Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/002—Packages specially adapted therefor ; catheter kit packages
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B46/00—Surgical drapes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
  • A61B50/33—Trays
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/90—Identification means for patients or instruments, e.g. tags
  • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
  • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
  • A61B2050/3008—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments having multiple compartments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
  • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
  • A61B2050/314—Flexible bags or pouches
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/90—Identification means for patients or instruments, e.g. tags

Definitions

• This invention relates generally to storage containers for medical devices, and more
• a storage container for a long, flexible medical implement such as a catheter, and related medical devices, as well as an instruction manual included therewith.
• Medical devices including surgical instruments, supplies, and so forth, are generally shipped from manufacturer to medical services provider in sterile packaging.
• a scalpel may be shipped to a surgeon in a plastic, vacuum-sealed, sterile package.
• bandages may be shipped in paper, plastic, or paper composite sterile wrappers.
• catheter assemblies and other flexible equipment is generally shipped in a coiled configuration. Once the sterile packaging is removed, the catheter must be uncoiled prior to use. Care must be taken in shipping, unwrapping, and using the catheter. For instance, if a catheter is inadvertently bent, kinked, or otherwise damaged, it may no longer be suitable for use. Compounding this issue, catheters are available in a variety of lengths ranging from 100 centimeters to over 250 centimeters. Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT)
• FIG. 1 illustrates a top, front, right perspective view of one embodiment of a tray for a catheter or similar assembly in accordance with embodiments of the invention.
• FIG. 2 illustrates a top, front, left perspective view of one embodiment of a tray for a catheter or similar assembly in accordance with embodiments of the invention.
• FIG. 3 illustrates a top plan view of one embodiment of a tray for a catheter or similar assembly in accordance with embodiments of the invention.
• FIG. 4 illustrates a front elevation view of one embodiment of a tray for a catheter or similar assembly in accordance with embodiments of the invention.
• FIG. 5 illustrates a cut-away, left elevation view of one embodiment of a tray for a
• FIG. 6 illustrates a bottom plan view of one embodiment of a tray for a catheter or similar assembly in accordance with embodiments of the invention.
• FIG. 7 illustrates a top, front, right perspective view of one embodiment of a tray for a catheter or similar assembly, with a catheter and corresponding procedural devices disposed therein, in accordance with embodiments of the invention.
• FIG. 8 illustrates a top plan view of one embodiment of a tray for a catheter or similar assembly, with a catheter and corresponding procedural devices disposed therein, in accordance with embodiments of the invention.
• FIG. 9 illustrates a transparent, front elevation view of one embodiment of a tray for a catheter or similar assembly, with a catheter and corresponding procedural devices disposed therein, in accordance with embodiments of the invention.
• FIG. 10 illustrates a perspective view of one embodiment of a tray for a catheter or
• FIG. 11 illustrates a method of manufacturing one embodiment of a tray for a catheter or similar assembly, with a catheter and corresponding procedural devices disposed therein, in accordance with embodiments of the invention.
• FIG 12 illustrates one embodiment of printed instructions in accordance with
• FIG. 13 illustrates one embodiment of printed instructions in accordance with
• FIGS. 14-19 illustrate exemplary panels of printed instructions in accordance with
• FIG. 20 illustrates a physical configuration of printed instructions in accordance with one embodiment of the invention.
• FIG. 21 illustrates a method in accordance with embodiments of the invention.
• FIGS. 22-30 illustrate various stages of a method of enclosing a medical procedure kit configured in accordance with embodiments of the invention.
• FIGS. 31-33 illustrate various stages of a method of deploying a medical procedure kit configured in accordance with embodiments of the invention.
• FIGS. 34-37 illustrate various stages of an alternative method of enclosing a medical procedure kit configured in accordance with embodiments of the invention.
• FIGS. 38-39 illustrate various stages of an alternative method of enclosing a medical procedure kit configured in accordance with embodiments of the invention.
• FIG. 40 illustrates printed materials configured as an adhesive label with an opening flap in accordance with one embodiment of the invention.
• FIG. 41 illustrates printed materials affixed to a medical procedure kit in accordance with one or more embodiments of the invention.
• FIG. 42 illustrates printed materials configured as a booklet affixed to a medical
• FIGS. 43 and 44 illustrate instructional materials configured in accordance with one or more embodiments of the invention.
• FIG. 45 illustrates a peelable label being removed from printed materials in accordance with embodiments of the invention.
• FIG. 46 illustrates one embodiment of a detached peelable label.
• FIG. 47 illustrates an alternative patient portion of printed instructions configured as a greeting card and having patient information therein, in accordance with one embodiment of the invention.
• Embodiments of the present invention provide a medical procedure kit that includes medical products for performing a medical procedure.
• the medical procedure kit is configured for a catheterization procedure.
• Such an embodiment will be used herein for illustration purposes. However, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that embodiments of the invention are not so limited.
• Other medical Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) procedure kits for performing other procedures could be substituted for the illustrative catheterization tray disclosed herein by substituting other medical implements for the
• a tray is configured to accommodate a medical device or assembly.
• the medical device is a coiled device, such as a catheter or catheter assembly.
• embodiments of the present invention are also configured to contain devices and materials intended for use with the coiled medical device.
• a catheter assembly when a catheter assembly is inserted into a patient, sterile water may be used to inflate the catheter. Additionally, the catheter may be coated in a lubricating jelly prior to insertion into the patient. Fluids and other samples may then be monitored and obtained from the patient via the catheter.
• Embodiments of the present invention provide a single container configured to accommodate not only the catheter assembly and fluid bag, but also syringes containing sterile water or lubricants. Further, the tray can accommodate a sterile specimen jar for capturing samples taken from the patient via the catheter.
• the tray is configured to provide the medical services provider with mnemonic devices instructing them in which order to use each device.
• a compartment containing syringes in one embodiment, includes an inclined, stair-stepped bottom member to present the plungers of each syringe at an easy to reach angle and at different heights based upon order of use.
• compartments have multi-purpose functionality.
• a container configured to accommodate a syringe having lubricating jelly disposed therein is also configured to be used as a lubricating jelly applicator.
• a medical services provider first dispenses the lubricating jelly into the syringe compartment.
• the medical services provider then passes the catheter from another compartment through an opening in a barrier separating the compartments into the lubricating Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) jelly.
• the tray not only serves as a shipping and storage container for an assembly of devices used with a catheter procedure, but also as an application device to assist a medical services provider in using those products together.
• FIGS. 1-6 illustrated therein are views of one embodiment of a tray 100 configured to accommodate a catheter assembly in accordance with embodiments of the invention.
• FIG. 1 illustrates a top, front right perspective view of the tray 100.
• FIG. 2 illustrates a top, front, left perspective view of the tray 100.
• FIG. 3 illustrates a top plan view of the tray 100.
• FIG. 4 illustrates a front elevation view of the tray 100.
• FIG. 5 illustrates a cut-away, left elevation view of one embodiment of a tray 100.
• FIG. 6 illustrates a bottom plan view of the tray 100.
• these figures will be referred to collectively with like reference numerals referring to identical or functionally similar elements throughout the separate views.
• the tray 100 in one embodiment, is formed by a contoured surface 104 that defines the various features and compartments of the tray 100.
• the contoured surface 104 of the tray 100 can be manufactured in various ways.
• the tray 100 can be thermally formed on a mold from a soft thermoplastic, such as styrene or polystyrene.
• the tray 100 can be injection molded.
• the tray can be poured on a mold using a quick setting plastic, epoxy, or resin. Other methods of manufacture will be obvious to those of ordinary skill in the art having the benefit of this disclosure.
• Exemplary dimensions for one embodiment of the tray 100 are as follows: The length
• 112 can be between nine and twelve inches, such as ten inches.
• One illustrative length 112 may be 10.380 inches.
• the width 113 can be between eight and eleven inches, such as nine inches.
• One illustrative width 113 is 9.250 inches.
• the height 114 can be between one and three inches.
• One illustrative height 114 is 1.750 inches.
• the tray 100 includes three main compartments: a first compartment
• the first compartment 101 is separated from the second compartment 102 by a first barrier 105.
• the second compartment 102 is separated from the third compartment 103 by a second barrier 106.
• the compartments are open from the top of the tray 100 - the top being opposite the base members of the tray 100 - and are bounded on the bottom by a first base member 107, a second base member 108, and a third base member 109.
• the compartments are bounded on the sides by a perimeter wall 110.
• the perimeter wall 110 ends in a horizontal flange 11 1 extending substantially orthogonally from the perimeter wall 110. It will be clear to those of ordinary skill in the art having the benefit of this disclosure that embodiments other than that shown in FIG. 1 are possible without departing from the spirit and scope of the invention.
