Enhanced aspiration processes and mechanisms for instragastric devices

A sealing device attached to an intragastric balloon device having a at least one flexible membrane aligned with and configured to seal an aspiration port of a lumen when the membrane is in a closed state and further configured to provide access to the lumen when the membrane is in a open state.

RELATED REFERENCES

BACKGROUND

This disclosure relates to implantable, expandable gastric devices. In particular, this disclosure relates to mechanisms and procedures for controlled deflation and explant of such devices.

Many conventional implantable gastric devices have a balloon filled with a biocompatible fluid. Such gastric devices are generally inserted into the stomach when the balloon is deflated and then inflated in vivo. The gastric devices are often left in the stomach for an extended period of time to treat severe obesity or other conditions. The gastric devices are eventually removed after completing the treatment or for other reasons by deflating the balloon, grasping the gastric device with an extraction tool, and extracting the gastric device via the esophagus and mouth. Conventional gastric devices are deflated by attempting to puncture the balloon and aspirate the biocompatible fluid through a needle.

One challenge of deflating conventional devices is that the balloon may rupture when it is punctured by the needle. For example, the balloon typically degrades over time because stomach acids, fungi, and bacteria may degrade the integrity of the balloon wall, and the needle puncture may cause a degraded balloon wall to fail. Also, it is difficult to control the angle between the needle and the balloon, and the needle will tend to rip the balloon as opposed to puncturing the balloon at certain angles. When the balloon ruptures, the biocompatible fluid is quickly expelled into the stomach, which complicates the extraction procedure and may be uncomfortable to the patient.

Another challenge of implantable gastric devices is grasping the device for extraction. Several existing devices are grasped by a claw or snare. These procedures can be challenging because projections and/or other features that are easy to grasp may agitate the stomach wall. Thus, there is a need to improve the deflation and extraction of implantable gastric devices.

DETAILED DESCRIPTION

Specific details of several embodiments of the present technology are described below with reference to an intragastric device with a sealing device and methods for implanting and explanting such devices. Although many of the embodiments are described below with respect to a dual balloon intragastric device, but other types of devices with only one balloon or more than two balloons may be within the scope of the technology. Moreover, several other embodiments of the technology can have different configurations, components, or procedures than those described in this section. A person of ordinary skill in the art, therefore, will accordingly understand that the technology may have other embodiments with additional elements, or the technology may have other embodiments without several of the features shown and described below with reference toFIGS. 1-19.

Several embodiment of the present technology are directed to a sealing device for use with an intragastric device comprising a body fixedly attached to an intragastric balloon device and a head attached to the body. The sealing device can have at least one flexible membrane aligned with and configured to seal an aspiration port of a lumen when the membrane is in a closed state. The sealing device can be further configured to provide access to the lumen when the membrane is in a open state (e.g., when a needle is passed through the membrane).

Additional embodiments of the technology are directed to an intragastric balloon device comprising a shaft having a plurality of lumens and a plurality of balloons carried by the shaft. Each balloon can be fluidically coupled to a corresponding lumen of the shaft such that an interior portion of each balloon is in fluid communication with its corresponding lumen. The intragastric balloon device can further include a sealing device having a body fixedly attached to the shaft and/or one of the balloon. The sealing device can also have a head attached to the body and at least one flexible membrane configured to seal an aspiration port of one of the lumens when the membrane is in a closed state and to provide fluidic access to the lumen when the membrane is in a open state.

Still additional embodiments of the present technology are directed to a method of aspirating an intragastric balloon device, comprising providing an endoscope device to the intragastric balloon device within a gastric cavity. The intragastric balloon device includes at least one fluid-filled balloon and a sealing device with a body fixedly attached to the intragastric balloon device. The sealing device further includes a head attached to the body and at least one flexible membrane configured to seal an aspiration port of a lumen of the intragastric device when the membrane is in a closed state and to provide fluidic access to the lumen when the membrane is in a open state. The method can further comprise securing the endoscope device to at least a portion of the sealing device, penetrating the membrane of the sealing device with an aspiration device, whereby access to fluid in the corresponding lumen is achieved, and aspirating the fluid from the at least one balloon via the lumen.

In one embodiment, an intragastric device10may include at least one collapsible, space-filling component, such as a balloon. As shown inFIG. 1, a plurality of balloons (e.g., first balloon30aand second balloon30b) may be fixed to shaft20of intragastric device10.

