US20160174829A1 - Balloon access device for endoscope - Google Patents

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

RELATED APPLICATIONS
• 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.
FIELD OF INVENTION
• The present apparatus embodied relates, in general, to medical devices and in particular, to access balloons used in combination with endoscopes.
BACKGROUND
• 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.
SUMMARY OF INVENTION
• 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, the1 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.
DETAILED DESCRIPTION
• 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.
• FIG. 1 is an isometric view of one embodiment of aballoon access device30 installed upon anendoscope100. Theballoon access device30 is configured to fit within anoperative channel102 of theendoscope100 when undeployed, and to deploy a transparenthollow balloon60 across adistal face104 of theendoscope100. Theballoon60 is transparent so that scope optics can view GI tissue there through, andballoon60 can be dome shaped on at least a distal end. A distally locatedguide tip62 is supported solely on a distal end of the dome shape by amembrane wall65 of theballoon60. The configuration of the deployedguide tip62 andballoon60 on theendoscope100 is such that non-insufflated GI tissue can be parted and spread with thetip62 and theballoon60 in response to pushing with theendoscope100. Theballoon access device30 andendoscope100 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 tip62 can be visually aimed at a center of the collapsed lumen of the non-insufflated GI tract by articulating adistal end106 of theendoscope100. When theguide tip62 is aimed, pushing theendoscope100 initiates the spreading and parting of the collapsed tissue walls with theballoon access device30, thereby enabling passage of theendoscope100 along a center of the non-insufflated lumen of the GI tract.
• As shown inFIG. 1, theballoon access device30 is shown inserted into anoperative channel102 of theendoscope100 and comprises aproximal handle portion50 extending from a proximal opening of theinstrument channel102. Abiopsy valve108 is provided on the proximal opening of theinstrument channel102 and ahollow cannula70 extends from theproximal handle portion50, through thebiopsy valve108, and into theinstrument channel102. A distal end of thecannula70 is secured to a proximal end of thetransparent balloon60 shown extending across a distally locatedfront face104 of theendoscope100.
• Aballoon seal cap40 of theballoon access device30 is removably secured to thedistal end106 of theendoscope100 and forms a fluid tight seal with at least one surface on a proximal end of theballoon60. Alternatively, it will be appreciated that thecap40 may be integral with the endoscope. Theseal cap40 may be any suitable shape, such as cylindrically shaped. The sealing interaction of theseal cap40 with theendoscope100, and theballoon60 with theseal cap40, can create a sealed volume across thefront face104 of theendoscope100 to prevent the egress of unwanted fluids across theoptical lens105 of an endoscope camera located on the front face104 (seeFIG. 17). Additionally, once the seal is formed, theballoon60 can be further secured to theseal cap40 by applying a vacuum to theinstrument channel102 to draw theballoon60 into further engagement with theseal cap40. Alternately, a vacuum port (not shown) in theendoscope100 can be used to draw theballoon100 against thefront face104 of the endoscope. Theballoon device30 can be rapidly deployed and inflated into place on theendoscope100 for advancement, and rapidly deflated and withdrawn from theinstrument channel102 of theendoscope100 for the insertion and deployment of another surgical instrument from theinstrument channel102 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 device30. The handle orproximal handle portion50 includes ahollow passage72 that extends longitudinally through thehandle portion50, through thehollow cannula70, and operatively connects to an inner volume of theballoon60.Handle portion50 includes aproximal luer lock52 to removably engagehollow passage72 with compressed gas and/or vacuum lines and or fluid lines, avalve54 to control the flow of gas and vacuum to thedistal balloon60, agrip56, andorientation wings58.Hollow cannula70 can be configured to have sufficient length to work with anendoscope100 as described above, or long enough to work with a variety ofendoscopes100 with differing lengths.
