US20070288033A1 - Intragastric balloon retrieval mechanisms - Google Patents

Abstract

A mechanism for removing a fluid-filled object from a patient. The apparatus includes a deflation tube with a puncture member at one end of the tube for piercing a hole in the object wall. The apparatus includes a retrieval mechanism slidable within the deflation tube lumen. The retrieval mechanism includes an expansion element that is expandable when positioned within the object from a first configuration with a dimension less than that of the deflation tube lumen to a second or deployed configuration with a dimension that is greater than an outer dimension of the puncture member. The expansion element contacts an inner surface of the inflatable object as the deflation tube and retrieval mechanism are withdrawn from the body cavity. The expansion element may be a T-bar, a foldable anchor, an inflatable member, or another expandable form.

Description

BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates, in general, to the use of an intragastric balloon and similar fluid-filled objects in treating obesity, and more particularly, to the devices and systems for endoscopical deflating and removing or retrieving such intragastric balloons and/or other fluid-filled objects from the stomachs of patients.
• 2. Relevant Background
• Intragastric balloons, such as that described in U.S. Pat. No. 5,084,061 or other balloons and objects commercially available, are designed for providing short-term therapy for moderately obese individuals who need to shed pounds in preparation for surgery or as part of a dietary and behavioral modification program. A challenge with such balloons or fluid-filled objects is their removal after completion of therapy.
• A typical intragastric balloon is a made of a silicone elastomer shell that is inserted into the stomach of a patient and then filled with fluid. For example, commercially available intragastric balloons are filled with saline solution or air but other fluids may be used in some situations. The intragastric balloon functions by partially filling the stomach, which enhances appetite control. Placement and filling of the intragastric balloon is completed non-surgically with a surgeon or doctor using an endoscope, gastroscope, or other device that is adapted for viewing internal cavities of a patient and with lumen or hollow channels for passing the retrieval instruments. Placement of intragastric balloons is temporary, and intragastric balloons are typically removed after six to twelve months.
• Historically, endoscopic deflation and extraction of intragastric balloons has been an arduous task due to the difficulty associated with manipulating the balloon within the stomach. One method of removing the balloon involves several steps, each with its own tool. A sharp-ended puncture device, sometimes called a “killer,” is inserted through the working channel of an endoscope to puncture the balloon. The puncture device is then removed, and the saline solution is either allowed to enter the stomach cavity, or removed via an aspiration tube inserted through the working channel and into the balloon. Finally, a grasping device or “grasper” having prongs, teeth, or a wire loop is inserted through the working channel to snag or snare the outside surfaces of the balloon. Once the outside of the balloon is hooked or grasped, the grasping device is used to pull the balloon through the esophagus as the gastroscope is removed. Other tools have been developed that provide a single tool that can pierce the balloon's shell, evacuate the fluid to deflate the balloon, and grasp or hook the outer surfaces of the balloon.
• Even with these efforts, the retrieval of untethered intragastric balloons or other fluid-filled objects from a patient's stomach continues to present problems and can be a difficult task. The outer surface of the balloons is coated with gastric fluids in the stomach and tends to be very slippery or slick, which makes it difficult for even a relatively sharp grasper tool to grasp the balloon. One technique for addressing this issue is described in U.S. Pat. No. 5,084,061 and includes providing a retrieval tab on the outer surface of the balloon. A tool with a hook, loop, or snare then has to be latched onto the tab to allow retrieval. This technique has not been widely adopted as it requires specially manufactured balloons or objects with the external tab and also requires that the balloon be manipulated within the patient's stomach to find and align the tab with the hook on the removal tool, and this is often difficult to perform endoscopically (e.g., with limited tool dexterity and in limited visibility and light provided by the endoscope).
• Therefore, it is desirable to provide an endoscopic device for removing an intragastric balloon in which the above mentioned disadvantages are substantially overcome.
• Hence, there remains a need for an improved tool for supporting deflation and retrieval of intragastric balloons and other fluid-filled objects from the stomach of patients. Preferably, such a tool would be useful with existing medical systems or tools such as endoscopes and would provide quicker and more effective grasping or capture of the balloon or object to better support out-patient procedures.
SUMMARY OF THE INVENTION
• The present invention addresses the above problems by providing a system and method for removing fluid-filled objects, such as intragastric balloons, from a body cavity of a patient. In contrast to prior devices that grasp the outer surfaces of an object, the removal system of the present invention includes a retrieval mechanism that can be inserted within the object via a lumen of the device used to deflate or aspirate the object contents (e.g., an aspirator tube or the like). The retrieval mechanism includes an expansion element that can be compressed or provided in a first configuration that allows it to readily pass through the deflation tube lumen but that expands to a second or deployed configuration when it is positioned within the unrestricted space within the interior of deflated object to be removed. The second or deployed configuration of the expansion element is typically significantly larger than the outer dimensions of the deflation tube, and as a result, surfaces of the expansion element contact the inner surfaces of the object when the retrieval mechanism is withdrawn from the body cavity, thereby capturing and removing the object. The expansion element may take numerous forms, as discussed in detail herein, such as, but not limited to, a T-bar, a foldable anchor, an inflatable member, a spring retriever, an elongate body with tabbed ends, an expandable tubular body, and a rollable or collapsible cone.
