CA1313099C - I.v. catheter with self-locating needle guard - Google Patents
I.v. catheter with self-locating needle guardInfo
- Publication number
- CA1313099C CA1313099C CA000605276A CA605276A CA1313099C CA 1313099 C CA1313099 C CA 1313099C CA 000605276 A CA000605276 A CA 000605276A CA 605276 A CA605276 A CA 605276A CA 1313099 C CA1313099 C CA 1313099C
- Authority
- CA
- Canada
- Prior art keywords
- needle
- catheter
- guard
- hub
- engaging means
- 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.)
- Expired - Lifetime
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
- 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
-
- 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
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3273—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel freely sliding on needle shaft without connection to syringe or needle
Abstract
I.V. CATHETER WITH SELF-LOCATING NEEDLE GUARD
Abstract of the Disclosure An I.V. catheter is described, including a catheter and hub assembly and a needle and hub assembly. A needle guard, including a tubular distal portion and a split proximal flange, is located about the needle at the distal end of the needle hub. The needle includes a slot near the needle tip. As the needle assembly is withdrawn from the catheter, the needle guard slides along the needle until the split flange engages the needle slot, which locks the tubular distal portion of the guard over the needle tip.
Abstract of the Disclosure An I.V. catheter is described, including a catheter and hub assembly and a needle and hub assembly. A needle guard, including a tubular distal portion and a split proximal flange, is located about the needle at the distal end of the needle hub. The needle includes a slot near the needle tip. As the needle assembly is withdrawn from the catheter, the needle guard slides along the needle until the split flange engages the needle slot, which locks the tubular distal portion of the guard over the needle tip.
Description
1 3 1 30qq I.V. CATHETER WITH SELF-LOCATING NEEDL~ GUARD
This invention relates to intravenous (I.V.~ catheters and, in particular, to I.V. catheters which cover the cannula tip after use to prevent accidental injury from used needles.
Intravenous catheters for the infusion of fluids into the peripheral veins of a patient are one of th~ most common devices used in I.V. therapy. I.V. catheters may be produced in two general forms: through-the-needle catheters, in which a catheter is threaded through the needle cannula and into the vein of a patient, and over-the-needle catheters, in which the needle and concentric outer catheter are inserted into the vein and the needle is withdrawn through the emplaced catheter.
A typical over-the-needle I.V. catheter requires the user to remove and then dispose of a contaminated needle after the needle tip and catheter are properly located in the vein of the patient. Once the needle is withdrawn from the catheter, the user's immediate priorities are infusion set connection and site preparation, including the taping of the catheter to the patient. Because of the urgency of these procedures, the needle is normally just dropped conveniently nearby and then retrieved later.
Since the needle at this time is e~posed and located close to where the user is completing work with the catheter, accidental self-inflicted needle injuries are not uncommon. For reasons of the desirability of protecting the user from exposure to hepatitis and AIDS, there is an increasing need to protect the user from accidental needle in~ury .
A catheter design which is directed toward this need .
. : , `
.
is shown in United States Patent No. 4,762,516. The catheter shown in this patent includes an elongate body which houses a sliding needle guard. As the needle is withdrawn from the emplaced catheter, the user pushes the tab at the distal end of the needle guard, thereby sliding the needle guard ou-t of the housing and along the needle, until the distal end of the guard covers the needle tip and the proximal end of the guard locks in the housing. The needle and guard may then be set aside with the needle tip fully protected.
While the arrangement described in this patent provides full protection against accidental needle injury, the requirement of a sliding needle guard which exceeds the length of the needle necessarily requires a rather long and bulky assembly. Moreover, since the user must push the guard tab along the full length of the needle before the guard will lock in place over the needle tip, the arrangement is somewhat cumbersome to operate for users with small hands and fingers.
Accordingly it would be desirable for a needle to be securely protected by a small needle guard, and it would be most preferable for the needle guard to be moved into position over the needle tip automatically upon withdrawal of the needle from the patient, without the intervention of any special motion by the user.
In accordance with the principles of the present invention, an I.V. catheter with a self-locating needle guard is provided. The needle guard is located about the needle at the jointure of the needle and needle hub. Prior to use of the catheter the guard, which is of sufficient length to cover just a distal portion of the needle, is located within the 1 3 1 30q9 catheter hub. At its proximal end the tubular guard includes a split locking flange, which retains the guard within the interior of the catheter hub. The guard will remain within the catheter hub while the needle is withdrawn from the patient until the locking flange engages a slot located near the distal end of the needle. The guard will then lock in place over the needle tip as the needle is fully withdrawn from the catheter.
