A common type of catheter assembly includes a peripheral intravenous catheter (“PIVC”) that is over-the-needle. As its name implies, the PIVC that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. The catheter assembly may include a catheter adapter, the PIVC extending distally from the catheter adapter, and the introducer needle extending through the PIVC. The PIVC and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient immediately prior to insertion into the skin. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician may confirm that there is flashback of blood in a flashback chamber of the catheter assembly or in a space between the introducer needle and the PIVC. Once placement of the introducer needle has been confirmed, the clinician may remove the introducer needle, leaving the PIVC in place for future blood withdrawal or fluid infusion.
In some instances, the catheter assembly, such as, for example, the BD INSYTE™ AUTOGUARD™ Shielded IV Catheter, available from Becton Dickinson and Company of Franklin Lakes, New Jersey, may include a push button configured to retract the introducer needle after the PIVC is in place within the vein. A common problem with this type of retraction mechanism is blood splatter due to rapid and/or non-linear retraction of the introducer needle after depression of the push button. The blood splatter may contribute to increased occurrences of blood-borne virus exposures. Silicon gel is often used as a damper to delay a release time of a spring configured to retract the introducer needle, which may reduce the blood splatter. The silicon gel, however, may be messy and/or difficult to apply.
The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced.
The present disclosure relates generally to vascular access. More particularly, the present disclosure relates to a catheter system that includes a needle retraction mechanism, as well as related devices and methods. In some embodiments, the needle retraction mechanism may be configured to reduce blood splatter and thereby reduce a risk of exposure to blood-borne viruses. A first set of embodiments is now described. In some embodiments, a catheter system may include a catheter assembly, which may include a catheter adapter. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter.
In some embodiments, the catheter system may include a needle assembly, which may include a barrel. In some embodiments, the barrel may include a proximal end and a distal end. In some embodiments, the needle assembly may include an introducer needle, which may include a sharp distal tip and a proximal end. In some embodiments, the needle assembly may include a needle hub affixed to the introducer needle and movably disposed in the barrel. In some embodiments, the needle assembly may include a spring disposed around the needle hub.
In some embodiments, the needle assembly may include a push button configured for selective engagement with the needle hub. In some embodiments, the push button may hold the needle hub against the bias of the spring. In some embodiments, the introducer needle may extend beyond the distal end of the barrel and through the catheter when the catheter adapter is adjacent to the distal end of the barrel. In some embodiments, the needle assembly may include a projection extending from the push button for engagement with the catheter adapter to prevent movement of the push button when the catheter adapter is adjacent to the distal end of the barrel. In some embodiments, the needle assembly may include a distally-extending arm contacting an inner surface of the barrel. In some embodiments, the distally-extending arm may be configured to drag along the inner surface of the barrel in response to depression of the push button and expansion of the spring.
In some embodiments, a distal end of the distally-extending arm may include a hook. In some embodiments, the distally-extending arm may be monolithically formed as a single unit with the spring. In some embodiments, the needle assembly may include a clip separate from the spring, and the clip may include the distally-extending arm. In some embodiments, the distally-extending arm may be a first distally-extending arm. In some embodiments, the needle assembly may include a second distally-extending arm opposite the first distally-extending arm. In some embodiments, the clip may include a coil. In some embodiments, a first end of the coil may include the first distally-extending arm, and a second end of the coil may include the second distally-extending arm. In some embodiments, a distal end of the first distally-extending arm may include a hook, and a distal end of the second distally-extending arm may include another hook.
A second set of embodiments is now described. In some embodiments, a catheter system may include a catheter assembly, which may include a catheter adapter. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter.
In some embodiments, the catheter system may include a needle assembly, which may include a barrel. In some embodiments, the barrel may include a proximal end, a distal end, and a side hole between the proximal end of the barrel and the distal end of the barrel. In some embodiments, the needle assembly may include an introducer needle, which may include a sharp distal tip and a proximal end. In some embodiments, the needle assembly may include a needle hub affixed to the introducer needle and movably disposed in the barrel. In some embodiments, the needle hub may include a distally-extending arm forming a push button within the side hole. In some embodiments, the push button may be configured for selective engagement with the barrel.
