US20190160261A1 - Safety Needle Set For Delivering Fluid To An Access Port - Google Patents
Safety Needle Set For Delivering Fluid To An Access Port Download PDFInfo
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- US20190160261A1 US20190160261A1 US16/264,375 US201916264375A US2019160261A1 US 20190160261 A1 US20190160261 A1 US 20190160261A1 US 201916264375 A US201916264375 A US 201916264375A US 2019160261 A1 US2019160261 A1 US 2019160261A1
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- needle
- safety
- pad
- assembly
- wing
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- 0 C1C2=CCN2*1 Chemical compound C1C2=CCN2*1 0.000 description 1
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- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
- B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
- B32B37/14—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
- B32B37/142—Laminating of sheets, panels or inserts, e.g. stiffeners, by wrapping in at least one outer layer, or inserting into a preformed pocket
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
- B32B37/14—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers
- B32B37/16—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating
- B32B37/18—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating involving the assembly of discrete sheets or panels only
- B32B37/182—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the properties of the layers with all layers existing as coherent layers before laminating involving the assembly of discrete sheets or panels only one or more of the layers being plastic
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1581—Right-angle needle-type devices
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- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
- A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve
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- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3256—Constructional features thereof, e.g. to improve manipulation or functioning having folding ring sections
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- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
- A61M2025/0273—Holding devices, e.g. on the body using pads, patches, tapes or the like having slits to place the pad around a catheter puncturing site
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- 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
- A61M2209/00—Ancillary equipment
- A61M2209/04—Tools for specific apparatus
- A61M2209/045—Tools for specific apparatus for filling, e.g. for filling reservoirs
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- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0208—Subcutaneous access sites for injecting or removing fluids
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3275—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
Abstract
A safety needle set for delivering fluid to an access port, the safety needle set having insertion and safety configurations. The safety needle set includes a needle assembly and a base assembly. The needle assembly includes a needle having a distal end with a non-coring tip, the distal end angled with respect to a proximal end of the needle. The needle assembly also includes a pair of foldable wings coupled to the needle, including a first wing and a second wing. The first wing may have a recess, and the second wing may have a protrusion, such that when the first wing contacts the second wing in a wing folded configuration, the recess receives the protrusion. The base assembly includes a housing, a safety needle assembly at least partially disposed in an interior of the housing, and an interface pad coupled to a bottom surface of the housing.
Description
- This application is a division of U.S. patent application Ser. No. 14/789,341, filed Jul. 1, 2015, which claims priority to U.S. Provisional Application No. 62/019,807, filed Jul. 1, 2014, and which is a continuation-in-part of U.S. patent application Ser. No. 14/070,246, filed Nov. 1, 2013, which claims priority to U.S. Provisional Application No. 61/721,412, filed Nov. 1, 2012, and which is a continuation-in-part of U.S. patent application Ser. No. 13/229,573, filed Sep. 9, 2011, now U.S. Pat. No. 9,248,234, which claims priority to U.S. Provisional Application No. 61/381,762, filed Sep. 10, 2010. Each of the foregoing applications is incorporated herein by reference in its entirety.
- Briefly summarized, embodiments of the present invention are directed to a safety needle assembly of an infusion set for infusing fluids into a subcutaneously implanted access port. The needle assembly is configured to prevent fluid escape therefrom so as to reduce or prevent fluid exposure to a clinician using the needle assembly.
- In one embodiment, the needle assembly comprises a handle portion including a needle extending therefrom, the needle defining a lumen for passage of a fluid therethrough. The needle assembly also includes a safety assembly defining a needle hole through which the needle initially extends. The safety assembly is axially slidable along the needle in order to shield a distal tip of the needle and prevent user contact therewith. A fluid isolation component is included in the safety assembly for isolating fluid escape from the needle to prevent exposure to a clinician.
- In one embodiment, a self-sealing pad is included on the safety assembly base through which the needle initially penetrates. When it is later shielded by the safety assembly after use, the needle is also retracted back through the self-sealing pad. The pad prevents any fluids that may have leaked from the distal opening of the needle from passing through the pad and escaping the needle assembly, thus preventing unintended exposure to the clinician.
- In another embodiment, an interface pad is included on a bottom portion of the needle assembly and includes an antimicrobial and/or haemostatic agent to protect the needle insertion site. In yet another embodiment, the interface pad is included on a hub of a catheter assembly, or on a suitable portion of other medical devices, to protect the needle insertion site.
- These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter.
- A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
-
FIG. 1 is a perspective view of an infusion set including a safety needle assembly according to one embodiment; -
FIG. 2 is a side view of the needle assembly ofFIG. 1 ; -
FIGS. 3A-3C show actuation of needle assembly ofFIG. 1 ; -
FIG. 4 shows a perspective view of an infusion set including a safety needle assembly in a first configuration according to one embodiment; -
FIG. 5 shows a perspective view of the infusion set ofFIG. 4 with the safety needle assembly in a second configuration; -
FIGS. 6A-6C show actuation of the safety needle assembly ofFIGS. 4 and 5 ; -
FIGS. 7A-7C shows actuation of a safety needle assembly according to another embodiment; -
FIGS. 8A and 8B show a bottom view of a safety needle assembly including a fluid isolation component according to one embodiment; -
FIGS. 9A and 9B are cross sectional side views of a safety needle assembly including a fluid isolation component according to one embodiment; -
FIG. 10 is a cross sectional side view of a safety needle assembly including a fluid isolation component according to one embodiment; -
FIG. 11 is a perspective view of a safety needle assembly according to one embodiment; -
FIGS. 12A and 12B are bottom views of the safety needle assembly ofFIG. 11 ; -
FIG. 13 is a top view of a shutter of the safety needle assembly ofFIG. 10 , including a fluid isolation component according to one embodiment; -
FIG. 14 is a perspective view of the shutter ofFIG. 13 including the fluid isolation component; -
FIG. 15 is a cross sectional side view of a safety needle assembly according to one embodiment; -
FIGS. 16A and 16B are various views of a safety needle assembly according to one embodiment; -
FIG. 17 is a cross sectional side view of a luer connector including a fluid isolation component according to one embodiment; -
FIGS. 18A-18B are cross sectional side views of the luer connector ofFIG. 17 during use; -
FIGS. 19A and 19B show various views of a fluid isolation component together with an infusion set, according to one embodiment; -
FIG. 20 is a bottom view of a safety needle assembly including a fluid isolation component according to one embodiment; -
FIGS. 21A and 21B are various views of a needle assembly including a self-sealing pad according to one embodiment; -
FIGS. 22A and 22B are various views of the self-sealing pad ofFIGS. 21A and 21B ; -
FIGS. 23A and 23B are various views of the needle assembly ofFIGS. 21A and 21B ; -
FIG. 24 is a perspective view of a self-sealing pad according to one embodiment; -
FIG. 25 is a perspective view of a plurality of catheters including an interface pad according to one embodiment; -
FIGS. 26A and 26B are side views of a catheter including an interface pad according to one embodiment; -
FIGS. 27A and 27B are various views of an interface pad according to one embodiment; -
FIGS. 28A and 28B are various views of an interface pad according to one embodiment; -
FIGS. 29A and 29B are various views of an interface pad according to one embodiment; -
FIG. 30 is a side view of a catheter including an interface pad according to one embodiment; -
FIG. 31 is a side view of a catheter including an interface pad according to one embodiment; -
FIG. 32 is a side view of a strip of antimicrobial foam for use as an interface pad according to one embodiment; -
FIG. 33 is a side view of a catheter including an interface pad according to one embodiment; -
FIG. 34 is a side view of a catheter including an interface pad according to one embodiment; -
FIG. 35 is a cross sectional side view of the catheter and interface pad ofFIG. 34 ; -
FIGS. 36A and 36B are various views depicting one method for forming an interface pad according to one embodiment; -
FIG. 37 is a side view of a catheter including an antimicrobial interface according to one embodiment; -
FIG. 38 is a perspective view of an infusion set including an interface pad according to one embodiment; -
FIGS. 39A-39D are various views of portions of the infusion set ofFIG. 38 ; -
FIGS. 40A-40E are various views of an infusion set including an interface pad according to one embodiment; and -
FIG. 41 is a partial cross-sectional side view of the infusion set ofFIGS. 40A-40E operably connected to an implanted access port according to one embodiment. - Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale.