According to a still further broad aspect of the present invention, there is provided an I.V.
catheter with a self-locating needle guard. A
catheter assembly is provided and includes a catheter attached to a hollow catheter hub. An introducer needle assembly is also provided and includes a hollow needle with a distal tip. The needle is affixed near its proximal end to a needle hub. The distal end of the needle hub is suitable for engagement with the hollow catheter hub. The needle also includes means for engaging a needle guard. The needle guard includes a proximal portion having means for engaging the engaging means of the needle and a distal portion for extending over the needle tip when the proximal portion is engaged with the engaging means of the needle. The needle guard is located proximal the catheter and distal the needle hub and mounted for relative motion with respect to the needle as the needle is withdrawn from -the catheter until the engaging means of the needle guard engages the engaging means of the needle. Retaining means is provided for retaining the needle guard within the catheter hub prior to engagement of the needle engaging means and the needle guard engaging means.
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- 3a -According to a still further broad aspect of the present invention, there is provided an I.V.
catheter with a self-locating needle guard. The catheter comprises a catheter assembly including a catheter attached to a catheter hub. An introducer needle assembly is provided for connection with the catheter assembly and includes a hollow needle with a distal tip and a needle hub. The needle is affixed near its proximal end to extend distally exposed from the distal end of the needle hub. The needle includes means located distal of the distal end of the needle hub for engaging a needle guard. The needle guard is initially located about the needle at the distal end of the needle hub and is capable of axial movement relative to the needle. The needle guard includes a proximal portion having means for engaging the engaging means of the needle and a distal portion for extending over the needle tip when the proximal portion is engaged with the engaging means of the needle. Retaining means is provided for retaining the needle guard within the catheter hub prior to engagement of the needle engaging means and the needle guard engaging means.
'~' - 3b - 1 3 1 3099 In the drawings:
FIGURE 1 illustrates an I.V. catheter in perspective and constructed in accordance with the principles of the present invention;
FIGURE 2 illustrates the I.V. catheter of FIGURE 1 in partial cross-section without a needle guard;
FIGURE 3 illustrates the cross-sectional view of FIGURE 2 with the needle guard in place in the catheter hub;
FIGU~É 4 illustrates the needle quard of FIGURE 3 in cross-sectional detail FIGURE 5 illustrates the needle guard when positioned at the proximal end of the needle; and FIGURE 6 illustrates the needle quard when locked at the distal end of the needle;
FIGURE 7 illustrates in partial cross-section an alternate embodiment of the slotted I.V. catheter needle of the present invention; and FIGURE 8 illustrates in partial cross-section a slotted I.V. catheter needle arranged for prompt blood flash detection.
Referring first to FIGURE 1, an I.V. catheter '~ .
:' :
.....
~4~ 1 3 1 3099 constructed in accordance with the principles of the present invention is shown. The catheter 10 comprises a tube 15 made of fluorinated ethylene propylene or polyurethane material. The tube 15 is tapered at its distal end where it may easily slide into an opening in the patient's body formed by a hollow needle 12. The proximal end of catheter tube 15 is concentrically affi~ed within the distal end of a catheter hub 16, 1~. The dual diameter hub terminates at its proximal end in a tab or fitting 14, suitable for attaching the catheter hub to a tubing set which administers a source of intravenous fluid.
The catheter 10 is engaged by the hollow needle 12, which is affi~ed at its pro~imal end to a needle hub 20.
The needle hub 20 is hollow and includes a pro~imally located flange 2~. Molded to the flange is a hollow flash chamber 26, which is made of a transparent or translucent polymer such as polypropylene or polycarbonate. The proximal end of the needle terminates in the hub 20, just short of the flash chamber.
Inserted into the flash chamher 26 (but shown separated just prior to insertion in FIGURE 1) is a flash plug 30. The flash plug 30 is made of a polymeric material and will frictionally remain in place when inserted into the flash chamber. The flash plug body comprises a smaller diameter distal end 32 sized for a frictional fit in the flash chamber 26, and a somewhat square proximal end 34 with conve~ sides, which enables the flash plug to be easily grasped and inserted into the flash chamber. The flash plug 30 is hollow with an aperture 36 e~tending completely through the flash plug body. The distal opening of the aperture 36 is visible in ~IGURE 1. An insert made of a porous material is located within the aperture 36. The porous insert is pervious to i ~ ` 5- ( ~ 3 1 3~99 the flow of air out of the flash chamber as the chamber fills with blood, but the pores of the insert are small enough to impede any blood flow therethrough.
Referring ne~t ~o FIGURE 2, the catheter 15 and its hub 16, 18, and the needle 12 and needle hub 20 are shown in cross~sectional detail. The pro~imal end of the catheter 15 is secured within passageway 17 of the distal end 16 of the catheter hub by a sleeve 40. The sleeve 40 is positioned within the prosimal end of the lumen of the catheter 15. By forcing sleeve 40 into the lumen of the catheter, the sleeve effects an e~pansion of the pro~imal end of the catheter into contact with the internal surface of the passageway 17, thereby locking the hub and catheter together to prevent axial movement therebetween. The sleeve 40 is outwardly tapered at its pro~imal end to form a flange 42 which acts to securely position the sleeve 40 relative to the passageway 17.
