|Número de publicación||WO2001041843 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||PCT/US1999/029541|
|Fecha de publicación||14 Jun 2001|
|Fecha de presentación||13 Dic 1999|
|Fecha de prioridad||13 Dic 1999|
|También publicado como||CA2394328A1, CA2394351A1, CA2394351C, EP1239900A2, EP1239900A4, EP1239904A1, WO2001041830A2, WO2001041830A3, WO2001041830A8|
|Número de publicación||PCT/1999/29541, PCT/US/1999/029541, PCT/US/1999/29541, PCT/US/99/029541, PCT/US/99/29541, PCT/US1999/029541, PCT/US1999/29541, PCT/US1999029541, PCT/US199929541, PCT/US99/029541, PCT/US99/29541, PCT/US99029541, PCT/US9929541, WO 0141843 A1, WO 0141843A1, WO 2001/041843 A1, WO 2001041843 A1, WO 2001041843A1, WO-A1-0141843, WO-A1-2001041843, WO0141843 A1, WO0141843A1, WO2001/041843A1, WO2001041843 A1, WO2001041843A1|
|Inventores||Vance D. Campbell, Jr., Joseph Nebolon, Robert D. Adams|
|Solicitante||Futura Medical Technologies, Inc.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (11), Citada por (6), Clasificaciones (8), Eventos legales (11)|
|Enlaces externos: Patentscope, Espacenet|
SYRINGE WITH RETRACTABLE NEEDLE ASSEMBLY
BACKGROUND OF THE INVENTION
The present invention relates generally to protection against an accidental
sharps injury or stick from an unprotected needle. More particularly, the present
invention relates to a retractable needle syringe for protection from an accidental
sharps injury or stick from a used needle of the type commonly associated with
medical practice. Most particularly, the present invention relates to an automatic
retractable needle syringe for protection against an accidental sharps injury or stick
from a used syringe.
For some time, the art has recognized the desirability of protecting personnel
from accidental sharps injuries or needle sticks. More recently, concerns have been
expressed about the possibility of transmitting serious or potentially fatal infection
as a result of such accidents. Most recently, legislation requiring the use of safe
needle technology is pending in a number of States and before the Occupation
Safety and Health Administration. Although, the art has recognized the desirability
of protecting against accidental sharps injuries or needle sticks, it is believed that
practical protective devices are still not available.
U.S. Patent No. 5,209,739 discloses a hypodermic needle assembly and a
syringe, both having a retractable cannula. An elastomeric tube is connected
between the cannula and the passage to the fluid chamber. In each of the
embodiments, a separate mechanical device must be independently operated by the
user to cause retraction of the cannula into a second compartment. Since the fluid must travel through the elastomeric tube to bypass the second compartment, there
is a potential risk of injecting air directly into the patient if the elastomeric tube
European Patent No. 0 862 Al discloses a device in which a needle is
retracted into the syringe. In several of the embodiments, the device requires the
user to independently operate a mechanical device to cause retraction of the needle.
In the one embodiment which utilizes an elastic member, the elastic member is not
preloaded and requires the user to depress the plunger to load the elastic member
and thereafter continue to apply pressure on the plunger to avoid premature
withdrawal of the plunger. As such, the device requires two hands for its
Various methods of providing a preloaded retraction assembly which permit
one hand operation are disclosed in co-owned PCT Application No.
PCT US97/20646, International Publication No. WO 98/20923. While these
devices operate successfully, it has been found that the devices may have a
somewhat reduced shelf life since the retraction member remains in a tensioned,
Other devices which allow the retraction member to be loaded by the user
have been introduced. However, these devices generally require a complicated or
non-routine procedure to accomplish such. The further a device is from routine
operation, the generally less accepted it is by the medical community. Additionally,
some of these devices require a mechanical altering of the device which may be difficult to accomplish or may cause deformities which prevent the device from
operating properly. See for example U.S. Patent Nos. 5,928,200 and 5,836,917.