• InFIGS. 2 and 3, thetransparent balloon60 is shown in the normal unpressurized or “as manufactured” shape wherein thehollow balloon60 can have adistal dome64 and at least one sealingsurface66 on a proximal side. Theballoon60 is configured to be symmetrical and concentric about a longitudinal axis of theballoon60 and a longitudinal axis of thecannula70, and thedistal dome64 can be hemispherical or elliptical in shape about the axis. Aproximal collar68 securely seals theballoon60 to thecatheter70 via an attachment method such as but not limited thereto, by an adhesive or a shrink fit as described later.Proximal collar68 can be cylindrical and can include a conical or curved portion for engaging with or sealing with theinstrument passage102 ofendoscope100. Theguide tip62 can be a separate piece that can be secured to the dome of theballoon60 in the exemplary manner. As best shown inFIG. 3, theguide tip62 has a rounded distal tip and a steppedproximal post69 that can be adhesively secured into adistal collar67 formed from theballoon membrane65. Alternately, the guide tip could be a rounded bump formed from theballoon membrane65, or an injection of sealing material into thedistal collar67 such as a gob of silicone placed inside thedistal collar67. Theguide tip62 can be transparent for visualization therethrough, or can be opaque or translucent. As shown,guide tip62 is supported by only theballoon membrane65 which can provide some freedom of motion of thetip62 relative to theendoscope100. This freedom of motion can beneficial when navigating through collapsed tissue A hollowballoon insertion tube80 is shown distal to theguide tip62 may be provided to receive and store theballoon60 andtip62 within when the balloon is deflated by drawing a vacuum prior to being inserted into an adjacentballoon insertion tube80 , andtube80 can have a length sufficient to guide theballoon60 andtip62 into and beyond a “Y” portion of theoperative channel102 within theendoscope100, A deflatedballoon60 is shown inFIG. 4 just prior to insertion within a hollow of theballoon insertion tube80. Before insertion,balloon60 may have one or more deflation folds of theballoon60 wrapped or twisted about a longitudinal axis of the balloon (not shown) to create a more compact and organized deflatedballoon60.
• FIG. 5 shows theaccess device30 ready for installation onto theendoscope100. In this view, thecylindrical seal cap40 is positioned for placement onto thedistal end106 of theendoscope100. Theballoon60 is fully deflated as shown inFIG. 4, and resides within theballoon insertion tube80. A dashed line is provided to show how theballoon insertion tube80 of theaccess device30 can be inserted into the proximal opening of theinstrument channel102 ofendoscope100, and if abiopsy valve108 is provided, through thebiopsy valve108. Theballoon insertion tube80 can be configured to feed theballoon60 directly into theinstrument channel102 through theballoon insertion tube108 with theguide tip62 leading the collapsed balloon.Balloon insertion tube80 can be the length as shown, or can be longer to guide the collapsed balloon past a “Y” withininstrument channel102Balloon insertion tube80 can be constructed from a slick or lubricious plastic such as PTFE, or can be lubricated to reduce egress of the collapsedballoon60 into or out of thetube80.FIG. 1 shows how theballoon insertion tube80 can be retracted proximally around thecannula72 to a position adjacent to thehandle portion50 after the full insertion of theaccess device30 into theinstrument channel102.
• FIG. 6 shows the fully deflated balloon as it is being pushed downchannel102 of theendoscope100 prior to emergence of theballoon60 from thedistal face40 of theendoscope100. Theguide tip62 can be configured with a tip diameter that is close to the inner diameter of theinstrument channel102 of theendoscope100, and an appropriate length so that thetip62 will not cock and jam within theinstrument channel102 of thescope100. The tip of theguide tip62 can be any shape that is conducive to steering the guide tip along theinstrument channel102 such as therounded tip62 shown, or any other guiding shape such as but not limited to a cone.
• FIG. 7 shows theballoon60 after emerging from thedistal end106 of theendoscope100. Once theballoon60 is extended from theendoscope60 and beyond theseal cap40, atmospheric air may be induced through thehollow passage72 to allow theballoon60 to expand into the non-pressurized shape as shown. Once theballoon60 is fully inflated with a fluid, such as air, to an operating pressure or volume, theballoon60 is pulled proximally in the direction of the arrow to engage theballoon60 with theseal tip40. This pulling of theballoon60 to seal against theseal tip40 can be accomplished by pulling on thecatheter70 or thehandle portion50 outside of the patient. If required, theballoon60 is free to pivot somewhat about the attachment point to thecannula70 to center itself in theseal cap40.
