CA2405331C - Safety catheter - Google Patents
Safety catheter Download PDFInfo
- Publication number
- CA2405331C CA2405331C CA002405331A CA2405331A CA2405331C CA 2405331 C CA2405331 C CA 2405331C CA 002405331 A CA002405331 A CA 002405331A CA 2405331 A CA2405331 A CA 2405331A CA 2405331 C CA2405331 C CA 2405331C
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- CA
- Canada
- Prior art keywords
- needle
- catheter
- arms
- needle tip
- distal end
- 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.)
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
- A61M2005/325—Means obstructing the needle passage at distal end of a needle protection sleeve
-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
A catheter and introducer needle assembly having a needle attached to a needle hub, and a enlarged area disposed thereon, and a tubular catheter wherein the introducer needle being coaxially received within the catheter. The device has 4 hollow catheter hub attached to the catheter and in fluid communication therewith. The catheter hub has an interior having a raised annular rib disposed thereon. The assembly includes a needle tip protector disposed within the catheter hub and including at least one unrestrained radially extending lip disposed distal to the annular rib so as to retain the protector within the hub. The distal end of the protector does not abut against the hub interior. The protector has a proximal opening at the proximal end having an unrestrained size greater than the size of the needle diameter and smaller than the enlarged area such that when the needle is removed from the catheter the protector remains attached to the needle.
Description
SAFETY CATHETER
Field of the Invention The present invention relates, in general, to intravenous (IV) catheters and, more particularly, to a safety IV catheter with a needle tip protector that will automatically cover the needle tip upon needle withdrawal.
-Background of the Invention I.V. catheters are used primarily to administer fluids directly into a patient's vascular system. The catheter is inserted into a patient's vein by a clinician using a handheld placement device that includes a needle with a sharp distal end. The needle is positioned in the interior hollow portion of the catheter with its sharp distal tip extended slightly beyond the distal edge of the catheter. The proximal end of the needle is connected to a needle hub which is held by the clinician during the insertion procedure.
During the insertion procedure, the clinician inserts the needle and catheter together into the patient's vein. After insertion of the needle point into the vein, the catheter is forwarded into the vein of the patient by the clinician pushing the catheter with their finger.
The clinician then withdraws just the needle by grasping the hub attached to the proximal end of the needle while at the same time applying pressure to the patient's skin at the insertion site, thus holding the catheter fixed in place. The clinician then typically tapes the proximal end of the now inserted catheter to the patient's skin and connects the proximal end of the 25, catheter, containing a Luer connector catheter hub, to the source of the fluid to be administered into the patient's vein.
It is the period of time just as the needle is withdrawn from the catheter that poses great risk to the clinician. The clinician is at risk of an accidental needle stick from the sharp needle which has just been contaminated with a patients blood. This leaves the clinician vulnerable to the transmission of dangerous blood-borne pathogens, including hepatitis and AIDS. The risk of a contaminated needle stick is not isolated just to clinicians. Careless disposal of used needles can put other health care workers at risk as well.
Even others outside the health care profession, for example those involved in the clean-up and final 35 disposal of medical waste, are at risk of an accidental needle stick from a carelessly discarded needle.
A number of "safety" IV catheters have been developed to address the issue of accidental needle stick. For example, in US Patent No. Re. 34,416 to Lemieux, a safety 40 catheter is disclosed which includes an element which covers the needle tip upon removal of the needle from the catheter. The safety element includes a split flange at its proximal end which is expanded by the needle as the needle is inserted into an undersized hole at the center of this flange. The safety element is thus held secure within the catheter hub by inserting the needle through the undersized hole which forces the outside perimeter of the split flange 45 against the inside wall of the catheter hub.
One of the drawbacks to this design is the amount of friction force exerted against the needle by the split flange. A tight fit of the flange against the catheter wall causes great friction against the needle making it difficult to be withdrawn from the catheter by the 50 clinician. A loose fit leaves the flange prone to releasing prematurely from the catheter as the needle is withdrawn, creating the potential that the needle tip will be left exposed.
In US Patent No. 6,117,108 to Woehr et al, a safety IV catheter is described including a resilient needle guard which protects the needle tip upon removal of the needle 55 from the catheter hub. The needle guard includes an arm that includes an opening through which a needle passes causing radial movement of the arm. This radial movement forces the arm into a groove or behind a rib located on the inside of the catheter hub, capturing the needle guard in the catheter hub. A potential issue with this design develops when the needle guard is not properly seated into the catheter hub. If the distal end of the needle guard arm is 60 not in alignment with the groove in the catheter hub, excessive forces are placed on the needle causing a high drag force as the clinician removes the needle. And, since the needle guard arm is not properly seated in the groove, it may prematurely release from the catheter hub upon the removal of the needle leaving the needle tip exposed.
65 The prior art safety catheters all exhibit one or more drawbacks that have thus far limited their usefulness and full acceptance by health-care workers. What is needed therefore is a safety IV catheter that functions reliably, is easy and inexpensive to manufacture, and easy to use.
70 Summarv of the Invention In accordance with the present invention there is provided a catheter and introducer needle assembly including a needle having a diameter, proximal end, attached to a needle hub, a distal end, and a enlarged area disposed therebetween. The assembly further includes a 75 tubular catheter having proximal and distal ends, the introducer needle being coaxially received within the catheter, and a hollow catheter hub having a distal end attached to the proximal end of the catheter and in fluid communication with the catheter. The catheter hub includes an interior having a raised annular rib disposed thereon. The assembly also includes a needle tip protector having a proximal end and a distal end disposed within the catheter 80 hub. The proximal end including at least one unrestrained radially extending lip disposed distal to the annular rib so as to retain the protector within the hub, wherein the distal end of the protector does not abut against the hub interior. The protector having a proximal opening at the proximal end having an unrestrained size greater than the size of the needle diameter and smaller than the enlarged area such that when the needle is removed from the 85 catheter the protector remains attached to the needle.
Field of the Invention The present invention relates, in general, to intravenous (IV) catheters and, more particularly, to a safety IV catheter with a needle tip protector that will automatically cover the needle tip upon needle withdrawal.
-Background of the Invention I.V. catheters are used primarily to administer fluids directly into a patient's vascular system. The catheter is inserted into a patient's vein by a clinician using a handheld placement device that includes a needle with a sharp distal end. The needle is positioned in the interior hollow portion of the catheter with its sharp distal tip extended slightly beyond the distal edge of the catheter. The proximal end of the needle is connected to a needle hub which is held by the clinician during the insertion procedure.
