JP2003250903A - Compact needle shielding device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a needle shield which is compact and is easy to handle. <P>SOLUTION: A catheter and introducer needle assembly with needle shield that is connected to the needle hub by a pleated tether. The tether defines a plurality of holes therein to allow the introducer needle to extend through the tether. The tether prevents unwanted proximal movement of the needle with respect to the needle shield once the needle is withdrawn into the needle shield. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to catheters and introducer needle assemblies that include a needle shield that can safely cover the sharp end of the introducer needle after the needle has been used to insert the catheter into a patient. Is.

[0002]

BACKGROUND OF THE INVENTION Catheter, especially venous (IV) catheters, are used to infuse patients with fluids such as saline and various medications and total parenteral nutrition, or to draw blood from patients. Has been done. Peripheral IV catheters tend to be relatively short, with an overall length of approximately 1.5.
It is on the order of inches. The most common type of IV catheter is the over-the-needle peripheral IV catheter.
Needle catheter). As the name implies, suture needles are mounted on introducer needles that have a sharp end. The catheter and the guide needle
The distal end of the introducer needle is assembled to extend beyond the distal end of the catheter with the bevel of the needle diverging from the patient's skin.

A catheter and introducer needle assembly is inserted into a peripheral blood vessel through a patient's skin at a shallow angle. These are small blood vessels that are not directly connected to the heart,
It is a branch of the central blood vessel that is directly connected to the heart. To confirm proper placement of the assembly in the blood vessel, the clinician asks if there is a flashback of blood in the flashback chamber located in the needle and at the proximal end of the needle, which is typically formed as part of the needle hub. Confirm that. The flashback chamber is usually formed as part of the needle hub. Once the proper placement is confirmed, the clinician applies pressure to the blood vessel by pushing down on the patient's skin over the ends of the introducer needle and catheter. This finger pressure blocks further blood flow through the introducer needle. The clinician withdraws the introducer needle leaving the catheter in place and attaches the fluid handling device to the catheter hub.

Clinicians commonly use special techniques when inserting a needle catheter into a patient. The technique depends on whether a ported catheter or a straight catheter is used. The ported catheter includes a side port integral with a radially extending catheter hub. In a ported catheter, the fluid handling device is connected to the side port. Such ported catheters are commonly used in Europe. The straight catheter does not include a side port so that the fluid handling device is connected to the proximal end of the catheter hub. Such straight catheters are commonly used in the United States.

Once the introducer needle is pulled away from the catheter, it becomes a "blood-contaminated sharps" and must be handled properly. In recent years, there has been significant interest in the contamination of clinicians by the blood of patients and the recognition that "blood-contaminated sharps" must be immediately disposed of. Such concern is transmitted by the exchange of body fluids from an infected person to another person, the acquired immunodeficiency syndrome (AI).
It is caused by the advent of incurable and mortal diseases such as DS) and hepatitis. Therefore, contact with body fluids of AIDS or hepatitis infected persons must be avoided in order to prevent transmission of such diseases to healthy persons. As described above, when the guide needle is used to place the catheter in the vein of an AIDS or hepatitis infected person, the guide needle is a medium for transmitting the disease. Clinicians
While aware of the need to properly handle "blood-contaminated sharps," contaminated needlestick needlesticks are needed in certain unforeseen medical settings, such as emergencies and the consequences of carelessness or neglect.
cks) are still occurring.

Due to the problem of accidental needle sticks due to "blood-contaminated sharps", various needle shields have been developed. Such needle shields generally operate for their intended purpose, but could still be improved. For example, some needle shields are bulky, difficult to use, require special equipment or techniques to function, or are ergonomically uncomfortable for use by the clinician. In addition, some needle shields cannot be used for both ported and straight catheters, requiring significant technical modification by the clinician for use with both ported and straight catheters. . Moreover, certain needle shields prevent the introducer needle from accessing the blood vessel during intravenous injection.

[0007]

SUMMARY OF THE INVENTION An object of the present invention is to provide a compact needle shield.

Another object of the present invention is to provide a needle shield which is simple and easy to use.

Yet another object of the present invention is to provide a needle shield that does not require special equipment or techniques to function.

Yet another object of the present invention is to provide a needle shield that is ergonomically comfortable for use by a clinician.

