US20050131350A1 - IV catheter introducer with retractable needle - Google Patents
IV catheter introducer with retractable needle Download PDFInfo
- Publication number
- US20050131350A1 US20050131350A1 US11/042,941 US4294105A US2005131350A1 US 20050131350 A1 US20050131350 A1 US 20050131350A1 US 4294105 A US4294105 A US 4294105A US 2005131350 A1 US2005131350 A1 US 2005131350A1
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- United States
- Prior art keywords
- needle
- housing
- needle holder
- plunger
- catheter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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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
- A61M25/06—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
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
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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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
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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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0693—Flashback chambers
-
- 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
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
- A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
Definitions
- the invention is a medical device used to insert a catheter into a patient's body, especially for the intravenous delivery of a fluid. More particularly, the invention is a catheter introducer having a retractable needle that prevents reuse and avoids needle stick injuries to medical personnel and others.
- Catheter insertion devices are well known. When a catheter is inserted into a patient for the intravenous delivery of a fluid, a disposable needle passing through the catheter is utilized to puncture a vein to permit entry of the catheter. The needle is then withdrawn, leaving the catheter in place for connection to an IV bag or bottle, or to be capped for later use.
- An IV catheter introducer is therefore needed that can be manufactured economically and reliably at high speed, that will not retract the needle prematurely, that can be operated with one hand, and that will fully protect the user and others from accidental sticks and exposure to blood-borne pathogens.
- a single use IV catheter introducer is disclosed that provides significant advantages over prior art devices, even those comprising retractable needles.
- Principal structural improvements include a reliable detent structure that holds the needle holder and plunger in proper positional alignment prior to needle retraction; following insertion of the catheter; a plunger end cap that vents air displaced from inside the plunger bore during needle retraction; and a transparent viewing area that permits the user to view the flash chamber of the needle holder more easily through the clear plastic housing.
- barrel wings that facilitate one-handed operation and prevent the catheter introducer from rolling when placed on a surface
- a needle holder opening that is tapered to permit easy insertion of the flash chamber plug during manufacture
- a needle holder configuration that prevents the blunt needle end from being occluded during manufacture and makes the flow of blood into the flash chamber more visible.
- the IV catheter introducers of the invention have few parts, can be manufactured reliably at high speed, significantly reduce the likelihood of premature needle retraction during storage and handling, are easily useable in one hand, and will protect medical and other ancillary personnel from accidental needle sticks and the possibility of resultant infection by blood-borne pathogens.
- Use of the present invention also affords significant economic benefits to health care providers and insurers through reduced testing and follow-up costs.
- FIG. 1 is a simplified perspective view of the IV catheter introducer of the invention with the catheter needle ready for use;
- FIG. 2 is an enlarged, cross-sectional elevation view taken along line 2 - 2 of FIG. 1 ;
- FIG. 3 is a view as in FIG. 2 , but with the needle retracted following use;
- FIG. 4 is an enlarged detail view taken from FIG. 2 , and depicts the detent structure holding the landed front opening of the plunger tube in the desired position relative to the retractable needle holder prior to retraction;
- FIG. 5 is an enlarged plan view of the vented plunger end cap
- FIG. 6 is a cross-sectional elevation view taken along line 66 of FIG. 5 .
- IV catheter introducer 10 preferably comprises tubular plastic housing 12 , needle holder assembly 14 , retraction mechanism 16 , plunger assembly 18 and IV catheter 20 .
- Plastic housing 12 has an internal bore 22 that narrows progressively between open end 24 and reduced diameter tip 26 , except for a short distance below inwardly projecting annular ring 102 , as described below.
- Plastic housing 12 is preferably injection molded from a substantially transparent polymeric resin such as polycarbonate to permit easy viewing through sidewall 28 .
- housing 12 generally follows the tapered narrowing of internal bore 22 , so that sidewall 28 has a substantially constant thickness except where it flares outwardly to form laterally extending wings 30 and to provide a longitudinally spaced series of annular ridges 31 nearer to tip 26 to create a textured gripping area for the fingers of the user.
- Needle holder assembly 14 is retractably mounted within the lower portion of housing 12 and preferably comprises a tapered, elongate tubular body 32 , needle 34 and porous plug 36 .
- Body 32 of needle holder assembly 14 is preferably injection molded from a substantially transparent polymeric resin such as polycarbonate and comprises a tapering sidewall of substantially constant thickness that further defines flash chamber 42 , spring guide section 44 and needle support section 46 , each of which has a progressively smaller diameter.
- Tubular body 32 of needle holder assembly 14 is desirably shaped so as to permit needle holder assembly 14 to be inserted into sliding engagement with housing 12 during assembly, as described in greater detail below.
- retraction mechanism 16 which is preferably a spring, is confined within annular space 90 between housing 12 and spring guide section 44 of tubular body 32 , and is held in compression between downwardly facing shoulder 92 of tubular body 32 and upwardly facing shoulder 94 of housing 12 .
- this embodiment uses a compressed spring that exerts a retraction force by expanding, other similarly effective means such as an extension spring can likewise be used to retract the needle.
- Needle 34 is hollow and has a beveled end 48 , which is inserted into a patient's vein during use, and a blunt end 50 that extends into flash chamber 42 .