During the insertion procedure, the clinician inserts the needle and catheter together into the patient's vein. After insertion of the needle point into the vein, the catheter is forwarded into the vein of the patient by the clinician pushing the catheter with their finger.
The clinician then withdraws just the needle by grasping the hub attached to the proximal end of the needle while at the same time applying pressure to the patient's skin at the insertion site, thus holding the catheter fixed in place. The clinician then typically tapes the proximal end of the now inserted catheter to the patient's skin and connects the proximal end of the 25, catheter, containing a Luer connector catheter hub, to the source of the fluid to be administered into the patient's vein.
It is the period of time just as the needle is withdrawn from the catheter that poses great risk to the clinician. The clinician is at risk of an accidental needle stick from the sharp needle which has just been contaminated with a patients blood. This leaves the clinician vulnerable to the transmission of dangerous blood-borne pathogens, including hepatitis and AIDS. The risk of a contaminated needle stick is not isolated just to clinicians. Careless disposal of used needles can put other health care workers at risk as well.
Even others outside the health care profession, for example those involved in the clean-up and final 35 disposal of medical waste, are at risk of an accidental needle stick from a carelessly discarded needle.
A number of "safety" IV catheters have been developed to address the issue of accidental needle stick. For example, in US Patent No. Re. 34,416 to Lemieux, a safety 40 catheter is disclosed which includes an element which covers the needle tip upon removal of the needle from the catheter. The safety element includes a split flange at its proximal end which is expanded by the needle as the needle is inserted into an undersized hole at the center of this flange. The safety element is thus held secure within the catheter hub by inserting the needle through the undersized hole which forces the outside perimeter of the split flange 45 against the inside wall of the catheter hub.
One of the drawbacks to this design is the amount of friction force exerted against the needle by the split flange. A tight fit of the flange against the catheter wall causes great friction against the needle making it difficult to be withdrawn from the catheter by the 50 clinician. A loose fit leaves the flange prone to releasing prematurely from the catheter as the needle is withdrawn, creating the potential that the needle tip will be left exposed.
In US Patent No. 6,117,108 to Woehr et al, a safety IV catheter is described including a resilient needle guard which protects the needle tip upon removal of the needle 55 from the catheter hub. The needle guard includes an arm that includes an opening through which a needle passes causing radial movement of the arm. This radial movement forces the arm into a groove or behind a rib located on the inside of the catheter hub, capturing the needle guard in the catheter hub. A potential issue with this design develops when the needle guard is not properly seated into the catheter hub. If the distal end of the needle guard arm is 60 not in alignment with the groove in the catheter hub, excessive forces are placed on the needle causing a high drag force as the clinician removes the needle. And, since the needle guard arm is not properly seated in the groove, it may prematurely release from the catheter hub upon the removal of the needle leaving the needle tip exposed.
65 The prior art safety catheters all exhibit one or more drawbacks that have thus far limited their usefulness and full acceptance by health-care workers. What is needed therefore is a safety IV catheter that functions reliably, is easy and inexpensive to manufacture, and easy to use.
70 Summarv of the Invention In accordance with the present invention there is provided a catheter and introducer needle assembly including a needle having a diameter, proximal end, attached to a needle hub, a distal end, and a enlarged area disposed therebetween. The assembly further includes a 75 tubular catheter having proximal and distal ends, the introducer needle being coaxially received within the catheter, and a hollow catheter hub having a distal end attached to the proximal end of the catheter and in fluid communication with the catheter. The catheter hub includes an interior having a raised annular rib disposed thereon. The assembly also includes a needle tip protector having a proximal end and a distal end disposed within the catheter 80 hub. The proximal end including at least one unrestrained radially extending lip disposed distal to the annular rib so as to retain the protector within the hub, wherein the distal end of the protector does not abut against the hub interior. The protector having a proximal opening at the proximal end having an unrestrained size greater than the size of the needle diameter and smaller than the enlarged area such that when the needle is removed from the 85 catheter the protector remains attached to the needle.
Brief Description of the Drawings The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, 95 together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
Figure 1 is a perspective view of the catheter and needle assembly of the present invention;
Figure 2 is an exploded perspective view of the catheter assembly and needle assembly including the needle tip protector of the present invention;
Figure 3 is a perspective view of the needle tip protector of the present invention;
Figure 4 is an elevation view of Figure 3 taken along line 4 - 4 illustrating the hole positions in the rear flanges of the needle tip protector as manufactured;
Figure 5 is a section view of the catheter assembly and needle assembly taken along 110 line 5 - 5 of Figure 1;
Figure 6 is an enlarged partial section view of Figure 5 illustrating the relative position of the needle tip protector tab and catheter hub rib;
115 Figure 7 is a section view of the catheter hub with needle tip protector installed taken along line 7 - 7 of Figure 5;
Figure 8 is a perspective view of the needle tip protector shown as installed in the catheter hub with the needle inserted there through, catheter hub not shown for clarity;
Figure 1 is a perspective view of the catheter and needle assembly of the present invention;
Figure 2 is an exploded perspective view of the catheter assembly and needle assembly including the needle tip protector of the present invention;
Figure 3 is a perspective view of the needle tip protector of the present invention;
Figure 4 is an elevation view of Figure 3 taken along line 4 - 4 illustrating the hole positions in the rear flanges of the needle tip protector as manufactured;
Figure 5 is a section view of the catheter assembly and needle assembly taken along 110 line 5 - 5 of Figure 1;
Figure 6 is an enlarged partial section view of Figure 5 illustrating the relative position of the needle tip protector tab and catheter hub rib;
115 Figure 7 is a section view of the catheter hub with needle tip protector installed taken along line 7 - 7 of Figure 5;
Figure 8 is a perspective view of the needle tip protector shown as installed in the catheter hub with the needle inserted there through, catheter hub not shown for clarity;
Figure 9 is a perspective view of the needle tip protector shown as removed from the catheter hub and illustrating the needle tip covered by the protector;
Figure 10 is a perspective view of an alternate embodiment of the needle tip protector 125 of the present invention.
Detailed Description of the Invention 130 As used herein, the term "proximal" refers to a location on the catheter and needle assembly with needle tip protector closest to the clinician using the device and thus furthest from the patient on which the device is used. Conversely, the term "distal"
refers to a location farthest from the clinician and closest to the patient.