Furthermore, many retractable systems employ a geometrically configured
retraction member which mates with a geometrically configured member of the
needle assembly. A common problem associated with such is the geometrically
configured retraction member is forward of the plunger sealing surface and thereby
engages and seals the passageway through the needle assembly before all of the
fluid is expelled. As a result, pressure builds in the syringe body. As the needle
assembly retracts, a fluid passage opens and the pressurized fluid is ejected
Another concern with prior art devices is the complicated and costly
manufacturing processes. With the tremendous number of syringes and other
needle devices used by the medical community, any substantial rise in cost of the
products is undesirable and generally unacceptable.
Accordingly, there is a need for a syringe having an automatically retracted
used needle assembly that can be used in a conventional manner and does not
require elaborate manufacturing.
SUMMARY OF THE INVENTION
The present invention relates to a disposable, single use syringe including
a hollow body, a retractable needle assembly positioned in the hollow body, and a
plunger assembly in the hollow body. The plunger assembly includes an elongated frame portion extending between a sealing platform and a catch platform and
defining at least one guide track between the platforms. The sealing platform
sealingly engages the hollow body. A retraction member is releasably secured to
the sealing platform and a catch member having a catch tip is positioned with a
guide configured to travel in the plunger frame guide track. An elastomeric
member extends between the retraction member and the catch member. A retention
assembly depends from the catch platform and is configured to receive and secure
the catch tip and thereby tension the elastomeric member. The needle assembly and
the retraction member have complimentary mating members, whereby the tension
on the elastomeric member is released when the needle assembly and the retraction
member mate and the injection means is drawn into the hollow body. A method of
manufacture is also provided.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is an expanded view of a syringe assembly in accordance with the
Figure 2 is a cross sectional view of the preferred syringe barrel.
Figure 3 is an exploded view of the closed end of the syringe barrel of
Figure 4 is a side elevation of the needle assembly.
Figure 5 is an isometric view of the preferred plunger assembly of the
present invention. Figure 6 is a cross sectional view of the plunger frame of the plunger
assembly of Figure 5.
Figure 7 is an exploded view of the sealing end of the plunger frame of
Figure 8 is a cross sectional view of the plunger assembly along the line 8-8
in Figure 5.
Figure 9 is an exploded view of the retention end of the plunger assembly
of Figure 8.
Figure 10 is a side elevation view of the preferred mandrel of the present
Figure 11 is a side elevation view of the preferred catch plate of the present
Figure 12 illustrates the preferred syringe in an assembled but unused
Figure 13 illustrates the syringe of Figure 12 upon initial substantial
depression of the plunger assembly.
Figure 14 illustrates the syringe of Figure 12 after loading of the syringe.
Figure 15 illustrates the forward portion of the syringe of Figure 12 as it is
inserted in a patient.
Figure 16 illustrates the forward portion of the syringe of Figure 12 upon
substantial injection depression of the plunger assembly.
Figure 17 illustrates the forward portion of the syringe of Figure 12 after the mandrel tip has entered the needle assembly cavity.
Figure 18 illustrates the forward portion of the syringe of Figure 12 upon
complete depression of the plunger assembly.
Figure 19 illustrates the syringe of Figure 12 after retraction of the needle
Figure 20 shows the plunger assembly members formed from the first
injection mold shot in accordance with the preferred method of manufacture.
Figure 21 shows the plunger assembly as formed from the second injection
overmold shot in accordance with the preferred method of manufacture.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The preferred embodiments will be described with reference to drawing
figures where the numerals represent like elements throughout.
With reference to Figure 1, the components of the preferred embodiment
8 of the invention will be described. The syringe assembly 8 is comprised generally
of the cap member 10, the syringe barrel 40, the needle assembly 70, and the
plunger assembly 100.