• the top of the tray 100 could have a hinged or snap-coupled lid that is opened or removed to reveal the compartments there beneath.
• the tray 100 is configured to hold or otherwise
• the tray 100 is configured to hold not only the catheter assembly, but the medical devices corresponding to catheter use as well.
• the following devices will be used: a syringe holding sterile water, a syringe holding lubricating jelly or another equivalent lubricant, a catheter assembly, skin cleansing or preparation materials, and a specimen jar.
• the various compartments and features of the tray 100 shown in FIGS. 1 -6 will be described for use with these devices.
• additional objects can be included with the tray, such as one or more towels, a drape to cover the patient, rubber gloves, hand sanitizing materials, swab sticks, a securement device, a Foley insert tag, a printed instruction pamphlet, and so forth.
• the syringe holding sterile water, syringe holding lubricating jelly, catheter assembly, and specimen jar are used for illustration Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) purposes only, as it will be clear that other objects may be added to or substituted for these objects. Further, subsets of these objects may be used.
• the tray 100 is configured such that these objects are ordered in accordance with their use during the procedure.
• the tray 100 includes a first compartment 101 for accommodating one or more syringes, a second compartment 102 for accommodating the catheter assembly, and a third compartment 103 for accommodating the specimen jar.
• a first compartment 101 for accommodating one or more syringes
• a second compartment 102 for accommodating the catheter assembly
• a third compartment 103 for accommodating the specimen jar.
• the first compartment base member 107 includes a stair- stepped contour 115 suitable for accommodating a plurality of syringes at different heights.
• a first step portion 116 of the stair-stepped contour 115 may be at a different height within the tray 100 than a second step portion 117 of the stair-stepped contour.
• the first step portion 116 - which is disposed farther from the first barrier 105 than the second step portion 117 - is shallower than the second step portion 117.
• the second step portion 117 is disposed at a greater depth within the tray 100 than the first step portion 116.
• the stair-stepped contour 115 can be used as mnemonic device when multiple syringes are stored within the first compartment 101. For example, it may be intuitive that a syringe placed on a higher step portion may need to be used first. This intuition is further enforced when the higher step portion is disposed farther to the left in a left-to-right usage configuration. Thus, a user receives a mnemonic reminder to use a syringe disposed on the first step portion 116 prior to a syringe disposed on the second step portion 117, as it is both higher and farther to the left.
• the first compartment base member 107 can further be configured for syringe ease of use.
• the first compartment base member 107 is inclined relative to other compartment base members.
• the second compartment base member 108 and third compartment base member 109 are substantially coplanar with each other.
• the second compartment base member 108 and third compartment base member 109 are generally flat in these views, although it will be clear to those of ordinary skill in the art having the benefit of this disclosure that contours could be incorporated into one or both of these base members.
• the first compartment base member 107 is configured to be inclined relative to one or both of the second compartment base member 108 and third compartment base member 109.
• the stair-stepped contour 115 forms a ramp upon which syringes may be placed so that the plunger of each syringe is predisposed to project upward and out of the tray 100.
• the stair-stepped contour 115 is configured such that the first step portion 116 and the second step portion 117 are disposed in a non -parallel orientation relative to the second compartment base member 108. This configuration makes it easier for a medical services provider to grasp the syringes and remove them from the tray 100.
• the first compartment base member 107 may include other features suitable for
• first step portion 116 and second step portion 117 include recesses 118,119 for accommodating a syringe flange. These recesses 118,119 generally function to prevent the syringes from sliding lengthwise within the first compartment 101.
• first step portion 116 and the second step portion 117 include protrusions 120 that help to prevent the syringes from sliding laterally within the first compartment 101.
• first barrier 105 and the second barrier 106 include openings disposed therein.
• first barrier Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT)
• the 105 includes a first opening 121 between the first compartment 101 and the second compartment 102.
• the second barrier 106 includes a second opening 122 between the second compartment 102 and the third compartment 103.
• Each of these openings has an opening depth associated therewith.
• each opening has an opening width associated therewith.
• the first opening 121 is bounded by a first opening base member 129 and two inclined first opening side members 127,128, while the second opening 122 is bounded by a second opening base member 131, an inclined second opening side member 130, and the perimeter wall 110.
• the opening depths can be the same, in one embodiment the opening depths are different.
• the first opening 121 has a first opening depth 123 that is less than the second opening depth 124 of the second opening 122.
• the opening widths are different.
• the first opening 121 has a first opening width 125 that is less than the second opening width 126 of the second opening 122.
• a pair of syringes - such as syringes having a one-half inch diameter - fits easily into the first compartment 101 when the tray 100 is made with the illustrative dimensions set forth above.
• some procedures require one or more of the syringes to be larger.
• some syringes are larger in diameter.
• These larger syringes are capable of nesting within the first opening 121 and second opening 122.
• the inclined opening side members prevent the syringe from moving lengthwise, while the disparate opening heights present the plunger of the syringe to the medical services provider for easy removal from the tray 100.
• the stair-stepped contour 115 gives the tray additional advantages over prior art catheter containers.
• the first Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) compartment 101 has a first compartment base member 107 configured with a stair-stepped contour 115, the first compartment 101 can be used as a lubricant applicator for the catheter.
• the medical services provider may dispense the lubricating jelly along the second step portion 117.
• the second step portion 117 serves as a channel in which the lubricating jelly may spread.
• a medical services provider may then pass the catheter through the first opening 121, through the channel formed by the second step portion 117, i.e., along the second step portion 117 through the dispensed lubricating jelly, and out the top of the tray 100 to the patient.
• This feature of the tray 100 greatly eases the application of lubricating jelly to the catheter when compared to prior art solutions.
• the tray 100 is packaged with printed instructions showing the medical services provider how to apply lubricating jelly in this manner. The printed instructions will be described in more detail below with respect to FIGS. 12-23.
• the lubricating jelly is dispensed directly onto the catheter tubing while the tubing is in or above the first compartment 101. Excess lubricant falling from the catheter tubing can then collect, and be retained, in the second step portion 117.
• the catheter can become contaminated when moving it from its shipping container. Consequently, the patient can be at an elevated risk of infection as the catheter is moved from one tray to another.
• Embodiments of the present invention solve this problem by providing a single level tray 100 with compartments.
• the first compartment 101 includes the first opening 121 so the catheter can stay in place during and after lubrication.
• the medical services provider can more easily prepare and use the components within the tray 100. This helps to minimize the risk of contaminating the patient or the sterile field during the procedure.
• the second step portion 117 is configured to be inclined at a
• the second step portion 117 includes a "cutdown" so that the catheter can stay within the channel both during and after lubrication.
• the catheter can be placed in both the first opening 121 and second opening
• the second opening 122 helps to align the catheter with the first opening for easy passage through the lubrication channel formed by the second step portion 117.
• the tray 100 of FIGS. 1 -6 includes additional advantages over prior art catheter
• instructions 132 or other graphical indicia can be printed, placed upon, or molded into the horizontal flange 111.
• compartment designations can be placed above each compartment to ensure the medical services provider uses the correct device or material at the correct time.
• expiratory dates for materials or devices disposed within the tray 100 may be placed on the horizontal flange 111.
• Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) the invention is not so limited. Any number of various text or picture combinations can be printed on, placed upon, or molded into various parts of the tray.
• graphical indicia can be applied to the compartment base members in addition to the horizontal flange 1 1 1. Note that the horizontal flanges, in one embodiment, can terminate in downwardly protruding vertical flanges for increased stability during the printing process.
• tray 100 Another advantage of the tray 100 is that its compartmentalized configuration helps to reduce the risk of contaminating a patient or compromising the sterile nature of the components stored in the tray 100. Since both the catheter assembly and medical devices corresponding to catheter use are stored within the same tray 100, the risk of cross-contamination between sterile work areas and non-sterile spaces is minimized. Further, by having the catheter assembly and the devices corresponding to catheter use stowed in a one-level tray rather than a multi-level, stacked configuration, the medical services provider can more easily prepare and use the catheter and corresponding devices disposed within the tray 100.
• FIGS. 7-9 illustrated therein is a tray having a catheter assembly 700, syringes 701 ,702, and a specimen container 703 stored therein as a catheter packaging system in accordance with one embodiment of the invention.
• FIGS. 7-9 will be referred to collectively with like reference numerals referring to identical or functionally similar elements throughout the separate views.
• FIG. 7 illustrates a top, front, right perspective view of the catheter packaging system
• FIG. 8 illustrates a top plan view of the catheter packaging system.
• FIG. 9 illustrates a transparent, front elevation view of the catheter packaging system.
• the illustrative catheter packaging system of FIGS. 7-9 includes a tray 100 having a first compartment 101 , a second compartment 102, and a third compartment 103.