135 As illustrated in Figures 1 and 2, IV catheter assembly 20 comprises catheter assembly 22 and needle assembly 24. Needle assembly 24 further includes needle tip protector 26. Catheter assembly 22 includes catheter 28 which is a tubular structure having a proximal end 31 and distal end 29. Proximal end 31 of catheter 28 is fixedly attached to catheter hub 30. Catheters are well known in the medical art and one of many suitable 140 materials, most of which are flexible thermoplastics, may be selected for use in catheter 28.
Such materials may include, for example, polyurethane or fluorinated ethylene propylene.
Catheter hub 30 is a generally tubular structure having an internal cavity in fluid communication with the internal lumen of catheter 28. Catheter hub 30 may be made from a suitable, rigid medical grade thermoplastic such as, for example, polypropylene or 145 polycarbonate. For illustration purposes catheter hub 30 is shown translucent, though in actual use it may be translucent or opaque. At the proximal end of catheter hub 30 is integrally attached Luer fitting 32, commonly known in the medical art. Luer fitting 32 provides for secure, leakproof attachment of tubing, syringes, or any of many other medical devices used to infuse or withdraw fluids through the catheter assembly. As is more clearly 150 illustrated in Figures 5 and 6, rib 34 is a raised annular ring integral to and extending from = CA 02405331 2002-09-26 internal sidewall 36 of catheter hub 30. Rib 34 is located approximately mid way between the proximal end and distal end of sidewall 36. Rib 34 plays an important role in securing needle tip protector 26 in catheter hub 30, as will be described in more detail later.
155 Referring again to Figures 1 and 2, needle assembly 24 comprises needle 38, which is a tubular structure with a proximal end 39 and distal end 41, needle hub 40, and needle tip protector 26. Needle tip protector 26 is assembled slidably on needle 38.
Needle 38 is preferably made of stainless steel. Proximal end 39 of needle 38 is fixedly attached to needle hub 40. A bevel 42 is located at the most distal end of needle 38 creating a sharp piercing tip.
160 Needle crimp 44 is located at the distal end of needle 38 proximal to bevel 42 and is larger in diameter than the nominal diameter of needle 38. Needle crimp 44 is created by "coining" an area on the outside diameter of needle 38 resulting in two opposed bumps located approximately 180 degrees across the center axis of needle 38. Coining is a process well known in the metal forming art and involves using a hardened tool to strike a softer object to 165 deform or displace a portion of the softer object. In the present case a portion of the exterior surface of the softer metal needle 38 is displaced by a harder metal tool so as to raise bumps on the exterior surface of needle 38. The resulting crimp 44 is larger in dimension than the nominal diameter of needle 38. Crimp 44 is larger in dimension than the diameter of second flange hole 72 in needle tip protector 26 and is important in preventing the complete removal 170 of needle tip protector 26 from needle 38, as will be described in more detail later. In the preferred embodiment the dimension across crimp 44 is.0001- .004 inches larger than second flange hole 72, dependant upon needle "gauge" size.
Needle hub 40 is generally a tubular structure having an internal cavity in fluid 175 communication with the lumen in needle 38. It is preferably made of a translucent or transparent generally rigid thermoplastic material such as, for example, polycarbonate. At the most proximal end of the internal cavity in needle hub 40 is fixedly attached porous plug 46.
A flashback chamber 48 is created in the cavity distal to porous plug 46.
Porous plug 46 contains a plurality of microscopic openings which are large enough to permit the passage of 180 air and other gasses but small enough to prevent the passage of blood.
Flashback chamber 48 = CA 02405331 2002-09-26 fills with blood upon successful entry of the needle tip into the targeted vein, providing the clinician visual conformation of the correct placement of the needle.
Referring now to all figures, needle tip protector 26 has a proximal end 49 and distal 185 end 50 and is preferably a unitary structure formed from a single piece of thin, resilient material, preferably stainless steel. First flange 66 and second flange 68 are generally square and are integrally connected at right angles to first outer wall 74 and second outer wall 76, respectively. First outer wall 74 is connected at a right angle to first tab flange 78. First tab flange 78 and second tab flange 80 are each formed at angles slightly greater than 90 degrees 190 to second outer wall 76 so that the resulting dimension c is slightly larger than inside diameter d (see Figures 6- 7) across rib 34 in catheter hub 30. In the preferred embodiment angles a and b are each approximately 94.25 degrees. In the preferred embodiment dimension c is approximately .001 - .009 inches larger than dimension d. First flange hole 70 is located in the center of first flange 66 and is over-sized to slidably receive needle 38.
Second flange hole 195 72 and skirt 82 are located in the center of second flange 68. Skirt 82 is integral to second flange hole 72 and is formed by extruding material from second flange hole 72 in a direction distal to second flange 68. This permits for a very close but slidable fit over the nominal diameter of needle 38. Skirt 82 also functions to help maintain alignment of needle 38 to the center axis of needle tip protector 26. As would be understood by one skilled in the art, 200 flange hole 72 would be appropriately sized to the particular needle "gauge" size to which it is designed to receive.
First tab 86 and second tab 88 are connected at right angles to first tab flange 78 and second tab flange 80, respectively, and protrude outward away from the center axis of needle tip 205 protector 26. First tab edge 90, located on the outer portion of first tab 86, and second tab edge 92, located on the outer portion of second tab 88, are each arcuate to approximately match the curve of sidewall 36 in catheter hub 30.
Referring again to Figure 3, first beam 96 extends distally from first outer wall 74 and 210 is angled toward and extends past the center axis of needle tip protector 26. At the distal end I
of first beam 96 is integrally formed curved first lip 98 which extends across and through the center axis of needle tip protector 26. Second beam 100 extends distally from second outer wall 76 and is angled toward and extends past the center axis of needle tip protector 26. At the distal end of second beam 100 is stop flange 102 which extends across and normal to the 215 center axis of needle tip protector 26. At the end of stop flange 102 opposite its connection to second beam 100 is integrally formed curved second lip 104.
Referring now to all figures, needle tip protector 26 is assembled to needle 38 as follows;
The. proximal end of needle 38 is fixedly attached to the distal end of needle hub 40, which contains porous plug 46 fixedly attached to its proximal end;
The distal end of needle 38 is inserted through first flange hole 70 and then through 225 second flange hole 72 in needle tip protector 26, moving from proximal to distal;
First beam 96 and second beam 100 are flexed, as a result of their resilient properties, normal to the center axis of needle tip protector 26 so that needle 38 will pass between first lip 98 and second lip 104 (see Figure 8);
Needle crimp 44 is 'added to the distal end of needle 38 just proximal to bevel 42.