In some embodiments, the needle assembly may include a spring disposed around the needle hub. In some embodiments, when the push button is within the side hole, the push button may hold the needle hub against the bias of the spring. In some embodiments, in response to depression of the push button, the spring may be configured to expand to retract the introducer needle. In some embodiments, the distally-extending arm may be a first distally-extending arm. In some embodiments, the needle hub may include a second distally-extending arm opposite the first distally-extending arm. In some embodiments, the side hole may be a first side hole. In some embodiments, the barrel may include a second side hole opposite the first side hole, the second distally-extending arm forming another push button within the second side hole. In some embodiments, the other push button may be configured for selective engagement with the barrel. In some embodiments, in response to depression of the push button and the other push button, the spring may be configured to expand to retract the introducer needle. In some embodiments, the catheter system may include a vent plug at a proximal end of the needle hub.
A third set of embodiments is now described. In some embodiments, a catheter system may include a catheter assembly, which may include a catheter adapter. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include a catheter extending from the distal end of the catheter adapter. In some embodiments, the catheter system may include a needle assembly, which may include a telescopic barrel. In some embodiments, the telescopic barrel may include a main barrel and one or more inner sleeves nested within the main barrel. In some embodiments, the main barrel may include a side hole. In some embodiments, the inner sleeve may include a distally-extending arm forming a push button within the side hole. In some embodiments, the push button may be configured for selective engagement with the main barrel.
In some embodiments, the needle assembly may include an introducer needle, which may include a sharp distal tip and a proximal end. In some embodiments, the needle assembly may include a needle hub affixed to the introducer needle and coupled to the telescopic barrel. In some embodiments, the needle assembly may include a spring disposed around the needle hub. In some embodiments, when the push button is within the side hole, the push button may hold the needle hub against the bias of the spring.
In some embodiments, in response to depression of the push button, the spring may be configured to expand. In some embodiments, in response to the spring expanding, the telescopic barrel may expand and the introducer needle may be retracted into the telescopic barrel. In some embodiments, the push button may include a distal stop surface configured to contact a rim of the main barrel to prevent collapsing of the telescopic barrel after the telescopic barrel expands and the introducer needle is retracted into the telescopic barrel. In some embodiments, the distal stop surface may be perpendicular to a longitudinal axis of the telescopic barrel. In some embodiments, the catheter system may include a vent plug at a proximal end of the telescopic barrel.
A fourth set of embodiments is now described. In some embodiments, a catheter system may include a catheter assembly, which may include a catheter adapter. In some embodiments, the catheter adapter may include a distal end, a proximal end, and a catheter adapter lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter assembly may include a catheter extending from the distal end of the catheter adapter.
In some embodiments, the catheter assembly may include a needle assembly. In some embodiments, the needle assembly may include a barrel, which may include a proximal end, a distal end, and a side hole between the proximal end of the barrel and the distal end of the barrel. In some embodiments, the introducer needle may extend beyond the distal end of the barrel and through the catheter.
In some embodiments, the needle assembly may include an introducer needle, which may include a sharp distal tip and a proximal end. In some embodiments, the needle assembly may include a needle hub affixed to the introducer needle. In some embodiments, the needle hub may include a flexible extension disposed within the side hole and holding the needle hub against the bias of the spring. In some embodiments, the needle assembly may include a spring disposed around the needle hub.
In some embodiments, the needle assembly may include a lever arm coupled to the barrel and aligned with the side hole in the barrel. In some embodiments, in response to depression of the lever arm into the side hole, the lever arm may release the flexible extension from the side hole and the spring may expand. In some embodiments, in response to the expanding of the spring, the needle hub may be moved proximally and the introducer needle may be retracted.
In some embodiments, the needle hub may include another flexible extension opposite the flexible extension. In some embodiments, the other flexible extension may be configured to drag along the inner surface of the barrel in response to the expanding of the spring. In some embodiments, a proximal end of the lever arm may include a protrusion. In some embodiments, the flexible extension may be configured to drag along the inner surface of the barrel in response to the expanding of the spring.
It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.
Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Referring now to
When push button 34 is “up” in the non-activated position, a smaller portion of keyhole shaped opening 36 is in communication with a lumen of the barrel 31. In this position, the smaller opening engages the needle hub 33 and holds the needle hub 33 adjacent to the distal end of barrel 31 against the force of the spring 39. The needle hub 33 has a generally hour-glass shape so that its medial portion has a smaller diameter than either end. This shape facilitates engagement between the smaller opening in keyhole shaped opening 36 of the push button 34 and the needle hub 33. When the push button 34 is in the non-activated position, the projection 40 is located inside the catheter adapter 22. Thus, when the catheter 20 is still located on the introducer needle 32 with the catheter adapter 22 adjacent to the distal end of the barrel 31, the projection 40 prevents the push button 34 from being moved “down” into the activated position. The projection 40 generally has a length of between about 0.5 mm and about 2.5 mm. The length used should be long enough so projection 40 engages the catheter adapter 22 when the catheter adapter 22 is adjacent to the distal end of barrel 31. However, the projection 40 should not be so long that it interferes with the use of the catheter 20 and the introducer needle 32.
