Patent Application
20230040450
The present invention relates to methods and devices for circumferentially sealing and securing medical devices in order to decrease complication and failure rates. Medical devices include, but are not limited to, vascular access catheters or other devices inserted into the human body.
The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
Peripheral, central and other (e.g., intra-osseous, umbilical, etc.) vascular access catheter insertion and care may be complex and highly variable processes involving gathering, setting up, and using multiple disparate pieces of equipment. This may lead to a highly variable and contaminated result. Deficiencies of vascular access catheter care may fall into two groups: (1) inadequate catheter protection, leading to internal and external contamination of the catheter, and (2) inadequate catheter securement and stabilization, leading to tissue injury and catheter damage/dislodgement.
In certain instances, vascular access technology and application technique may not allow simple, clinically reproducible, and durable sterile-sealing protection of the vascular access catheter. Because dressing technology may not seal and fully protect the catheter and its insertion site, catheter contamination commonly occurs. Past and existing attempts at placing and preserving a sterile catheter and catheter site using “aseptic no touch” technique have generally failed and have significantly contributed to the high rate of vascular catheter access failure (e.g., 35-50% of peripheral vascular catheters fail). Compounding the problem of contamination is that vascular catheter securement and stabilization technology may be inadequate in certain circumstances, leading to the need for a set of “compensatory” measures such as dedicated securement devices and extension “j-tubing”— measures that may increase clinical complexity, discomfort, and cost. The cost and complexity of these measures can be a strong deterrent to their use.
It is therefore highly desirable in certain instances to have a device that seals, stabilizes, and secures an inserted vascular access catheter—or any device inserted into the body—in a way that is simple to apply, effective in achieving intended therapeutic goals, and able to achieve this goal in a highly reproducible manner.
The catheter dressing systems disclosed can provide a fully sealed and secured vascular access device. The catheter dressing systems may be used to fully seal and secure any type of medical device that is inserted into the body of a patient. For example, the catheter dressing systems disclosed herein can be used to dress and secure straight peripheral intravenous (IV) catheter, an integrated peripheral IV catheter, a peripherally inserted central (PIC) catheter, a midline catheter, a central line catheter, an umbilical catheter, intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO), percutaneous endoscopic gastrostomy (PEG) feeding tubes, percutaneous nephrostomy device, epidural pain catheters, temporary pacemaker access devices, etc. The disclosed catheter dressing systems may be used across a broad spectrum/arena of patient care, from battlefield or EMS/ER front line, to ICU and floor care, to outpatient care facilities.
The disclosed catheter dressing systems disclosed may be configured to decrease the number of separate dressing material components and separate sterile and unsterile packaged materials that need to be gathered and assembled at the patient's bedside for catheter dressing placement over a newly inserted catheter device or other medical device inserted into a patient's body. The separately packaged and other non-packaged materials that may be gathered to establish a secured and covered catheter device when not using the disclosed catheter dressing system can include: (1) a sheet of adhesive dressing; (2) a dedicated securement device; (3) dedicated antimicrobial device; and (4) supplemental tape.
Using the disclosed catheter dressing system, the number of dressing material components and separate sterile and unsterile packaged materials that may be gathered and assembled at the patient's bedside may be reduced to 1 (one).
