WO2012129236A1

WO2012129236A1 - Gastric decompression and drainage device and method

Info

Publication number: WO2012129236A1
Application number: PCT/US2012/029816
Authority: WO
Inventors: Marshall Keith PROULX
Original assignee: Proulx Marshall Keith
Priority date: 2011-03-21
Filing date: 2012-03-20
Publication date: 2012-09-27

Abstract

Embodiments of the present disclosure provide a gastric decompression and drainage device and method for use in association with enteral feeding. Embodiments include a sealed or sealable reservoir for connection to an enteral feeding device such as a g-button. Embodiments may be used for decompression and drainage followed by gravity feeding to return drained nutrients to a patient.

Description

GASTRIC DECOMPRESSION AND DRAINAGE DEVICE AND METHOD

FIELD OF THE DISCLOSURE

[0001] The invention relates to medical apparatus for decompression and/or drainage. The device further relates to gastric decompression and/or drainage associated with enteral nutrition.

BACKGROUND

[0002] Enteral nutrition is a way to provide food through a tube placed in the nose, the mouth, the stomach, or the small intestine using an enteral feeding device. Often patients receiving enteral nutrition experience symptoms of poor gastric motility, pain, and bloating. When these symptoms are present the treatment is to decompress the patient allowing gas and fluid ("Contents") to be expelled. Often, the fluid includes nutrition that may be returned to the patient's gastric system. In addition, the Contents contain digestive juices and fats which aid in digestion and maintain the pH and electrolyte balances within the digestive system. Returning the fluid Contents to the patient prevents dehydration due to loss of fluids and ensures proper digestion of the formula.

[0003] A standard syringe with the plunger removed may be used to collect and return the Contents to the patient. The syringe remains open ended and unenclosed during the

decompression allowing for Contents to be easily spilled. The syringe system provides limited relief because the gas contents within the patient cannot overcome the hydrostatic pressure of the fluid contents that fills the syringe and therefore the gas remains inside the patient. Accordingly, the syringe system is not effective in eliminating the prominent problem that causes pain and bloating for the patient— gas pressure.

[0004] The syringe system also relies upon a standard syringe which retains only 60 ml of fluid nutrition whereas fluid quantities significantly greater than 60ml may be expelled causing the user to empty the syringe as it fills. Any excess fluid that is emptied from the syringe may include undigested nutrition which may be lost, or may be poured back into the syringe if it is salvaged. In addition, using a large rigid syringe is cumbersome to carry and operate which reduces portability of the system and may lower the freedom and quality of life for the patient.

[0005] Furthermore, this system requires the unenclosed syringe to be held by either the user or caregiver during decompression. While holding the syringe, the user or caregiver must also tend to moving the air within the patient, ensure proper operation of the system, and provide support and care for the patient. For example, in order to ensure all gaseous pressure is relieved from the patient, the stomach needs to be massaged to move the air bubbles from the stomach into the decompression device taking one hand away from the user. Often the decompression device also needs to be adjusted and unclogged to allow the gas to escape into it which takes away another hand. Further, the patient is many times neurologically impaired, in pain, and thrashing about spilling the contents of the open syringe.

[0006] Other systems for gastric pressure relief in conjunction with enteral feeding have two operative lines feeding into one side of a Y-connector. The first line is the feeding line which is attached to a feeding system, such as a formula pump which pumps formula (nutrients) to the patient. The second line is attached to a gastric relief bag that is required to be at or above the height of the feeding container. The other side of the Y-connector is directed to the patient for enteral feeding. This patient line below the Y-connector is required to be at or below the patient to ensure the formula is directed to the patient and to prevent air from being pumped into the patient potentially increasing discomfort or pain to the patient.