Crimp 44 increases the diameter of needle 38 locally to a dimension larger than the inside diameter of second flange hole 72 (see Figure 9) thus preventing the complete removal of needle tip protector 26 from the distal end of needle 38.
Now needle assembly 24, including needle tip protector 26, is assembled into catheter assembly 22 as follows;
The distal end of needle 38 is positioned into the proximal end of catheter hub 30 and 240 needle assembly 24 is moved distally causing needle 38 to enter catheter 28;
.
As needle assembly 24 continues to move distally, needle tip protector 26 enters the opening in the proximal end of catheter hub 30;
245 Continued distal movement of needle assembly 24 causes the distal edge of needle hub 40 to push first tab 86 and second tab 88 on needle tip protector 26 into contact with rib 34 located on hub sidewall 36;
Continued distal movement forces first tab 86 and second tab 88, due to the resilient 250 properties of needle tip protector 26, past rib 34 and in contact with sidewall 36, just distal to rib 34.
Needle tip protector 26 is thus held distal to rib 34 inside the cavity in catheter hub 30 by the flexural forces of first tab 86 and second tab 88 -since dimension c on needle tip 255 protector 26 is larger than dimension d across rib 34 inside catheter hub 30. (see figure 6).
As is best illustrated in Figure 7, the movement of first tab 86 and second tab 88 as needle tip protector 26 is finally seated distal to rib 34 causes flexure in second outer wall 76 and first tab flange 78 resulting in the approximate alignment of first flange hole 70 and 260 second flange hole 72.
Now, in actual clinical use, the IV catheter assembly 20 of the present invention functions as follows;
265 The distal end of needle 38 which extends just past the distal end of catheter 28 is inserted into the patient's vein;
The clinician observes blood in the flash chamber in needle hub 40;
270 The clinician grasps needle hub 40, and catheter assembly 22 alone is moved distally into the vein;
The clinician applies slight pressure to the insertion site to hold catheter assembly 22 secure;
The clinician grasps the needle hub and begins withdrawal of needle assembly 24 from catheter assembly 22. During this process, needle tip protector 26 remains secure inside catheter hub 30 until raised crimp 44 on the distal end of needle 38 comes into contact with second flange hole 72. Just before raised crimp 44 encounters second 280 flange hole 72, the biasing forces of first beam 96 and second beam 100 cause stop flange 102 and first lip 98 to move normal to and across the center axis of needle 38, blocking any further distal movement of needle 38 relative to needle tip protector 26;
Since crimp 44 is larger than second flange hole 72, continued proximal movement of 285 needle 38 carries needle tip protector 26 proximal as well, forcing first tab 86 and second tab 88 on needle tip protector 26 against rib 34. First tab 86 and second tab 88 are forced to flex normal to and toward the center axis of needle tip protector 26, permitting continued movement proximal, past rib 34;
290 Needle assembly 24 is now removed entirely from catheter assembly 22, with the needle tip covered by needle tip protector 26 of the present invention.
Figure 10 shows an alternate embodiment of the present invention. In this embodiment, needle tip protector 126, is preferably a unitary structure formed from a 29'i single piece of thin, resilient material such as, for example, stainless steel, similar to needle tip protector 26. Needle tip protector 126 includes first flange 166 and second flange 168. First flange 166 and second flange 168 are generally arcuate and are integrally connected to first outer wall 174 and second outer wall 176, respectively.
Extending distally from first outer wall 174 of needle tip protector 126 is first beam 300 196. First beam 196, which has an arcuate outer edge, is angled toward and extends past the center axis of needle tip protector 126. First beam 196 further includes first rib 314 coined therein to add stiffness.
At the distal end of first beam 196 is integrally formed curved first lip 198 305 which extends across and through the center axis of needle tip protector 126.
Extending distally from second outer. wall 176 of needle tip protector 126 is second beam 200. Second beam 200, which has an arcuate outer edge, is angled toward and extends past the center axis of needle tip protector 126. Second beam 200 further includes second rib 316 (not visible) coined therein to add stif~'ness. The distal end of 310 second beam 200 is connected to the proximal end of wing base 306. Wing base 306 extends across and parallel to the center axis of needle tip protector 126.
Wing base 306 further comprises first wing side 308 and second wing side 310. Integrally attached to first wing side 308 of wing base 306 at approximately a 90 angle is wing 312. Wing 312, which extends parallel to the center axis of needle tip protector 126, 315 prevents any further radial movement of needle 138 by retaining it within needle tip protector 126. Connected to the distal end of wing base 306 is the proximal end of stop flange 302. Stop flange 302 extends across needle 138 and is angled toward the center axis of needle tip protector 126. At the distal end of stop flange 302 opposite its connection to wing base 306 is integrally formed curved second lip 304.
Second 320 lip 304 is curved toward proximal end 149 of needle tip protector 126 to prevent any further distal movement of needle 138.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by 325 way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function.
Figure 10 is a perspective view of an alternate embodiment of the needle tip protector 125 of the present invention.
Detailed Description of the Invention 130 As used herein, the term "proximal" refers to a location on the catheter and needle assembly with needle tip protector closest to the clinician using the device and thus furthest from the patient on which the device is used. Conversely, the term "distal"
refers to a location farthest from the clinician and closest to the patient.
135 As illustrated in Figures 1 and 2, IV catheter assembly 20 comprises catheter assembly 22 and needle assembly 24. Needle assembly 24 further includes needle tip protector 26. Catheter assembly 22 includes catheter 28 which is a tubular structure having a proximal end 31 and distal end 29. Proximal end 31 of catheter 28 is fixedly attached to catheter hub 30. Catheters are well known in the medical art and one of many suitable 140 materials, most of which are flexible thermoplastics, may be selected for use in catheter 28.
Such materials may include, for example, polyurethane or fluorinated ethylene propylene.
Catheter hub 30 is a generally tubular structure having an internal cavity in fluid communication with the internal lumen of catheter 28. Catheter hub 30 may be made from a suitable, rigid medical grade thermoplastic such as, for example, polypropylene or 145 polycarbonate. For illustration purposes catheter hub 30 is shown translucent, though in actual use it may be translucent or opaque. At the proximal end of catheter hub 30 is integrally attached Luer fitting 32, commonly known in the medical art. Luer fitting 32 provides for secure, leakproof attachment of tubing, syringes, or any of many other medical devices used to infuse or withdraw fluids through the catheter assembly. As is more clearly 150 illustrated in Figures 5 and 6, rib 34 is a raised annular ring integral to and extending from = CA 02405331 2002-09-26 internal sidewall 36 of catheter hub 30. Rib 34 is located approximately mid way between the proximal end and distal end of sidewall 36. Rib 34 plays an important role in securing needle tip protector 26 in catheter hub 30, as will be described in more detail later.
