WO2001083019A1

WO2001083019A1 - Balloon catheter

Info

Publication number: WO2001083019A1
Application number: PCT/US2001/013929
Authority: WO
Inventors: Vernon Lee Vincent
Original assignee: Bioenterics Corporation
Priority date: 2000-04-28
Filing date: 2001-04-30
Publication date: 2001-11-08
Also published as: WO2001083019B1; AU2001257442A1

Abstract

An apparatus and method for transferring particles and fluids to or from a patient's body and adapted to inflate a balloon (110) inside a patient's body during surgical procedures to facilitate the identification of anatomical landmarks and to provide guidance for surgical dissections are disclosed. The apparatus includes an inflation lumen (120) communicating with the balloon (110) and a transfer lumen (130) in communication with one or more openings (136). The method permits a surgeon to empty the contents of the stomach, decompress the stomach, inflate the balloon (110), perform an operation, such as one involving gastric banding or gastric bypass, using the balloon (110) as a landmark, and irrigate the stomach to check for gastric perforations at the end of the surgical procedure.

Description

BALLOON CATHETER BACKGROUND OF THE INVENTION

1. Field of the Invention The invention relates in general to an apparatus and method employed during surgical procedures. More particularly, the invention relates to a catheter device and method for using it designed to transfer particles and fluids to or from a patient's body and adapted to inflate a balloon inside a patient's body during surgical procedures to facilitate the identification of anatomical landmarks and to provide guidance for surgical dissections.

2. Description of the Related Art

Devices and techniques utilized to improve safety and efficacy of various surgical procedures, including gastric banding surgery, are known. For example, U.S. Patent Nos. 4,696,288, and 5,462,528 are directed to advances in operative apparatuses and methods, the disclosures of which are incoφorated by reference in their entirety.

Specifically, U.S. Patent No. 4,696,288 discloses a gastric banding method including introducing a balloon and sensor apparatus into the stomach, inflating the balloon, constricting the stomach immediately below the balloon and tightening an adjustable band around the constricted stomach and sensor. This disclosed method and apparatus suffer from many deficiencies, including, among other things, not providing for decompression of the stomach, suctioning of the contents of the stomach or irrigating the stomach during or after the surgical procedure.

U.S. Patent No. 5,462,528 discloses a stomach tube for use in administering anesthesia having an inflatable balloon for closing the stomach opening to reduce reflux and an indicator for indicating the balloon pressure at first and second predetermined pressure levels. After the stomach tube is inserted, the stomach balloon is inflated without tension on the stomach tube until the lower pressure level is indicated. The stomach tube with inflated balloon is then tensioned against the stomach opening or esophagus until the higher pressure level is indicated and then held in place with a nose stop. In use, the stomach tube prevents reflux, while a series of suction openings along the distal end of the tube provide for suctioning the contents of the stomach.

This device also suffers from a number of deficiencies, the foremost of which is the danger of stomach tissue becoming lodged in the suction openings thereby damaging the stomach tissue.

The foregoing demonstrates that there is a need for a safe and effective balloon catheter device which protects the patient from harm yet effectively aids surgical techniques.

SUMMARY OF THE INVENTION The invention satisfies the need and avoids the drawbacks of the prior art by providing a device and method that accurately, quickly, and safely allows a surgeon to transfer particles and fluids to or from the stomach and other operative sites and facilitates locating and appropriately sizing a gastric pouch or volume during various surgical procedures. Specifically, the invention provides a surgical apparatus and technique including suctioning to decompress or collapse the stomach, and irrigating or flushing the stomach to check for gastric perforations, while providing an inflatable balloon as a readily observable landmark or guide for surgical dissection or for confirming the positioning or insertion of a gastric band, surgical staples, or other gastric device.

One particular embodiment includes a balloon catheter apparatus having a stomach tube, an attached balloon, an inflation lumen disposed within the stomach tube and in fluid communication with the balloon, and a transfer lumen disposed within the stomach tube and in communication with one or more openings located at or near the balloon end of the stomach tube.

In another embodiment, the transfer lumen and the inflation lumen may be provided with universal connectors for attachment to standard hospital equipment for providing suction, inflation, medication, and the like.

In yet another embodiment, visual length-indicating markers may be disposed along the length of the stomach tube to indicate the distance the balloon catheter has been introduced into the patient. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is an elevation view of a balloon catheter constructed according to the principles of the invention. Figure 2 is an elevation view, including partial cross-sections, of the balloon catheter of Figure 1 constructed according to the principles of the invention.

Figure 3 is an elevation view of another embodiment of a balloon catheter constructed according to the principles of the invention.