- For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a needle placed within the body of a patient is considered a distal end of the needle, while the needle end remaining outside the body is a proximal end of the needle. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”
- Embodiments of the present invention are generally directed to a safety infusion set and accompanying needle assembly for infusing fluids, such as chemotherapy agents or other medicaments for example, into an access port or other medical device subcutaneously implanted into the body of a patient. The infusion set and/or needle assembly includes one or more components for isolation of the fluid, including vapors thereof, which may otherwise leak from a needle or other portion of the infusion set. This in turn reduces or prevents possible clinician exposure to the fluid/vapors, which in some cases may be hazardous. Potential harm to the clinician is therefore reduced.
- Reference is first made to
FIG. 1 , which depicts an infusion set generally designated at 10, including a safety needle assembly (“needle assembly”) 20 and one ormore extension legs 24. The infusion set 10 is employed to gain access to a subcutaneously implanted access port or other device disposed below the skin of a patient in order to infuse medicaments or other fluids into the patient, and to withdraw fluids therefrom. Aluer connector 26 is included on a proximal end of theextension leg 24 so as to enable the infusion set 10 to be placed into fluid communication with a fluid delivery device or system. Acap 28 can be disposed in theluer connector 26 to cover the opening thereof. -
FIG. 1 shows that theneedle assembly 20 includes aneedle 30 extending from ahandle 44 and in fluid communication with the tubing of theextension leg 24. Aneedle safety component 40 is also included in theneedle assembly 20, including dual extensible wings that are hinged so as to be selectively extended to substantially cover the length of theneedle 30 and isolate adistal end 30A thereof after use of theneedle assembly 20 in order to prevent an unintended needle stick of the clinician by the needle tip. Examples of such a hinged safety assembly can be found in U.S. Pat. No. 5,951,522, which is incorporated herein by reference in its entirety. - As best seen in
FIG. 2 , theneedle assembly 20 further includes afluid isolation component 50 for isolating any fluid or vapor that may unintentionally escape from theneedle 30 during use of the needle assembly. Specifically, thefluid isolation component 50 in the present embodiment includesabsorbent pads 52 disposed on aninner surface 42A of eachwing 42 of theneedle safety component 40. Thepads 52 are disposed such that when thewings 42 of theneedle safety component 40 are deployed to cover thedistal tip 30A of the needle 30 (FIG. 2 ), the pads sandwich the body and distal tip of the needle therebetween. Any fluid present on an external surface of the needle or any fluid/vapor leaking from the distal end thereof is captured and absorbed by thepads 52, thus preventing escape of the fluid, which as mentioned above may contain hazardous substances. This in turn protects the clinician from fluid exposure. -
FIGS. 3A-3C show the manner in which thewings 42 of theneedle safety component 40 extend to cover theneedle 30 and itsdistal tip 30A, and additionally the manner in which thepads 52 sandwich and partially encapsulate theneedle 30, including its external surfaces and itsdistal tip 30A, to prevent fluid/vapor escape. In one embodiment, thepads 52 can include an absorbent foam and/or rubber material, though many other suitable materials can be employed, including activated charcoal, etc. -
FIGS. 4 and 5 show the infusion set 10 including aneedle assembly 120 according to another embodiment, wherein the needle assembly includes ahandle portion 122 withhandles 124 extending therefrom. Aneedle 130 extends from thehandle portion 122 and initially through asafety assembly 134 that is slidably disposed with respect to theneedle 130 so as to be axially slidable therewith. Thesafety assembly 134 includes a base 136 that houses a needle safety component 140 (FIGS. 8A, 8B ) for shielding adistal tip 130A of theneedle 130 when use of the needle assembly is complete. - The
needle assembly 120 further includes afluid isolation component 150 for isolating any fluid or vapor that may unintentionally escape from theneedle 130 during use of the needle assembly. Specifically, thefluid isolation component 150 in the present embodiment includes a conically shaped,extensible shroud 152 disposed about the body of theneedle 130 and extending between thehandle portion 122 and the axiallyslidable safety assembly 134. Including plastic such as PET or other substantially impermeable, collapsible, and suitable durable material, theshroud 152 forms a hollow cone about theneedle 130 and is corrugated withcorrugations 154 in a bellows-like manner to enable it to fold up compactly when thesafety assembly 134 is undeployed (FIG. 4 ) and to extend to cover and substantially encompass theneedle 30 when thesafety assembly 134 is deployed (FIG. 5 ), i.e., the safety assembly is axially slid down theneedle 130 toward thedistal tip 130A such that theneedle safety component 140 shields the distal tip.FIGS. 6A-6C depict the manner of deployment of thesafety assembly 134 and the extension of thecorrugated shroud 152. In the extended state shown inFIGS. 5 and 6C , theshroud 152 assists in isolating fluids/vapors present on theneedle 130 or emitted from the needledistal tip 130A from contact with the clinician. - Note that examples of safety needles that can utilize principles discussed here and in other embodiments herein can be found in the following United States patents: U.S. Pat. Nos. 7,717,888; 8,066,678; 8,597,253; and 8,231,582. Each of the afore-mentioned patents is incorporated herein by reference in their entirety.