• FIG. 8 shows the fully inflatedballoon60 pulled against theseal cap40 at thedistal end106 of theendoscope100. In this view, it can be seen that the inflation of theballoon60 has changed the at least oneproximal sealing surface66 into a rounded dome that has maintained a fluid-tight seal with theseal cap40. The rounding of the at least oneproximal sealing surface66 has moved thedistal dome64 distally, and thedistal dome64 has expanded both in diameter and longitudinally as shown. The inflation of theballoon60 can be accomplished prior to insertion of theendoscope100 into the patient, or after insertion of theendoscope100 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 theballoon60, andballoon seal cap40 of the present apparatus. Theguide tip62 is also depicted. The exemplary and previously described embodiment ofballoon60 and seal collar90 is best shown inFIGS. 2, and 3, and is shown in cross section inFIG. 11. The reader is advised to note that theballoon access device30 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, aballoon60 in one embodiment may become a balloon60ain another alternate embodiment. If differences in functions exist between like numbers such as sealing surfaces66 and66a,the description associated with the number and sub-identifier will prevail for that embodiment. All embodiments described below have aballoon60,60a.60b,60cand aseal cap40,40a,40b,40c.
• The embodiment ofFIG. 11 comprises thehollow balloon60, theballoon seal cap40 and theguide tip62. This embodiment uses a ring-in-groove seal between the balloon andseal cap40. Theballoon60 comprises the previously describeddistal dome64, themembrane65, and the at least one sealingsurface66. With this embodiment of theballoon60, the at least one sealingsurface66 of the balloon comprises two distinct portions. The first portion comprises a circular rib61 that rings the longitudinal axis of theballoon60 and is configured to engage with and seal with the circular groove41 in theseal cap40. The second portion of the at least one sealingsurface66 is a dish shaped portion that extends substantially radially inwardly between the largest diameter ofdistal dome64 to the circular rib portion. The dish shaped portion can be configured to seal against at least adistalmost surface48 of thecap40. Thedistal collar67 ofballoon60 extends distally from thedome64 and is configured to seal with thedistal tip62. Theproximal collar68 extends proximally from the at least one sealingsurface66 and is configured to seal with the hollow cannula70 (seeFIGS. 2 and 3).
• Theballoon seal cap40 ofFIG. 11 comprises a hollow cylinder having anendoscope receptacle42 extending into a proximal end of theseal cap40 to receive and seal with thedistal end106 of theendoscope100. Acircular rib45 can be provided at a distal end of theendoscope receptacle42 to act as a stop that engages thefront face104 of theendoscope100 once thescope100 is fully received within theseal cap40. Anopening46 is provided through therib45 to distally expose the optics, lights, and openings on theendoscope front face104. Aballoon sealing portion44 extends distally from therib45 and includes the previously described circular groove41 to retain and seal with the circular rib61 of theballoon60. Thedistalmost surface48 of theballoon sealing portion44 can seal with theballoon60. As shown, thereceptacle42, theopening46, and theballoon sealing portion44 comprise the open hollow of thecylindrical seal cap40.
• The embodiment ofFIG. 9 comprises a balloon60aand aseal cap40aand is configured to provide a ball-in-socket type of sealing. The balloon60ahas a substantially curved at least one sealing surface66athat nests within and seals with an outwardly flaring cuplike balloon sealing portion44aof theseal cap40a.Seal cap40acan be configured to flare outward to provide a larger support for the balloon60aand can exceed the diameter of theendoscope100.Seal cap40ais a hollow cylinder that further comprises an endoscope sealing receptacle42a,circular rib45a,opening46a, as well as the previously described balloon sealing portion44a. Balloon60aincludes a distal dome64a, amembrane65a, a distal collar67a, and a proximal collar68a. Cuplike balloon sealing portion44aof theseal cap40acan also be used to flatten luminal folds, for example to discern pathologies behind the luminal folds.