• More particularly, an apparatus is provided for removing an inflatable object from a body cavity of a patient. The apparatus includes an aspiration or deflation tube with a lumen and a puncture member, such as a hollow needle, at one end of the tube for piercing a hole in the wall of the inflatable object. The puncture member includes a lumen that is in fluid communication or is fluidly coupled with the deflation tube lumen. The apparatus further includes a retrieval mechanism that can be slid within the deflation tube lumen. Significantly, the retrieval mechanism includes an expansion element that is expandable when positioned within the inflatable object from a first configuration with a dimension less than that of the deflation tube lumen to a second or deployed configuration with a dimension measured transverse to the deflation tube lumen that is greater than an outer dimension of the puncture member. In this second or deployed configuration, the expansion element has at least one contact surface (e.g., a surface extending transverse to an axis of the puncture member lumen) that contacts an inner surface of the inflatable object proximate to the hole formed in the wall of the inflatable object as the deflation tube and retrieval mechanism are withdrawn from the body cavity.
• According to another aspect of the invention, a method is provided for evacuating and removing a fluid-filled object positioned in a body cavity. The method includes positioning an aspirator device in the body cavity and piercing a wall of the fluid-filled object with the aspirator device that includes a tube with a lumen, e.g., the piercing results in a portion of the tube passing through the shell wall and providing access to the interior of the object via the lumen. The method continues with advancing a retrieval mechanism into the lumen of the aspirator tube. The retrieval mechanism includes an expansion element that has a deployed configuration that is greater in size than the outer diameter of the aspirator tube, and the advancing includes extending the expansion element at least partially out of the lumen and into the pierced object. The expansion element then expands to its deployed configuration, and then the retrieval mechanism is withdrawn along with the aspirator device, which results in the expansion element contacting an inner surface of the object wall to cause the object to be removed from the body cavity along with the retrieval mechanism.
• The retrieval mechanism typically also includes a flexible deployment member (such as a wire, wire rope, flexible tube, or the like) that is attached to the expansion element. The expansion element may take a number of forms, and for example, it may be selected from: a T-bar, an object inflated during the expanding of the expansion element, a folding anchor device that unfolds to the deployed configuration, a spring element that returns to an at-rest position during the expanding of the expansion element, an elongate body with tabs attached at opposite ends, a tubular body with slits cut in a spaced-apart manner, parallel to a longitudinal axis of the tubular body and with a tensioning wire attached to an end of tubular body, and a funnel collapsible into a cylinder and expandable into a frustaconical shape in the deployed configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates a partial cutaway view of an inflatable object retrieval system according to one embodiment that is useful for deflating and removing a fluid-filled object such as an intragastric balloon from the stomach or other cavity of a patient;
• FIGS. 2A-2C illustrate in more detail the “T-bar” retrieval mechanism shown in the system ofFIG. 1 as it is being used to grasp and remove an object after deflation;
• FIGS. 3A-3C illustrate similarly toFIGS. 2A-2C a retrieval mechanism according to the invention in which the expansion or grasper portion or element itself is inflatable and may be used in object retrieval systems such as that shown inFIG. 1;
• FIGS. 4A and 4B is another retrieval mechanism according to the invention that may be used with the system shown inFIG. 1 and that utilizes a “folding anchor” type of expansion or grasper element;
• FIGS. 5A and 5B is yet another retrieval mechanism that may be used with the system ofFIG. 1 and that includes an expansion or grasper element that is made up of a spring member that uncoils to its at rest configuration within the retrieved object;
• FIGS. 6A and 6B illustrate a retrieval mechanism with an expansion or grasper element similar to that shown inFIGS. 2A-2C that utilizes a plurality of tabs to engage the inner surface of an object being retrieved;
• FIGS. 7A and 7B illustrates still another retrieval mechanism useful with the retrieval systems of the invention that includes yet another embodiment of an expansion or grasper element (e.g., an expandable tube tip) useful for grasping or engaging inner surfaces of a balloon or other inflatable/deflatable object; and
• FIGS. 8A-8D illustrates a retrieval mechanism with a funnel-based expansion or grasper element.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention is directed to methods and systems for retrieving fluid-filled objects from stomachs or other cavities of patients. The following description describes particularly systems and their operations for deflating, engaging or grasping, and retrieving or removing intrastric balloons from the stomach of a patient, but the concepts are equally applicable to nearly any object or hollow shape that is inflatable with fluid. Intragastric balloon retrieval systems of the invention are described as being useful with standard endoscopes, gastroscopes or the like that include a working channel through which the retrieval system can be passed to a stomach of a patient. Further, in a typical embodiment, the retrieval systems include a device for puncturing the shell of the intragastric balloon and for inserting an end of a tube, or an outlet of a lumen in such tube, within the intragastric balloon. The lumen can be used to deflate or aspirate the contents of the balloon. Then, during balloon retrieval procedures, a retrieval mechanism of the invention is inserted through the lumen (or is passed further through the lumen in embodiments in which the mechanism remains in the lumen during deflation).