[0007] As mentioned, the gastric relief bag is required to be at or above the feeding container which is located above the patient's stomach level. This placement provides a sufficient height such that hydrostatic pressure within the line to the gastric relief bag prevents backflow of formula into the gastric relief bag during normal operation. However, when the patient has increased gastric pressure or an occlusion occurs in the system, formula may backflow into the gastric relief bag. In such cases, a user may need to use the syringe system described above to decompress the pressure, or the line to the gastric relief bag may be clamped shut to increase pressure to the patient and overcome the occlusion or excess pressure. [0008] Due to the height of the gastric relief bag and the required line section below the patient level, the system requires a long set of tubing which increases effects of cohesion within the tube. The cohesion effect, hydrostatic pressures, and pressure from the pump also counteract and limit the efficiency of any decompression to the gastric relief bag of fluid or gas Contents. In addition, the line length and connection to the feeding system significantly limits portability of the existing devices. The systems further recommend operation with the patient connected to the gastric relief bag for 24 hours.

SUMMARY

[0009] The disclosed gastric decompression and drainage device minimizes and/or eliminates one or more of the problems of the existing devices. Embodiments of the system comprise a hermetically sealed and enclosed inflatable reservoir. This allows Contents to be collected in a hand free and spill free manner. In addition, during decompression and drainage the device is laid flat and below the patient, this allows all gas to escape from the patient's gastric system because any hydrostatic back pressure is minimized and/or eliminated. In addition, the reservoir may contain much greater quantities of nutritional fluid than a standard syringe, and improves portability because of the sealed design with a minimal size and pliable structure. After decompression and drainage, when nutritional fluid needs to be returned to the patient's gastric system, the user or caregiver can elevate the device and gravity feed the fluid contents back to the user while the gas contents remain in the reservoir.

[0010] Embodiments of the disclosed device allow the user to minimize and/or eliminate gaseous contents from remaining in the patient. Embodiments of the device also provide a spill free and hands free manner to remove gaseous content from the patient, while also allowing the user to concentrate on ensuring all gasses escape the patient. This also allows the user to console the patient by holding or caressing the patient with their free hands.

[0011] Embodiments of the gastric decompression apparatus may include a reservoir, wherein said reservoir comprises an internal compartment defined by a flexible material and a seal, wherein said flexible material permits expansion from an initial state to allow an increase in a volume of said internal compartment; a tube access operatively associated with said internal compartment of said reservoir; a tube operatively associated with said tube access, wherein said tube is sufficiently sized to allow gastric decompression without occlusion of said tube due to cohesion or hydrostatic pressure when placed at or below a patient's level; and a connector, wherein said connector operatively associates an enteral feeding device with said tube.

[0012] Some embodiments may include a reservoir that comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening. Some embodiments may include a tube that is less than three feet in length. Some embodiments may include an enteral feeding device that is a g-button device. Some

embodiments may also include a reservoir harness that is wearable by a person and provides support to said reservoir during operation.

[0013] Embodiments of the method for gastric decompression of a patient may comprise the steps of: connecting a gastric decompression device to an enteral feeding device, wherein said gastric decompression device comprises a sealed reservoir having an internal compartment and a flexible and inflatable design, a tubular path operatively associated with said internal compartment and an enteral device connector, wherein said enteral device connector allows an operative connection between said tubular path and said enteral feeding device; and placing the reservoir of said gastric decompression device at or below the level of said patient's stomach, whereby nutrient and gas contents of said patient are drained from said patient.

[0014] Some embodiments of the method also include raising said reservoir of said gastric decompression device above the level of said patient's stomach after said nutrient and gas contents of said patient have drained into said tubular path, whereby said gas contents rise within said reservoir and at least partially separate from said nutrient contents, and said nutrient contents are returned to said patient via said tubular path and said enteral feeding device. Some embodiments may include administering a medicine into said nutrient contents via an access junction, wherein said gastric decompression device further includes said access junction. In some embodiments, the step of connecting said gastric decompression device to said enteral feeding device comprises: connecting said gastric decompression device to an enteral decompression set, and connecting said enteral decompression set to said enteral feeding device.

