 shown extending across a distally locatedfront face 104 of theendoscope 100. - A
balloon seal cap 40 of theballoon access device 30 is removably secured to thedistal end 106 of theendoscope 100 and forms a fluid tight seal with at least one surface on a proximal end of theballoon 60. Alternatively, it will be appreciated that thecap 40 may be integral with the endoscope. Theseal cap 40 may be any suitable shape, such as cylindrically shaped. The sealing interaction of theseal cap 40 with theendoscope 100, and theballoon 60 with theseal cap 40, can create a sealed volume across thefront face 104 of theendoscope 100 to prevent the egress of unwanted fluids across theoptical lens 105 of an endoscope camera located on the front face 104 (seeFIG. 17 ). Additionally, once the seal is formed, theballoon 60 can be further secured to theseal cap 40 by applying a vacuum to theinstrument channel 102 to draw theballoon 60 into further engagement with theseal cap 40. Alternately, a vacuum port (not shown) in theendoscope 100 can be used to draw theballoon 100 against thefront face 104 of the endoscope. Theballoon device 30 can be rapidly deployed and inflated into place on theendoscope 100 for advancement, and rapidly deflated and withdrawn from theinstrument channel 102 of theendoscope 100 for the insertion and deployment of another surgical instrument from theinstrument channel 102 into the lower GI tract. An example of such another surgical instrument can be, but is not limited thereto, a snare or tissue biopsy device to retrieve a tissue sample from a suspect site. -
FIG. 2 shows an isometric view of theballoon access device 30. The handle orproximal handle portion 50 includes ahollow passage 72 that extends longitudinally through thehandle portion 50, through thehollow cannula 70, and operatively connects to an inner volume of theballoon 60.Handle portion 50 includes aproximal luer lock 52 to removably engagehollow passage 72 with compressed gas and/or vacuum lines and or fluid lines, avalve 54 to control the flow of gas and vacuum to thedistal balloon 60, agrip 56, andorientation wings 58.Hollow cannula 70 can be configured to have sufficient length to work with anendoscope 100 as described above, or long enough to work with a variety ofendoscopes 100 with differing lengths. - In
FIGS. 2 and 3 , thetransparent balloon 60 is shown in the normal unpressurized or “as manufactured” shape wherein thehollow balloon 60 can have adistal dome 64 and at least one sealingsurface 66 on a proximal side. Theballoon 60 is configured to be symmetrical and concentric about a longitudinal axis of theballoon 60 and a longitudinal axis of thecannula 70, and thedistal dome 64 can be hemispherical or elliptical in shape about the axis. Aproximal collar 68 securely seals theballoon 60 to thecatheter 70 via an attachment method such as but not limited thereto, by an adhesive or a shrink fit as described later.Proximal collar 68 can be cylindrical and can include a conical or curved portion for engaging with or sealing with theinstrument passage 102 ofendoscope 100. Theguide tip 62 can be a separate piece that can be secured to the dome of theballoon 60 in the exemplary manner. As best shown inFIG. 3 , theguide tip 62 has a rounded distal tip and a steppedproximal post 69 that can be adhesively secured into adistal collar 67 formed from theballoon membrane 65. Alternately, the guide tip could be a rounded bump formed from theballoon membrane 65, or an injection of sealing material into thedistal collar 67 such as a gob of silicone placed inside thedistal collar 67. Theguide tip 62 can be transparent for visualization therethrough, or can be opaque or translucent. As shown,guide tip 62 is supported by only theballoon membrane 65 which can provide some freedom of motion of thetip 62 relative to theendoscope 100. This freedom of motion can beneficial when navigating through collapsed tissue A hollowballoon insertion tube 80 is shown distal to theguide tip 62 may be provided to receive and store theballoon 60 andtip 62 within when the balloon is deflated by drawing a vacuum prior to being inserted into an adjacentballoon insertion tube 80 , andtube 80 can have a length sufficient to guide theballoon 60 andtip 62 into and beyond a “Y” portion of theoperative channel 102 within theendoscope 100, A deflatedballoon 60 is shown inFIG. 4 just prior to insertion within a hollow of theballoon insertion tube 80. Before insertion,balloon 60 may have one or more deflation folds of theballoon 60 wrapped or twisted about a longitudinal axis of the balloon (not shown) to create a more compact and organized deflatedballoon 60. -