In the particular embodiments of the technology shown inFIGS. 1-3, the intragastric device10may include or be configured to interface with sealing device100at an end of the intragastric device10and a plug45at another end of the intragastric device10. As used herein, the terms “proximal”, “distal”, “first”, and “second” refer to relative locations and orientations of structures, devices, and components. For example, the terms “proximal”, “distal”, “first”, and “second” may be understood to refer to relative identifiers, rather than absolute identifiers except where expressly stated as such. As those having skill in the relevant art will recognize, variation and modification of the disclosure on the same basis is considered within the present disclosure.

Referring toFIG. 3, the shaft20of the intragastric device10may include a plurality of lumens in which each lumen corresponds to a balloon of intragastric device10. For example, first lumen40amay provide fluid communication from first inflation port47ato an interior portion of first balloon30avia first inflation opening32a. Likewise, second lumen40bmay provide fluid communication from second inflation port47bto an interior portion of second balloon30bvia second inflation opening32b.

According to embodiments, and as shown inFIG. 3, each lumen may have a corresponding inflation port at an end of the lumen. Inflation ports may be configured to allow infusion of fluids into corresponding lumens and inhibit or prevent exit of fluids from the same. Inflation ports may include check valves, clack valve, non-return valve, one-way valve, duckbill valves, reed valves, etc. For example, a plug45may be positioned at the end of the first balloon30ato dispose the first inflation port47aat an end of first lumen40aand to dispose the second inflation port47bat an end of second lumen40b.

According to embodiments, and as shown inFIG. 3, each lumen of shaft20may be divided into inflation and aspiration chambers. For example, first lumen40amay be divided into first inflation chamber42aand first aspiration chamber44aby first barrier46a. Likewise, second lumen40bmay be divided into second inflation chamber42band second aspiration chamber44bby second barrier46b. Such barriers may partition a lumen into at least two separate chambers that may be fluidly connected via the interior portion of a corresponding balloon.

According to embodiments, each balloon may have an opening that fluidly connects the interior portion of the balloon with at least a portion of a corresponding lumen. According to embodiments, and as shown inFIG. 3, each balloon may have a plurality of openings that connect the interior portion of the balloon with disparate chambers of a corresponding lumen. For example, first inflation opening32amay provide a fluid connection between the interior of first balloon30aand first inflation chamber42a, and first aspiration opening34amay provide a fluid connection between the interior of first balloon30aand first aspiration chamber44a.

According to embodiments, and as shown inFIGS. 3 and 3A, sleeves may be provided, each within the interior of a balloon and covering an inflation opening. Such sleeves may provide inflation of the balloon from the corresponding lumen while inhibiting or preventing deflation through the same opening. The sleeves may wrap radially around the portion of shaft20near the corresponding opening. For example, first sleeve50amay be provided within the interior portion of first balloon30aand covering at least first inflation opening32a. Likewise, second sleeve50bmay be provided within the interior portion of second balloon30band covering at least second inflation opening32a. Sleeves may inhibit or prevent undesirable fluid pressure on inflation ports and thereby reduce leakage and associated issues. For example, when pressure within the balloon exceeds pressure in the corresponding lumen, a sleeve may be pressed against the corresponding opening to inhibit or prevent leakage into the lumen. When pressure within the lumen exceeds pressure within the corresponding balloon, a sleeve may separate from the corresponding opening and permit infusion into the balloon via a space formed between the sleeve and shaft housing the lumen. Fluid flowing from first inflation chamber42a, through first inflation opening32a, through a space formed between first sleeve50aand the exterior surface of shaft20, and into the interior of first balloon30ais shown schematically by flow arrows31a. Fluid flowing from the interior of first balloon30a, through first aspiration opening34a, and into first aspiration chamber44ais shown schematically by flow arrows33a. Likewise, second inflation opening32bmay provide a fluid connection between the interior of second balloon30band second inflation chamber42b, and second aspiration opening34bmay provide a fluid connection between the interior of second balloon30band second aspiration chamber44b. Fluid flowing from second inflation chamber42b, through second inflation opening32b, through a space formed between second sleeve50band the exterior surface of shaft20, and into the interior of second balloon30bis shown schematically by flow arrows3lb. Fluid flowing from the interior of second balloon30b, through second aspiration opening34b, and into second aspiration chamber44bis shown schematically by flow arrows33b.

According to embodiments, and as shown inFIG. 3, each lumen may have a corresponding aspiration port at an end of the lumen. Aspiration ports may be selectively covered by sealing device100, as further disclosed herein. For example, first aspiration port48amay be provided at an end of first lumen40a. Likewise, second aspiration port48bmay be provided at an end of second lumen40b.