155 Referring again to Figures 1 and 2, needle assembly 24 comprises needle 38, which is a tubular structure with a proximal end 39 and distal end 41, needle hub 40, and needle tip protector 26. Needle tip protector 26 is assembled slidably on needle 38.
Needle 38 is preferably made of stainless steel. Proximal end 39 of needle 38 is fixedly attached to needle hub 40. A bevel 42 is located at the most distal end of needle 38 creating a sharp piercing tip.
160 Needle crimp 44 is located at the distal end of needle 38 proximal to bevel 42 and is larger in diameter than the nominal diameter of needle 38. Needle crimp 44 is created by "coining" an area on the outside diameter of needle 38 resulting in two opposed bumps located approximately 180 degrees across the center axis of needle 38. Coining is a process well known in the metal forming art and involves using a hardened tool to strike a softer object to 165 deform or displace a portion of the softer object. In the present case a portion of the exterior surface of the softer metal needle 38 is displaced by a harder metal tool so as to raise bumps on the exterior surface of needle 38. The resulting crimp 44 is larger in dimension than the nominal diameter of needle 38. Crimp 44 is larger in dimension than the diameter of second flange hole 72 in needle tip protector 26 and is important in preventing the complete removal 170 of needle tip protector 26 from needle 38, as will be described in more detail later. In the preferred embodiment the dimension across crimp 44 is.0001- .004 inches larger than second flange hole 72, dependant upon needle "gauge" size.
Needle hub 40 is generally a tubular structure having an internal cavity in fluid 175 communication with the lumen in needle 38. It is preferably made of a translucent or transparent generally rigid thermoplastic material such as, for example, polycarbonate. At the most proximal end of the internal cavity in needle hub 40 is fixedly attached porous plug 46.
A flashback chamber 48 is created in the cavity distal to porous plug 46.
Porous plug 46 contains a plurality of microscopic openings which are large enough to permit the passage of 180 air and other gasses but small enough to prevent the passage of blood.
Flashback chamber 48 = CA 02405331 2002-09-26 fills with blood upon successful entry of the needle tip into the targeted vein, providing the clinician visual conformation of the correct placement of the needle.
Referring now to all figures, needle tip protector 26 has a proximal end 49 and distal 185 end 50 and is preferably a unitary structure formed from a single piece of thin, resilient material, preferably stainless steel. First flange 66 and second flange 68 are generally square and are integrally connected at right angles to first outer wall 74 and second outer wall 76, respectively. First outer wall 74 is connected at a right angle to first tab flange 78. First tab flange 78 and second tab flange 80 are each formed at angles slightly greater than 90 degrees 190 to second outer wall 76 so that the resulting dimension c is slightly larger than inside diameter d (see Figures 6- 7) across rib 34 in catheter hub 30. In the preferred embodiment angles a and b are each approximately 94.25 degrees. In the preferred embodiment dimension c is approximately .001 - .009 inches larger than dimension d. First flange hole 70 is located in the center of first flange 66 and is over-sized to slidably receive needle 38.
Second flange hole 195 72 and skirt 82 are located in the center of second flange 68. Skirt 82 is integral to second flange hole 72 and is formed by extruding material from second flange hole 72 in a direction distal to second flange 68. This permits for a very close but slidable fit over the nominal diameter of needle 38. Skirt 82 also functions to help maintain alignment of needle 38 to the center axis of needle tip protector 26. As would be understood by one skilled in the art, 200 flange hole 72 would be appropriately sized to the particular needle "gauge" size to which it is designed to receive.
First tab 86 and second tab 88 are connected at right angles to first tab flange 78 and second tab flange 80, respectively, and protrude outward away from the center axis of needle tip 205 protector 26. First tab edge 90, located on the outer portion of first tab 86, and second tab edge 92, located on the outer portion of second tab 88, are each arcuate to approximately match the curve of sidewall 36 in catheter hub 30.
Referring again to Figure 3, first beam 96 extends distally from first outer wall 74 and 210 is angled toward and extends past the center axis of needle tip protector 26. At the distal end I
of first beam 96 is integrally formed curved first lip 98 which extends across and through the center axis of needle tip protector 26. Second beam 100 extends distally from second outer wall 76 and is angled toward and extends past the center axis of needle tip protector 26. At the distal end of second beam 100 is stop flange 102 which extends across and normal to the 215 center axis of needle tip protector 26. At the end of stop flange 102 opposite its connection to second beam 100 is integrally formed curved second lip 104.
Referring now to all figures, needle tip protector 26 is assembled to needle 38 as follows;
The. proximal end of needle 38 is fixedly attached to the distal end of needle hub 40, which contains porous plug 46 fixedly attached to its proximal end;
The distal end of needle 38 is inserted through first flange hole 70 and then through 225 second flange hole 72 in needle tip protector 26, moving from proximal to distal;
First beam 96 and second beam 100 are flexed, as a result of their resilient properties, normal to the center axis of needle tip protector 26 so that needle 38 will pass between first lip 98 and second lip 104 (see Figure 8);
Needle crimp 44 is 'added to the distal end of needle 38 just proximal to bevel 42.
Crimp 44 increases the diameter of needle 38 locally to a dimension larger than the inside diameter of second flange hole 72 (see Figure 9) thus preventing the complete removal of needle tip protector 26 from the distal end of needle 38.
Now needle assembly 24, including needle tip protector 26, is assembled into catheter assembly 22 as follows;
The distal end of needle 38 is positioned into the proximal end of catheter hub 30 and 240 needle assembly 24 is moved distally causing needle 38 to enter catheter 28;
.
As needle assembly 24 continues to move distally, needle tip protector 26 enters the opening in the proximal end of catheter hub 30;
245 Continued distal movement of needle assembly 24 causes the distal edge of needle hub 40 to push first tab 86 and second tab 88 on needle tip protector 26 into contact with rib 34 located on hub sidewall 36;
Continued distal movement forces first tab 86 and second tab 88, due to the resilient 250 properties of needle tip protector 26, past rib 34 and in contact with sidewall 36, just distal to rib 34.