The hollow needle 12 e~tends from its distal tip through the catheter 15 and sleeve 40, and into a passageway 2~ in the center of the needle hub 20. The proximal portion of the needle 12 is affi~ed by epo~y 24 at the distal end of the needle hub 20. The proximal end of the needle 12 extends beyond the epoxy and into the passageway so that the lumen of the needle will not become filled with epoxy during the attachment procedure.
The distal end 28 of the needle hub 20 is of a lesser diameter than the major portion of the needle hub. This lesser diameter end is dimensioned to engage the open pro~imal end of the catheter hub 18.
In a conventional catheter and introducer needle assembly, the lesser diameter distal end of the needle hub is generally elongated and tapered to subs~antially occupy the pro~imal interior of the catheter hub. In the catheter assembly of the present invention, it may be seen that the major portion 22 of the cavity within the proximal end 18 of the catheter hub is unoccupied, with only the needle 12 e~tending through this region. The reason for reserving this space within~the catheter hub is made clear with reference to FIGURE 3.
In FIGURE 3 it may be seen that a needle point guard 30 is located within the cavity of the catheter hub.
FIGURE 4 is an enlarged cross-sectional view of the needle point guard 30, which resembles a flanged cylinder. The cylindrical distal portion 32 of the guard has an internal aperture with a diameter that enables the portion 32 to slide smoothly along the needle 12. The inner diameter of the cylindrical portion 32 is thus just slightly larger than the outer diameter of the needle. At the pro~imal end of the guard 30 is a circular locking flange 34 with a central aperture 36 that is concentric with that of the cylindrical portion 32. The diameter of the flange aperture 36 is slightly less than the outer diameter of the needle 12. The flange 34 and a pro~imal portion of the cylindrical portion 32 is slit horizontally by an expansion slot 38. The needle point guard 30 is made of a flexible material so that the flange and cylindrical portion will flex open and closed again as described below Referring concurrently to FIGURES 3 and 5, when the catheter and introducer needle are assembled prior to use, the needle point guard is slipped over the point of the needle to slide to a position adjacent the distal end of the needle hub 20. Since the flange aperture 36 is slightly smaller than the outside diameter of the needle, the needle will spread the needle point guard open at the ( -7-~3130')9 e~pansion slot 38. The catheter and catheter huh ar_ slipped over the needle until the hub 18 enyages the distal end of the needle hub as shown in FIGURE 3. The needle point guard 30 is thereby enclosed within the cavity 22 of the catheter hub. The spreading of the flange 34 causes the top and bottom of the flange to engage the inner wall of the catheter hub, as indicated at 39. The needle point guard is thus snugly retained within the catheter hub cavity 22. To ensure retention of the needle point guard with;n the cavity 2~, it may further be desirable to form projections e~tending from the inner wall of the catheter hub just proximal the intended location of the guard, as indicated at 44.
After the user has properly positioned the needle tip and distal end of the catheter within the artery or vein of a patient, as indicated by the presence of blood in the flash chamber, the needle and needle hub are withdrawn from the catheter in preparation for attachment of a tubing set to the catheter hub. As the needle is initially withdrawn, the needle point guard 30 slides along the ne~dle, but remains in position in the cavity 22 due to the engagement of the flange 34 and catheter hub at 39. The needle point guard 30 slides along the needle as shown in FIGURE 5. Finally, the needle is withdrawn so that an engagement slot 50 near the tip of the needle 12 becomes aligned with the flange 34. At this moment the expansion slot 38 of the guard springs closed as the rim of the flange about aperture 36 is captured in engagement with the slot 50. Since the flange is no longer spread it i5 no longer retained within the catheter hub, but will leave the cavity 22 in engagement with the needle 12 and slot 50, as shown in FIGURE 6. The needle may then be safely set aside without danger of accidental injury.
In an I.V. catheter constructed in accordance with the principles of the present invent.ion, it may be desirable to insure that the initial "flash~ of blood resulting from successful venipuncture be directed immediately through the needle lumen to the flash chamber 26, without any blood leakage out the engagement slot 50. To provide for this performance, the engagement slot 50 may be covered by a thin membrane 52 as shown in FIGURE 7. The membrane may partially or completely surround the needle 12 at the slot location. The mPmbrane will seal the engagement slot to prevent blood leakage out of the needle at this point, but must be sufficiently fle~ible so that it will distend without rupturing as the guard flange 34 engages the slot S0. The needle point guard 30 will thus be securely engaged in the engagement slot 50 while the membrane 52 prevents any blood leakage throu~h the slotO
However, for some applications it may be desirable to take advantage of the open engagement slot 50. The standard technique for venipuncture requires the practitioner to visualize blood in the needle hub flash chamber to ascertain that the needle tip and catheter are within the vessel. For small sizes of I.V. catheters the flash of blood is very small, and is inhibited from immediate visualization by the length of travel to the flash chamber. Moreover, there is the further distraction of having to avert one's vision between the venipuncture site and the flash chamber at the proximal end of the catheter. Accordingly it would be desirable to provide for more rapid detection of the blood flash, and to obviate the need for the practitioner to avert his vision from the venipuncture site.