• The embodiment ofFIG. 10 comprises a balloon60band a seal cap40band uses a peg- in-hole arrangement for sealing. In this embodiment, the balloon60bis sized to have about the same radial diameter as thedistal end106 of the endoscope and the balloon60bnests and seals with a receptacle of a cylindrical balloon sealing portion44a. Mushroom shaped balloon60acomprises adistal dome64 with at least one sealing surface66athat is substantially flat and circular. Balloon60bis configured to fit snugly in the cylindrical balloon sealing portion44aand to seal the at least one sealing surface66aagainst a rib45b. Cylindrically shaped cap40bfurther comprises anendoscope sealing receptacle42b, and an opening46bextending through rib45b. Balloon60bincludes adistal dome64b, a membrane65b, a distal collar67b,and aproximal collar68b.
• The embodiment ofFIG. 12 comprises a balloon60candseal cap40cthat is configured to provide a flat-to flat seal as the balloon60cis pulled against a distalmost surface48cofseal cap40c. As the inflating balloon60cchanges shape from the mushroom shape to a rounded elliptical ball shape, the seal can move to a beveled portion of a distal balloon sealing portion44c. Balloon60cmay be substantially mushroom shaped with a substantially flat at least one sealingsurface66cadjacent to adome64c. Unlike the embodiment ofFIG. 10, the balloon60cis larger than an outer diameter of aseal cap40cand overhangs theseal cap40c. Cylindrically shapedcap40cfurther comprises an endoscope sealing receptacle42c,circular rib45c, and opening46c. Balloon60afurther comprises a distal dome64a, amembrane65a,a distal collar67a, and a proximal collar68a.
• Theballoons60,60a,60b, and60care 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 caps40,40a,40b, arid40ccan 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 theballoon60,60a,60b, and60cagainst the rigid cap that creates the seal. In yet another embodiment, the seal caps40,40a,40b, and40ccan 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 distalballoon sealing portion44,44a,44b,44cof thecaps40,40a,40b, and40ccould be rigid or elastomeric and can further comprise one or more deformable gasket materials to create a seal such as but not limited to: an elastomeric lip seal, an o-ring, an over-molded elastomer, or a foam seal (not shown). Such seals can seal with theballoon40, theendoscope100 or both.
• Thedistal guide tip62 can be used with any balloon embodiments such as60,60a,60b, and60c. Thedistal guide tip62 can include the steppedproximal post69 which is configured to fit within thedistal collar67,67a,67b,or67cto create a smooth exterior when mated with theballoon60,60a,60b, or60c(see at leastFIGS. 1&2). Theguide tip66 and cannula70 can be adhered to theballoon60,60a,60b, or60cwith adhesives such as but not limited to polyurethanes or cyanoacrylates. Or, alternate fastening techniques can be used withdistal guide tip62 andcannula70 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 tip62, they can be used for all other embodiments of the apparatus such as elements of thehandle portion50 or attachment of theproximal collar68 to thecannula80.
• FIGS. 13-16 are side views that detail the inflation of the distal portion of theballoon access device30 on theendoscope30. The mushroom shaped balloon60candcap40care 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 balloon60candcap40cas the balloon60cis inflated.
• FIG. 13 shows balloon60cin a normal un-inflated normal shape wherein the inner air pressure is the same as the outside atmospheric pressure and the balloon60chas assumed the “as manufactured” mushroom shape. As shown, the normal shape of balloon60cis substantially mushroom shaped, and comprises thedistal dome64cattached to the proximal at least one sealingsurface66c. The at least one sealingsurface66cis substantially flat and has been pulled back (via catheter70) to seal against a ring of contact with the ring shaped distalrnost surface48cof theseal cap40. With atmospheric pressure within balloon60c, and thevalve54 of thehandle portion50 closed, theballoon62 is very flaccid and theguide tip62 is substantially supported by only the membrane65c. Pushing theguide tip62 towards thecannula70 creates a large indention crater with thetip62 standing proud within as thetip62 is completely pushed into thedome64c. Measurements of the balloon60cofFIG. 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 balloon60candcannula70 of the actual test balloon60crequired about 2-2.1 ml of air to arrive at the flaccid shape ofFIG. 13.
