WO2001066165A2

WO2001066165A2 - Wound irrigators and wound irrigation kit designs

Info

Publication number: WO2001066165A2
Application number: PCT/US2001/005873
Authority: WO
Inventors: Rhoda Zione
Original assignee: Rhoda Zione
Priority date: 2000-02-23
Filing date: 2001-02-23
Publication date: 2001-09-13
Also published as: WO2001066165A3; AU2001239847A1

Abstract

A disposable apparatus comprises a syringe or a collapsible type irrigator. A kit (4.0) containing the irrigator is also disclosed.

Description

WOUND IRRIGATORS WITH CELL FILL TECHNOLOGY; WOUND IRRIGATION KITS DESIGNS; CARBOHYDRATE MANAGEMENT FOR DIABETIC CONTROL

DESCRIPTION

A disposable apparatus for packaging liquids and solids for single use application.

Irrigators with cell fill technology are an apparatus and associated method for packaging liquids and solids such as but not limited to saline solutions, gels, ointments and other semi-liquids for irrigation, lavaging, and treatment applications. These cell-filled devises reinforce product packaging and manufacturing to promote the preservation and SSto safe guard against damage to the fluid cell during shipping and handling of the product. The apparatus having a cell fill with 35 ml of fluid inside of a syringe or device with flexible sidewalk and measurement markings such as but not limited to those of disposable blow-fill seal containers, and having a funnel apparatus with a opening for direct assess to tubes or treatment applications with gentle pressure of 4 - 12 PSI of pressure and a twist off cap. Markings are provided on the syringe or device for indicating when the desired quantity of saline or other solution has been prepared or delivered. The funnel apparatus has a spiked or beveled end that opens to the inside of the syringe or device. When the syringe or device is pushed or compressed, this spike engages the fluid-filled cell, thereby, releasing the fluid into the funnel of the apparatus. Typical procedures for both the syringe and the device involves the irrigation of tubes, such as but not limited to urinary catheters, neprostomoy tubes, gastric tubes and treatment applications that involve but are limited to the application of liquids, gels, ointments or semi-liquids such as, but not limited to wound lavage or hydrogel application therapies. To begin irrigation or treatment procedure the cap is twisted off, the syringe plunger is pushed or the top and bottom of the device are compressed. After irrigating or applying the treatment procedure, the apparatus can be disposed and the treatment regimen continued for the application of a wound dressing or as indicated. Current irrigation devices such as the bulb syringe are deficient of adequate pressure application for effective wound irrigation. Food and Drug Administration recommends the use of 4 - 15 PSI of pressure, with an application volume of 35 ml. These-apparatus apply 1 - 2 PSI of pressure and many have application volumes that exceed 35ml. Also, the use of such equipment increased the risk of contamination because a separate container such as a specimen cup would need to be used as a receptacle for saline and then aspired into the syringe thereby increasing the risk of cross contamination and infection.

Wound irrigation kits are a systematic way of organizing disposable or other equipment needed to perform a safe irrigation or lavage regimen. These kits include but are not limited to disposable and or re-usable equipment. These kits are designed to enhance treatment applications, improve material cost management, and prevent infection caused by the use of contaminated equipment. There are seven kit designs. The components of each kit contains some or all of these items: 1) wound irrigators, 2) 4x4 gauze dressings, 3) sterile barrier drape, 4) wound irrigation catheter, 5) gloves, 6) wound cleanser, and 7) wound irrigation tray or receptacle. The wound irrigation tray or receptacle is an apparatus that doubles as both the packaging organizer and receptacle. As a packaging organizer, all the components of the kit are placed inside of it and then sealed for sterilization. As a receptacle, the tray is positioned to catch the irrigation fluids, drainage and debri from the tissue irrigation procedure to facilitate compliance with infection control protocols and patient comfort. The wound irrigators are disposable apparatuses that are pre-filled with saline and are used to lavage or irrigate tissue. The 4x4 gauze ■ dressings are absorbable sponges used to aid in cleaning and drying tissue after treatment. The sterile barrier drape is used to make a sterile field on which all of the items of the kit can be organized for safe irrigation or lavage implementation. A wound catheter is a cannula that attaches on the tip of the wound irrigator. It is used to irrigate undermine, tunnel and small areas in wounds. Gloves are disposable, protective coverings for the hands which are used in irrigation procedures to prevent infection. Wound cleanser is a liquid or solid material used to reduce bacterial load on the tissue and skin surface and to aid in the prevention of infection. The use of wound irrigation kits has remarkably improved wound healing, reduced material waste and reduce cost in comparison to prior art. The average cost for materials used in an irrigation procedure can easily exceed $ 40.00. With the use of an irrigation kit, this cost can be reduced 60%. In addition, tissue infection is remarkedly reduced when disposable items and pre-fill irrigators are used in wound care. Figure 4 outlines seven kits: Kit 1 is indicated for small, superficial wounds; Kit 2 is indicated for small wounds with tunnels or undermines; Kit 3 is for any type of wound such as but not limited too infectious, draining, and small wounds; Kit 4 is for 3 is for any type of small wound such as but not limited too infectious, and draining; Kit 5 is for a small, deep wound with tunnels or undermines. Kit 6 is for a moderate size deep wound; and Kit 7 is for a large size deep wound.