- The
shroud 152 as thefluid isolation component 150 can include other configurations. One such configuration is shown inFIGS. 7A-7C , wherein the shroud includes a plurality of interlocked, telescoping segments that are extendible to cover and encompass the needle body when thesafety assembly 134 is deployed (FIG. 7C ). When thesafety assembly 134 is undeployed, thetelescoping segments 156 are stacked together, as shown inFIG. 7A . Again, these and other configurations for encompassing the needle body illustrate manners by which a fluid isolation component can isolate the needle body and tip in order to prevent fluid exposure to clinician. -
FIGS. 8A and 8B depict details of theneedle safety component 140 of theneedle assembly 120 ofFIGS. 4-7C . Particularly,FIGS. 8A and 8B depict bottom views of theneedle assembly 120. Theneedle safety component 140 is shown, including a coiledwire torsion spring 160 included within thebase 136 of thesafety assembly 134. The spring includes at one end thereof an obstruction component, i.e., a loopedportion 162 that is biased to lie against theneedle 130 when the needle extends through ahole 136A defined in thebase 136 of thesafety assembly 134, as shown inFIG. 8A . As shown inFIG. 8B , once the distal tip of theneedle 130 is withdrawn into the base 136 in connection with extension of the safety assembly 134 (e.g.,FIGS. 5, 6C, 7C ), thespring 160 expands such that the loopedportion 162 slides over theneedle hole 136A to prevent re-emergence of the needle distal tip. - In addition, a
fluid isolation component 170 is included with thespring 160 for isolating any fluid or vapor that may unintentionally escape from theneedle 130 during use of the needle assembly. Specifically, thefluid isolation component 170 includes ashield 172, shown inFIGS. 8A and 8B , which is attached proximate the loopedportion 162 of thespring 160. Thus, when the loopedportion 162 slides over to prevent re-emergence of thedistal tip 130A of theneedle 130 through thehole 136A (FIG. 8B ), the shield fully covers and occludes the hole so as to prevent any fluid/vapor leaking from the distal tip of the needle from exiting through the hole and potentially contaminating the environment or clinician. Theshield 172 thus serves to occlude thehole 136A and isolate any fluids/vapors from the clinician. Note that the particular size, shape, and configuration of the shield can vary from what is shown and described herein, as can the particular configuration of the needle assembly. In one embodiment, it is appreciated that the shield can include an absorbent material so as to absorb any leaked fluid. -
FIGS. 9A and 9B depict details of theneedle assembly 120 according to another embodiment, including afluid isolation component 180 for isolating any fluid or vapor that may unintentionally escape from theneedle 130 during use of the needle assembly. As shown, thefluid isolation component 180 in the present embodiment includes acylindrical absorption plug 182 included with the axiallyslidable safety assembly 134 of theneedle assembly 120 and including a central cavity so as to be positioned about a portion of the body of the needle 130 (FIG. 9A ). The central cavity of theplug 182 is sized such that the plug is able to wipe the outer surface of the body of theneedle 130 as thesafety assembly 134 is axially slid down the needle toward thedistal tip 130A thereof, thus removing fluid from the outer needle surface and capturing it in the plug itself. In addition, once thesafety assembly 134 has fully shielded the needledistal tip 130A (FIG. 9B ), theplug 182 is positioned about the distal opening of the lumen of theneedle 130 so as to catch and absorb any fluids/vapors emanating therefrom. - It is appreciated that the absorption plug can include a variety of size, type, and material configurations, and can be employed on a variety of needle-based devices where residual fluid/vapor capture is desired. In one embodiment, for instance, the absorption member includes activated charcoal. In other embodiments, other materials and membranes can be employed, including silica gel, clays, activated alumina, zeolites, 0.2 micron or other filtration material, etc. The description included herein is therefore not intended to limit the present disclosure in any way.
-
FIG. 10 shows details of afluid isolation component 200 according to another embodiment, including anabsorption disk 202 included with thesafety assembly 134. Theabsorption disk 202 is disposed above theneedle safety component 140 in thesafety assembly base 136 and is slit to enable theneedle 130 to pass therethrough. Extension of thesafety assembly 134 down the length of theneedle 130 enables theabsorption disk 202 to wipe the outer needle surface so as to remove any fluid present thereon. In addition, once thesafety assembly 134 is fully extended to shield the needle 130 (FIG. 10 ), theabsorption disk 202 is positioned so as to absorb any fluid/vapor leaking from the distal lumen opening at the needledistal tip 130A. As with the previous embodiment, theabsorption disk 202 in one embodiment includes activated charcoal or other suitable, absorbent material as outlined above in connection with theabsorption plug 182 shown inFIGS. 9A and 9B . The position, shape, thickness or other configuration of the absorption disk can vary from what is shown and described herein. -
FIGS. 11-12B depict various details of aneedle assembly 220 that can include a fluid isolation component, according to one embodiment. As shown, theneedle assembly 220 includes ahandle portion 222 from which extends aneedle 230. Theneedle 230 initially extends through asafety assembly 234 that is slidably disposed with respect to the needle so as to be axially slidable therewith. Thesafety assembly 234 includes a base 236 that houses a needle safety component 240 (FIGS. 12A, 12B ) for shielding adistal tip 230A of theneedle 230 when use of the needle assembly is complete. - In greater detail,
FIGS. 12A and 12B show that theneedle safety component 234 includes two spring-basedshutters 242 that each define ahole 244 through which theneedle 230 passes when the needle extends through thesafety assembly 234 and out ahole 236A defined in thebase 236, such as in the configuration shown inFIG. 11 . Theshutters 242 each further include aspring arm 246. As seen inFIG. 12A , when thesafety assembly 234 is undeployed (FIG. 11 ), theholes 244 of theshutters 242 are aligned so that theneedle 230 passes therethrough. This constrains theshutters 242 andspring arms 246 into the configuration shown inFIG. 12A . - When the
safety assembly 234 is actuated, however, it is slid down the length of theneedle 230 so as to cause the needledistal tip 230A to recede from thehole 236A and the shutter holes 244 so as to be shielded within thesafety assembly base 236. As shown inFIG. 12B , this causes theshutters 242 to no longer be constrained by theneedle 230 and enables theshutter spring arms 246 to slide the shutters laterally within thebase 236 so as to cover and occlude thehole 236A defined in the base, thus preventing reemergence of the needledistal tip 230A. Note that further information regarding this and other related needle safety assemblies can be found in U.S. Pat. No. 6,585,704 to Luther et al., titled “Method of Retaining a Tip Protector on a Needle with a Curved Tip.” - In accordance with one embodiment the
needle assembly 220 includes afluid isolation component 250 for isolating any fluid or vapor that may unintentionally escape from theneedle 130 during use of the needle assembly. Specifically, thefluid isolation component 250 in the present embodiment includes anabsorption pad 252 disposed on a backside of one or both of theshutters 242 of thesafety assembly 234. As shown inFIGS. 13 and 14 , thepad 252 is disposed on theshutter 242 so that thedistal tip 230A of theneedle 230 rests against it after the distal tip has been withdrawn and shielded by thebase 236 of thesafety assembly 234. Should any fluid leak from the distal opening of the lumen of theneedle 230, it can be readily captured by thepad 252, thus preventing its escape outside of thesafety assembly 234. The pad can include one or more of suitable materials including those listed above in connection with the embodiment ofFIGS. 9A and 9B , silicone, rubber, etc. As shown, the pad can also be recessed within theshutter 242 so as to provide a basin for capture of the fluid, in one embodiment. Note that the pad and shutters can vary in size, number, shape, design, etc. -