- a longitudinally extending bore provides fluid communication through needle 34 between beveled end 48 and blunt end 50 .
- Needle 34 is preferably insert molded into needle support section 46 of tubular body 32 to create an insert molded needle. However, needle 34 can be glued or sonically welded into body 32 if desired.
- a tapered needle insertion opening 47 is desirably provided at the lower end of needle support section 46 if needle 34 is to be inserted after molding needle support section 46 .
- porous plug 36 that frictionally engages the walls of annular recess 55 in body 32 .
- the insertion of porous plug 36 into tubular body 32 is preferably made easier by tapered inside wall 54 adjacent to end 52 .
- Porous plug 36 is preferably made of any suitable porous material that will allow air to be displaced out of needle 34 and flash chamber 42 by blood rising through needle 34 following insertion into a vein, but will prevent any such minor amount of blood from exiting flash chamber 42 .
- a significant advantage of IV catheter introducer 10 disclosed herein is that flash chamber 42 is visible through only two layers of clear plastic: the transparent wall of tubular body 32 around flash chamber 42 ; and the transparent wall of housing 12 . With many devices disclosed in the prior art, the user must peer through three or more plastic layers to view the flash chamber, making it more difficult to observe when blood begins entering the chamber.
- Plunger assembly 18 preferably comprises a polymeric plunger tube 40 having a substantially cylindrical sidewall with a lower end portion 56 that is proximal to end 52 of tubular body 32 of needle holder assembly 14 , and an upper end portion 58 that projects longitudinally outward from open end 24 of housing 12 .
- Plunger tube 40 is preferably injection molded from a polymeric resin, and most preferably, from a substantially transparent polymer such as polycarbonate.
- Lower end portion 56 of plunger assembly 18 releasably engages tubular body 32 of needle holder assembly 14 and cooperates with needle holder assembly 14 to form the detent structure of the invention as described in greater detail below in relation to FIG. 4 .
- Upper end portion 58 of plunger tube 40 preferably comprises a small, radially extending annular flange 60 surrounding a tapered annular recess 62 in surface 64 that receives and frictionally engages end cap 66 , which is further described and explained in relation to FIGS. 5 and 6 .
- upper end 58 of plunger assembly 18 desirably extends from about 1.5 to about 3 inches from housing 12 so that upper end 58 can be nestled against the palm of the hand while the user's fingers grip wings 30 or annular ridges 31 of housing 12 to facilitate one-handed operation. Pulling back on housing 12 with the fingers triggers retraction of needle holder assembly 14 , as discussed below in relation to FIG. 3 .
- end cap 66 is preferably molded from a polymeric resin and, most preferably, from a resin that is pigmented in a color chosen to correspond to the gauge of needle 34 , shown in FIGS. 1-2 , to assist users in readily differentiating among IV catheter introducers 10 having different sized needles.
- End cap 66 preferably further comprises a substantially continuous, circular end wall 68 connected to a longitudinally extending annular skirt 70 that is inwardly tapered to provide contacting frictional engagement with annular recess 62 of plunger tube 40 as previously described. It should be understood that there are many ways of engaging end cap 66 into upper end portion 58 of plunger tube 40 .
- Vent hole 72 is preferably centrally disposed in end wall 68 and is desirably surrounded by surface relief features such as a plurality of outwardly extending molded ribs 74 that extend across surface 68 . Ribs 74 are preferably of sufficient number, spacing and height that vent hole 72 is not blocked by the hand of the user, even when part of the hand is placed over end cap 66 during operation of IV catheter introducer 10 . Vent hole 72 is preferably large enough to rapidly vent the volume of air displaced from retraction cavity 76 when needle holder assembly 14 is retracted into plunger tube 40 following insertion of the catheter.
- IV catheter 20 preferably includes a flexible rubber or plastic cannula 78 and a hub 80 having a needle channel 82 and a tubular section 84 with an annular flange 86 defining an opening 88 having a diameter such that opening 88 will receive and frictionally engage tip 26 of housing 12 .
- At the end of cannula 78 is an inwardly tapered end 81 that provides an interference fit near beveled end 48 of needle 34 .
- needle 34 is inserted through flexible cannula 78 and inwardly tapered end 81 , with beveled end 48 extending slightly beyond the inwardly tapered end 81 .
- the inside diameter of cannula 78 is preferably slightly greater than the outside diameter of needle 34 to permit easy retraction of needle 34 through cannula 78 following insertion.
- Hub 80 is preferably also adapted for easy connection to a convention IV tubing connector following retraction of needle 34 and removal of tip 26 from tubular section 84 of hub 80 .
- IV catheter introducer 10 of the invention is preferably assembled by dropping retraction spring 16 through opening 22 into housing 12 .
- Retraction spring 16 which is a coil spring biased against compression, preferably has a diameter that causes it to seat just above inclined annular shoulder 94 inside housing 12 , where it is supported in substantially vertical alignment by section 33 of sidewall 28 .
- Pre-manufactured needle holder assembly 14 is then inserted downwardly through open end 22 of housing 12 , with beveled end 48 of needle 34 passing downwardly through retraction spring 16 and tip 26 of housing 12 , until inclined annular shoulder 96 of tubular body 32 abuts against shoulder 94 of housing 12 .