• Significantly, each embodiment of the retrieval mechanisms of the invention includes an expansion or grasping element at or proximal to its distal end that is inserted through the lumen of the deflation tube so as to extend beyond the tip or end of the deflation tube (or beyond a needle, prong, or other component used to pierce the balloon shell). These expansion elements each are adapted to contact and engage the inner surface of the intragastric balloon as the retrieval mechanism and the deflation or aspiration tube is withdrawn from the stomach of the patient. Typically, each expansion member is capable of taking on a first profile or dimensions (deployment configuration or profile) smaller than or equal to the inner diameter of the lumen such that it can pass through the deflation or aspiration tube. When in the open or unrestricted space within the intragastric balloon, the expansion element expands to a second profile or dimensions (deployed or retrieval configuration or profile) substantially greater than the outer diameter of the needle and/or tube.
• This larger-sized profile or configuration and the contact surface(s) of the expansion element allow the expansion element to effectively contact or “grasp” the inner surface of the balloon adjacent to the hole that was previously formed in the balloon shell by the needle or puncture member of the retrieval mechanism. In some cases, the “grasping” includes trapping or pinching balloon material near the formed hole between the contact surfaces of the expansion element and the outer surfaces of the needle or puncture member or deflation tube. These and other features of the invention will become clear from the following description of the retrieval systems of the invention and the multiple embodiments of retrieval mechanisms useful in such systems to contact the inner surface of intragastric balloons so as to grasp or capture the balloons for efficient retrieval from a patient.
• FIG. 1 illustrates an inflatable/deflatableobject removal system110 of the invention that is particularly well suited for use when the object is an intragastric balloon. Theobject removal system110 includes asingle lumen tubing120 that is configured with anouter wall122 that has a diameter such that thetube120 is small enough to pass through a working channel or lumen of an endoscope, gastroscope, or the like (not shown). Thetube wall122 defines alumen124 that extends from one to the other end of thetube120. At the distal end, a needle orpuncture member112, such as a hollow cannulated needle with a relativelysharp tip114, is provided, which may be an extension of thetube120 or a separate component that is attached to thetube wall122. Thepuncture member112 optionally has its lumen or hollow center coupled to thelumen124 or other channel through thetube120 such that fluid (not shown) can be aspirated from an object orballoon104 that has its shell orwall106 pierced by thetip114 of themember112.
• During deflation operations, the fluid contained by theinner surfaces108 of theballoon wall106 may be allowed to flow into the stomach or cavity of a patient, but often it is desirable to aspirate or evacuate the fluid via thetube120. In this regard, the insertion of theneedle member112 results in thelumen124 provided in thetube120 being exposed to the interior space of theballoon104 defined by theinner surface108 of the balloon wall106 (e.g., via theneedle member112 depending upon how deep thetube120 is inserted into the balloon104). To facilitate insertion and later deflation of theballoon104, a connector126 (e.g., a luer connector or the like) is provided with a tube connector that is also hollow or has aninternal channel129 at the proximal end of theremoval system110. After thetube120 is positioned in a patient and thetip114 has pierced aballoon104, theconnector126 can be connected to a suction mechanism to apply suction and evacuate fluid from theballoon104 vianeedle112 andlumen124 oftube120. While thesystem110 is shown with thesingle lumen tube120 and a particular connector and puncture arrangement, these components can be varied significantly to practice the invention such as with a dual lumen tube, a different connector, and a differing needle or piercing device, with an important feature of the aspirator portion being the ability to pierce thewall106 and position a lumen port, opening, or end within theballoon104 to provide access to theinner surface108 of thewall106.
• A significant feature of thesystem110 is the improved ability of thesystem110 for grasping and retrieving the deflatedballoon104. To this end, thesystem110 includes a retrieval mechanism (which is shown in more detail inFIGS. 2A-2C). The retrieval mechanism includes adeployment member132 that may be a wire, a twisted wire rope, a flexible rod, a tube, or other component that is adapted for being pushed and pulled through thelumen124 of thetube120. As shown, the retrieval mechanism includes ahandle138 attached to the proximal end of themember132 and an expansion element made up of a bar (or T-bar)134 attached with connector136 (such as a pin, solder or other connection). Thehandle138 is used by an operator (such as doctor, surgeon, or other medical technician) to push the wire ormember132 until the distal end of the wire ormember132 and thebar134 passes thetip114 of theneedle112 and is positioned within theballoon104. At this point (i.e., the deployed or fully deployed position), the expansion element is able to expand or convert from a first, smaller profile or configuration to a second, larger profile or configuration (e.g., a first profile with dimensions that allow the bar andwire134 and132 to fit within thelumen124 and a second profile with dimensions that are larger than thetip114 used to pierce the balloon wall106). Because the expansion or conversion element is an important feature of the invention andsystem110, the following figures and discussion emphasize a number of embodiments of retrieval mechanisms with varying expansion or conversion elements, with thetube120 and other features of thesystem110 being useful in combination with any of the retrieval mechanisms (and, as discussed earlier, the retrieval mechanisms being useful with removal systems other than that shown inFIG. 1).