When the catheter 20 is moved off the introducer needle 32 so the catheter adapter 22 is not adjacent to the distal end of the barrel 31, the push button 34 can be depressed or moved “down,” i.e. activated, because the catheter adapter 22 no longer interferes with the movement of the projection 40. In this position, the larger opening of the keyhole shaped opening 36 no longer engages the needle hub 33. The larger opening of the keyhole shaped opening 36 should be larger than the maximum diameter of the needle hub 33. The spring 39 can thus force the needle hub 33 to the proximal end of the barrel 31 and withdraw the sharp distal tip of the introducer needle 32 into the barrel 31.
The projection 40 on the push button 34 can also be angled. This configuration allows a clinician to activate the push button 34 by pressing down firmly on the push button 34. This downward force will transmit some axial force to the catheter adapter 22 because of a wedge shape of the projection. The catheter adapter 22 will then be advanced in the distal direction clearing the way for complete depression of push button 34. The wedge may be at an angle of between about 15 degrees and about 25 degrees to the longitudinal axis of catheter adapter 22. In some embodiments, the push button 34 of the prior art catheter system 10 may operate similar to the activation latch described in U.S. Pat. No. 5,501,675, filed Dec. 27, 1994, entitled “SAFETY CATHETER ASSEMBLY HAVING SAFETY STOP PUSH BUTTON”, which is hereby incorporated by reference in its entirety.
The spring 39 of the prior art catheter system 10 is uniformly tapered inwardly from a distal end 42 to a proximal end 44 of the spring 39. Thus, an outer diameter and an inner diameter of the spring 39 at the distal end 42 may be greater than an outer diameter and an inner diameter, respectively, of the spring 39 at the proximal end 44. The spring 39 that is uniformly tapered inwardly may contribute to blood splatter when the push button 34 is depressed and the spring 39 expands to force the needle hub 33 to the proximal end of the barrel 31.
Referring now to
In some embodiments, the catheter system 50 may include a needle assembly 62, which may include a barrel 64. In some embodiments, the barrel 54 may act as a grip for a user. In some embodiments, the barrel 64 may include a proximal end 66 and a distal end 68. In some embodiments, the needle assembly 62 may include an introducer needle 70, which may include a sharp distal tip 72 and a proximal end 74. In some embodiments, the needle assembly 62 may include a needle hub 76 affixed to the introducer needle 70 and movably disposed in the barrel 64. In some embodiments, the needle assembly 62 may include a spring 78 disposed around the needle hub 76.
In some embodiments, the needle assembly 62 may include a push button 80 configured for selective engagement with the needle hub 76. In some embodiments, the push button 80 may hold the needle hub 76 against the bias of the spring 78, which may be compressed. In some embodiments, the introducer needle 70 may extend beyond the distal end 68 of the barrel 64 and through the catheter 60 when the catheter adapter 54 is adjacent to the distal end 68 of the barrel 64. In some embodiments, the needle assembly 62 may include a projection 82 extending from the push button 80 for engagement with the catheter adapter 54 to prevent movement or depression of the push button 80 when the catheter adapter 54 is adjacent to the distal end 68 of the barrel 64.
In some embodiments, the needle assembly 62 may include a distally-extending arm 84 contacting an inner surface 86 of the barrel 64. In some embodiments, the distally-extending arm 84 may be configured to drag along the inner surface 86 of the barrel 64 in response to depression of the push button 80 and expansion of the spring 78. In some embodiments, the distal end of the distally-extending arm 84 may drag along the inner surface 86 of the barrel 64 along an entire distance the distal end of the distally-extending arm 84 moves after depression of the push button 80 and during expansion of the spring 78 to withdraw the introducer needle 70.
In some embodiments, a distal end of the distally-extending arm 84 may include a hook 88, which may increase friction between the distally-extending arm 84 and the inner surface 86 of the barrel 64. In some embodiments, the distally-extending arm 84 may create friction between the inner surface 86 and the spring 78, which may decrease a speed of the needle hub 76 when the spring 78 expands and the introducer needle 70 is withdrawn. The decrease in the speed of the needle hub 76 may prevent blood from splattering during withdrawal of the needle hub 76. In some embodiments, due to the decrease in the speed of the needle hub 76 when the introducer needle 70 is withdrawn, the catheter system 50 may not include a septum within the barrel 64 and/or may not include silicon gel or a similar gel. In some embodiments, the distally-extending arm 84 may extend across a clearance or space between a coil portion 90 of the spring and the inner surface 86 of the barrel 64.