FIG. 15 shows theneedle assembly 220 including afluid isolation component 260 according to one embodiment, wherein the fluid isolation component includes an O-ring 262 that is disposed within thesafety assembly 234 about a portion of theneedle 230. So positioned, the O-ring 262 wipes the length of theneedle 230 when thesafety assembly 234 is axially slid down the needle in order to shield the needledistal tip 230A. The O-ring 262 is sized such that its wiping action cleans the outer needle surface of any fluids that might otherwise be exposed to the clinician and prevents their escape from thesafety assembly base 236. In one embodiment, the O-ring can be configured to be absorbent so as to soak up any fluid it comes into contact with during wiping of the needle. Note that the O-ring can be placed in other locations with respect to the needle safety assembly and that the needle housing and safety assembly can vary in configuration from what is shown. -
FIGS. 16A and 16B depict various details of aneedle assembly 320 including a fluid isolation component, according to one embodiment. Theneedle assembly 320 includes ahandle portion 322 from which extends aneedle 330. Theneedle 330 initially extends through ahole 344 defined in asafety assembly 334 that is pivotally movable with respect to thehandle portion 322 and theneedle 330 via ahinge point 338. Thesafety assembly 334 houses aneedle safety component 340 including a laterallyslidable shutter 342, disposed in ashutter cavity 346, for shielding adistal tip 330A of theneedle 230 when use of the needle assembly is complete. Afoam pad 354 is disposed on the bottom of thesafety assembly 334. - As shown in
FIG. 16B , theneedle 330 is biased while residing in thehole 344 of thesafety assembly 334 such that when thedistal tip 330A is withdrawn from the hole, theneedle 330 urges theshutter 342 to laterally slide within theshutter cavity 346, thus covering the hole and preventing re-emergence of the needle distal tip. In another embodiment, the shutter itself can be biased to urge the needle distal tip laterally. - The
needle assembly 320 further includes a fluid isolation component, here configured as anextensible shroud 352 that extends about theneedle 330 between thehandle portion 322 and thesafety assembly 334 to isolate the body of the needle and any vapors present therewith. Thus, theshroud 352 provides isolation of fluids present on theneedle 330. In addition, theshutter 342 provides some fluid isolation as well. -
FIGS. 17-18B disclose aluer connector 426 including a fluid isolation component, according to one embodiment. As shown, theconnector 426 is a female-type luer connector, though the principles described here can be extended to other connective or fluid-carrying components of an infusion set or other suitable fluid delivery medical device. Connected to theextension leg tubing 24, theconnector 426 includes a body that defines acavity 428 suitable for receiving a male-type connector 456 (FIGS. 18A, 18B ) therein. Theconnector 426 can include threads to enable themale connector 456 to threadably connect therewith. Thecavity 428 defines a portion of a fluid pathway through the connector body. - A
fluid isolation component 450 is included in theconnector 426. In particular, thefluid isolation component 450 in the present embodiment includes aslit valve 452 that is disposed in the fluid pathway defined by theconnector 426. Other suitable types of valves may also be employed. - As seen in
FIGS. 18A and 18B , when themale connector 456 is received but not fully seated within thecavity 428 of thefemale connector 426, thevalve 452 remains closed, thus isolating any fluid contained in theextension leg tubing 24 attached thereto. When themale connector 456 is fully inserted into thefemale connector 426, the distal end of the male connector engages and opens thevalve 452, thus allowing fluid flow therethrough. This configuration of theconnector 426 thus serves as one example a connector-based fluid isolation component; other configurations of this principle are contemplated. -
FIGS. 19A and 19B depict another example of a fluid isolation component for preventing unintended contact with fluid or vapors resulting from use of an infusion set. In particular, an infusion set 10 is shown, including aneedle assembly 220,extension leg tubing 24, andluer connector 26. Also shown is afluid isolation component 470, which in the present embodiment includes abag 472 of plastic or other substantially fluid-impermeable material. The bag includes a sealableopen end 474 and aclosed end 476. Thebag 472 is attached to thetubing 24 of the infusion set 10 or other suitable component thereof via andadhesive strip 478 or other suitable connective apparatus. - The
bag 472 is initially inside-out before use of the infusion set 10. Once use of the infusion set 10 has ended, the user reaches a hand through theopen end 474 of thebag 472 and pulls the infusion set into the bag, turning the bag right side-out in the process. Once the infusion set 10 is fully within thebag 472, theopen end 474 of thebag 472 is sealed, as seen inFIG. 19B , thus isolating the user from any fluids or vapors included on theneedle assembly 220 or any other portion of the infusion set 10. Note that the bag can be configured in one or more sizes and shapes, can include one-time, resealable, or other suitable type of sealing mechanism, and can be included with the infusion set in a variety of ways, both attached and detached thereto. The bag in the present embodiment is transparent, though in other embodiments it need not be. -
FIG. 20 depicts details of another possible fluid isolation component for use with the needle assembly 220 (shown inFIGS. 11-12B ), or another suitable needle assembly. In particular, afluid isolation component 480 is disclosed, including an amount of suitableviscous oil 482, such as silicone oil, interposed as a film between theshutters 242. When theneedle 230 is retracted from thehole 236A in theneedle assembly base 236, which retraction causes theshutters 242 to slide over and cover the hole, theoil 482 produces a fluid impermeable barrier layer between the shutters, thus preventing any fluid/vapor escaping the needle from escaping past the shutters. In other embodiments, other barriers can be employed between the shutters, including a gasket, O-ring, other compliant/elastomeric member, etc. -
FIGS. 21A-24 depict various details regarding a fluid isolation component according to yet another embodiment, for use with a safety needle assembly. As will be described, the fluid isolation component in the present embodiment includes a self-sealing pad that prevents unintended leakage of fluids (e.g., liquids, gases) from the needle after use of the needle assembly. The self-sealing pad thus prevents undesired exposure to clinicians of potentially hazardous substances. -
FIGS. 21A and 21B show theneedle assembly 120 in similar configuration to that described further above in connection withFIGS. 5-6C . As before, theneedle assembly 120 includes a first needle assembly portion, i.e., thehandle portion 122, withhandles 124 extending therefrom. Thehollow needle 130 extends from thehandle portion 122 and initially through thesafety assembly 134 that is slidably disposed with respect to theneedle 130 so as to be axially slidable therewith. Thesafety assembly 134 includes the base, also referred to herein as a second needle assembly portion or thebase portion 136, which houses the needle safety component 140 (FIGS. 8A, 8B ) for shielding thedistal tip 130A of theneedle 130 when use of the needle assembly is complete. - As already described further above, the
needle assembly 120 further includes a firstfluid isolation component 150 for isolating any fluid or vapor that may unintentionally escape from theneedle 130 during use of the needle assembly. Specifically, the firstfluid isolation component 150 includes the conically shaped,extensible shroud 152 disposed about the body of theneedle 130 and extending between thehandle portion 122 and the axiallyslidable safety assembly 134 of thebase portion 136. Theshroud 152 forms a hollow cone about theneedle 130 and is corrugated withcorrugations 154 in a bellows-like manner to enable it to fold up compactly when thesafety assembly 134 is undeployed (FIG. 4 ) and to extend to cover and substantially encompass theneedle 30 when thesafety assembly 134 is deployed (FIG. 5 ). As already discussed, in the extended state shown inFIGS. 5 and 6C , theshroud 152 assists in isolating fluids/vapors present on theneedle 130 or emitted from the needledistal tip 130A from contact with the clinician. -