• FIGS. 2A-2C illustrate one embodiment of aretrieval mechanism230 that may be used in a removal system, such assystem110 ofFIG. 1. As shown, a deflation oraspiration tube220 with awall222 defines a lumen224 (such as a lumen with a circular or other shaped cross section). At the end of thetube220 is a puncture orneedle member212 that is affixed to thetube wall222 such as by threading and/or adhesive or the like. Thetubing220 andmember212 may be made of a number of materials to practice the invention such as flexible plastic or elastomer, e.g., PTFE, ETFE, or PDVF. With its outer dimensions being selected to be less than the inner diameter of an endoscope working channel, such as less than about 0.1 inches, this results in a lumen outer diameter less than this dimension, such as 0.08 inches, 0.05 inches, or less. The deploying or first profile or configuration of theretrieval mechanism230 is selected to be less than the diameter of the lumen to allow its deployment into the balloon interior. Clearly, the specific dimensions are not limiting with the more important aspect being the relative dimensions.
• Thepuncture member212 is shown after it has been used to pierce theballoon104 by making a hole in thewall106. As shown, the outlet or tip216 of themember212 is within theballoon104 such that the lumen orchannel214 of themember212 is within theballoon104. InFIG. 2A, theretrieval mechanism230 is being deployed as shown atarrow231 through thelumen224 into the interior of theballoon104. Theretrieval mechanism230 includes a deployment member232 (e.g., a wire, wire rope, flexible rod, or the like made of metal or other materials), which is connected to a handle (not shown). Anexpansion element225 is attached withconnector226 to the end of thedeployment member232. Theexpansion element225 can be thought of as a T-bar and includes an elongate body of a width, W, with two opposingends228,229 (shown curved in this embodiment but may take other shapes to practice the invention). The width, W, of theexpansion element225 is less than thelumen224 andchannel214 in thepuncture member212. As shown, theexpansion element225 is collapsible onto the wire ordeployment member232 while it is being deployed through thelumen224 of thetube220. In other words, the bar or body of theexpansion element225 may be aligned with thewire232 to fit into thetubing220, and when emerging from thetubing220end212 resumes a perpendicular orientation.
• FIG. 2B illustrates theexpansion element225 in its deployed profile or configuration in which its body is perpendicular to (or at least no longer aligned with)wire232. Theexpansion element225 swings down as shown witharrow240 to the deployed or second larger profile. The larger or second profile results in the body orexpansion element225 having a length, L, that is larger than the outer diameter of thepuncture element212, and the length, L, is typically significantly larger than this diameter (e.g., 2 to 6 or more times larger than this diameter) with the upper limitation being that the length of theextension element225 as measured along the elongate body fromend228 to end229 is less than the inner diameter of the channel through which thetube220 andballoon104 be removed, e.g., less than a patient's esophagus inner diameter such as less than about 0.75 inches). With this profile, theelement225 is longer than the hole formed in theballoon wall104.
• As shown, theextension element225 has a contact or graspingsurface227. When theretrieval mechanism230 is withdrawn or pulled back toward thetube220 as shown atarrow242, thecontact surface227 of theexpansion element225 contacts (engages or grasps) theinner surface108 of theballoon wall106. This grasping or contact by theexpansion element225 is shown inFIG. 2C. As shown, once the wire ordeployment member232 is pulled or withdrawn until thecontact surface227 abuts the tip or end216 of the puncture member212 (or pinches balloon wall106), thetube220 of the removal system is pulled or withdrawn as shown atarrows246 to remove theballoon104 along with thetube220 andretrieval mechanism230. Theexpansion element225 is effective for grasping theballoon104 by contacting theinner surface108, and theballoon shell106 can be pulled out of its environment (e.g., a stomach or other patient cavity) draped over the T-bar or elongate body of theexpansion element225.
• FIGS. 3A to 3C illustrate another embodiment of aretrieval mechanism330 being deployed into aballoon104 that has been pierced bytube220 and puncture member212 (with similar components shown inFIGS. 2A to 2C not being described in detail). Themechanism330 can be thought of as using a balloon grasper to grasp theinner surface108 of theballoon wall106. Specifically, theretrieval mechanism330 includes a tube of smaller diameter than thetube220, and this tube is advanced as shown inFIG. 3A atarrow331 through thelumen224. At the end of thetube332, a small balloon orinflatable expansion element336 is provided in thelumen334 ofsmaller tube332. Theexpansion element336 is attached at or near theend338 of thetube332.
• As shown inFIG. 3B, theexpansion element336 includes a wall orshell337 and aninner surface339. When the expansion element336 (or end338 of tube332) is positioned within the balloon104 (or past the hole in wall106), air orother fluid344 is forced through thelumen334 of tube (or deployment member)332 to force theelement336 out of thetube332 and to apply pressure againstinner surface339 ofwall337 and inflate theexpansion element336 as shown witharrows348. The inflation ofelement336 may be controlled by achieving a predetermined pressure in thelumen334 andelement336 or by inserting a predetermined volume of gas orfluid344. AtFIG. 3C, theexpansion element336 is shown inflated to a second configuration or profile and an outer diameter, D, that is greater than the outer diameter of the puncture member212 (and hole in wall106), e.g., 10 times larger or the like. The outer surfaces of the wall337 (e.g., contact surfaces of the expansion element336) abut or engage theinner surface108 of theballoon wall106 when thetube332 is withdrawn into thedeployment tube220 until theexpansion element336 hits or is adjacent to thetip216 of thepuncture member212. Thetube220 can then be withdrawn to remove the deflatedintragastric balloon104 with theballoon shell106 draped over theexpansion element336. Again the diameter, D, is selected to be larger than the outer diameter of themember212 and smaller than the channel through which thetube220 is removed from a patient's body, such as less than about 0.75 inches when the channel is a patient's esophagus. Thewall337 of theexpansion element336 may be formed from many elastic materials such as rubber or the like, and in some cases, the contact surface or outer surface ofwall337 is rough (or roughened) to improve the “grasping” ofinner surface108 ofballoon104.