• FIG. 14 is another side view of theaccess device30 on theendoscope30 where about 2.5 ml of air have been placed into the balloon60candcannula70. At this air volume, thedistal dome64cmaintained substantially the same shape, but the at least one sealingsurface66cdomed slightly and pushed thedistal dome64candguide tip62 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 sealingsurface66cwhich increased dimension B2. Pushing on thedistal guide tip62 so that it is embedded within the balloon created a slightly smaller dish shaped indent with theguide tip62 standing proud in the indent. The increased volume of fill also increased the resistance to movement of thetip62. The balloon60cdid not appear to move longitudinally from pushing on theguide tip62 but expanded radially when filled with 2.5 ml of air.
• FIG. 15 is another side view of theaccess device30 on theendoscope30 where about 3.5 ml of air have been placed into the balloon60candcannula70. Once again, thedistal dome64cmaintained substantially the same shape and the at least one sealingsurface66ccontinued 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 sealingsurface66c. The dimension D2 increased slightly to 18.73 mm. When theguide tip62 was pushed distally into the balloon60c, thedistal guide tip62 had substantial resistance. Pushing on thedistal guide tip62 so that it is embedded within the balloon created a noticeably smaller dish shaped indent with theguide tip62 standing proud in the indent. As theguide tip62 was embedded into the balloon60c, the balloon60calso moved distally as some of the distal movement of theguide tip62 was transferred to the balloon60c. Visually, it appears that there is about the same amount of distal longitudinal movement of the balloon60cas there is distal embedding of theguide tip62. The distal movement of the balloon60cis primarily in the at least one sealingsurface66c .
• FIG. 16 is another side view of theaccess device30 on theendoscope100 where about5 ml of air have been placed into the balloon60candcannula70. 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 sealingsurface66c. There was some additional rounding of thedistal dome64cwhich may account for some of the reduction in overall diameter D1 and some of the length change. With respect to pushing distally on theguide tip62 with 5 ml of air, theguide tip62 has substantial resistance and the combination of balloon geometry (mushroom shape), fill volume (ml) balloon membrane65cthickness and material durometer have combined to provide an unexpected shift in load transfer that seems to prevent theguide tip62 from creating much of a dish indent in the balloon. With this fill volume, a substantial portion of the movement of theguide tip62 towards thecannula70 comes from a longitudinal compression of the balloon60cto a different elliptical shape, and not from dishing theguide tip62 into theballoon60. This effect may be advantageous to tunneling through non-insufflated tissue lumens to maintain the distalmost positioning of theguide tip62 during airless burrowing of theaccess device30 and theendoscope100. It is the distalmost position of theguide tip62 which can enable theguide tip62 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 balloon60cas theaccess device30 andendoscope100 advances along the GI tract.
• FIGS. 17 and 18 are side cross sectional views of theballoon access device30 installed upon anendoscope100 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 device30 is providing both a visualization pocket and a tissue separator for the operator of theendoscope100 so that theendoscope100 can be easily advanced farther into the patient. An arrow is provided to indicate the direction of movement of theballoon access device30 andendoscope100. In this cross section, the collapsedluminal tissue200 is partially spread by theballoon access device30 andendoscope100 as it burrows towards a bend in thetissue200. Theendoscope100 is shown in cross section and has theinstrument channel102 andfront face104 shown.Front face104 of thescope100 further comprises alens105 that views tissue through thetransparent balloon60. A viewing angle of thelens105 is shown as dashed lines extending from the lens105 (seeFIG. 18). To prevent reduction of the viewing angle, thecap40 may protrude above thefront face104 of the scope between about 0.5 mm to about6mm. Alternately, thecap40 may protrude above thefront face104 of the scope between about1mm to about 3 mm. If desired, the vacuum in theendoscope100 can be used to draw theballoon100 against thefront face104 and thelens105 of theendoscope100. Thehollow catheter70 extends longitudinally along theinstrument channel102 and is attached to theballoon60 which is inflated (via the catheter70) an amount that substantially restricts the embedding of theguide tip62 into the balloon as described previously. Thecap40 is sealed against the endoscope and theballoon60 is sealed within thecap40 to seal thefront face104 of theendoscope100 from fluids, mucous, and residual natural materials normally found within the luminal structure. As shown, ring61 of the balloon is embedded in the groove41 in theseal cap40 to create a seal.