[0015] In some embodiments, said reservoir comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening. The tubular path may be less than three feet in length.

[0016] Embodiments of the medical drainage apparatus may include a reservoir, wherein said reservoir comprises an internal compartment defined by a flexible material and a seal, wherein said flexible material permits expansion from an initial state to allow an increase in a volume of said internal compartment; a tube access operatively associated with said internal compartment of said reservoir; a tube operatively associated with said tube access, wherein said tube is sufficiently sized to allow medical drainage from a body without occlusion of said tube due to cohesion or hydrostatic pressure when placed at or below a patient's level; and a connector, wherein said connector operatively associates a body drainage device with said tube.

[0017] Some embodiments may include a reservoir that comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening. Some embodiments may include a tube that is less than three feet in length. Some embodiments may also include a reservoir harness that is wearable by a person and provides support to said reservoir during operation.

[0018] Additional aspects, advantages and features of the present invention are included in the following description of exemplary examples thereof, which description should be taken in conjunction with the accompanying figures, wherein like numerals are used to describe the same feature throughout the figures. A BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1 is a depiction of a syringe system for gastric decompression;

[0020] FIG. 2 is a depiction of an embodiment of the disclosure positioned for gastric decompression;

[0021] FIG. 3 is a depiction of an embodiment of the disclosure positioned for gravity feeding; and

[0022] FIG. 4 is a depiction of an alternate embodiment of the disclosure. DETAILED DESCRIPTION

[0023] Fig. 1 is a depiction of a syringe system of the existing art. A patient 2 is shown lying horizontally with a view of a portion of the gastric system. Specifically, an area of the stomach 2a of patient 2 is shown. Attached to the patient's stomach 2a is an enteral feeding device 4. In this embodiment, the enteral feeding device 4 is a feeding tube known in the art as a gastric button or g-button. The g-button maintains a tubular path 4a between the patient's stomach 2a and the atmosphere. This tubular path 4a allows nutrition to enter via an enteral feeding source (not shown). In addition, the g-button may also be used to decompress a patient of fluid and gas Contents.

[0024] An enteral decompression set 6 is inserted into the tubular path 4a allowing fluid and gas Contents to escape from the patient's stomach 2a. The enteral decompression set 6 comprises a proximal end having a female luer adapter 6c joined to a feeding tube 6b joined to a distal end with a decompression member 6a.

[0025] The female luer adapter 6c seats with a male luer adapter 8a at the distal end of a standard syringe 8. The standard syringe 8 operates as a reservoir to capture the fluid contents in the syringe body 8b and exhaust some gaseous contents to the atmosphere via the opening at the proximal end of the syringe 8. The syringe 8 is held in a vertical or near vertical position in order to prevent spilling any contents. However, as discussed above, it is often difficult for the user or operator of the syringe system to properly care for the patient, deal with the patient's movements, and keep from spilling the open ended syringe. Spilling the fluid Contents decreases sanitary conditions and causes the loss of the nutrition of the fluid Contents to the patient which may otherwise be reinserted into the patient's gastric system for the nutritional benefits. As mentioned above, the failure to return digestive juices and fats contained in the fluid Contents may harm the pH and electrolyte balance in the digestive system and interfere with proper digestion of the formula.

[0026] Fig. 2 depicts a system using an embodiment of the present disclosure. Similar to Fig. 1, a patient 2 is shown lying horizontally with a view of a portion of the gastric system. Specifically, an area of the stomach 2a of patient 2 is shown. The patient's stomach 2a retains an enteral feeding device 4. In this embodiment, the enteral feeding device 4 is a feeding tube known in the art as a gastric button or g-button. The g-button maintains a tubular path 4a between the patient's stomach 2a and the atmosphere. This tubular path 4a allows nutrition to enter via an enteral feeding source (not shown). In addition, the g-button may also be used to decompress a patient of fluid and gas Contents.