Still further, it is an object of the present invention to provide a needle shield that can be used for both ported and straight catheters without requiring the clinician to change insertion techniques.

It is a further object of the present invention to provide a needle shield which can be accessed by a guide needle during intravenous injection.

[0013]

SUMMARY OF THE INVENTION A catheter and introducer needle assembly with a needle shield and tether of the present invention includes a catheter having a distal end and a proximal end connected to the distal end of a catheter hub. The introducer needle has a sharp end and a proximal end connected to the end of the needle hub. The flashback chamber is formed within the needle hub. A vent plug may be placed at the open proximal end of the flashback chamber to allow air to exit the flashback chamber as blood enters the flashback chamber from the introducer needle. During intravenous injection, the clinician can access the blood vessel through the introducer needle when the vent plug is removed. The catheter is coaxially placed on the introducer needle with the sharp end of the introducer needle distal to the end of the catheter.

The needle shield is disposed substantially between the catheter and the needle hub and defines a longitudinally extending passageway through which the introducer needle extends. The needle shield may include a barrier or other mechanism that prevents the sharp end of the needle from moving distally with respect to the needle shield after the sharp end of the needle has been retracted into the needle shield. This prevents the sharp end of the needle from re-exposing once it has been retracted into the needle shield.

The needle shield is connected to the needle hub by a tether which, once the needle is retracted proximally within the needle shield, causes the needle shield to move distally beyond the sharp end of the needle. Prevent you from doing so. The combination of the tether with the barrier or other mechanism associated with the needle shield prevents distal movement of the needle relative to the needle shield. This ensures that the sharp end of the needle remains trapped within the needle shield after it has been retracted proximally within the needle shield after use.

The tether is self-folding to form a plurality of pleats, such as an accordion. Each fold or fold forms a central opening in it, whether or not the tether is fully extended or fully folded with the needle shield adjacent to the needle hub. It allows the needle to extend through the folds and folds of the. The tether can be folded into a small space to be placed between the needle shield and the needle hub, thus making the overall device compact. This makes the entire device easier to control by the clinician. in addition,
The pleated configuration of the tether allows the clinician better control over the movement of the needle shield. The tether is connected to the needle hub and needle shield by various mechanisms such as gluing, heat sealing and mechanical engagement.

[0017]

DETAILED DESCRIPTION OF THE INVENTION As used herein, the term "proximal" includes the needle shield and tether of the present invention in relation to the device used when the device is used in normal operation. Position closest to the clinician using the catheter and introducer needle assembly device, and farthest from the patient. Conversely, the term "distal" is most commonly used by clinicians who use the device of the catheter and introducer needle assembly with the needle shield and tether of the present invention in relation to the device used when the device is used in normal operation. A distant position, which means the position closest to the patient.

The catheter and introducer needle assembly of the present invention is generally identified by the numeral 10. It includes a catheter assembly 20 and an introducer needle assembly 30 that includes a needle shield 40 and a tether 44.

Catheter assembly 20 includes a catheter 21 having a proximal end and a distal end. Catheter hub 24
Is fixed to the proximal end of the catheter 21. Suitable materials for the catheter 21 include, but are not limited to, thermoplastic resins such as polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP) and polyurethane. Preferably, the catheter 21 is
It is formed from a thermoplastic hydrophilic polyurethane that mitigates exposure to physiological conditions in the patient's body. Catheter hub 24
Suitable materials for include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene.

The catheter hub 24 is a fluid handling device and catheter 2 for injecting fluid into a patient's blood vessel.
It may also include a radially outwardly extending side port 25 which is useful for connecting with 1. Refer to Figure 1. Preferably, the side port 25 extends upwardly away from the patient when the catheter 21 is inserted into the patient. In addition, the pair of wings 26 may be attached to the catheter hub 24 or may be integrally formed with the catheter hub 24. The wings 26 are useful for stabilizing the catheter 21 within the patient, and for securing the catheter 21 properly in the patient's vasculature, the catheter assembly 2 may
It provides a surface that easily tapes 0.

However, while the catheter and introducer needle assembly 10 of the present invention has been described primarily with catheters having side ports, it should be understood that the present invention may also be used with straight catheters. Refer to the embodiment of FIG.

The cover 27 may be used to cover the catheter 21 and the guide needle 31 prior to use. Preferably, cover 27 is formed from a rigid polymeric material such as a thermoplastic polymeric resin including polycarbonate, polystyrene, polypropylene and the like. Of course, other materials may be used for the cover 27.