FIG. 5 shows theaccess device 30 ready for installation onto theendoscope 100. In this view, thecylindrical seal cap 40 is positioned for placement onto thedistal end 106 of theendoscope 100. Theballoon 60 is fully deflated as shown inFIG. 4 , and resides within theballoon insertion tube 80. A dashed line is provided to show how theballoon insertion tube 80 of theaccess device 30 can be inserted into the proximal opening of theinstrument channel 102 ofendoscope 100, and if abiopsy valve 108 is provided, through thebiopsy valve 108. Theballoon insertion tube 80 can be configured to feed theballoon 60 directly into theinstrument channel 102 through theballoon insertion tube 108 with theguide tip 62 leading the collapsed balloon.Balloon insertion tube 80 can be the length as shown, or can be longer to guide the collapsed balloon past a “Y” withininstrument channel 102Balloon insertion tube 80 can be constructed from a slick or lubricious plastic such as PTFE, or can be lubricated to reduce egress of the collapsedballoon 60 into or out of thetube 80.FIG. 1 shows how theballoon insertion tube 80 can be retracted proximally around thecannula 72 to a position adjacent to thehandle portion 50 after the full insertion of theaccess device 30 into theinstrument channel 102. -
FIG. 6 shows the fully deflated balloon as it is being pushed downchannel 102 of theendoscope 100 prior to emergence of theballoon 60 from thedistal face 40 of theendoscope 100. Theguide tip 62 can be configured with a tip diameter that is close to the inner diameter of theinstrument channel 102 of theendoscope 100, and an appropriate length so that thetip 62 will not cock and jam within theinstrument channel 102 of thescope 100. The tip of theguide tip 62 can be any shape that is conducive to steering the guide tip along theinstrument channel 102 such as therounded tip 62 shown, or any other guiding shape such as but not limited to a cone. -
FIG. 7 shows theballoon 60 after emerging from thedistal end 106 of theendoscope 100. Once theballoon 60 is extended from theendoscope 60 and beyond theseal cap 40, atmospheric air may be induced through thehollow passage 72 to allow theballoon 60 to expand into the non-pressurized shape as shown. Once theballoon 60 is fully inflated with a fluid, such as air, to an operating pressure or volume, theballoon 60 is pulled proximally in the direction of the arrow to engage theballoon 60 with theseal tip 40. This pulling of theballoon 60 to seal against theseal tip 40 can be accomplished by pulling on thecatheter 70 or thehandle portion 50 outside of the patient. If required, theballoon 60 is free to pivot somewhat about the attachment point to thecannula 70 to center itself in theseal cap 40. -
FIG. 8 shows the fully inflatedballoon 60 pulled against theseal cap 40 at thedistal end 106 of theendoscope 100. In this view, it can be seen that the inflation of theballoon 60 has changed the at least oneproximal sealing surface 66 into a rounded dome that has maintained a fluid-tight seal with theseal cap 40. The rounding of the at least oneproximal sealing surface 66 has moved thedistal dome 64 distally, and thedistal dome 64 has expanded both in diameter and longitudinally as shown. The inflation of theballoon 60 can be accomplished prior to insertion of theendoscope 100 into the patient, or after insertion of theendoscope 100 into the natural orifice such as the anus of the patient. -
FIGS. 9 through 12 shows exploded cross sectional views of alternate exemplary embodiments of theballoon 60, andballoon seal cap 40 of the present apparatus. Theguide tip 62 is also depicted. The exemplary and previously described embodiment ofballoon 60 and seal collar 90 is best shown inFIGS. 2, and 3 , and is shown in cross section inFIG. 11 . The reader is advised to note that theballoon access device 30 is not limited to the previously described embodiment ofFIG. 11 , nor to the alternate embodiments ofFIGS. 9-10 and 12 , nor to any of the materials or manufacturing techniques described. Since many of the embodiments of the balloons and seal caps have features that perform the same function, like numbers are identified with sub-identifiers and are meant to correspond to like features on alternate embodiments. For example, aballoon 60 in one embodiment may become a balloon 60 a in another alternate embodiment. If differences in functions exist between like numbers such as sealing surfaces 66 and 66 a, the description associated with the number and sub-identifier will prevail for that embodiment. All embodiments described below have aballoon 60, 60 a. 60 b, 60 c and aseal cap - The embodiment of