The cap member 10 includes an open, mating end 12 and a closed cone
section 14. The mating end 12 is preferably configured to slidingly engage the
syringe barrel 40. Alternatively, the mating end 12 may be provided with threads
(not shown) which may engage corresponding threads (not shown) on the syringe
barrel 40. Other cap and corresponding barrel configurations are known and may also be employed. The closed cone section 14 preferably includes a plurality of ribs
16 which assist gripping of the cap member 10.
Referring to Figures 2 and 3, the syringe barrel 40 is comprised of a hollow
body portion 42 which has a closed end 44 and an open end 54. An external
stabilized grip member 56 extends from the body 42 proximate, but forward the
open end 54. The grip member 56 may have various configurations, the preferred
elliptical configuration being shown. An internal annular shoulder 60 is defined
in the hollow body 42 at approximately the same position as the grip member 56.
The open end 54 defines an open cavity 58 rear of the internal annular shoulder 60.
An internal annular lip 62 may also be provided adjacent the open end 54.
The closed end 44 is defined by a truncated cone 46 which includes a
truncating plane having an aperture 48. On the interior of the hollow body 42, at
a position adjacent to the closed end 44, is a retaining groove 50 that retains the
needle assembly 70 in position during use as will be described in more detail
hereinafter. Referring to Figure 3, the closed end proximate the truncated cone 46
has a generally convex taper 47 and at least one internal ramp 52, the functions of
which will be described hereinafter.
Referring to Figure 4, the needle assembly 70 is comprised of a needle 72
which is centrally positioned in the conical projection 74. The conical projection
74 generally complements the interior of the truncated cone 46 of the syringe barrel
40. Immediately adjacent to the projection 74 is a sealing ring 76. The projection
74 and the sealing ring 76 are preferably formed as a unitary molding of synthetic rubber. The interior passage 78 of needle assembly 70 communicates with the
hollow needle 72 and the geometrically configured cavity 80 extending into the rear
surface of the needle assembly 70. In the preferred embodiment, the cavity 80 has
a cylinder portion 80a and a hemispheric portion 80b which complement the
geometrically configured tip 176 of the plunger mandrel 170. The needle assembly
70 is positioned within the syringe barrel 40 such that the needle 72 extends
through aperture 48 and the sealing ring 76 is positioned in and retained by the
retaining groove 50.
Referring to Figures 1 and 5-11, the plunger assembly 100 includes a
plunger frame 110, a retraction assembly 160, a thumb pad 104 and a sealing
member 150. The plunger frame 110 includes a retention end 114 and a sealing
end 130 with a pair of opposed connecting rods 126 extending therebetween. The
opposed connecting rods 126 define opposed retraction assembly guide tracks 128.
The sealing end 130 includes an apertured shelf 132 extending between the
connecting rods 126, an apertured cylinder 134 extending from the shelf 132 and
terminating in an apertured pressure cone 138. The apertures are preferably
concentric such that a continuous aperture 140 passes through the sealing end 130
from the shelf 132 to the pressure cone 138. The aperture 140 is preferably tapered
such that the diameter is greater withing the shelf 132 than within the pressure cone
138. Additionally, an internal annular ring 142 extends into the aperture 140
proximate the pressure cone 138. An external annular retaining ring 136 is
positioned about the juncture of the cylinder 134 and pressure cone 138. The function of the taper and the internal and external rings 136 and 142 will be
described in more detail hereinafter.
Referring to Figure 6, the retention end 114 of plunger frame 110 includes
a terminating plate 116 extending between and bridging the opposed connecting
rods 126. An annular thumb pad retaining ring 117 extends about the terminating
plate 116. Additionally, a guide member 118 may extend outward from each
connecting rod 126 proximate the terminating pad 116. A retention assembly 120
extends inward from the terminating plate 116 between the opposed connecting
rods 126. The preferred retention assembly 120 includes a pair of opposed L-
shaped members 122, each L-shaped member having a beveled catch 124 extending
therefrom. Other retention assemblies which permit inward passage and then
retention of a geometrically configured tip are within the scope of the invention.
