SLEEVE TUBE AND METHOD OF USE

Methods, systems, and devices are described for fabricating and using an orogatric tube. The orogastric tube may have: a proximal end section; a distal end section opposite the proximal end section, the distal end having a flexible, resilient curved portion; at least one sump channel extending from the proximal end section along a pre-determined length of the orogastric tube to the distal end section; at least one balloon channel extending from the proximal end section along a pre-determined length of the orogastric tube to the distal end section, the balloon channel being in communication with an expandable balloon in the distal end section; and a main channel enclosing a pre-determined length of both the sump channel and the balloon channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and incorporates by reference, the applicants' prior provisional patent application, titled Sleeve Tube and Method of Use, Ser. No. 62/245,542, filed Oct. 23, 2015.

FIELD OF THE DISCLOSURE

The present disclosure relates to an orogastric sleeve tube (“sleeve tube”) and methods of use, and in one aspect relates to a multi-channel sleeve tube that may be used in laparoscopic sleeve gastrectomy surgery. The sleeve tube may combine unique features of a gastric aspiration tube utilizing sump technology in combination with a novel sizing calibration tube.

In some embodiments, the sleeve tube may be a calibration device to be used within the lumen of a patient's stomach, where the sleeve tube may be fabricated with a material or a combination of materials enabled to provide a modifiable curvature which can conform to the natural shape of the stomach. In other embodiments, sump aspiration may be enabled to evacuate gastric contents from the stomach. The sleeve tube further provides a unique diameter augmentation balloon at the modifiable curvature of the sleeve tube and/or incisura area of the stomach (e.g., an angular notch in the stomach indicative of a separation point between the body of the stomach and where the stomach connects to the duodenum). In still other embodiments, the sleeve tube may provide a mechanism to perform a leak test after the completion of a sleeve gastrectomy.

In some embodiments, the sleeve tube may be used for gastrectomy surgeries for gastric tumors, and/or for other types of procedures such as, but not limited to, laparoscopic sleeve gastrectomy surgery, bariatric surgery, and endoscopic procedures.

BACKGROUND OF SOME ASPECTS OF THE DISCLOSURE

Sleeve gastrectomy surgery is one of the most frequently performed procedures for the treatment of morbid obesity with estimates that more than 200,000 gastrectomy procedures may be performed in the United States in the next year. Using existing technology, operating room personnel use multiple individual tubes to perform gastric procedures. The multiple individual tubes include (i) a standard tube with sump feature to evacuate the gastric contents, such as a nasogastric tube (ii) a sizing calibration tube during the cutting/stapling of the stomach, and (iii) another insertion of a standard nasogastric tube at the end of the procedure to instill colored dye and distend the stomach for a leak test.

Existing tube technology fails to conform to the curvature of the natural human stomach, and thus creates risks of technical complications in sleeve gastrectomy surgery—the existing tubes are typically straight, having no curvature and no way to make diameter adjustments at the incisura. Existing straight gastrectomy calibration system tubes include, for example, a ViSiGi 3D tube from Boheringer Ingelheim (e.g., having a French (Fr) gauge of 36 or 40). These tubes are used to decompress the stomach and/or remove gastric fluids with suction. In addition, these tubes may be used for irrigation and/or as a sizing guide during surgery; however, the Boehringer Ingelheim tubes do not have adjustable curvature, lack a sump channel, and lack both a balloon channel and a balloon to augment the diameter at the incisura. Other existing technology includes standard nasogastric tubes that lack a sump channel, and thus a separate sump tube must be used such as a Nasogastric Sump tube model number 0042140 from Bard Medical (for example, shaving French gauges of 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr).

Furthermore, existing tube technology fails to suction, aspirate, and deflate the stomach adequately; commonly used prior art tubes either have no suction capabilities or the tubes use a simple, single-channel suction system that does not involve a sump, resulting in a system that can easily become clogged with gastric mucus or particulate matter. In addition, existing technology may employ a tube having a blunt tip, where the tip is difficult to insert into the patient's stomach or results in anatomical trauma.