FIG. 11 comprises thehollow balloon 60, theballoon seal cap 40 and theguide tip 62. This embodiment uses a ring-in-groove seal between the balloon andseal cap 40. Theballoon 60 comprises the previously describeddistal dome 64, themembrane 65, and the at least one sealingsurface 66. With this embodiment of theballoon 60, the at least one sealingsurface 66 of the balloon comprises two distinct portions. The first portion comprises a circular rib 61 that rings the longitudinal axis of theballoon 60 and is configured to engage with and seal with the circular groove 41 in theseal cap 40. The second portion of the at least one sealingsurface 66 is a dish shaped portion that extends substantially radially inwardly between the largest diameter ofdistal dome 64 to the circular rib portion. The dish shaped portion can be configured to seal against at least adistalmost surface 48 of thecap 40. Thedistal collar 67 ofballoon 60 extends distally from thedome 64 and is configured to seal with thedistal tip 62. Theproximal collar 68 extends proximally from the at least one sealingsurface 66 and is configured to seal with the hollow cannula 70 (seeFIGS. 2 and 3 ). - The
balloon seal cap 40 ofFIG. 11 comprises a hollow cylinder having anendoscope receptacle 42 extending into a proximal end of theseal cap 40 to receive and seal with thedistal end 106 of theendoscope 100. Acircular rib 45 can be provided at a distal end of theendoscope receptacle 42 to act as a stop that engages thefront face 104 of theendoscope 100 once thescope 100 is fully received within theseal cap 40. Anopening 46 is provided through therib 45 to distally expose the optics, lights, and openings on theendoscope front face 104. Aballoon sealing portion 44 extends distally from therib 45 and includes the previously described circular groove 41 to retain and seal with the circular rib 61 of theballoon 60. Thedistalmost surface 48 of theballoon sealing portion 44 can seal with theballoon 60. As shown, thereceptacle 42, theopening 46, and theballoon sealing portion 44 comprise the open hollow of thecylindrical seal cap 40. - The embodiment of
FIG. 9 comprises a balloon 60 a and aseal cap 40 a and is configured to provide a ball-in-socket type of sealing. The balloon 60 a has a substantially curved at least one sealing surface 66 a that nests within and seals with an outwardly flaring cuplike balloon sealing portion 44 a of theseal cap 40 a.Seal cap 40 a can be configured to flare outward to provide a larger support for the balloon 60 a and can exceed the diameter of theendoscope 100.Seal cap 40 a is a hollow cylinder that further comprises an endoscope sealing receptacle 42 a, circular rib 45 a, opening 46 a, as well as the previously described balloon sealing portion 44 a. Balloon 60 a includes a distal dome 64 a, amembrane 65a, a distal collar 67 a, and a proximal collar 68 a. Cuplike balloon sealing portion 44 a of theseal cap 40 a can also be used to flatten luminal folds, for example to discern pathologies behind the luminal folds. - The embodiment of
FIG. 10 comprises a balloon 60 b and a seal cap 40 b and uses a peg- in-hole arrangement for sealing. In this embodiment, the balloon 60 b is sized to have about the same radial diameter as thedistal end 106 of the endoscope and the balloon 60 b nests and seals with a receptacle of a cylindrical balloon sealing portion 44 a. Mushroom shaped balloon 60 a comprises adistal dome 64 with at least one sealing surface 66 a that is substantially flat and circular. Balloon 60 b is configured to fit snugly in the cylindrical balloon sealing portion 44 a and to seal the at least one sealing surface 66 a against a rib 45 b. Cylindrically shaped cap 40 b further comprises anendoscope sealing receptacle 42 b, and an opening 46 b extending through rib 45 b. Balloon 60 b includes adistal dome 64 b, a membrane 65 b, a distal collar 67 b, and aproximal collar 68 b. - The embodiment of
FIG. 12 comprises a balloon 60 c andseal cap 40 c that is configured to provide a flat-to flat seal as the balloon 60 c is pulled against a distalmost surface 48 c ofseal cap 40 c. As the inflating balloon 60 c changes shape from the mushroom shape to a rounded elliptical ball shape, the seal can move to a beveled portion of a distal balloon sealing portion 44 c. Balloon 60 c may be substantially mushroom shaped with a substantially flat at least one sealingsurface 66 c adjacent to adome 64 c. Unlike the embodiment ofFIG. 10 , the balloon 60 c is larger than an outer diameter of aseal cap 40 c and overhangs theseal cap 40 c. Cylindrically shapedcap 40 c further comprises an endoscope sealing receptacle 42 c,circular rib 45 c, and opening 46 c. Balloon 60 a further comprises a distal dome 64 a, amembrane 65 a, a distal collar 67 a, and a proximal collar 68 a. - The
balloons 60, 60 a, 60 b, and 60 c are transparent and can be constructed from a substantially rigid balloon material or an elastomeric material. Substantially rigid cannot expand greatly beyond the normal “as made” shape when inflated and many such materials are well known in the art for use as expansion balloons for cardiac stent deployment products. Elastomeric balloons are expandable, and can comprise material such as, for example, some grades or durometers of elastomers such as polyurethane, latex, natural rubbers, silicones and the like. - The seal caps 40, 40 a, 40 b, arid 40 c can comprise a substantially rigid material such as a thermoform plastic, a thermoset plastic, or a metal. With rigid embodiments of the caps, it is the deformation of the
