WO1997017997A1

WO1997017997A1 - Apparatus and method for the irrigation and aspiration of the gastrointestinal tract

Info

Publication number: WO1997017997A1
Application number: PCT/US1996/018262
Authority: WO
Inventors: David S. Zimmon
Original assignee: Zimmon Science Corporation
Priority date: 1995-11-16
Filing date: 1996-11-15
Publication date: 1997-05-22
Also published as: AU7732696A

Abstract

A method and apparatus (15) for the irrigation and aspiration of the gastrointestinal tract. In one form of the present invention a closed system having two fluid compartments (16, 25) is connected to an irrigation tube that is positionable within a patient's stomach. The irrigation fluid is allowed to flow into the patient's stomach by removing a flow control device. Upon having sufficiently irrigated the patient's stomach the fluid flow control device is manipulated to allow the contents of the stomach to be aspirated. The contents are delivered into a second fluid recovery container (25). The present invention forms a substantially closed system which limits the introduction of irrigation fluid and other fluids into the environment surrounding a patient.

Description

APPARATUS AND METHOD FOR THE IRRIGATION AND ASPIRATION OF THE GASTROINTESTINAL TRACT

BACKGROUND OF THE INVENTION

The present invention relates generally to the treatment of the gastrointestinal tract in patients with gastrointestinal bleeding or who have ingested a potentially toxic substance. More particularly in one embodiment the present invention relates to a closed irrigation-aspiration system for use in the gastrointestinal tract. While the present invention was developed for use in treating the gastrointestinal tract, it may have application in other areas of medicine.

A medical practitioner realizes that it is a common procedure to irrigate and aspirate the stomach in a patient with upper gastrointestinal bleeding. This procedure is done to evaluate the magnitude and rate of bleeding and to reduce the risk of pulmonary aspiration by emptying the patient's stomach prior to a diagnostic or therapeutic endoscopic procedure. Currently, the available apparatus for aspirating the stomach utilizes a tube, syringe or aspiration bulb, and a basin filed with water. The patient's stomach is irrigated using the syringe and then emptied with the bloody returns from the stomach often being mixed with the irrigation fluid. Mixing of the bloody returns and the irrigation fluid results from the inevitable fluid carry over from the syringe. This prior technique is inefficient and dirty and requires that the bloody gastric aspirate be transported and emptied into an adjacent basin or sink. A common limitation of the prior technique is the spreading of the blood and irrigation fluid on the operating room floor, the patient, and the personnel involved in the surgical procedure. Exposure of personnel to a patient's blood constitutes a serious risk for the transmission of diseases, such as AIDS or hepatitis, particularly hepatitis A, B, and C. Exacerbating the spread of blood and irrigating fluid throughout the operating room is the fact that these procedures are often required to be performed in great haste because the patient is actively bleeding. Another limitation associated with the prior therapeutic technique is the general difficulty in controlling the volume of irrigation fluid used, and to account for the volume of bloody returns. Therefore, an accurate indication of the volume of irrigation fluid ingested or removed and the volume of bloody returns is not available to the medical practitioner. As a consequence, the patient may receive an excess amount of irrigation fluid that passes from the stomach into the intestine and then is absorbed. Similarly, the volume of blood in the bloody returns cannot be measured quantitatively and in a patient with active bleeding can be a number of liters.

Although the prior techniques are steps in the right direction for the treatment of gastrointestinal bleeding, the need for additional improvement still remains. The present invention satisfies this need in a novel and unobvious way.

SUMMARY OF THE INVENTION

An apparatus for irrigating a patient's stomach with irrigation fluid and for aspirating from the stomach the irrigation fluid and other fluids. The apparatus comprising; a tube positionable within the stomach; irrigation fluid delivery means connected to the tube for delivering irrigation fluid to the stomach; fluid recovery means connected to the tube for receiving from the stomach at least a portion of one of the irrigation fluid and the other fluids; at least one flow control device for controlling the fluid flow between the tube and the irrigation fluid delivery means and the fluid recovery means; and the irrigation fluid delivery means, the fluid recovery means, and the tube forming a substantially closed system to limit the introduction of the irrigation fluid and other fluids into the environment surrounding the patient.