• the first compartment 101 is configured to accommodate syringes 701 ,702.
• the second compartment 102 is configured to accommodate a coiled medical device, such as catheter assembly 700.
• the third compartment 103 is configured to accommodate the specimen container 703.
• the third compartment 103 can accommodate other materials as well, including skin Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) sanitizers and cleansing liquids, solutions, or gels.
• additional devices corresponding to catheter use including towels, drapes, rubber gloves, and so forth, can be disposed in the tray 100 as well.
• a towel 704 is disposed beneath the catheter assembly 700.
• the flange 111 can include instructions 770 or other graphical indicia.
• the implements disposed in the various compartments 101,102,103 can have implements therein arranged in accordance with use.
• the instructions 770 can be coordinated with this arrangement, indicating that components disposed in the first compartment 101 should be used first, components disposed in the second compartment 102 should be used next, and so forth.
• arrows 771 or other directional elements can be included on the flange 111 as well.
• each compartment of the tray 100 includes a compartment base member. Further, each compartment is separated by a barrier having an opening therein. A first barrier 105 having a first opening 121 therein separates the first compartment 101 from the second compartment 102. Similarly, a second barrier 106 having a second opening 122 therein separates the second compartment 102 from the third compartment.
• Syringes 701,702 are disposed in the first compartment, with one syringe 701 being
• the tray 100 can be packed with larger syringes.
• a large syringe (not shown) can be supported laterally within the tray 100 when it is placed across the tray 100 such that it lies within both the first opening 121 of the first barrier 105 and the second opening 122 of the second barrier 106.
• Such a syringe will pass across the top of the catheter assembly 700, but will be held in place by the side members of each opening.
• FIG. 10 illustrated therein is an exploded view of the tray 100 having the catheter assembly 700, a pair of syringes 701 ,702, and a specimen container 703 disposed therein. While only a specimen container 703 is shown as being disposed in the third compartment, note that additional items could also be included within the third compartment, including swab sticks. Other devices could also be inserted into the tray 100 in various compartments as well. For example, in one embodiment, a catheter securement device, and a Foley insertion tag, which is a dated and/or time stamped label that is secured to the catheter tubing once the catheter is inserted, can be inserted into the second compartment 102.
• the pair of syringes 701,702 can be configured as shown in FIG. 10, or alternatively can be both inserted in the first compartment, as described above.
• one syringe 702 is disposed laterally in the first opening 121 and the second opening 122 of the first barrier 105 and second barrier 106, respectively. This configuration is illustrative only.
• the tray can be sealed with a wrap 1000 to keep the internal components sterile.
• the wrap 1000 can be any of a number of types of material.
• the wrap 1000 comprises a Central Sterile Reprocessing (CSR) wrap that is used widely by medical professionals in hospitals, ambulatory surgical centers, and the like during medical procedures. While a CSR wrap is one example of a wrap that can be used, it will be clear to those of ordinary skill in the art that other wraps, such as plastic, Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) cotton, linen, paper, or combinations thereof, can be substituted without departing from the spirit and scope of the invention.
• BPMDL0005JT.P4 PCT 10055U CIP4 PCT
• the CSR wrap 1000 is folded about the tray 100 for sealing, and can be correspondingly unfolded to reveal the tray 100. Once unfolded, the CSR wrap 1000 can then be used in the catheter insertion process.
• an unfolded CSR wrap 1000 can be used to provide a sterile field in which the tray 100 sits for unloading and subsequent use. This process will be explained in more detail in the discussion of FIGS. 22-30 below.
• Printed instructions 1001 can then be attached to, disposed upon, or disposed within the tray 100.
• the printed instructions 1001 include a health care services portion and a patient portion, as will be shown in FIGS. 12-13 below.
• the health care services portion can include instructions telling the health care services provider, for example, how to set up a sterile or otherwise clean work environment, how to prepare the catheter assembly 700 disposed within the tray, how to use the other devices within the tray, how to insert the catheter, how to secure the drainage bag to the catheter, how to empty the drainage bag, how to obtain a urine sample, and so forth.
• the instructions can include pictures or illustrations showing visually how the various steps should be done as well.
• the patient portion can include helpful suggestions or instructions for the patient.
• the patient portion can be detachably coupled to the health care services portion, such as by a perforated line that is easily torn to separate the patient portion from the health care services portion.
• suggestions or instructions that may be included in the patient portion include information on what a catheter is, what the patient should understand about the catheter, how to reduce the chance of getting an infection, information about infections commonly associated with catheters, symptoms of infections commonly associated with catheters, and suggestions for home use of the catheter assembly 700.
• the health care services portion may include an instruction for the health care services provider to detach the Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) patient portion from the health care services portion and instructions to discuss the patient portion with the patient.
• BPMDL0005JT.P4 PCT 10055U CIP4 PCT
• the health care services portion can tell the medical services provider how to perform a standard catheterization procedure.
• the tray 100 is equipped with an adhesive label that can be used to identify the patient or specimen in the specimen container 703.
• a label can be included to mark or otherwise identify the material in the fluid bag attached to the catheter.
• Such labels can include pre-printed fields, such as date, time and name. Further the printed instructions 1001 can notify the medical services provider that the devices disposed within the tray 100 are ordered corresponding to use during the catheterization procedure.
• the printed instructions 1001 can inform the medical services provider of special instructions. For instance, in one embodiment the printed instructions 1001 can inform the medical services provider not to leave a catheter in a patient for more than forty- eight hours without a physician's approval. Where the printed instructions 1001 include such information, the labels included in the tray 100 may have pre-printed fields for the time of insertion that can be filled in by the medical services provider performing the catheterization procedure.
• the assembly can be sealed in a sterile wrap 1002 such as a thermally sealed bag.
• a thermally sealed bag can optionally include a preformed opening.
• the opening can include one or more tabs that a health care services provider is instructed to pull to open the bag.
• Inclusion of a sterile wrap 1002 not only keeps the contents within the bag sterile, but also allows the instructions to be included with the tray assembly, yet outside the CSR wrap 1000.
• the printed instructions 1001 are disposed atop the CSR wrap 1000 such that the health care services portion of the printed instructions 1001 is disposed on the top of the printed instructions 1001, with the patient portion being disposed adjacent to the CSR wrap 1000, such as when the printed instructions 1001 are configured as an accordion-style folded instruction pamphlet.
• the printed instructions 1001 of one embodiment are configured as a folded, printed, separate article disposed atop the CSR wrap 1000, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that the invention is not so limited.
• the sterile wrap 1002 can be optional.
• the instructions for use can be printed on the CSR wrap 1000 as well.
• an adhesive instruction tag 1003 can be affixed to the sterile wrap 1002.
• the instruction tag may be adhered to an outer packaging, that encloses the tray, the sterile wrap material or both.
• the instruction tag 1003 can include information regarding whether a catheter procedure is needed. Text 1004 such as "Is there a valid clinical reason?" may be included under an instruction to "Stop" that includes the following information:
• checklist text 1005 may be included, such as "Checklist for Foley Catheter
• Additional information may also be included, such as a fillable form 1006 that provides fields for the date and time of insertion of the catheter to be recorded, the name of the health care services provider, and the signature of the health care services provider.
• the above text 1004 for the instruction tag 1003 is illustrative only, and may be customized as desired by the
• FIG. 11 illustrated therein is a method 1100 for manufacturing a
• the manufacturer provides a tray (100) having at least a first compartment (101) for accommodating one or more syringes (701 ,702) and a second compartment (102) for accommodating a flexible medical device, such as a catheter assembly (700).
• the first compartment (101) will have a first compartment base member (107) having an inclined, stair- stepped contour (115).
• the first compartment (101) and second compartment (102) can be separated by a first barrier (105) having an opening (121) therein.
• the manufacturer can dispose at least one syringe (701) in the first compartment (101) at step 1102.
• the manufacturer may Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) include additional components with the tray (100).
• a catheter securement device, a Foley insert tag, or other complementary components may be included at this step 1103.
• a second syringe (702) will be
• the second syringe (702) will be disposed laterally within the first opening (121) and, where present, a second opening (122) at step 1107.
• the manufacturer will place the catheter assembly (700) in the second
• compartment (102) Other components may be disposed in the tray (100) as well, including a specimen container (703) that is disposed in a third compartment (103) at step 1108. Further, other devices may be included, such as towels, drapes, printed instructions, one or more antiseptic packets, and so forth. These other devices can be disposed in various compartments within the tray (100).
• the tray (100) is sealed. This can be accomplished by folding a CSR wrap about the tray (100). In such an embodiment, the CSR wrap can be used during the catheter insertion procedure as well.
