Supports – Pipe or cable – Brackets
Reexamination Certificate
2000-01-17
2001-11-06
Ramirez, Ramon O. (Department: 3632)
Supports
Pipe or cable
Brackets
C128SDIG006, C604S180000
Reexamination Certificate
active
06311933
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a device for securely retaining and stabilizing tubular, cylindrical or similar objects and maintaining their forms. In particular, a combination holder and stabilizer with reinforcement for securing and maintaining medical tubes, rods and/or catheters applied to a patient.
BACKGROUND OF THE INVENTION
In the medical field, cylinders, tubes and catheters are routinely used to interface different parts of a patient's body, such as for infusion and drainage therapies. For example, intravenous (I.V.) treatment, Foley catheters, nasal gastric treatment, wound suction or drainage, evacuators tubing, gravity drains, urinary tubes, etc. Infusion and drainage therapies are often cumbersome and uncomfortable to the patient as it requires the connection and support of tubes and/or catheters to the patient. Discomfort to a patient increases if the tube and/or catheter is not securely attached to the patient in an accurate position. Furthermore, a twisted or tangled tube and/or catheter may detrimentally affect the flow of the treatment or drainage. In many instances, the positioning, stability and secured retainment of the tubes and/or catheters is crucial to the outcome of the treatment, and certainly to the comfort of the patient on which it is used.
A twisted or insecurely retained tube and/or catheter can lead to many complications and cause discomfort to the patient, such as decreasing the flow of treatment or drainage or accidentally withdrawing it from the patient's body, which disrupts the treatment. Even in cases where the insecurely retained tube and/or catheter is not completely removed from the body, needless interference with the positioning and shape of the tube and/or catheter can cause problems to the patient. For example, a twisted tube may cut off the natural flow of the treatment or drainage. An unexpected, inadvertent movement of an I.V. tube can cause the needle to damage the wall of the vein or blood vessel. For nasal gastric treatment, constant accurate positioning of the tube in the nostril and through the nasal passage is critical. An improperly positioned tube can cause the tube to either adhere to the stomach walls and cause the stomach lining to bleed or cause erosion through the nasal septum and, in extreme cases create a hole in the nasal septum.
The traditional method of securing tubes and/or catheters to a patient and maintaining their forms is the use of adhesive tapes such as surgical tape or bandage. Adhesive tapes cannot securely retain tubes and/or catheters for accurate positioning due to the thinness and pliability of the tapes. The tube and/or catheters may be accidentally twisted or removed from the patient from the patient's own movement. Secure retainment is compromised if the adhesive power of non-surgical grade tape is traded off for breathability of the skin of surgical tape for minimal irritation. Stability of the tube and/or catheter is further compromised by having the tube and/or catheter rests directly against the flexible, compressible and movable skin of a patient.
During the course of an infusion or drainage treatment, which can last for several weeks to several months, it is often necessary to adjust the positioning of the tube and/or catheter during use. The traditional use of adhesive tape to secure a tube and/or catheter does not provide an easy method of adjustment of the tube and/or catheter. To adjust these normally requires the removal and replacement of the adhesive tape after repositioning the tube and/or catheter because the adhesive power of the tape decreases substantially from the oily excretions from the patient's skin. Over a period of time, such removal and replacement of the tape causes discomfort to the patient, such as sensitive skin, irritation and pain.
Therefore, there is a need for a device that comfortably, quickly and securely retains and stabilizes tubes and/or catheters applied to a patient and maintains their forms yet facilitates easy repositioning and readjustment of the tubes and/or catheters, with little discomfort to the patient.
SUMMARY OF THE INVENTION
The invention provides a combination holding and stabilizing device that quickly and securely positions and retains tubes and/or cylinders such as catheters and maintains their form to facilitate shaping and repositioning of the tube and/or catheter with a minimum of discomfort to the patient.
The combination holding and stabilizing device of the present invention preferably comprises a combination of two components, a securing unit and an anchoring unit. The securing unit is for holding and stabilizing a cylinder, tube and/or catheter at a constant position relative to the device of the present invention. The anchoring unit is for holding and stabilizing the securing unit at a constant position relative to a fixed location, such as a patient's body. The securing and anchoring units work cooperatively to achieve the optimal retainment, flexibility in choice of placement, and security of tubes and/or catheters to a patient.
The securing unit of the present invention has preferably a generally elongated body such as a rectangular shaped longitudinal body made of a layer of thin flexible foam having a first top surface and a second bottom surface. The body has first and second lateral portions, preferably equal in size, extending from a fold line whereby the second lateral portion foldably overlays the first lateral portion. The top surface of the body has a resealable adhesive for securing a tube and/or catheter sandwiched between the first portion and the second overlay portion along the axis of the folding line for optimal stability. Advantageously, at both ends of the elongated body, the top surface of the first and second portions have separable holding elements such as corresponding hooks and loops of a VELCRO™ interlocking mechanism to both releasably secure the first and second portions together and to facilitate separation of the second overlay portion from the first portion for quick and easy adjustment of the tube and/or catheter.
Illustratively, the anchoring unit of the present invention has a rectangular shaped longitudinal body, similar to the securing unit, having a first top surface and a second bottom surface. The bottom surface has adhesive for attaching to a fixed location. The anchoring unit has a length proportionally longer than the first portion of the securing unit. The bottom surface of the first portion of the securing unit is attached to the top surface of the anchoring unit with the anchoring unit extending beyond at least the axis of the fold line of the securing unit to provide maximum anchoring and stability to the tubes and catheters secured in the securing unit. It is preferable that the anchoring unit is a medical-grade adhesive tape, which is generally known to one skilled in the art, that is suitable for application to a patient's skin.
In an alternative embodiment of the present invention, the foam body of the securing unit has at least one generally rectangular thin plastic strip embedded longitudinally across the body. The plastic strip is malleable and pliable to the extent that when it is pressed against the tube and/or catheter in the securing unit, it molds and conforms to the shape of the tube and/or catheter to increase and reinforce the holding and stabilizing power of the securing unit. Such plastics having this ability are well known in the art. Another advantage of using plastic strips is the ability to generally decrease the thickness of the foam body without losing the holding and stabilizing power of a thicker and firmer foam.
The thin plastic strip embedded in the body may alternatively have a wave-like structure. One or more of the wave-like strip may be embedded longitudinally across the body, either horizontally or vertically in relation to the top and bottom surfaces of the body of the securing unit. When a wave-like strip is embedded horizontally, it improves the holding and stabilizing power of the securing unit yet pr
Miskin Howard C.
Ramirez Ramon O.
Tsui-Yip Gloria
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