balloon 60, 60 a, 60 b, and 60 c against the rigid cap that creates the seal. In yet another embodiment, the seal caps 40, 40 a, 40 b, and 40 c can comprise an elastomeric material such as but not limited to a polyurethane, a polyethylene, silicone, rubber and the like. As such, the elastomeric properties of this embodiment can have sufficient rigidity to generally support the balloon against normal surgical operating forces, yet provide atraumatic characteristics, should substantial resistance be encountered. Rigidity of the elastomeric material could be altered by changing a durometer of the material during manufacturing. - Alternately, the distal
balloon sealing portion 44, 44 a, 44 b, 44 c of thecaps balloon 40, theendoscope 100 or both. - The
distal guide tip 62 can be used with any balloon embodiments such as 60, 60 a, 60 b, and 60 c. Thedistal guide tip 62 can include the steppedproximal post 69 which is configured to fit within thedistal collar 67, 67 a, 67 b, or 67 c to create a smooth exterior when mated with theballoon 60, 60 a, 60 b, or 60 c (see at leastFIGS. 1&2 ). Theguide tip 66 and cannula70 can be adhered to theballoon 60, 60 a, 60 b, or 60 c with adhesives such as but not limited to polyurethanes or cyanoacrylates. Or, alternate fastening techniques can be used withdistal guide tip 62 andcannula 70 such as but not limited to heat staking, ultrasonically welding, or laser welding. Whereas these fastening techniques are described for the attachment of thedistal guide tip 62, they can be used for all other embodiments of the apparatus such as elements of thehandle portion 50 or attachment of theproximal collar 68 to thecannula 80. -
FIGS. 13-16 are side views that detail the inflation of the distal portion of theballoon access device 30 on theendoscope 30. The mushroom shaped balloon 60 c andcap 40 c are the embodiments shown in cross section inFIG. 12 . For this inflation description, only the embodiment ofFIG. 12 will be described, and the description is based on physical measurements of an actual balloon 60 c andcap 40 c as the balloon 60 c is inflated. -
FIG. 13 shows balloon 60 c in a normal un-inflated normal shape wherein the inner air pressure is the same as the outside atmospheric pressure and the balloon 60 c has assumed the “as manufactured” mushroom shape. As shown, the normal shape of balloon 60 c is substantially mushroom shaped, and comprises thedistal dome 64 c attached to the proximal at least one sealingsurface 66 c. The at least one sealingsurface 66 c is substantially flat and has been pulled back (via catheter 70) to seal against a ring of contact with the ring shaped distalrnost surface 48 c of theseal cap 40. With atmospheric pressure within balloon 60 c, and thevalve 54 of thehandle portion 50 closed, theballoon 62 is very flaccid and theguide tip 62 is substantially supported by only the membrane 65 c. Pushing theguide tip 62 towards thecannula 70 creates a large indention crater with thetip 62 standing proud within as thetip 62 is completely pushed into thedome 64 c. Measurements of the balloon 60 c ofFIG. 13 show an outer dimension D1 of about 18 mm at the widest diameter, and the sum of io longitudinal lengths A1 and B1 equal about 11 mm. The balloon 60 c andcannula 70 of the actual test balloon 60 c required about 2-2.1 ml of air to arrive at the flaccid shape ofFIG. 13 . -
FIG. 14 is another side view of theaccess device 30 on theendoscope 30 where about 2.5 ml of air have been placed into the balloon 60 c andcannula 70. At this air volume, thedistal dome 64 c maintained substantially the same shape, but the at least one sealingsurface 66 c domed slightly and pushed thedistal dome 64 c andguide tip 62 in the distal direction. This increased the sum of longitudinal lengths A1 and A2 to about 11.7 mm without an appreciable change in D2. It is visually seen that the majority of the 0.7 mm balloon longitudinal length change occurred in the doming of the at least one sealingsurface 66 c which increased dimension B2. Pushing on thedistal guide tip 62 so that it is embedded within the balloon created a slightly smaller dish shaped indent with theguide tip 62 standing proud in the indent. The increased volume of fill also increased the resistance to movement of thetip 62. The balloon 60 c did not appear to move longitudinally from pushing on theguide tip 62 but expanded radially when filled with 2.5 ml of air. -
