METHOD AND APPARATUS FOR COAPTIVE ULTRASOUND GASTROSTOMY

Abstract

Disclosed is a system and method for the placement of elongate medical members within a patients body using coaptive ultrasound. In a particularly preferred embodiment, a flexible tube includes a first balloon at a distal end of the tube, and a second balloon at the distal end of the tube and positioned within the first balloon. The first and second balloons are inflatable to form one or more echogenic windows between them, which echogenic window may be detected from within a patient's body by an ultrasound probe that is external to the patient's body. Detection of such echogenic window is used to identify an acceptable location on the patient's body at which to insert a guidewire configured to receive an elongate medical member without damage to surrounding patient tissues or organs.

Claims

1. A device for placement of an elongate medical member, comprising: a flexible tube having a distal end and a proximal end opposite said distal end; a first balloon affixed to said distal end of said flexible tube; a second balloon affixed to said distal end of said flexible tube and positioned within an interior of said first balloon; wherein each of said first balloon and said second balloon are inflatable and are configured to form at least one echogenic window between an interior of said first balloon and an exterior of said second balloon.

2. The device of claim 1, further comprising a plurality of spacers between said first balloon and said second balloon.

3. The device of claim 2, wherein said spacers comprise rivets positioned between an interior face of said first balloon and an exterior face of said second balloon.

4. The device of claim 2, wherein said spacers comprise a plurality of ridges on an exterior face of said second balloon.

5. The device of claim 1, further comprising a first lumen extending along said flexible tube from said proximal end to an interior of said first balloon, and a second lumen extending along said flexible tube from said proximal end to an interior of said second balloon.

6. The device of claim 5, further comprising an open channel extending through said flexible tube.

7. The device of claim 6, further comprising at least one opening extending through said flexible tube into said open channel, said at least one opening positioned adjacent the distal end of said flexible tube and proximal to said first balloon and said second balloon.

8. The device of claim 1, further comprising a snare extending through said elongate member and having a closeable snare head positioned within said second balloon.

9. A device for placement of an elongate medical member within a patient's body, comprising: a flexible tube having a distal end and a proximal end opposite said distal end; and a balloon affixed to said distal end of said flexible tube, said balloon having a pouch on an exterior wall of said balloon, said pouch having an echogenic material therein; wherein said balloon is inflatable so as to position said pouch in contact with an interior of a patient's stomach upon inflation.

10. The device of claim 9, further comprising a lumen extending along said flexible tube from said proximal end to an interior of said balloon.

11. The device of claim 9, further comprising an open channel extending through said flexible tube.

12. The device of claim 11, further comprising at least one opening extending through said flexible tube into said open channel, said at least one opening positioned adjacent the distal end of said flexible tube and proximal to said balloon.

13. The device of claim 9, further comprising a snare extending through said elongate member and having a closeable snare head positioned within said second balloon.

14. A method for placing an elongate medical member within a patient's body, comprising the steps of: providing a flexible tube having a distal end and a proximal end opposite said distal end, a first balloon affixed to said distal end of said flexible tube, and a second balloon affixed to said distal end of said flexible tube and positioned within an interior of said first balloon; inserting said distal end of said flexible tube into a patient's body; inflating said first balloon and said second balloon with one or more fluids to form an echogenic window; and detecting a location of said echogenic window within a patient and to identify an acceptable location on the patient's body to insert a guidewire configured to receive said elongate medical member.

15. The method of claim 14, wherein said detecting step further comprises using an ultrasound probe to detect said location of said echogenic window.

16. The method of claim 14, further comprising the steps of: inserting an angiocatheter at said acceptable location so that said angiocatheter extends into said second balloon; inserting a guidewire through said angiocatheter so that a distal end of said guidewire is positioned within said second balloon; capturing said distal end of said guidewire from a proximal end of said flexible tube; deflating said first balloon and said second balloon; and retracting said flexible tube from said patient.

17. The method of claim 14, wherein a plurality of spacers are provided between said first balloon and said second balloon.

18. The method of claim 17, wherein said spacers comprise rivets positioned between an interior face of said first balloon and an exterior face of said second balloon.

19. The method of claim 17, wherein said spacers comprise a plurality of ridges on an exterior face of said second balloon.

20. The method of claim 14, wherein said flexible tube further comprises a first lumen extending along said flexible tube from said proximal end to an interior of said first balloon, and a second lumen extending along said flexible tube from said proximal end to an interior of said second balloon.