- spring 16 can be placed over needle holder assembly 14 prior to insertion of needle holder assembly 14 into housing 12 .
- needle 34 can be glued or sonically welded into needle holder assembly 14 after needle holder assembly 14 is inserted into housing 12 .
- Inclined annular shoulder 92 of tubular body 32 preferably will not contact inclined annular shoulder 98 , to permit shoulder 96 to seat properly against shoulder 94 .
- lower end portion 56 of pre-manufactured plunger assembly 18 is next introduced into housing 12 through opening 22 .
- nose 104 of plunger tube 40 reaches and slides over end 52 of tubular body 32 of needle holder assembly 14 .
- radially extending annular boss 100 on plunger tube 40 is still disposed above inwardly projecting annular ring 102 of housing 12 , and the inside diameter of plunger tube 40 at nose 104 is sufficiently greater than the outside diameter of end 52 to permit lower end portion 56 of plunger tube 40 to slidably engage the portion of tubular body 32 that is adjacent to end 52 .
- annular boss 100 engages and overrides annular ring 102 .
- Annular ring 102 then resists rearward movement of plunger tube assembly 18 and combined needle holder assembly 14 once they are installed in the housing with the needle extended for use. If there is an attempt to withdraw the plunger tube assembly 18 from housing 12 , the shoulder of annular boss 100 will contact the shoulder of annular ring 102 and prevent the withdrawal unless there is an exertion of substantial force.
- annular ring 102 is desirably sufficiently small to allow for the withdrawal of a molding tool during the manufacturing process. Referring to FIG. 4 , a detail view taken from FIG.
- plunger tube 40 continues to slide downwardly over tubular body 32 of the needle holder assembly until inwardly facing annular boss 106 on the inside surface of lower end portion 56 reaches and snaps into engagement with cooperatively sized and aligned, outwardly facing annular recess 108 of tubular body 32 .
- the configuration and dimensions of annular boss 106 and annular recess 108 cause boss 106 to be biased radially inward into annular recess 108 .
- boss 106 on the inside of plunger tube 40 is not required to be circumferentially coextensive with annular recess 108 of tubular body 32 .
- boss 106 can instead comprise a circumferentially spaced array of discrete, inwardly extending bumps that are biased into engagement with recess 108 .
- recess 108 extend completely around tubular body so that the slidable engagement between plunger tube 40 and tubular body 32 does not require a specific rotational alignment between the two parts.
- boss 106 and recess 108 are preferably such that the force required to slidably disengage boss 106 from recess 108 by forcing plunger tube 40 farther down into housing 12 is greater than the biasing force being exerted against needle holder assembly 14 by compressed retraction spring 16 and by the additional force that is exerted upwardly on the needle 34 during catheter insertion procedures.
- IV catheter 20 can be assembled to tip 26 of housing 12 prior to the insertion of needle holder assembly 14 and plunger assembly 18 into housing 12 .
- plunger assembly 18 and needle holder assembly 14 (sometimes referred to as a needle support assembly) can also be assembled to each other prior to insertion into housing 12 .
- the frictional engagement between boss 106 and recess 108 when they are cooperatively engaged is preferably sufficient to permit needle holder assembly 14 and plunger assembly 18 to be inserted together into housing 12 .
- Beveled needle end 48 and a portion of cannula 78 are desirably inserted into a patient's vein while grasping annular ridges 31 of housing 12 with the thumb and fingers.
- needle holder assembly 14 is retracted by grasping wings 30 or annular ridges 31 with one's fingers, or thumb and fingers, and then using the palm or heel of the hand against end cap 66 to force plunger tube 40 farther down into housing 12 .
- the frictional engagement between boss 106 and recess 108 is over-pressured, causing boss 106 to ride up onto surface 112 of tubular body 32 .
- retraction spring 16 is fully expanded and top end 52 of needle holder assembly 14 is at least partially withdrawn into retraction cavity 76 .
- Air previously present in retraction cavity 76 of plunger tube 40 has been vented through vent hole 72 as needle holder assembly 14 moved upwardly within the cavity in response to expansion by retraction spring 16 .
- Top end 52 of needle holder assembly 14 has moved upward within retraction cavity 76 sufficiently that beveled end 48 of needle 34 is withdrawn into housing 12 .
- tip 26 of housing 12 can be safely detached from IV hub 80 .
- the improved IV catheter introducer of the invention is well suited for automated manufacture and assembly. Aside from the catheter, needle and spring, only a housing, retractable needle holder and a capped, vented plunger tube are needed.
- housing 12 can be made in a straight configuration with a straight internal wall, it is preferably made with a stepped configuration that, with the exception of the lower shoulder of annular ring 102 , tapers inwardly from top to bottom. This taper makes it easy to withdraw a core mandrel used in the molding process.
- beveled end 48 of needle 34 is preferably protected during the manufacturing process, shipping and storage by a tubular cover that slides upwardly over the outside of cannula 78 , preventing the needle from being damaged.
- An important aspect of the subject IV catheter introducer is the fact that the operator can conveniently operate the retractable introducer structure with one hand.