The introducer needle assembly 30 includes an introducer needle 31 having a sharp end formed by a beveled surface. The proximal end of the guide needle 31 is connected to the needle hub 34. Guide needle 3
1 is preferably made of stainless steel. Needle hub 34 can include an integral flashback chamber having an open proximal end.

The needle hub 34 is preferably formed from the same type of material used to form the catheter hub 24. Preferably, the open proximal end of the needle hub 34 occludes the flow of liquid by a vent plug 35 through which gas can flow but liquid cannot flow. This promotes the inflow of blood flow into the flashback chamber and prevents blood from leaking.

The vent plug 35 may be removably connected to the open proximal end of the needle hub 34. This allows
Allows the clinician to access the patient's blood vessels during intravenous injection. In this way, the syringe can be attached to the open proximal end of the needle hub 34 for aspiration during insertion of the catheter and introducer needle assembly 10.

Needle hub 34 may include a radially extending tab 36 that may be grasped in conjunction with side port 25 to facilitate insertion of assembly 10 into a patient. The tab 36 is also effective for withdrawing the introducer needle 31 from the catheter 21 after the catheter 21 has been properly placed in the patient's vasculature.

In addition, needle hub 34 may include a pair of longitudinally extending fingers 39. The fingers 39 frictionally engage the needle shield 40. In this way, needle hub 34 is positioned adjacent catheter hub 24 such that the sharp end of introducer needle 31 extends outward of the end of catheter 21. The proximal force required to overcome the frictional engagement between finger 39 and needle shield 40 is the proximal force required to overcome the detachable connection between needle shield 40 and catheter hub 24. Less than the power of.

As mentioned above, the introducer needle assembly 30 may include a needle shield 40. Suitable materials for needle shield 40, such as catheter hub 24 and needle hub 34, include, but are not limited to, thermoplastic polymeric resins such as polycarbonate, polystyrene, polypropylene, and the like. Needle shield 40 includes a body portion 41 defining a passageway 42 extending longitudinally therethrough. In the passage 42 extending in the longitudinal direction, the guide needle 31 is provided in the main body portion 4.
It is possible to extend in the longitudinal direction through 1. The diameter of the passage 42 extending in the longitudinal direction is slightly larger than that of the direct line of the main body portion of the guide needle 31. As a result, the guide needle 3
It allows one body portion to easily pass through the longitudinally extending passageway 42.

The annular lip 43 is located along the distal portion of the longitudinally extending passageway 42. Preferably, the lip 43 is integrally formed with the needle shield 40, and the guide needle 3
1. Contact the body part of 1. In this way, the lip 43
Serves as a liquid seal along the main body of the guide needle 31. During intravenous injection, blood flow between the introducer needle 31 and needle shield 40 is minimized to minimize leakage of blood from the device.

The transverse barrier 49 serves to act as a barrier against re-exposure of the sharpened end of the introducer needle 31 after the sharp end portion of the introducer needle 31 has been withdrawn into the body portion 41.
It is located inside. The transverse barrier 49 is preferably
It is integrally formed of a resilient metal such as stainless steel. Preferably, the transversal barrier extends generally proximally from the distal end of the body portion 49b.
It is formed as a substantially cylindrical body portion 49b having two l) shaped lips 49a. The size of the body portion 49b and the lip 49a in the longitudinal direction can be any value, but preferably, the body portion 49b is longer than the lip 49a. This relationship facilitates the manufacture of the device and allows for a more robust design.

Prior to use, the lip 49a extends toward the proximal end of the introducer needle 31 and is generally parallel to the body portion of the introducer needle 31. Refer to FIG. After proper placement of the catheter 21 in the patient's blood vessel, the lip 49a is provided with
When is pulled from the catheter 21, it rides along the main body of the guide needle 31. Once the sharp end of the guide needle 31 is retracted to the proximal position of the lip 49a,
The elasticity of the lips 49a returns them to a position where they cross the introducer needle 31. The configuration of lip 49a as shown in FIG. 8 prevents sharp end re-exposure from occurring if the introducer needle 31 then attempts to move distally with respect to the needle shield 40. Refer to FIG.

