DEVICE AND METHOD FOR DEFLATION AND REMOVAL OF IMPLANTABLE AND INFLATABLE DEVICES

Abstract

A deflation device including a catheter having a proximal opening at a proximal end and a distal opening at a distal end; and a coring member disposed within the catheter and comprising a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter; wherein pressing said distal end of said catheter against said wall of said balloon creates a substantially normalized surface of said balloon relative to a coring tip and wherein the coring tip is a sharpened, hollow cylinder. A method for deflating and removing an implantable, inflatable device comprising: pressing a distal end of a catheter against the wall of an inflated balloon of an implanted device; advancing the coring tip within the catheter beyond the distal end of the catheter and into the balloon, whereby a hole adapted for advancing the catheter is created in the wall of the balloon; and advancing the catheter into the balloon.

Description

RELATED APPLICATIONS

This application claims the full Paris Convention benefit of and priority to U.S. Provisional Patent Application Ser. No. 61/160,207, filed Mar. 13, 2009; U.S. Provisional Patent Application Ser. No. 61/228,081, filed Jul. 23, 2009; and U.S. Provisional Patent Application Ser. No. 61/245,630, filed Sep. 24, 2009, the contents of which are incorporated by reference herein in their entirety, as if fully set forth herein.

This application incorporates by reference U.S. Pat. Pub. No. 2007/0100368, published May 3, 2007; U.S. Pat. Pub. No. 2007/0100369, published May 3, 2007; U.S. Pat. Pub. No. 2007/0149994, published Jun. 28, 2007; WIPO Pub. No. WO 2007/053556, published Oct. 5, 2007; WIPO Pub. No. WO 2007/053707, published Oct. 5, 2007; WIPO Pub. No. WO 2007/053706, published Oct. 5, 2007; and WIPO Pub. No. WO 2007/075810, published May 7, 2007; each as if fully set forth herein in its entirety.

FIELD OF THE INVENTION

This disclosure relates generally to maintenance of implantable, inflatable devices. In particular, the present invention relates to a device and method for deflation and removal of implantable gastric devices.

SUMMARY

According to embodiments, disclosed is a method for deflating and removing an implantable, inflatable device comprising: pressing a distal end of a catheter against the wall of an inflated balloon of an implanted device; advancing the coring tip within the catheter beyond the distal end of the catheter and into the balloon, whereby a hole adapted for advancing the catheter is created in the wall of the balloon; and advancing the catheter into the balloon. The method may further comprise retracting the coring device from within the balloon or removing the contents of the balloon through the catheter.

Pressing the distal end of the catheter against the wall of the balloon may create a substantially normalized surface of the balloon relative to the coring tip. The coring tip may be advanced into the balloon while applying a pressure lower than the pressure inside the balloon at the point of contact between the distal end of the catheter and the wall of the balloon. The coring tip may also be advanced into the balloon while rotating the coring tip or while applying longitudinal and/or rotational oscillation to the coring tip. The longitudinal and/or rotational oscillation may be applied at a frequency in the ultrasound range. The coring tip may also be advanced into the balloon while applying an energy, such as RF hi-frequency electrical energy to the coring tip.

According to embodiments, disclosed is a deflation device including a catheter having a proximal opening at a proximal end and a distal opening at a distal end; and a coring member disposed within the catheter and comprising a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter; wherein the coring tip is a sharpened, hollow cylinder. The device may further comprise at least a luer connector assembly disposed adjacent to the proximal end of the catheter.

The coring tip may be configured to puncture a wall of a balloon when pressed against a portion of the wall of the balloon. The distal end of the catheter may be configured to be pressed against a portion of the wall of the balloon without puncturing the wall of the balloon. The catheter may have an inner diameter of between about 0.060 inches and about 0.085 inches, and an outer diameter of between about 0.080 inches and about 0.125 inches. The coring tip may have an inner diameter of between about 0.030 inches and about 0.045 inches and an outer diameter of between about 0.040 inches and about 0.065 inches. The cable may be configured to transfer to the coring tip at least one of torque, tension, and compression applied to the handle.

According to embodiments, disclosed is a kit, comprising: a catheter having a proximal opening at a proximal end and a distal opening at a distal end; and a coring member disposed within the catheter and comprising a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter; wherein the coring tip may be a sharpened, hollow cylinder; and directions for use.

DRAWINGS

The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which:

FIG. 1 is a plan and schematic view of embodiments of a device for deflation and removal of an implantable gastric device, according to illustrative aspects of the present disclosure.

FIG. 2A is a view of embodiments of a proximal portion of a deflation device during approach toward a balloon, according to illustrative aspects of the present disclosure.

FIG. 2B is a view of embodiments of a distal portion of a deflation device during approach toward a balloon, according to illustrative aspects of the present disclosure.

