Invented by Matt Loui, Matthew W. Bown, Glade H. Howell, Jennifer Stryker, Ryan E. Emmerson, Thomas Johnson, Kelly J. Christian, CR Bard Inc
The CR Bard Inc invention works as followsThe disclosure is “Medical Device Kits for Use in Placing, Maintaining, Altering, and/or Removing Medical Devices in, On, or From the Body of a Patient”. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. According to present embodiments the one or multiple wrap assemblies can have various features that assist the clinician in performing the procedure. In one embodiment, the medical wrap assembly comprises a foldable body with a front face that is configured to define an sterile area. The front surface of the body includes a plurality of pockets. The pockets can contain a variety of medical components. The pockets are configured to contain medical components in an order predetermined for use in the medical procedure.
Background for Wrap systems for medical devices kits
The present invention is directed, in a nutshell, to medical device kits that can be used for placing, maintaining or altering medical devices on a patient’s body, or removing them from it. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure.
According to the present embodiments, one or more of the wrap assemblies in the medical device kit may include different features that can assist the clinician when performing a particular procedure. In one embodiment a medical device kit is disclosed that comprises a foldable body with a front face, the front face being configured to define an sterile area.
A number of pockets are included on the surface of the body wrap. The pockets can be configured to hold a variety of medical components. The pockets are configured to contain medical components in an order that is predetermined for use in a particular medical procedure. The wrap body can have folded edges to keep the components from sliding off and to make it easier for a clinician to grasp the wrap without compromising sterility.
These and other features of embodiments will be more clearly apparent in the following description and attached claims. Or, they may be learned through the practice of embodiments as described hereinafter.
Reference will now take place to figures, wherein like structures will have like reference designations. The drawings represent exemplary embodiments, but are not intended to be limiting or drawn to scale.
The word ‘proximal’ is used for clarity. The word “proximal” refers to a direction that is relatively close to the clinician who uses the device described herein. While the word “distal?” refers to a direction that is farther away. Refers to a direction that is further away from the clinician. The distal end is the catheter that is placed inside a patient’s body. The proximal end is the catheter that is left outside the body. The words “including” are also acceptable. ?has,? ?has,? as used in the claims shall have the same meanings as the word “comprising
Embodiments” of the present invention generally refer to kits that are used for placing, maintaining or altering medical devices on a patient’s body, or removing them from it. Such medical device kits can include one or more wrap assemblies for use in the placement/maintenance procedure. According to the present embodiments, one or more of the wrap assemblies can have various features that will assist the clinician in performing the procedure. Below, we will describe these features in more detail.
Referring first to FIG. 1. This figure shows a catheter 10, with a catheter tube 12, inserted transcutaneously into a patient’s skin 22 via an insertion point 20. The catheter 10 is a PICC, but the principles and features below can be applied to other catheters or medical devices. Other catheters and elongated tubular devices can include dialysis, urinary and Foley catheters as well as feeding tubes, balloons catheters, PIVs etc. Access ports, such as vascular and other types, are also examples of medical devices. The catheter 10, or any other medical device, can also be placed in other parts of the body, such as the top or subcutaneous area of the patient. In one embodiment, the medical devices are not in contact or connected to the body of the patient. These and other modifications, therefore, are contemplated.
As shown in FIG. It is necessary to replace the existing/current dressing assembly on the indwelling cathter 10 with a new one periodically. As such, FIG. FIG. Indeed, FIG. “Figure 1 shows a clinician removing the old adhesive dressing (32A) from the skin of a patient 22.
FIG. The medical device kit (kit?) shown in FIG. According to one embodiment 50 can be used to replace an old dressing assembly (?kit?) with a new dress assembly for an indwelling cather, such as that shown in FIG. 1. The kit 50 shown in FIG. In the present embodiment, 2 is also referred as a kit for changing a dressing assembly and includes the various components required to perform the dressing assembly change procedure. It is understood that the kit could be configured to suit a number of different procedures involving medical devices. This discussion is intended to serve as an example and not be construed as being limiting. The kit 50 includes, as shown, a transparent pouch 52, in which all the components are contained, and a label to identify the kit. The pouch can be configured differently than that shown here.
FIG. 3A shows various details of an assembly, specifically a removal wrapping assembly 60, according to one embodiment. In one embodiment, the wrap assemblies described herein serve as a sterile and platform for the components of the kit. The removal wrap assembly is included in kit 50 in this embodiment and is configured to be used as a platform by components that are typically used for changing the dressing assembly of the catheter 10. The wrap assemblies described here can be configured in many ways, and with various kits to use with a wide variety of medical devices.
In greater detail, the removal wrap assembly 60 includes a substantially flat, flexible and foldable wrap body 62, including a spunbond-meltblown-spunbond (?SMS?) Nonwoven fabric, or any other suitable material/fabric. The wrap body material 62 has a density of 60 grams per square meter in the current embodiment. Other densities may be possible, but are not required. The wrap body 62 has a front face, as shown in FIG. The wrap body 62 includes a front surface, as shown in FIG. As shown in FIG. 3A. The wrap body described in this embodiment is approximately 22? In one embodiment, the wrap body described herein is about 22? Square, but other sizes can be made to suit your needs and intended uses, etc.