Each component of the plunger frame 110 is preferably manufactured from
polypropylene or glass filled polypropylene. Other materials, including various
plastics, may also be used. As described in more detail hereinafter, the plunger
frame 110, in addition to components of the retraction assembly 150, is preferably
formed as a first shot of a multiple shot injection molding procedure.
Referring to Figure 8, plunger sealing member 150 is positioned about the
cylinder 134 and the external retaining ring 136 and is maintained in position by
external ring 136. The sealing member 150 includes annular seals 152 and 154 at
each end with a narrower portion 156 positioned therebetween. When the plunger
assembly 100 is positioned in the syringe barrel 40, annular seal 152 sealingly
engages the inside surface of the hollow body portion 42 with an area of open space about the narrower portion 156. Annular seal 154 may also sealingly engage
the hollow body 142, but may also include a passage to prevent creating a vacuum
in the narrower portion 156. The sealing member 150 is preferably manufactured
from an elastomer. A material found to be suitable is Kraton™ manufactured by
Shell Oil. A preferred material is Kraton™ G2706 manufactured by Shell Oil. As
will be described in detail hereinafter, the sealing member 150 is preferably
overmolded directly in position, but may be manufactured separately and
subsequently positioned about the cylinder 134 and retaining ring 136.
The retention end 114 of plunger frame 110 can be utilized with the
terminating plate 116 only. However, it is preferable to provide a thumb pad 104
about the terminating plate 116 and retained by the retaining ring 117 as shown in
Figure 9. The thumb pad 104 is also preferably manufactured from an elastomer,
most preferably Kraton™. As with the sealing member 150, it is preferable that the
thumb pad 104 be overmolded directly in position, but it too may be manufactured
separately and subsequently positioned and secured about the terminating plate 116.
The preferred retraction assembly 160 will be described with reference to
Figures 8, 10 and 11. The retention assembly 160 includes a mandrel 170, a catch
plate 190 and a resilient member 164. Referring to Figure 10, the mandrel 170
includes a generally cylindrical body 172 with a tapered portion 174 extending
from one end and a shaft portion 180 extending from the other. The tapered
portion 174 terminates in a geometrically configured tip 176. A mandrel annular
retaining ring 178 extends about the cylindrical body 172 proximate the juncture with the tapered portion 174. The shaft portion 180 includes a plurality of barbs
182 or the like extending therefrom for retaining the resilient member 164.
Referring to Figures 8, an annular stop 184 extends about the cylindrical body 172
adjacent the shaft end. The stop 184 is preferably elastomeric and therefore is
preferably formed in conjunction with the resilient member 164.
Referring to Figures 5 and 11, the catch plate 190 includes an elongated
plate 192 which is sized such that each end of the elongated plate 192 extends into
and travels within a respective retraction assembly guide track 128 of the plunger
frame 110. Extending from one side of the elongated plate 192 is a shaft 194 with
barbs 196 or the like extending therefrom for retaining the resilient member 164.
A second shaft 198 extends from the opposite side of the elongated plate 192 and
terminates in a geometrically configured catch tip 200. The tip 200 is configured
to mate with and be retained by the retention assembly 120 of the plunger frame
The mandrel 170 and the catch plate 190 are preferably manufactured from
the same material as the plunger frame 110. As such, these components can also
be formed during the first shot of the multiple shot injection molding procedure
used to form the plunger frame.110.