One object of the present invention is to provide an improved apparatus for the irrigation and aspiration of the gastrointestinal tract. Related objects and advantages of the present invention will be apparent from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a irrigation tube positioned within a patient.

FIG. 2. is a perspective view of an irrigation-aspiration apparatus according to one form of the present invention.

FIG. 3 is a perspective view of an irrigation-aspiration apparatus according to another form of the present invention,

DESCRIPTION OF THE PREFERRED EMBODIMENT

For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.

Referring to FIG. 1, there is shown an illustrative view of a portion of the gastrointestinal tract of a patient 10. An irrigation tube 11 is placed through the esophagus and into the stomach 12 to allow irrigation and aspiration of the patient's stomach. The irrigation tube 11 is of sufficient length such that the contents of the stomach can be irrigated by the passage of fluid through the tube 11. it is understood that FIG. 1 is purely illustrative and in most cases the tube will extend into the stomach about 60 cm. The irrigation tube 11 has a proximal open end Ila and a distal open end lib that allows for the passage of fluid therethrough. Irrigation tubes and the method of placement and use are generally known to those of ordinary skill in the art.

With reference to FIG. 2, there is illustrated a preferred embodiment of the closed irrigation-aspiration apparatus 15. The apparatus 15 is designed and constructed to provide the efficient and controlled treatment of the stomach 12 of a patient having gastrointestinal bleeding, or one who has ingested a potentially toxic substance. The apparatus 15 is referred to herein as a closed system, and that term means in this context that there are no open connections external to the patient thereby minimizing and/or eliminating the problems associated with blood, irrigation fluid, and other fluids being expelled from the stomach and contaminating the surrounding personnel or facility.

In the preferred embodiment the closed irrigation-aspiration apparatus 15 utilizes two fluid reservoirs that are in fluid communication with the irrigation tube 11. An irrigation fluid reservoir 16 is connected to the irrigation tube 11 by a fluid tubing 17. The fluid tubing 17 being connected to the irrigation tube 11 by a "T"-fitting 18, which has an irrigation fluid side 18a and a fluid return side 18b. A clamp 19 is configured to be receivable on tubing 17 and tubing 20 to control the flow of fluid through the respective tubes and ultimately the fluid flow into or out of the respective fluid reservoirs. In the preferred embodiment the irrigation fluid is sterile water, which is used to wash a patient's stomach. Irrigation fluid reservoir 16 is re oveably connected to a stand 21. The fluid reservoirs, tubes and connectors are all able to be removed and disassembled to facilitate maintenance and the changing of supplies. The stand 21 has an adjustable height to allow a medical practitioner to control the elevation of the irrigation fluid reservoir 16, thereby controlling the force of the fluid flow into the irrigation tube 11, and ultimately to the patient's stomach 12. Stand 21 is merely representative of ways to facilitate elevational changes of the reservoir and should not be viewed as limiting; it is understood that other apparatus providing the same function as stand 21 are contemplated by the present invention. In the preferred embodiment irrigation fluid reservoir 16 is a bag, having a vent 23, with calibration marks 22 formed thereon. It is understood that the reservoir can be a rigid container or a non-rigid container. In the preferred embodiment the calibration marks 22 are positioned at 100 mililiter increments. The calibration marks 22 provide the practitioner with an optical verification as to the quantity of fluid that has been dispensed from the irrigation fluid reservoir 16. A vent 23 is disposed on the top of reservoir 16 to facilitate the flow of fluid from the reservoir.

A fluid recovery reservoir 25 is positioned beneath the irrigation tube 11 in order to facilitate the aspiration of fluid from a patient's stomach by syphonage. It is understood to those skilled in the art that syphonage refers to a method to draw off or empty fluid from a container, such as a stomach by using a syphon. The fluid recovery reservoir 25 is connected to the "T"-fitting 18 by a fluid tube 20 that is connected to the fluid return side 18b.