• the manufacturer can enclose printed instructions (1001). In one embodiment, the printed instructions (1001) will direct a user to discharge contents of at least one syringe into the first compartment (101) and to pass at least a portion of the catheter assembly (700) through the opening and into the contents to lubricate the catheter.
• the manufacturer can place a sterile wrap about the tray (100) and the
• the completed assembly can be shipped to a medical services provider.
• FIGS. 22-30 illustrated therein is a method of packaging a catheter
• FIGS. 22-30 Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) illustrate one exemplary method graphically, which each figure representing one or more steps of the method, as the illustrations serve to better explain these steps than would a flow chart or other diagram. While FIGS. 22-30 illustrate one method of packaging a tray and catheter assembly, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that other methods can be used as well. Further, in creating this article of manufacture, i.e., the packaged catheter assembly, the steps of FIGS. 22-30 may be either manual or automated. A person can execute the steps to create the article of manufacture in one embodiment. Alternatively, industrial machinery, equipment, and robotics can be designed and programmed to execute the steps with the assistance of one or more processors and executable instructions stored in memory.
• a tray 100 is provided.
• the tray includes at least one compartment, such as the first compartment 101 that is configured for receiving the catheter assembly 700.
• the tray 100 can include additional compartments as well, such as those for receiving syringes, specimen jars, and so forth.
• the catheter assembly 700 is placed within the first compartment 101 as previously described.
• the tray is then placed upon one or more layers of wrap material 2200.
• the wrap material 2200 can be CSR wrap.
• the wrap material 2200 comprises a white layer of CSR wrap measuring 24 inches square.
• other materials can be used as well, including plastic materials, cotton materials, paper materials, synthetic materials and so forth.
• the wrap material 2200 can be of different shapes and sizes as well.
• the tray 100 can be sealed with a simple layer of plastic adhered to the top of the tray 100, providing the wrap material 2200 can be advantageous in many applications.
• a medical services provider may unfold the wrap about the tray 100 to create a sterile field for the catheterization procedure. For this reason, one or Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) more layers of wrap material 2200 are simply folded about the tray 100 in this illustrative embodiment.
• the tray 100 will be described as having four sides: a first side 2201, a second side 2202, a third side 2203, and a fourth side 2204. As these sides will not be visible in every view, due to the folding of the wrap material 2200 about the tray 100, they are initially noted here. Note that four sides are used because the illustrative tray 100 is rectangular in shape. Were the tray a triangle, there would be three sides. Were the tray ovular or circular, there would be an infinite number of sides.
• a first portion 2301 of the one or more layers of wrap material 2200 is folded about a first side (2201) of the tray 100.
• the tray 100 is oriented at a rotation of approximately forty-five degrees relative to the one or more layers of wrap material 2200, with both the wrap material 2200 and the tray 100 being rectangular in shape.
• the first portion 2301 comprises a first corner of the wrap material 2200.
• the wrap material 2200 can be configured as a circle or oval. Executing the step shown in FIG. 22, a first portion of that material could be folded about a first side of the tray 100 in similar fashion.
• FIG. 23 illustrated therein is an optional step that can be included in the
• the one or more layers of wrap material 2200 can be unfolded to create a sterile field about the tray 100. A patient can be placed atop this sterile field for the catheterization procedure. Even if the surface below the wrap material 2200 is also sterile, the use of the wrap material 2200 as a foundation for the procedure further ensures that the sterile field will not be breached.
• a package of liquid hand sanitizer 2401 Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) or other cleanser and/or a package of rubber gloves 2402 may be included.
• other medical implements such as alcohol wipes or other materials could be enclosed as well.
• the health care services provider may - before ever touching the catheter assembly or tray contents - apply the liquid hand sanitizer 2401 to their hands and dawn rubber gloves.
• the inclusion of these accessories in the packaging eliminates the need for the health care services provider to have to leave the sterile field to wash their hands, obtain gloves, and so forth.
• the package of liquid hand sanitizer 2401 and package of rubber gloves 2402 are simply placed atop the first portion 2301 of the one or more layers of wrap material 2200. As will be shown below, they will be held in place by other portions of the one or more layers of wrap material 2200 by way of subsequent folding steps. Other methods of holding them in place, including light adhesives or the design of pockets in the one or more layers of wrap material 2200 may also be used.
• the sanitizer 2401 and gloves 2402 are shown placed atop the first portion 2301, but may be alternatively placed atop, and therefore outside of the sterile field, other layers of the wrap as well, (for example, 2501, 2601, 2801 or the like).
• a second portion 2501 of the one or more layers of wrap material 2200 is folded about a second side (2202) of the tray 100.
• the second portion 2501 of the one or more layers of wrap material 2200 may be folded so as to cover or partially cover these items.
• a third portion 2601 of the one or more layers of wrap material 2200 is folded about a second side (2203) of the tray 100.
• the third portion 2601 of the one or more layers of wrap material 2200 may be folded so as to cover or partially cover these items.
• the packaged catheter assembly can include an additional layer of wrap material 2701.
• the additional layer of wrap material 2701 comprises a folded layer of CSR wrap measuring 17 by 17.5 inches.
• the additional layer of wrap material 2701 in this illustrative embodiment is folded as a 4 by 2 matrix.
• the one or more layers of wrap material 2200 and the additional layer of wrap material 2701 can be different.
• the additional layer of wrap material 2701 can be a fenestrated wrap with one or more pre-formed openings suited to the catheterization procedure.
• the additional layer of wrap material 2701 is configured to be visibly distinguishable from the one or more layers of wrap material 2200.
• the additional layer of wrap material 2701 is a different color than the one or more layers of wrap material 2200.
• the one or more layers of wrap material 2200 can be white, for instance, while the additional layer of wrap material 2701 can be light blue or light green. Other color combinations can equally be used.
• the additional layer of wrap material 2701 can be placed atop portions of the one or more layers of wrap material 2200.
• the additional layer of wrap material 2701 can be held in place by way of subsequent folding steps, as the additional layer of wrap material 2701 is disposed along other folded portions of the one or more layers of wrap material 2200 prior to folding a fourth portion of the one or more layers of wrap material about the fourth side (2204) of the tray (100).
• inventions of the invention can include printed instructions.
• the printed instructions can include a patient portion and a health care services provider portion.
• the health care services provider portion can include information such as how to use the medical procedure kit, what is included therein, checklists, and so forth.
• the patient portion can include helpful information for the patient, such as information about the procedure, questions to ask, and post procedure care suggestions. These two portions can be detachably coupled together. Alternatively, they can be separate.
• the health care services portion of the printed instructions are physically separated from the patient portion, it can be advantageous to stage the various portions at different locations within the assembled medical procedure kit.
• One advantage offered by embodiments of the invention is that the medical devices and implements can be staged within the kit in accordance with an order of use. Accordingly, the health care services provider can draw out each device in order of use.
• FIG. 34 illustrated therein is an alternate embodiment of the stage shown in FIG. 27.
• the embodiment of FIG. 34 is well suited to situations in which the health care services portion is physically separated from the patient portion.
• FIG. 34 another optional step corresponding to a method of packaging a medical procedure kit is shown.
• the medical procedure kit of FIG. 34 illustrates a packaged catheter assembly.
• the packaged catheter assembly can include an additional layer of material 2701, which may be a patient drape, under-buttocks drape, or a combination thereof disposed within one or more layers of wrap material 2200.
• the additional layer of material 2701 can be configured to be visibly distinguishable from the one or more layers of wrap material 2200.
• the additional layer of material 2701 is a different color than the one or more layers of wrap material 2200.
• the package of liquid hand sanitizer 2401 and package of rubber gloves 2402, optionally the additional layer of material 2701 , and the separated health care services portion 3401 of the printed instructions can be placed atop portions of the one or more layers of wrap material 2200.
• the package of liquid hand sanitizer 2401, the rubber gloves 2402, the additional layer of material 2701, and the separated health care services portion 3401 can be held in place by way of subsequent folding steps, as they are disposed along other folded portions of the one or more layers of wrap material 2200 prior to folding a fourth portion of the one or more layers of wrap material about the fourth side (2204) of the tray (100). Accordingly, the health care services provider will be readily able to access these devices after unfolding a single fold of the one or more layers of wrap material 2200.
• the tray (100) is enclosed in the one or more layers of wrap material 2200 by folding a fourth portion 2801 of the one or more layers of wrap material 2200 about a fourth side (2204) of the tray (100) and then tucking at least one of the first portion (2301), the second portion (2501), the third portion (2601), or the fourth portion 2801 of the one or more layers of wrap material 2200 beneath at least another of the first portion (2301), the second portion (2501), the third portion (2601), or the fourth portion 2801 of the layer of wrap material 2200.