Other types of transverse barriers can also be used. For example, a transversal barrier having a single arm can be used in place of a pair of duckbill-shaped lips 49a as described above.

The body portion 41 may include a plurality of longitudinally extending fingers 47. Finger 47
Engages the catheter hub 24 and introduces the introducer needle assembly 3
0 together with the catheter assembly 20. In this manner, needle shield 40 remains adjacent to catheter hub 24 while needle hub 24 moves proximally with respect to catheter hub 24. As described in more detail below, the tether 44 has a length that retains the sharp end of the introducer needle 31 on the body portion 41 of the needle shield when the tether 44 is fully extended. Thus, once the guide needle 3
When the sharpened end of 1 is moved into the body portion 41 of the needle shield 40, any additional proximal movement applied to the needle hub 24 will result in finger 47 and catheter hub 24.
Overcome the friction between and. In this way, the needle shield 40 can be removed from the catheter hub 24. If desired, replace needle shield 40 with catheter hub 24.
The body portion 41 may be configured such that the outer surface of the distal portion of the body portion 41 frictionally engages the inner surface of the catheter hub 24 to aid in retention therewith.

The fingers 47 are the projections 4 on the radially inner side.
8 may be included. The protrusion 48 is sized to mechanically engage the catheter hub 24 by a snap fit. If protrusions 48 are used, the force required to remove body portion 41 from catheter hub 24 can be controlled more precisely than simply using fingers 47 or a friction fit. Once a suitable proximal force is applied to the body portion 41, the protrusion 48 rides on the catheter hub 24 and the body portion 41 can be removed from the catheter hub 24. Further, the tether 44 holds the body portion 41 in a suitable position such that the sharp end of the introducer needle 31 is safely positioned within the body portion 41 of the needle shield 40.

The tether 44 has a length corresponding to the exposed length of the guide needle 31. This length is sufficient for the body portion 41 of the needle shield 40 when the tether 44 is fully extended.
Holds the sharp end of the introducer needle 31 therein. Tether 44
Are themselves folded to form a plurality of accordion-like bellows folds (pleats) 44a. Each fold 44a
Has a central opening 45 formed therein and whether the tether 44 is fully expanded as shown in FIG. 4, the tether 44 of the needle shield 40 adjacent the needle hub 34 as shown in FIG. Whether fully folded with the body portion 41, it allows the introducer needle 31 to expand through its respective fold 44a. By forming the tether 44 in this manner, a compact design of the catheter and introducer needle assembly 10 is achieved.

The tether 44 can be made of any material that is relatively hard but flexible. However, polyethylene terephthalate (PET) is the preferred material. One advantage of using PET is that it is relatively stiff so it provides a slight biasing force that helps keep the tether 44 in its fully extended position when folded into an accordion-like shape with pleats. It is to be. This also helps hold the needle shield 40 in position to cover the sharp end of the introducer needle 31.

The tether 44 is attached to the needle hub 34 and needle shield 40 by standard methods such as gluing or heat sealing.
Can be connected to. Preferably, tether 44 is connected to needle hub 34 and needle shield 40 by mechanical engagement similar to gluing. For example, the slot 37 may be formed along the distal portion of the needle hub 34 where one end of the tether 44 may be located. Thus, the slot 37 provides an end along the proximal fold 44b of the tether 44 that can mechanically engage the needle hub 34 to prevent the tether 44 from disengaging from the needle hub 34 during use. prevent.
See FIGS. 5 and 6. On the other hand, a button 32 extending radially and forming a slot 33 therein may be formed along the bottom of the needle hub 34. One end of the tether 44 is disposed around the button 32 and the slot 33 provides an end along a proximal fold 44b that can mechanically engage the needle hub 34. 10 to 1
Refer to 2. With respect to the body portion 41, the terminal folds (pleats) 44c are provided on the body portion 4 of the needle shield 40 to prevent the tether 44 from coming off the body portion 41 during use.
Can be wrapped around once. See FIGS. 5 and 6. As mentioned above, it is preferred to connect the tether 44 to the needle hub 34 and the needle shield 40, but it should be understood that other well known techniques for joining the two members together may be used.