These objectives may be met by utilizing the slot 50 for early detection of even a small flash of blood. As -9- ~313099 shown in FIGURE 8, the slot S0 is located just proximal the needle tip and the tapered distal end 19 of the catheter 15. When the blood vessel is punctured the blood will flow up the lumen of the needle to the slot 50, where it will fill the slot cavity as shown at 54. The blood will then flow through the small space between the needle 12 and tlle catheter 15 as shown at 56. When this interlumenal blood flow extends beyond the skin line (indicated schematically by dashed line 60~, the blood will be visible between the catheter and needle as shown at 58. This small flash of blood 58 will thus ~e readily visible through the transparent or translucent catheter at the venipuncture site, indicating to the practitioner that the venipuncture was successful.
It may be appreciated that the detection of blood flash in this manner obviates the need for the flash chamber at the pro~imal end of the needle hub.
Consequently, blood leakage from a vented flash plug may be prevented. Furthermore, it is also not necessary for blood to fill the entire needle lumen which may if desired be blocked or terminated proximal the slot 50. Rapid detection of even a small blood flash is accordingly enhanced.
From the foregoing description of the present invention, additional enhancements and modifications will be apparent to the user. For instance, to insure proper alignment between the engagement slot 50 and the flange 34 of the needle point guard, it may be desirable to form mating slots and projections in the inside of the catheter hub 18 and the outer periphery of the distal end 28 of the needle hub 20 and the edges 39 of the needle point guard.
By tracking the catheter components in this manner the longitudinal edges of the engagement slot 50 will be ~RK-115 maintained i.n alignment with the expansion slot 38 of the guard for assured engagement of the guard flange in the engagement slot.
~RK-115
This invention relates to intravenous (I.V.~ catheters and, in particular, to I.V. catheters which cover the cannula tip after use to prevent accidental injury from used needles.
Intravenous catheters for the infusion of fluids into the peripheral veins of a patient are one of th~ most common devices used in I.V. therapy. I.V. catheters may be produced in two general forms: through-the-needle catheters, in which a catheter is threaded through the needle cannula and into the vein of a patient, and over-the-needle catheters, in which the needle and concentric outer catheter are inserted into the vein and the needle is withdrawn through the emplaced catheter.
A typical over-the-needle I.V. catheter requires the user to remove and then dispose of a contaminated needle after the needle tip and catheter are properly located in the vein of the patient. Once the needle is withdrawn from the catheter, the user's immediate priorities are infusion set connection and site preparation, including the taping of the catheter to the patient. Because of the urgency of these procedures, the needle is normally just dropped conveniently nearby and then retrieved later.
Since the needle at this time is e~posed and located close to where the user is completing work with the catheter, accidental self-inflicted needle injuries are not uncommon. For reasons of the desirability of protecting the user from exposure to hepatitis and AIDS, there is an increasing need to protect the user from accidental needle in~ury .
A catheter design which is directed toward this need .
. : , `
.
is shown in United States Patent No. 4,762,516. The catheter shown in this patent includes an elongate body which houses a sliding needle guard. As the needle is withdrawn from the emplaced catheter, the user pushes the tab at the distal end of the needle guard, thereby sliding the needle guard ou-t of the housing and along the needle, until the distal end of the guard covers the needle tip and the proximal end of the guard locks in the housing. The needle and guard may then be set aside with the needle tip fully protected.
While the arrangement described in this patent provides full protection against accidental needle injury, the requirement of a sliding needle guard which exceeds the length of the needle necessarily requires a rather long and bulky assembly. Moreover, since the user must push the guard tab along the full length of the needle before the guard will lock in place over the needle tip, the arrangement is somewhat cumbersome to operate for users with small hands and fingers.
Accordingly it would be desirable for a needle to be securely protected by a small needle guard, and it would be most preferable for the needle guard to be moved into position over the needle tip automatically upon withdrawal of the needle from the patient, without the intervention of any special motion by the user.
In accordance with the principles of the present invention, an I.V. catheter with a self-locating needle guard is provided. The needle guard is located about the needle at the jointure of the needle and needle hub. Prior to use of the catheter the guard, which is of sufficient length to cover just a distal portion of the needle, is located within the 1 3 1 30q9 catheter hub. At its proximal end the tubular guard includes a split locking flange, which retains the guard within the interior of the catheter hub. The guard will remain within the catheter hub while the needle is withdrawn from the patient until the locking flange engages a slot located near the distal end of the needle. The guard will then lock in place over the needle tip as the needle is fully withdrawn from the catheter.
According to a still further broad aspect of the present invention, there is provided an I.V.
catheter with a self-locating needle guard. A
catheter assembly is provided and includes a catheter attached to a hollow catheter hub. An introducer needle assembly is also provided and includes a hollow needle with a distal tip. The needle is affixed near its proximal end to a needle hub. The distal end of the needle hub is suitable for engagement with the hollow catheter hub. The needle also includes means for engaging a needle guard. The needle guard includes a proximal portion having means for engaging the engaging means of the needle and a distal portion for extending over the needle tip when the proximal portion is engaged with the engaging means of the needle. The needle guard is located proximal the catheter and distal the needle hub and mounted for relative motion with respect to the needle as the needle is withdrawn from -the catheter until the engaging means of the needle guard engages the engaging means of the needle. Retaining means is provided for retaining the needle guard within the catheter hub prior to engagement of the needle engaging means and the needle guard engaging means.
