WO2016109707A1 - Cathéter intraveineux de sécurité à fonction de rétention et de désactivation basée sur le frottement - Google Patents
Cathéter intraveineux de sécurité à fonction de rétention et de désactivation basée sur le frottement Download PDFInfo
- Publication number
- WO2016109707A1 WO2016109707A1 PCT/US2015/068122 US2015068122W WO2016109707A1 WO 2016109707 A1 WO2016109707 A1 WO 2016109707A1 US 2015068122 W US2015068122 W US 2015068122W WO 2016109707 A1 WO2016109707 A1 WO 2016109707A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- needle
- catheter
- resilient clip
- catheter hub
- introducer needle
- Prior art date
Links
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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
-
- 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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
- A61M25/0625—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
Definitions
- the present invention relates to intravenous catheters, and more particularly, to an intravenous catheter with friction-based retention between a catheter hub and a needle shield.
- IV catheters are used for infusing fluid (such as normal saline solution, various medicaments, and total parenteral nutrition) into a patient, withdrawing blood from a patient, or monitoring various parameters of the patient's vascular system.
- Peripheral IV catheters tend to be relatively short, and typically are on the order of about two inches or less in length.
- the most common type of IV catheter is an over-the- needle peripheral IV catheter.
- an over-the-needle catheter is mounted over a hollow introducer needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter and thus facilitates insertion of the catheter into the blood vessel.
- the catheter and the introducer needle are assembled so that the sharp distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up and away from the patient's skin.
- the catheter and introducer needle assembly is inserted at a shallow angle through the patient's skin into a blood vessel.
- the clinician confirms that there is flashback of blood in a flashback chamber.
- the flashback chamber is typically formed as part of the introducer needle hub.
- the clinician applies pressure to the blood vessel by pressing down on the patient's skin over the blood vessel distal of the introducer needle and the catheter. This finger pressure occludes or at least minimizes further blood flow through the introducer needle and the catheter. The clinician then withdraws the introducer needle, leaving the catheter in place, and attaches an appropriate device to the catheter.
- Such a device can include a fluid delivery device, a PRN device (pro re nata– i.e.,“as the circumstances may require”), a deadender cap, or a blood pressure monitoring probe.
- needle shields Because of the problem of accidental needlesticks by blood contaminated sharps, various types of needle shields have been developed. Generally, such needle shields work for their intended purpose but could be improved. For example, some needle shields are bulky, difficult to use, require special features or techniques to be operative, or may leave the sharp distal tip exposed after use until the clinician manually activates the needle shielding mechanism.
- a catheter and introducer needle assembly including a flexible catheter having a proximal end and a distal end, and a catheter hub in fluid communication with the proximal end of the catheter and having a distal end connected to the proximal end of the catheter, the catheter hub having an uninterrupted outer surface portion and a Luer-connecting feature.
- the assembly also includes an introducer needle disposed in the catheter and having a proximal end and a distal end, and an axis extending from the proximal end to the distal end; and a needle shield having a proximal portion and a distal portion.
- the assembly additionally includes a resilient clip adapted to flex between a first position and a second position in a plane perpendicular to the axis of the introducer needle, the resilient clip having a cantiievered arm with a pawl: and a disabling feature extending radially outward from a proximal portion of the catheter hub and being axially aligned with and spaced apart from, the pawl when the resilient clip is in the first position.
- the cantiievered arm of the resilient clip In the first position of the resilient clip, the cantiievered arm of the resilient clip is flexed so that the pawl frictionally contacts the uninterrupted outer surface portion of the catheter hub and thereby frictionally retains the needle shield with the catheter hub, and in the second position of the resilient clip, the pawl no longer frictionally contacts the uninterrupted outer surface portion, thereby permitting displacement of the needle shield relative to the catheter hub.
- the resilient clip is held to one side of the introducer needle in a biased position.
- the flexible clip flexes to an unbiased or less biased position in which it no longer frictionally retains the needle shield with the catheter hub.
- the resilient clip may comprise an angled clip, at least a portion of which is movably disposed within the needle shield.
- the angled clip may have an angled portion with the cantiievered arm extending therefrom.
- the resilient clip may comprise an angled portion having a needle blocker extending therefrom; wherein when the flexible clip flexes to the unbiased or less biased position, the needle blocker is disposed to prevent distal displacement of the distal end of introducer needle distal outside of the needle shield.
- the catheter hub includes a proximal port adapted for fluid communication with the catheter and connection with a Luer connector.
- the catheter hub may further comprise a secondary side port adapted for fluid communication with the catheter when the proximal port is in use.
- the assembly may further comprise a needle hub disposed at the proximal end of the introducer needle.
- a flexible tether may be located connecting the needle shield and the needle hub.
- the assembly may further comprise a flexible cantilevered fin extending radially from the needle shield toward a central axis of the needle shield.
- the fin is preferably disposed between the introducer needle and the resilient clip.