The resilient member 164 extends between the mandrel 170 and the catch
plate 190. The resilient member 164 is manufactured from a resilient material,
which is preferably an elastomer, but which can be other materials, for example a
stainless steel spring or the like. The resilient member 164 is preferably manufactured from Kraton™. In the preferred method of manufacture described
below, the resilient member 164 is formed between the mandrel 170 and the catch
plate 190 with a second injection, overmolding shot. Do to the resilient member
164 being directly overmolded over the barbed shafts 180 and 194 and the innate
bonding property of the preferred material, there is generally not a need for
additional securing means, for example adhesive, to maintain the resilient member
164 secured to the mandrel 170 and catch plate 190. It is contemplated that the
resilient member 164, irrespective of the material from which it is manufactured,
may also be manufactured separately and secured to the mandrel 170 and catch
plate 190. Since the sealing member 150, thumb pad 104 and stop 184 are all also
preferably manufactured from the same material as the resilient member 164, they
are also preferably formed during the second injection, overmolding shot.
Having described the components of the preferred syringe 8, its assembly
and use will now be described with reference to Figures 12-19. The needle
assembly 70 is positioned in the syringe barrel 40 with the needle 72 extending
through the aperture 48. The needle assembly 70 is inserted until the sealing ring
76 seats in and is retained by the syringe body retaining groove 50. The cap
member 10 may be mated with the closed end 44 of the syringe barrel 40 either
before or after insertion of the needle assembly 70.
The plunger assembly 100 is assembled by assembling the plunger frame
100, which already has the thumb pad 104 and sealing member 150 positioned
thereon, and the retraction assembly 160. As explained above, the resilient member 164 is preferably molded directly to the mandrel 170 and catch plate 190, to form
the retraction assembly 160. If not formed integrally, the resilient member 164 is
secured to the mandrel and catch plate barbed shafts 180 and 194. With the
retraction assembly 160 complete, the mandrel 170 is inserted through the aperture
140 passing through the plunger frame sealing end 130. The mandrel 170 is
inserted until the mandrel retaining ring 178 is secured by the sealing end internal
annular ring 142. The mandrel retaining ring 178 forms a fluid tight seal with the
plunger sealing end 130 proximate the pressure cone 138, thereby sealing the
aperture 140. The resilient stop 184 abuts against the rear surface of the shelf 132,
thereby forming a fluid tight seal about that end of the aperture 140. As the plunger
assembly is withdrawn from the hollow body 42, a vacuum is created therein. The
seal provided by the resilient stop 184 helps prevent air or other materials from be
pulled past the mandrel 170 into the syringe body 42 by the internal vacuum force.
With the mandrel 170 in place, the plunger assembly 100 is ready to be
inserted into the syringe barrel 40 through the open end 54. The annular seals 152
and 154 sealingly engage the inside of the syringe barrel 40 as the plunger assembly
100 is inserted. The plunger assembly 100 is inserted approximately half-way into
the syringe barrel 40 until the elongated plate 192 abuts the shoulder 60, as shown
in Figure 12. The syringe 8 is ready for packaging and delivery. It should be
noted that at this time the resilient member 164 is not tensioned. This helps
increase the shelf life of the syringe 8 since the resilient member 164 is not under
constant tension. If shelf life is not a concern, the catch plate 190 can be secured to the retention assembly 120 prior to packaging, whereby the syringe 8 would have
a preloaded elastomeric member.
After removing the syringe assembly 8 from the packaging, the operator can
hold the syringe in a typical one hand manner, i.e. with two fingers abutting the
grip member 56 and the thumb on the thumb pad 104. The operator presses on the
thumb pad 104 to depress the plunger assembly 100 into the syringe barrel 40 with
a substantially complete compression to expel air from the syringe hollow body 42.
This is similar to standard syringe operation. As the plunger assembly 100 is
compressed, the elongated plate 192, and thereby the catch plate 190, is retained by
the shoulder 60 such that the catch plate 190 cannot travel forward. However, the
plunger frame 110 continues its forward travel. Since the catch plate 190 is
retained but the plunger frame 110 and secured mandrel 170 continue forward, the
resilient member 164 begins to stretch and tension. As travel continues forward,
the catch plate geometrically configured tip 200 mates with and is retained by the
retention assembly 120 of the plunger frame 110 as shown in Figure 13. The
resilient member 164 is thereby tensioned in a loaded condition between the
secured mandrel 170 and the secured catch plate 190. As the tip 200 and retention
assembly 118 mate, an audible "click" may occur to provide a signal of proper
mating to the operator. Additionally, in the preferred embodiment, the syringe
barrel annular lip 62 adjacent the open end will discourage complete depression of
the plunger assembly 100 at this time.