I ~
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.
::
~: .
: . ' ~
,: , . .
.. .. . .
- 3a -According to a still further broad aspect of the present invention, there is provided an I.V.
catheter with a self-locating needle guard. The catheter comprises a catheter assembly including a catheter attached to a catheter hub. An introducer needle assembly is provided for connection with the catheter assembly and includes a hollow needle with a distal tip and a needle hub. The needle is affixed near its proximal end to extend distally exposed from the distal end of the needle hub. The needle includes means located distal of the distal end of the needle hub for engaging a needle guard. The needle guard is initially located about the needle at the distal end of the needle hub and is capable of axial movement relative to the needle. The needle guard includes a proximal portion having means for engaging the engaging means of the needle and a distal portion for extending over the needle tip when the proximal portion is engaged with the engaging means of the needle. Retaining means is provided for retaining the needle guard within the catheter hub prior to engagement of the needle engaging means and the needle guard engaging means.
'~' - 3b - 1 3 1 3099 In the drawings:
FIGURE 1 illustrates an I.V. catheter in perspective and constructed in accordance with the principles of the present invention;
FIGURE 2 illustrates the I.V. catheter of FIGURE 1 in partial cross-section without a needle guard;
FIGURE 3 illustrates the cross-sectional view of FIGURE 2 with the needle guard in place in the catheter hub;
FIGU~É 4 illustrates the needle quard of FIGURE 3 in cross-sectional detail FIGURE 5 illustrates the needle guard when positioned at the proximal end of the needle; and FIGURE 6 illustrates the needle quard when locked at the distal end of the needle;
FIGURE 7 illustrates in partial cross-section an alternate embodiment of the slotted I.V. catheter needle of the present invention; and FIGURE 8 illustrates in partial cross-section a slotted I.V. catheter needle arranged for prompt blood flash detection.
Referring first to FIGURE 1, an I.V. catheter '~ .
:' :
.....
~4~ 1 3 1 3099 constructed in accordance with the principles of the present invention is shown. The catheter 10 comprises a tube 15 made of fluorinated ethylene propylene or polyurethane material. The tube 15 is tapered at its distal end where it may easily slide into an opening in the patient's body formed by a hollow needle 12. The proximal end of catheter tube 15 is concentrically affi~ed within the distal end of a catheter hub 16, 1~. The dual diameter hub terminates at its proximal end in a tab or fitting 14, suitable for attaching the catheter hub to a tubing set which administers a source of intravenous fluid.
The catheter 10 is engaged by the hollow needle 12, which is affi~ed at its pro~imal end to a needle hub 20.
The needle hub 20 is hollow and includes a pro~imally located flange 2~. Molded to the flange is a hollow flash chamber 26, which is made of a transparent or translucent polymer such as polypropylene or polycarbonate. The proximal end of the needle terminates in the hub 20, just short of the flash chamber.
Inserted into the flash chamher 26 (but shown separated just prior to insertion in FIGURE 1) is a flash plug 30. The flash plug 30 is made of a polymeric material and will frictionally remain in place when inserted into the flash chamber. The flash plug body comprises a smaller diameter distal end 32 sized for a frictional fit in the flash chamber 26, and a somewhat square proximal end 34 with conve~ sides, which enables the flash plug to be easily grasped and inserted into the flash chamber. The flash plug 30 is hollow with an aperture 36 e~tending completely through the flash plug body. The distal opening of the aperture 36 is visible in ~IGURE 1. An insert made of a porous material is located within the aperture 36. The porous insert is pervious to i ~ ` 5- ( ~ 3 1 3~99 the flow of air out of the flash chamber as the chamber fills with blood, but the pores of the insert are small enough to impede any blood flow therethrough.
Referring ne~t ~o FIGURE 2, the catheter 15 and its hub 16, 18, and the needle 12 and needle hub 20 are shown in cross~sectional detail. The pro~imal end of the catheter 15 is secured within passageway 17 of the distal end 16 of the catheter hub by a sleeve 40. The sleeve 40 is positioned within the prosimal end of the lumen of the catheter 15. By forcing sleeve 40 into the lumen of the catheter, the sleeve effects an e~pansion of the pro~imal end of the catheter into contact with the internal surface of the passageway 17, thereby locking the hub and catheter together to prevent axial movement therebetween. The sleeve 40 is outwardly tapered at its pro~imal end to form a flange 42 which acts to securely position the sleeve 40 relative to the passageway 17.