• FIG. 18 is an enlarged side cross sectional view ofFIG. 17. In this view, the spreading of thecollapsed opening204 of thetissue200 can be seen through thetransparent balloon60. Thelens105 of the endoscope can be seen with dashed lines indicating a field of view through theballoon access device30. Arrows show how a spreading force F1 is applied from theguide tip62 onto thetissue200. 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 balloon60. Once again, the spreading force F2 is perpendicular or normal to the point of contact of themembrane65 of theballoon60 on the tissue.
• FIG. 19 is a view through thelens105 of the camera of theendoscope100 looking at collapsed tissue through thetransparent balloon60 andguide tip62. In this view, the surgeon has steered theguide tip62 of theballoon60 to a centered position of the collapsed tissue opening204 of thetissue200. Since thetissue guide200 is transparent,tissue200 can be seen therethrough. Once theguide tip62 of theballoon60 is centered, the surgeon is confident that theballoon access device30 andendoscope100 are aimed at the center of the collapsed lumen, and that theballoon access device30 andendoscope100 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 device30 equippedendoscope100 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 die210 has a piece of expandable polyethylene tubing220 placed along a longitudinal axis of the balloon shape of thedie210. Once the tubing220 is heated, warm compressed air can be blown to expand the polyethylene tubing220 against the cooler inner walls of themold210 which can be held slightly below the melting temperature of the polyethylene tubing220. When the flow of warm expansion air is shut off, the tubing220 has expanded against the walls of themold210 and sets in the net or normal “as manufactured” shape. Then the moldedballoon60 can be extracted by opening thedie210 to release theballoon60. The dashed lines show the expansion stages of the polyethylene tubing220 as it expands towards themold walls210. The natural tendency of the hot tubing220 is to expand as a sphere until the expanding material contacts the walls of thedie210. As a consequence, different portions of the balloon membrane65 (seeFIG. 2) will be thinner than others and may taper between the thick and thin portions. For example, the portions of the tubing220 that form theproximal collar68 anddistal collar67 will expand not at all or very slightly and will be thicker than theballoon membrane65 at the points of largest expansion away from the longitudinal axis. The shape of the balloon can affect the location of the thick andthin membrane65 portions and a stiffened disk may be found near the proximal anddistal collars67,68 which can affect the manner in which theballoon60 expands (seeFIGS. 13-16). This thickening could affect or restrict the displacement of theguide tip62 from tissue contact by creating a more rigid “island” ofmembrane65 around thedistal tip62 that may explain the deflection behavior described previously. In an alternate embodiment, theballoon60 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 membrane65 can be used (such as polyurethane), or alternate dipping material may be used.
• With some embodiments of the balloon such as that found inFIG. 12, a tension or pulling force may be applied to thecannula70 to pull the balloon60cinto contact with theseal cap40cto create a seal. It may be further desirable to include a lock orclamp mechanism250 to hold thecannula70 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 mechanism250 that can be used to clamp or lock the tensionedcannula70 relative to theendoscope100 to maintain a sealing contact between balloon60candseal cap40c.Clamp mechanism250 comprises a releasably lockable clamp mechanism that contacts and gripscannula70 and is actuated and released via apull member252 to clamp thecannula70. Alternate clamp mechanisms such asclamp mechanism260 can surround thecannula70 and retain it in place via frictional contact. One example ofclamp member260 would be abiopsy valve108 or an adaption thereof wherein thebiopsy valve108 grips theendoscope100 and thecannula70 with an elastomeric material. And, in yet another embodiment of a clamp mechanism, theproximal sleeve68 of the balloon may be configured to expand within theoperative channel102 of theendoscope100 to lock the inflated balloon to the end of the endoscope. When the balloon is deflated, theproximal sleeve68 unlocks from theoperative channel102.