- One handed operation is possible because the plunger tube desirably extends about 1.5 to about 3 inches past where the wings of the housing are located. This allows force to be applied against the plunger tube by the fleshy part of the palm while using the fingers behind the wings or the annular ridges of the housing to resist the force and smoothly initiate retraction.
- the other hand remains free to grasp the hub of the catheter. Timing for freeing the hub from the introducer device and attaching an IV tube to the hub is under complete control of the operator.
- the hub of the catheter can be separated from the insertion device, which can then be safely set aside while the connection is then made to the IV tube or other device that is to be connected to the patient.
- the catheter introducer can be safely set aside without concern onto a bed or tray, because the needle has already been safely retracted before the catheter assembly is disconnected from the housing.
- the operator can both hear and see that the needle is safely retracted and immediately disengage and safely set aside the device to free his hand for use in making the necessary IV connection before loss of fluid from the patient occurs.
- the IV catheter introducer of the invention does not have to resist as much force imposed by the needle on the retraction parts as does a conventional syringe that is required to puncture a rubber seal commonly used on vials. Consequently, the retractable parts need only be able to resist the force encountered during normal clinical use without retracting. With the apparatus disclosed herein, dimensional tolerances and differential thermal expansion rates are less critical than with devices where the only frictional engagement is provided by surface-to-surface contact between smooth facing surfaces.
- the IV catheter introducer disclosed herein is less likely to retract the needle prematurely than prior art devices, even when subjected to rough handling and widely varying temperatures and humidity during shipment and storage prior to use.
- the invention has a simple, streamlined shape and a retraction spring that is simpler to operate and more reliable than others previously used.
- the device can be operated with one hand in any rotational position where the wings are accessible because it has no external latches that require placing the device in a particular orientation. Further, the wings prevent the catheter introducer from rolling when placed on an oblique surface. With the device held in the hand, the retraction force is applied linearly along the main longitudinal axis. A very short stroke movement is sufficient to trigger retraction. Successful retraction is noted both visually and audibly because the operator can easily see the retracted parts in the housing and retraction creates an unobtrusive noise.
Abstract
An IV catheter introducer having a retractable needle holder and a tubular plunger that are held by a detent structure in a preferred positional relationship prior to and during insertion of the catheter. Following insertion, the plunger is pushed past the detent structure, permitting a compressed spring to force the needle holder upwardly into the plunger. A vented end cap in the plunger permits rapid venting of air displaced during retraction of the needle holder. The needle holder includes a flash chamber that is easily viewable through a clear plastic housing. Wings are provided on the housing to facilitate one-handed operation of the device. A method for assembling the subject catheter introducer is also disclosed.
Description
- This application is a continuation of U.S. application Ser. No. 10/047,662, filed Oct. 26, 2001.
- 1. Field of the Invention
- The invention is a medical device used to insert a catheter into a patient's body, especially for the intravenous delivery of a fluid. More particularly, the invention is a catheter introducer having a retractable needle that prevents reuse and avoids needle stick injuries to medical personnel and others.
- 2. Description of Related Art
- Catheter insertion devices are well known. When a catheter is inserted into a patient for the intravenous delivery of a fluid, a disposable needle passing through the catheter is utilized to puncture a vein to permit entry of the catheter. The needle is then withdrawn, leaving the catheter in place for connection to an IV bag or bottle, or to be capped for later use.
- In recent years, because of the prevalence of blood-borne pathogens such as HIV hepatitis, there has been an increasing need for catheter introducers that prevent accidental needle stick injuries to medical personnel and to other employees who handle trash, laundry or other refuse containing used needles. As a result, new products have been designed that incorporate special needle covers or mechanisms for retracting the needle following use. Such devices are disclosed, for example, in U.S. Pat. Nos. 4,747,831; 4,828,548; 5,129,884; 5,501,675; 5,817,058 and 5,989,220. Many of the prior art devices contain numerous complicated parts that substantially increase manufacturing costs and interfere with the user's ability to feel when the needle is properly inserted into the patient. Other devices require two-handed operation or are prone to premature needle retraction during shipment, storage and handling.
- An IV catheter introducer is therefore needed that can be manufactured economically and reliably at high speed, that will not retract the needle prematurely, that can be operated with one hand, and that will fully protect the user and others from accidental sticks and exposure to blood-borne pathogens. These and other advantages are provided by the invention disclosed below.
- A single use IV catheter introducer is disclosed that provides significant advantages over prior art devices, even those comprising retractable needles. Principal structural improvements include a reliable detent structure that holds the needle holder and plunger in proper positional alignment prior to needle retraction; following insertion of the catheter; a plunger end cap that vents air displaced from inside the plunger bore during needle retraction; and a transparent viewing area that permits the user to view the flash chamber of the needle holder more easily through the clear plastic housing. Other improvements include barrel wings that facilitate one-handed operation and prevent the catheter introducer from rolling when placed on a surface, a needle holder opening that is tapered to permit easy insertion of the flash chamber plug during manufacture, and a needle holder configuration that prevents the blunt needle end from being occluded during manufacture and makes the flow of blood into the flash chamber more visible.