• a part of the fourth portion 2801 is tucked beneath parts of each of the (2301), the second portion (2501), and the third portion (2601).
• This step of tucking encloses both the additional layer of wrap material 2701 and the package of liquid hand sanitizer (2401) and the package of gloves (2402) within the one or more layers of wrap material 2200.
• FIG. 35 illustrated therein is a variation of FIG. 28 in which the
• the printed instructions include a health care services portion and a patient portion, wherein these portions are separate.
• the tray (100) is enclosed in the one or more layers of wrap material 2200 by folding a fourth portion 2801 of the one or more layers of wrap material 2200 about a fourth side (2204) of the tray (100) and then tucking at least one of the first Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) portion (2301), the second portion (2501), the third portion (2601), or the fourth portion 2801 of the one or more layers of wrap material 2200 beneath at least another of the first portion (2301), the second portion (2501), the third portion (2601), or the fourth portion 2801 of the layer of wrap material 2200.
• the separated health care services portion 3401 of the printed instructions is thus tucked within the fourth portion 2801.
• the separated patient portion 3501 is then placed atop the fourth portion 2801.
• the health care services provider is therefore able to access the separated patient portion 3501 and deliver it to, and possibly discuss it with, a patient prior to unfolding the fourth portion 2801.
• the step of tucking shown in FIG. 34 encloses each of the additional layer of wrap material 2701, the separated health care services portion 3401, the package of liquid hand sanitizer (2401) and the package of gloves (2402) within the one or more layers of wrap material 2200, while leaving the patient portion 3501 outside the various folds of the one or more layers of wrap material 2200.
• the packaged catheter assembly 2901 can be sealed in a bag
• printed instructions 1001 Prior to depositing the packaged catheter assembly 2901 into the bag 2902, optional printed instructions 1001 can be attached to or disposed upon the packaged catheter assembly 2901 as well.
• the printed instructions 1001 can include a health care services portion and a patient portion as shown in FIGS. 12-13.
• the instructions can include pictures or illustrations showing visually how the various steps should be done as well.
• FIG. 36 illustrated therein is an alternative to FIG. 29, which is used when printed instructions including a health care services provider portion and a patient portion, each physically separate from the other, is included.
• the packaged catheter assembly 2901 having the tucked-in, separated health care services portion 3401 of the printed instructions is sealed in a packaging material.
• the packaging material of FIG. 36 is illustratively shown as a bag 2902.
• the separated patient portion 3501 of the optional printed instructions can be attached to or disposed upon the packaged catheter assembly 2901 as described in FIG. 35.
• the assembly can be sealed in a sterile wrap such as a bag 2902, which may be thermally or otherwise sealed.
• a sterile wrap such as a bag 2902, which may be thermally or otherwise sealed.
• the completed assembly 3001 is shown in FIGS. 30 and 37, where an outer packaging material is shown.
• the outer packaging material is a thermally sealed bag 2902.
• the thermally sealed bag 2902 optionally includes a preformed opening 3002.
• the preformed opening 3002 can include one or more tabs that a health care services provider is instructed to pull to open the bag 2902. Inclusion of a sterile wrap not only keeps the contents within the bag sterile, but also allows the printed instructions 1001 to be included with the tray assembly, yet outside the one or more layers of wrap material (2200).
• the printed instructions 1001 are disposed atop the one or more layers of wrap material 2200 such that the health care services portion of the printed instructions 1001 is disposed on the top of the printed instructions 1001, with the patient portion being disposed adjacent to the one or more layers of wrap material 2200.
• additional instruction materials may be included with the completed assembly as well.
• an adhesive instruction tag 1003 can be affixed to the bag 2902.
• FIGS. 38 and 39 illustrated therein are steps of method of assembling yet another embodiment of medical procedure kit in accordance with embodiments of the invention.
• the printed instructions are physically separated into a patient portion 3801 and a health care services provider portion 3802, as was the case in FIGS. 34-37.
• BPMDL0005JT.P4 PCT 10055U CIP4 PCT
• FIGS. 34-37 the embodiment of FIGS. 38 and 39 has the health care services provider portion 3802 configured as an adhesive label with the instruction tag 1003, configured here as a checklist and forming an extension thereof. Further, as will be shown in more detail in FIG. 40, the health care services provider portion 3802 has a picture of the contents of the medical procedure kit on the top, and has a peelable flap 3803 that may be opened to reveal instructions and other indicia therein.
• the patient portion 3801 is configured as a greeting card.
• Experimental testing has shown that when the patient portion is configured as an instruction or informational sheet, it is less likely that the patient portion will be delivered to the patient.
• the patient portion 3801 by configuring the patient portion 3801 as a greeting card, such as with a pleasant picture of flowers or similar objects on the front and stylized text providing the information therein, it is more likely to be given to the patient.
• the patient portion 3801 will be described in more detail below.
• FIG. 38 illustrated therein is an exploded view of a tray 100 suitable for use in a medical procedure kit.
• the tray 100 has the catheter assembly 700, a pair of syringes 701,702, and a specimen container 703 disposed therein. While only a specimen container 703 is shown as being disposed in the third compartment, note that additional items could also be included within the third compartment, including swab sticks. Other devices could also be inserted into the tray 100 in various compartments as well. For example, in one embodiment, a catheter securement device, and a Foley insertion tag can be inserted into the second
• the pair of syringes 701,702 can be configured as shown in FIG. 38, or alternatively can be both inserted in the first compartment, as described above.
• one syringe 702 is disposed laterally in the first opening 121 and the second Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) opening 122 of the first barrier 105 and second barrier 106, respectively.
• BPMDL0005JT.P4 PCT 10055U CIP4 PCT
• the tray can be enclosed with a wrap 1000.
• the wrap 1000 can be one or more layers in number, and further can be any of a number of types of material.
• the wrap 1000 comprises a CSR wrap.
• the CSR wrap 1000 is folded about the tray 100 for sealing, and can be correspondingly unfolded to reveal the tray 100 and other implements. Once unfolded, the CSR wrap 1000 can then be used in the catheter insertion process.
• an unfolded CSR wrap 1000 can be used to provide a sterile field in which the tray 100 sits for unloading and subsequent use. This process is explained in more detail in the discussion of FIGS. 22-30.
• Print instructions can then be attached to, disposed upon, or disposed within the tray
• the printed instructions are configured as a physically separate health care services portion 3802 and a patient portion 3801, as will be shown in more detail in FIGS. 40-41 below.
• the health care services portion 3802 can include instructions telling the health care services provider, for example, how to set up a sterile or otherwise clean work environment, how to prepare the catheter assembly 700 disposed within the tray, how to use the other devices within the tray, how to insert the catheter, how to secure the drainage bag to the catheter, how to empty the drainage bag, how to obtain a urine sample, and so forth.
• the instructions can include pictures or illustrations showing visually how the various steps should be done as well.
• the health care services portion 3802 is configured with an instruction tag 1003, which can be configured as a checklist and extends from the health care services portion 3802. Further, the health care services portion 3802 includes, in one
• a photograph of the contents disposed within the medical procedure kit When Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) viewing the health care services portion 3802 from the top, the health care services provider is able to easily inventory what contents are disposed therein.
• the health care services portion 3802 includes a peelable flap 3803.
• the health care services portion 3802 opens to reveal instructions and other information therein.
• the interior of the health care services portion 3802 can include one or more of the panels shown in FIGS. 15-19.
• the health care services portion 3802 may include an instruction for the health care services provider to give the patient portion 3801 to the patient, and in one embodiment, instructions to discuss the patient portion 3801 with the patient.
• the patient portion 3801 can include helpful suggestions or instructions for the patient.
• the patient portion 3801 can be configured as a greeting card to make the information more pleasantly received by a patient.
• suggestions or instructions that may be included in the patient portion include information on what a catheter is, what the patient should understand about the catheter, how to reduce the chance of getting an infection, information about infections commonly associated with catheters, symptoms of infections commonly associated with catheters, and suggestions for home use of the catheter assembly 700.
• the patient portion 3801 is disposed within the packaging
• the medical procedure kit of FIG. 38 can include an additional layer of wrap material 2701 disposed within one or more layers of wrap material 2200.
• the additional layer of wrap material 2701 can be configured to be visibly distinguishable from the one or more layers of wrap material 2200.
• the additional layer of wrap material 2701 is a different color than the one or more layers of wrap material 2200.
• the patient portion 3801 can be placed atop the additional layer of wrap material 2701.
• the package of liquid hand sanitizer (where used), the rubber gloves (where used), the additional layer of wrap material 2701, and the patient portion 3801 can be held in place by way of a final folding step 3805. Accordingly, they will be held in place by a folded portion 3806.