21-35. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The numerous advantages of the present invention may be better understood by those skilled in the art by reference to the accompanying figures in which:

[0019] FIG. 1 is a schematic view of an example double balloon conduit device of the present invention;

[0020] FIG. 2 is a schematic view of the double balloon conduit with a deployed balloon assembly;

[0021] FIG. 3 illustrates an example distal end of the device with a deployed balloon assembly, in which the inner balloon includes ridges to prevent the collapse of the echogenic window;

[0022] FIG. 4 illustrates an example distal end of the device with a retracted balloon assembly;

[0023] FIG. 5 is a flow chart that demonstrates one method of using the double balloon conduit device; and

[0024] FIG. 6A-C illustrate the method steps described in FIG. 5.

BEST MODE(S) FOR CARRYING OUT THE INVENTION

[0025] The invention summarized above may be better understood by referring to the following description, claims, and accompanying drawings. This description of an embodiment, set out below to enable one to practice an implementation of the invention, is not intended to limit the preferred embodiment, but to serve as a particular example thereof. Those skilled in the art should appreciate that they may readily use the conception and specific embodiments disclosed as a basis for modifying or designing other methods and systems for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent assemblies do not depart from the spirit and scope of the invention in its broadest form.

[0026] FIG. 1 is a schematic view of the double balloon conduit 100. Conduit 100 includes a flexible tube 110 having a distal end 120 and a proximal end 130. The flexible tube 110 is preferably sized to extend from the patient's mouth to the distal end of the patient's stomach. In the figure the patient's stomach is marked as 197 and the esophagus is marked as 199. These elements are not part of the invention but rather are included for illustrative purposes.

[0027] Proximal end 130 includes a sump port 150, inner balloon port 160, and outer balloon port 170. Sump port 150 communicates with one or more sump fenestrations 355 (FIGS. 3 and 4) located at the distal end 120 of the double balloon conduit 100. One or more central lumens extend the length of the double balloon conduit 100 to allow for passage of fluid, gases, or other material between the distal end 120 and outside of the patient. The sump port 150 may be configured to communicate with a manual or mechanical pumping system to assist with the removal of debris. Inner balloon port 160 communicates with an inner balloon 260 located at the distal end 120 of the double balloon conduit 100. One or more lumens extend the length of the double balloon conduit 100 to allow for the inner balloon 260 to be inflated or deflated. The inner balloon port 160 may be connected to an external fluid handler (e.g., a pump) to inject or remove fluid or gas from the inner balloon 260. Outer balloon port 170 communicates with an outer balloon 270 at the distal end 120 of the double balloon conduit 100 via one or more lumens that run the length of the double balloon conduit 100. Outer balloon port 170 may also be connected to a pump to inject or remove fluids or gasses from the outer balloon 270. In certain embodiments, the inner balloon pump and outer balloon pump are programmed to run in tandem with each other so that the balloons 260 and 270 will expand and contract in tandem with each other. The pumps may also be programed to pump to a predetermined pressure to ensure proper expansion of the balloons 260 and 270.

[0028] FIG. 1 also illustrates optional snare release 140. The snare release communicates with a snare head located at the distal end of the double balloon conduit in embodiments that are configured to snare. Such snare configurations and snare releases 140 are of well-known construction to those skilled in the art, and thus are not further detailed here.

[0029] FIG. 2 is an expanded schematic view of the double balloon conduit 100 while a balloon assembly is deployed. In the illustrated embodiment, inner balloon 260 is nested within outer balloon 270 and inflated. The outer balloon 270 is configured to expand to the inner surface of the patient's stomach when insufflated via the outer balloon port 170. The shape of the inner balloon 260 and outer balloon 270 may vary provided that the outer balloon 270 is sized to contact the inner surface of a patient's stomach at the location in which the gastrostomy tube is to be placed. The shape of the balloons 260 and 270 also allow for one or more cavities 220 between the inner balloon 260 and outer balloon 270 when inflated.