According to embodiments, and as shown inFIGS. 4 and 10, guidewire channel112may extend through sealing device100and shaft20of intragastric device10. Guidewire channel112may be configured to accommodate a guidewire for assisted delivery and management of intragastric device10during implant, explant, or maintenance thereof

According to embodiments, sealing device100may be provided to selectably seal an end of intragastric device10. As shown inFIGS. 5-6 and 9-10, sealing device100may include body102and head104. Body102and head104may be fixably connected to each other. Body102may be selectably or fixedly attached to at least a portion of shaft20or intragastric device10.

According to embodiments, and as shown inFIGS. 5-10, flange106may extend radially outward from portions of head104that do not otherwise exceed the circumferential limit of other components, such as body102. Flange106may provide increased surface area and distribute forces applied at head104across a greater surface area. Flange106may be provided in a variety of geometries. For example, as shown inFIGS. 5-6 and 9-10, head104and flange106separately or together may form a substantially smooth, convex surface which may be viewed as an arc in cross-section. For example, the top surface of the head104may be configured in an arc such that imaginary extensions of such at least generally extend tangentially with the nearby surface of a balloon (as shown inFIGS. 3 and 4) so as to provide a smooth transition between the outer surfaces of head104and balloon30b. Likewise, the plug45can have a flat surface (or a convex surface similar to the surface of the head104and flange106) that substantially aligns with the nearby surface of a balloon so as to provide a smooth transition between the outermost surface of plug45and the balloon30a. It is believed that geometries that form a step or a sizable gap between the surfaces of the head and balloon provide inflection points that result in trauma in a biological environment. As also shown inFIG. 4, the shape of walls of the balloons30aand30bmay have a constant or near constant curvature as the surface of the balloon approaches the location of the sealing device100or plug45. As shown inFIG. 4, the walls of the balloons30aand30bcan be further curved proximate to the sealing device100or plug45so as to curve sharply towards the inside of the balloon to join to the shaft20at a position disposed about the body102of the sealing device or about the base of the plug.

The balloons may be formed to present a fully-deflated state and a fully-inflated state, or a series of partially-inflated or over-inflated states suitable for the use of the intragastric device. A fully deflated state disposes the balloon so that it is pressed against or disposed loosely about the surface of the shaft so as to present a low profile facilitating delivery. In a fully-inflated state, the balloon presents a profile in which the curvature of the surface of the balloon aligns with the curvature of the sealing device so as to minimize inflection points. In an over-inflated state, that balloon extends beyond the position observed with the fully-inflated state so as to present a balloon surface that curves inwardly towards an inwardly disposed sealing device. The balloon may also be formed of a material, or reinforced with a material, that limits the inflation of the balloon to a predetermined fully-inflated state, or that prevents further expansion of the balloon once the balloon achieves a fully-inflated state. The balloon may also be constructed of a flexible non-expandable material that is in a folded stated when deflated and in an fully unfolded state when fully inflated.

According to embodiments, and as shown inFIGS. 7 and 8, flange106may include interruptions108, such as tabs, around at least a portion of a perimeter of head104. Interruptions108may be configured to further distribute forces applied at head104. Interruptions108may further be configured to facilitate securement and interfacing with a securement device such as a snare, such that a portion of the snare is disposed within an interruption. For example, a snare configured to secure by radial constriction may better secure to sealing device100by way of at least one of interruptions108.

According to embodiments, and as shown inFIGS. 5, 7, and 9, at least one membrane may be provided to cover a corresponding lumen and provide controlled access by an aspiration device. For example, first membrane110amay be configured to cover first lumen40aat an end of the lumen (i.e., at first aspiration port48a). Likewise, second membrane110bmay be configured to cover second lumen40bat an end of the lumen (i.e., at second aspiration port48b). Such a condition may define a “closed state” of the membrane. The membrane may be of thin walls to provide selective access to the corresponding lumen for aspiration of the lumen by controlled crossing, penetration, or breach of the membrane. Such a condition may define an “open state” of the membrane. The measure of thinness may be determined by the nature of materials used and known pressure conditions during inflation of intragastric device10. Accordingly, membranes may be of a rigid, semi-rigid, or flexible material to facilitate aspiration procedures. According to embodiments, membranes and surrounding structure may facilitate controlled aspiration by providing a sufficiently thin or flexible membrane that permits crossing, penetration, or breach of the membrane by an aspiration device while resisting undesirable rupture of the membrane beyond the locality of the aspiration device under pressurized conditions.