FIG. 3 is a view of embodiments of a distal portion of a deflation device pressed against a balloon, according to illustrative aspects of the present disclosure.

FIG. 4A is a view of embodiments of a proximal portion of a deflation device during a coring phase of operation, according to illustrative aspects of the present disclosure.

FIG. 4B is a view of embodiments of a distal portion of a deflation device during a coring phase of operation, according to illustrative aspects of the present disclosure.

FIG. 5 is a view of embodiments of a distal portion of a deflation device inserted into a balloon, according to illustrative aspects of the present disclosure.

FIG. 6A is a view of embodiments of a proximal portion of a deflation device during a deflation phase of operation, according to illustrative aspects of the present disclosure.

FIG. 6B is a view of embodiments of a distal portion of a deflation device during a deflation phase of operation, according to illustrative aspects of the present disclosure.

DETAILED DESCRIPTION

Medical devices for the treatment of obesity are available. Such devices entail a single or multiple balloon system that is implanted in the stomach, inter alia. These balloons may be made of silicone or other bio-compatible substances and are filled with saline solution as part of the implantation process. After a clinically designated or otherwise desired implant period within the stomach, it is desirable to pierce the balloon wall so that the balloon contents can be evacuated, such as by aspiration.

Due to a combination of balloon system design, degradation of the balloon material physical properties, and the nature of conventional beveled or conical piercing tips, the balloons frequently tear or rupture when the tip is advanced into the balloon wall. Fluid collects in the stomach as it escapes from the torn or ruptured balloon. This fluid then needs to be evacuated via the endoscope and adds time and complexity to the procedure. There is also an increased risk of fluid aspirating into the trachea, causing breathing difficulties for the patient. Additionally, when the balloon tears or ruptures, the piercing tip or its surrounding catheter cannot be used to fully vacuum out the fluid in the balloon. This leads to additional work removing the balloons, as the user is required to cut or tear drains in the balloon wall, such as by scissors or other suitable means, so that any retained fluid or air in the balloon is released, preventing unwanted drag in the esophagus during removal of the device.

Conventional piercing catheters such as the Cook Medical Baron™ brand of aspiration needle are composed of two members and are advanced down an endoscope into the stomach with the inner member retracted. Under direct endoscopic visualization, the inner member is advanced to expose the beveled piercing tip and the entire device is pushed forward to puncture the balloon. This often results in a tear or rupture of balloons.

Another intragastric balloon removal device, such as the Balloon Extraction Set™ (BES) manufactured by Aprime Medical and Surgical Supplies, is composed of two members: the outer member is a simple tubular catheter and the inner member is a wire with a conical piercing tip. This device is advanced down an endoscope into the stomach with the inner member retracted so that the piercing tip is concealed within the tip of the outer catheter. Under direct endoscopic visualization, the BES is advanced out of the endoscope, the inner piercing member is exposed, and the device is pushed forward into the balloon wall to pierce it. This also often results in a tear or rupture of balloons.

It has been observed that devices, such as the BES, have relatively high surface friction and poor stretch resistance. As a result, maneuverability of the device is compromised and the outer catheter stretches to the point that it covers the tip of the inner member and the device cannot be used to puncture the balloon.

According to embodiments of the present disclosure, devices and methods are provided to make a cored opening in the form of a small hole in the wall of an inflated balloon with a coring member, and advance an outer catheter into the opening with the opening forming a seal around the outer catheter. Then, with the coring member removed, the fluid within the balloon may be evacuated using a vacuum on the proximal end of the outer catheter.

Referring to FIG. 1, those skilled in the art readily understand an illustrative, and not limiting, example is shown. Scale issues are obviated by the need for illustration, and not intended to be limiting. A deflation device 10 may include a catheter 20, having a proximal end 22 and a distal end 24, and a coring member comprising a coring tip 32, a cable 34, and a handle 36.

Catheter 20 may comprise a single-lumen tube. A female luer connector 40 may be affixed to proximal end 22. Catheter 20 may have markings 42 and 44 near the distal end 24. The markings may each indicate a distance from the distal end 24 as a reference during use of the device 10. Catheter 20 may have a square-cut distal end 24 and may have a tapered distal section extending from distal end 24, as shown in FIG. 1.

According to embodiments, coring tip 32 may be a square-cut, hypo tube with a sharp distal edge. Cable 34 may comprise a wire rope core, solid stylet, or a cable such as the Helical Hollow Strand™ by Fort Wayne Metals®, of Fort Wayne, Ind. Cable 34 may be designed to transfer tension, compression, and torque without kinking or whipping. Cable 34 may be attached to a proximal hypo tube that is attached to handle 36, disposed at the proximal end 22 of catheter 20. The coring member may be configured to travel within catheter 20, such that coring tip 32 may be retracted within the catheter or extended beyond the distal end 24 of catheter 20.