[0030] In preferred embodiments, the outer balloon 270 is filled with a fluid, such as water, saline, or other ultrasound-compatible fluid, and the inner balloon 260 is filled with a fluid that may be the same fluid as in the outer balloon or a different fluid, such as air or other non-toxic gas. When the cavity 220 between inner balloon 260 and outer balloon 270 is filled with ultrasound-compatible fluid, it provides an echogenic window for safely placing the gastrostomy tube. The echogenic window and ultrasound placement improves visualization of subcutaneous tissues and the inner balloon 260 and outer balloon 270 beneath the subcutaneous tissues, and prevents accidental piercing of the bowel, vessels, spleen, liver, or other organs that could jeopardize the health of the patient. By creating one or more echogenic windows 220 between inner balloon 260 and outer balloon 270 and placing the PEG tube by ultrasound, an operator may easily ensure that insertion of an angiocatheter into a patient's stomach is carried out at the intended location and with minimal risk of inadvertently piercing other organs or patient tissues.

[0031] Different mechanisms are provided herein to prevent the inner balloon 260 from eliminating the echogenic window by coming into contact with the outer balloon 270. In certain embodiments, one or more spacers, such as rivets 230, are provided between the two balloons 260 and 270. The rivets 230 maintain the preferred distance between the inner and outer balloons 260 and 270. The rivets 230 may be located around the entire surface of the inner balloon 260 or just the area where the echogenic window is desired.

[0032] Alternatively, one or both of balloons 260 and 270 may themselves incorporate spacers that are configured to maintain cavities 220 between the two balloons 260 and 270. FIG. 3 is an exploded view of the distal end of the double balloon conduit 100 having a deployed balloon head. Inner balloon 260 incorporates spacers in the form of one or more ridges 310 that maintain the desired spacing between inner balloon 260 and outer balloon 270. The size, number and location of the ridges 310 may vary depending on the application, such as location within the patient and purpose for placement. In other non-illustrated embodiments, the material properties of the inner and outer balloons 260 and 270 are chosen to maintain the spacing between the two balloons 260 and 270 when deployed. For example, stiffer materials can be employed to prevent the migration of the inner balloon 260 as it is filled with air. Another example configuration includes an expandable frame within the inner balloon 260 that will prevent the inner balloon 260 from contacting the outer balloon 270. Differential pressurization of the balloons 260 and 270 can also be used to obtain the desired configuration and response.

[0033] FIG. 3 illustrates other features of the distal end 120 of the double balloon conduit 100. In certain embodiments, snare 245 of traditional configuration extends through the inner balloon 260 and includes a snare head 347 to capture elements passing through the balloons 260 and 270. Sump fenestrations 355 are also illustrated, extending through a sidewall of flexible tube 110. The fenestrations 355 may vary in size, shape and orientation, depending on the patient needs. In certain embodiments, two or more fenestrations 355 are provided to reduce the likelihood of clogging.

[0034] Inner balloon tubing 360 and outer balloon tubing 370 allow for balloons to communicate with their respective ports 160 and 170 at the proximal end of the double balloon conduit 100. In the illustrated embodiment, a single tube for each of balloon 260 and 270 is provided. However, in alternative embodiments, two or more tubes may be used to supply each balloon 260 and 270. Multiple tubes may be preferred when there are multiple cavities between the inner balloon 260 and outer balloon 270. Separate tubes may be used to provide different pressures within the cavities 220 or when the cavities 220 are completely independent of the others.

[0035] FIG. 4 is an exploded view of the distal end 120 of the double balloon conduit 100 with the inner balloon 260 and outer balloon 270 retracted. The balloon assembly 410 (including, in combination, inner balloon 260 and outer balloon 270) is configured to retract within the distal end 120 of the double balloon conduit 100 to make it low profile and help facilitate passage of the double balloon conduit 100 into and out of the stomach. In certain embodiments, the balloon assembly 410 is connected to a cord that runs the length of the double balloon conduit 100 to the proximal end 130. This cord is used to fully retract the balloon assembly 410 after inflation. In other embodiments, the snare release 140 can be configured to perform this task.

[0036] Additional features of the double balloon conduit 100 may be used to help secure the guidewire to the distal end 120 of the double balloon conduit 100 and also ensure the guidewire is pulled through the patient as the double balloon conduit 100 is removed. For example, guidewires having anchoring features may be used. In this case, the distal tip of the guidewire can expand or otherwise change shape to help create an anchor inside one or both of the balloons 260 and 270. One example anchor is a “T” shape and another is a bulky knot. In such configuration, the anchor may be inserted into inner balloon 260 before inner balloon 260 is deflated. Thus, as inner balloon 260 is deflated, it surrounds the anchor within inner balloon 260, such that pulling double balloon conduit 100 out of the patient's mouth or nose will likewise cause inner balloon 260 to pull the anchor, along with the attached guidewire.