BRIEF SUMMARY OF SOME ASPECTS OF THE DISCLOSURE

The applicants believe they have discovered at least some of the problems and issues with the prior art noted above. They have therefor invented a multi-channeled sleeve tube sleeve for use in gasterectomies and other procedure. Other procedures may include, for example, surgeries for gastric tumors, bariatric surgery, and endoscopic procedures and other surgeries where a curved calibration tube can be utilized. Yet other procedures may be performed as described infra.

One aspect of the present disclosure provides a multi-channeled sleeve tube having two or more among a main channel, a sump channel, and a balloon channel extending through a body section of the sleeve tube. In some embodiments, the sleeve tube of the present disclosure combines many of the features of multiple, independent tubes of the prior art, while also providing, in some embodiments, a curved working section adjacent the distal end of the sleeve tube.

In some embodiments, having one multi-channeled tube that performs multiple functions can eliminate or reduce the number of placements and removals of tubes into the patient's esophagus; and in some applications, reducing the number of placements can be particularly useful because each time a tube is introduced there is a risk of perforation, laceration, and injury to the tissues of the oropharynx and esophagus. By eliminating two or three passage procedures, in at least a substantial number of applications, complications to the patient can be significantly decreased, and cost savings can accrue because valuable operating room time can be saved.

In some embodiments, the distal end of the sleeve tube may have a series of perforations that may, in some instances, further enable evacuation of gastric contents as well as facilitate injection of fluid into the stomach such as during a dye leak test. Additionally, some embodiments of the sleeve tube of the present disclosure may provide a sump channel to vent or supply air or gas when using the sleeve tube.

Some embodiments have a balloon channel coupled to a balloon mounted on the distal end section of the sleeve tube. In some embodiments, the diameter of the balloon may be adjusted by increasing the volume of air or gas forced into the balloon. In some embodiment, inflation of the balloon may cause the working section of the tube sleeved to curve or further curve.

In some embodiments, the sleeve tube of the present disclosure can include a soft, tapered distal nose or tip that can, in some applications, facilitate smoother and less traumatic insertion of the sleeve tube into the patient's mouth, esophagus, and stomach, reducing the incidence of sore throat, tearing of the esophageal lining, and esophageal bleeding.

In some embodiments having a curved or curvable working section, the curvature can established using a plurality of thermoplastic materials having “shape memory” properties that cause the working section to be biased toward providing a free-state predetermined curvature at certain temperatures, such as the internal temperature of the lumen of the stomach, and to be biased toward be straight in the free state at normal room temperature. In some applications, when the sleeve tube is inserted into the stomach, the temperature of the stomach causes the working section to curve to conform more closely to the natural curvature of the interior stomach wall.

Other embodiments may provide a sleeve tube with a flexible, resilient working section permanently biased to a predetermined curved free state. The working section can easily straighten for insertion or withdrawal through the patient's esophagus while returning to the curved state in the patient's stomach.

Other advantages of various embodiments of the sleeve tube can variously include the reduction in complications such as leaks, stenosis, obstruction, and/or encroachment at the incisura which results in improved patient outcomes, decreased complications, and reduction in costs that would otherwise be incurred during the corrective procedures and subsequent medical care.

Obstruction of the sleeve can occur in approximately 1% of sleeve gastrectomy procedures due to a phenomenon termed the “wind sock deformity” in which the lower stomach twists and folds, effectively blocking the channel through the stomach lumen. At least some embodiments of the sleeve tube can prevent the “wind sock deformity” complication by maintaining a natural anatomic curve of the stomach and preventing the surgeon from introducing a twist in the gastric sleeve that could favor a folding event that would create obstruction.

In addition, post-operative stenosis or narrowing occurs in between 1% and 3% of cases of sleeve gastrectomy. These cases are then typically treated with endoscopic dilatation procedures in the weeks and months following the initial surgery, at considerable expense. At least some embodiments of the sleeve tube described in this disclosure can solve this problem by adding volume to the calibration tube at the most vulnerable area, thus creating additional space and area where narrowing might otherwise occur.