FIGS. 21A-21B further show a self-sealingpad 500 disposed on a bottom external surface of thebase portion 136. Thepad 500 includes a self-sealing material that enables theneedle 130 to extend therethrough, as seen inFIG. 21A (also referred to as the first needle position), but seals when the needle is retracted back through the pad via separation of thebase portion 136 from thehandle portion 122, as seen inFIG. 21B (also referred to as the second needle position). In particular, and as shown inFIG. 21B , the full extension of thebase portion 136 from thehandle portion 122 causes thedistal tip 130A of theneedle 130 to be drawn through thepad 500 such that the distal tip is shielded within the base portion, in particular, shielded by theneedle safety component 140. Because of its self-sealing characteristics, thepad 500 substantially seals the hole through which theneedle 130 was disposed during needle assembly use, thus preventing any fluid leakage from the distal opening of theneedle 130 to escape thebase portion 136, as desired. Note that, though shown and described herein in connection with theneedle assembly 120, the self-sealingpad 500 can be included with needle assemblies and infusion sets of a variety of configurations in addition to those discussed herein. -
FIGS. 22A and 22B depict various features of the self-sealingpad 500 according to the present embodiment. As shown, thepad 500 includes abody 502 shaped to conform to the shape of thebase 136, though in other embodiments the pad could include other shaped configurations. Thebody 502 defines anupper surface 502A that is configured to mate with thebase portion 136 and abottom surface 502B that serves as a skin-contacting surface for theneedle assembly 120. - A
groove 504 is defined about the perimeter and configured in the present embodiment to receive therein a corresponding protrudedsurface 506 defined on a bottom surface of thebase portion 136. The receipt of the protrudedsurface 506 by thegroove 504 assists in maintaining engagement of thepad 500 with thebase portion 136, in one embodiment. Thepad 500 can be affixed to thebase portion 136 via a suitable adhesive or by other suitable methods, including mechanical fixation. - In one embodiment, the
pad 500 includes silicone, though other self-sealing materials, plastics, and elastomers can be employed. In one embodiment, a liquid silicone rubber (“LSR”) that is injection molded then cured is employed to form thepad 500. So configured, the skin-contactingbottom surface 502B of thepad 500 provides a compliant surface to rest against the skin of the patient during use of theneedle assembly 120. - The
pad body 502 further defines a centrally disposed raisedportion 508, best seen inFIGS. 22A and 22B , which is shaped so as to compressively fit within anopening 136A that is defined in thebase portion 136. As shown inFIGS. 23A and 23B , the raisedportion 508 of thepad 500 is disposed within theopening 136A and is partially maintained in place via a compressive fit with the opening. So configured, the raisedportion 508 acts as a septum to provide a robust fluid barrier when theneedle 130 is withdrawn therethrough and shielded by thesafety assembly 134, which occurs when thebase portion 136 is selectively extended from thehandle portion 122, as shown inFIG. 23B . Indeed, compression of the raisedportion 508 by theopening 136A assists in the self-sealing characteristics of thepad 500 when theneedle 130 is retracted, in one embodiment. Thus, the self-sealingpad 500 serves as a second fluid isolation component, together with theshroud 152, for preventing fluid/vapor escape from the needle assembly. The shape and size of both the raised portion and the opening can vary from what is shown and described herein. In the present embodiment, thedistal tip 130A of theneedle 130 fully withdraws from the raisedportion 508, though in other embodiments the distal tip can remain in the raisedportion 508 after shielding thereof by the safety assembly. An example of the latter configuration would include the distal tip of the needle retracting fully from thelower surface 502B of the pad body while still residing within raisedportion 508 of the pad. - The self-sealing pad can be configured in other ways. For instance,
FIG. 24 shows thebottom surface 502B as including a plurality of texture features 510 for increasing patient comfort while theneedle assembly 120 is disposed on the skin of the patient. Also, in one embodiment, it is appreciated that the self-sealing pad can be treated so as to offer antimicrobial/antibacterial properties. Further, in one embodiment, the bottom surface of the self-sealing pad can include an adhesive material to enable the pad to act as a securement device in maintaining the infusion set in place at a desired position on the patient's skin during use of the needle assembly. It is further appreciated that the needle assembly and accompanying infusion set can include one of many possible shapes, sizes, and configurations in addition to those shown and discussed herein. -
FIGS. 25-41 depict various features of an interface pad or other structure for inclusion on a medical device, such as a needle assembly or catheter assembly, so as to provide an interface between the medical device and the skin surface of the patient after the device has been percutaneously inserted into the patient via an insertion site. Particularly, the interface pad is positioned on the medical device so as to rest against the insertion site on the patient's skin once the device has been inserted into the patient. - Further, the interface pad includes one or more components that provide desirable effects at the insertion site. In accordance with one embodiment, for instance, an antimicrobial agent and/or haemostatic agent are impregnated into the interface pad so as to provide antimicrobial and/or haemostatic properties to the insertion site via contact of the agents from the pad with the insertion site. In this way, infection, undesired bleeding, etc. can be controlled via use of the interface pad. In addition to the above-mentioned agents, other substances can be included in the interface pad to impart other desirable characteristics, such as antithrombogenic agents, for instance.
- Reference is first made to
FIG. 25 , which shows a catheter assembly (“catheter”), generally designated at 610, according to one embodiment. As shown, the catheter includes ahub 614 to which is connected at a distal end thereof an elongate,hollow catheter tube 612 defining alumen 615. Thecatheter 610 includes aneedle 616 inserted through thehub 614 so as to extend into thelumen 615 of thecatheter tube 612. Theneedle 616 is used to assist with percutaneous insertion of thecatheter tube 612 into the body of the patient via an insertion site 618 (FIG. 26B ). Once thecatheter 10 is percutaneously inserted within the patient, thehub 614 rests above askin surface 630 of the patient, as seen inFIG. 26B . Note that, though shown here as defining asingle lumen 615, thecatheter tube 612 can define more than one lumen, such as two, three, or more lumens, in one embodiment. Also note that, though describing a catheter assembly herein, the present disclosure contemplates that other types of catheters including PICCs, PIVs, midline and intermediate dwell catheters, Foley and balloon catheters, epidural catheters, feeding catheters, drainage catheters, infusion sets, needle assemblies, and other medical devices can benefit from the teachings herein. The discussion to follow, therefore, is not intended to be limiting of the present disclosure. -
FIG. 1 further shows an interface pad (“pad”) 620, configured according to one embodiment, attached tocatheter 610. As shown, thepad 620 is interposed between thedistal end 614B of thehub 614 and theskin surface 630 so as to rest adjacent to and substantially cover the insertion site 618 (FIG. 26B ) when thecatheter 610 is percutaneously inserted into the patient. -