• the health care services provider will be readily able to access these implements after unfolding the folded portion 3806 shown in FIG. 38.
• the health care services portion 3802 can be affixed to the packaging 3804.
• packaging 3804 can optionally include a preformed opening.
• the opening can include one or more tabs that a health care services provider is instructed to pull to open the packaging 3804.
• FIG. 39 illustrated therein is the medical procedure kit 3901 of FIG. 38 having the patient portion 3802 tucked- into the one or more layers of wrap material 2200.
• the health care services portion 3802 is affixed to the packaging 3804.
• the packaging 3804 of FIG. 39 is illustratively shown as a thermally or adhesively sealed bag.
• FIGS 12-13 illustrated therein is one embodiment of the printed
• the printed instructions 1001 can be configured as an instruction manual suitable for inclusion with a tray (100) as described above.
• FIG. 12 illustrates a view of a first side of the instruction manual
• FIG. 13 illustrates a view of a second side of the instruction manual.
• the printed instructions 1001 are configured as a two-portion
• the patient portion 1202 is detachably coupled to the health care services portion 1201, and is thus separated from the health care services portion 1201, by a perforation 1203.
• the perforation 1203 can be a perforated line running Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) along a dimension of the printed instructions 1001 such that the printed instructions 1001 can be easily torn along the perforation 1203 to separate the patient portion 1202 from the health care services portion 1201.
• FIGS. 12 and 13 is but one illustrative embodiment of the invention.
• the patient portion 1202 need not be detachably coupled to the health care services portion 1201. As will be shown in FIGS. 27-34 below, the patient portion 1202 may be physically separate from the health care services portion 1201 as well. In the separated configuration, the health care services portion 1201 and patient portion 1202 can be disposed at different locations within a medical procedure kit.
• the printed instructions 1001 are configured as a plurality of panels
• the printed instructions 1001 can be configured as an instruction manual that is formed with an accordion- style fold, with each of the panels 1204,1205,1206,1301,1302,1303 forming a page of the instruction manual.
• panels 1204,1205 and panels 1301,1302 form the health care services portion 1201, while panels 1206,1303 form the patient portion.
• Panels 1206,1303 are separated from panels 1204,1205 and panels 1301,1302 by the perforation 1203 such that the patient portion 1202 is tearably separable from the health care services portion 1201.
• the health care services portion 1201 includes instructions 1304 for using the catheter assembly and other corresponding medical devices disposed within the accompanying tray.
• the instructions 1304 can include text and/or figures or illustrations showing how to use the catheter assembly and corresponding medical devices on the patient, as well as instructions on preparation, taking samples, preventing infection, and so forth.
• the instructions 1304, in one embodiment, also include an instruction to detach the patient portion 1202, give the patient portion 1202 to the patient, as well as an instruction to discuss the information disposed on the patient portion 1202 with the patient.
• the patient portion 1202 may also include instructions 1305 and/or helpful suggestions for the patient who is undergoing the catheterization procedure.
• this information can include any one or more of the following: a description of what a catheter is, what the patient should know about the catheter, how to reduce the chance of getting an infection from the catheterization procedure, what infections commonly associated with catheterization procedures typically are, the symptoms associated with infections commonly associated with catheterization procedures, and information about using the catheter at home.
• the patient portion 1202 may include custom information as well.
• the patient portion 1202 includes an informational section configured such that the health care service provider's name and contact information can be written thereon. It will be clear to those of ordinary skill in the art having the benefit of this disclosure that the invention is not so limited. For example, additional types of health care service instructions or patient instructions or suggestions can also be included.
• FIGS. 14-19 illustrated therein are exemplary panels
• 1204,1205,1206,1301,1302,1303 and the information printed thereon can be varied in any number of ways without departing from the spirit and scope of the invention as described herein and recited in the following claims.
• the number of panels can be varied.
• the information printed thereon can be condensed, expanded, or altered without departing from the spirit and scope of the invention. Also, the exemplary information may be moved from the panels shown to other panels, as a particular application may warrant.
• FIG. 14 illustrated therein is one exemplary panel 1204.
• panel 1204 will be configured such that when the catheter package assembly within Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) which the instruction manual is disposed is initially opened, panel 1204 will be readily viewable. For example, where the catheter package assembly is assembled as shown in FIG. 10 above, once the sterile wrap (1002) is removed, the panel 1204 will be viewable prior to removal of the CSR wrap (1000).
• Panel 1204 can include general information about the catheter assembly and
• this information can include part number information 1401, trade name information 1402, and manufacturer information 1403.
• a diagram 1404 of the contents of the package assembly may be included as well.
• the illustrative diagram 1404 of FIG. 14 illustrates a tray 100 having a catheter assembly 700 and corresponding medical devices disposed therein.
• the corresponding medical devices of this illustrative embodiment include a pair of syringes 701,702 and a specimen container 703.
• swab sticks 1408, a catheter securement deice 1409, a Foley insert tag 1410, vinyl gloves 1411, a fenestrated drape 1412, an underbuttocks drape 1413, and a hand sanitizer 1414 solution or wipe are disposed within the tray 100.
• panel 1204 can also include a written description 1407 of the elements included in the tray 100. Further, sterility information 1407 can be included. Panel 1204 can even include instructional material 1406 on how to use the instruction manual as well.
• FIG. 15 illustrated therein is one embodiment of panel 1301.
• the printed instructions (1001) are configured as an accordion-style folded instruction manual.
• panel 1301 can be disposed on the back of panel 1204. Panel 1301 will therefore be visible upon a health care services provider opening the instruction manual.
• Panel 1301 can include instructions for using the catheter assembly and the
• panel 1301 can Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) include instructions for setting up a clean work area.
• the instructions can include text, pictures, illustrations, or combinations of these.
• the instructions for setting up a clean work area include a hygiene performance step 1501, which may include instructions to wash hands, optionally put on gloves (which at this step can be non-sterile gloves), and so froth.
• the instructions may then include information on opening the remainder of the catheter package assembly.
• step 1502 indicates that the health care provider should remove the CSR wrap (1000), which in this case is folded about the tray (100). Note that in this illustrative embodiment, as the CSR wrap (1000) is folded about the tray (100), removal of the CSR wrap (1000) by unfolding creates a sterile field about the tray (100).
• Step 1503 then instructs the health care provide to pick up the underbuttocks of the
• Step 1504 then instructs the health care provider to use the hand sanitizing solution provided with the catheter package assembly.
• the various panels may include suggestions
• step 1301 includes instructions for preparing the catheter assembly (700) as well. For example, step
• Step 1506 instructs the health care services provider to don sterile gloves, as the hands were sanitized at step 1504.
• Step 1507 tells the health care services provider to place the fenestrated drape with a shiny side down on the patient without contaminating the sterile gloves donned at step 1506.
• Step 1508 instructs the health care services provider to test the balloon of the catheter assembly with Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) the water-filled syringe stored in the first compartment.
• Step 1508 also instructs the health care services provider to leave the syringe connected to the catheter assembly.
• Step 1509 then provides instructions on using the first compartment of the tray as a
• step 1509 instructs the health care services provider to inject the lubricating jelly found in the second syringe of the first compartment into the first compartment.
• step 1509 also instructs the health care services provider to pass the tip of the catheter through the first opening in the wall separating the first compartment and second compartment into the lubricating jelly, thereby lubricating the tip of the catheter.
• FIG. 16 illustrated therein is an exemplary embodiment of panel 1302.
• the instructions printed thereon continue to provide the health care services provider with information regarding use of the catheter assembly.
• this information includes instructions on inserting the catheter.
• the instructions direct the health care services provider to tear open the swab stick package and to use the swab sticks to clean the patient from the top down.
• the instruction also notes that each swab stick is intended for one use only to properly maintain the sterile field.
• Step 1602 directs the health care services provider to initiate the catheterization process by inserting the catheter assembly into the patient.
• Steps 1603 and 1604 continue this process as shown in FIG. 16.
• Step 1605 directs the health care services provider to secure the drainage bag to the
• Step 1606 directs the health care services provider to clean up upon completion of the catheterization process.
• Step 1607 provides instructions on completing the label on the Foley insertion tag included with the catheter package assembly and attaching it to the tubing or drain bag attached to the catheter assembly.
• step 1608 the health care services provider is instructed to detach the patient portion
• Step 1609 further instructs the health care services provider to discuss the patient information printed upon the patient portion (1202) with the patient. Step 1609 instructs that documentation of the entire procedure should be completed.
• FIG. 17 illustrate therein is one embodiment of panel 1303, which
• This panel 1303 represents a first side of the patient portion (1202).
• This panel 1303 includes information 1701 describing what a catheter is and why a catheter might be used.