- the assembly further comprises a septum and an actuator disposed within the catheter hub; wherein the septum is pierceable by actuator displacement; and the resilient clip is disposed proximal to the septum.
- a coefficient of friction between the pawl and the uninterrupted outer surface portion of the catheter hub is in the range of 0.25 to 0.4.
- a catheter and introducer needle assembly including a catheter hub having a. first fluid path, an uninterrupted outer surface portion, and a disabling feature extending radially outward from a proximal portion of the catheter hub; a catheter communicating with the first fluid path; and an introducer needle assembly.
- the introducer needle assembly includes an introducer needle, a needle hub fixedly disposed at a proximal end of the introducer needle; a needle shield selectively disposed at the catheter hub and connected with the needle hub; and a resilient clip.
- the introducer needle is disposed through the needle shield, the catheter hub, and the catheter.
- the resilient clip is movably disposed within the needle shield and has a cantilevered arm extending therefrom with a pawl at the free end of the cantilevered arm.
- the cantilevered arm is flexed so that the pawl frictionally contacts the uninterrupted outer surface portion and frictionally retains the needle shield with the catheter hub.
- the disabling feature is axially aligned with and spaced apart from the pawl.
- the hub may further comprise a Luer-connecting feature.
- the introducer needle holds the resilient clip in a first compressed position until a sharpened distal end of the introducer needle proximaily passes the resilient clip; and subsequent to the distal end of the introducer needle proximaily passing the resilient clip, the resilient clip expands laterally to an unbiased or less biased position in which the pawl no longer frictionaliy contacts the uninterrupted outer surface portion and the resilient clip no longer frictionaliy retains the needle shield with the catheter hub.
- the resilient clip may comprise an angled clip having an angled portion with the cantiievered arm extending therefrom.
- the catheter hub includes a proximal port adapted for fluid communication with the catheter and connection with a Luer connector.
- the catheter hub comprises a secondary side port adapted for fluid communication with the catheter when the proximal port is in use.
- a flexible tether connects the needle shield and the needle hub.
- the assembly may further comprise a flexible cantiievered fin extending radially from the needle shield toward a central axis of the needle shield.
- the fin is preferably disposed between the introducer needle and the resilient clip.
- the assembly further comprises a septum and an actuator disposed within the catheter hub; wherein the septum is pierceable by actuator displacement.
- the resilient clip may be disposed proximal to the septum.
- a normal force applied by the pawl on the uninterrupted outer surface portion is in the range of 0.4 to 1.4 Newtons.
- a coefficient of friction between the pawl and the uninterrupted outer surface portion is in the range of 0.25 to 0.4.
- a catheter and introducer needle assembly including a flexible catheter having a proximal end and a distal end, and a catheter hub with a distal end connected to the proximal end of the catheter.
- the catheter hub includes an uninterrupted outer surface portion, at least one wing to aid in securing the catheter hub to a patient, a proximal port in fluid
- a secondary side port with a val ve disposed therein for selecti ve fluid communication with the proximal end of the catheter, a Luer -connecting feature, and a disabling feature extending radially outward from a proximal portion of the catheter hub.
- the assembly also includes an introducer needle having a proximal end, a sharpened distal end, and an axis extending from the proximal end to the distal end: a needle hub fixedly disposed at the proximal end of the introducer needle; a needle shield having a proximal portion and a distal portion, and also having a flexible cantilevered fin extending toward a central axis of the needle shield: an expandable tether connecting the proximal portion of the needle shield with a distal portion of the needle hub; and a resilient clip adapted to flex between a first position and a second position in a plane perpendicular to the axis on the introducer needle.
- the resilient clip includes an anchoring portion anchoring the resilient clip in the needle shield, an angled portion extending from the anchoring portion and having a needle blocker extending therefrom, a cantilevered arm extending distally from the angled portion, and a pawl disposed at a distal end of the cantilevered arm, extending toward the catheter hub.
- the introducer needle is disposed through the needle shield, the catheter hub, and the catheter so that the sharpened distal end of the introducer needle extends beyond the distal end of the catheter; the needle shield is disposed at the proximal end of the catheter hub and at least a portion of the needle shield is disposed within the needle hub; the tether is in a collapsed state; the resilient clip is flexed into the first position by the introducer needle, with the fin of the needle shield being disposed between the introducer needle and the angled portion of the resilient clip; the needle blocker of the resilient clip is not disposed across a pathway of the introducer needle; the pawl is axially aligned with and spaced apart from the disabling feature; and the cantilevered arm of the resilient clip is flexed so that the pawl frictionaliy contacts the uninterrupted outer surface portion of the catheter hub at a distance from the disabling feature and frictionaliy retains the needle shield with the catheter hub.