With the resilient member 164 loaded, the syringe 8 can be loaded in a typical fashion by removing the cap 10, inserting the needle 42 into a desired vial
or the like, and withdrawing the plunger assembly 100 to draw up a desired dose
as shown in Figure 14. Since the resilient member 164 is tensioned between two
components secured to the plunger frame 110, withdrawal of the plunger assembly
100 will not trigger the resilient member 164. Instead, the plunger assembly 100
will operate as a standard syringe plunger.
Once any air has been purged from the syringe barrel 40 in a known manner,
the device 8 is ready for injection of the needle 72 into the patient. As stated
above, the resilient member 164 is tensioned between two fixed components, and
therefore, is not acting to move the plunger assembly 100 in either direction. As
such, the user does not have to maintain constant pressure on the plunger assembly,
but is free to hold the syringe 8 in the traditional dart like fashion between their
thumb and forefinger of one hand, and use the other hand to pinch the patient' s
skin at the point of insertion for subcutaneous injection, spread the skin for
intramuscular injection, and stabilize the skin for IV injection. These methods of
injection are the generally preferred methods in the medical field. As the needle 72
is inserted, a rearward force, indicated by the arrow A in Figure 15, is applied
against the needle assembly 70. However, the needle assembly sealing ring 76 is
sufficiently secured within the retaining groove 50. Additionally, since the syringe
barrel tapered surface 47 about the truncated cone 46 is convex, the rearward force
causes the syringe barrel surface to urge inward, as indicated by arrows B, thereby
creating a tighter retention force about the needle assembly 70. Once the user has inserted the needle 72 into the patient, the user injects the substance into the patient
by depressing the thumb pad 104.
As shown in Figure 16, upon substantial depression of the plunger assembly
100, the mandrel tip 176 begins to enter the needle assembly cavity 80. At
approximately the same time, the first annular seal 152 meets and is deflected by
the ramps 52 adjacent the closed end 44 of the syringe barrel 40, thereby breaking
the fluid tight seal. Any fluid trapped between the plunger sealing member 150 and
the needle assembly 70 is permitted to pass the deflected annular seal 152 into the
open space around narrower portion 156. The second annular seal 154 may remain
in sealing engagement with the syringe barrel 40 to prevent any unwanted inward
or outward flow past the sealing member 150. However, the annular seal 154 may
include a small passage to let trapped air about the narrower portion 156 escape.
The mandrel tip 176 passes through the needle assembly cavity cylindrical
portion 80a into the geometrically configured cavity hemispherical portion 80b
whereby the mandrel 170 is secured to the needle assembly 70 as shown in Figure
17. In this position, the mandrel tip 176 has moved as far into the needle assembly
70 as possible, yet the plunger frame 110 has not completed its full stroke. As
such, continued force on the thumb pad 104 will continue to move the plunger
frame 110 forward. Since the mandrel 170 position is fixed and the plunger frame
110 is being forced forward, the mandrel retaining ringl78 will be forced inward
past the plunger sealing end retaining ring 136, thereby releasing the mandrel 170
as shown in Figure 18. That is, the mandrel retaining ring 178 moves behind the
retaining ring 136 as shown in phantom. Since the mandrel 170 is under the load of the resilient member 164 but no longer retained by the retaining ring 136, the
load of the resilient member 164 automatically retracts the mandrel 170 into the
plunger frame 110 between the connecting rods 126. Through the connection of
mandrel tip 176 and the geometrically configured needle assembly cavity 80, the
needle assembly 70 is also retracted into the plunger frame 110, as shown in Figure
19. The tapered pressure cone 138 on the sealing end of the plunger frame 110
contacts the convex, tapered portion 47 of cone 46 and causes it to spread slightly.