[0037] Other anchoring devices would be recognized in the field and do not deviate from the spirit of the invention. Alternatively, or in conjunction with the anchor, the guidewire may have a magnetic tip that is configured to communicate with, or attract, a magnetic tip that can be added to the distal end 120 of the double balloon conduit 100. This magnetic attraction can also help facilitate passage through the patient.

[0038] Single balloon configurations are also provided. In certain single balloon examples, the balloon is configured to expand until at least a portion of the balloon's outer face is resting against at least a portion of the inner wall of the patient's stomach. The balloon is configured to expand when it is filled with fluid or another echogenic material. When the balloon is sufficiently full it creates an echogenic window for ultrasound guided guidewire placement. In other single balloon configurations, the balloon has one or more pouches on its surface that are configured to fill with fluid or another echogenic material. When the balloon is sufficiently inflated with a gas, the one or more pouches are pressed against the wall of the stomach. When filled, the pouches create an echogenic window for ultrasound guided guidewire placement. In another single balloon configuration, the balloon's pouches are made from echogenic materials and do not require infusion with echogenic materials.

[0039] FIG. 5 is a flow chart that depicts the steps for inserting a guidewire into a patient for placement of an elongate medical member, such as a gastrostomy tube, using a device according to at least certain aspects of and embodiment of the present invention. In step 501, the distal end 120 of the double balloon conduit 100 is passed into the patient's mouth and down into the patient's stomach. Next, in step 502, the pumps are attached to the sump port 150 and inner and outer balloon ports 160 and 170. Outer balloon 270 and inner balloon 260 are deployed in step 503. The order of the balloon deployment will generally depend on the configuration of the double balloon conduit 100. In certain embodiments, the inner and outer balloons 260 and 270 will deploy simultaneously, while in other embodiments, the inner balloon 260 will be filled first with a fluid and then the one or more cavities 220 between the inner and outer balloons 260 and 270 will be filled with a fluid to form an echogenic window.

[0040] In step 504, an ultrasound probe will be used to select an appropriate location for inserting the angiocatheter needle. More particularly, an ultrasound probe will be used to detect the location of the echogenic window between inner balloon 260 and outer balloon 270. Step 505 includes inserting the angiocatheter into the stomach once a location is identified that is clear of obstructions. Inserting the needle is monitored by ultrasound.

[0041] Step 506 includes inserting the guidewire into the stomach through at least one of the balloons 260 and 270. In embodiments that include a snare, the guidewire passes through the snare head in order to be captured. In embodiments that use a snare, step 507 includes retracting the snare 245 into the distal end 120 of the double balloon conduit 100, thereby securing the guidewire. When using a device that utilizes a guidewire anchor, the guidewire anchor is deployed or secured inside one or more of the balloons 260 and 270. The balloon assembly 410 is then emptied/deflated and retracted into the distal end 120 as well. In step 508 the entire assembly is removed from the patient's mouth. The guidewire can then be used to insert a gastrostomy tube using known techniques.

[0042] The steps described above and in FIG. 5 are partially illustrated in FIGS. 6a-6c. FIG. 6a shows a deployed outer balloon 270 and inner balloon 260. Cavities 220 are filled with water or saline to create an echogenic window. Ultrasound probe 610 is used to identify an appropriate site of entry for the angiocatheter needle, 620, and guidewire, 630. FIG. 6b shows the distal end 120 of the double balloon conduit 100 after the guidewire 630 has been captured by the snare and the balloon assembly 410 has been retracted. FIG. 6c shows the guidewire 630 remaining after the device has been removed from the patient's mouth.

[0043] In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. Throughout this specification and the claims, unless the context requires otherwise, the word “comprise” and its variations, such as “comprises” and “comprising,” will be understood to imply the inclusion of a stated item, element or step or group of items, elements or steps but not the exclusion of any other item, element or step or group of items, elements or steps. Furthermore, the indefinite article “a” or “an” is meant to indicate one or more of the item, element or step modified by the article.

[0044] Having now fully set forth the preferred embodiments and certain modifications of the concepts underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concepts. It should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein.

INDUSTRIAL APPLICABILITY

[0045] The present invention is applicable to devices and methods for placing medical devices into patients, particularly through ultrasound-guided placement. The devices can be made in industry and practiced in the medical device field.