This disclosure provides a novel system and method of fabrication and use of a multi-channeled sleeve tube. There are many other novel features and aspects of this disclosure. The will become apparent as this specification proceeds. It is to be understood, however, that the scope of a claim in this matter is to be determined by the claim as issued and not by whether the claim addresses an issue, or provides a feature, because the issue or feature is referenced in the Background or Brief Summary sections above.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

The prior Brief Summary and the following description provide examples that are not limiting of the scope of this specification. One skilled in the art would recognize that changes can be made in the function and arrangement of elements discussed without departing from the spirit and scope of the disclosure. Various embodiments can omit, substitute, add, or mix and match various procedures or components as desired. For instance, the methods disclosed can be performed in an order different from that described, and various steps can be added, omitted, or combined. Also, features disclosed with respect to certain embodiments can be combined in or with other embodiments as well as features of other embodiments.

In an exemplary gastrectomy procedure, one embodiment of the sleeve tube includes each of a balloon channel, main channel, and sump channel extending from the proximal end of the sleeve tube to the working, distal section of the sleeve tube. The distal end of the sleeve tube is inserted into a patient's and through the patient's esophagus into the patient's stomach. Laparoscopic technology can also be utilized to operation personnel to view the placement of the sleeve tube on video monitors present in the operating room. I

In some cases, the sleeve tube may be comprised of a low friction material to facilitate easier entry into the body. The sleeve tube may alternatively or in addition be lubricated with a water-soluble lubricant prior to the insertion step.

First, gastric contents are aspirated from within the lumen of the stomach through perforations in the working end of the sleeve tube and then through the main channel and possibly the sump channel as well.

The sleeve tube is then advanced into the stomach so that its distal tip passes along the lesser curvature aspect of the stomach. Operation personnel can adjust the working section of the sleeve tube to provide the proper placement, adjustment of the sleeve tube curvature, and inflation of the sleeve tube balloon as desired.

When the sleeve tube is in position, the balloon is inflated, the desired curvature is established in the working section, the operation personnel can then use conventional suction techniques to apply suction to the main suction tube to hold gastric tissues snugly to the tube so that the surgery may then proceed. Thus, the sleeve tube serves as a stomach sizing device, enabling the surgeon to remove the outer portion of the stomach safely.

After completion of the sleeve tube gastrectomy procedure, the surgeon can also use the sleeve tube to perform a leak test to test the integrity of the staple line on the stomach. A leak test can be done by injecting colored dye into the main channel of the multi-channeled sleeve tube while the surgeon occludes the sump outlet, thus tautly distending the stomach and stressing a newly created staple line. The surgeon can then observe the integrity of the staple line. When desired, the dye is aspirated through the main channel, the balloon is deflated, and the sleeve tube is then removed from the patient.

The sump channel can be used during the procedure to inject gas or air into the distal end section of the sleeve tube. The sump channel can thus aid to clear blockage of sleeve tube perforations and the main channel. The sump channel can also be used to prevent excessive sucking through the main channel and the associated perforations in communication with the main channel.

Referring now toFIG. 1, one embodiment an elongated sleeve tube100has a proximal end102opposite a distal end105. The sleeve tube100can provide a multi-channel orogastric tube system for use in conducting sleeve gastrectomy surgery. In other embodiments, the sleeve tube100also or alternatively can be used as a calibration device within the lumen of a person's stomach.

The sleeve tube100may be conceptually divided into four sections: the elongated sleeve tube100as a whole; an aperture section106providing differing apertures for each three tubular channels or conduits; a main body section104secured to the distal end of the aperture section106and having three tubular channels extending longitudinally within and along the length of the sleeve tube100; and an expandable section110extending from the main body section204at the distal end105of the sleeve tube100. The expandable section110terminates in a tapered nose section112at the distal end113of the expandable section110.