The hollow needle 12 e~tends from its distal tip through the catheter 15 and sleeve 40, and into a passageway 2~ in the center of the needle hub 20. The proximal portion of the needle 12 is affi~ed by epo~y 24 at the distal end of the needle hub 20. The proximal end of the needle 12 extends beyond the epoxy and into the passageway so that the lumen of the needle will not become filled with epoxy during the attachment procedure.
The distal end 28 of the needle hub 20 is of a lesser diameter than the major portion of the needle hub. This lesser diameter end is dimensioned to engage the open pro~imal end of the catheter hub 18.
In a conventional catheter and introducer needle assembly, the lesser diameter distal end of the needle hub is generally elongated and tapered to subs~antially occupy the pro~imal interior of the catheter hub. In the catheter assembly of the present invention, it may be seen that the major portion 22 of the cavity within the proximal end 18 of the catheter hub is unoccupied, with only the needle 12 e~tending through this region. The reason for reserving this space within~the catheter hub is made clear with reference to FIGURE 3.
In FIGURE 3 it may be seen that a needle point guard 30 is located within the cavity of the catheter hub.
FIGURE 4 is an enlarged cross-sectional view of the needle point guard 30, which resembles a flanged cylinder. The cylindrical distal portion 32 of the guard has an internal aperture with a diameter that enables the portion 32 to slide smoothly along the needle 12. The inner diameter of the cylindrical portion 32 is thus just slightly larger than the outer diameter of the needle. At the pro~imal end of the guard 30 is a circular locking flange 34 with a central aperture 36 that is concentric with that of the cylindrical portion 32. The diameter of the flange aperture 36 is slightly less than the outer diameter of the needle 12. The flange 34 and a pro~imal portion of the cylindrical portion 32 is slit horizontally by an expansion slot 38. The needle point guard 30 is made of a flexible material so that the flange and cylindrical portion will flex open and closed again as described below Referring concurrently to FIGURES 3 and 5, when the catheter and introducer needle are assembled prior to use, the needle point guard is slipped over the point of the needle to slide to a position adjacent the distal end of the needle hub 20. Since the flange aperture 36 is slightly smaller than the outside diameter of the needle, the needle will spread the needle point guard open at the ( -7-~3130')9 e~pansion slot 38. The catheter and catheter huh ar_ slipped over the needle until the hub 18 enyages the distal end of the needle hub as shown in FIGURE 3. The needle point guard 30 is thereby enclosed within the cavity 22 of the catheter hub. The spreading of the flange 34 causes the top and bottom of the flange to engage the inner wall of the catheter hub, as indicated at 39. The needle point guard is thus snugly retained within the catheter hub cavity 22. To ensure retention of the needle point guard with;n the cavity 2~, it may further be desirable to form projections e~tending from the inner wall of the catheter hub just proximal the intended location of the guard, as indicated at 44.
After the user has properly positioned the needle tip and distal end of the catheter within the artery or vein of a patient, as indicated by the presence of blood in the flash chamber, the needle and needle hub are withdrawn from the catheter in preparation for attachment of a tubing set to the catheter hub. As the needle is initially withdrawn, the needle point guard 30 slides along the ne~dle, but remains in position in the cavity 22 due to the engagement of the flange 34 and catheter hub at 39. The needle point guard 30 slides along the needle as shown in FIGURE 5. Finally, the needle is withdrawn so that an engagement slot 50 near the tip of the needle 12 becomes aligned with the flange 34. At this moment the expansion slot 38 of the guard springs closed as the rim of the flange about aperture 36 is captured in engagement with the slot 50. Since the flange is no longer spread it i5 no longer retained within the catheter hub, but will leave the cavity 22 in engagement with the needle 12 and slot 50, as shown in FIGURE 6. The needle may then be safely set aside without danger of accidental injury.
In an I.V. catheter constructed in accordance with the principles of the present invent.ion, it may be desirable to insure that the initial "flash~ of blood resulting from successful venipuncture be directed immediately through the needle lumen to the flash chamber 26, without any blood leakage out the engagement slot 50. To provide for this performance, the engagement slot 50 may be covered by a thin membrane 52 as shown in FIGURE 7. The membrane may partially or completely surround the needle 12 at the slot location. The mPmbrane will seal the engagement slot to prevent blood leakage out of the needle at this point, but must be sufficiently fle~ible so that it will distend without rupturing as the guard flange 34 engages the slot S0. The needle point guard 30 will thus be securely engaged in the engagement slot 50 while the membrane 52 prevents any blood leakage throu~h the slotO
However, for some applications it may be desirable to take advantage of the open engagement slot 50. The standard technique for venipuncture requires the practitioner to visualize blood in the needle hub flash chamber to ascertain that the needle tip and catheter are within the vessel. For small sizes of I.V. catheters the flash of blood is very small, and is inhibited from immediate visualization by the length of travel to the flash chamber. Moreover, there is the further distraction of having to avert one's vision between the venipuncture site and the flash chamber at the proximal end of the catheter. Accordingly it would be desirable to provide for more rapid detection of the blood flash, and to obviate the need for the practitioner to avert his vision from the venipuncture site.