- The IV catheter introducers of the invention have few parts, can be manufactured reliably at high speed, significantly reduce the likelihood of premature needle retraction during storage and handling, are easily useable in one hand, and will protect medical and other ancillary personnel from accidental needle sticks and the possibility of resultant infection by blood-borne pathogens. Use of the present invention also affords significant economic benefits to health care providers and insurers through reduced testing and follow-up costs.
- The apparatus of the invention is further described and explained in relation to the following figures of the drawing wherein:
-
FIG. 1 is a simplified perspective view of the IV catheter introducer of the invention with the catheter needle ready for use; -
FIG. 2 is an enlarged, cross-sectional elevation view taken along line 2-2 ofFIG. 1 ; -
FIG. 3 is a view as inFIG. 2 , but with the needle retracted following use; -
FIG. 4 is an enlarged detail view taken fromFIG. 2 , and depicts the detent structure holding the landed front opening of the plunger tube in the desired position relative to the retractable needle holder prior to retraction; -
FIG. 5 is an enlarged plan view of the vented plunger end cap; and -
FIG. 6 is a cross-sectional elevation view taken alongline 66 ofFIG. 5 . - Like reference numerals are used to describe like parts in all figures of the drawings.
- Referring to
FIGS. 1-2 , IV catheter introducer 10 preferably comprises tubularplastic housing 12,needle holder assembly 14,retraction mechanism 16,plunger assembly 18 and IVcatheter 20.Plastic housing 12 has aninternal bore 22 that narrows progressively betweenopen end 24 and reduceddiameter tip 26, except for a short distance below inwardly projectingannular ring 102, as described below.Plastic housing 12 is preferably injection molded from a substantially transparent polymeric resin such as polycarbonate to permit easy viewing throughsidewall 28. The outside diameter ofhousing 12 generally follows the tapered narrowing ofinternal bore 22, so thatsidewall 28 has a substantially constant thickness except where it flares outwardly to form laterally extendingwings 30 and to provide a longitudinally spaced series ofannular ridges 31 nearer to tip 26 to create a textured gripping area for the fingers of the user. -
Needle holder assembly 14 is retractably mounted within the lower portion ofhousing 12 and preferably comprises a tapered, elongatetubular body 32,needle 34 andporous plug 36.Body 32 ofneedle holder assembly 14 is preferably injection molded from a substantially transparent polymeric resin such as polycarbonate and comprises a tapering sidewall of substantially constant thickness that further definesflash chamber 42,spring guide section 44 andneedle support section 46, each of which has a progressively smaller diameter.Tubular body 32 ofneedle holder assembly 14 is desirably shaped so as to permitneedle holder assembly 14 to be inserted into sliding engagement withhousing 12 during assembly, as described in greater detail below. The upper end portion oftubular body 32 is adapted to releasably engagelower end 56 ofplunger assembly 18 as described below in relation toFIG. 4 . As viewed inFIG. 2 ,retraction mechanism 16, which is preferably a spring, is confined withinannular space 90 betweenhousing 12 andspring guide section 44 oftubular body 32, and is held in compression between downwardly facingshoulder 92 oftubular body 32 and upwardly facingshoulder 94 ofhousing 12. Although this embodiment uses a compressed spring that exerts a retraction force by expanding, other similarly effective means such as an extension spring can likewise be used to retract the needle. -
Needle 34 is hollow and has abeveled end 48, which is inserted into a patient's vein during use, and ablunt end 50 that extends intoflash chamber 42. A longitudinally extending bore provides fluid communication throughneedle 34 betweenbeveled end 48 andblunt end 50.Needle 34 is preferably insert molded intoneedle support section 46 oftubular body 32 to create an insert molded needle. However,needle 34 can be glued or sonically welded intobody 32 if desired. A taperedneedle insertion opening 47 is desirably provided at the lower end ofneedle support section 46 ifneedle 34 is to be inserted after moldingneedle support section 46. By using aneedle 34 that is long enough to extend intoflash chamber 42, the bore ofneedle 34 will not become occluded during insert molding. Also, because a minor amount of blood flows upwardly throughneedle 34 intoflash chamber 42 wheneverneedle 34 is introduced into the vein of a patient, makingblunt end 50 visible inflash chamber 42 permits the user to view blood as soon as it entersflash chamber 42, confirming to the user thatneedle 34 is properly positioned inside the vein. - At the top of
flash chamber 42 ofneedle holder assembly 14,end 52 oftubular body 32 is blocked withporous plug 36 that frictionally engages the walls ofannular recess 55 inbody 32. The insertion ofporous plug 36 intotubular body 32 is preferably made easier by tapered insidewall 54 adjacent toend 52.Porous plug 36 is preferably made of any suitable porous material that will allow air to be displaced out ofneedle 34 andflash chamber 42 by blood rising throughneedle 34 following insertion into a vein, but will prevent any such minor amount of blood from exitingflash chamber 42. A significant advantage of IV catheter introducer 10 disclosed herein is thatflash chamber 42 is visible through only two layers of clear plastic: the transparent wall oftubular body 32 aroundflash chamber 42; and the transparent wall ofhousing 12. With many devices disclosed in the prior art, the user must peer through three or more plastic layers to view the flash chamber, making it more difficult to observe when blood begins entering the chamber. -