This reduces the retaining force of cone 46 on the needle assembly 70 to assist
retraction of the needle assembly 70. Furthermore, since the tapered portion 47 is
convex, the forward fluid and plunger force, as indicated by arrow C in Figure 18,
urge the tapered portion 47 outward, as indicated by arrows D, further easing the
retaining force and thereby reducing the requisite retraction force. This flexing
preferably occurs simultaneously or slightly after the mandrel 176 enters the
hemispherical portion 80a of the needle assembly cavity 80.
Referring again to Figure 19, as the plunger assembly 100 completes its
stroke, the thumb pad 104 enters the open cavity 58 at the end of the syringe barrel
40. In the preferred embodiment, the thumb pad 104 is manufactured from a
resilient material which sealingly engages the syringe barrel 40 wall, thereby
closing the open end 54 and preventing any inadvertent fluid flow out of the
syringe barrel 40. Additionally, since the thumb pad 104 enters and is recessed in
the open cavity 58, it makes it difficult for anyone to inadvertently or intentionally
remove the plunger assembly 100 and expose the used needle 72. The thumb pad 104 preferably has a semi-domed configuration which enhances its inaccessibility.
Additionally, the thumb pad 104 is preferably inserted past the inner annular lip 62
and retained thereby, further enhancing inaccessibility.
The preferred method of manufacture thereof will now be described with
reference to Figures 20 and 21. A first shot injection mold procedure is utilized
to form the plunger frame 110 components (the retention end 114, the sealing end
130 and the connecting rods 126 extending therebetween), the mandrel 170, and
the catch plate 190 in a single shot of the desired material, in the preferred
embodiment, polypropylene. The resultant component is shown in Figure 20. The
mandrel 170 and the catch plate 190 are maintained in position relative to one
another and the plunger frame 110 by runners 210 extending from the components
170 and 190 to the connecting rods 126. The formed plunger frame 110, mandrel
170 and catch plate 190 are then positioned in a second mold cavity. Using a
second injection, overmold shot of the desired material, in the preferred
embodiment, Kraton™, the resilient member 164, stop 184, sealing member 150
and thumb pad 104 are formed directly over the corresponding parts of the plunger
frame 110, mandrel 170 and catch plate 190 as shown in Figure 21. After the
plunger assembly 100 is removed from the second mold, the runners 210 are
trimmed off the mandrel 170 and connecting rods 126, thereby freeing the mandrel
170. The mandrel 170 is then pushed through the plunger sealing end aperture 140
until it is retained in position by the interaction of the mandrel retaining ring 178
and the plunger sealing end retaining ring 136. After the mandrel 170 is secured, the runners 210 can be trimmed between the catch plate 190 and the connecting
rods 126. While it is possible to trim all of the runners 210 at the same time, it is
preferable to maintain the runners 210 supporting the catch plate 190 to avoid
excessive movement of the retraction assembly 160 during insertion of the mandrel
170. Once the mandrel 170 is inserted and the runners 210 are trimmed, the
plunger assembly 100 is ready for use in accordance with the above.
This method of overmolding a resilient, elastomeric material about a frame
assembly is also contemplated for use in forming various other medical and non-
medical articles. With respect to medical articles, retractable blood collection
devices, automated lancets, syringes with tensioned or tensionable elastomeric
inner or outer sheaths, and butterfly devices are among the articles considered.
While the present invention has been described in terms of the preferred
embodiments, other variations which are within the scope of the invention as
defined in the claims will be apparent to those skilled in the art.
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|Clasificación internacional||A61M5/31, A61M5/32, A61M5/178, A61M5/34, A61M5/315|
|Clasificación cooperativa||A61M5/3234, A61M2005/3241|
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