FIGS. 26A and 26B depict further details of thepad 620, according to one embodiment. As shown inFIG. 26A , thepad 620 includes acompliant body 622 that can be permanently or temporarily attached to thedistal end 614B of the hub 14, though other attachment locations to the medical device are possible. As will be seen, thepad body 622 can be configured in any one of a variety of shapes, sizes, etc. In the present embodiment, thepad body 622 defines a disk-shaped configuration and is adhered by an adheringsurface 626 to the hubdistal end 614B via a biocompatible adhesive, though other modes of attachment, including chemical, mechanical, frictional, etc., can be employed. Example adhesives in one embodiment include cyanoacrylate, UV- or heat-cured adhesives, epoxies, solvent bonding adhesives, acrylic-based, silicone-based, rubber-based, urethane-based, and hydrocolloid adhesives. In other embodiments, the interface pad is not compliant or compressible, but substantially rigid. For instance, an incompressible polymeric material that includes the ability to leach one or more agents (discussed below) for treating theinsertion site 618 could be employed for thepad body 622. These and other variations of the pad are therefore contemplated. - Though a variety of suitable, biocompatible materials can be employed, in the present embodiment the
pad body 622 includes a compressible polyurethane foam that is capable of absorbing and holding agents (discussed below) that may be impregnated into the foam. Manufacture of thepad body 622 from a compressible/compliant material enables the pad to conform to theskin surface 630 about theinsertion site 618 when thecatheter tube 612 is percutaneously inserted into the patient's body. As such, one or more portions of an outer surface of thepad body 622 serve as adeformable contact surface 624 so as to provide a cushioning interface between thecatheter hub 614 and thepatient skin 630, as seen inFIGS. 25 and 26B . The cushioning effect of thepad body 622 serves to increase patient comfort when the catheter is disposed in the patient. - Specifically, in one embodiment, the
pad body 622 includes an aromatic polyether polyurethane foam, including a TDI or MDI hard segment and a PTMEG (polytetramethylene ether glycol) soft segment. Other suitable polymer-based foam materials as well as non-foam materials can also be employed for thepad body 622. In one embodiment, desired characteristics for a foam material used for thepad body 622 include hydrophilicity (absorptive), a suitably large surface area to volume ratio for the foam, and a suitable diffusion coefficient. These desired characteristics are useful when one or more agents for treating theinsertion site 618 are included with thepad body 622, as will be described below. In addition, other materials can be employed, including polyethylene, woven and non-woven fabrics including felt and cotton, gels, and hydrogels. In one embodiment, the pad body includes a compressed foam that expands in size upon activation with blood or other body fluid/liquid. In such an embodiment, a dry antimicrobial or other agent can be included with the pad body. - As mentioned above, the
pad 620 is configured in one embodiment to include one or more agents for treating theinsertion site 618 of thecatheter 610 or other medical device. In one embodiment, a liquid solution (or other suitable medium) including an antimicrobial agent, a haemostatic agent, an antithrombogenic agent, or other substance to protect, heal, or otherwise assist care of theinsertion site 618 is included in thepad body 622. In the present embodiment, thepad 620 includes a liquid antimicrobial agent that is infused during manufacture into the polyurethane foam material from which thepad body 622 is formed. Once thecatheter 610 has been placed percutaneously into the patient and thepad 620 is positioned adjacent thepatient skin 630 as shown inFIG. 26B , the antimicrobial agent previously infused into thefoam pad body 622 contacts theinsertion site 618 via thecontact surface 624 of thepad body 622 and provides antimicrobial effect, thus desirably protecting the insertion site from infection. - In the present embodiment, a liquid haemostatic agent is also infused during manufacture into the polyurethane foam material from which the
pad body 622 is formed. When thepad 620 is positioned adjacent to theinsertion site 618 as just described and as shown inFIG. 26B , the haemostatic agent previously infused into thefoam pad body 622 contacts the insertion site via thecontact surface 624 of thepad body 622 and provides haemostatic effect, thus desirably preventing excessive bleeding from the insertion site. Note that thepad body 622 in one embodiment is absorptive so as to take up effusion of blood and other fluids from theinsertion site 618, in one embodiment. - In one embodiment, the antimicrobial agent can include silver, copper (and other biocompatible antimicrobial metals, silver sulfadiazine, chlorhexidine, chlorhexidine gluconate (“CHG”), chlorhexidine acetate (“CHA”), other suitable chlorhexidine-based antimicrobial agents, isopropyl alcohol (“IPA”), etc. In one embodiment, the haemostatic agent includes microdispersed oxidized cellulose, other suitable hydrocolloids, etc. In one example embodiment, a solution included in the
pad 620 includes an antimicrobial agent of about 11% by weight CHG and a haemostatic agent of about 8% by weight microdispersed oxidized cellulose, though these percentages can vary in other formulations. For example, in one embodiment, the amount of CHG by weight in the solution can vary between about 11% to about 25%, though other ranges are possible, depending on various factors, including the type of pad material employed, processing parameters during pad manufacture, etc. In another embodiment, it is appreciated that the antimicrobial agent, haemostatic agent, or other agent included with the interface pad can be in a dry state, such as a solid or powder, for instance. - In yet another embodiment, the foam itself of the interface pad body can be configured to impart haemostatic properties and therefore act as the haemostatic agent. Indeed, in one embodiment, negatively charged sulfonate groups can be incorporated into the soft segment (e.g., polytetramethylene ether glycol) of a polyurethane foam so as to impart haemostatic properties thereto. In such a case, no other haemostatic agent need be added, though an additional agent could be, if desired.
- Further details regarding antimicrobial and haemostatic agents that may be used according to one embodiment are found in U.S. Patent Publication No. 2013/0110025, filed Jul. 4, 2011, and titled “Dressing Device for Use with a Cannula or a Catheter,” which is incorporated herein by reference in its entirety. In yet another embodiment, the antimicrobial agent (such as CHG) is incorporated into the material from which the interface pad body is composed, such as a solvent acrylic adhesive. Details regarding such a configuration can be found in U.S. Pat. No. 9,346,981, issued May 24, 2016, and titled “Chlorhexidine Gluconate Containing Solvent Adhesive,” which is incorporated herein by reference in its entirety. In yet another embodiment, an antimicrobial silicone adhesive, such as that produced by Covalon Technologies Ltd., Mississauga, Ontario, can be used to form the interface pad body and antimicrobial agent. In yet another embodiment, a hydrogel or other hydrocolloid in which the antimicrobial and/or haemostatic agent is incorporated can be used to form the interface pad body.
- It is appreciated that one or more of a variety of agents can be included with the
pad 620 to render to it desirable qualities or characteristics. For instance, the pad body can include an antithrombotic agent. Note also that in one embodiment, the antimicrobial/haemostatic agent can be incident on theinsertion site 618 via liquid dispersion. - It is further appreciated that, in one embodiment, the afore-mentioned desirable qualities of the pad body material—including hydrophilicity/absorptiveness and sufficiently large surface area to volume ratio—assist in enabling the microdispersed oxidized cellulose haemostatic agent to be present in the pad body and to contact and interact with the insertion site, as desired. Additionally, in one embodiment the afore-mentioned desirable quality of suitable diffusion coefficient for the pad body material assists in enabling the antimicrobial agent to contact and interact with the insertion site so as to provide desired antimicrobial properties.