In some embodiments, the catheter system 50 may be similar or identical to the prior art catheter system 10 of
Referring now to
Referring now to
In some embodiments, the distally-extending arm 84 may be a first distally-extending arm. In some embodiments, the needle assembly 62 may include a second distally-extending arm 100, which may be opposite the first distally-extending arm. In some embodiments, a first end 102 of the coil 98 may include the first distally-extending arm, and a second end 104 of the coil 98 may include the second distally-extending arm 100. In some embodiments, a distal end of the first distally-extending arm may include the hook 88, and/or a distal end of the second distally-extending arm 100 may include another hook 106.
In some embodiments, the first distally-extending arm and the second distally-extending arm 100 may be configured to drag along the inner surface 86 of the barrel 64 in response to depression of the push button 80 and expansion of the spring 78. In some embodiments, the first distally-extending arm and the second distally-extending arm 100 may drag along the inner surface 86 of the barrel 64 along an entire distance the distal end of the distally-extending arm 84 moves after depression of the push button 80 and during expansion of the spring 78 to withdraw the introducer needle 70. In some embodiments, the first distally-extending arm and the second distally-extending arm 100 may create friction between the inner surface 86 and the spring 78, which may decrease a speed of the needle hub 76 when the spring 78 expands and the introducer needle 70 is withdrawn.
Referring now to
In some embodiments, the catheter system 108 may include a needle assembly 120, which may include a barrel 122. In some embodiments, the barrel 122 may include a proximal end 124, a distal end 126, and a side hole 128 between the proximal end 124 of the barrel 122 and the distal end 126 of the barrel 122. In some embodiments, the needle assembly 120 may include an introducer needle 130, which may include a sharp distal tip 132 and a proximal end 134. In some embodiments, the needle assembly 120 may include a needle hub 136 affixed to the introducer needle 130 and movably disposed in the barrel 122.
In some embodiments, the needle hub 136 may include a distally-extending arm 138 forming a push button 140 within the side hole 128. In some embodiments, the push button 140 may be configured for selective engagement with the barrel 122. In some embodiments, the needle assembly 120 may include a spring 142 disposed around the needle hub 136. In some embodiments, when the push button 140 is within the side hole 128, the push button 140 may hold the needle hub 136 against the bias of the spring 142. In some embodiments, in response to depression of the push button 140, the spring 142 may be configured to expand to retract the introducer needle 130.
In some embodiments, the distally-extending arm 138 may be a first distally-extending arm. In some embodiments, the needle hub 136 may include a second distally-extending arm 144 opposite the first distally-extending arm, which may facilitate linear withdrawal of the needle hub 136. In some embodiments, the side hole 128 may be a first side hole. In some embodiments, the barrel 122 may include a second side hole 146 opposite the first side hole, the second distally-extending arm 144 forming another push button 148 within the second side hole. In some embodiments, the other push button 148 may be configured for selective engagement with the barrel 122. In some embodiments, in response to depression of the push button 140 and the other push button 148, the first distally-extending arm and the second distally-extending arm 144 may slide inside the shield as the spring 142 expands to retract the introducer needle 130. In some embodiments, the push button 140 within the side hole 128 and the other push button 148 within the second side hole 146 may prevent accidental activation or expansion of the spring 142.
In some embodiments, the catheter system 108 may include a vent plug 150 at a proximal end 152 of the needle hub 136. In some embodiments, the catheter system 108 may include a needle cover 154 configured to cover the sharp distal tip 132 when the introducer needle 130 is in an insertion configuration ready for insertion into a patient, such as illustrated, for example, in
In some embodiments, a proximal end of the barrel 122 may include opposing slots 160 each configured to receive one of the distally-extending arm 138 and the second distally-extending arm 144. In some embodiments, the opposing slots 160 may allow the distally-extending arm 138 and the second distally-extending arm 144 to move outwardly after being biased inwardly against an inner surface of the barrel 122. In some embodiments, distal ends of each of the opposing slots 160 may act as a stop, contacting the distally-extending arm 138 and the second distally-extending arm 144 to prevent distal movement of the needle hub 136 after the introducer needle 130 is retracted within the barrel 122. In some embodiments, a bump 162 within a proximal end of the barrel 122 may act as a retention feature and hold the needle hub 136 within the barrel 122.