[0027] Similar to Fig. 1 , when the need arises to decompress a patient of fluid and gas Contents, an enteral decompression set 6 is inserted into the tubular path 4a allowing fluid and gas to escape from the patient's stomach 2a. The enteral decompression set 6 comprises a proximal end having a female luer adapter 6c joined to a feeding tube 6b which is in turn joined to a decompression member 6a at the distal end.

[0028] In this embodiment, the gastric decompression and drainage device 10 comprises the male luer adapter 10a, the tubular path 10b, and the reservoir 10c. The female luer adapter 6c operatively attaches with a male luer adapter 10a at the distal end of the gastric decompression and drainage device 10. The male luer adapter 10a is joined to a tubular path 10b which is joined to a reservoir 10c. The reservoir 10c is operable to capture the fluid and gaseous Contents which escape the patient 2 as shown in Fig. 2, and is operable to provide nutrition to patient 2 as shown in Fig. 3. [0029] In this embodiment, the gastric decompression and drainage device 10 comprises a flexible tubular path 10b which is operatively associated with the enteral decompression set 6 using a luer connector 10a. One skilled in the art will recognize that any connection method that allows a sealed operative association between tubular path 10b and the enteral decompression set 6 may be employed and remain within the scope and spirit of the present disclosure. In some embodiments, the tubular path 10b may be joined directly to a connector such as decompression member 6a or some other decompression member type bypassing the use of the enteral decompression set 6.

[0030] For decompression and drainage, the reservoir 10c of the gastric decompression and drainage device 10 is placed at a level below the patient's stomach 2a the hydrostatic pressure is directed towards the reservoir 10c and away from the stomach 2a. One skilled in the art will recognize that the device may also be operable for gastric decompression and drainage at higher levels. However, the effects of hydrostatic pressure within tubular path 10b increase as the level is raised and may hinder the drainage process and prevent sufficient decompression of the Contents.

[0031] Embodiments of the present disclosure allow for a shorter tubular path 10b than used in existing systems because it is not necessary to attach the gastric decompression and drainage device 10 at a raised level during drainage and decompression. Accordingly, tubular path 10b is only required to be long enough to place the reservoir 10c at or below the patient's stomach 2a. In some embodiments, the length of tubular path may be between six inches and forty-eight inches. Exemplary optional lengths may include six inches, two feet, three feet, or four feet in length. Tubular path 10b may be sufficiently short to allow mobility and minimize effects of cohesion and/or surface tension on fluid within the tube. Cohesion and/or surface tension may cause an increased resistance to Contents traveling through the flexible tube 10b. In some embodiments, the effects of cohesion may further be reduced by using a tubular path 10b with a larger internal diameter.

[0032] In this embodiment, the reservoir 10c is hermetically enclosed and comprised of a flexible surface 1 Of joined to a flexible surface lOg at flexible seal lOd. Flexible surfaces lOf and lOg are deformable to allow inflation of reservoir 10c during operation. One skilled in the art will recognize a variety of ways to design for flexibility and inflatability of the reservoir 10c which remain within the scope and spirit of the present disclosure. For example, the surfaces may include excess material within its sealed boundary to allow greater inflation potential. The flexible and inflatable reservoir 10c of the gastric decompression and drainage device 10 allows the reservoir 10c to maximize volume potential for holding fluid and gaseous Contents while minimizing the size of said reservoir 10c.

[0033] In this embodiment, flexible surface lOf includes demarcation lines lOe to allow a user to gauge the amount of Contents in reservoir 10c. One skilled in the art will recognize that the reservoir 10c may include any variety of unit volume graduation markers to indicate amount of fluid contents captured, or may not include any demarcation lines lOe and remain within the scope and spirit of the present disclosure.