FIG. 15 is another side view of theaccess device 30 on theendoscope 30 where about 3.5 ml of air have been placed into the balloon 60 c andcannula 70. Once again, thedistal dome 64 c maintained substantially the same shape and the at least one sealingsurface 66 c continued to move towards a dome shape. The longitudinal length (sum of A1 and B1) increased to about 12.2 mm with the majority of the 0.5 mm additional length increase coming from additional doming of the at least one sealingsurface 66 c. The dimension D2 increased slightly to 18.73 mm. When theguide tip 62 was pushed distally into the balloon 60 c, thedistal guide tip 62 had substantial resistance. Pushing on thedistal guide tip 62 so that it is embedded within the balloon created a noticeably smaller dish shaped indent with theguide tip 62 standing proud in the indent. As theguide tip 62 was embedded into the balloon 60 c, the balloon 60 c also moved distally as some of the distal movement of theguide tip 62 was transferred to the balloon 60 c. Visually, it appears that there is about the same amount of distal longitudinal movement of the balloon 60 c as there is distal embedding of theguide tip 62. The distal movement of the balloon 60 c is primarily in the at least one sealingsurface 66 c . -
FIG. 16 is another side view of theaccess device 30 on theendoscope 100 where about 5 ml of air have been placed into the balloon 60 c andcannula 70. The diameter D1 reduced back to the original 18 mm diameter and the longitudinal length (sum of A1 and B1) increased to about 14.75 mm. Once again, the majority of the additional length increase (2.55 mm) appears to be coming from additional doming of the at least one sealingsurface 66 c. There was some additional rounding of thedistal dome 64 c which may account for some of the reduction in overall diameter D1 and some of the length change. With respect to pushing distally on theguide tip 62 with 5 ml of air, theguide tip 62 has substantial resistance and the combination of balloon geometry (mushroom shape), fill volume (ml) balloon membrane 65 c thickness and material durometer have combined to provide an unexpected shift in load transfer that seems to prevent theguide tip 62 from creating much of a dish indent in the balloon. With this fill volume, a substantial portion of the movement of theguide tip 62 towards thecannula 70 comes from a longitudinal compression of the balloon 60 c to a different elliptical shape, and not from dishing theguide tip 62 into theballoon 60. This effect may be advantageous to tunneling through non-insufflated tissue lumens to maintain the distalmost positioning of theguide tip 62 during airless burrowing of theaccess device 30 and theendoscope 100. It is the distalmost position of theguide tip 62 which can enable theguide tip 62 to initiate separation of the collapsed luminal tissue. Once the initial separation occurs, the collapsed tissue separation may then be transferred to the outer surface of the balloon 60 c as theaccess device 30 andendoscope 100 advances along the GI tract. -
FIGS. 17 and 18 are side cross sectional views of theballoon access device 30 installed upon anendoscope 100 as it burrows through non-insuf Rated luminal tissue of the GI tract.FIG. 18 is an enlarged view of a portion of the cross sectional view ofFIG. 17 . As shown, the luminal tissue has collapsed, and theballoon access device 30 is providing both a visualization pocket and a tissue separator for the operator of theendoscope 100 so that theendoscope 100 can be easily advanced farther into the patient. An arrow is provided to indicate the direction of movement of theballoon access device 30 andendoscope 100. In this cross section, the collapsedluminal tissue 200 is partially spread by theballoon access device 30 andendoscope 100 as it burrows towards a bend in thetissue 200. Theendoscope 100 is shown in cross section and has theinstrument channel 102 andfront face 104 shown.Front face 104 of thescope 100 further comprises alens 105 that views tissue through thetransparent balloon 60. A viewing angle of thelens 105 is shown as dashed lines extending from the lens 105 (seeFIG. 18 ). To prevent reduction of the viewing angle, thecap 40 may protrude above thefront face 104 of the scope between about 0.5 mm to about 6mm. Alternately, thecap 40 may protrude above thefront face 104 of the scope between about 1mm to about 3 mm. If desired, the vacuum in theendoscope 100 can be used to draw theballoon 100 against thefront face 104 and thelens 105 of theendoscope 100. Thehollow catheter 70 extends longitudinally along theinstrument channel 102 and is attached to theballoon 60 which is inflated (via the catheter 70) an amount that substantially restricts the embedding of theguide tip 62 into the balloon as described previously. Thecap 40 is sealed against the endoscope and theballoon 60 is sealed within thecap 40 to seal thefront face 104 of theendoscope 100 from fluids, mucous, and residual natural materials normally found within the luminal structure. As shown, ring 61 of the balloon is embedded in the groove 41 in theseal cap 40 to create a seal. -