Aperture section106attaches to the main body section204by way of a tubular coupler end section115at the distal end123of the aperture section106. In turn, the main body section104penetrates the distal end117of the coupler end section or sleeve115to couple the main body section104to the aperture section106.

In some embodiments, a balloon116is mounted to, or formed in, the expandable section110of the sleeve tube100. The balloon116can be controllably inflated outwardly from, and controllably deflated to retract toward, the body119of the expandable section110.

The sleeve tube100can thus be formed of separate sections and elements, for example,106,104,110, and112, joined together by adhesives or other inter-connecting devices or methods (for example, by thermal bonding or fusing techniques). The adhesives can be, but are not limited to, Federal Drug Administration (FDA) approved medical adhesive materials (for example, Luer-Lok, Luer-Slip, catheter tip, barbed fittings, solvents, etc.). In other embodiments, the sleeve tube100may be molded (for example, by extrusion or injection molding) as a single piece without the need to join together multiple pieces. In yet other embodiments, the sleeve tube100or any of its components can be three-dimensionally printed using polymeric or other suitable material.

In one embodiment, the nose section112is first formed as a separate unit from the balance of the expandable section110and secured to the balance of the expandable section110with medical adhesive or other coupling devices or methods as described above. The nose section112is frustoconical, or somewhat so, to provide a conically narrowing but rounded distal end113of the nose section112opposite its junction with the balance of the expandable section110. The proximal end121of the nose section112secured to the balance of the expandable section110is approximately the same diameter in width as the balance of the expandable section110(e.g., 13.3 mm or 40 Fr).

In some embodiments, the nose section112is made of the same material as the balance of the expandable section110(and may formed as part of it) to provide similar flexibility and resilience for the expandable section110and the nose section112. In some embodiments, the nose section112provides an atraumatic distal end105that can help prevent mucosal trauma as the sleeve tube100is inserted into the patient's body.

With reference now toFIG. 2, the aperture section106has three separate channels or tubes114,202,206providing three corresponding tubular lumens (that is, cavities or passages), with these lumens extending from the aperture section106longitudinally through main body section104to penetrate the expandable section110of the sleeve tube100. The expandable section110extends from the distal end205of the main body section104and includes an outwardly inflatable balloon116, shown in an inflated state inFIG. 2.

With reference now toFIG. 3A, the tubular proximal ends311,313,315of the main channel114, balloon channel202, and sump channel206, respectively can inter-connect with syringes, suction devices, or stopcocks as desired. The opposed ends317,319,321of the main channel114, the balloon channel202, and the sump channel206, respectively, converge to penetrate the main body section104and provide a multi-channeled tubular main body section204having a tubular outer periphery surrounding the main channel114, balloon channel202, and sump channel206contained within the tubular outer periphery of main body section104.

With reference toFIG. 3B, the outer diameter D1 of the balloon channel202is the same as the outer diameter of the sump channel206, whereas the outer diameters D3 and D5 of the main channel114and main body section104, respectively, are larger than D1. In yet other embodiments, the outer diameters of channels202,204, and206may otherwise differ or be the same as desired, and thus they may all differ from one another, respectively, if desired for a given application.

Similarly, the inner diameters (that is, the lumen diameters) of the balloon channel202and sump channel206may have the same, or approximately the same, diameter D2, including extending along and within the lateral length of the main body section104. The inner diameter D4 of the main channel114may be larger than D2. In yet other embodiments, the inner diameters of channels202,204, and206may all differ from other another, respectively, or be similar as otherwise desired.

In one example, D3 may be between 28 Fr and 52 Fr, with a preferred diameter of 40 Fr. These exemplary diameters may be altered as desired.