According to embodiments, membranes may be of a variety of geometries, including flat, as shown inFIG. 9, convex (not shown), or concave (not shown). For example, an inner surface may be configured to extend into a corresponding lumen. By further example, an outer surface may be shaped to naturally guide an aspiration device to a desired location for subsequent operations. As shown inFIG. 9A, the first membrane110aand second membrane110bmay be disposed with in a recess111so that the walls113of the recess111guide an aspiration device into an engagement with the intragastric device before the membranes are engaged. According to embodiments, membranes may be configured to adequately seal each corresponding lumen to retain fluids therein and avoid inadvertent evacuation of fluids out of intragastric device10or into other lumens. According to embodiments, membranes may be self-sealing, such that a sufficiently small hole pierced therein may recover a sealed state when the piercing object is removed. Such self-sealing may be facilitated by the nature of at least a portion of the fluid present at the membrane.

According to embodiments, any number of membrane layers may be provided. Where a plurality of layers are present, each layer may have disparate characteristics, such as rigidity, flexibility, expansion, porosity, etc. For example, two or more layers may cover ends of an inner layer that may have enhanced self-sealing characteristics by expanding when exposed to fluids caused by breach of the surrounding layers.

According to embodiments, methods of inflating and aspirating balloon device10are disclosed. According to embodiments, intragastric device10may be provided with balloons (e.g., first balloon30aand second balloon30b) in a deflated state. Sealing device100may be provided installed onto intragastric device10.

According to embodiments, intragastric device10may be provided to a gastric cavity of a patient and inflated. An insufflation fluid may be provided to balloons via inflation ports, lumens, and openings. Where sleeves (e.g., first sleeve50aand second sleeve50b) and barriers (e.g., first barrier46aand second barrier46b) are provided, fluid may travel from inflation chambers (e.g., first inflation chamber42aand second inflation chamber42b) through inflation openings (e.g., first inflation opening32aand second inflation opening32b) and past sleeves (e.g., first sleeve50aand second sleeve50b) to inflate balloons. Where aspiration openings (e.g., first aspiration opening34aand second aspiration opening34b) and aspiration chambers (e.g., first aspiration chamber44aand second aspiration chamber44b) are provided, fluid may flow there through during inflation or be restricted from the same until an aspiration process.

According to embodiments, a method for aspirating and explanting intragastric device10after emplacement and inflation thereof is disclosed. According to embodiments, and as shown inFIG. 11, endoscope200may be provided to view and interact with sealing device100of intragastric device10. Where sealing device100is at an end of intragastric device10that is distally located from an entrance point into the gastric cavity, a standard endoscope in a retroflexed position (e.g., a “U-turn” shaped endoscope) may be used, as shown inFIG. 11. Endoscope200may provide a variety of structures and functions, including visualization, working channels, and devices as disclosed further herein.

According to embodiments, and as shown inFIG. 12, a snare210may be deployed from endoscope200and secured to at least a portion of sealing device100. For example, snare210may be secured onto at least one of head104, at least one flange106, and at least one interruption108, including combinations thereof. Where initial securement is not satisfactory, partial securement may be used to reposition intragastric device10or sealing device100prior to re-securement. Those having skill in the art will recognize that a variety of devices, tools, and structures may be used to engage and operate on sealing device100from endoscope200. For example, snare210may be any snare, grasper, forceps, needle, or other securing device for interfacing with at least a portion of sealing device100.

According to embodiments, and as shown inFIG. 13, aspiration device230may be provided to engage sealing device100. Aspiration device230may perform controlled crossing, penetration, or breach of a membrane to access a corresponding lumen by aspiration device230or another device. Such action may facilitate localized evacuation of fluids, as opposed to uncontrolled rupture of the surface of an inflated balloon, where widespread rupture and uncontainable release of fluids is common due to the pressure conditions thereof. The aspiration device230may be directed into position to breach the membrane by guiding walls of a recess surrounding the membranes. The walls of the recess may guide the aspiration device230into alignment with the membranes before breaching the membranes.

According to embodiments, suction device220may be provided with endoscope200for operation on intragastric device10, as shown inFIGS. 14-18. Suction device220may be compatible with, attachable to, a component of, or an integral part of endoscope200. For example, suction device220and endoscope200may provide workspace250when brought to a portion of intragastric device10, such as sealing device100, before, during, or after opening at least one lumen of intragastric device10. Suction device220may cause fluid released from intragastric device10to actively or passively be directed to a desired location (e.g., through endoscope vacuum channel222or working lumen202to a reservoir). Accordingly, pressure at a distal end of suction device220may be managed by any variety of devices, such as at a proximal end of suction device220. Suction device220may cover all or part of the exposed portions of sealing device100. Suction device220may mate onto or within at least one lumen to controllably aspirate fluid from intragastric device10. In an alternative embodiment shown inFIG. 19, the workspace251may be configured to have an internal shape or internal diameter that corresponds to the outer shape or outer diameter of the body102, so as to facilitate the insertion of a portion of the sealing device100(such as the sealing device shown inFIG. 9) into the workspace251and to align the first membrane110awith first aspiration interface252aand align the second membrane110bwith second aspiration interface252b.