Figure 4 is an elevation view, including partial cross-sections, of the balloon catheter of Figure 3 constructed according to the principles of the invention.

DETAILED DESCRIPTION OF THE DRAWINGS Balloon catheter 100 is depicted in Figs. 1 and 3 according to the principles of the invention. Balloon catheter 100 may contain an inflatable balloon 110 that is preferably attached to a stomach tube 140, both of which are adapted for insertion into a patient. The stomach tube 140 may provide a passageway for a plurality of tubes or lumens through which fluids, particles, food, anesthesia, medications, surgical instruments and the like can pass. In a preferred embodiment of the invention, stomach tube 140 includes visual markers 160 along its length for indicating the distance balloon catheter 100 has been introduced into a patient. The proximal ends of the lumens within the stomach tube 140 may be designed for releasable engagement with standard hospital equipment for providing suction, pressure, irrigation, administration of anesthesia and medications, or the like. Various universal connectors well known in the hospital and medical arts may be utilized for these puφoses. In Figs. 1 and 3, an inflation lumen 120 is shown extending through the stomach tube 140, passing the tube-balloon interface 150 and opening into the interior portion of the balloon 110 through balloon bore 115. Inflation lumen 120 is illustrated having a one-way stopcock 125 near its proximal end and a universal connector 126 connected to its proximal end. Transfer lumen 130 is depicted extending through the stomach tube 140, passing the tube- balloon interface 150, and terminating at the distal end of stomach tube 140. Stomach tube 140 may extend through the interior of balloon 110 and be affixed to the interior or exterior shell of the balloon. It is understood that stomach tube 140 may be affixed to the balloon 110 in any position on the balloon 110 by any known means.

In one embodiment, the distal end 132 of the transfer lumen 130 is open at the distal end of stomach tube 140 to allow for the transfer of fluids, particles, food, anesthesia, medications, surgical instruments and the like through the distal end 132 of transfer lumen 130 and into or out of the body of a patient. In another embodiment, the transfer lumen may be closed or plugged at the distal end of stomach tube 140, or at some intermediate point between the tube-balloon interface 150 and the distal end of stomach tube 140. In Figure 2, the proximal end of transfer lumen 130 is illustrated having a flared universal connector 135 suitable for connecting to a source of suction.

Transfer lumen 130 includes one or more openings 136 above the balloon 110 to allow the transfer of fluids and the like through such openings into or out of the body of a patient. Openings 136 may consist of channels or bores through stomach tube 140 into transfer lumen 130. In a preferred embodiment, the transfer lumen 130 contains two or more openings 136, and more preferably three or four openings. It is understood that multiple openings are advantageous so that during transfer, particularly during suctioning, the openings do not become blocked or obstructed with lodged particles or tissue from a patient's body, thereby interrupting passage through the openings. Such multiple openings also serve to avoid or minimize tissue damage to the patient.

Figs. 1 and 2 show an embodiment of the present invention in which inflation lumen 120 passes through inflation tube 122 and junction fitting 121. Similarly, transfer lumen 130 passes through transfer tube 131 and junction fitting 121. Figs. 3 and 4 show an alternative embodiment of the invention in which inflation lumen 120 passes through inflation tube 122 and through inflation bore 123 directly into stomach tube 140. Balloon catheter 100 may be made of silicone but may be also constructed of a number of materials which are compatible with body tissues (i.e., do not induce rejection or cause other adverse body reaction) such as polypropylene, polyethylene, or polyvinylchloride. Balloon 110 may be made of silicone, latex, or any number of biocompatible, expandable materials. The following example is demonstrative of one of the many procedures for which the balloon catheter of the invention may be employed. At the proximal end, the balloon catheter 100 may be preferentially connected to pressure and vacuum sources, including standard hospital equipment, and the distal end of the balloon catheter may be inserted through a patient's mouth, then through the pharynx, esophagus and into the stomach. Visual markers 160 along the length of balloon catheter 100 may be used to indicate the progression of the catheter into the patient's gastric system. Once the balloon catheter is in position, particles and body fluids are removed from the stomach via suction applied to the transfer lumen 130 through openings 136, and, in a preferred method, through the opening at distal end 132. After the removal of particles and fluids, the stomach may be decompressed through application of additional suction through transfer lumen 130. Before, during or after the removal of particles and fluids from the stomach, the balloon 110 may be inflated via inflation lumen 120 using a source of pressure, preferably a calibrated, air- filled syringe. The balloon may be inflated with other fluids, including saline. In a preferred method for carrying out a gastric banding procedure, the balloon is inflated approximately 15 to 25 cubic centimeters, while in other procedures a larger or small balloon may be desired.

