Patent Publication Number: US-2020289810-A1

Title: Dual lumen tubing extending from bodily inserted medical appliance and colocated infusion and vacuum pumps

Description:
RELATED APPLICATIONS 
     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. 
    
    
     FIELD OF THE INVENTION 
     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. 
     BACKGROUND OF THE INVENTION 
     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. 
       FIG. 1  depicts a PAD generally at  100  as shown in U.S. application Ser. No. 13/416546 to Kantrowitz. A cap  102  is formed of a material such as silicone, a polymer or a metal and serves to keep debris from entering the device  100 . Preferably, the cap  102  is remote from the surface of the epidermis E. The medical appliance  34  depicted as a catheter and vacuum or hydrodynamic draw tubing  104  pass through complementary openings  106  and  108 , respectively formed in the cap  102 . The tubing  104  provides fluid communication between a vacuum or hydrodynamic draw source  22  and an inner sleeve  12 d. The inner sleeve  12 d is characterized by a large and rigid pore matrix  18  in fluid communication to a vacuum source  22  such that the source  22  draws (arrow  22 D) tissue fluid and fibroblasts  21  into the sleeve  12 d. Sleeve  12 d has a surface  24  that is optionally nanotextured to promote fibroblast adhesion. The surface  24  is optionally decorated with a pattern of contoured cell-conveying channels. It is appreciated that inner sleeve  12 d optionally includes matrix  26  thereover, a coating substance  27 , or a combination thereof. The coating  27  is appreciated to need not cover the entire surface  24 . The tissue contacting surface  29  of substance  27  is optionally nanotextured. A flange  112  is provided to stabilize the implanted device  100  within the subcuteanous layer S. A flange  112  is constructed from materials and formed by methods conventional to the art. For example, those detailed in U.S. Pat. Nos. 4,634,422; 4,668,222; 5,059,186; 5,120,313; 5,250,025; 5,814,058; 5,997,524; and 6,503,228. 
     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  FIG. 1 , where a slit extends outward from the aperture. A portal is configured for insertion of a vacuum tube is on the main body, where the portal is in fluid communication with a vacuum channel on a bottom side of the main body. A foam layer is positioned under the main body, and at least one driveline inserted through the aperture and into the appliance. The modular external interface provides additional mechanical stability to an implanted PAD so as to speed healing around a semi-permanent implanted PAD, as well as connection points for vacuum lines and at least one drive line for the insertion of medical devices. 
       FIGS. 2A-2C  illustrate the aforementioned modular external interface housing  200  coupled to the PAD  100  of  FIG. 1 . The modular external interface  200  forms a collar about the neck  110  of the PAD  100  with the main body  216  with a locking feature  218 , such as a male extension that engages a female receptacle or cavity as a mechanical overlap connection. In a specific embodiment the main body  216  is made of silicone. As best shown in  FIG. 3 , the collar seal between the main body  216  and the neck  110  of the PAD  100  forms a hermetic seal with a gasket  230 , which in a specific embodiment is a flexible gasket integrated into the main body  216 . In a specific embodiment the gasket  230  may be a floating gasket. The stabilization of the PAD  100  within the skin to form a germ-free barrier requires subject cells to grow onto the neck surfaces  16  of the PAD  100  adjacent to the subject&#39;s epidermis E. The neck surface region  16  is adapted to promote growth of autologous fibroblast cells thereon. A suitable exterior side surface substrate for fibroblast growth is a nanotextured polycarbonate (LEXAN®). 
     The modular external interface  200  is secured and sealed to an outer layer of a patient&#39;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 Tegaderm TM  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  FIG. 3  a skin protection layer  228  and a foam disc  226  are positioned in the interior of the modular external interface  200 . 
     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&#39;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&#39;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. 
     SUMMARY OF THE INVENTION 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       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: 
         FIG. 1  is a prior art, partial cutaway view of a flanged percutaneous access device (PAD) with relative dimensions of aspect exaggerated for visual clarity; 
         FIGS. 2A-2C  are prior art perspective views of a modular external interface seal for a PAD appliance; 