Irrigation tube 11, irrigation fluid reservoir 16, and the fluid recovery reservoir 25 are in a closed fluid communication relationship. Therefore, there are no open connections in the irrigation apparatus 15 external to the patients stomach. This closed system facilitates the ability to control the volume of irrigation fluid dispensed to the patient's stomach while being able to quantify the amount of irrigation fluid and other fluids aspirated from the patient's stomach. The closed irrigation-aspiration apparatus 15 has a variety of medicinal applications including the use in patients having active gastrointestinal bleeding and/or patients who have ingested a potentially toxic substance. Upon aspiration of a patient's stomach it is normal to recover a quantity of blood from the bleeding sites, and/or poison from someone who has ingested a potentially toxic substance. Blood and potentially toxic substances will be referred to herein as other fluids, however, this is not intended to be limiting and apparatus 15 is designed and intended for use to aspirate any type of material from the patient's stomach. An example of one use of the irrigation-aspiration apparatus 15 will be set forth to illustrate potential methods of use. The irrigation fluid reservoir 16 is initially filled with a sufficient quantity of irrigation fluid and clamp 19 is positioned on tube 18 to prevent the flow of irrigation fluid from this reservoir to the irrigation tube 11. A second clamp 19, identical to the first clamp 19, is clamped across tube 20 to prevent fluid flow into the fluid recovery reservoir 25. In another form of the present invention, one clamp is utilized to operate this apparatus, and the clamp is moved from tube to tube to open and close the fluid path. After the practitioner has removed clamp 19 from tube 17 and positioned a second clamp 19 on tubing 20 the irrigation fluid can flow from the reservoir 16 through the irrigation tube 11 and into the patient's stomach. It is understood to one of ordinary skill in the art that the rate and force of the fluid flow is controlled by the vertical adjustment of the irrigation fluid reservoir 16, and the size of the fluid tubing that the fluid flows through. Therefore, prior to allowing the irrigation fluid to flow, the practitioner selects and adjusts the desired elevation for the reservoir 16, and determines the quantity of fluid that should be delivered to the patient. The geometric relationship of the elements of apparatus 15 is associated with providing the motive power necessary to drive the irrigation fluid into the patient's stomach and the operator is free to carefully observe the patient.

The present apparatus 15 alleviates the trauma and irritation that often occurs in prior art manual techniques of this nature, wherein the medical practitioner may inadvertently assert excessive force to an aspiration or irrigation syringe in order to hasten the procedure. In contrast the present invention of appartus 15 controls the flow of fluids by gravitational forces and differences in pressure.

After the desired quantity of irrigation fluid has been dispensed from the irrigation fluid reservoir 16 through the irrigation tube 11 into the patient's stomach 12 the practitioner replaces the clamp 19 on the tubing 17 to stop the flow of fluid from this reservoir. The practitioner can now aspirate the stomach 12 by removing clamp 19 that is obstructing the flow of fluid through tube 20. After removal of the clamp 19 from tube 20 the irrigation fluid and other fluids are drawn from the patient's stomach and delivered to the fluid recovery reservoir 25 by a syphon action. Once again the removal of fluid from the stomach is an automated process and does not require manual intervention such as aspiration with a bulb syringe. In order to accomplish the satisfactory treatment of a patient it may be necessary to repeatedly irrigate and aspirate the patient's stomach which may entail adding additional irrigation fluid and additional fluid recovery reservoirs 25. Further, the practitioner can observe the calibration marks 22 on the reservoir 25 to quantify the amount of fluid removed from the stomach.

