Patent Application
20200289810
The present invention in general relates to medical devices and systems and in particular to integrated multi-lumen tubing for a combination of intravenous infusion lines, vacuum lines, and in some instances monitoring lines for attachment to a percutaneous access device or long term implant.
In patients requiring long-term intravenous (IV) drug therapy, total parenteral nutrition, temporary access for kidney dialysis, or frequent blood testing, repeated access to a vein may be necessary over an extended period of time. Multiple needle sticks into a vein can be difficult, painful, and time-consuming. In such cases, a thin, flexible tube system known as a central venous catheter (also called a central line) may be inserted under the skin and into a large vein. This type of catheter may be safely and comfortably left in place for percutaneous access for days, weeks, or months. Additionally, peripherally inserted central catheters (PICC), skeletal guide wires, cardiac assist device lines, or other instruments may be kept in place for weeks or months with a precutaneous access device (PAD).
A common problem associated with implantation of a cutaneous access device (PAD) or other skin penetrating appliance is skin regeneration about the periphery of the appliance to form an immunoprotective seal against infection. New cell growth and maintenance is typically frustrated by the considerable mechanical forces exerted on the interfacial layer of cells. In order to facilitate skin regeneration about the exterior of the appliance, subject cells are often harvested and grown in culture onto appliance surfaces for several days prior to implantation in order to allow an interfacial cell layer to colonize appliance surfaces in advance of implantation. Unfortunately, cell culturing has met with limited acceptance owing to the need for a cell harvesting surgical procedure preceding the implantation procedure. Additionally, maintaining tissue culture integrity is also a complex and time-consuming task.
A related context in which cell growth is needed is wound healing, with DACRON® based random felt meshes have been used to promote cell regrowth in the vicinity of a wound, such felts have uncontrolled pore sizes that harbor bacterial growth pockets.
U.S. Pat. No. 7,704,225 to Kantrowitz solves many of these aforementioned problems by providing cell channeling contours, porous biodegradable polymers and the application of vacuum to promote cellular growth towards the surface the neck of a PAD. The facilitating of rapid cellular colonization of a PAD neck allows the subject to act as their own cell culture facility and as such affords more rapid stabilization of the PAD, and lower incidence of separation and infection.
U.S. application Ser. No. 15/555,952 assigned to the assignee of this application discloses a modular external interface that includes a main body with an aperture configured to form a collar seal about an external neck portion of a skin penetrating appliance, such as the PAD 100 of
The modular external interface 200 is secured and sealed to an outer layer of a patient's skin with a medical dressing. In a specific embodiment the medical dressing is a preform patterned and shaped to conform to the exterior of the modular external interface 200. In a specific embodiment the medical dressing preform may be in two halves (212, 214) that overlap. In a specific embodiment the medical dressing preform may be transparent. In a specific embodiment the medical dressing preform may be made of TegadermTM manufactured by Minnesota Mining and Manufacturing Company.
The modular external interface 200 has a central opening adapted at least one drive line 220 for insertion into a PAD, and a portal 224 for a vacuum line 222. As best shown in
U.S. application Ser. No. 15/125,273 assigned to the assignee of this application discloses the measurement and monitoring of wound hermaticity of a patient with one or more sensors. The one or more sensors that measure parameters that correlate to a degree of wound hermaticity are incorporated into the design of a percutaneous skin access device (PAD), a bone anchor, a wound dressing, or a bandage. The degree of wound hermaticity is related to impedance measurements performed on the patient's skin, via measurements of humidity in a vacuum line to the PAD or the bone anchor, or via measurements of local tissue oxygenation in the immediate vicinity of the PAD or the bone anchor interface with the patient's skin. The hermaticity measurement parameters are communicated by wired or wireless connection to a computing or a communication device for immediate or remote monitoring.
While there have been many advances in skin penetrating appliance designs for preventing infection at the site of skin access, there continues to be a need for improved external interfaces for implanted appliances. In particular, the myriad of intravenous infusion lines, vacuum lines, and monitoring lines that connect to the PAD and other inserted instruments tend to get tangled, interfere with patient comfort and movement, and are potentially difficult for health care workers to change and maintain.
Thus, there exists a need for improved and integrated multi-lumen tubing for intravenous infusion lines, vacuum lines, and monitoring lines for attachment to percutaneous access devices.
An integrated multi-lumen tubing includes two or more lumens. A webbing is provided between each of said two or more lumens and holding the two or more lumens together as a ribbon. A set of terminations are provided at opposing ends of each of the two or more lumens. A sheath can also be provided surrounding the two or more lumens.
A system for supply of intravenous fluid and vacuum to a patient includes the aforementioned integrated multi-lumen tubing. An intravenous bag or bottle is provided that is in fluid communication with an infusion pump. The integrated multi-lumen tubing connects the infusion pump and a vacuum pump to a percutaneous access device (PAD).
A method of using said integrated multi-lumen tubing to delivery simultaneously two or more inputs into a subject in need thereof is also provided.
The subject matter that is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
The present invention has utility as a system and method for integrated multi-lumen tubing for intravenous infusion lines, vacuum lines, and monitoring lines for attachment to percutaneous access devices. The integration of the intravenous infusion lines, vacuum lines, and monitoring lines that connect to the PAD and other inserted instruments organizes the myriad of intravenous infusion lines, vacuum lines, and monitoring lines that connect to the PAD and other inserted instruments that tend to get tangled, interfere with patient comfort and movement, and are potentially difficult for health care workers to change and maintain.
While embodiments of the integrated multi-lumen tubing are depicted in the accompanying figures as being used with an embedded percutaneous access device (PAD), it is appreciated that it is applicable to a variety of such implant appliances including a catheter, a PICC line, an IV, a Steinman pin, and a Kirschner wire. Embodiments of the integrated muti-lumen tubing provide for the hermaticity in the vicinity of the skin-appliance (PAD) interface with fluid exudate or transudate egres sing from the vicinity of the skin-PAD interface via a vacuum or low pressure tube.
Referring now to the figures,
Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference.
The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.
This application claims priority benefit of U.S. Provisional Application Ser. No. 62/818,470 filed 14 Mar. 2019; the contents of which are hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62818470 | Mar 2019 | US |