• FIG. 22 shows an alternate embodiment of aclamping mechanism270 that could be configured to replace the previously described hollowballoon insertion tube80 with aclamping mechanism270 that combines a hollowballoon insertion tube280 with a user actuatedclamp282. Theclamping mechanism270 has a longitudinal hollow that would slide freely over thecannula70 and the collapsed balloon60ccould reside within (not shown). The hollowballoon insertion tube280 can be configured to fit within theoperative channel102 of the endoscope and the biopsy valve108 (if provided). The hollowballoon insertion tube280 may be sized to be inserted into theoperative channel102 to a position past a “Y” branch of thechannel102. The collapsed balloon60ccan then be introduced into theinstrument passage102 of theendoscope100 without direct contact with the “Y”. Once the balloon60cwas extended from the scope and inflated, theclamping mechanism270 could be pushed inward to bring astop collar288 into contact with the proximal opening of the instrument passage, or the biopsy valve108 (if present). Pulling on thehandle50 or thecannula70 while pushing on theclamping mechanism270 can ensure a seal between the balloon60cand theseal cap40c(not shown). Locking the user actuatedclamp282 ensures the seal is locked and maintained between balloon60cand theseal cap40c. As shown inFIG. 22 but not limited thereto, the user actuatedclamp282 can comprise adeflectable cantilever beam284 that can, when deflected, simultaneously clamp on thecannula70 and lock with aclamp arm286. Theclamp arm286 can also be a cantilever, and can be deflected to release thedeflectable cantilever beam284 to unlock the user actuatedclamp282, and to release thecannula70.Stop collar288 can be used to contact and push against the endoscope or thebiopsy valve108 to maintain tension on thecannula70.
• Turning now toFIG. 23, a front view of thefront face104 of the endoscope is shown. Theoperative channel102 of the endoscope is non-concentrically disposed in the endoscope, and accordingly thecatheter70 and balloon are non-concentrically disposed relative to a central axis of the endoscope. As described previously, when thecap40 andballoon60 are installed on the endoscope, pulling on the catheter seals theballoon60 against thecap40 and the non-concentricallydisposed balloon60 is free to pivot somewhat about the attachment point to thecannula70 to center itself in theseal cap40.
• During operation, as theballoon60 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 end106 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 end106 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, theseal cap40 can be configured to grip theballoon60 and theendoscope100, thereby securing theballoon60 to theendoscope100.
• 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 ofclaim 17, wherein the gastrointestinal endoscopic imaging procedure is a colonoscopy procedure.

19. The method ofclaim 17, wherein the gastrointestinal endoscopic imaging procedure is a small bowel enteroscopy procedure.

20. The method ofclaim 17, wherein the non-insufflated gastrointestinal lumen is part of the upper gastrointestinal tract.

21. The method ofclaim 17, wherein the non-insufflated gastrointestinal lumen is part of the lower gastrointestinal tract.

22. The method ofclaim 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 ofclaim 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 ofclaim 23, wherein the outwardly flaring distal portion meets the second end of the endoscope receptacle at an obtuse angle.

25. The method ofclaim 17, wherein the proximal side of the inflatable balloon comprises a proximally extending collar.

26. The method ofclaim 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 ofclaim 17, wherein the inflatable balloon is inflated using a fluid.

28. The method ofclaim 27, wherein the inflatable balloon is inflated using air or gas.

29. The method ofclaim 17, wherein the inflatable balloon is transparent and hollow.

30. The method ofclaim 17, wherein the distal side of the inflatable balloon comprises a distal dome.

31. The method ofclaim 30, wherein the distal dome comprises a tip.

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