With reference to FIG. 3, there is illustrated another embodiment of the irrigation-aspiration apparatus of the present invention. Irrigation-aspiration apparatus 150 is a closed system, as previously defined, and thus there are no open connections external to the patient thereby minimizing or eliminating the contamination of the surrounding environment with blood and/or other fluids. The irrigation-aspiration apparatus 150 includes a pair of fluid reservoirs that are connected to an irrigation tube 151. The irrigation tube 151 is analogous to the irrigation tube 11 of apparatus 15 and is utilized to irrigate and aspirate the patient's stomach. The irrigation tube 151 contains a portion that is positionable within the patient's gastrointestinal tract and extending into the stomach.

A syringe or bulb aspirator 152 is connected to the irrigation tube 151 to provide the motive power to move the fluids in and out of the patient's stomach. It is preferred that syringe 152 is at least a 100 cc aspiration syringe, and the syringe 152 is utilized to aspirate and irrigate the stomach through the irrigation tube 151. Aspiration syringes and their associated use are generally known to those skilled in the art.

The pair of fluid reservoirs include an irrigation fluid reservoir 155 and a fluid recovery reservoir 156 which are adjustably and re oveably mounted to a stand 157. It is understood that the physical arrangement of the reservoirs 155 and 156 relative to stand 157 can be varied as required by specific local parameters. A pair of tubings 158 and 159 connect their respective fluid reservoirs 155 and 156 to the irrigation tube 151. Each of the tubes 158 and 159 have a clamp 160 and 161 positionable thereon for controlling fluid flow associated with the respective reservoir. The clamps 160 and 161 are identical, and are designed to be manipulated by the practitioner to block the flow of fluid between each reservoir and irrigation tube. A clamp 162 is positionable on irrigation tube 151 in order to control the flow of fluid between apparatus 150 and the patient's stomach.

With reference to FIG. 3, there will now be described an example of the operation of apparatus 150 as deployed for use with an irrigation tube 151. As shown in FIG. 3, the three fluid control clamps 160, 161, and 162 are seated on their respective tubes 158, 159 and 151 to block the flow of fluid therein. A fresh fluid reservoir 155 having a sufficient quantity of irrigation fluid (preferably water) therein is connected to tube 158. It is understood that the tubes and reservoirs are able to be disassembled to facilitate changing the reservoir and maintaining the apparatus. Each of the fluid reservoirs are marked with graduations 170 which facilitate a practitioners recognition of the quantity of fluid delivered from the fluid reservoir 155, and the quantity of fluid drawn from the patient's stomach and delivered into the fluid recovery reservoir 156. A practitioner inserts the irrigation tube 151 into the patient as illustrated in FIG. 1. The deployment and positioning of an irrigation tube within a patient is a matter that is within the scope of a person of ordinary skill in the art. The practitioner now connects the irrigation-aspiration system 150 to the irrigation tube 151, clamps 160, 161 and 162 are initially closed, and then clamp 162 is opened to allow syringe 152 to be used to aspirate the contents of the stomach. Aspiration is accomplished by applying manual force to the head 200 of the syringe 152 and then releasing. When the fluid retention chamber of syringe 152 is full of fluids aspirated from the stomach, clamp 162 is closed, and then clamp 161 is opened to allow the waste fluid to pass into reservoir 156. The waste fluid is expelled from syringe 152 by pushing the head 200 in the direction of arrow X. Following the purging of the syringe 152, clamp 161 is closed and clamp 160 is opened to provide a fluid communication path between the irrigation fluid reservoir 155 and the syringe 152. Withdrawing the head of the syringe 152 in a direction opposite to arrow X fills the syringe with fresh irrigation fluid. After the syringe 152 is full of a quantity of irrigating fluid the clamp 158 is closed and clamp 162 is opened to create a fluid communication path to the patient's stomach. Movement of the head 200 in the direction of arrow X forces the irrigation fluid through the irrigation tube 151 and into the patient's stomach. The practitioner by varying the amount of force he applies to the head 200 of syringe 152 can adjust the relative force applied to the fluid delivered or drawn from the stomach.

In embodiment 150 of the present invention it is understood that the system is closed and manually aspirated. Further, the calibration marks 170 on fluid reservoir 155 and 156 allow for a practitioner to visually quantify the amount of irrigation fluid dispensed to the patient, and the amount of irrigation fluid and other fluids aspirated from the patient's stomach. The type of material that is normally aspirated from the patient's stomach includes blood, irrigation fluid, and other ingested materials.