         FIG. 3  illustrates a side cross sectional view of  FIG. 2C ; 
         FIG. 4  illustrates web linked integrated multi-lumen tubes for an intravenous infusion line and a vacuum line for attachment to percutaneous access devices according to an embodiment of the invention; 
         FIG. 5  illustrates web linked integrated muti-lumen tubes for intravenous infusion lines, vacuum lines, and monitoring lines for attachment to percutaneous access devices according to an embodiment of the invention; 
         FIG. 6  illustrates a sheath covering integrated muti-lumen tubes for an intravenous infusion line and a vacuum line for attachment to percutaneous access devices according to an embodiment of the invention; 
         FIG. 7  illustrates a system for suppling intravenous fluids and a vacuum via an embodiment of the integrated muti-lumen tubes to the modular external interface seal of  FIG. 2  for PAD appliances; and 
         FIG. 8  illustrates a system with a collocated infusion pump and vacuum pump for suppling intravenous fluids and a vacuum, respectively via an embodiment of the integrated muti-lumen tubes to the modular external interface seal of  FIG. 2  for PAD appliances. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     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,  FIG. 4  illustrates an inventive embodiment of a ribbon cable  300  with a webbing  306  that links two or more lumens or tubes for an intravenous infusion line  302  and a vacuum line  304  for attachment to percutaneous access devices. The ribbon cable  300  is generally made of a clear (transparent or translucent) anti-kink material so fluids being transported are visible, as well as to make obvious if any obstructions occur. Non-limiting examples of materials for the lumens or tubes include synthetic polymers such as polytetrafluoroethylene (PTFE), polyvinyl plastic (PVC), polyethylene, or polypropylene plastic. PVC tubing is softened with plasticizers to make it flexible. The webbing  306  is made so that the web may be teared apart to separate the lumens ( 302 ,  304 ) at the terminating ends to facilitate connections. The terminations  308  may be color coated or keyed to avoid improper connections. 
       FIG. 5  illustrates an inventive embodiment of an expanded version  320  of web linked integrated muti-lumen tubes for an intravenous infusion line  322 , a vacuum line  324 , and a monitoring line  326  for wound healing measurements for attachment to percutaneous access devices. A set of insulated wires  328  may be also be attached to the monitoring line  326  for transmitting impedance measurements. Measured parameters that correlate to a degree of wound hermaticity may be 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&#39;s skin, via measurements of humidity in a vacuum line  324  to the PAD, or via measurements of local tissue oxygenation in the immediate vicinity of the PAD as read via monitoring line  326 . The hermaticity measurement parameters may be communicated by the wire  328  to a computing or a communication device for immediate or remote monitoring. 
       FIG. 6  illustrates an inventive embodiment of a cable  340  with a sheath  342 , which is generally clear but is shown as opaque for illustrative clarity, covering integrated muti-lumen tubes for an intravenous infusion line  344  and a vacuum line  346  for attachment to percutaneous access devices. The sheath  342 , which is flexible, holds the lumens together and avoids entanglements. It is appreciated that while only two lumens are shown, more than two lumens may be enclosed in the sheath  342  in accordance with embodiments of the invention. 
       FIG. 7  illustrates a system  400  for suppling intravenous (IV) fluids and a vacuum via an embodiment of the integrated muti-lumen tubes to the modular external interface seal  200  of  FIG. 2  for PAD appliances. An intravenous bag or bottle  402  is shown supplying an infusion pump  404 . The IV fluids are supplied via an infusion line  408  to the driveline  220  of the PAD  200 . A vacuum line  410  attached to the infusion line  408  with web  306  terminates in a vacuum pump  22  and the vacuum line  222  of the PAD  200 . 
       FIG. 8  illustrates a system  440  with an integrated device  442  with a collocated infusion pump  404 ′ and vacuum pump  22 ′ for suppling intravenous fluids and a vacuum, respectively via an embodiment of the integrated muti-lumen tubes to the modular external interface seal of  FIG. 2  for PAD appliances. An intravenous bag or bottle  402  is shown supplying an infusion pump  404 ′. The IV fluids are supplied via an infusion line  408  to the driveline  220  of the PAD  200 . A vacuum line  410  attached to the infusion line  408  with web  306  terminates in a vacuum pump  22  and the vacuum line  222  of the PAD  200 . 
     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.