- In addition to agent-based protection, the
pad 620 also physically protects theinsertion site 618 by providing a physicalbarrier and cushion for the insertion site, which provide patient comfort when thecatheter 610 or other medical device is resting against the skin, as seen inFIG. 26B . As such, it is appreciated that the pad can be manufactured using one or more of a variety of materials and in a variety of shapes, sizes, and configurations. In one embodiment, as mentioned, the pad body includes a gel or hydrogel material. - In light of the above,
FIGS. 27A-29B depict various examples of possible shapes for thebody 622 of thepad 620, according to example embodiments.FIGS. 27A and 27B show thepad body 622 defining acentral hole 632 for passage therethrough of the needle 616 (FIG. 25 ), similar to the pad configuration ofFIGS. 25-26B . In one embodiment, the thickness of thepad body 622 ofFIGS. 27A and 27B is about 0.0625 inch, though other thicknesses are possible. Generally, the thickness of the pad body should be such that sufficient absorption of the antimicrobial and/or haemostatic agents is possible, while not becoming too thick so as to decrease the useful length of the catheter tube. -
FIGS. 28A and 28B show arectangular pad body 622, wherein a hole therethrough for passage of thecatheter 610 may be made by piercing the pad body with theneedle 616 during the catheter insertion procedure or during manufacture. -
FIGS. 29A and 29B show a disk-like pad body 622 with aslit 634 defined from an edge of the disk to the center thereof to enable its attachment to or removal from thecatheter 610. As such, it is appreciated that thepad 620 can be permanently or removably attached to thecatheter hub 614, such as is seen inFIG. 26A or in another suitable location, as appreciated by one skilled in the art. These and other suitable pad body shapes and configurations are therefore contemplated. -
FIG. 30 depicts details of another possible shape configuration for thepad 620, wherein thepad body 622 defines an angular shape, from the perspective shown inFIG. 30 , such that thecontact surface 624 thereof is substantially parallel to theskin surface 30 when the catheter tube 12 is percutaneously inserted into the patient, as shown. Such a configuration distributes the contact load of thepad 620 with thepatient skin 630 across the relatively parallel andflat contact surface 624, thus diminishing contact force at any given point on the contact surface, which increases patient comfort, and increases the relative surface area of the contact surface about the insertion site to enhance the effectiveness of the antimicrobial and/or haemostatic agents. -
FIG. 33 depicts yet another possible pad configuration to maximize skin contact, wherein thepad body 622 approximately defines a parallelogram shape, from the perspective shown inFIG. 33 , which also desirably produces a relatively parallel pad contact surface with respect to theskin surface 30.FIG. 33 further shows that, in one embodiment, thedistal end 614B of thehub 614 can be angled to be substantially parallel with theskin surface 630 after percutaneous catheter insertion is completed. -
FIGS. 31 and 32 depict details of another embodiment of theinterface pad 620, wherein the pad is produced from afoam strip 640 that includes a pattern of spaced-apart teeth 642, as seen inFIG. 32 . During pad manufacture, thefoam strip 640 is rolled about theproximal end 612A of thecatheter tube 612 and secured in its rolled configuration (via adhesive or the like) to define theinterface pad 620 shown inFIG. 31 . The toothed pattern of thefoam strip 640 imparts an angled configuration for the pad body, which assists in providing a contact surface for the pad that is relatively more parallel to theskin surface 630 of the patient, as has been discussed. Note that theteeth 642 shown here is just one of a variety of different patterns that can be included in thefoam strip 640 from which thepad 620 can be manufactured. -
FIGS. 34 and 35 depict details of aninterface pad 720 according to one embodiment. As shown, thepad 720 includes abody 722 that defines acavity 726 so as to form a cap-shaped configuration. So configured, thecavity 726 of thepad body 722 receives a portion of thecatheter hub 614 therein such that the distal end of the hub is covered, or capped, by the pad. Thepad 720 can be temporarily or permanently secured to thehub 614 along an adheringsurface 726 via adhesive or other suitable fixation mode. Thepad 720 defines anouter contact surface 724 for deformable contact with theskin surface 630. As before, thepad 720 can include an antimicrobial, haemostatic, or other suitable agent for protecting/healing theinsertion site 618 of thecatheter 610 and for destroying microbes that may otherwise be present on portions of thecatheter tube 612 in contact with the interface pad. Also, in one embodiment, thepad 720 can be scored or include a slit so as to make it readily removable from the catheter hub or other medical device to which it is at least temporarily attached. -
FIGS. 36A and 36B depict details of theinterface pad 620 according to one embodiment, wherein the pad is produced from a foam strip, such as thefoam strip 640 shown inFIG. 36A . As shown inFIG. 36A , during pad manufacture, thefoam strip 640 is rolled about thecatheter tube 612. Thefoam strip 640 can include aliner 644 that is peeled away during rolling such that an adhesive under the liner adheres the pad to thecatheter tube 612 and/orhub 614. Once thefoam strip 640 has fully encircled thecatheter tube 612/hub 614, it can be cut to define thepad 620 shown inFIG. 36B . These and other pad manufacturing methods are therefore contemplated. Thefoam strip 640 can include one of a variety of lengths, thicknesses, compositions, and other configurations. -
FIG. 37 shows yet another embodiment for providing an antimicrobial/haemostatic interface for thecatheter 610, wherein a proximal portion of thecatheter tube 612 adjacent theproximal end 612A thereof is coated to provide acoated portion 730 that includes an antimicrobial, haemostatic, and/or other suitable agent for protecting and/or healing the insertion site of thecatheter 610 through theskin 630 of the patient. The amount of the proximal portion of the catheter tube that is coated to form thecoated portion 230 can vary according to need, catheter size, amount of the catheter to remain outside the patient body, etc., but in one embodiment, thecoated portion 730 extends distally from about one to about five millimeters from thedistal end 614B of thehub 614. -
FIGS. 38-39D depict various details of an interface pad for use with yet another type of percutaneous device, according to example embodiments. In particular,FIGS. 38-39D show a safety needle infusion set (“infusion set”) 808, typically used to provide percutaneous access to a subcutaneously implanted access port. As shown, the infusion set 808 includes aneedle assembly 810 from which extendstubing 812. Thetubing 812 is operably connected with aneedle hub 814 of theneedle assembly 810 so as to be in fluid communication with aneedle 816 that extends from the needle hub. Theneedle hub 814 includes anextensible base 815 that in turn defines abottom surface 815A. The base is included as part of a needle safety component to prevent needle sticks to the user by the distal tip of the needle, in one embodiment. Aconnector 818 is included on the opposite end of thetubing 812. As mentioned, theneedle 816 is configured to percutaneously pierce the patient's skin via an insertion site so as to access a subcutaneously implanted access port. - In accordance with one embodiment, the
needle assembly 810 includes aninterface pad 820 included on thebottom surface 815A of theneedle hub base 815. As seen inFIGS. 39A-39D , the interface pad includes abody 822 and ahole 832 through which theneedle 816 extends. The composition of thepad body 822 and the antimicrobial/haemostatic agents it contains is similar to what has been described in the embodiments above. - The
body 822 of theinterface pad 820 in the present embodiment defines aperimeter 828 that is shaped to correspond to the perimeter shape of theneedle hub base 815. Theinterface pad body 822 further includes an adheringsurface 826 where the pad body attaches to thebottom surface 815A of theneedle hub base 815, and acontact surface 824. In the present embodiment, the adheringsurface 826 of thepad body 822 is permanently attached to thebottom surface 815A of theneedle hub base 815 via a suitable adhesive or other mode as discussed herein. In another embodiment, thepad body 822 is removably attached. Thecontact surface 824 rests against the skin when the infusion setneedle 816 is percutaneously disposed within the patient. As has been described, this enables the antimicrobial/haemostatic agents included with theinterface pad 820 to be in contact with and protect the needle insertion site. -