After inflation, the balloon catheter 100 may be preferentially adjusted so that the balloon 110 is lodged below the gastroesophageal junction where the esophagus meets the stomach. The balloon 110 may then be employed to provide a visual/tactile landmark to facilitate laparoscopic or laparotomic gastric dissections. In a preferred aspect, the balloon may be deflated and the balloon catheter withdrawn into the esophagus a few centimeters. Once the balloon 110 has been used to facilitate dissection, gastric banding or gastric bypass techniques may be accomplished according to the procedures disclosed in U.S. Patent Nos. 4,592,339, 5,074,868, 5,226,429, and 5,449,368, the disclosures of which are incoφorated by reference in their entirety. For example, in the case of a gastric banding surgery, the balloon 110 gives a visual and tactile indicator for the location of the dissection, preferably at the equator or midpoint of the inflated balloon 110. To minimize the risk of perforation, it is preferred that dissection be carried out after the balloon 110 has been deflated and withdrawn into the esophagus. Employing the balloon as a point of reference provides for a quicker and easier dissection, which results in a reduced chance of perforating the stomach during the procedure.

Suction may be maintained through transfer lumen 130 throughout the surgical procedure or applied intermittently as needed to remove particles and fluid from the stomach or to keep the stomach decompressed. Before, during and after surgery, transfer lumen 130 may also be used to inflate the stomach, to irrigate the stomach with fluids or to introduce food, anesthesia, medications, surgical instruments such as guide-wires, stents, endoscopic instruments, and illuminating catheters, and the like. According to a preferred method for carrying out surgery according to the invention, the stomach is checked for gastric perforations after dissection by irrigating the stomach with a dye, preferably methylene blue, introduced through transfer lumen 130. The device of the present invention may be used in other surgical procedures, including gastric partitioning and stapling, gastric bypass, and other gastric restriction surgeries. The device may be used advantageously not only in laparoscopic and laparotomic procedures, but in open surgery as well. For performing a laparoscopic gastric bypass, the balloon catheter of the present invention may be used advantageously to guide a staple anvil down through the esophagus to the gastric pouch for stapling the small intestine to the pouch.

The present invention has been described with respect to particular illustrative embodiments. It is to be understood that the invention is not limited to the above-described embodiments, and that various changes and modifications may be made by those of ordinary skill in the art without departing from the spirit and scope of the appended claims.

Claims

What is claimed is:

1. A balloon catheter apparatus for transferring fluids or particles to or from a patient's body and facilitating identification of anatomical landmarks within the body during surgery, comprising: a stomach tube having a proximal end and a distal end; a balloon attached to said stomach tube approximately at said distal end of said stomach tube, wherein said stomach tube does not extend substantially beyond said balloon; an inflation lumen having a proximal end and a distal end, said inflation lumen disposed within said stomach tube and in fluid communication with said balloon; a transfer lumen having a proximal end and a distal end, said transfer lumen disposed within said stomach tube and in communication with at least one opening approximately at the location of said balloon.

2. The balloon catheter apparatus of claim 1, further comprising a universal connector attached to the proximal end of said inflation lumen.

3. The balloon catheter apparatus of claim 1, further comprising a universal connector attached to the proximal end of said transfer lumen.

5. The balloon catheter apparatus of claim 1, wherein said transfer lumen comprises a flared proximal end.

6. The balloon catheter apparatus of claim 1, wherein said inflation lumen comprises a one-way stopcock.

7. The balloon catheter apparatus of claim 1, further comprising visual length-indicating markers disposed along the length of said stomach tube.

8. The balloon catheter apparatus of claim 1, wherein at least one said opening is located approximately at said distal end of said stomach tube.

9. The balloon catheter apparatus of claim 1, wherein said at least one said opening is located approximately at a proximal end of said balloon.

10. A method of performing surgery near the stomach and esophagus of a patient comprising: inserting a catheter in fluid communication with a balloon into the stomach; attaching said catheter to a source of suction; imposing a reduced pressure on the stomach via said catheter; emptying any contents of the stomach via said catheter; attaching said catheter to a source of pressure; inflating said balloon within the stomach; lodging said balloon immediately below the junction of the stomach and the esophagus; using said inflated balloon as a landmark; and irrigating the stomach using said catheter to check for perforations.

11. The method of claim 10, further comprising placing a band around the stomach.

12. The method of claim 11, further comprising using said balloon to size said band.

13. The method of claim 11, further comprising using said balloon to locate said band.

14. The method of claim 10, further comprising placing a band around the esophagus.

15. The method of claim 14, further comprising using said balloon to size said band.

16. The method of claim 14, further comprising using said balloon to locate said band.