• FIGS. 4A and 4B illustrate another embodiment of aretrieval mechanism430 that includes an expansion element that can be thought of as a “folding anchor.”FIG. 4A illustrates the expansion element in the first or deploying profile or configuration in which it has dimensions that are less than or equal to the inner diameter of thelumen224 oftube220. The expansion element includes aconnector434 attached to the end of deployingmember433. Theconnector434 may be a circular disk or plate that and themember433 may be a wire, a wire rope, or other flexible component. The expansion element further includes a number of anchor legs432 (such as 3 or more) that are elongate bodies with twoends436,439 and acontact surface438.
• FIG. 4B illustrates how thelegs432 expand out or unfold/deploy when the expansion element is positioned beyond thetip216 ofpuncture member212 within the interior volume of theballoon104 defined byshell106. To this end, the legs are pivotally attached at ends439 to theconnector434. In some embodiments, the legs and connector are formed such that the deployed or second profile shown inFIG. 4B is an “at rest” configuration (such as by forming the anchor expansion element as a single piece) and the unfolding is the result of the legs returning to their at rest position. As shown, though, the legs “fall” or pivot from their first configuration shown inFIG. 4A proximate to thedeployment member433 to the deployed or expanded, second configuration shown inFIG. 4B. In the fully deployed position ofFIG. 4B, the expansion element ofretrieval mechanism430 has a “diameter” (or width), D, that is measured from theouter tip436 of oneleg432 to an outer tip of an opposing leg. This diameter, D, again is significantly larger than the outer diameter of thetube220 and/or puncture member212 (e.g., such as 2 to 10 times or more larger) and less than a predetermined maximum value to allow removal from a patient. Then, as shown atarrow450, thedeployment member433 is pulled back into thetube lumen224 until thecontact surface438 of thelegs432 contacts theinner surface108 of theballoon wall106 when the connector abuts or is proximate to thetip216 ofmember212. Then, thetube220 anddeployment member433 are withdrawn or pulled from the patient to retrieve the deflatedballoon104.
• FIGS. 5A and 5B illustrate yet anotherretrieval mechanism530 useful in object removal systems of the invention. With thisretrieval mechanism530, theaspirator tube220 is again placed within the hollow shape or shell106 of the object orballoon104. Theretrieval mechanism530 is then advanced down thelumen224 into theballoon104. Theretrieval mechanism530 includes a deployment member (e.g., a wire or the like)534 that is connected at afirst end538 to anexpansion element536. The otherdistal end539 of theexpansion element536 is fed into theballoon104. This embodiment of theretrieval mechanism530 can be thought of as a “spring” embodiment as theexpansion element536 may be made up of a length of spring, a spring coil, spring wire, or the like that can be “straightened” into a first profile or configuration for feeding through thetube lumen224 and then, when in an unrestricted space such as the interior space of theballoon shell106, theexpansion element spring536 returns to its at rest or second profile or configuration.
• The unrestricted or at rest configuration of theexpansion element536 can be defined as having an outer dimension, D (even if not a true circle or sphere) that is larger than the outer diameter of thepuncture member212 and/ortube220 as shown inFIG. 5B (e.g., 2 to 10 or more times larger). As shown atarrow550, the wire ordeployment member534 is withdrawn or pulled back up thelumen224 of thetube220 until the first orproximal end538 of theexpansion element536 contacts or is pulled within thelumen214 of thepuncture member212. At this point, the unrestricted spring, which has resumed its natural or at rest state of a coil, spiral, or other non-linear shape, may compress somewhat but is selected to have a stiffness (or resistance to leaving its at rest state) that allows it to contact theinner surface108 of theballoon wall106 and grasp theballoon104. In other words, theexpansion element536 shown inFIG. 5B is selected such that forces applied by the deflated balloon inner surface108 (“retraction forces”) do not compress theelement536 to a point where its dimension, D, is less than the outer diameter of themember212. As a result, theexpansion element536 is able to “grasp” or engage theinner surfaces108 when thetube220 is withdrawn from the hole in thewall104, and theballoon shell106 can be pulled out of its environment draped over thespring element536.
• FIGS. 6A and 6B show anotherretrieval mechanism630 with a “tab-based” expansion element. As shown byarrow631, the tab expansion element is fed through thelumen224 of theaspiration tube220 with wire ordeployment member632. Themember632 is attached to thebody634 of the expansion element, and thebody634 can be aligned with themember632 in a first, smaller profile or configuration of the expansion element. Theelongated body634 may be a relatively stiff or rigid tube or wire. On each opposite end of thebody634 is attached a tab or graspingmember638,639. Each of thesetabs638,639 may have a variety of shapes and be made of a variety of materials to practice the invention. As shown, thetabs638,639 are relatively planar and have a circular shape. In other cases, thetabs638,639 may be more spherical or hemispherical in shape or range toward planar but with a different shape such as square, rectangular, triangular, hyperbolic, or the like. The materials used for thebody634 andtabs638,639 may be the same (such as when these components are stamped out or formed as a unitary piece), may be selected for easy joining (such as soldering or the like), or may be different.