Needle tip protector 26 is thus held distal to rib 34 inside the cavity in catheter hub 30 by the flexural forces of first tab 86 and second tab 88 -since dimension c on needle tip 255 protector 26 is larger than dimension d across rib 34 inside catheter hub 30. (see figure 6).
As is best illustrated in Figure 7, the movement of first tab 86 and second tab 88 as needle tip protector 26 is finally seated distal to rib 34 causes flexure in second outer wall 76 and first tab flange 78 resulting in the approximate alignment of first flange hole 70 and 260 second flange hole 72.
Now, in actual clinical use, the IV catheter assembly 20 of the present invention functions as follows;
265 The distal end of needle 38 which extends just past the distal end of catheter 28 is inserted into the patient's vein;
The clinician observes blood in the flash chamber in needle hub 40;
270 The clinician grasps needle hub 40, and catheter assembly 22 alone is moved distally into the vein;
The clinician applies slight pressure to the insertion site to hold catheter assembly 22 secure;
The clinician grasps the needle hub and begins withdrawal of needle assembly 24 from catheter assembly 22. During this process, needle tip protector 26 remains secure inside catheter hub 30 until raised crimp 44 on the distal end of needle 38 comes into contact with second flange hole 72. Just before raised crimp 44 encounters second 280 flange hole 72, the biasing forces of first beam 96 and second beam 100 cause stop flange 102 and first lip 98 to move normal to and across the center axis of needle 38, blocking any further distal movement of needle 38 relative to needle tip protector 26;
Since crimp 44 is larger than second flange hole 72, continued proximal movement of 285 needle 38 carries needle tip protector 26 proximal as well, forcing first tab 86 and second tab 88 on needle tip protector 26 against rib 34. First tab 86 and second tab 88 are forced to flex normal to and toward the center axis of needle tip protector 26, permitting continued movement proximal, past rib 34;
290 Needle assembly 24 is now removed entirely from catheter assembly 22, with the needle tip covered by needle tip protector 26 of the present invention.
Figure 10 shows an alternate embodiment of the present invention. In this embodiment, needle tip protector 126, is preferably a unitary structure formed from a 29'i single piece of thin, resilient material such as, for example, stainless steel, similar to needle tip protector 26. Needle tip protector 126 includes first flange 166 and second flange 168. First flange 166 and second flange 168 are generally arcuate and are integrally connected to first outer wall 174 and second outer wall 176, respectively.
Extending distally from first outer wall 174 of needle tip protector 126 is first beam 300 196. First beam 196, which has an arcuate outer edge, is angled toward and extends past the center axis of needle tip protector 126. First beam 196 further includes first rib 314 coined therein to add stiffness.
At the distal end of first beam 196 is integrally formed curved first lip 198 305 which extends across and through the center axis of needle tip protector 126.
Extending distally from second outer. wall 176 of needle tip protector 126 is second beam 200. Second beam 200, which has an arcuate outer edge, is angled toward and extends past the center axis of needle tip protector 126. Second beam 200 further includes second rib 316 (not visible) coined therein to add stif~'ness. The distal end of 310 second beam 200 is connected to the proximal end of wing base 306. Wing base 306 extends across and parallel to the center axis of needle tip protector 126.
Wing base 306 further comprises first wing side 308 and second wing side 310. Integrally attached to first wing side 308 of wing base 306 at approximately a 90 angle is wing 312. Wing 312, which extends parallel to the center axis of needle tip protector 126, 315 prevents any further radial movement of needle 138 by retaining it within needle tip protector 126. Connected to the distal end of wing base 306 is the proximal end of stop flange 302. Stop flange 302 extends across needle 138 and is angled toward the center axis of needle tip protector 126. At the distal end of stop flange 302 opposite its connection to wing base 306 is integrally formed curved second lip 304.
Second 320 lip 304 is curved toward proximal end 149 of needle tip protector 126 to prevent any further distal movement of needle 138.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by 325 way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function.
Claims (58)
1. A catheter and introducer needle assembly, comprising:
a) a needle having a diameter, a proximal end attached to a needle hub, a distal end, and an enlarged area disposed therebetween;
b) a tubular catheter having proximal and distal ends, said introducer needle being coaxially received within said catheter;
c) a hollow catheter hub having a distal end attached to said proximal end of said catheter and in fluid communication with said catheter, said catheter hub including an interior having a raised annular rib disposed thereon; and d) a needle tip protector having a proximal end and a distal end disposed within said catheter hub, said proximal end including at least one unrestrained radially extending lip disposed distal to said, annular rib so as to retain said protector within said hub, said distal end of said protector does not abut against said hub interior, said protector having a proximal opening at said proximal end having an unrestrained size greater than said size of said needle diameter and smaller than said enlarged area such that when said needle is removed from said catheter said protector remains attached to said needle.
a) a needle having a diameter, a proximal end attached to a needle hub, a distal end, and an enlarged area disposed therebetween;
b) a tubular catheter having proximal and distal ends, said introducer needle being coaxially received within said catheter;
c) a hollow catheter hub having a distal end attached to said proximal end of said catheter and in fluid communication with said catheter, said catheter hub including an interior having a raised annular rib disposed thereon; and d) a needle tip protector having a proximal end and a distal end disposed within said catheter hub, said proximal end including at least one unrestrained radially extending lip disposed distal to said, annular rib so as to retain said protector within said hub, said distal end of said protector does not abut against said hub interior, said protector having a proximal opening at said proximal end having an unrestrained size greater than said size of said needle diameter and smaller than said enlarged area such that when said needle is removed from said catheter said protector remains attached to said needle.
2. The catheter and introducer needle assembly of claim 1 wherein said enlarged area on said needle is 0.0001-0.004 inches larger than said needle diameter.
3. The catheter and introducer needle assembly of claim 1 wherein said annular rib has an inner diameter that is 0.001-0.009 inches smaller than the distance across said lip on said needle tip protector.
4. The catheter and introducer needle assembly of claim 1 wherein said distal end of said needle tip protector is biased to abut against said needle.
5. The catheter and introducer needle assembly of claim 1 wherein said lip further comprises an outer edge that is generally arcuate.