- the tether In a deployed assembly configuration subsequent to the withdrawal of the sharpened distal end of the introducer needle proximaily past the resilient clip, the tether is extended and the resilient clip is disposed in the second position, in which the needle blocker is disposed across a pathway of the introducer needle and the pawl no longer frictionaliy contacts the uninterrupted outer surface portion, thereby permitting displacement of the needle shield relative to the catheter hub and preventing displacement of the sharpened distal tip of the introducer needle distally past the resilient clip.
- Fig. 1 is a top perspective view of a safety intravenous catheter assembly in accordance with an embodiment
- Fig. 2 is a bottom perspective partial view, partially in cross -section, of the catheter assembly of Fig. 1 ;
- Fig. 3 is a bottom perspective view of a resilient clip of the catheter assembly of Fig. 1 in a first, biased position;
- Fig. 4 is a bottom, perspective view of the resilient clip of Fig. 3 in a second, unbiased or less biased position;
- Fig. 5 is an enlarged bottom perspective view, partially in cross-section, of the catheter assembly of Fig. 1;
- Fig. 6 is an enlarged partial rear perspecti ve cross-sectional view of the catheter assembly of Fig. 1;
- Fig. 7 is an enlarged bottom rear perspective view, partially in cross-section, of the catheter assembly of Fig. 1 after the resilient clip has been activated;
- Fig. 8 is another enlarged bottom rear perspective view, partially in cross-section, of the catheter assembly of Fig. 1 after the resilient clip has been activated;
- Fig. 9 is a bottom perspective view of the catheter assembly of Fig. 1 after a needle shield has been removed from a catheter hub;
- Fig. 10 is an enlarged bottom perspective view, partially in cross-section, of a catheter assembly in accordance with another embodiment
- Fig. 11 is an enlarged bottom perspective view, partially in cross-section, of a catheter assembly in accordance with yet another embodiment.
- Fig. 12 is an enlarged bottom perspective view, partially in cross-section, of a catheter assembly in accordance with yet another embodiment.
- Fig. 1 is a top perspective view of a safety intravenous catheter assembly 100 embodiment in a ready-to-use state
- Fig.2 is a bottom perspective view, partially in cross-section, of the catheter assembly 100.
- the catheter assembly 100 includes a flexible plastic catheter 102 secured with a catheter hub 104.
- the catheter 102 and the catheter hub 104 form a first fluid pathway extending along a longitudinal axis of the catheter 102 and proximally terminating at a proximal port 103 (best shown in Fig.9) adapted for connection with, for example, a Luer fitting, using Luer lugs or thread segments 128.
- the catheter hub 104 may include stabilization wings 107, which facilitate skin attachment after the catheter is inserted, for example, by securing the wings 107 to the skin with tape.
- the catheter hub 104 also may include a secondary side port 105 that forms a second fluid pathway in communication with the first fluid pathway.
- the secondary side port 105 preferably includes a barrier, such as an internal tubular valve.
- the secondary side port 105 can be used, for example, to introduce additional fluid or medicament into a patient when the proximal port 103 is already in use.
- the proximal end of the catheter hub 104 is substantially cylindrical.
- the catheter hub 104 does not include stabilization wings or a secondary side port.
- Suitable materials for the flexible catheter 102 include, but are not limited to, thermoplastic resins such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyurethane and the like.
- FEP fluorinated ethylene propylene
- PTFE polytetrafluoroethylene
- the catheter 102 is formed from a
- thermoplastic hydrophilic polyurethane that softens with exposure to physiological conditions present in the patient's body.
- Suitable materials for the catheter hub 104 include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene, and the like.
- the catheter assembly 100 also includes a hollow introducer needle 106 having a sharp distal tip defined by an upwardly facing bevel and a proximal end fixedly connected to a handle portion or needle hub 108 and disposed within the catheter 102.
- the introducer needle 106 is preferably formed from stainless steel and has a longitudinal axis generally parallel to the longitudinal axis of catheter and introducer needle assembly 100.
- the handle portion 108 may be formed from the same types of materials used to form catheter hub 104, but other materials could also be used to form the handle portion 108.
- the catheter assembly 100 additionally includes a needle shield 110 and a resilient clip 112.
- the resilient clip 112 may be a V-shaped or W- shaped clip 112.
- the resilient clip 112 is formed from stainless steel having a memory characteristic. It will be understood by one skilled in the art, however, that other flexible, strong, resilient materials could also be used to form the resilient clip 112, such as nitinol, co-polyesters, polypropylene, or other ductile plastics.
- the needle shield 110 may be formed from the same types of materials used to form catheter hub 104, but other materials could also be used to form the needle shield 110.
- the needle shield 110 has distal and proximal orifices 111 and 113 (best shown, respectively, in Figs. 6 and 7) through which the introducer needle 106 is disposed.
- the needle shield 110 is located within the handle portion 108, and a distal end 131 of the needle shield 110 is located within the catheter hub 104 to help center the needle shield 110 with respect to the catheter hub 104.