According to embodiments, accessing at least one lumen of intragastric device10may cause fluid from within a corresponding balloon thereof to be capable of deflation. For example, a lumen that has been accessed may be in fluid communication with an interior portion of a balloon via an opening. According to embodiments, accessing at least one lumen of intragastric device10may cause automatic deflation of a balloon based on a tendency of the balloon to contract or constrict or based on a pressure differential between the interior and exterior of the balloon. According to embodiments, a suction device220may be provided over sealing device100before, during, or after accessing at least one lumen. The suction device may cause fluid released to actively or passively be directed to a desired location (e.g., through endoscope200to a reservoir). Accordingly, pressure at a distal end of the suction device may be managed by any variety of devices, such as at a proximal end thereof. The suction device may cover all or part of the exposed portions of sealing device100. The suction device may mate onto or within at least one lumen or membrane to controllably aspirate fluid from intragastric device10. For example, a lumen may be provided within aspiration device230as a conduit for fluid.

According to embodiments, where membranes are of a self-sealing configuration, retraction of aspiration device230may result in at least substantial recovery of a seal over a corresponding lumen.

According to embodiments, partial or full deflation of intragastric device10may facilitate subsequent explant, removal, or adjustment thereof. According to embodiments, intragastric device10may be removed along with endoscope200after deflation.

According to embodiments, a kit of parts is disclosed, including components disclosed herein, for use by a user. Included in the kit may be instructions for use.

It should also be understood that a variety of changes may be made without departing from the essence of the invention. Such changes are also implicitly included in the description. They still fall within the scope of this invention. It should be understood that this disclosure is intended to yield a patent covering numerous aspects of the invention both independently and as an overall system and in both method and apparatus modes.

Further, each of the various elements of the invention and claims may also be achieved in a variety of manners. This disclosure should be understood to encompass each such variation, be it a variation of an embodiment of any apparatus embodiment, a method or process embodiment, or even merely a variation of any element of these.

Particularly, it should be understood that as the disclosure relates to elements of the invention, the words for each element may be expressed by equivalent apparatus terms or method terms—even if only the function or result is the same.

Such equivalent, broader, or even more generic terms should be considered to be encompassed in the description of each element or action. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled.

It should be understood that all actions may be expressed as a means for taking that action or as an element which causes that action.

Similarly, each physical element disclosed should be understood to encompass a disclosure of the action which that physical element facilitates.

Any patents, publications, or other references mentioned in this application for patent are hereby incorporated by reference. In addition, as to each term used it should be understood that unless its utilization in this application is inconsistent with such interpretation, common dictionary definitions should be understood as incorporated for each term and all definitions, alternative terms, and synonyms such as contained in at least one of a standard technical dictionary recognized by artisans and the Random House Webster's Unabridged Dictionary, latest edition are hereby incorporated by reference.

Finally, all referenced listed in the Information Disclosure Statement or other information statement filed with the application are hereby appended and hereby incorporated by reference; however, as to each of the above, to the extent that such information or statements incorporated by reference might be considered inconsistent with the patenting of this/these invention(s), such statements are expressly not to be considered as made by the applicant(s).

In this regard it should be understood that for practical reasons and so as to avoid adding potentially hundreds of claims, the applicant has presented claims with initial dependencies only.

Support should be understood to exist to the degree required under new matter laws—including but not limited to United States Patent Law 35 USC 132 or other such laws—to permit the addition of any of the various dependencies or other elements presented under one independent claim or concept as dependencies or elements under any other independent claim or concept.

To the extent that insubstantial substitutes are made, to the extent that the applicant did not in fact draft any claim so as to literally encompass any particular embodiment, and to the extent otherwise applicable, the applicant should not be understood to have in any way intended to or actually relinquished such coverage as the applicant simply may not have been able to anticipate all eventualities; one skilled in the art, should not be reasonably expected to have drafted a claim that would have literally encompassed such alternative embodiments.

Such terms should be interpreted in their most expansive forms so as to afford the applicant the broadest coverage legally permissible.