Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-06-08
2003-04-22
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C128SDIG001
Reexamination Certificate
active
06551285
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to a medical line securement device and, in particular, to a device that interconnects and releasably secures an elongated medical line to a neonate's skin.
2. Description of the Related Art
Premature babies usually require assistance to breathe and eat, and thus, are often fully instrumented. An endotracheal tube typically extends down the trachea of the neonate to supply oxygen to the lungs from a ventilation machine. These babies also are usually fed intravenously by an intravenous (IV) catheter inserted into a vein, usually on the dorsal side of the neonate's hand or forearm. In some cases, a naso-gastric tube may be inserted through the neonate's nose and used either for feeding/hydrating purposes or to drain gastric secretions. An arterial catheter may also be inserted on the ventral side of the neonate's hand for purposes of monitoring blood oxygenation.
The umbilical stump additionally is often catheterized. An umbilical catheter is inserted through the umbilical stump and is placed into the neonate's circulation system, with the assistance of fluoroscope or x-ray visualization, to precisely position the distal end of the catheter. The umbilical catheter allows medication to be directly introduced into the bloodstream and permits routine blood sampling, without having to frequently puncture the delicate skin of the neonate.
Each of these catheters and tubes is precisely positioned, and the position of each is fixed relative to the neonate to prevent migration or dislodgment. Healthcare personnel usually secure the IV, arterial and/or umbilical catheters using tape (and sometimes using sutures), and also fix the endotracheal and/or naso-gastric tube with tape. The catheters and tubes remain in place for several days or weeks, and often require repositioning and/or replacement on a periodic basis. The tape thus must be removed and reapplied to the neonate's delicate skin.
Tape often collects dirt and other contaminants. Normal protocol therefore also requires periodic tape changes to inhibit bacteria and germ growth at the securement site.
Frequent tape changes exfoliate the upper layers of the neonate's skin. Such exfoliation of the upper layers of skin can lead to abrasions on the neonate's skin because the neonate's skin is so thin, sensitive and fragile. Moreover, infection and disease can occur as a result of such skin wounds owing to the relatively undeveloped nature of a neonate's immune system.
Additional disadvantages exist with the use of tape to secure the catheters and tubes to the neonate. Valuable time of the healthcare provider is spent applying and reapplying the tape. Further, because most healthcare providers find such taping procedures difficult and cumbersome when wearing latex gloves, they often remove their gloves when taping. Not only does this further lengthen the taping procedure, but it also subjects the healthcare provider to possible infection. Moreover, even if the healthcare provider remains gloved, contact between the adhesive surface of the tape and the latex gloves causes micro-holes in the gloves, thereby degrading the integrity of the glove and subjecting the healthcare provider to possible infection.
A number of medical line securement devices have recently been developed that obviate the need for frequent application and removal of surgical tape and to removably secure the medical line to the patient. One such system is disclosed by U.S. Pat. No. 5,192,273 issued to the present Applicant. These systems, however, tend to be relatively large when used with neonates. A need thus exists for a medical line securement device particularly adapted for use with neonates that obviates the need for frequent application and removal of surgical tape.
SUMMARY OF THE INVENTION
The medical line securement device of the present invention is particularly adapted for use with neonates and obviates the need for frequent application and removal of surgical tape. The device provides a small securement surface to accommodate the small body parts of a neonate, through which the device releasably engages the medical line to the neonate's skin.
The medical line securement device of the present invention also recognizes the need for a multifunctioning device that can secure a variety of medical lines (e.g., catheters and tubes) to a variety of locations on the neonate's body. One way that the securement device fulfils this need is by the components of the securement device being configured to cooperate with each other in multiple orientations. The securement device can also be part of a kit that includes a plurality of components, each of which has one of a variety of sizes, shapes and adhesives. Particular components can be selected based on the particular medical line used and the particular portion of the neonate's skin to which the medical line will be attached.
In accordance with one aspect of the present invention, a securement device is provided for securing a medical line to the skin of a patient. The securement device comprises a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient. A coupler is releasably attachable to the patch. The coupler includes a patch attachment section and a medical line attachment section connected together. Both sections include a first side and an opposite second side. At least two fastener elements are disposed on the patch attachment section of the coupler. Each is cooperative with the fastener element on the patch to releasably secure the coupler to the patch. One is positioned on the first side of the patch attachment section and the other is positioned on the second side of the patch attachment section. An adhesive is disposed on the first side of the medical line attachment section. The resulting two-sided patch attachment section permits the coupler to be attached to the patch regardless of the orientation of the adhesive side of the medical line attachment section.
In a preferred mode, the patch is configured and sized so that the fastener element covers only a portion of the first side of the patch. The remainder of the patch is thereby configured so that it can be trimmed into a shape which matches the shape of the region of the skin of the patient to which it will be applied. In this manner, it is possible for a medical practitioner to custom shape the adhesive surface of the patch so as to provide securement to the skin of the patient, while minimizing the unusable surface are of the patch which may irritate the patient, or complicate attachment of the patch.
Another aspect of the present invention involves a securement device comprising a patch including at least one fastener element on a first side of the patch and an adhesive on at least a portion of an opposite second side of the patch to secure the patch to the skin of the patient. A coupler has a patch attachment section and a medical line attachment section which are connected together by a narrow flexible neck. The patch attachment section includes at least one fastener element that is cooperative with the fastener element on the patch to releasably secure the coupler to the patch. An adhesive on the medical line attachment section is capable of attaching the coupler to the medical line to be secured to the patient. The flexible neck permits the medical line attachment section to assume different orientations relative to the patch attachment section when attached to the patch.
Another aspect of the present invention involves including within a kit for securing a medical line to the skin of a patient a number of parts including at least one patch for attachment to the skin of a patient, at least one coupler for attachment to the medical line and releasable connection to the patch, and at least one tape strip for any additional securement. Such a kit may
Kennedy Sharon
Knobbe Martens Olson & Bear LLP
Venetec International, Inc.
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