FIG. 18 is an enlarged side cross sectional view ofFIG. 17 . In this view, the spreading of thecollapsed opening 204 of thetissue 200 can be seen through thetransparent balloon 60. Thelens 105 of the endoscope can be seen with dashed lines indicating a field of view through theballoon access device 30. Arrows show how a spreading force F1 is applied from theguide tip 62 onto thetissue 200. The guide force F1 is perpendicular or normal to the point of contact on the tissue. A second spreading force F2 is exerted on the tissue by theinflated balloon 60. Once again, the spreading force F2 is perpendicular or normal to the point of contact of themembrane 65 of theballoon 60 on the tissue. -
FIG. 19 is a view through thelens 105 of the camera of theendoscope 100 looking at collapsed tissue through thetransparent balloon 60 andguide tip 62. In this view, the surgeon has steered theguide tip 62 of theballoon 60 to a centered position of the collapsed tissue opening 204 of thetissue 200. Since thetissue guide 200 is transparent,tissue 200 can be seen therethrough. Once theguide tip 62 of theballoon 60 is centered, the surgeon is confident that theballoon access device 30 andendoscope 100 are aimed at the center of the collapsed lumen, and that theballoon access device 30 andendoscope 100 can now be pushed down a center of the lumen such as the large intestine. During testing of the device in actual tissue, several of the medical professional operators were surprised at the depth of penetration of theballoon access device 30 equippedendoscope 100 in such a short time. -
FIG. 20 is a cross sectional view of a blow molding dies that is configured to make the balloon ofFIG. 12 . As shown, the blow molding die 210 has a piece of expandable polyethylene tubing 220 placed along a longitudinal axis of the balloon shape of thedie 210. Once the tubing 220 is heated, warm compressed air can be blown to expand the polyethylene tubing 220 against the cooler inner walls of themold 210 which can be held slightly below the melting temperature of the polyethylene tubing 220. When the flow of warm expansion air is shut off, the tubing 220 has expanded against the walls of themold 210 and sets in the net or normal “as manufactured” shape. Then the moldedballoon 60 can be extracted by opening thedie 210 to release theballoon 60. The dashed lines show the expansion stages of the polyethylene tubing 220 as it expands towards themold walls 210. The natural tendency of the hot tubing 220 is to expand as a sphere until the expanding material contacts the walls of thedie 210. As a consequence, different portions of the balloon membrane 65 (seeFIG. 2 ) will be thinner than others and may taper between the thick and thin portions. For example, the portions of the tubing 220 that form theproximal collar 68 anddistal collar 67 will expand not at all or very slightly and will be thicker than theballoon membrane 65 at the points of largest expansion away from the longitudinal axis. The shape of the balloon can affect the location of the thick andthin membrane 65 portions and a stiffened disk may be found near the proximal anddistal collars balloon 60 expands (seeFIGS. 13-16 ). This thickening could affect or restrict the displacement of theguide tip 62 from tissue contact by creating a more rigid “island” ofmembrane 65 around thedistal tip 62 that may explain the deflection behavior described previously. In an alternate embodiment, theballoon 60 can be further stiffened in local areas by a dipping process to build up the balloon wall thickness. For example, the same material as theballoon membrane 65 can be used (such as polyurethane), or alternate dipping material may be used. - With some embodiments of the balloon such as that found in
FIG. 12 , a tension or pulling force may be applied to thecannula 70 to pull the balloon 60 c into contact with theseal cap 40 c to create a seal. It may be further desirable to include a lock orclamp mechanism 250 to hold thecannula 70 relative to the endoscope to ensure that the fluid tight seal is maintained in all tissue contacting situations.FIG. 21 illustrates an embodiment of aclamp mechanism 250 that can be used to clamp or lock the tensionedcannula 70 relative to theendoscope 100 to maintain a sealing contact between balloon 60 c andseal cap 40 c.Clamp mechanism 250 comprises a releasably lockable clamp mechanism that contacts and gripscannula 70 and is actuated and released via apull member 252 to clamp thecannula 70. Alternate clamp mechanisms such asclamp mechanism 260 can surround thecannula 70 and retain it in place via frictional contact. One example ofclamp member 260 would be abiopsy valve 108 or an adaption thereof wherein thebiopsy valve 108 grips theendoscope 100 and thecannula 70 with an elastomeric material. And, in yet another embodiment of a clamp mechanism, theproximal sleeve 68 of the balloon may be configured to expand within theoperative channel 102 of theendoscope 100 to lock the inflated balloon to the end of the endoscope. When the balloon is deflated, theproximal sleeve 68 unlocks from theoperative channel 102. -
