U.S. patent application number 09/730370 was filed with the patent office on 2001-11-22 for safety needle apparatus and method.
Invention is credited to DeMichele, John L., DeMichele, Louis R., McDonald, Michael B..
Application Number | 20010044607 09/730370 |
Document ID | / |
Family ID | 23141571 |
Filed Date | 2001-11-22 |
United States Patent
Application |
20010044607 |
Kind Code |
A1 |
DeMichele, Louis R. ; et
al. |
November 22, 2001 |
Safety needle apparatus and method
Abstract
Disclosed is a safety catheter that automatically sheaths the
needle upon withdrawal of the needle from a patient. The catheter
can include a plunger for drawing a vacuum to draw blood or
alternatively may delete the plunger and use nearly identical
components with the addition of a blocking plug. The catheter also
includes a cap/re-cap device that provides additional sheathing of
the needle during assembly, shipping, and use of the needle. It
also includes raised indicia that serves as a trademark as well as
a friction gripping surface. The catheter includes improved
catheter hub mounting structure as well as strengthened ribbed
areas for grasping during use of the catheter.
Inventors: |
DeMichele, Louis R.;
(Barrington, IL) ; DeMichele, John L.;
(Barrington, IL) ; McDonald, Michael B.;
(Mundelein, IL) |
Correspondence
Address: |
McAndrews, Held & Malloy, Ltd.
34th Floor
500 West Madison Street
Chicago
IL
60661
US
|
Family ID: |
23141571 |
Appl. No.: |
09/730370 |
Filed: |
December 5, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09730370 |
Dec 5, 2000 |
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09477213 |
Jan 4, 2000 |
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6156015 |
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09477213 |
Jan 4, 2000 |
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09102467 |
Jun 22, 1998 |
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6010487 |
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09102467 |
Jun 22, 1998 |
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08823830 |
Mar 25, 1997 |
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5769827 |
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08823830 |
Mar 25, 1997 |
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08296329 |
Aug 25, 1994 |
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Current U.S.
Class: |
604/192 ;
604/164.01; 604/164.08 |
Current CPC
Class: |
A61M 25/0631 20130101;
A61M 5/322 20130101 |
Class at
Publication: |
604/192 ;
604/164.01; 604/164.08 |
International
Class: |
A61M 005/178; A61M
005/32 |
Claims
1. An improved needle apparatus comprising in combination: a. a
first housing having a first end; b. a needle secured to said first
housing, extending beyond said first end, and having a point which
can be injected into a patient; c. a second housing movably
captured with respect to said first housing, said second housing
having a first end and an opposite end, wherein said first housing
and needle are manually movable, with respect to said second
housing, between a needle exposing position at which said needle
point is outside said second housing, and a needle sheathing
position at which said point is withdrawn into said second housing
after said needle is fully withdrawn from a patient to prevent an
accidental needle stick; and d. a one-piece removable cap having a
first end adapted for engaging said first housing to provide a
sheath for said needle, and also having a second end adapted for
engaging said second housing to provide a sheath for said
needle.
2. The needle apparatus of claim 1, wherein said needle has an
axially extending internal passage, and said second housing
includes a generally cylindrical internal wall defining a chamber
communicating with said internal passage.
3. The needle apparatus of claim 2, further comprising a plunger
disposed within said generally cylindrical internal wall and
slidably engaging said generally cylindrical internal wall to
define a piston.
4. The needle apparatus of claim 3, further comprising a plunger
rod having a first portion secured to said plunger and a second
portion accessible to a user for sliding said plunger within said
generally cylindrical internal wall.
5. The needle apparatus of claim 1, further comprising a catheter,
wherein said needle is inserted through said catheter when in said
needle exposing position and removed from said catheter when in
said needle sheathing position.
6. The needle apparatus of claim 1, wherein the opposite end of
said second housing is disposed within at least a portion of said
first housing.
7. The needle apparatus of claim 1, wherein at least one of said
first and second housings has an exterior portion accessible for
grasping and provided with a grip.
8. The needle apparatus of claim 1, wherein said grip is formed by
raised indicia on said exterior portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of application Ser. No. 09/477,213,
filed Jan. 4, 2000, now U.S. Pat. No. 6,156,015, which is a
continuation of application Ser. No. 09/102,467, filed Jun. 22,
1998, now U.S. Pat. No. 6,010,487, which is a continuation of
application Ser. No. 08/823,830, filed Mar. 25, 1997, now U.S. Pat.