The front face of the wrap body 6 includes a number of pockets 64, aligned along bottom edge of bottom portion 62B as shown in FIGS. 3A and 3B. The material that defines the pockets 64 can be SMS nonwoven fabric like the other portions of wrap body 62 or any other suitable material/fabric. In the present embodiment the material defining pockets 64 is one piece of wrap material that is ultrasonically weld to the front of the wrap body. This allows the bottom, sides and top of pockets 64 to be defined. In another embodiment, an adhesive such as hot glue or any other suitable fixation method can be used to secure the material of the pockets to the wrap body. Another embodiment is to fold the edge of the wrap over and secure it with the underlying part of the wrap.
Each of the pockets 64 is sized to receive therein a corresponding one or more of a plurality of removal components 70 that are to be used during a removal procedure to remove the old dressing assembly from the catheter 10. In the present embodiment, the removal components 70 include, from left to right as shown in FIGS. 3A and 3B, a pair of masks 70A, a drape 70B, a hand sanitizer 70D glued via glue dot (or attached via a sticker or other adhesive mode) to a pair of gloves 70C, a tape measure 70E, three alcohol prep pads 70F, and tape strips 70G. In the present embodiment, the removal components 70 are positioned from left to right in the predetermined order that they are to be used by the clinician when performing the removal procedure to remove the old dressing assembly from the catheter 10. The components could vary in number, type, position, etc., in other embodiments, however. Similarly, the size, shape, number, and configuration of the pockets themselves can vary from what is shown and described herein. In the present embodiment, the wrap body includes six pockets, though other numbers of pockets can be included.
In the present embodiment, every pocket 64 includes a notch 66 for facilitating the removal of an item from that pocket. The front surface of removal wrap body 62, as shown in FIGS. The components 70 of the removal wrap body 62, which are in a medically-clean state, can be used in a clean environment. In one embodiment, the kit is sterilized in a way that the front of the wrap body surface 62 becomes a sterile area for the components 70. The removal wrap assembly shown in FIGS. The wrap assembly is shown in FIGS. In another embodiment, in place of being sterile, the front of the wrap body is configured to be clean. This is useful for procedures where a sterile area is not required. In other embodiments the front or another surface of the body wrap can be configured to other field types including aseptic in one embodiment.
FIGS. “FIGS. During kit production, FIG. 2 shows the various stages of folding the wrap assembly 60 along fold lines 90 so that it can be packaged in pouch 52 (FIG. FIG. The wrap body 62 is divided by an imaginary lateral folding line 90 to form the wrap top portion 62A, and the wrap bottom portion 62B. The wrap body is first folded along the lateral fold 90A, so that the top portion of the wrap is 62A is then folded on top of the bottom portion to cover the removal component 70. 3C. The removal components 70 are preserved in a clean, sterile condition by folding the wrap body 62.
FIGS. “FIGS. The vertical fold line is between the pockets 64 that contain the alcohol prep pads (70F) and tape strips (70G). In Figure 3C the vertical fold lines are located between the pockets 64 with the alcohol preparation pads (70F) and the tape strip 70G. The vertical fold line is between the pockets that contain the gloves 70C, and the measuring tapes 70E in FIG. 3D. The vertical fold line is between the pockets that contain the masks (70A) and the drape (70B). From the left side, it moves inwards. The vertical fold line is between the pockets that contain the gloves 70C and the drape 70B in FIG. 3F. This folding produces the removal pack 142, which includes the folded removal assembly 60 as shown in FIG. 3G. FIG. 3G shows, that in one embodiment, the insignia can be placed on selected surfaces of the body of the wrap 62, as shown here, wherein the insignia is a brand and an identifier for the wrap. Insignia can convey a wide range of information in one or more surfaces of the wrap, such as documentation, instructions, trademarks etc. In this embodiment and others, the wraps for the kits can be folded in a variety different ways. The removal wrap assembly 60 is unrolled in the opposite direction to that shown and described. The wrap body may be rolled instead of folded or reduced in size to fit into a pouch, or any other container.
FIG. 4A shows various details of a body of an application wrapping assembly 110 configured according to a particular embodiment. The application wrap assembly is also included in the kit, just like the removal wrapping assembly 60, and it serves as a platform to include various components used for placing a new dress assembly over the catheter 10.
In more detail, the application wrapping assembly 110 includes an essentially flat, flexible, and foldable body 112, which includes a SMS nonwoven material of approximately 60 GSM. Other materials can be used. Wrap body 112 has a front face, as shown in FIG. The wrap body 112 includes a front surface as shown in FIG. 5.
The wrap body’s front surface 112 has a number of pockets 114 in the middle of the wrap surface 112. As shown in FIGS. 4A and 6, the pockets 114 are aligned on a central part of the front of the wrap. The pockets 114 are aligned along a central portion of the front surface of the wrap body, as shown in FIGS. Material defining pockets 114 can be SMS nonwoven fabric, or any other suitable material/fabric. In one embodiment, material for the pockets 114 may be a thermoplastic, such as polypropylene. In the present embodiment the material defining pockets 114 can be a single-piece and ultrasonically weld (or otherwise attached) onto the front surface 112 of the wrap. This defines the bottom, sides and top of each separate pocket 114. In the present embodiment, there are three pockets 114. However, other numbers of pocket can be used. Another embodiment uses an adhesive such as hot glue to attach the pocket material to wrap body 112.Click here to view the patent on Google Patents.