Plunger assembly 18 preferably comprises apolymeric plunger tube 40 having a substantially cylindrical sidewall with alower end portion 56 that is proximal toend 52 oftubular body 32 ofneedle holder assembly 14, and anupper end portion 58 that projects longitudinally outward fromopen end 24 ofhousing 12.Plunger tube 40 is preferably injection molded from a polymeric resin, and most preferably, from a substantially transparent polymer such as polycarbonate.Lower end portion 56 ofplunger assembly 18 releasably engagestubular body 32 ofneedle holder assembly 14 and cooperates withneedle holder assembly 14 to form the detent structure of the invention as described in greater detail below in relation toFIG. 4 .Upper end portion 58 ofplunger tube 40 preferably comprises a small, radially extendingannular flange 60 surrounding a taperedannular recess 62 insurface 64 that receives and frictionally engagesend cap 66, which is further described and explained in relation toFIGS. 5 and 6 . With IV catheter introducer 10 prepared for use,upper end 58 ofplunger assembly 18 desirably extends from about 1.5 to about 3 inches fromhousing 12 so thatupper end 58 can be nestled against the palm of the hand while the user's fingers gripwings 30 orannular ridges 31 ofhousing 12 to facilitate one-handed operation. Pulling back onhousing 12 with the fingers triggers retraction ofneedle holder assembly 14, as discussed below in relation toFIG. 3 . - Referring to
FIGS. 5 and 6 ,end cap 66 is preferably molded from a polymeric resin and, most preferably, from a resin that is pigmented in a color chosen to correspond to the gauge ofneedle 34, shown inFIGS. 1-2 , to assist users in readily differentiating amongIV catheter introducers 10 having different sized needles.End cap 66 preferably further comprises a substantially continuous,circular end wall 68 connected to a longitudinally extendingannular skirt 70 that is inwardly tapered to provide contacting frictional engagement withannular recess 62 ofplunger tube 40 as previously described. It should be understood that there are many ways of engagingend cap 66 intoupper end portion 58 ofplunger tube 40.End cap 66 may be glued, snapped-on, sonically welded, dual shot molded or engaged by any other similarly effective means. Dual shot molding refers to any molding process that allows different materials or different colored materials to be molded concurrently.Vent hole 72 is preferably centrally disposed inend wall 68 and is desirably surrounded by surface relief features such as a plurality of outwardly extending moldedribs 74 that extend acrosssurface 68.Ribs 74 are preferably of sufficient number, spacing and height that venthole 72 is not blocked by the hand of the user, even when part of the hand is placed overend cap 66 during operation ofIV catheter introducer 10.Vent hole 72 is preferably large enough to rapidly vent the volume of air displaced fromretraction cavity 76 whenneedle holder assembly 14 is retracted intoplunger tube 40 following insertion of the catheter. - Referring again to
FIGS. 1-2 ,IV catheter 20 preferably includes a flexible rubber orplastic cannula 78 and ahub 80 having aneedle channel 82 and atubular section 84 with anannular flange 86 defining anopening 88 having a diameter such thatopening 88 will receive and frictionally engagetip 26 ofhousing 12. At the end ofcannula 78 is an inwardlytapered end 81 that provides an interference fit nearbeveled end 48 ofneedle 34. During the attachment ofhub 80 to tip 26,needle 34 is inserted throughflexible cannula 78 and inwardly taperedend 81, withbeveled end 48 extending slightly beyond the inwardly taperedend 81. The inside diameter ofcannula 78 is preferably slightly greater than the outside diameter ofneedle 34 to permit easy retraction ofneedle 34 throughcannula 78 following insertion.Hub 80 is preferably also adapted for easy connection to a convention IV tubing connector following retraction ofneedle 34 and removal oftip 26 fromtubular section 84 ofhub 80. - Referring to
FIG. 2 ,IV catheter introducer 10 of the invention is preferably assembled by droppingretraction spring 16 throughopening 22 intohousing 12.Retraction spring 16, which is a coil spring biased against compression, preferably has a diameter that causes it to seat just above inclinedannular shoulder 94 insidehousing 12, where it is supported in substantially vertical alignment bysection 33 ofsidewall 28. Pre-manufacturedneedle holder assembly 14 is then inserted downwardly throughopen end 22 ofhousing 12, withbeveled end 48 ofneedle 34 passing downwardly throughretraction spring 16 andtip 26 ofhousing 12, until inclinedannular shoulder 96 oftubular body 32 abuts againstshoulder 94 ofhousing 12. Alternatively,spring 16 can be placed overneedle holder assembly 14 prior to insertion ofneedle holder assembly 14 intohousing 12. Also, if desired,needle 34 can be glued or sonically welded intoneedle holder assembly 14 afterneedle holder assembly 14 is inserted intohousing 12. Inclinedannular shoulder 92 oftubular body 32 preferably will not contact inclinedannular shoulder 98, to permitshoulder 96 to seat properly againstshoulder 94. - Referring to
FIGS. 2 and 4 ,lower end portion 56 ofpre-manufactured plunger assembly 18 is next introduced intohousing 12 throughopening 22. Asplunger tube 40 travels downwardly intohousing 12,nose 104 ofplunger tube 40 reaches and slides overend 52 oftubular body 32 ofneedle holder assembly 14. Whennose 104 reachesend 52, radially extendingannular boss 100 onplunger tube 40 is still disposed above inwardly projectingannular ring 102 ofhousing 12, and the inside diameter ofplunger tube 40 atnose 104 is sufficiently greater than the outside diameter ofend 52 to permitlower end portion 56 ofplunger tube 40 to slidably engage the portion oftubular body 32 that is adjacent to end 52. Asplunger assembly 18 is inserted farther intohousing 12,annular boss 100 engages and overridesannular ring 102.Annular ring 102 then resists rearward movement ofplunger tube assembly 18 and combinedneedle holder assembly 14 once they are installed in the housing with the needle extended for use. If there is an attempt to withdraw theplunger tube assembly 18 fromhousing 12, the shoulder ofannular boss 100 will contact the shoulder ofannular ring 102 and prevent the withdrawal unless there is an exertion of substantial force. However, it should be understood thatannular ring 102 is desirably sufficiently small to allow for the withdrawal of a molding tool during the manufacturing process. Referring toFIG. 4 , a detail view taken fromFIG. 2 ,plunger tube 40 continues to slide downwardly overtubular body 32 of the needle holder assembly until inwardly facingannular boss 106 on the inside surface oflower end portion 56 reaches and snaps into engagement with cooperatively sized and aligned, outwardly facingannular recess 108 oftubular body 32. Referring toFIGS. 2 and 4 , the configuration and dimensions ofannular boss 106 andannular recess 108cause boss 106 to be biased radially inward intoannular recess 108. - It should be understood that