• the panel 1303 also includes information 1702 describing what the patient should know regarding catheters and catheter use. For example, this information 1702 might notify the patient that the health care services provider should wash hands prior to inserting the catheter, and that it is acceptable to ask them to do so if they have not done so before the patient.
• the panel 1303 also includes information 1703 regarding how the patient can reduce the chances of getting an infection.
• This information 1703 can include a statement that the patient should wash their hands prior to touching the catheter assembly.
• the information 1703 may also include a statement that the drainage bag should always be kept at a level beneath the patient's navel, and that the patient should inform a helper when the bag is more than half full.
• FIG. 18 illustrated therein is one embodiment of panel 1206. In this case
• panel 1206 forms the second side of the patient portion (1202) of the instruction manual, and accordingly, includes additional information that a patient may wish to know when using a catheter assembly.
• information 1801 informs the patient as to what common infections associated with catheter use are and how they are contracted.
• Information 1802 provides symptoms of these common infections, such as fever, blood in the urine, burning or painful Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) urination, or frequent or more urgent urination after catheter removal.
• Information 1803 informs the patient of what they should know prior to going home after a catheter procedure.
• Information 1804 comprises an informational section configured such that a health care provider's name and contact information may be written thereon. This is helpful to the patient in the event that the symptoms recited in information 1802 should arise after the procedure, in that the patient has readily available access to the information required to contact a physician or other health care provider.
• An advantage of having this information 1804 on the patient portion (1202) when the patient portion (1202) is detachable is that the patient can take it with them upon completion of the procedure.
• FIG. 19 is a portion of the health care services portion (1201), illustrated therein is one embodiment of panel 1205 that provides additional health services information.
• information 1901 for emptying the drain bag and information 1902 describing how to obtain a urine sample can be included.
• FIG. 20 illustrated therein is one physical configuration in which the printed instructions 1001 can be delivered along with the catheter package assembly in accordance with embodiments of the invention.
• FIG. 20 is but one of many configurations, and embodiments of the invention are not to be limited in this respect, as FIG. 20 is illustrative only.
• the printed instructions 1001 are configured as a tri-section, accordion style bi-folded panel. Three sections 2000,2001,2002 are folded in an accordion style, with two folds 2003,2004 existing between the sections 2000,2001,2002.
• folding the printed instructions 1001 in this manner allows the health care services portion 1201 to be disposed atop the patient portion 1202. Further, when the printed instructions are disposed atop a CSR wrap (1000) as shown in FIG.
• the health care services provider Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) removing the sterile wrap (1002) off of the catheter package assembly will be assured of seeing the health care services portion 1201 first.
• FIG. 40 illustrated therein is another embodiment of printed instructions
• the printed instructions 4000 of FIG. 40 include a printed label 4401 and a peelable label 4402.
• the peelable label 4402 is separable from the printed label 4401.
• the printed label 4401 is configured as a booklet, with a peelable flap formed by at least one page that is peelable from at least another page.
• the peelable label 4402 is separable from the printed label 4401 such that the peelable label 4402 may be removed and attached to medical records while the printed label stays affixed to outer packaging or an outer wrap of a medical procedure kit.
• the peelable label 4402 includes a red banner 4006 and one or more yellow panels 4007.
• the red banner 4006 is configured as a warning label.
• the one or more yellow panels 4007 are configured with checkable boxes corresponding to elements associated with the warning on the red banner 4006.
• the printed instructions 4000 are configured for use with a catheter tray assembly.
• the red banner 4006 includes information relating to usage of a catheter assembly.
• the warning message in FIG. 40 includes information 4403 questioning whether there is a valid reason for using the catheter tray assembly. Specifically, this information 4403 recites the warning "Stop,” followed by the question "Is there a valid clinical reason [for using the catheter assembly]?"
• the medical conditions that, where present, would provide a reason for using the catheter tray assembly. Each of these medical conditions has a white, markable square thereby.
• the medical conditions read "Select surgical procedures," "Prolonged Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) immobilization,” "End-of-life care,” “Acute urinary retention or obstruction,” “Precise measurement of urinary output,” and "Open wounds in incontinent patient.” These conditions are illustrative only, as others will be readily apparent to those of ordinary skill in the art having the benefit of this disclosure. Further, the conditions in the illustrative embodiment of FIG. 40 correspond to catheter use. Where the medical procedure kit is something other than a catheter kit, other conditions will be more appropriate for listing in the yellow panel 4007.
• the white, markable squares By providing the white, markable squares, a medical services provider is able to mark with a pen or pencil which condition justifies the use of the medical procedure kit.
• the peelable label 4402 is configured for detachment from the printed label 4401 and attachment to medical records. Accordingly, the white, markable squares permit a nurse, doctor, or other medical services provider to create procedure-specific medical records without the need of obtaining specialized forms.
• the peelable label 4402 of FIG. 40 includes a red banner 4006 set against one or more yellow panels 4007.
• Experimental testing has shown that this particular color combination works as an "attention getter” for medical professionals in that they easily recognize this color combination. Further, the use of red serves as a mnemonic that a warning is present. Experimental testing has shown that the color yellow works as a mnemonic for a to-do list.
• white for the markable squares works to make them easily identifiable. Further, markings therein are easily visible and capable of photocopying where necessary without degrading the medical service provider's writing.
• the red banner 4006 also includes
• the information 4404 indicating that a checklist corresponding to the use of the medical procedure kit is provided.
• the information 4404 corresponds to the use of a catheter, and reads "Check: Insertion Checklist.”
• the steps include "Obtain order form from physician/provider,” “Document clinical reason for insertion,” “Use the smallest catheter possible,” “Follow aseptic technique,” “Explain procedure to the patient,” “Perform hand hygiene,” and “Provide patient education.” These steps are illustrative only, as others will be readily apparent to those of ordinary skill in the art having the benefit of this disclosure. Further, the steps of the illustrative embodiment of FIG. 40 correspond to catheter use. Where the medical procedure kit is something other than a catheter kit, other steps will be more appropriate for listing in the yellow panel 4007.
• each of the steps is provided with a white, markable square thereby.
• a medical services provider is able to mark with a pen or pencil which steps were completed so that a physician or other person may review the steps at a later time.
• the white, markable squares permit a nurse, doctor, or other medical services provider to create procedure-specific medical records without the need of obtaining specialized forms.
• the peelable label 4402 includes red text 4405 indicating that the peelable label 4402 is configured for attachment to corresponding medical records. Further, a red symbol 4406 indicating a location at which a user can peel the peelable label 4402.
• the printed label 4401. can be configured as a booklet with at least one page that is configured to be peeled away from at least another page to reveal pictorial, step-by-step instructions for using the medical procedure kit.
• an outer page of the printed label 4401 includes a color photograph
• the color photograph 4003 is disposed on a panel beneath a color banner 4004 comprising a description of the medical assembly.
• the colored banner 4004 is either purple or blue, while the panel is black to emphasize the contents shown in the color photograph 4003.
• a textual listing 4407 of the medical assembly and corresponding implements disposed within the medical procedure kit is provided in the black panel.
• the printed label 4401 is configured as a booklet comprising at least one peelable flap that, when opened, reveals instructional material corresponding to usage of the medical kit therein
• at least one page can be configured to be longer than at least another page so as to have a portion 4005 extending beyond the at least another page so as to be visible when the booklet is closed.
• a bottom page extends beyond the top page having the color photograph 4003 disposed thereon, so as to reveal the portion 4005.
• the portion 4005 is configured to be yellow so as to be set off from the black panel disposed beneath the color photograph 4003.
• the portion 4005 comprises an indication instructional material is disposed within the booklet.
• this indication is configured as black text disposed atop a yellow banner.
• the portion 4005 works to identify the printed label 4401 as being a booklet, and further provides notice that more information is located within the printed instructions 4000.
• the additional information which can be one or more of the panels shown in FIGS. 15-19 above, can be accessed by a peelable flap.
• FIG. 41 illustrated therein is one embodiment of a medical procedure kit
• the printed instructions 4001 includes instructional information describing how to use the medical assembly and corresponding implements disposed within the Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) medical procedure kit.
• BPMDL0005JT.P4 PCT 10055U CIP4 PCT
• Experimental testing has shown that placement of the printed instructions 4001 on the outer packaging 4101 can be superior to placing the instructions within the outer packaging 4101 for a variety of reasons.
• One illustrative reason is that patients may be less comfortable when a medical services provider is reading the instructions corresponding to the use of the medical assembly in front of a patient.
• the medical procedure kit is sterile when sealed within the outer packaging 4101.