Accordingly, it is a principal object of the inventions of cell-filled irrigators and wound irrigation kits that address the use of all disposable irrigators such as but not limited to, blow-fill seal, cell-filled, and hermetically sealed to provide a user friendly, disposable, pre-organized, treatment application, easy to use systems that engage the support of paraprofessional medical personnel and fosters patient independence in treatments via the use of disposable irrigators and irrigation kits. These inventions can be utilized in physicians' offices,, hospitals, clinics, nursing homes, military facilities and by home health care givers. These inventions also utilize care provided by individuals not conversant in the primary . language of the region to utilize the system fully and appropriately with little difficult by using the kits.

It is a further object of the kit invention to prevent complication which may result in amputations do to inadequate wound care, to prevent the deterioration of partial thickness wounds to full thickness wounds, and to eliminate for the full range of wounds. - Still another object^rόf 'the invention is to reduce the cost of irrigation procedures in such areas but not limited to, wound management overall hospitals nursing facilities, other health care facilities and home care agencies. The present kit invention reduces costs while increasing healing outcomes without complications.

It is an object of the kit inventions to provide improved elements and arrangements; thereof for- the purposes described which is inexpensive, spend ble and full effective in accomplishing its intended purposes. These and other objects of the present inventions will become readily apparent upon further review of the following specification and drawings.

The Carbohydrate Management for Diabetic Treatment Scale ( CMDTS ) is a tool to aid clinicians in the tfeatrrient of diabetes. The scales outlines carbohydrate intake of 100 to 300 per day to enhance the maintenance of optimal blood sugar level in the range of 70 - 120 and weight reduction to normal weight in proportion to height. The scale emphasizes, reduced intake of carbohydrates at the evening meal and increased intake of carbohydrates; at the breakfast meal. Such strategies in carbohydrate intake have been effective in reducing the , need for medication therapies for blood sugar management, in both insulin and non-insulin dependent diabetics and weight reduction in obese diabetic patients.

Carbohydrate Management Diabetic Treatment Scale

Accordingly, it is a principal object of the inventions of Carbohydrate Management Treatment Scale is to provide a user friendly, simply formulas for health promotion that engage the support of paraprofessional medical personnel and fosters patient independence in health management via reduction of dietary carbohydrates. It is observed by clinicians across America that juvenile diabetes has increase in the past five years and also adult onset diabetes. Research has demonstrated a direct association of these health crises to be related to increased dietary carbohydrates above 300 gm per day, which are comprised mostly of complex carbohydrates such as pies, cookies, and cakes. The invention therefore is a system for health promotion and patient education that clarifies dietary intake of carbohydrates for the optimal maintenance of health. The 300gm Carbohydrate Dietary Nutritional Intake Scale directs carbohydrate intake for persons who are of normal weight in proportion to height. The 200gm Carbohydrate Dietary Nutritional Intake Scale use is indicated for persons who are equal to or less than 30 lbs over weight. When their weight loss is achieved, they are then increased to the 300 gm per day scale and maintained there. The lOOgm Carbohydrate Dietary Nutritional Intake Scale use is indicated for persons who are more than 30 lbs over weight. When their weight loss is achieved, they are then increased to the 300 gm per day scale and maintained there. This invention can be utilized by patients', in physicians' offices, hospitals, clinics, nursing homes, military facilities and by home health care givers. These inventions also utilize care provided by individuals not conversant in the primary language of the region to utilize the system fully and appropriately with little difficult by using this scale.