- This distal end 131 also provides stability for the introducer needle 106 and blood retention for the catheter hub 104 as the assembly 100 is being inserted into a patient.
- a flexible tether 134 connects the handle portion 108 and the needle shield 110.
- the tether 134 is omitted from the drawings for clarity.
- other mechanisms for connecting the handle portion 108 and the needle shield 110 can be employed without departing from the scope of the present invention, for example, a bump on the introducer needle 106 and a corresponding catch feature in the resilient clip 112, or a washer type feature in the needle shield 110.
- slots 130 in the needle shield 110 cooperate with the Luer lugs 128 of the catheter hub 104 to prevent rotation of the needle shield 110 relative to the catheter hub 104.
- Figs.3 and 4 respectively illustrate the resilient clip 112 in a first, biased position, and in a second, unbiased or less biased position. According to one embodiment, in the second position, the resilient clip is not biased.
- the resilient clip 112 includes an anchoring portion 114 for anchoring the resilient clip 112 in the needle shield 110 so that when the resilient clip moves, it moves in a direction substantially perpendicular to the longitudinal direction of the introducer needle 106 and catheter 102.
- the resilient clip 112 also includes an angled portion 116 with a needle blocker or transverse barrier 118 extending substantially perpendicular to the angled portion 116.
- the angled portion 116 is V-shaped. According to the embodiment shown, the needle blocker 118 extends from a distal portion of the angled portion 116. According to another embodiment, the needle blocker 118 extends from a proximal portion of the angled portion 116. As shown in Figs.3 and 4, the needle blocker extends from only one side of the V-shaped angled portion (i.e., one arm of the V-shape). According to yet another embodiment, a needle blocker 118 extends from each side of the angled portion 118 toward the middle of the angled portion 118.
- a cantilevered arm 120 also extends from the angled portion 116, and a finger or pawl 122 extends radially inward from the free, distal end of the cantilevered arm 120.
- the resilient clip 112 also includes a stiffening or reinforcing rib 121 for stiffening the cantilevered arm 120. Further details of a similar resilient clip can be found in the aforementioned U.S. Patent No.6,749,588.
- the needle shield 110 is disposed at the proximal portion of the catheter hub 104.
- Anchoring portion 114 is fixedly disposed within a cavity 124 of the needle shield 110.
- the introducer needle 106 directly contacts a side of the angled portion 116 and holds the resilient clip 112 in the first or biased position.
- the summation of the forces on the needle shield 110 in the proximal direction is less than the summation of forces on the needle shield 110 in the distal direction (primarily generated by the interaction between the pawl 122 and an uninterrupted outer surface portion 126 of the catheter hub 104), thereby keeping the needle shield 110 in contact with the catheter hub 104 until the resilient clip 112 is activated, to avoid accidental exposure of the sharp distal end of the introducer needle 106.
- a thin, flexible cantilevered extension or fin 123 extends radially inward from the needle shield 110 toward a central axis of the needle shield 110 to rest against a side of the angled portion 116 and intervene between the angled portion 116 and the introducer needle 106.
- the coefficient of friction between metal and metal is higher than the coefficient of friction between metal and the material or materials used to form the needle shield 110 and fin 123, for example, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene, and the like.
- the fin 123 reduces frictional contact with introducer needle 106 to a coefficient of friction of about 0.25-0.4.
- the introducer needle 106 holds the resilient clip 112 in the first or biased position via the fin 123.
- a lubricant such as a silicone lubricant
- the introducer needle extends through the orifice 111 in a distal portion 125 of the needle shield 110, which contacts and guides the introducer needle 106.
- An orifice 113 in a proximal portion of the needle shield 110 also contacts and guides the introducer needle 106.
- the lubricant can be employed on the introducer needle 106 and/or the needle shield 110 (e.g., at the two orifices 111 and 113) to reduce friction between the needle shield 110 and the introducer needle 106.
- the cantilevered arm 120 is flexed or bent to cause the pawl 122, which extends radially toward the catheter hub 104, to frictionally contact the uninterrupted outer surface portion 126 of the catheter hub 104 and thereby frictionally retain the needle shield 110 with the catheter hub 104. Additionally, contact between the distal end 131 of the needle shield 110 and the catheter hub 104, as well as contact between the Luer lugs 128 and the needle shield 110, may play a role in frictionally retaining the needle shield 110 with the catheter hub 104. The sum of these retaining forces is chosen to be greater than the sum of the previously described forces (e.g., those resulting from the proximally moving introducer needle 106) that tend to separate the needle shield 110 from the catheter hub 104.
- the uninterrupted outer surface portion 126 is continuous, and substantially featureless. In other words, on the uninterrupted outer surface portion 126, no cavities or recesses or protrusions exist, so that the uninterrupted outer surface portion 126 is unbroken.
- the uninterrupted outer surface portion 126 may be smooth, or may be provided with a surface texture to enhance friction.