With reference toFIGS. 4A and 4B, the expandable section110has a central laterally extending, generally tubular section401extending from the main body section104and terminating in the nose section112. The balloon116is securely mounted in a balloon mounting slot403penetrating, and laterally extending along, the outer periphery405of the central generally tubular section401,

The distal end407of the main tube section204has a thinned wall409providing a female distal receptacle409to matingly surround, abut, and grasp (in conjunction with adhesive to form a secure bond with) a narrowed mating male proximal end411of the expandable section110. The distal end413of the balloon tube202connects to the proximal end415of the balloon116so that the balloon tube202can thereby (i) inject air or other gas into the balloon116, causing the balloon116(i) controllably inflate by injecting air or other gas in the proximal end (not shown inFIGS. 4A and 4B) of the balloon channel202, and (ii) controllably deflate by venting or withdrawing air or other gas from the proximal end (id.) of the balloon channel202to, with reference toFIG. 4B, collapse the balloon116within the balloon mounting slot403. In the deflated state, the outer periphery of the balloon116lies flush with the outside surface of the curved working section110. In this deflated state, the sleeve tube100may be inserted through the patient's mouth and esophagus and into the patient's stomach.

With continuing reference toFIG. 4B, the sump channel206extends past the female distal receptacle409well into the general tubular interior of the generally tubular section401. The generally tubular section401has multiple laterally extending rows, e.g.,417,419, of tubular perforations, e.g.,421,423, penetrating the generally tubular section401and extending from the interior to the outer periphery405of the generally tubular section401. The sump channel206thus can be used to withdraw or inject gas into the generally tubular section401, and the main channel114, which is in communication with the interior of the generally tubular section401, can inject or withdraw gas, and withdraw material from, the interior of the generally tubular section401through the perforations, e.g.,421,423, in that section401. Material or gas sucked into the generally tubular section401can be withdraw from the stomach through the main channel114, and the sump channel206can be used to inject air or gas into the generally tubular section401in order to, for example, clear blockage of material within the perforations, e.g.,421,423. The sump channel206can alternatively be used to aspirate gastric contents of the patient's stomach.

In contrast, a single channel tube system (for example, in procedures using multiple separate tubes) may clog easily, thus resulting in a failure to successfully evacuate gastric contents. The sump channel206, as part of the multi-channel system100, allows air to travel through the system and provides a secondary channel that may be used to clear a clogged tube, thus improving the effectiveness when the system is used as an evacuation tool for gastric contents. Furthermore, use of the sump channel206can be used to vent the main channel114reduce the risk of applying too much suction pressure to the main channel114, resulting in gastric mucosal lining tissue being pulled toward and within perforations, e.g.,421,423, in the sleeve tube100, which can lead to tearing of the stomach lining or bleeding when the sleeve tube is removed.

The balloon116may be fabricated by dip forming of a thermoset polymer, or by blow molding or extrusion of a thermopolymer, such as polyvinyl chloride, polyurethane, etc. The balloon116may be affixed to the balloon mounting slot403with compatible medical adhesives, by heat shrinkable tubing, by mechanical means such as thread ties for example, or by a combination of such techniques and/or others.

In one embodiment, the uninflated width W1 of the inflatable section110is 10 mm and the lateral length of the balloon116is 6 cm, with the distal end427of the balloon116spaced 2 cm from the distal end105of the sleeve tube. When air or other gases are inserted into the balloon116, the balloon inflates to cause the width of inflatable section to increase to, for example, 23.3 mm. The volume of the balloon can116vary of course, and in some embodiments, the balloon can fully inflate when pressurized with air or gas to 2 ATM. In addition, the balloon may be further pressurized to provide a more rigid balloon for greater support.

With reference now toFIG. 5, the balloon channel202and the sump channel206may be located inside and coupled to, or abutting, the interior side wall of the main body section104. Alternatively, as shown inFIG. 6A, the balloon channel202and the sump channel206may be spaced from the interior side or wall of the main channel204.

In another alternative ofFIG. 6B, the main body section204includes an interior tube602extending inwardly from the interior surface604of the main tube602. The portions of the balloon channel202and sump channel206within the main body section104can consist of separated, opposed D-shaped channels sharing a common central wall605within the interior tube602. A laterally extending portion of the interior tube602penetrates, and is partially formed within, a portion of the wall of the main body section104.