While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

WHAT IS CLAIMED IS:

1. An apparatus for irrigating a patient's stomach with irrigation fluid and for aspirating from the stomach irrigation fluid and other fluids, comprising: a tube positionable within the stomach; irrigation fluid delivery means connected to said tube for delivering irrigation fluid to the stomach; fluid recovery means connected to said tube for receiving from the stomach at least a portion of one of the

10 irrigation fluid and the other fluids; at least one flow control device for controlling the fluid flow between said tube and said irrigation fluid delivery means and said fluid recovery means; and wherein said irrigation fluid delivery means, said fluid , r recovery means, and said tube forming a substantially closed system to limit the introduction of the irrigation fluid and other fluids into the environment surrounding the patient.

AMENDED CLAIMS

[received by the International Bureau on 4 March 1997 (04.03.97); original claim 1 amended; new claims 2-17 added (6 pages)]

1. An apparatus for irrigating a patient's stomach with irrigation fluid and for aspirating from the stomach irrigation fluid and other fluids, comprising: an elongated tube positionable through the patient's esophagus into the stomach; an irrigation fluid delivery reservoir positioned above the patient's stomach and coupled to said tube for delivering irrigation fluid to the stomach, the motive force for moving the irrigation fluid through said tube is gravitational forces; a fluid recovery reservoir coupled to said tube for receiving from the stomach at least a portion of one of the irrigation fluid and the other fluids, said fluid recovery reservoir spaced vertically below the patient's stomach so that aspiration of fluid from the patient's stomach is by siphonage; at least one flow control device for controlling the fluid flow between said tube and said irrigation fluid delivery reservoir and said fluid recovery reservoir; and wherein said irrigation fluid delivery reservoir, said fluid recovery reservoir, and said tube forming a closed system to limit the introduction of the irrigation fluid and other fluids into the environment surrounding the patient.

2. The apparatus of claim 1, wherein said irrigation fluid delivery reservoir comprises an "irrigation fluid bag and a delivery tube interconnecting said bag and said tube positioned in the patient's stomach.

AMENDED SHEET (ARTICLE \%

3. The apparatus of claim 2, wherein said fluid recovery reservoir comprises a recovery bag and a recovery tube interconnecting said recovery bag and said tube positioned in the stomach.

4. The apparatus of claim 3, wherein said recovery bag further comprises calibration marks to determine the volume of fluid recovered.

5. The apparatus of claim 4, wherein said irrigation fluid bag further comprises calibration marks to determine the volume of irrigation fluid delivered.

6. The apparatus of claiifi 2, wherein said irrigation fluid bag includes a vent for facilitating the flow of fluid from said irrigation fluid bag.

7. The apparatus of claim 1, further comprising a stand having said irrigation fluid delivery reservoir coupled thereto, said stand being adjustable so that a practitioner may adjust the height of said stand and thereby adjust the vertical space of said irrigation fluid delivery reservoir above the patient's stomach to control fluid flow into the patient's stomach.

8. The apparatus of claim 1, wherein said tube positioned in the patient's stomach is a single lumen tube.

9. The apparatus of claim 1, wherein: said irrigation fluid delivery reservoir comprises an irrigation fluid bag and a delivery tube interconnecting said bag and said tube positioned in the patient's stomach; said fluid recovery reservoir comprises a recovery bag and a recovery tube interconnecting said recovery bag and said tube positioned in the stomach; said recovery bag comprises calibration marks to determine the volume of fluid recovered; said irrigation fluid bag further comprises calibration marks to determine the volume of irrigation fluid delivered; said irrigation fluid bag comprises a vent for facilitating the flow of fluid from said irrigation fluid bag; and a stand having said irrigation fluid delivery reservoir coupled thereto, said stand being adjustable so that a practitioner may adjust the height of said stand and thereby adjust the vertical space of said irrigation fluid delivery reservoir above the patient's stomach to control fluid flow into the patient's stomach.