It is a further object of the invention to reduce use of medication therapy for both diabetics, patients by promoting health through management of carbohydrate intake. The Food and Drug Administration advises a daily carbohydrate intake of 300 gm. The clinical observation of the inventor is that most overweight diabetic patients have a daily dietary intake of 300 or more carbohydrates per day.

Still another object of the invention is to reduce the health risk factors and complications of diabetes such as stroke, heart attack, and hyperglycemia with the use of this scale. The present invention reduces risks factors for these complications while increasing optimal health outcomes without complications.

It is an object of this invention to eradicate illnesses that are derived from excessive carbohydrate dietary intake such as obesity and diabetes.

BRIEF DESCRIPTIONS OF THE DRAWNINGS Fig. 1 is a drawing of a collapsible device with a fluid-fill 35 ml cell in it that is utilized in irrigation or lavage treatment regimens of tubes and tissue.

Fig. 2 is a drawing of a syringe with a fluid-fill 35 ml cell in it that is utilized in irrigation or lavage treatment regimens of tubes and tissue.

Fig. 3 is a drawing of a syringe with a fluid-fill 35 ml cell in it and a ribbed funnel top to enhance gripping when accessing engagement structures such as but not limited to tubes. It is utilized in irrigation or lavage treatment regimens of tubes and tissue.

Fig. 4 is a plan of seven wound irrigation kits with disposable supplies or equipment is utilized in irrigation or lavage regimens.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A disposable apparatus for packaging liquids and solids for single use application. Irrigators with cell fill technology are an apparatus and associated method for packaging liquids and solids such as but not limited to saline solutions, gels, ointments and other semi-liquids for irrigation, lavaging, and treatment applications. The apparatus having a fluid filled cell ( 35 ml ) inside of a syringe or device with flexible sidewalk and measurement markings such as but not limited to those of disposable blow-fill seal containers, and having a funnel apparatus for direct assess to tubes or treatment applications with a twist off cap. Typical procedures for both the syringe and the device involves the irrigation and treatment applications that involve but are limited to the application of liquids, gels, ointments or semi-liquids such as, but not limited to wound lavage or hydrogel application therapies. ( Fig. 1 ) A system for medical management of wounds and tissue irrigation or lavage procedures. Wound irrigation kits are a systematic way of organizing disposable or other equipment needed to perform a safe irrigation or lavage regimen. These kits include, but are not limited to, disposable and or re-usable equipment. These kits are designed to enhance treatment applications, improve material cost management, and prevent infection caused by the use of contaminated equipment. There are seven kit designs. The components of each kit contains some or all of these items: 1) wound irrigators, 2) 4x4 gauze dressings, 3) sterile barrier drape, 4) wound irrigation catheter, 5) gloves, 6) wound cleanser, and 7) wound irrigation tray or receptacle.

Figure 1 shows collapsible type cell-filled irrigator with twist off cap ( 1.0 ); funnel port ( 1.2 ); spiked apparatus ( 1.4); engagement seal (1.6); fluid capsule or cell (1.8); plunger (1.10). Figure 2 shows syringe type cell-filled irrigator with twist off cap ( 2.0 ); funnel port ( 2.2 ); spiked apparatus ( 2.4); engagement seal (2.6); fluid capsule or cell (2.8); plunger (2.10). Figure 3 shows collapsible type cell-filled irrigator with twist off cap ( 3.0 ); ribbed funnel port ( 3.2 ); spiked apparatus

( 3.4); engagement seal (3.6); fluid capsule or cell (3.8); plunger (3.10). Figure 4 Kit 1 : irrigation for small wound /tissue surface area (4.0); Kit 2 : irrigation for small wound with undermine or tunnel; Kit 3 : irrigation for but not limited to small infectious or draining wounds; Kit 4 : irrigation for but not limited to small infectious draining wounds with undermines and/or tunnels; Kit 5 irrigation for but not limited to small deep wounds; Kit 6 irrigation for but not limited to moderate size deep wounds; and Kit 7 irrigation for but not limited to large deep wounds.