These objectives may be met by utilizing the slot 50 for early detection of even a small flash of blood. As -9- ~313099 shown in FIGURE 8, the slot S0 is located just proximal the needle tip and the tapered distal end 19 of the catheter 15. When the blood vessel is punctured the blood will flow up the lumen of the needle to the slot 50, where it will fill the slot cavity as shown at 54. The blood will then flow through the small space between the needle 12 and tlle catheter 15 as shown at 56. When this interlumenal blood flow extends beyond the skin line (indicated schematically by dashed line 60~, the blood will be visible between the catheter and needle as shown at 58. This small flash of blood 58 will thus ~e readily visible through the transparent or translucent catheter at the venipuncture site, indicating to the practitioner that the venipuncture was successful.
It may be appreciated that the detection of blood flash in this manner obviates the need for the flash chamber at the pro~imal end of the needle hub.
Consequently, blood leakage from a vented flash plug may be prevented. Furthermore, it is also not necessary for blood to fill the entire needle lumen which may if desired be blocked or terminated proximal the slot 50. Rapid detection of even a small blood flash is accordingly enhanced.
From the foregoing description of the present invention, additional enhancements and modifications will be apparent to the user. For instance, to insure proper alignment between the engagement slot 50 and the flange 34 of the needle point guard, it may be desirable to form mating slots and projections in the inside of the catheter hub 18 and the outer periphery of the distal end 28 of the needle hub 20 and the edges 39 of the needle point guard.
By tracking the catheter components in this manner the longitudinal edges of the engagement slot 50 will be ~RK-115 maintained i.n alignment with the expansion slot 38 of the guard for assured engagement of the guard flange in the engagement slot.
~RK-115
Claims (11)
1. An I.V. catheter with a self-locating needle guard comprising:
a catheter assembly including a catheter attached to a hollow catheter hub;
an introducer needle assembly, including a hollow needle with a distal tip, said needle being affixed near its proximal end to a needle hub, the distal end of said needle hub being suitable for engagement with said hollow catheter hub, and said needle including means for engaging a needle guard;
and a needle guard including a proximal portion having means for engaging said engaging means of said needle and a distal portion for extending over said needle tip when said proximal portion is engaged with said engaging means of said needle, said needle guard located proximal said catheter and distal said needle hub and mounted for relative motion with respect to said needle as said needle is withdrawn from said catheter until said engaging means of said needle guard engages said engaging means of said needle; and retaining means for retaining said needle guard within said catheter hub prior to engagement of said needle engaging means and said needle guard engaging means.
a catheter assembly including a catheter attached to a hollow catheter hub;
an introducer needle assembly, including a hollow needle with a distal tip, said needle being affixed near its proximal end to a needle hub, the distal end of said needle hub being suitable for engagement with said hollow catheter hub, and said needle including means for engaging a needle guard;
and a needle guard including a proximal portion having means for engaging said engaging means of said needle and a distal portion for extending over said needle tip when said proximal portion is engaged with said engaging means of said needle, said needle guard located proximal said catheter and distal said needle hub and mounted for relative motion with respect to said needle as said needle is withdrawn from said catheter until said engaging means of said needle guard engages said engaging means of said needle; and retaining means for retaining said needle guard within said catheter hub prior to engagement of said needle engaging means and said needle guard engaging means.
2. The I.V. catheter of claim 1, wherein said engaging means of said needle comprises an engagement slot located near said distal tip of said needle.
3. The I.V. catheter of claim 2, wherein said distal portion of said needle guard comprises a cylindrical portion having an inner diameter slightly larger than the outer diameter of said needle.
4. The I.V. catheter of claim 3, wherein said proximal portion of said needle guard comprises a flange having a central aperture aligned with said distal cylindrical portion, and said needle guard engaging means includes an axially aligned expansion slot passing through said flange.
5. The I.V. catheter of claim 4, wherein said needle guard becomes locked in engagement with said needle when the rim of said flange aperture engages said engagement slot of said needle.
6. The I.V. catheter of claim 4, wherein the diameter of said flange aperture is less than the outer diameter of said needle, whereby said needle spreads said flange about said expansion slot when the full diameter of said needle passes through said flange aperture.
7. The I.V. catheter of claim 1, wherein said proximal portion of said needle guard comprises a radially extending flange having a central aperture, and said retaining means includes an axially aligned expansion slot passing through said flange, whereby said flange is brought into contact with said catheter hub when said expansion slot opens in response to the passage of said needle through said central aperture.