- the portion of the catheter hub 104 in which the uninterrupted outer surface portion 126 is disposed is substantially cylindrical.
- the doctor, nurse, other medical professional, or other user grasps the catheter assembly 100 and inserts the introducer needle 106 and catheter 102 into the patient’s vein. After the catheter is placed in the patient’s vein, the user begins to proximally withdraw the introducer needle using the needle hub 108 while holding the catheter 102 in position. Thus, the introducer needle 106 is moving relative to the catheter hub.
- the pawl 122 retains the needle shield 110 with the catheter hub 104.
- the frictional force generated by the contact between the pawl 122 and the uninterrupted outer surface portion 126 is greater than the force required to overcome the drag forces on the introducer needle 106.
- the pawl 122 retains the needle shield 110 with the catheter hub 104 as the user proximally withdraws the introducer needle 106.
- the releasable retention force resulting from the interaction between the pawl 122 and the uninterrupted outer surface portion 126 is only frictional, and this releasable frictional force frictionally retains the needle shield 110 with the catheter hub 104 against ⁇ forces in the proximal direction generated as the introducer needle is withdrawn in the proximal direction.
- the introducer needle 106 no longer compresses and holds the resilient clip 112 in the first, biased position.
- the resilient clip 112 activates and expands laterally in a direction substantially perpendicular to the longitudinal axis of the introducer needle 106 to the second, unbiased or less biased position (best illustrated in Fig.4), causing the pawl 122 to move laterally out of contact with the uninterrupted outer surface portion 126.
- the needle blocker 118 moves into a position across the longitudinal axis of the introducer needle 106, thereby preventing the user from distally displacing the introducer needle 106 past the needle blocker 118, and potentially re-exposing the sharp distal tip of the introducer needle 106.
- the resilient clip 112 activates, the resilient clip 112 no longer frictionally retains the needle shield 110 with the catheter hub 104, and the resilient clip 112 prevents the introducer needle from displacing distally past the resilient clip 112.
- the flexible tether 134 connects the needle shield 110 with the needle hub 108.
- the tether 134 expands substantially to its full length, preventing further proximal displacement of the introducer needle 106 relative to the needle shield 110.
- the needle blocker 118 prevents the introducer needle 106 from displacing distally relative to the needle shield 110 because the sharp distal tip of the introducer needle 106 is safely captured within the needle shield 110.
- the resilient clip no longer frictionally retains the needle shield 110 with the catheter hub 104, as the user continues to proximally displace the introducer needle 106, the proximal force applied by the fully extended tether overcomes any remaining friction and separates the needle shield 110 from the catheter hub 104, as shown in Fig.9, thereby exposing the proximal port 103 for connection with medicament or other fluids.
- the frictional force of the contact between the pawl 122 and the uninterrupted outer surface portion 126 is chosen to exceed the remaining forces acting on the introducer needle 106 and the needle shield 110 during initial withdrawal of the introducer needle 106 to frictionally retain the needle shield 110 with the catheter hub 104.
- the goal is to increase the frictional force of the pawl-catheter hub interface and to decrease the frictional forces of the interactions of other device components.
- the frictional force (F f ) of the contact between the pawl 122 and the uninterrupted outer surface portion 126 is defined as being equal to ⁇ N, where ⁇ is the coefficient of friction and N is the“normal force” or the force that is applied normal (perpendicular) to the uninterrupted outer surface portion 126.
- ⁇ is the coefficient of friction
- N is the“normal force” or the force that is applied normal (perpendicular) to the uninterrupted outer surface portion 126.
- the edge of the pawl 122 that contacts the uninterrupted outer surface portion 126 is substantially linear.
- the shape of the pawl end can be modified to optimize this contact.
- contact area is not a term in the frictional equation, optimizing the contact area can help provide a better mechanical interface between the two parts. This can be accomplished by shaping the pawl end to match the curvature of the uninterrupted outer surface portion 126. Different gauge insertion needles, however will compress the angled portion 116 of the resilient clip 112 to different degrees, and therefore, will affect the positioning of the pawl 122.
- the linear shape of the pawl 122 illustrated in Figs.3 and 4 represents a shape optimized to provide the desired normal force in combination with a range of different gauge introducer needles.
- the pawl arm edge condition can be also be optimized.
- the pawl edge can be sharpened, which can help by digging or biting into the softer plastic material of the catheter hub 104.
- the cantilevered arm 120 can be stiffened using features such as additional stiffening ribs or gussets that provide a higher normal force on the uninterrupted outer surface portion 126 as the cantilevered arm 120 is flexed, thus increasing the total frictional force.
- the height or length of the pawl 122 can be adjusted to provide a greater pawl arm bias angle. If the pawl is taller, the cantilevered arm 120 must bend further, thereby providing a higher normal force, and thus, a greater frictional force.
- the diameter of the catheter hub 104 at the uninterrupted outer surface portion can be increased to increase the bending of the cantilevered arm 120, thereby increasing the normal force and the resulting frictional force.