6. A catheter and introducer needle assembly, comprising:
a) a needle having a diameter, a proximal end attached to a needle hub, a distal end, and an enlarged area disposed therebetween;
b) a tubular catheter having proximal and distal ends, said introducer needle being coaxially received within said catheter;
c) a hollow catheter hub having a distal end attached to said proximal end of said catheter and in fluid communication with said catheter, said catheter hub including an interior having a raised annular rib disposed thereon; and d) a needle tip protector having a proximal end and a distal end disposed within said catheter hub, said proximal end including at least one unrestrained radially extending lip disposed distal to said annular rib so as to retain said protector within said hub, said distal end of said protector does not abut against said hub interior, said protector having a proximal opening at said proximal end having an unrestrained size greater than said size of said needle diameter and smaller than said enlarged area such that when said needle is removed from said catheter said protector remains attached to said needle, said protector further comprising an outer wall, a first tab flange, a second tab flange, said first tab flange attached to said outer wall at an angle greater than 90 degrees, and said second tab flange attached to said outer wall, opposite said first tab flange, at an angle greater than 90 degrees.
a) a needle having a diameter, a proximal end attached to a needle hub, a distal end, and an enlarged area disposed therebetween;
b) a tubular catheter having proximal and distal ends, said introducer needle being coaxially received within said catheter;
c) a hollow catheter hub having a distal end attached to said proximal end of said catheter and in fluid communication with said catheter, said catheter hub including an interior having a raised annular rib disposed thereon; and d) a needle tip protector having a proximal end and a distal end disposed within said catheter hub, said proximal end including at least one unrestrained radially extending lip disposed distal to said annular rib so as to retain said protector within said hub, said distal end of said protector does not abut against said hub interior, said protector having a proximal opening at said proximal end having an unrestrained size greater than said size of said needle diameter and smaller than said enlarged area such that when said needle is removed from said catheter said protector remains attached to said needle, said protector further comprising an outer wall, a first tab flange, a second tab flange, said first tab flange attached to said outer wall at an angle greater than 90 degrees, and said second tab flange attached to said outer wall, opposite said first tab flange, at an angle greater than 90 degrees.
7. The catheter and introducer needle assembly of claim 6 wherein said enlarged area on said needle is 0.0001-0.004 inches larger than said needle diameter.
8. The catheter and introducer needle assembly of claim 6 wherein said annular rib has an inner diameter that is 0.001-0.009 inches smaller than the distance across said lip on said needle tip protector.
9. The catheter and introducer needle assembly of claim 6 wherein said distal end of said needle tip protector is biased to abut against said needle.
10. The catheter and introducer needle assembly of claim 6 wherein said lip further comprises an outer edge that is generally arcuate.
11. The catheter and introducer needle assembly of claim 6 wherein said angle between said outer wall and said first tab flange is 94.25 degrees.
12. The catheter and introducer needle assembly of claim 6 wherein said angle between said outer wall and said second tab flange is 94.25 degrees.
13. A needle tip protector for shielding a needle tip and having a proximal end, a distal end and a needle receiving space extending therebetween; approximal opening at the proximal end sized to receive a shaft of a needle therethrough and into the needle receiving space; first and second arms extending from the proximal end toward the distal end, with the first arm crossing the second arm on respective first and second sides of the needle receiving space, each of the first and second arms terminating in a distal end portion configured to pass said needle shaft therebetween in a first position of the first and second arms, at least one of the distal end portions blocking a tip of said needle in a second position of the first and second arms; and a first wing supported on the first arm proximal the distal end portion thereof so as to extend adjacent one of the first and second sides of the needle receiving space.
14. The needle tip protector of claim 13 further having a second wing supported on the second arm proximal the distal end portion thereof so as to extend adjacent the other of the first and second sides of the needle receiving space.
15. The needle tip protector of claim 14 wherein the second wing is disposed on the first side of the needle receiving space.
16. The needle tip protector of claim 15 wherein the first wing is disposed on the second side of the needle receiving space.
17. The needle tip protector of claim 13 wherein the first and second arms each has an intermediate narrow portion such that said needle shaft can pass between the crossing first and second arms.
18. The needle tip protector of claim 13 wherein the first and second arms are of resilient material such that said needle shaft applies an outward radial force on the distal end portions to hold the arms in the first position until said needle tip passes from between the distal end portions of the first and second arms.
19. The needle tip protector of claim 13 wherein the distal end portions of the first and second arms overlap one another.
20. The needle tip protector of claim 13 wherein the distal end portions each includes a curved lip.
21. The needle tip protector of claim 20, the curved lips engaging said needle shaft in the first position of the first and second arms.
22. The needle tip protector of claim 21 wherein at least one of the curved lips confronts said needle tip in the second position of the first and second arms.
23. The needle tip protector of claim 20 wherein at least one of the curved lips confronts said needle tip in the second position of the first and second arms.
24. The needle tip protector of claim 13 further having a skirt extending in a distal direction from the opening coaxial with the needle receiving space.
25. The needle tip protector of claim 13 wherein the proximal end of the needle tip protector includes a first proximal end wall and an overlapping second proximal end wall.
26. The needle tip protector of claim 25, each end wall having the opening extending therethrough, the first arm extending from the first end wall and the second arm extending from the second end wall.
27. The needle tip protector of claim 13 being an integral metal piece.
28. A catheter and introducer needle assembly, comprising:
a) a catheter portion having a catheter hub and a tubular catheter extending from the catheter hub;
b) a needle portion having a needle hub and a needle shaft extending from the needle hub, the needle shaft having a tip end; and c) a needle tip protector positioned on the needle shaft; the needle tip protector having a proximal end, a distal end and a needle receiving space extending therebetween and through which the needle shaft projects; a proximal opening at the proximal end with the needle shaft received therethrough and into the needle receiving space; first and second arms extending from the proximal end toward the distal end, with the first arm crossing the second arm on respective first and second sides of the needle receiving space, each of the first and second arms terminating in a distal end portion configured to pass the needle shaft therebetween in a first position of the first and second arms, at least one of the distal end portions blocking the needle tip in a second position of the first and second arms; and a first wing supported on the first arm proximal the distal end portion thereof so as to extend adjacent one of the first and second sides of the needle receiving space, wherein, in the first position of the first and second arms, the needle being disposed within the tubular catheter and the needle tip extending beyond the tubular catheter, the first and second arms being in the second position after withdrawal of the needle from the tubular catheter and the needle tip passes from between the distal end portions of the first and second arms so as to be disposed in the needle tip protector.
a) a catheter portion having a catheter hub and a tubular catheter extending from the catheter hub;
b) a needle portion having a needle hub and a needle shaft extending from the needle hub, the needle shaft having a tip end; and c) a needle tip protector positioned on the needle shaft; the needle tip protector having a proximal end, a distal end and a needle receiving space extending therebetween and through which the needle shaft projects; a proximal opening at the proximal end with the needle shaft received therethrough and into the needle receiving space; first and second arms extending from the proximal end toward the distal end, with the first arm crossing the second arm on respective first and second sides of the needle receiving space, each of the first and second arms terminating in a distal end portion configured to pass the needle shaft therebetween in a first position of the first and second arms, at least one of the distal end portions blocking the needle tip in a second position of the first and second arms; and a first wing supported on the first arm proximal the distal end portion thereof so as to extend adjacent one of the first and second sides of the needle receiving space, wherein, in the first position of the first and second arms, the needle being disposed within the tubular catheter and the needle tip extending beyond the tubular catheter, the first and second arms being in the second position after withdrawal of the needle from the tubular catheter and the needle tip passes from between the distal end portions of the first and second arms so as to be disposed in the needle tip protector.