boss 106 on the inside ofplunger tube 40, is not required to be circumferentially coextensive withannular recess 108 oftubular body 32. Thus, for example,boss 106 can instead comprise a circumferentially spaced array of discrete, inwardly extending bumps that are biased into engagement withrecess 108. It is preferred, however, thatrecess 108 extend completely around tubular body so that the slidable engagement betweenplunger tube 40 andtubular body 32 does not require a specific rotational alignment between the two parts. The configuration and dimensions ofboss 106 andrecess 108 are preferably such that the force required to slidably disengageboss 106 fromrecess 108 by forcingplunger tube 40 farther down intohousing 12 is greater than the biasing force being exerted againstneedle holder assembly 14 bycompressed retraction spring 16 and by the additional force that is exerted upwardly on theneedle 34 during catheter insertion procedures.IV catheter 20 can be assembled to tip 26 ofhousing 12 prior to the insertion ofneedle holder assembly 14 andplunger assembly 18 intohousing 12. Alternatively,plunger assembly 18 and needle holder assembly 14 (sometimes referred to as a needle support assembly) can also be assembled to each other prior to insertion intohousing 12. The frictional engagement betweenboss 106 andrecess 108 when they are cooperatively engaged is preferably sufficient to permitneedle holder assembly 14 andplunger assembly 18 to be inserted together intohousing 12. -
Beveled needle end 48 and a portion ofcannula 78 are desirably inserted into a patient's vein while graspingannular ridges 31 ofhousing 12 with the thumb and fingers. Following insertion of the catheter into a patient,needle holder assembly 14 is retracted by graspingwings 30 orannular ridges 31 with one's fingers, or thumb and fingers, and then using the palm or heel of the hand againstend cap 66 to forceplunger tube 40 farther down intohousing 12. When this occurs, the frictional engagement betweenboss 106 andrecess 108, as seen inFIG. 4 , is over-pressured, causingboss 106 to ride up ontosurface 112 oftubular body 32. Continued downward movement ofplunger tube 40 relative totubular body 32, which is firmly seated againsthousing 12, causesboss 106 to drop offinclined shoulder 114 oftubular body 32. When this occurs, there is no remaining significant frictional force being exerted against compressedretraction spring 16, andspring 16 rapidly expands, causingneedle holder assembly 14 to be propelled upwardly intoretraction cavity 76, simultaneously withdrawingneedle 34 at least to a position wherebeveled end 48 is withdrawn intohousing 12. - Referring to
FIG. 3 ,retraction spring 16 is fully expanded andtop end 52 ofneedle holder assembly 14 is at least partially withdrawn intoretraction cavity 76. Air previously present inretraction cavity 76 ofplunger tube 40 has been vented throughvent hole 72 asneedle holder assembly 14 moved upwardly within the cavity in response to expansion byretraction spring 16.Top end 52 ofneedle holder assembly 14 has moved upward withinretraction cavity 76 sufficiently thatbeveled end 48 ofneedle 34 is withdrawn intohousing 12. Whenneedle 34 is in the position shown inFIG. 3 ,tip 26 ofhousing 12 can be safely detached fromIV hub 80. - The improved IV catheter introducer of the invention is well suited for automated manufacture and assembly. Aside from the catheter, needle and spring, only a housing, retractable needle holder and a capped, vented plunger tube are needed. Although
housing 12 can be made in a straight configuration with a straight internal wall, it is preferably made with a stepped configuration that, with the exception of the lower shoulder ofannular ring 102, tapers inwardly from top to bottom. This taper makes it easy to withdraw a core mandrel used in the molding process. Although not illustrated in the drawings, it should be understood thatbeveled end 48 ofneedle 34 is preferably protected during the manufacturing process, shipping and storage by a tubular cover that slides upwardly over the outside ofcannula 78, preventing the needle from being damaged. - An important aspect of the subject IV catheter introducer is the fact that the operator can conveniently operate the retractable introducer structure with one hand. One handed operation is possible because the plunger tube desirably extends about 1.5 to about 3 inches past where the wings of the housing are located. This allows force to be applied against the plunger tube by the fleshy part of the palm while using the fingers behind the wings or the annular ridges of the housing to resist the force and smoothly initiate retraction. The other hand remains free to grasp the hub of the catheter. Timing for freeing the hub from the introducer device and attaching an IV tube to the hub is under complete control of the operator. In one motion, the hub of the catheter can be separated from the insertion device, which can then be safely set aside while the connection is then made to the IV tube or other device that is to be connected to the patient. The catheter introducer can be safely set aside without concern onto a bed or tray, because the needle has already been safely retracted before the catheter assembly is disconnected from the housing. When the fingers pull back on the wings or annular ridges of the housing to trigger retraction, the operator can both hear and see that the needle is safely retracted and immediately disengage and safely set aside the device to free his hand for use in making the necessary IV connection before loss of fluid from the patient occurs.