[0034] Fig. 3 depicts the system of Fig. 2 with the gastric decompression and drainage device 10 in a raised position to allow gravity feeding the collected nutrients from an earlier gastric decompression. After gastric decompression, the reservoir 10c of the gastric decompression and drainage device 10 is placed at a level above the patient's stomach 2a allowing the reservoir 10c to attain a higher pressure than the decompressed stomach 2a. As discussed above, the reservoir 10c in this embodiment is hermetically enclosed and comprises of a flexible surface 1 Of joined to a flexible surface lOg at flexible seal lOd. In this position, the reservoir 10c allows unwanted gaseous contents within the reservoir 10c to buoyantly rise above desired fluid contents with in the reservoir 10c. The fluid contents which are generally of a nutritional value may return to patient's stomach 2a via hydrostatic pressure.

[0035] In some embodiments, the enteral decompression set 6 and/or the tubular path 10b may include a junction having an alternate connection. The alternate connection may be used to add medicine or other contents into the nutrients which are returned to the patient. One skilled in the art will recognize that the alternate connection may be used for multiple additional reasons. For example, the alternate connection may allow a syringe insertion to pull a sample of the Contents for further analysis during decompression and drainage and/or returning nutrients to the patient. [0036] In some embodiments, the reservoir 10c of the gastric decompression and drainage device 10 may include an additional port hermetically sealable with a reusable cap. The port may provide the user access for internally cleaning the reservoir 10c. Internal cleaning may extend the usable life of the gastric decompression and drainage device 10. In addition, the port may be used to conduct bolus feeding for the patient 2 by filling the reservoir 10c with the desired nutritional formula and using hydrostatic pressure to deliver the formula to the patient 2. One skilled in the art will recognize that other embodiments of the disclosure may be prefilled with a nutrient formula for use as a bolus feeding device.

[0037] The design of embodiments of the present disclosure allow for increased portability of the device and mobility of the patient than existing systems. For example, the present disclosure does not require a raised support, such as an IV pole, and/or connection to a separate feeding system, such as a formula pump. During drainage and/or decompression, the gastric decompression and drainage device 10 may be placed next to the patient 2 on a bed or other surface below the patient's stomach 2a. During the process of returning nutrients to the patient 2, the gastric decompression and drainage device 10 may be placed on a surface higher than the patient's stomach 2a. For example, the gastric decompression and drainage device 10 may be placed on a table that the patient is using. These design capabilities allow for a shorter length necessary for tubular path 10b which limits effects of cohesion as discussed above. In addition, the ability to utilize the device in a multitude of settings allows for greater mobility and quality of life for the patient 2.

[0038] In some embodiments, during operation the gastric decompression and drainage device may be placed in a harness worn by the patient while standing or sitting up or worn by a caregiver that is holding the patient. The harness may provide increased portability for the drainage device and mobility for the patient. The harness may be designed to support the device below the patient's stomach and/or above the patient's stomach. For example, the harness may be a belt with a support compartment designed to hold the reservoir, wherein the belt may be fitted around the hips of a patient during drainage and fitted around the shoulder or chest during gravity feeding. One skilled in the art will recognize that the design and placement of the harness may vary and remain within the scope and spirit of the present disclosure. [0039] Fig. 4 depicts two images of another gastric decompression device 1 1 which is an alternate version of the gastric decompression and drainage device 10 described above. Gastric decompression and drainage device 1 1 may operate in the same manner as described in relation to Figs. 2 and 3 for gastric decompression and drainage device 10. As discussed above, the gastric decompression and drainage device 11 in this embodiment has a flexible and inflatable reservoir which will receive Contents from the patient and return those Contents to the patient following decompression. Unlike the gastric decompression and drainage device 10, this embodiment of the gastric decompression and drainage device 11 includes reservoir opening 1 lh and reservoir cap Hi. In one image, reservoir cap 1 li is shown operatively connected with reservoir opening 1 lh sealing the reservoir of gastric decompression and drainage device 11. In the second image, reservoir cap 1 li is shown above reservoir opening 1 lh allowing formula, medicines, or other contents to be placed in the reservoir for gravity or bolus feeding. Reservoir opening 1 lh may also be utilized to access the inside of the reservoir for cleaning the gastric decompression and drainage device 11. Such cleaning may extend the usable life of the gastric decompression and drainage device 11.