• As shown inFIG. 6B,body634 of the expansion element “expands” by swinging out of alignment with thewire632, such as to a perpendicular or transverse position relative to thewire632. This expanded or second, larger profile or configuration of the expansion element results in the expansion element having a dimension or width, D, that is larger than the outer diameter of thepuncture element212 and tube wall222 (e.g., 2 to 8 time or more larger with the ratio of 5:1 being used in some embodiments). When thewire632 is withdrawn into thelumen224, a surface of thebody632 proximate to thewire632 contacts the tip or end216 of thepuncture member212. In this illustrated position, thetabs638,639 extend outward from thepuncture member212. When, as shown byarrow652, thetube220 andretrieval mechanism630 are withdrawn, contact surfaces of thetabs638,639 contact or “grasp” the inner surfaces of theballoon shell106. The contact surfaces of eachtab638,639 are typically about the size of or less than the inner diameter of thetube lumen224 orlumen214 of thepuncture element212, whichever is less, to allow thetabs638,639 to be passed through thetube220 andmember212 into theballoon104. Theballoon shell104 can then be pulled out of its environment draped over the shapedextensions638,639 of the expansion element of theretrieval mechanism630.
• FIGS. 7A and 7B illustrate still anotherretrieval mechanism730 useful with object removal systems of the invention. As shown, theexpansion element733 of theretrieval mechanism730 can be though of as an expandable tube retriever or grasper. To this end, theretrieval mechanism730 includes ahollow tube732 of flexible plastic or elastomeric materials with an outer diameter less than the inner diameters ofaspiration tube220 andpuncture member212. Thetube732 can be passed or advanced as shown atarrow731 in a deflatedballoon104. The tip orexpansion element733 includes a number of cut slits parallel to the axis of thetube732, e.g., 4 slits spaced about 90 degrees apart about the circumference of thetip733. Theretrieval mechanism730 further includes awire735 that is attached toward the distal end of thetip733 such as to aplate736 at or near the distal end oftip733. When the expansion element ortip733 is positioned within theshell106 of theballoon104, tension is applied as shown atarrow750 to the wire orstring735 such that the attached end of the tip orplate736 is pulled with thewire735 toward thetube220 orpuncture member212. This movement causes theexpansion element733 with the slits734 to buckle and expand from the first small profile to a second profile (e.g., a cruciform shape or the like) with a width, W, that is larger than the outer diameter of thepuncture member212 and tube wall222 (e.g., 2 to 5 or more times larger with a minimum ratio of 3.5:1 being used in some cases). The outer surfaces of theexpansion element733 then provide contact surfaces that contact theinner surface108 of theballoon wall106 when theretrieval mechanism730 is pulled bywire735 such that the expandedtip733 abuts thepuncture element212 and thetube220 is withdrawn as shown at752.
• FIGS. 8A to 8D illustrate aretrieval mechanism830 that makes use of afunnel expansion element834. Theretrieval mechanism830 includes a feed ordeployment wire832 that is used to deploy as shown atarrow831 theexpansion element834, which is attached to thewire832, through thelumen224 of theaspiration tube220. As shown byarrows842 inFIG. 8B, thefunnel expansion element834 expands outward from its first profile that is smaller than the inner diameter of thetube220 andpuncture member212 to its second profile with a width (or diameter), W, that is larger than the outer dimensions of thetube220 andmember212. Theexpansion element834 may include acircular plate835 that is attached to thewire832 and an expandable/retractable wall836. Thewall836 may take a number of forms, and in one embodiment, is made of a plurality of vanes or ribs (such as elongate metal plates) that are wrapped about thewire832. In this case, thewall836 expands outward to width, W, and exposesinterior surfaces838 of thewall836.
• As shown byarrow852 inFIG. 8C, thetube220 is withdrawn from the balloon such that thewire832 of theretrieval mechanism830 extends through thehole856 in theballoon wall106 and theexpansion element834 remains in the balloon104 (e.g., thetube220 is withdrawn initially without withdrawing or tensioning the wire832). Then, as shown byarrow862 inFIG. 8D, tension is applied to thewire832 of theretrieval mechanism830 such that thefunnel expansion element834 moves toward thepuncture member212 andtube220. Theinner surface108 of theballoon wall106 is contacted by the upper edge of thewall836 such that a portion of theballoon wall106 is pinched or sandwiched between theinner surface838 of thewall836 of theexpansion element834 and the outer surfaces of thepuncture member212 and/ortube wall222. Preferably, to support this grasping action, the shape of thewall836 in the expanded or second configuration is selected to correspond to the conical shape of the exterior surfaces of the tip orpuncture member212 or end oftubing220. When retracted, theballoon wall106 is captured between thefunnel expansion element834 and thecone tip212 with some force. Theballoon shell104 can then be pulled out of its environment by applying tension to thetube220 and thewire832 of theretrieval mechanism830.
• Although the invention has been described and illustrated with a certain degree of particularity, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the combination and arrangement of parts can be resorted to by those skilled in the art without departing from the spirit and scope of the invention, as hereinafter claimed. For example, the body or bar225 shown inFIGS. 2A to 2C may include a groove along one side for receiving thewire232 when the expansion element is placed in the first profile for deploying through the aspiration tube. In other embodiments, the T-bar225 can be attached by a loop at the end of the wire rather than being attached to the end of thewire232. In theretrieval mechanism430 ofFIGS. 4A and 4B, theanchor legs432 may have a curved (or concave) shape to increase their strength and the outer ends ortips436 may be textured or include small prongs or the like for enhanced grabbing of theinner surface108 of theballoon wall106. Further, thetube expansion element733 ofFIGS. 7A and 7B can be “locked” in the expanded position, such as, for example, by providing a slot or recessed latching surface in the inner lumen walls of thetube732. A bead or ball or other shape may be attached to thewire735 within the tip733 (such as proximal to the plate736). When the bead or ball is pulled to the slot or recessed latching surface within thetip733, theexpansion element733 becomes latched or locked in the cruciform or expanded profile.