With reference now toFIGS. 7A and 7B, a static, secured portion704of the balloon116is secured to the interior wall of the portion balloon channel202within the balloon mounting slot403in the expandable section110. As it is inflated, the balloon116extends outwardly from balloon mounting slot, and in the embodiment ofFIG. 7A, the balloon116expands to provide an inflated section702having an oblong cross-section extending from, and along the lateral length of, the U-shaped balloon mounting slot403.

With reference toFIG. 8A, the parallel rows of perforations, e.g.,801,803, extend laterally along, and all around the general tubular periphery of the bulk of the expandable section11. In one embodiment, the rows of perforations, e.g.,801,803, are located within 15-20 cm of, as shown inFIG. 1, the distal end105of the sleeve tube100. The number, size, and location of the perforations, e.g.,805,807, can be varied to facilitate removal of particulates when suction is applied to the main channel204(not shown inFIG. 8A). In addition, the perforations, e.g.,805,807, can enable a leak test in which colored dye is forced into the sleeve tube100to fill the stomach through the perforations, e.g.,805,807, to distend the stomach and test a surgical staple line for leakage

Referring now toFIG. 8B, an alternative embodiment of the expandable section110has a differing or additional balloon804. This balloon804expands to provide a rounded exterior periphery substantially wider W3 than external diameter D3 of the balance of the laterally extending expandable section110.

In another embodiment (not shown), yet another balloon structure, along with a supporting channel, can be also be included in a single sleeve tube to augment the diameter of the sleeve tube at, for example, just below the gastroesophageal junction. This location is an area where surgeons generally should avoid encroachment and making the stomach too tight, which can result in leaks and strictures.

With reference now toFIG. 9, the sleeve tube100, including any or all of the associated sections and parts, may be manufactured in any of many ways. In one example, each of the elements of sleeve tube100shown inFIG. 9may be fabricated individually and then subsequently assembled into the completed sleeve tube100. In some embodiments, the sleeve tube100may be molded in two halves (less the balloon) combined to form a complete device from a thermoset material (silicone for example). The balloon can then secured to the sleeve tube100with adhesive.

In another example, at least the main body section104may be injection molded using a thermoset material (silicon for example), with each of three channels202,204, and206created by inserting long core pins that are removed after the entire sleeve tube assembly is removed from the mold.

In yet another example, elements of the sleeve tube100assembly such as shown inFIG. 9may be extruded or molded separately of silicone rubber. More specifically, the sleeve tube's main body section204can be formed of extruded silicone rubber formed with a distal end curvature before vulcanizing. The branching aperture end106can be injection molded. The expandable section110can be injection molded to provide the perforations802and balloon mounting slot403(or other balloon mounting structure), and nose section112. After production, the parts can be bonded together such as with adhesive or other bonding techniques well known in the art. Other methods of production may be utilized, such as three-dimensional printing for example.

In order to facilitate passage of the sleeve tube100into the stomach and to enable the creation of the adjustable curvature of the curvable working section110, the sleeve tube100can be fabricated or coated with a low friction polymer, such as, but not limited to, polytetrafluoroethylene (PTFE) or other hydrophilic materials. In one embodiment, at least the working section110alternatively at least dominantly consists of silicone, with curvature of this section100formed a in a secondary curing process.

In some embodiments, each or any of the parts, sections, or elements described may be symmetrical along an axis; however, in other embodiments, the parts, sections, or elements may be asymmetrical. For example, a proximal end may be thicker than a distal end, or different materials may be used at one end versus another. In some cases, the material may be patterned in one section and not in others.

In one embodiment, the sleeve tube100is approximately 100 cm in length from the proximal ends of the tube at the aperture section106to the distal end105of the nose section112and has a diameter of approximately 13.3 mm (40 Fr). These dimensions may be adjusted as needed or desired for differing applications. Generally, however, the diameter of the sleeve tube100for human gastric applications may be up to 150% greater than 13.3 mm, and the length of such a sleeve tube may be up to 75% shorter and 100% longer than 100 cm.