According to embodiments, coring tip 32 provides a hole-making element instead of a beveled or conical piercing tip. Coring tip 32 may be a sharpened, hollow cylinder. Coring tip 32 may puncture a balloon without causing a tear, leak, or rupture at the point of puncture. Beveled or conical piercing tips create stress concentrations and tear propagation points when the balloon is pierced. This stress concentration is further exacerbated when the pierced opening is stretched greatly to accommodate the outer catheter's outer diameter. Coring tip 32 may cut a smooth and circular hole in the balloon, which creates a smooth and symmetric opening that dramatically reduces the possibility of tear propagation points and stress concentrations. Coring tip 32 also creates a larger opening for catheter 20 to be inserted without significant stretching of the opening to accommodate catheter 20. These outcomes combine to allow for a consistent balloon puncture with minimal risk of tear, rupture, or not sealing around catheter 20. Catheter 20 may be designed to provide low surface friction with respect to the coring member. Catheter 20 may further be designed to provide resistance to stretching.

Catheter 20 may be designed to provide low surface friction with respect to the endoscope lumen that the catheter is delivered through. This may be achieved by covering the catheter's outer surface with a Teflon jacket or a hydrophilic coating. Catheter 20 may further designed to provide resistance to stretching by reinforcing the catheter tubing with a stainless steel or nitinol braid.

Catheter 20 may be configured to be delivered and operated through the working channel of a flexible endoscope, for example with a channel length of at most about 57 inches and minimum channel diameter of about 2.8 mm.

According to certain embodiments and prototypes, coring tip 32 may have an outer diameter slightly smaller than the outer diameter of catheter 20. For example, catheter 20 may have an inner diameter of between about 0.060 inches and about 0.085 inches, and an outer diameter of between about 0.080 inches and about 0.125 inches. Cather 20 may have a length of between about 25 inches and about 75 inches. Coring tip 32 may have an inner diameter of between about 0.030 inches and about 0.045 inches and an outer diameter of between about 0.040 inches and about 0.065 inches. For example, catheter 20 may have an inner diameter of about 0.073 inches and an outer diameter of about 0.103 inches. Cather 20 may have a length of about 63 inches. Coring tip 32 may have an inner diameter of about 0.040 inches and an outer diameter of about 0.052 inches. The result is a cored opening of a balloon that wraps around the outer wall of catheter 20 and forms a leak-proof seal during the fluid removal procedure, and facilitates the complete evacuation of the contents of the balloon through catheter 20.

According to embodiments, luer connector 40 of catheter 20 may be a standard luer adaptor or connector. According to embodiments, luer connector 40 may be threaded on its inner surface, and handle 36 may include threading or other extensions on its outer surface, such that handle 36 mates with luer connector 40. According to embodiments, the threaded mating between handle 36 and luer connector 40 may allow a user to thread handle 36 into luer connector 40, which would simultaneously apply torque (rotation) and longitudinal force on coring tip 32. According to embodiments, threaded mating between handle 36 and luer connector 40 may also help maintain the coring member's position relative to catheter 20, such that travel of coring tip 32 within catheter 20 may be limited, thereby reducing the wear on coring tip 32 against the inner walls of catheter 20. According to embodiments, such threading, extensions, or other channels that regulate the rotational or axial movements of the coring member and coring tip 32 may be provided along any portion of catheter 20 or the coring member.

According to embodiments, the coring member may include a device to provide rotation and advancement of coring tip 32. Such a mechanism could be either electrically powered, mechanically powered (such as spring loaded), manually powered, or combinations thereof.

A method for deflating and removing implantable gastric devices is disclosed herein. The method may include pressing distal end 24 of catheter 20 against the wall of a balloon (or other inflatable device), with coring tip 32 refracted, as shown in FIG. 2A-B. By pressing catheter 20 against the balloon wall with coring tip 32 retracted, the user can identify a stable position for the device against the balloon. When pressure is applied to the surface of the balloon by the distal end 24 of catheter 20, the device stretches flat a normalized section of the balloon wall across the distal opening at the distal end 24 of catheter 20, as shown in at least FIG. 3. This normalized section provides a smooth surface conducive to a symmetrical, smooth and circular cut when coring tip 32 is advanced. Furthermore, pushing distal end 24 of catheter 20 against the balloon wall builds up force such that, when the cored opening is made, catheter 20 naturally passes through the cored opening as the balloon wall expands outward. Thus, the opening seals itself around catheter 20 when catheter 20 travels into the balloon, relative to the balloon wall.