- The IV catheter introducer of the invention does not have to resist as much force imposed by the needle on the retraction parts as does a conventional syringe that is required to puncture a rubber seal commonly used on vials. Consequently, the retractable parts need only be able to resist the force encountered during normal clinical use without retracting. With the apparatus disclosed herein, dimensional tolerances and differential thermal expansion rates are less critical than with devices where the only frictional engagement is provided by surface-to-surface contact between smooth facing surfaces.
- The IV catheter introducer disclosed herein is less likely to retract the needle prematurely than prior art devices, even when subjected to rough handling and widely varying temperatures and humidity during shipment and storage prior to use. The invention has a simple, streamlined shape and a retraction spring that is simpler to operate and more reliable than others previously used. The device can be operated with one hand in any rotational position where the wings are accessible because it has no external latches that require placing the device in a particular orientation. Further, the wings prevent the catheter introducer from rolling when placed on an oblique surface. With the device held in the hand, the retraction force is applied linearly along the main longitudinal axis. A very short stroke movement is sufficient to trigger retraction. Successful retraction is noted both visually and audibly because the operator can easily see the retracted parts in the housing and retraction creates an unobtrusive noise.
- Other alterations and modifications of the preferred embodiment described above will become apparent to those of ordinary skill in the art upon reading this disclosure, and it is intended that the scope of the invention disclosed herein be limited only by the broadest interpretation of the appended claims to which the inventor is legally entitled.
Claims (1)
1. An IV catheter introducer comprising a tubular housing; a needle holder assembly having a tubular body slidably engaged inside the housing; a retraction mechanism seated in an annular space between the housing and the needle holder assembly; a plunger assembly having a plunger tube releasably engaged with the tubular body inside the housing; and a catheter attached by frictional engagement to the tubular housing; wherein
the needle holder assembly comprises a flash chamber with an interior space that is viewable through no more than two layers of clear plastic.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/042,941 US20050131350A1 (en) | 2001-10-26 | 2005-01-25 | IV catheter introducer with retractable needle |
US12/148,440 US7740615B2 (en) | 2001-10-26 | 2008-04-18 | IV catheter introducer with retractable needle—continuation |
US12/464,555 US8048031B2 (en) | 2001-10-26 | 2009-05-12 | IV catheter introducer |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/047,662 US6872193B2 (en) | 2001-10-26 | 2001-10-26 | IV catheter introducer with retractable needle |
US11/042,941 US20050131350A1 (en) | 2001-10-26 | 2005-01-25 | IV catheter introducer with retractable needle |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/047,662 Continuation US6872193B2 (en) | 2001-10-26 | 2001-10-26 | IV catheter introducer with retractable needle |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US12/148,440 Continuation US7740615B2 (en) | 2001-10-26 | 2008-04-18 | IV catheter introducer with retractable needle—continuation |
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US20050131350A1 true US20050131350A1 (en) | 2005-06-16 |
Family
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US11/042,941 Abandoned US20050131350A1 (en) | 2001-10-26 | 2005-01-25 | IV catheter introducer with retractable needle |
US12/148,440 Expired - Fee Related US7740615B2 (en) | 2001-10-26 | 2008-04-18 | IV catheter introducer with retractable needle—continuation |
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Application Number | Title | Priority Date | Filing Date |
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US12/148,440 Expired - Fee Related US7740615B2 (en) | 2001-10-26 | 2008-04-18 | IV catheter introducer with retractable needle—continuation |
Country Status (2)
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US (2) | US20050131350A1 (en) |
PL (1) | PL207120B1 (en) |
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Publication number | Publication date |
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PL376042A1 (en) | 2005-12-12 |
US20080215009A1 (en) | 2008-09-04 |
US7740615B2 (en) | 2010-06-22 |
PL207120B1 (en) | 2010-11-30 |
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