[0040] Although discussed herein as a gastric decompression and drainage device, one skilled in the art will recognize that the gastric decompression and drainage device may also be used for alternative needs for medical drainage from the body. For example, the gastric decompression and drainage device may be used as a post operation drainage bag. The sealed and inflatable reservoir would contain drained fluids which may be utilized and/or disposed of in a safe manner. The harness described above may be of additional benefit for alternative forms of medical drainage from the body wherein the drainage system may be clipped to a patient and used over an extensive period of time.

[0041] The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the system or method described.

Claims

WHAT IS CLAIMED:

1. A gastric decompression apparatus comprising:

a reservoir, wherein said reservoir comprises an internal compartment defined by a flexible material and a seal, wherein said flexible material permits expansion from an initial state to allow an increase in a volume of said internal compartment;

a tube access operatively associated with said internal compartment of said reservoir; a tube operatively associated with said tube access, wherein said tube is sufficiently sized to allow gastric decompression without occlusion of said tube due to cohesion or hydrostatic pressure when placed at or below a patient's level; and

a connector, wherein said connector operatively associates an enteral feeding device with said tube.

2. The apparatus according to claim 1 , wherein said reservoir comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening.

3. The apparatus according to claim 1, wherein said tube is less than three feet in length.

4. The apparatus according to claim 1, wherein said enteral feeding device is a g-button device.

5. The apparatus according to claim 1, comprising a reservoir harness wherein said reservoir harness is wearable by a person and provides support to said reservoir during operation.

6. A method for gastric decompression of a patient comprising the steps of:

connecting a gastric decompression device to an enteral feeding device, wherein said gastric decompression device comprises a sealed reservoir having an internal

compartment and a flexible and inflatable design, a tubular path operatively associated with said internal compartment and a enteral device connector, wherein said enteral device connector allows an operative connection between said tubular path and said enteral feeding device; and placing the reservoir of said gastric decompression device at or below the level of said patient's stomach, whereby nutrient and gas contents of said patient are drained from said patient.

7. The method according to claim 6, further comprising the steps of:

raising said reservoir of said gastric decompression device above the level of said patient's stomach after said nutrient and gas contents of said patient have drained into said tubular path, whereby said gas contents rise within said reservoir and at least partially separate from said nutrient contents, and said nutrient contents are returned to said patient via said tubular path and said enteral feeding device.

8. The method according to claim 7, comprising the step of administering a medicine into said nutrient contents via an access junction, wherein said gastric decompression device comprises said access junction.

9. The method according to claim 6, wherein the step of connecting said gastric

decompression device to said enteral feeding device comprises: connecting said gastric decompression device to an enteral decompression set, and connecting said enteral decompression set to said enteral feeding device.

10. The method according to claim 6, wherein said reservoir comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening.

11. The method according to claim 6, wherein said tubular path is less than three feet in length.

12. A medical drainage apparatus comprising:

a tube access operatively associated with said internal compartment of said reservoir; a tube operatively associated with said tube access, wherein said tube is sufficiently sized to allow medical drainage from a body without occlusion of said tube due to cohesion or hydrostatic pressure when placed at or below a patient's level; and a connector, wherein said connector operatively associates a body drainage device with said tube.

13. The apparatus according to claim 12, wherein said reservoir comprises a reservoir opening and a removable reservoir opening cover, wherein said reservoir opening provides access to the internal compartment of said reservoir when said removable reservoir cover is removed, and wherein said removable reservoir cover seals said reservoir when connected to said reservoir opening.

14. The apparatus according to claim 12, wherein said tube is less than three feet in length.

15. The apparatus according to claim 12, comprising a reservoir harness wherein said reservoir harness is wearable by a person and provides support to said reservoir during operation.