Referring now to
In some embodiments, the catheter assembly 166 may include a catheter 174 extending from the distal end 170 of the catheter adapter 168. In some embodiments, the catheter system 164 may include a needle assembly 176, which may include a telescopic barrel 178. In some embodiments, the telescopic barrel 178 may include a main barrel 180 and at least one inner sleeve 182 nested within the main barrel 180. In some embodiments, the main barrel 180 may include a side hole 184. In some embodiments, the inner sleeve 182 may include a distally-extending arm 186 forming a push button 188 within the side hole 184. In some embodiments, the push button 188 may be configured for selective engagement with the main barrel 180. In some embodiments, the inner sleeve 182 may be a first inner sleeve 182a, and the telescopic barrel 178 may include a second inner sleeve 182b that nests within the first inner sleeve and the main barrel 180, as illustrated, for example, in
In some embodiments, the needle assembly 176 may include an introducer needle 190, which may include a sharp distal tip 192 and a proximal end 194. In some embodiments, the needle assembly 176 may include a needle hub 196 affixed to the introducer needle 190 and coupled to the telescopic barrel 178. In some embodiments, the needle assembly 176 may include a spring 198 disposed around the needle hub 196. In some embodiments, when the push button 188 is within the side hole 184, the push button 188 may hold the needle hub 196 against the bias of the spring 198.
In some embodiments, in response to depression of the push button 188, the spring 198 may be configured to expand. In some embodiments, in response to the spring 198 expanding, the telescopic barrel 178 may expand and the introducer needle 190 may be retracted into the telescopic barrel 178. In some embodiments, when the introducer needle 190 is retracted within the telescopic barrel 178, the main barrel 180 may surround the sharp distal tip 132 and/or a notch of the introducer needle 130 to reduce a risk of blood escaping the catheter system 164. In some embodiments, the push button 188 may include a distal stop surface 200 configured to contact a rim 202 of the main barrel 180 to prevent collapsing of the telescopic barrel 178 after the telescopic barrel 178 expands and the introducer needle 190 is retracted into the telescopic barrel 178. In some embodiments, the distal stop surface 200 may be perpendicular to a longitudinal axis 204 of the telescopic barrel 178. In some embodiments, the catheter system 164 may include a vent plug 206 at a proximal end of the telescopic barrel 178.
In some embodiments, the catheter system 164 may include a vent plug 206, which may allow passage of air therethrough. In some embodiments, the vent plug 206 may be disposed at a proximal end of the needle hub 196 and may allow collapsing the telescopic barrel 178 or nesting of the at least one inner sleeve 182 within the main barrel 180.
Referring now to
In some embodiments, the catheter assembly 212 may include a needle assembly 224. In some embodiments, the needle assembly 224 may include a barrel 226, which may include a proximal end 228, a distal end 230, and a side hole 232 between the proximal end 228 of the barrel 226 and the distal end 230 of the barrel 226.
In some embodiments, the needle assembly 224 may include an introducer needle 234, which may include a sharp distal tip 236 and a proximal end 238. In some embodiments, the introducer needle 234 may extend beyond the distal end 230 of the barrel 226 and through the catheter 222. In some embodiments, the needle assembly 224 may include a needle hub 240 affixed to the introducer needle 234. In some embodiments, the needle hub 240 may include a flexible extension 242 disposed within the side hole 232 and holding the needle hub 240 against the bias of a spring 244 disposed around the needle hub 240.
In some embodiments, the needle assembly 224 may include a lever arm 246 coupled to the barrel 226 and aligned with the side hole 232 in the barrel 226. In some embodiments, in response to depression of the lever arm 246 into the side hole 232, the lever arm 246 may release the flexible extension 242 from the side hole 232 and the spring 244 may expand. In some embodiments, in response to the expanding of the spring 244, the needle hub 240 may be moved proximally and the introducer needle 234 may be retracted.
In some embodiments, the needle hub 240 may include another flexible extension 248, which may be opposite the flexible extension 248. In some embodiments, the other flexible extension 248 may be configured to drag along an inner surface 250 of the barrel 226 in response to the expanding of the spring 244. In some embodiments, a proximal end 252 of the lever arm 246 may include a protrusion 254. In some embodiments, the flexible extension 242 may be configured to drag along the inner surface 250 of the barrel 226 in response to the expanding of the spring 244.
All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.