Claims (25)

1. An apparatus for removing an inflatable object from a body cavity of a patient, comprising:

a deflation tube having a puncture member at one end for forming a hole in a wall of the inflatable object and a lumen running there through; and

a retrieval mechanism slidably movable within the lumen, wherein the retrieval mechanism comprises an expansion element expandable from a first configuration in which the expansion element fits within the lumen to a second configuration in which the dimensions of the expansion element are greater than the lumen.

2. The apparatus ofclaim 1, wherein the expansion element in the second configuration comprises at least one contact surface transverse to a longitudinal axis of the lumen, whereby the contact surface contacts an inner surface of the inflatable object proximate to the hole when the deflation tube and retrieval mechanism are withdrawn from the body cavity.

3. The apparatus ofclaim 1, wherein the retrieval mechanism further comprises a flexible deployment member and wherein the expansion element comprises an elongate body attached to an end of the deployment member, wherein the body has a width less than an inner diameter of the deflation tube lumen and a length equal to the dimension of the second configuration of the expansion element.

4. The apparatus ofclaim 1, wherein the retrieval mechanism further comprises a tube with an outer diameter less than an inner diameter of the deflation tube lumen and with a lumen and wherein the expansion element is attached proximal to one end of the tube and in fluid communication with the lumen, the expansion element comprising an inflatable shell adapted for inflation to have an outer diameter of at least about the dimension of the second configuration of the expansion element, whereby outer surfaces of the inflatable shell contact inner surfaces of the inflatable object when the retrieval mechanism is removed from the body cavity.

5. The apparatus ofclaim 1, wherein the retrieval mechanism further comprises a deployment member and wherein the expansion element comprises a connector attached to the deployment member and one or more legs attached at a first end to the connector such that each of the legs are foldable about the first end toward the deployment member in the first configuration and unfold away from the deployment member about the first end to position a second end spaced apart from the deployment member in the second configuration, the dimension of the second configuration being measured between two of the second ends of the legs.

6. The apparatus ofclaim 1, wherein the expansion element comprises a spring having the second configuration when unrestricted by external compressive force.

7. The apparatus ofclaim 1, wherein the retrieval mechanism comprises a flexible deployment member and wherein the expansion element comprises a substantially rigid, elongate body fixed to one end of the deployment member and two tabs fixed to opposite ends of the elongate body, the elongate body having a length greater than the outer dimension of the puncture member and the tabs having a maximum outer dimension less than an inner diameter of the lumens of the deflation tube and the puncture member.

8. The apparatus ofclaim 1, wherein the retrieval mechanism further comprises a tube with an outer dimension less than an inner diameter of the deflation tube lumen, the expansion element being provided at an end of the retrieval mechanism tube and comprising an elongate, tubular body with a plurality of slits cut parallel to a longitudinal axis of the tubular body and extending about the circumference of the tubular body and further comprising a wire within the retrieval mechanism tube and attached to the tubular body at a point distal to the retrieval mechanism tube, whereby tension applied to the wire causes the tubular body to expand from the first configuration to the second configuration by drawing the attachment point of the tubular body toward the retrieval mechanism tube.

9. The apparatus ofclaim 1, wherein the retrieval mechanism further comprises a flexible deployment member and the expansion element comprises a connector attached to the deployment member and a wall having a first end attached to the connector and a second end proximate to the deployment member, wherein the connector has a maximum dimension less than the inner diameter of the puncture member lumen and wherein the wall is formed to be rolled about the deployment member into the first configuration, the first configuration being substantially cylindrical, and to expand outward into the second configuration when unrestricted, the second configuration being frustaconical and the dimension of the second configuration being measured as the width of the wall at the second end.