FIG. 22 shows an alternate embodiment of aclamping mechanism 270 that could be configured to replace the previously described hollowballoon insertion tube 80 with aclamping mechanism 270 that combines a hollowballoon insertion tube 280 with a user actuatedclamp 282. Theclamping mechanism 270 has a longitudinal hollow that would slide freely over thecannula 70 and the collapsed balloon 60 c could reside within (not shown). The hollowballoon insertion tube 280 can be configured to fit within theoperative channel 102 of the endoscope and the biopsy valve 108 (if provided). The hollowballoon insertion tube 280 may be sized to be inserted into theoperative channel 102 to a position past a “Y” branch of thechannel 102. The collapsed balloon 60 c can then be introduced into theinstrument passage 102 of theendoscope 100 without direct contact with the “Y”. Once the balloon 60 c was extended from the scope and inflated, theclamping mechanism 270 could be pushed inward to bring astop collar 288 into contact with the proximal opening of the instrument passage, or the biopsy valve 108 (if present). Pulling on thehandle 50 or thecannula 70 while pushing on theclamping mechanism 270 can ensure a seal between the balloon 60 c and theseal cap 40 c (not shown). Locking the user actuatedclamp 282 ensures the seal is locked and maintained between balloon 60 c and theseal cap 40 c. As shown inFIG. 22 but not limited thereto, the user actuatedclamp 282 can comprise adeflectable cantilever beam 284 that can, when deflected, simultaneously clamp on thecannula 70 and lock with aclamp arm 286. Theclamp arm 286 can also be a cantilever, and can be deflected to release thedeflectable cantilever beam 284 to unlock the user actuatedclamp 282, and to release thecannula 70.Stop collar 288 can be used to contact and push against the endoscope or thebiopsy valve 108 to maintain tension on thecannula 70. - Turning now to
FIG. 23 , a front view of thefront face 104 of the endoscope is shown. Theoperative channel 102 of the endoscope is non-concentrically disposed in the endoscope, and accordingly thecatheter 70 and balloon are non-concentrically disposed relative to a central axis of the endoscope. As described previously, when thecap 40 andballoon 60 are installed on the endoscope, pulling on the catheter seals theballoon 60 against thecap 40 and the non-concentricallydisposed balloon 60 is free to pivot somewhat about the attachment point to thecannula 70 to center itself in theseal cap 40. - During operation, as the
balloon 60 pushes tangentially against the intestinal wall, the force attempts to unseat the balloon from the cap. The flaring portions of the cap, shown inFIG. 9 for example, seat the balloon to prevent the seal between the balloon and the cap from being broken or otherwise compromised. Additionally or alternatively, the cap, for example the cap shown inFIGS. 9-12 , may include one or more longitudinal cuts in a portion of the cap protruding past thedistal end 106 of the endoscope to prevent the balloon from being unseated from the cap when the balloon pushes against the intestinal wall. Alternatively, the portion of the cap protruding past thedistal end 106 of the endoscope may have portions of varying heights to seal with the balloon. - While the present medical apparatus has been illustrated by description of several embodiments, additional advantages and modifications may readily appear to those skilled in the art. For example, in embodiments, the
seal cap 40 can be configured to grip theballoon 60 and theendoscope 100, thereby securing theballoon 60 to theendoscope 100. - Although the invention has been shown and described with respect to a certain embodiment or embodiments, it is obvious that equivalent alterations and modifications will occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In particular regard to the various functions performed by the above described elements (components, assemblies, devices, compositions, etc.), the terms (including a reference to a “means”) used to describe such elements are intended to correspond, unless otherwise indicated, to any element which performs the specified function of the described element (i.e., that is functionally equivalent), even though not structurally equivalent to the disclosed structure which performs the function in the herein illustrated exemplary embodiment or embodiments of the invention. In addition, while a particular feature of the invention may have been described above with respect to only one or more of several illustrated embodiments, such feature may be combined with one or more other features of the other embodiments, as may be desired and advantageous for any given or particular application.