FIGS. 40A-40E shows aninfusion set 908 andinterface pad 920 according to another embodiment. As with the previous embodiment, a safety needle infusion set (“infusion set”) 908 is shown and includes aneedle assembly 910 from which extendstubing 912. Thetubing 912 is operably connected with aneedle hub 914 of theneedle assembly 910 so as to be in fluid communication with aneedle 916 that extends from the needle hub. Theneedle hub 914 includes anextensible base 915 that in turn defines abottom surface 915A. Theneedle hub 914 further includes a pair ofwings 917 for grasping theneedle assembly 910. Thebase 915 includes a pair ofextensions 919 to assist with using the infusion set 908. Note that the particular shape and configuration of the needle assembly can vary from what is shown and described herein. One ormore connectors 918 are included on the opposite end of thetubing 912. As mentioned, theneedle 916 is configured to percutaneously pierce the patient's skin via an insertion site so as to access a subcutaneously implanted access port. - In accordance with one embodiment, the
needle assembly 910 includes aninterface pad 920 included on thebottom surface 915A of theneedle hub base 915. As seen inFIGS. 40A-40E , the interface pad includes abody 922 and ahole 932 through which theneedle 916 extends. The composition of thepad body 822 and the antimicrobial/haemostatic agents it contains is similar to what has been described in the embodiments above. - The
body 922 of theinterface pad 920 in the present embodiment defines aperimeter 928 that is shaped to correspond to the perimeter shape of theneedle hub base 915, including the shape of theextensions 919 of the needle hub base. Theinterface pad body 922 further includes an adheringsurface 926 where the pad body attaches to thebottom surface 915A of theneedle hub base 915, and acontact surface 924. In the present embodiment, the adheringsurface 926 of thepad body 922 is permanently attached to thebottom surface 915A of theneedle hub base 915 via a suitable adhesive or other mode as discussed herein. In another embodiment, thepad body 922 is removably attached. - As seen in
FIG. 41 , theneedle assembly 910 of the infusion set 908 can be employed to access a subcutaneously implantedaccess port 940. As shown, theaccess port 940 includes abody 942 and aseptum 944 that cooperate to define areservoir 946. - As has been described, the
contact surface 924 of thepad 920 of the infusion setneedle assembly 910 rests against theskin 630 when theneedle 916 of theneedle assembly 910 is percutaneously disposed within the patient, such as in accessing theaccess port 940 shown inFIG. 41 . This enables the antimicrobial/haemostatic agents included with theinterface pad 920 to be in contact with and treat/protect theneedle insertion site 618. - In another embodiment, it is appreciated that the hole of the interface pad, such as the
hol 932 shown inFIG. 40E , can be sized larger than what is required for passage of theneedle 916. Note that the shape of the interface pad can be formed a number of ways, including die-cut. Thus, it is appreciated that the interface pad can include one of a variety of shapes, sizes, and configurations, and can be employed on a variety of percutaneous medical devices. In one embodiment, for example, the size of the interface pad is selected so as to not obscure the view of the clinician placing the medical device into the patient. - Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims (11)
1. A safety needle set designed for delivering fluid to an access port, comprising:
a needle assembly, comprising;
a needle, comprising:
a gauge;
a proximal end; and
a distal end including a non-coring tip, the distal end angled with respect to the proximal end;
a tube having a distal end coupled to the proximal end of the needle, and a proximal end coupled to a connector;
a clamp disposed over the tube between the needle and the connector; and
a pair of foldable wings coupled to the needle, including a first wing having a recess, and a second wing having a protrusion, the recess receiving the protrusion when the first wing contacts the second wing in a wing folded configuration, wherein at least one of the first wing and the second wing includes an indication of the gauge of the needle; and
a base assembly, comprising:
a housing having a bottom surface including an opening in communication with an interior of the housing, the bottom surface defined by an outer perimeter;
a safety needle assembly at least partially disposed in the interior of the housing; and
an interface pad coupled to the bottom surface of the housing around the outer perimeter, wherein the interface pad does not cover the opening in the bottom surface,
the safety needle set having an insertion configuration and a safety configuration, wherein the distal end of the needle extends through the housing and the opening in the bottom surface in the insertion configuration, and wherein the non-coring tip is prevented from exiting the housing in the safety configuration.
2. The safety needle set according to claim 1 , wherein the base assembly includes a first connecting element, and wherein the needle assembly includes a second connecting element, the first connecting element and second connecting element releasably coupling the needle assembly to the base assembly in the insertion configuration.
3. The safety needle set according to claim 2 , wherein the interface pad is permanently coupled to the bottom surface of the housing.
4. The safety needle set according to claim 1 , wherein the interface pad includes shape that matches a shape of a bottom surface of the needle hub, the interface pad including a hole through which the needle extends in the insertion configuration.
5. The safety needle set according to claim 1 , wherein the interface pad includes at least one of a haemostatic agent and an antimicrobial agent.
6. The safety needle set according to claim 5 , wherein the antimicrobial agent includes chlorhexidine gluconate.
7. The safety needle set according to claim 5 , wherein the haemostatic agent includes a hydrocolloid.
8. The safety needle set according to claim 5 , wherein the haemostatic agent includes microdispersed oxidized cellulose.
9. The safety needle set according to claim 1 , wherein the interface pad includes a foam material.
10. The safety needle set according to claim 9 , wherein the foam material includes an aromatic polyether polyurethane.
15. The safety needle set according to claim 1 , wherein the gauge of the needle is 20, and wherein “20G” is indicated on a top surface of at least one of the first wing and the second wing.
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US16/264,375 US20190160261A1 (en) | 2010-09-10 | 2019-01-31 | Safety Needle Set For Delivering Fluid To An Access Port |
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US13/229,573 US9248234B2 (en) | 2010-09-10 | 2011-09-09 | Systems for isolation of a needle-based infusion set |
US201261721412P | 2012-11-01 | 2012-11-01 | |
US14/070,246 US20140066894A1 (en) | 2010-09-10 | 2013-11-01 | Self-Sealing Pad for a Needle-Based Infusion Set |
US201462019807P | 2014-07-01 | 2014-07-01 | |
US14/789,341 US10525234B2 (en) | 2010-09-10 | 2015-07-01 | Antimicrobial/haemostatic interface pad for placement between percutaneously placed medical device and patient skin |
US16/264,375 US20190160261A1 (en) | 2010-09-10 | 2019-01-31 | Safety Needle Set For Delivering Fluid To An Access Port |
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US16/733,926 Active US10806900B2 (en) | 2010-09-10 | 2020-01-03 | Insertion device with interface pad and methods of making |
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US10525234B2 (en) | 2010-09-10 | 2020-01-07 | C. R. Bard, Inc. | Antimicrobial/haemostatic interface pad for placement between percutaneously placed medical device and patient skin |
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Also Published As
Publication number | Publication date |
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US10525234B2 (en) | 2020-01-07 |
US10806900B2 (en) | 2020-10-20 |
US20150297867A1 (en) | 2015-10-22 |
US20200139085A1 (en) | 2020-05-07 |
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