- the tip of the pawl 122 can also be covered with a material that has a higher coefficient of friction than that provided by the metal alone, for example, a rubber compound.
- the uninterrupted outer surface portion 126 can be formed, treated, or processed (e.g., machined) to provide more surface roughness, which can increase the coefficient of friction and the resulting friction force.
- the uninterrupted outer surface portion 126 can have a coating or a second material injected over the plastic of the catheter hub 104 in a two-shot molding operation.
- a coating or second material can be a rubber or a soft touch plastic coating.
- the coefficient of friction between rubber and metal can approach one, and thereby more efficiently translate the normal force into a higher frictional retaining force.
- the coefficient of friction between metal and plastic can range between 0.25 and 0.4.
- the predicted normal force of the pawl 122 on the uninterrupted outer surface portion 126 is approximately 0.4 Newtons to 1.4 Newtons, with an average around 0.8 Newtons to 1 Newton.
- other factors are also included in these predictions.
- the initial friction (tip adhesions and catheter drag force) between the introducer needle 106 and the catheter 102, flexing of the cantilevered arm 120 during operation, other material deformation, the pawl 122 biting into the uninterrupted outer surface portion 126, and chatter between the pawl 122 and the uninterrupted outer surface portion 126 all add together to provide the pawl-catheter hub holding force.
- lubrication can be placed where device components interact.
- the ⁇ coefficient of friction between plastic and plastic for static dry conditions can range between 0.3 and 0.4. With lubrication, this amount can be almost eliminated.
- a good candidate for such plastic-plastic lubrication is between the needle hub 108 and the needle shield 110.
- a washer is used as the mechanism for retaining the needle shield 110 with the needle hub 108 (as subsequently described with respect to another embodiment)
- lubrication, washer edge finishing levels, and the finish of the introducer needle 106 can all be optimized to reduce friction.
- the resilient clip 112 can be optimized for specific introducer needle gauge sizes. For example, for smaller gauge introducer needles 106, the resilient clip 112 is not as compressed as with larger introducer needles. Therefore, for smaller gauge introducer needles, the resilient clip 112 can be made thinner to provide the proper yielding force. The thinner resilient clip 112 will provide less normal force to the introducer needle 106. For larger gauge introducer needles, the resilient clip 112 endures greater lateral displacement. The material thickness and the hardness of the resilient clip 112 play a role in providing the proper restoring force, but consequently the force applied to the needle increases.
- Fig. 10 is an enlarged bottom perspective view, in partial cross-section, of another catheter assembly embodiment.
- all reference characters designating corresponding parts of the embodiments are the same as those in the embodiment of Figs. 1-9, except that they are in a different series, for example, in the 100 series, or the 200 series.
- the differences of the second embodiment with respect to the first embodiment will now be described.
- a disabling feature 232 in the form of an integral, radially extending projection is disposed at the proximal end of the catheter hub 204 in the event that the user improperly uses the device in such a way that would result in the resilient clip 212 not activating.
- the disabling feature 232 cannot prevent the needle shield 210 and the catheter hub 204 from separating. It is in fact possible, by applying sufficient force, to separate the needle shield 210 from catheter hub 204, despite the disabling feature 232, and in this case the needle tip is not entrapped by the needle blocker 218 (not shown) because clip 212 does not activate.
- the pawl 222 contacts the uninterrupted outer surface portion 226 at a distance from the disabling feature 232, which is axially aligned with the pawl 222 when the resilient clip 112 is in the first, biased position. If during the withdrawal of the introducer needle 206, the user mistakenly grasps the needle shield 210, instead of the needle hub 208, and moves the needle shield 210 relative to the catheter hub a far enough distance such that the pawl 222 contacts the disabling feature 232, the disabling feature 232 will disable the device 200 by resisting further movement of the needle shield 210 relative to the catheter hub 204.
- slots 230 in the needle shield 210 cooperate with the lugs 228 to prevent rotation of the needle shield 210 relative to the catheter hub 204.
- the pawl 222 can be forced proximally past the disabling feature 232, resulting in the accidental exposure of the sharp distal needle tip, because the resilient clip will not activate.
- the force required to overcome or defeat the disabling feature 232 in this way is between 14-17 Newtons (3.1- 3.8 lbs f ). This force is substantially greater than the force required to properly withdraw the introducer needle 206 from the catheter hub 204, which is approximately 0.03-0.06 Newtons (0.007-0.013 lbs f ).
- the disabling feature 232 serves as a tactile and/or audible indicator of improper use to the user, as well as an impediment to such improper use.
- it is the frictional forces resulting primarily from interaction between the pawl 222 and the uninterrupted outer surface portion 226, rather than any interaction between the pawl 222 and the disabling feature 232, that retains the needle shield 210 with the catheter hub 204 against the forces caused by the introducer needle 206 withdrawing from the catheter 202.