Claims (16)
1-16. (canceled)
17. A method for performing a gastrointestinal endoscopic imaging procedure within a non-insufflated gastrointestinal lumen of a subject, comprising:
providing a gastrointestinal endoscope, wherein the gastrointestinal endoscope comprises a distal end having distal face;
providing an elastomeric seal cap having a proximal end and a distal end defining a distal opening;
positioning the proximal end of the elastomeric seal cap about the distal end of the endoscope such that the distal end of the elastomeric seal cap extends distally relative to the distal endoscope face;
providing an inflatable balloon, wherein the inflatable balloon comprises an outer surface and includes a proximal side and distal side;
inflating, at least partially, the inflatable balloon;
seating the at least partially inflated balloon within the seal cap such that the seal cap circumferentially contacts the outer surface of the balloon while at least a portion of the proximal side of the at least partially inflated inflatable balloon contacts the distal face of the endoscope such that imaging using the endoscope occurs through at least a portion of the balloon; and
moving the gastrointestinal endoscope within the non-insufflated gastrointestinal lumen while the at least partially inflated balloon is in contact with the elastomeric seal cap and distal endoscope face to image portions of the gastrointestinal lumen wall along a length of the gastrointestinal lumen and though at least a portion of the inflated balloon.
18. The method of claim 17 , wherein the gastrointestinal endoscopic imaging procedure is a colonoscopy procedure.
19. The method of claim 17 , wherein the gastrointestinal endoscopic imaging procedure is a small bowel enteroscopy procedure.
20. The method of claim 17 , wherein the non-insufflated gastrointestinal lumen is part of the upper gastrointestinal tract.
21. The method of claim 17 , wherein the non-insufflated gastrointestinal lumen is part of the lower gastrointestinal tract.
22. The method of claim 17 , wherein the elastomeric seal cap further comprises;
a wall defining a circular lumen,
a proximal portion, the proximal portion comprising a cylindrical endoscope receptacle having a first, proximal end and a second, distal end,
an outwardly flaring distal portion extending distally away from the second end of the endoscope receptacle, and
wherein the method further comprises retracting the endoscope within the non-insufflated bowel, wherein retracting the endoscope causes the outwardly flaring distal portion of the seal cap to flatten luminal folds of the surrounding tissue.
23. The method of claim 22 , wherein the wall at the second end of the endoscope receptacle is wider than the seal cap wall of the outwardly flaring distal portion.
24. The method of claim 23 , wherein the outwardly flaring distal portion meets the second end of the endoscope receptacle at an obtuse angle.
25. The method of claim 17 , wherein the proximal side of the inflatable balloon comprises a proximally extending collar.
26. The method of claim 25 , wherein the gastrointestinal endoscope further comprises an instrument channel and a catheter extending through the instrument channel, and wherein the proximally extending collar is coupled to a distal end of the catheter and configured to expand within the instrument channel to seal with the instrument channel and to lock the balloon to the end of the endoscope.
27. The method of claim 17 , wherein the inflatable balloon is inflated using a fluid.
28. The method of claim 27 , wherein the inflatable balloon is inflated using air or gas.
29. The method of claim 17 , wherein the inflatable balloon is transparent and hollow.
30. The method of claim 17 , wherein the distal side of the inflatable balloon comprises a distal dome.
31. The method of claim 30 , wherein the distal dome comprises a tip.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US14/978,275 US20160174829A1 (en) | 2011-04-05 | 2015-12-22 | Balloon access device for endoscope |
Applications Claiming Priority (3)
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US11219351B2 (en) | 2015-09-03 | 2022-01-11 | Neptune Medical Inc. | Device for endoscopic advancement through the small intestine |
US11122971B2 (en) | 2016-08-18 | 2021-09-21 | Neptune Medical Inc. | Device and method for enhanced visualization of the small intestine |
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US11554248B1 (en) | 2018-07-19 | 2023-01-17 | Neptune Medical Inc. | Rigidizing devices |
US11724065B2 (en) | 2018-07-19 | 2023-08-15 | Neptune Medical Inc. | Nested rigidizing devices |
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US11937778B2 (en) | 2022-04-27 | 2024-03-26 | Neptune Medical Inc. | Apparatuses and methods for determining if an endoscope is contaminated |
Also Published As
Publication number | Publication date |
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CN103781394B (en) | 2016-09-28 |
WO2012138815A1 (en) | 2012-10-11 |
EP2693931A1 (en) | 2014-02-12 |
CN103781394A (en) | 2014-05-07 |
US9220396B2 (en) | 2015-12-29 |
US20120259175A1 (en) | 2012-10-11 |
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