According to embodiments, coring tip 32 may be advanced beyond distal end 24 of catheter 20, such that coring tip 32 creates a cored opening while distal end 24 of catheter 20 maintains pressure against the wall of the balloon, as shown in at least FIGS. 4A-B. Coring tip 32 may be advanced while being rotated. This rotation may be provided by handle 36 wherein cable 34 transfers a torque to coring tip 32 from handle 36. The combination of pressing coring tip 32 against the balloon wall while rotating coring tip 32 creates a coring action against the balloon wall that forms a smooth, symmetrical, circular cored opening in the balloon.

According to embodiments, longitudinal and/or rotational oscillation (along the length of the coring member) may be provided to coring tip 32 as coring tip 32 creates the cored opening. For example, longitudinal and/or rotational oscillation at a frequency in the ultrasound range may be applied to coring top 32 to facilitate improved coring.

The coring tip may also be advanced into the balloon while applying an energy, such as radiofrequency (RF) hi-frequency electrical energy, to the coring tip. RF energy may be applied via snares, needles, forceps, and the like. According to embodiments, RF energy may be applied to coring tip 32 to heat coring tip 32 and facilitate improved coring.

According to embodiments, once coring tip 32 has cut through most or the entire balloon wall thickness, the coring member and catheter 20 pass into the balloon, as shown in at least FIG. 5. Once at least distal end 24 of catheter 20 is inside the balloon, the coring member, include coring tip 32, may be retracted along and within catheter 20, as shown in at least FIG. 6A. According to embodiments, coring tip 32 may be completely removed from catheter 20, as shown in at least FIG. 6B. The contents of the balloon, including fluid and solid matter, may be evacuated using a syringe, vacuum pump, or other device to provide relatively lower pressure at proximal end 22 of catheter 20.

According to embodiments, catheter 20 or another catheter/scope may provide a relatively lower pressure to the portion of the outer surface of the balloon wall that is normalized by pressing catheter 20 or another catheter/scope against the balloon wall. The relatively lower pressure applied may further stabilize the area of the cored opening as coring tip 32 passes through the wall of the balloon. Furthermore, the relatively lower pressure applied may help ensure that the portion of the outer surface of the balloon wall that is contacted with coring tip 32 is normalized with respect to coring tip 32.

By employing embodiments of the present disclosure, tearing, leakage, or rupture of balloon is significantly reduced or altogether avoided, preventing excess fluid in the stomach and reducing the risk of fluid aspiration into the trachea. The balloon can be fully evacuated since coring tip 32 creates a cored opening that is substantially smaller in diameter than the outer diameter of catheter 20 and seals around catheter 20 when catheter 20 passes into the balloon. The fully evacuated balloon is much easier to remove and is less likely to create drag in the esophagus.

While the apparatus and method have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.

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

Further, each of the various elements of the disclosure 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 disclosure, 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 disclosure 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 disclosure(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 U.S.C. §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.

Further, the use of the transitional phrase “comprising” is used to maintain the “open-end” claims herein, according to traditional claim interpretation. Thus, unless the context requires otherwise, it should be understood that the term “compromise” or variations such as “comprises” or “comprising”, are intended to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps.

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

Claims

1-11. (canceled)

12. An improved medical device, comprising, in combination:

a catheter having a proximal opening at a proximal end and a distal opening at a distal end;

and a coring member disposed within said catheter and further comprising a handle disposed near said proximal end of said catheter, a cable, and a coring tip disposed near said distal end of said catheter;

wherein said coring tip is a sharpened, hollow cylinder.

13. The device of claim 12, wherein said coring tip is configured to puncture a wall of a balloon when pressed against a portion of said wall of said balloon.

14. The device of claim 12, wherein said distal end of said catheter is configured to create a substantially normalized surface of said balloon relative to said coring tip without puncturing said wall of said balloon when pressed against a portion of said wall of said balloon.

15. The device of claim 12, further comprising at least a luer connector assembly disposed adjacent to said proximal end of said catheter.

16. The device of claim 12, wherein said cable is configured to transfer to said coring tip at least one of torque, tension, and compression applied to said handle.

17. The device of claim 16, further comprising a threaded mating between said handle and a portion of said catheter, said threaded mating be configured to facilitate rotation of said coring member during longitudinal advancement thereof.

18. The device of claim 12, wherein said catheter is configured to operation within a working channel of a flexible endoscope.

19. A kit, comprising:

a catheter having a proximal opening at a proximal end and a distal opening at a distal end;

and a coring member disposed within said catheter and comprising a handle disposed near said proximal end of said catheter, a cable, and a coring tip disposed near said distal end of said catheter;

wherein said coring tip is a sharpened, hollow cylinder; and directions for use.

20. The kit of claim 19, further comprising a flexible endoscope having a working channel, said catheter being configured to operate within said working channel.

21. The device of claim 12 further comprising a flexible endoscope having a working channel, wherein the catheter is at least partially housed within the working channel.