- the shape of the proximal end of the catheter hub is substantially cylindrical.
- the intravenous catheter assembly 300 includes a catheter hub 304 with a cylindrical central section 304A and a proximal section 304B that tapers proximally.
- the taper is approximately 1.3° measured from a central longitudinal axis of the catheter hub 304 (approximately 2.6° total included angle).
- the uninterrupted outer surface portion 326 is disposed on the tapered proximal section 304B.
- the height of the disabling feature 332 above the axis is substantially the same as that of the cylindrical central section 304A.
- the proximal end of the catheter hub can be inversely tapered (with a diameter becoming larger toward the proximal end), or the proximal end can be cylindrical but have a reduced diameter compared to a central section of the catheter hub.
- the proximal end of the catheter hub can be triangular, square, pentagonal, hexagonal, or can have any other regular or irregular geometric shape.
- the shape, length, thickness, and positioning of the cantilevered arm of the resilient clip, as well as the shape and thickness of the pawl, and the surface texture of the catheter hub can be varied to provide the desired frictional interaction between the pawl and the catheter hub.
- the texture of the uninterrupted outer surface portion is an electrical discharge machined (EDM) surface texture finish.
- EDM electrical discharge machined
- the catheter hub 404 does not include stabilization wings, but does include a blood control mechanism 440 for selectively controlling activation of fluid flow in the intravenous catheter assembly 400.
- the blood control mechanism 440 includes a septum 442 and a hollow actuator 444.
- the septum 442 seals the catheter hub 404 until the user distally displaces the actuator 444, for example, by connecting a Luer connector with the catheter hub 404. Such displacement opens the septum 442 and permits fluid flow through the catheter hub 404.
- the septum includes axial channels 446, which are sized to permit passage of air, but not fluid. Blood control mechanisms are described in greater detail, for example, in U.S. Patent No.
- the resilient clip is disposed proximally with respect to the septum 442.
- the assembly 400 rather than a tether, the assembly 400 includes a washer 450 and the introducer needle 406 includes a radial protrusion (not shown) near its distal tip that engages the washer 450 subsequent to the distal tip of the introducer needle 406 proximally passing the resilient clip 412 during needle withdrawal.
- the through-hole in the washer 450 is not large enough to permit passage of the radial protrusion therethrough.
- the resilient clip 412 activates and displaces laterally to the second position, disposing the needle blocker 418 in the path of the introducer needle and preventing subsequent distal displacement of the introducer needle 406 relative to the needle shield 412. Because the washer 450 prevents further proximal displacement of the introducer needle 406 relative to the needle shield 412, the needle shield captures the sharp distal tip of the introducer needle 406, protecting against accidental needle sticks.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Priority Applications (12)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202010867431.3A CN112007259B (zh) | 2015-01-02 | 2015-12-30 | 具有基于摩擦的固位及禁用构件的安全静脉内导管 |
ES15841011T ES2935900T3 (es) | 2015-01-02 | 2015-12-30 | Catéter intravenoso de seguridad con característica de retención e inhabilitación basada en la fricción |
EP22202667.6A EP4166187A1 (fr) | 2015-01-02 | 2015-12-30 | Cathéter intraveineux de sécurité avec élément de rétention et de désactivation à base de frottement |
JP2017535421A JP6974901B2 (ja) | 2015-01-02 | 2015-12-30 | 摩擦に基づく保持力および使用不可機能を持つ安全な静脈カテーテル |
CN201580071856.0A CN107106816B (zh) | 2015-01-02 | 2015-12-30 | 具有基于摩擦的固位及禁用构件的安全静脉内导管 |
BR112017014390-9A BR112017014390B1 (pt) | 2015-01-02 | 2015-12-30 | Conjuntos de cateter e agulha de introdução |
AU2015374014A AU2015374014B2 (en) | 2015-01-02 | 2015-12-30 | Safety intravenous catheter with friction-based retention and disabling feature |
EP15841011.8A EP3240602B1 (fr) | 2015-01-02 | 2015-12-30 | Cathéter intraveineux de sécurité à fonction de rétention et de désactivation basée sur le frottement |
CA2972439A CA2972439C (fr) | 2015-01-02 | 2015-12-30 | Catheter intraveineux de securite a fonction de retention et de desactivation basee sur le frottement |
SG11201705111WA SG11201705111WA (en) | 2015-01-02 | 2015-12-30 | Safety intravenous catheter with friction-based retention and disabling feature |
MX2017008791A MX2017008791A (es) | 2015-01-02 | 2015-12-30 | Cateter intravenoso de seguridad con caracteristica de retencion y desactivacion basada en friccion. |