10. A method for evacuating and removing a fluid-filled object positioned in a body cavity of a patient, comprising:

positioning an aspirator device in the body cavity;

piercing a wall of the fluid-filled object with the aspirator device, wherein the aspirator device comprises a tube with a lumen;

sliding a retrieval mechanism in the lumen of the aspirator tube, wherein the retrieval mechanism comprises an expansion element having a deployed configuration greater in size than an outer diameter of the aspirator tube and wherein the sliding comprises extending the expansion element at least partially out of the lumen and into the pierced object;

expanding the expansion element to the deployed configuration; and

withdrawing the retrieval mechanism and the aspirator device from the body cavity, wherein during the withdrawing the expansion element contacts an inner surface of the object wall forcing the object to be removed from the body cavity with the retrieval mechanism.

11. The method ofclaim 10, wherein the retrieval mechanism comprises a flexible deployment member attached to the expansion element, and the method further comprises prior to the withdrawing, applying tension on the deployment member to force the expansion member to abut a tip fixed on the aspirator tube.

12. The method ofclaim 11, wherein the applying of the tension results in the expanding of the expansion element to the deployed configuration.

13. The method ofclaim 11, wherein the applying of the tension causes the expansion element to contact the inner surface of the object wall and to sandwich a portion of the wall between the expansion element and the tip of the aspirator tube.

14. The method ofclaim 10, wherein the expansion element is selected from the group consisting of a T-bar, an object inflated in the expanding of the expansion element, a folding anchor device that unfolds to the deployed configuration, a spring element that returns to an at-rest position during the expanding of the expansion element, an elongate body with tabs attached at opposite ends, a tubular body with slits cut in a spaced-apart manner, parallel to a longitudinal axis of the tubular body and with a tensioning wire attached to an end of tubular body, and a funnel collapsible into a cylinder and expandable into a frustaconical shape in the deployed configuration.

15. An intragastric balloon removal system, comprising:

means for deflating a fluid-filled object positioned in a body cavity of a patient to pierce a wall of an intragastric balloon, wherein the deflating means comprises a tube with a lumen extending through the balloon wall; and

a retrieval mechanism comprising a flexible deployment member and an expansion element attached to an end of the deployment member, wherein the retrieval mechanism is slidably movable in the lumen of the deflating means and the expansion element is adapted to be in a first configuration facilitating movement of the retrieval mechanism in the lumen and in a second configuration larger than the lumen when the expansion element is within a cavity defined by the balloon wall, whereby the expansion element contacts an inner surface of the object wall when the deflating means and retrieval mechanism are withdrawn from the body cavity.

16. The system ofclaim 15, wherein the expansion element comprises an elongate body attached to an end of the deployment member, wherein the body has a width less than an inner diameter of the lumen and a length larger than an outer diameter of the deflating means tube.

17. The system ofclaim 15, wherein the retrieval mechanism further comprises a tube with an outer diameter less than an inner diameter of the deflating means tube lumen and with a lumen and wherein the expansion element is attached proximal to one end of the retrieval mechanism tube and in fluid communication with the lumen, the expansion element comprising an elastic shell adapted for inflation to an outer diameter greater than an outer diameter of the deflating means tube, whereby outer surfaces of the inflatable shell contact inner surfaces of the balloon wall when the retrieval mechanism is removed from the body cavity.

18. The system ofclaim 15, wherein the expansion element comprises a connector attached to the deployment member and one or more legs attached at a first end to the connector such that each of the legs are foldable about the first end toward the deployment member for positioning within the deflation means tube lumen and pivotable away from the deployment member about the first end to position a second end of each of the legs spaced apart from the deployment member in the deployed configuration.

19. The system ofclaim 15, wherein the expansion element comprises a spring having the deployed configuration when unrestricted by external compressive force.

20. The system ofclaim 15, wherein the expansion element comprises a substantially rigid, elongate body fixed to one end of the deployment member and two tabs fixed to opposite ends of the elongate body, the elongate body having a length greater than an outer dimension of the deflating means tube and the tabs having a maximum outer dimension less than an inner diameter of the lumen of the deflating means tube.

21. The system ofclaim 15, wherein deployment member comprises a tube with an outer dimension less than an inner diameter of the deflating means tube lumen, the expansion element being provided at an end of the retrieval mechanism tube and comprising an elongate, tubular body with a plurality of slits cut parallel to a longitudinal axis of the tubular body and extending about the circumference of the tubular body and further comprising a wire within the retrieval mechanism tube and attached to the tubular body at a point distal to the retrieval mechanism tube, whereby tension applied to the wire causes the tubular body to expand from the first configuration to the second configuration by drawing the attachment point of the tubular body toward the retrieval mechanism tube.

22. The system ofclaim 15, wherein the expansion element comprises a connector attached to the deployment member and a wall having a first end attached to the connector and a second end proximate to the deployment member, wherein the connector has a maximum dimension less than the inner diameter of the deflating means tube lumen and wherein the wall is collapsible about the deployment member to be received within the deflating means tube lumen and expandable outward into the deployed configuration when unrestricted, the second configuration being frustaconical with a base at the second end of the wall.

23. The system ofclaim 15, wherein the expansion element comprises outer surfaces for contacting the inner surface of the object wall, the outer surfaces being modified to increase friction between the outer surfaces and the inner surface.

24. The system ofclaim 23, wherein the modification is performed by blasting, etching, or adding coatings.

25. The system ofclaim 23, wherein the inner surface of the object wall is modified to increase the friction between the outer surfaces of the expansion element and the inner surface.

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