10. An apparatus for irrigating a patient's stomach with irrigation fluid and for aspirating from the stomach irrigation fluid and other fluids, comprising: an elongated tube positionable through the patient's esophagus into the stomach; a syringe coupled to said tube for providing the motive force for irrigating the patient's stomach with irrigation fluid and for aspirating from the stomach irrigation fluid and other fluids; an irrigation fluid delivery reservoir for delivering fluid to said syringe for further delivery to the patient's stomach; a fluid recovery reservoir for receiving from said syringe at least a portion of the irrigation fluid and other fluids aspirated from the stomach; wherein said tube, said syringe, said fluid delivery reservoir, and said fluid recovery reservoir form a substantially closed system to limit the contamination of the environment surrounding the patient with fluids aspirated from the patient's stomach.

11. The apparatus of claim 10, further comprising: a first flow control means for controlling fluid flow through said elongated tube, said first flow control means attached to said elongated tube between the patient's stomach and the connection of both the fluid recovery reservoir and the delivery reservoir; a fluid delivery tube coupling said fluid delivery reservoir to said tube between said syringe and the patient's stomach; a second flow control means for controlling fluid flow through said fluid delivery tube, said second flow control means attached to said fluid delivery tube; a fluid recovery tube coupling said fluid recovery reservoir to said tube between said syringe and the patient's stomach; a third flow control means for controlling fluid flow through said fluid recovery tube, said third flow control means attached to said fluid recovery tube; and wherein each of said flow control means may be selectively positioned so as to allow said syringe to withdraw irrigation fluid from said irrigation fluid delivery reservoir, to deliver irrigation fluid from said syringe to the patient's stomach, to withdraw fluid from the patient's stomach and to deposit withdrawn fluid in said fluid recovery reservoir.

12. A method for irrigating a patient's stomach with irrigation fluid and for aspirating from the stomach irrigation fluid and other fluids, comprising: providing an elongated tube in a substantially closed relationships with an irrigation fluid delivery reservoir and a fluid recovery reservoir, further providing a flow control means for controlling fluid flow between the tube, the irrigation fluid delivery reservoir and the fluid recovery reservoir; placing the tube through the patient's esophagus and into the patient's stomach; elevating the irrigation fluid reservoir above the patient's stomach; permitting irrigation fluid to flow through the tube and into the patient's stomach; stopping the flow of irrigation fluid into the patient's stomach; and siphoning fluid from the patient's stomach into the fluid recovery reservoir.

13. The method of claim 12, wherein said stopping includes selectively positioning the flow control means.

14. The method of claim 13, wherein the flow control means includes a clamp and wherein said stopping includes placing the clamp on the tube adjacent the irrigation fluid reservoir.

15. The method of claim 12, further including coupling the irrigation fluid delivery reservoir to an adjustable stand, and wherein said elevating includes adjusting the stand so as to increase the elevation of the irrigation fluid delivery reservoir relative to the patient's stomach.

16. The method of claim 12, wherein the irrigation fluid delivery reservoir and fluid recovery reservoir each include calibration marks, and further including examining the fluid level in each of the reservoirs with respect to the calibration marks to quantify the volume of irrigation fluid administered and the volume of fluid recovered from the patient's stomach.

17. The method of claim 12, wherein: the flow control means includes a clamp; said stopping includeε selectively positioning the clamp on the tube adjacent the irrigation fluid reservoir; further including coupling the irrigation fluid delivery reservoir to an adjustable stand, and wherein said elevating includes adjusting the stand to increase the elevation of the irrigation fluid delivery reservoir in relation to the patient's stomach; and wherein the irrigation fluid delivery reservoir and fluid recovery reservoir each include calibration marks thereon, and further includes quantifying the volume of irrigation fluid administered and the volume of fluid recovered by examining the fluid level in each of the reservoirs with respect to the calibration marks.