AU2021200055A AU2021200055B2 (en) | 2015-01-02 | 2021-01-06 | Safety intravenous catheter with friction-based retention and disabling feature |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB1500012.8A GB2529270B (en) | 2015-01-02 | 2015-01-02 | Safety intravenous catheter with friction-based retention and disabling feature |
GB1500012.8 | 2015-01-02 | ||
US14/599,402 | 2015-01-16 | ||
US14/599,402 US9827400B2 (en) | 2015-01-02 | 2015-01-16 | Safety intravenous catheter with friction-based retention and disabling feature |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2016109707A1 true WO2016109707A1 (fr) | 2016-07-07 |
Family
ID=55485273
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2015/068122 WO2016109707A1 (fr) | 2015-01-02 | 2015-12-30 | Cathéter intraveineux de sécurité à fonction de rétention et de désactivation basée sur le frottement |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2016109707A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020508783A (ja) * | 2017-03-01 | 2020-03-26 | シー・アール・バード・インコーポレーテッドC R Bard Incorporated | カテーテル挿入装置 |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4231367A (en) | 1976-10-26 | 1980-11-04 | Viggo Ab | Infusion catheter assembly |
US6749588B1 (en) | 1998-04-09 | 2004-06-15 | Becton Dickinson And Company | Catheter and introducer needle assembly with needle shield |
US20080065015A1 (en) * | 2004-11-01 | 2008-03-13 | Richard Fiser | Locking clip with trigger bushing |
US20090182280A1 (en) * | 2006-11-22 | 2009-07-16 | Becton, Dickinson And Company | Reducing withdrawal force in a safety iv catheter |
US20110160671A1 (en) * | 2008-03-31 | 2011-06-30 | Terumo Kabushiki Kaisha | Indwelling needle assembly |
US8388583B2 (en) | 2009-08-20 | 2013-03-05 | Becton, Dickinson And Company | Systems and methods for providing a flushable catheter assembly |
-
2015
- 2015-12-30 WO PCT/US2015/068122 patent/WO2016109707A1/fr active Application Filing
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4231367A (en) | 1976-10-26 | 1980-11-04 | Viggo Ab | Infusion catheter assembly |
US6749588B1 (en) | 1998-04-09 | 2004-06-15 | Becton Dickinson And Company | Catheter and introducer needle assembly with needle shield |
US20040204681A1 (en) * | 1998-04-09 | 2004-10-14 | Thoresen Stephen L. | Catheter and introducer needle assembly with needle shield |
US20080065015A1 (en) * | 2004-11-01 | 2008-03-13 | Richard Fiser | Locking clip with trigger bushing |
US20090182280A1 (en) * | 2006-11-22 | 2009-07-16 | Becton, Dickinson And Company | Reducing withdrawal force in a safety iv catheter |
US20110160671A1 (en) * | 2008-03-31 | 2011-06-30 | Terumo Kabushiki Kaisha | Indwelling needle assembly |
US8388583B2 (en) | 2009-08-20 | 2013-03-05 | Becton, Dickinson And Company | Systems and methods for providing a flushable catheter assembly |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2020508783A (ja) * | 2017-03-01 | 2020-03-26 | シー・アール・バード・インコーポレーテッドC R Bard Incorporated | カテーテル挿入装置 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
AU2021200055B2 (en) | Safety intravenous catheter with friction-based retention and disabling feature | |
US10092322B2 (en) | Needle guard clip with heel | |
EP1752183B1 (fr) | Méchanisme de protection d'aiguille avec paroi de liaison oblique | |
EP1752178B1 (fr) | Mécanisme de protection d'aiguille avec ressort à lame | |
EP1752185A2 (fr) | Clip protecteur d'aiguilles avec lèvre | |
US11850377B2 (en) | Catheter assemblies and related methods | |
WO2016109707A1 (fr) | Cathéter intraveineux de sécurité à fonction de rétention et de désactivation basée sur le frottement | |
CN107661552B (zh) | 输注装置及针座组件 | |
GB2535671A (en) | Safety intravenous catheter with friction-based retention and disabling feature | |
GB2535670A (en) | Safety intravenous catheter with friction-based retention and disabling feature |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 15841011 Country of ref document: EP Kind code of ref document: A1 |
|
WWE | Wipo information: entry into national phase |
Ref document number: 11201705111W Country of ref document: SG |
|
ENP | Entry into the national phase |
Ref document number: 2972439 Country of ref document: CA |
|
ENP | Entry into the national phase |
Ref document number: 2017535421 Country of ref document: JP Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: MX/A/2017/008791 Country of ref document: MX |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
ENP | Entry into the national phase |
Ref document number: 2015374014 Country of ref document: AU Date of ref document: 20151230 Kind code of ref document: A |
|
REEP | Request for entry into the european phase |
Ref document number: 2015841011 Country of ref document: EP |
|
REG | Reference to national code |
Ref country code: BR Ref legal event code: B01A Ref document number: 112017014390 Country of ref document: BR |
|
ENP | Entry into the national phase |
Ref document number: 112017014390 Country of ref document: BR Kind code of ref document: A2 Effective date: 20170703 |