The combination of the material of the tether 44, the pleated shape of the tether 44 and the special connection of the terminal pleated 44c to the body portion 41, when the tether 44 is fully extended, results in a The longitudinal axis of the part 41 forms an inclined angle with respect to the introducer needle 31. This is because the sharp end of the guide needle 31 has a needle shield 40.
Helps ensure that it remains trapped inside, and then prevents the sharp end of the introducer needle 31 from re-exposing after use, even if the introducer needle 31 moves distally with respect to the body portion 41. .

To position the catheter 21 in a patient's blood vessel, the clinician aligns the introducer needle 31 and catheter 21 with the blood vessel of interest in a generally longitudinal direction. The groove forming the sharp end of the guide needle 31 should be oriented substantially away from the skin surface during intravenous injection. The clinician inserts the introducer needle 31 and the catheter 21 into the skin at a shallow angle, preferably less than about 35 degrees, so that the sharp end of the introducer needle 31 enters the target blood vessel. The clinician then preferably observes the blood flashback in the flashback chamber.

After confirming the placement of the guide needle 31 and the catheter 21 in the target blood vessel, the clinician advances the catheter 21 to a predetermined position in the blood vessel at the axial end along the guide needle. After proper placement of the catheter 21, the clinician places the finger of the other hand on the patient's skin over the end of the catheter 21 and the vascular end of the sharp end of the introducer needle 31. By placing a finger on the patient's skin and applying sufficient pressure to the skin, the clinician thereby minimizes blood flow through the catheter 21. After that, the clinician pulls out the guide needle 31 from the catheter 21 by pulling the needle hub 34 in the proximal direction. Once the guide needle 31
After the sharp end of the needle is positioned within the body portion 41 of the needle shield 40, continued movement of the needle hub 34 in the proximal direction results in:
The fingers 47 provide sufficient force to overcome the force holding the catheter hub 24, allowing the body portion 41 to be removed from the catheter hub 24. The clinician can then attach the desired fluid manipulation device to the side port 25 if using a ported catheter, or to the catheter hub 24 if using a straight catheter to initiate a given procedure. The body portion 41 of the needle shield 40 having the sharp end of the introducer needle 31 shielded therein can then be discarded according to the facility's disposal regulations.

[0041]

Therefore, it is compact, simple and easy to use, can be operated without any special equipment or technique, is ergonomically comfortable for the clinician to use, and can be operated by any clinician. Catheter and introducer needle assembly with needle shield and tether that can be used for both ported and straight catheters without technologic modification and allow access to the blood vessel through the introducer needle during intravenous injection I understand that it will be done.

[Brief description of drawings]

FIG. 1 is a perspective view of a ported catheter and introducer needle assembly with a needle shield and tether of the present invention prior to use.

FIG. 2 is a perspective view of a ported catheter and introducer needle assembly with a needle shield and tether of the present invention after the needle has been withdrawn from the catheter into the needle shield and the needle shield removed from the catheter hub.

FIG. 3 is a plan view of a ported catheter and introducer needle assembly with a needle shield and tether of the present invention prior to use.

FIG. 4 is a plan view of a ported catheter and introducer needle assembly with a needle shield and tether of the present invention after the needle has been withdrawn from the catheter into the needle shield and the needle shield removed from the catheter hub.

FIG. 5 is an exploded bottom perspective view with partial cross-section and partial perspective of a portion of the needle shield, tether and needle hub illustrating one technique for connecting the tether to the needle shield and needle hub.

FIG. 6 is a partial perspective and partially perspective bottom perspective view of a portion of the needle shield, tether and needle hub illustrating one technique for connecting the tether to the needle shield and needle hub.

FIG. 7 is a cross-sectional view of a portion of the introducer needle assembly showing the needle shield and tether attached to the catheter hub prior to use.

FIG. 8 is a cross-sectional view of a portion of the introducer needle assembly showing the needle shield and tether after the sharp end of the introducer needle has been withdrawn into the needle shield and the needle shield removed from the catheter hub.

FIG. 9 is a perspective view of a straight catheter and introducer needle assembly with a needle shield and tether of the present invention prior to use.

FIG. 10 illustrates a second technique for connecting the tether to a needle hub having a proximalmost fold of the tether off the needle hub, the needle shield where the needle shield is adjacent to the needle hub, the tether. FIG. 6 is a bottom perspective view of the needle hub.

FIG. 11: A needle shield where the needle shield is adjacent to the needle hub, illustrating a second approach for connecting the tether to a needle hub having a proximalmost fold (pleat) of the tether engaged with the needle hub, FIG. 9 is a bottom perspective view of a tether and needle hub.