When the sleeve tube100is properly placed within a patient's stomach, the balloon116may be inflated at a desired location within the stomach, such as at the gastric incisura or other desired locations causing them to similarly inflate. The ability to increase the diameter of the sleeve tube (and more specifically the curvable working section110of the sleeve tube100) may result in improving the safety of the sleeve procedure and/or prevent complications resulting from stenosis, staple link leaks, or gastric obstruction.

A primary risk factor in the development of gastric staple line leaks is the development of narrowing or stenosis at the lower part of the sleeve, which then increases the intra-luminal pressure, causing leaks. Some embodiments prevent this occurrence through the inflation of balloon116, which can add an additional up to 5-25 mm of width, and in one particular embodiment up to 10 mm of width, to the sleeve tube100at locations where stenoses typically form (for example, in the lower sleeve incisura region). After the sleeve procedure is completed, and the leak test is finished, the balloon116is deflated, and the sleeve tube100is removed from the patient.

In some embodiments, the sleeve tube100may be used for veterinarian applications. The lengths, diameters, and thicknesses, etc., of the sleeve tube100and corresponding components may be sized appropriately for such applications.

Turning now toFIG. 10, an alternative sleeve tube1000has an integral silicone main body1006with a proximal end1002opposite a distal end1004. With reference toFIG. 11a main channel1110and opposed balloon1102and sump1104channels feed together through a sealing sleeve1112into the main body section1006. Conversely, the opposed balloon1102and sump1104channels extend upwardly from the sealing sleeve1112and bend away spaced from each other1102,1104, providing a spread and forked configuration of the ends of main channel1110, balloon channel1102, and sump channel1104opposite the sealing sleeve1112. The width of this spread and forked configuration can make it impossible for the proximal end1002of the sleeve tube1000to penetrate the patient's mouth.

Referring toFIG. 12A, the sleeve tube1000assembly is formed to have a predetermined curved shape by placing the sleeve assembly1000in a curing cavity (not shown) having a predetermined curved section causing the curvable working section1206to curve within the cavity at a radius R1. Heat or another curing agent is then applied, causing the working section1206to bias toward taking on the predetermined shape of radius R1 when working section1206is subject to certain temperatures, such as when in the stomach of a patient. Depending on the materials used and the temperature of the working environment, the curvable working section1206can resume a straightened form when the sleeve tube1000is removed from the cavity and cools to room temperature, and then similarly return to having the pre-determined curvature when the curvable working section1206reaches the pre-determined temperature inside a patient's stomach.

With reference toFIG. 12B, when the sleeve tube and balloon1000is then inserted in a patient's stomach and the balloon1204is inflated by injecting gas into balloon channel1102, the inflating balloon1204forces the adjacent portion1202of the curvable working section1206to curve more that the predetermined curvature provided by heating of the working section1206within the stomach. As result, the inflated balloon1204forces the adjacent portion1202of the working section1206to have a radius R2 smaller than, as shown inFIG. 12A, radius R1.

In one embodiment, the sleeve tube1000is made from silicone having a Shore hardness on the A scale of 25 to 30. The silicone can be, for example, SILASTIC® brand biomedical grade Liquid Silicone Rubber (LSR) from Dow Corning or Thermoset Elastomer (TSE), such as Dow Corning SILASTIC® 7-4860 BIO LSR (heat cured) or Dow Corning SILASTIC® Q7-4535 BIO ETR Elastomer (peroxide cured)). In some embodiments, the silicone or other material should be of medical grade, have maximum lubricious characteristics, and be directly bondable.