• the outer packaging 4101 must be opened at the procedure site to avoid contamination in some situations. Accordingly, when the printed instructions 4001 is disposed within the outer packaging 4101, a medical services provider must read the instructions in front of a patient. Adhesively affixing the printed instructions 4001 to the outside of the outer packaging 4101 allows a medical services provider to refresh her memory as to the instructions without making a patient uncomfortable.
• the medical procedure kit 4100 can be manufactured in a variety of ways. In one
• the medical procedure kit 4100 is made by the following method: First, a manufacturer provides a tray configured to receive a medical assembly and corresponding implements. Next, the manufacturer disposes the medical assembly and the corresponding implements in the tray. Then, the manufacturer encloses the tray with the outer packaging 4101. Next, the manufacturer affixes the printed instructions 4001 to the outer packaging 4101.
• FIGS. 43 and 44 illustrated therein are one embodiment of instructional material 4202 suitable for inclusion in the booklet where the booklet is configured for use with a catheter assembly.
• the instructional material 4202 comprises pictorial, step- by-step instructions for using the medical procedure kit.
• the illustrative instructional material 4202 of FIGS. 43 and 44 is similar to that shown and described with reference to FIGS. 15, 16, and 19 above.
• Those of ordinary skill in the art having the benefit of this disclosure will appreciate that other types of medical procedure kits may include different instructions.
• the instructional material 4204 is presented in a colored, columnar format.
• the columnar format of FIG. 43 includes four columns 4301,4302,4303,4304.
• the columnar format of FIG. 44 includes four columns
• Each columnar format includes a heading banner 4305,4445 indicating a concept to which the pictorial steps below relate. Experimental testing has shown that such a columnar format is highly successful in quickly and accurately delivering the series of steps to a medical services provider.
• the columnar format employs alternating colors. Said differently, when viewing the columns, 4301 ,4302,4303,4304,4441 ,4442,4443,4444, any two adjacent columns have different colors.
• the illustrative colors of FIGS. 43 and 44 are blue and white. For example, column 4301 is blue, while column 4302 is white. It is contemplated that the blue color can be substituted with green or grey as well.
• the heading banners 4305,4445 alternate color as well in this illustrative embodiment. As shown in FIGS. 43, and 44, blue columns 4301,4303,4441,4443 have black heading banners 4305,4445, while white columns 4302,4304,4442,4444 have blue heading banners 4305,4445. Where grey or green is substituted for blue, white columns 4302,4304,4442,4444 may have grey or green heading banners 4305,4445.
• the solitary exception in the illustrative embodiment of FIGS. 43, and 44 is segment 4446. This segment 4446 relates to the prevention of injury or infection in the patient. Accordingly, it is given a higher priority and a differently colored heading banner. In the illustrative embodiment of FIG. 44, the segment 4446 appears red.
• a medical services provider 4203 is peeling 4503 away the
• peelable label 4402 from the printed instructions 4000.
• the peelable label 4402 once separated from the printed instructions 4000, appears in FIG. 46. Once separated, in one embodiment the peelable label 4402 is suitable for attachment to medical records as described above.
• FIG. 47 illustrated therein is one embodiment of a patient portion 3801 configured as a greeting card as was described with FIGS. 38-39.
• the patient portion 3801 in this illustrative embodiment includes an inspirational phrase 4703 on the front cover, along with an aesthetically pleasing image 4701.
• the aesthetically pleasing image 4701 of FIG. 47 is a vase of flowers, although it will be clear to those of ordinary skill in the art having the benefit of this disclosure that embodiments of the invention are not so limited. Other aesthetically pleasing images include puppies, sunsets, mountain streams, and so forth.
• the bottom of the patient portion 3801 includes in identifier 4703 that tells the patient the purpose of the patient portion 3801.
• the interior of the patient portion 3801 can include text.
• the interior includes the following illustrative text:
• the catheter helps:
• CAUTI urinary tract infection
• the above information on the patient portion 3801 can be printed in multiple languages, such as in Spanish or in English. Where two languages are used, the back portion may be the same as the image shown in FIG. 47, but with the inspirational phrase 4702 and identifier 4703 set forth in a different language. Further, alternatives and variations of the information can be substituted for the example set forth above.
• FIG. 21 illustrated therein is a method 2100 of using the printed
• a health care services provider removes the sterile wrap (1002) disposed about the catheter package assembly.
• the catheter package assembly is configured as shown in FIG. 10, removal of the sterile wrap (1002) will reveal the printed instructions (1001).
• the printed instructions (1001) are configured as described in Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT)
• FIG. 20 with the patient portion (1202) disposed adjacent to the CSR wrap (1000), the health care services provider will see the health care services portion (1201) first.
• the health care services provider accesses the printed instructions (1001) and begins to read the panels, which in one embodiment are panels configured in accordance with those described in FIGS. 14-19 above.
• the health care services provider unfolds the outer CSR wrap (1000), which in one embodiment is then used to create a sterile field about the tray (100).
• the health care services provider prepares the workspace, which in one embodiment may be in accordance with steps (1501,1502,1503,1504) of panel (1301) in FIG. 15. For example, this may include donning non-sterile gloves, as shown at step (1501) of FIG. 15. This may further include picking up the underbuttocks drape, included with the tray (100), by the edge without contaminating the contents and placing the shiny side down under the area of the patient to be prepped as shown at step (1503) of FIG. 15. This may further include using the hand sanitizer as shown at step (1504 of FIG. 15.
• the health care services provider prepares the catheter, which in one
• embodiment may be in accordance with steps (1506,1507,1508,1509) of panel (1301) as described in FIG. 15.
• this can include donning sterile gloves as shown at step
• This may include placing a fenestrated drape, included with the tray (100), with the shiny side down on the patient without contaminating the sterile gloves, as shown at step
• This may include filling a test balloon of the catheter assembly with water as shown at step (1508) of FIG. 15, and injecting lubricating jelly from a syringe into the first compartment of the tray (100) as shown at step 1509 of FIG. 15.
• the health care services provider inserts the catheter.
• this can be in accordance with steps (1601,1602,1603,1604) of panel (1302) as described in FIG. Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT)
• the health care provider secures the drain bag to the catheter assembly, which can be in accordance with steps (1605,1606,1607) described with respect to FIG. 16.
• the health care services provider detaches the patient portion (1202) of the printed instructions (1001) from the health care services portion (1201). In one embodiment, this occurs by tearing the patient portion (1202) from the health care services portion (1201) along the perforation (1203), thereby transforming the printed instructions (1001) or instruction manual from a singular or unitary object into a two-piece object consisting of the patient portion (1202) and the health care services portion (1201). As described, above, the health care services provider may then discuss the patient portion (1202) with the patient and further give the patient portion (1202) to the patient to take home after the procedure.
• FIGS. 31, 32, and 33 illustrated therein is one embodiment of a method of using the packaged catheter assembly 2901 of FIG. 29.
• a health care services provider 3101 opens the outer bag 2902 that is disposed about the tray 100 and removes the bag 2902 to reveal the packaged catheter assembly 2901 therein.
• the health care services provider 3101 can then access the printed instructions 1001 that are disposed atop the packaged catheter assembly 2901 in this illustrative embodiment.
• the health care services provider 3101 can then unfold the one or more layers of wrap material 2200. Where an additional layer of wrap material 2701 is included, this unfolding step reveals and makes accessible the additional layer of wrap material 2701. Note that portions of the additional layer of wrap material 2701 may be visible, as shown in FIG. 29, prior to the steps of unfolding.
• the one or more layers of wrap material 2200 can be unfolded to form a sterile field.
• FIG. 32 illustrated therein is a step of the method that utilizes this sterile field.
• the health care services provider 3101 places the one or more layers of wrap material 2200 beneath the patient 3201, thereby transforming the Attorney Docket No.: BPMDL0005JT.P4 PCT (10055U CIP4 PCT) area beneath the patient from a non-sterile field to a sterile field.
• the patient is effectively moved from a location that may have not been a sterile field to the sterile field atop the one or more layers of wrap material 2200.
• FIG. 33 illustrated therein is a step of the method that may be used when an additional layer of wrap material 2701 is included with the packaged catheter assembly 2901.
• the health care services provider 3101 is placing the additional layer of wrap material 2701 atop the patient 3201.
• the additional layer of wrap material 2701 is fenestrated, in that it includes a perforated opening 3301 suitable for performing a catheterization procedure.

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• 2011
  • 2011-12-30 EP EP11854003.8A patent/EP2658467A4/de not_active Ceased
  • 2011-12-30 CA CA2822905A patent/CA2822905A1/en not_active Abandoned
  • 2011-12-30 WO PCT/US2011/068193 patent/WO2012092598A2/en active Application Filing
  • 2011-12-30 CN CN201180066491.4A patent/CN103370026B/zh active Active
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