The disclosed embodiments of the catheter dressing system are configured to decrease the number of individual steps involved in dressing and securing an inserted catheter device. When not using the disclosed catheter dressing systems, dressing and securing the catheter device can involve 16 or more individual, often one-handed (as the other hand is needed to hold the newly inserted catheter in place), steps: A. Obtaining and arranging at the beside: (1) obtaining, arranging on a bedside surface, opening, and removing a sterile clear adhesive dressing; (2) obtaining, arranging on the bedside surface, opening, and removing a dedicated stabilization device; (3) obtaining, arranging on the bedside surface, opening, and removing a dedicated antimicrobial device; (4) obtaining, arranging on the bedside surface, opening, and removing a Luer-based extension tube, and (5) obtaining, arranging on the bedside surface adjunctive tape. B. Application of these gathered and arranged materials to the newly inserted catheter: (6) attaching a Luer-lock connector of the extension tubing to a catheter hub of the newly inserted catheter device; (7) placing the dedicated securement device beneath the extension tube Luer-lock connector and catheter hub by lifting them away from the skin surface; (8) peeling off an adhesive backing of the stabilization device; (9) adhering an adhesive of the stabilization device to the patient's skin adjacent a catheter skin insertion site; (10) activating a closure/securement mechanism of the stabilization device around the Luer-lock connector and catheter hub; (11) placing the anti-microbial device around the catheter-skin insertion site; (12) peeling off a central adhesive backing portion of a clear adhesive dressing; (13) placing the clear adhesive dressing over the connector hub and catheter device and adhering it to the surrounding skin surface; (14) peeling off a remaining adhesive backing from a rim/border portion of the adhesive dressing; (15) adhering the rim/border portion of the clear adhesive dressing to the skin; and (16) placing additional supplemental tape strips (e.g., strips included in an adhesive dressing kit or separate non-sterile strips from a roll).
When using the disclosed catheter dressing system, the number of individual steps may be decreased to 6 or less: (1) obtaining, opening and removing a catheter dressing system from its sterile packaging; (2) attaching a catheter connector of an extension tube to a hub of the inserted catheter device; (3) sliding the catheter dressing system over the extension tube into position over the catheter device and catheter connector; (4) closing a closure member of the catheter dressing system around the extension tube; (5) peeling off an adhesive backing of the an adhesive plate; and (6) adhering the adhesive plate to the skin.
Certain disclosed embodiments of the catheter dressing system have two states: open and closed. In the open state it can be easily placed over any catheter device without disturbing the catheter device. In the closed state, it provides two circumferential seals—one with the skin surrounding a catheter of the catheter device and its skin insertion site, and one around an extension tubing or other device attached to a hub of the catheter device. In the closed state, the catheter dressing system can seal the catheter and skin insertion site against external contamination and stabilize and secure the catheter device relative to the skin insertion site.
In one embodiment, the sterile sealing securing dressing is pre-mounted around a segment of tubing. A catheter device connector is attached to the distal end of this tubing and a needle-free or other connector is attached to the proximal end of the tubing. The open sterile sealing securing dressing is pre-mounted on the tubing between the two connector ends, the dressing having the ability to slide freely along the tubing through its two open circumferential orifices, both of which are in their open and non-sealed state. The pre-mounting of the dressing around the segment of tubing with its attached connectors allows several advantages: (1) the dressing and tubing connector can be packaged together as one sterile item in one sterile package that eliminates the need to open and combine multiple individual components, (2) the dressing can be packaged so that it is adjacent to the proximal connector (needle-free valve end away from the patient), leaving the distal tubing and connector easily available for finger-grasping and attachment to the catheter hub, (3) once the catheter connector is attached to the catheter hub and the dressing slid into final mounting position around the catheter hub-connector complex, the dressing can be grasped to stabilize the catheter while the two sterile seals are effected. The first circumferential sterile seal is achieved by removing the adhesive backing from the dressing and adhering the dressing to the skin, and the circumferential second is achieved by deploying the seal mechanism around the exiting tubing. The net result of this process is that two simple pre-integrated components—the dressing and the tubing with its attached mating connecter—can be treated as one simple unit, requiring only the opening of one package and the grasping of only this one simple unit. This single unit can then be used to fully sterilely seal and secure an inserted catheter in a way that is simple, intuitive, user-friendly, rapid, time and resource efficient, and highly reproducible.
Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
Reference throughout this specification to “an embodiment” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
In some embodiments, the adhesive plate 150 may be coupled to the shell 111, as shown in
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In use of any of the described embodiments of the catheter dressing systems 100, 200, 300, 400, 500, in order to decrease the number of steps required to achieve a fully sealed and secured catheter device, improve user-friendliness, and to reduce the variability in outcome, the catheter dressing system may be circumferentially mounted around a segment extension tube attached to a catheter connector configured to connect to a hub of a catheter device inserted into a patient's body. The catheter dressing system can be slid along the extension tube when the catheter dressing system is in an open state. The catheter dressing system can be moved to its final securing position around the inserted catheter device and catheter connector by sliding it down the extension tubing, and circumferential seals effected by: (1) removing an adhesive backing of an adhesive plate and adhering the adhesive plate to the skin to effect the first circumferential seal, and (2) actuating a closure member at an interface between the catheter dressing system and the segment of the extension tube that exits the catheter dressing system to effect the second circumferential seal when the catheter dressing system is in a closed state. In other words, the catheter dressing system can be configured to slide along the extension tube when in the open state, and to circumferentially seal and secure the catheter device when in an adherent and closed state.
In one embodiment, any of the catheter dressing systems 100, 200, 300, 400, 500 may be pre-mounted around a segment of an extension tube in an open state. A catheter connector can be coupled to a distal end of the extension tube and a needle-free or other connector can be attached to a proximal end of the extension tube. The catheter dressing system may be pre-mounted on the extension tube between the two connector ends, the catheter dressing system having the ability to slide freely along the extension tube through two open circumferential orifices, both of which are in open states. The pre-mounting of the catheter dressing system around the segment of tubing with its attached connectors may provide several advantages: (1) the catheter dressing system and a proximal connector can be packaged together as one sterile item in one sterile package that eliminates the need to open and combine multiple individual components; (2) the catheter dressing system can be packaged so that it is adjacent to the proximal connector (e.g., a needle-free valve end away from the patient), leaving a distal portion of an extension tube and a catheter connector easily available for finger-grasping and attachment to a catheter hub, (3) once the catheter connector is attached to the catheter hub and the catheter dressing system slid into final mounting position around the catheter device and catheter connector, the catheter dressing system can be grasped to stabilize the catheter device while two circumferential seals are effected. The first circumferential seal can be achieved by removal of an adhesive backing from the catheter dressing system and adhering the catheter dressing system to the skin, and the second circumferential can be achieved by deploying a closure member around the exiting extension tube. The result of this process can be that two pre-integrated components—the catheter dressing system and the extension tubing with its attached catheter connecter—can be treated as one unit, requiring only the opening of one package and the grasping of only this one unit. This single unit can then be used to sterilely seal and secure an inserted catheter device in a way that may be simple, intuitive, user-friendly, rapid, time and resource efficient, and highly reproducible.
The above delineated mounting sequence may eliminate a need to obtain, open, and arrange for sequential use, multiple individually packaged components. It also may eliminate a need to repeatedly reach for, grasp, and then sequentially use or attach these multiple individual components. Each individual component and its associated use methodology introduces room for error and for breaks in sterility, thereby increasing the potential suboptimal outcome. By eliminating the need for multiple components and their individual use steps, the disclosed catheter dressing system may decrease variability and improve outcomes. In addition, the embodiments disclosed may improve catheter stabilization and securement, and provide for durable sealing of the catheter device in order to fully protect the catheter device and its insertion site from the outside environment.
In the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim requires more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
The phrases “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component.
The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest to the practitioner during use.
“Fluid” is used in its broadest sense, to refer to any fluid, including both liquids and gases as well as solutions, compounds, suspensions, etc., which generally behave as fluids.
References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular configuration.
The terms “a” and “an” can be described as one, but not limited to one. For example, although the disclosure may recite a closure adaptor having “a radial projection,” the disclosure also contemplates that the closure adapter can have two or more radial projections.
Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element.
The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.
This application claims priority to U.S. Provisional Application No. 63/211,755, filed on Jun. 17, 2021 and titled “Sterile Sealed Secured IV Catheter Dressing” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63211755 | Jun 2021 | US |