FIG. 13is a partial elevational view of the sleeve tube1000ofFIG. 10with the working section1206in a curved configuration. With reference toFIG. 14, the opposed balloon channel1102and sump channel1104abut opposed interior sides of the interior wall of the main body section1006. The remaining space1404within the of the interior of main body section1006provides a main body section channel1404in communication with, as shown inFIG. 13, the upwardly extending main channel1110. In other words, with reference back toFIG. 14, the main body section1006has three interior, axially extending lumens1402,1404, and1406in communication with, as shown inFIG. 14, the balloon channel1102, the main channel1110, and the sump channel1104, respectively. The balloon channel1102and sump channel1104abut the opposed sides of the internal periphery of the main channel1110so that the exterior periphery of the main body section1006may be tubular and thus enable easier insertion and bending of the sleeve tube1000during insertion into the body.

With reference now toFIG. 15, the working section1206in sleeve tube1000has laterally extending rows (not shown inFIG. 15) of tubular, radially extending perforations or passages1501,1503passing from the exterior periphery of the working section1206into the main body section channel1404. Gas and material can pass through these radial passages1501,1503.

With reference now toFIGS. 16A and 16B, the lower end of the working section1206provides a laterally extending balloon channel1601having a relatively thin outer wall1603as compared to the inner wall1605of the balloon channel1102. The opposed portions of the main channel1006are also thinned at this location. Then, as shown inFIG. 16B, the relatively thin walled section1603provides the exterior wall of the balloon1605in its collapsed state. The thin walled section1603balloon can then, as shown inFIG. 16A, be blown up as shown inFIG. 16Aand then subsequently, as shown inFIG. 16B, again be deflated to its collapsed state.

With reference toFIGS. 17A, 17B, and 17C, the sleeve tu2be1000may be fabricated as a single part multilayer co-extrusion. With reference toFIG. 17A, a blank of the entire sleeve tube1000may be extruded from multiple thermoplastic elastomers with different glass transition temperatures. Then, with reference toFIG. 17B, the entre blank can then be heated to glass transition temperature, with the working section1206thermoformed to create the curvature and perforations as shown inFIG. 17B. Subsequently, the now-thermoformed sleeve tube can be heated to the glass transition temperature for the balloon channel202in order to secure the balloon116to the balloon channel slot or wall403(not shown inFIG. 17B). The entire device may be sealed in ways well known in the art.

In use, the working section1206is straightened and inserted into the patient's mouth, esophagus, and stomach. Within the stomach, the working section1206returns to its free, curved state as inFIG. 17B. Then, with reference toFIG. 17C, the balloon1605may be inflated by the practitioner to cause the working section1206abutting the balloon1605to further curve within patient's stomach. Conversely, the balloon1605may be deflated to cause thee working section1206to return to its free state and allow the sleeve tube1000to be withdrawn from the patient. During withdrawal, the flexible working section1206flexibly straightens, as inFIG. 1, to pass through the esophagus without causing edema to the patient.

On reading this specification, those of skill in the art will recognize that many of the components discussed as separate units may be combined into one unit and an individual unit may be split into several different units. Further, the various functions could be contained in one computer or spread over several networked computers and/or devices. The identified components may be upgraded and replaced as associated technology improves, advances are made in computing technology, or based on a developers skills or preferences.

The foregoing detailed description has described some specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the present systems and methods and their practical applications, to thereby enable others skilled in the art to best utilize the present systems, their components, and methods and various embodiments with various modifications as may be suited to the particular use contemplated.

Unless otherwise noted, the terms “a” or “an,” as used in the specification and claims, are to be construed as meaning “at least one of.” In addition, for ease of use, the words “including” and “having,” as used in the specification and claims, are interchangeable with and have the same meaning as the word “comprising.” In addition, the term “based on” as used in the specification and the claims is to be construed as meaning “based at least upon.” Also, as used herein, including in the claims, “or” as used in a list of items prefaced by “at least one of” indicates a disjunctive list such that, for example, a list of “at least one of A, B, or C” means A or B or C or AB or AC or BC or ABC (i.e., A and B and C).

Finally, any ranges stated above include all sub-ranges within the range.