29. The catheter and introducer needle assembly of claim 28, the needle tip protector being within the catheter hub in the first position of the first and second arms.
30. The catheter and introducer needle assembly of claim 28 wherein an enlarged area of the needle shaft engages the opening in the proximal end when the needle is withdrawn from the tubular catheter and the needle tip passes from between the distal end portions of the first and second arms so as to be disposed in the needle tip protector.
31. The catheter and introducer needle assembly of claim 28, the needle tip protector further having a second wing supported on the second arm proximal the distal end portion thereof so as to extend adjacent the other of the first and second sides of the needle receiving space.
32. The catheter and introducer needle assembly of claim 31 wherein the second wing is disposed on the first side of the needle receiving space.
33. The catheter and introducer needle assembly of claim 32 wherein the first wing is disposed on the second side of the needle receiving space.
34. The catheter and introducer needle assembly of claim 28 wherein the first and second arms each has an intermediate narrow portion such with the needle shaft passing between the crossing first and second arms.
35. The catheter and introducer needle assembly of claim 28 wherein the first and second arms are of resilient material with the needle shaft applying an outward radial force on the distal end portions to hold the arms in the first position until the needle tip passes from between the distal end portions of the first and second arms.
36. The catheter and introducer needle assembly of claim 28 wherein the distal end portions of the first and second arms overlap one another.
37. The catheter and introducer needle assembly of claim 28 wherein the distal end portions each includes a curved lip.
38. The catheter and introducer needle assembly of claim 37, the curved lips engaging the needle shaft in the first position of the first and second arms.
39. The catheter and introducer needle assembly of claim 38 wherein at least one of the curved lips confronts the needle tip in the second position of the first and second arms.
40. The catheter and introducer needle assembly of claim 37 wherein at least one of the curved lips confronts the needle tip in the second position of the first and second arms.
41. The catheter and introducer needle assembly of claim 28, the needle tip protector further having a skirt extending in a distal direction from the opening coaxial with the needle receiving space.
42. The catheter and introducer needle assembly of claim 28 wherein the proximal end of the needle tip protector includes a first proximal end wall and an overlapping second proximal end wall.
43. The catheter and introducer needle assembly of claim 42, each end wall having the opening extending therethrough, the first arm extending from the first end wall and the second arm extending from the second end wall.
44. The catheter and introducer needle assembly of claim 28, the needle tip protector being an integral metal piece.
45. A needle tip protector for shielding a needle tip and having a proximal end, a distal end and a needle receiving space extending therebetween; a proximal opening at the proximal end sized to receive a shaft of a needle therethrough and into the needle receiving space; first and second arms extending from the proximal end toward the distal end, with the first arm crossing the second arm on respective first and second sides of the needle receiving space, each of the first and second arms terminating in a distal end portion configured to pass said needle shaft therebetween in a first position of the first and second arms, at least one of the distal end portions blocking a tip of said needle in a second position of the first and second arms; and a skirt extending in a distal direction from the opening coaxial with the needle receiving space.
46. The needle tip protector of claim 45 wherein the first and second arms each has an intermediate narrow portion such that said needle shaft can pass between the crossing first and second arms.
47. The needle tip protector of claim 45 wherein the first and second arms are of resilient material such that said needle shaft applies an outward radial force on the distal end portions to hold the arms in the first position until said needle tip passes from between the distal end portions of the first and second arms.
48. The needle tip protector of claim 45 wherein the distal end portions of the first and second arms overlap one another.
49. The needle tip protector of claim 45, wherein the distal end portions each includes a curved lip.
50. The needle tip protector of claim 49, the curved lips engaging said needle shaft in the first position of the first and second arms.
51. The needle tip protector of claim 50 wherein at least one of the curved lips confronts said needle tip in the second position of the first and second arms.
52. The needle tip protector of claim 49 wherein at least one of the curved lips confronts said needle tip in the second position of the first and second arms.
53. In combination, the needle tip protector of claim 45, a needle having a needle shaft and needle hub, a catheter hub and a catheter extending from the catheter hub, wherein the needle tip protector is positioned on the needle shaft, the needle being disposed within the catheter with the first and second arms in the first position and the tip of the needle extending beyond the catheter, the first and second arms being in the second position after withdrawal of the needle from the catheter and the needle tip passes from between the distal end portions of the first and second arms so as to be disposed in the needle tip protector.
54. The combination of claim 53 wherein the needle tip protector is within the catheter bub in the first position of the first and second arms.
55. The combination of claim 53, wherein an enlarged area of the needle shaft engages the opening in the proximal end when the needle is withdrawn from the catheter and the needle tip passes from between the distal end portions of the first and second arms so as to be disposed in the needle tip protector.
56. The needle tip protector of claim 45 wherein the proximal end of the needle tip protector includes a first proximal end wall and an overlapping second proximal end wall.
57. The needle tip protector of claim 56, each end wall having the opening extending therethrough, the first arm extending from the first end wall and the second arm extending from the second end wall.
58. The needle tip protector of claim 45 being an integral metal piece.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/965,427 | 2001-09-27 | ||
US09/965,427 US6652486B2 (en) | 2001-09-27 | 2001-09-27 | Safety catheter |
Publications (2)
Publication Number | Publication Date |
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CA2405331A1 CA2405331A1 (en) | 2003-03-27 |
CA2405331C true CA2405331C (en) | 2008-05-06 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CA002405331A Expired - Fee Related CA2405331C (en) | 2001-09-27 | 2002-09-26 | Safety catheter |
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US (1) | US6652486B2 (en) |
EP (2) | EP1297859B1 (en) |
JP (2) | JP4294929B2 (en) |
CA (1) | CA2405331C (en) |
DE (2) | DE60232941D1 (en) |
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