FIG. 12 illustrates a second approach of connecting a tether to a needle hub, where the needle is withdrawn from the catheter into the needle shield,
FIG. 6 is a bottom perspective view of the introducer needle assembly with the needle shield and tether of the present invention after the needle shield has been removed from the catheter hub.

[Explanation of symbols]

10 Induction needle assembly 20 catheter assembly 21 catheter 24 catheter hub 25 side port 26 wings 27 cover 30 guide needle assembly 31 induction needle 32 buttons 33 slots 34 needle hub 35 Ventilation plug 36 tabs 37 slots 39 fingers 40 needle shield 41 body 42 passage 43 lips 43 annular lip 44 tether 45 Center opening 47 fingers 48 protrusions 49 Crossing barrier

   ─────────────────────────────────────────────────── ─── Continued front page    (71) Applicant 595117091             1 BECTON DRIVE, FRA             NKLIN LAKES, NEW JE             RSEY 07417-1880, UNITED               STATES OF AMERICA (72) Inventor Mans Wemert             Sweden 260 39 Haslasuppa             Nkarp 248 (72) Inventor Tommy Krona             Sweden 260 33 Paup Gleba             Sebague 3 (72) Inventor Lars Ringlen             Sweden 254 40 Helsingborg             Gucar X Gustavs Gar             66 F term (reference) 4C167 AA23 BB03 BB07 BB11 BB32                       CC29 HH09

Claims (10)

[Claims] 1. A catheter having a proximal end and a distal end; a catheter hub in fluid communication with the catheter, the catheter hub having a proximal end and a distal end connected to the proximal end of the catheter; An introducer needle having; a needle hub in fluid communication with the needle; having a proximal end and a distal end connected to the proximal end of the catheter; a radially extending button formed on the needle hub; A needle hub having a distal end removably connected to, forming a passageway extending longitudinally therethrough, the needle shield having a introducer needle extending through the passageway extending longitudinally, and a needle hub. A tether with a fold that is connected to the needle shield and that prevents undesired proximal movement of the guide needle with respect to the needle shield.
The tether with folds is formed from a plurality of folds (pleats), each of which forms a hole through which the guide needle extends, and the tether with folds (pleats) comprises a proximal fold (pleat) and a needle. A pleated tether including a proximally extending fold pleated around a button extending radially to provide mechanical engagement with a hub. And needle assembly. 2. The catheter and needle assembly of claim 1, wherein the radially extending button defines a slot and the proximal fold pleats engage the slot. 3. The tether with folds (pleats) includes an end fold (pleat) forming an end hole therein, the mechanical tether between the end fold (pleat) and the needle shield. The catheter and needle assembly of claim 2, wherein a portion of the needle shield extends through the distal hole to provide a connection. 4. The catheter and needle assembly of claim 3, wherein the tether is formed from polyethylene terephthalate. 5. The catheter and needle assembly of claim 4, wherein the needle shield further comprises a barrier that mates with a longitudinally extending passageway that engages the distal end of the introducer needle. 6. A needle hub having a proximal end and a distal end, a needle hub in fluid communication with the needle, the distal end connected to the proximal end and the proximal end of the catheter, and a radial extension formed on the needle hub. An existing button, a needle shield arranged around the needle, and a pleated tether that connects the needle hub to the needle shield, the tether with pleats comprising a plurality of pleats. ), Each forming a hole through which a needle extends, the tether with folds (pleats) includes a proximal fold (pleat), the proximal fold (pleat) being A needle, comprising: a tether with pleats disposed around a radially extending button that provides mechanical engagement between the end pleats and the needle hub. assembly 7. The needle assembly of claim 6, wherein the radially extending button defines a slot and the proximal fold pleats engage the slot. 8. The tether with folds (pleats) includes an end fold (pleat) forming an end hole therein, the mechanical tether between the end fold (pleat) and the needle shield. 7. The needle assembly of claim 6, wherein a portion of the needle shield extends through the distal hole to provide a connection. 9. The needle assembly of claim 8, wherein the tether is formed from polyethylene terephthalate. 10. The needle assembly of claim 4, wherein the needle shield further comprises a barrier coupled with a longitudinally extending passageway for engaging a distal end of the introducer needle.