8. An I.V. catheter with a self-locating needle guard comprising:
a catheter assembly including a catheter attached to a catheter hub;
an introducer needle assembly for connection with said catheter assembly, including a hollow needle with a distal tip and a needle hub, said needle being affixed near its proximal end to extend distally exposed from the distal end of said needle hub, and said needle including means located distal said distal end of said needle hub for engaging a needle guard;
and a needle guard, initially located about said needle at the distal end of said needle hub and capable of axial movement relative to said needle, said needle guard including a proximal portion having means for engaging said engaging means of said needle and a distal portion for extending over said needle tip when said proximal portion is engaged with said engaging means of said needle; and retaining means for retaining said needle guard within said catheter hub prior to engagement of said needle engaging means and said needle guard engaging means.
a catheter assembly including a catheter attached to a catheter hub;
an introducer needle assembly for connection with said catheter assembly, including a hollow needle with a distal tip and a needle hub, said needle being affixed near its proximal end to extend distally exposed from the distal end of said needle hub, and said needle including means located distal said distal end of said needle hub for engaging a needle guard;
and a needle guard, initially located about said needle at the distal end of said needle hub and capable of axial movement relative to said needle, said needle guard including a proximal portion having means for engaging said engaging means of said needle and a distal portion for extending over said needle tip when said proximal portion is engaged with said engaging means of said needle; and retaining means for retaining said needle guard within said catheter hub prior to engagement of said needle engaging means and said needle guard engaging means.
9. The I.V. catheter of claim 1, wherein said catheter hub further includes means for retaining said needle guard within said catheter hub prior to engagement of said needle engaging means and said needle guard engaging means.
10. The I.V. catheter of claim 9, wherein said retaining means includes a projection extending from said catheter hub and abutting said needle guard prior to engagement of said needle engaging means and said needle guard engaging means.
11. The I.V. catheter of claim 3, wherein said proximal portion of said needle guard includes an expandable central aperture which, in its unexpanded condition, has an inner diameter which is less than the outer diameter of said needle.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/217,246 US4952207A (en) | 1988-07-11 | 1988-07-11 | I.V. catheter with self-locating needle guard |
| US217,246 | 1988-07-11 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1313099C true CA1313099C (en) | 1993-01-26 |
Family
ID=22810252
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000605276A Expired - Lifetime CA1313099C (en) | 1988-07-11 | 1989-07-10 | I.v. catheter with self-locating needle guard |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US4952207A (en) |
| EP (1) | EP0352928B2 (en) |
| JP (1) | JP2925167B2 (en) |
| KR (1) | KR0136100B1 (en) |
| CN (1) | CN1027137C (en) |
| AT (1) | ATE83937T1 (en) |
| AU (1) | AU611817B2 (en) |
| BR (1) | BR8903380A (en) |
| CA (1) | CA1313099C (en) |
| DE (1) | DE68904136T2 (en) |
| MX (1) | MX169084B (en) |
| NZ (1) | NZ229821A (en) |
| PH (1) | PH25761A (en) |
| PT (1) | PT91106B (en) |
| ZA (1) | ZA895233B (en) |
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- 1989-07-05 PH PH38906A patent/PH25761A/en unknown
- 1989-07-10 AT AT89306957T patent/ATE83937T1/en not_active IP Right Cessation
- 1989-07-10 PT PT91106A patent/PT91106B/en not_active IP Right Cessation
- 1989-07-10 ZA ZA895233A patent/ZA895233B/en unknown
- 1989-07-10 EP EP89306957A patent/EP0352928B2/en not_active Expired - Lifetime
- 1989-07-10 BR BR898903380A patent/BR8903380A/en not_active IP Right Cessation
- 1989-07-10 DE DE68904136T patent/DE68904136T2/en not_active Expired - Lifetime
- 1989-07-10 CA CA000605276A patent/CA1313099C/en not_active Expired - Lifetime
- 1989-07-10 KR KR1019890009776A patent/KR0136100B1/en not_active IP Right Cessation
- 1989-07-11 AU AU38027/89A patent/AU611817B2/en not_active Expired
- 1989-07-11 CN CN89106713A patent/CN1027137C/en not_active Expired - Lifetime
- 1989-07-11 MX MX016763A patent/MX169084B/en unknown
- 1989-07-11 JP JP1177272A patent/JP2925167B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| US4952207A (en) | 1990-08-28 |
| ATE83937T1 (en) | 1993-01-15 |
| NZ229821A (en) | 1991-06-25 |
| MX169084B (en) | 1993-06-21 |
| CN1027137C (en) | 1994-12-28 |
| AU3802789A (en) | 1990-01-11 |
| CN1039728A (en) | 1990-02-21 |
| EP0352928B2 (en) | 1995-08-30 |
| ZA895233B (en) | 1991-03-27 |
| JPH0299070A (en) | 1990-04-11 |
| PH25761A (en) | 1991-10-18 |
| KR0136100B1 (en) | 1998-04-25 |
| PT91106A (en) | 1990-02-08 |
| KR900001386A (en) | 1990-02-27 |
| PT91106B (en) | 1997-08-29 |
| BR8903380A (en) | 1990-02-13 |
| JP2925167B2 (en) | 1999-07-28 |
| EP0352928B1 (en) | 1992-12-30 |
| EP0352928A1 (en) | 1990-01-31 |
| DE68904136D1 (en) | 1993-02-11 |
| AU611817B2 (en) | 1991-06-20 |
| DE68904136T2 (en) | 1996-01-25 |
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