A system for medical management of diabetic wounds that includes an outline of nutrition management of carbohydrate intake. The Carbohydrate Management Treatment

Claims

Scale is a tool to aid in the treatment of diabetes. The scales outlines carbohydrate intake of 100 to 300 gm per day to enhance the maintenance of optimal blood sugar level in the range of 70 - 120. The scale emphasizes the reduction of carbohydrates at the evening meal and increased intake of carbohydrates at the breakfast meal. Such strategies in carbohydrate intake has been effective in reducing the need for medication administration both insulin and non-insulin dependent diabetics.

I claim:

1 A disposable device for packaging liquids and solids for single use application in a, comprising:

2 a collapsible type with a twist top cap; funnel port for tube engagement or treatment

3 application; a spiked apparatus to pierce the fluid cell and allow fluid to flow from the cell into

4 the funnel port; engagement seal to stabilize the engaging of the spike and the fluid-fill cell and

5 Allow for the delivery of the liquid or solid when compressed.

6 wherein:

7 funnel port opening is between 16 - 20 gauge

8 fluid-fill cell has a 35 ml capacity

1 2. A disposable syringe for packaging liquids and solids for single use application in a, comprising:

1 with a twist top cap; funnel port for tube engagement or treatment 2 application; a spiked apparatus to pierce the fluid cell and allow fluid to flow from the cell into the 3 funnel port; engagement seal to stabilize the engaging of the spike and the fluid-fill cell and

4 a plunger to allow for the delivery of the liquid or solid by compression.

5 wherein: a. funnel port opening is between 16 - 20 gauge b. fluid-fill cell has a 35 ml capacity

1 3. A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for small, superficial wounds containing:

(1) wound irrigator

(4) 4x4 gauze

(1) sterile barrier

(1) wound irrigation receptacle tray

(1) package with or without gloves

1 4. A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for small, superficial wounds containing:

(1) wound irrigator

(6) 4x4 gauze

(1) sterile barrier

( 1 ) wound irrigation receptacle tray (1) package with or without gloves (1) wound catheter

1 5. A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for small, superficial wounds containing:

(1) wound irrigator

(8) 4x4 gauze

(1) sterile barrier

(1) wound irrigation receptacle tray

(1) package with or without gloves

(1) package of wound cleanser

1 6. A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for small, superficial wounds containing:

(1) wound irrigator

(8) 4x4 gauze

(1) sterile barrier

(1) wound irrigation receptacle tray

(1) package with or without gloves

(1) wound catheter

(1) package of wound cleanser

1 7. A system for medical management of tissue irrigation or lavage procedures, comprising: 2 a kit for small size, deep wounds that contains:

(2) wound irrigator (8) 4x4 gauze

(1) sterile barrier

( 1 ) wound irrigation receptacle tray

(1) package with or without gloves

(1) wound catheter

(1) package of wound cleanser

1 8. A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for moderate size, deep wounds that contains: >

(3) wound irrigator (8) 4x4 gauze

(1) sterile barrier

(1) wound irrigation receptacle tray

(1) package with or without gloves

(1) wound catheter

(1) package of wound cleanser

1 9: A system for medical management of tissue irrigation or lavage procedures, comprising:

2 a kit for large size, deep wounds that contains:

(4) wound irrigator (8) 4x4 gauze

(1) sterile barrier

(1) wound irrigation receptacle tray

(1) package with or without gloves

(1) wound catheter

(1) package of wound cleanser

1 10. A nutritional tool for the health promotion of diabetic management of optimal blood sugar

2 levels and body weight comprising:

3 three carbohydrate intake schedules that include: the intake of 300 gm of carbohydrate each day for normal weight patients the intake of 200 gm of carbohydrate each day for patients with weight excess of 30 lbs or less the intake of 100 gm of carbohydrate each day for patients with weight excess of more than 30 lbs.