No. 5,769,827, which is a continuation of application Ser. No.
08/296,329, filed Aug. 25, 1994 now abandoned. Each application
identified above is incorporated here by reference in its
entirety.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] NOT APPLICABLE
BACKGROUND OF THE INVENTION
[0003] This invention relates to safety needles of the type used to
puncture the skin of patients. More particularly, this invention
relates to intravenous catheters that protect the needle both
before use and upon withdrawal from a patient.
[0004] Safety needles and catheters are old in the art. For
example, safety catheters are disclosed in: (1) U.S. Pat. No.
4,834,718 ("the '718 patent") issued on May 30, 1989, to Michael
McDonald; and (2) U.S. Pat. No. 4,944,725 ("the '725 patent"),
issued on Jul. 31, 1990, to Michael McDonald. Mr. McDonald is one
of the inventors of the present invention in this application.
[0005] The catheter in the '718 patent was the first catheter to
provide convenient, reliable, economical, and automatic sheathing
of the needle upon withdrawal of the needle from the patient. The
'725 patent discloses improvements to Mr. McDonald's first patented
structure in the '718 patent. The applicants hereby incorporate by
reference the complete disclosures of the '718 and '725
patents.
[0006] The structures shown in the '718 and '725 patents were
significant advances in the art. They included "flash back"
chambers to determine, by relatively small sliding movement of an
outer housing away from the catheter, whether the vein had been
punctured sufficiently so that blood would flow through the
catheter and needle into the flash back chamber where the blood
could be seen at the back of the housing.
[0007] These prior structures, however, were not as effective in
drawing blood into the flash back chamber when used on trauma
patients with very low blood pressure. For these types of patients,
the blood pressure of the patient can be too low to force blood
through the catheter and needle into the flash back chamber in the
housing. These prior art devices did not provide any way to draw a
substantial vacuum in the housing in order to draw blood from the
trauma patient into the flash back chamber when the needle and
associated catheter penetrate the vein of the patient.
[0008] Other safety needles in the art have employed plungers
penetrating the back of the needle housing to draw a vacuum in the
housing. None of these prior art structures, however, have provided
such a vacuum plunger for the McDonald safety needles shown in the
'718 and '725 patents.
[0009] Another problem with the prior art safety catheters and
needles is the lack of capping structure for complete capping of
the entire needle and catheter during assembly, shipping, and
pre-use handling. Thus, the prior art catheters and needles such as
shown in the '718 and '725 patents provided an exposed needle
during needle assembly and shipping. The needles are also exposed
when removed from their packaging and prior to actual alignment for
injection into the patient. This brings about risk of inadvertent
needle sticks to manufacturers and needle operators, and subsequent
inappropriate use of the same needles on patients. Accidental
needle sticks can have dire consequences and have long been
recognized as a great problem in the industry and, indeed, in
society in general.
[0010] Needles such those shown in the '718 patent and '725 patent
do sheath the needle upon withdrawal from the patient. This
provides the great advantage of automatic sheathing and protection
against needle sticks upon withdrawal, but it leaves the operator
without the comfort of having taken any action on his or her own to
cover the needle. Existing paramedics, nurses, and doctors in the
field are often accustomed to the prior art devices that do not
automatically sheath the needle upon withdrawal from the patient.
These types of operators are often most comfortable with capping of
the needle whether it is necessary or not. The prior safety
catheters of the '718 and '725 patents, and other safety catheters
in the prior art, did not provide any such additional capping
feature, probably because it appears to be unnecessary. It is often
necessary, in fact, however, since such a cap can put certain types
of operators at ease and reduce their reluctance to use a safety
needle such as that shown in the '718 and '725 patents.
[0011] The prior McDonald safety catheters of the '718 and '725
patents incorporated needle hub design that had a reduced and thin
neck (shown as number 36 in FIG. 1 of the '718 patent). This neck
is easy for the operator to grasp and hold in place with one hand
while simultaneously, with the other hand, pulling back on the
outer housing and thus automatically sheathing the needle within
the needle housing. The reduced diameter neck is relatively weak,
however, and may be subject to breakage when in use out in the
field.
[0012] Finally, the prior McDonald safety catheter employed a
cylindrical outer housing with a smooth, transparent plastic
surface. The operator grasps and pushes and pulls on the this
smooth surface when using the device out in the field. Although
this cylindrical transparent design is particularly effective and
reliable for a number of reasons, the operator's fingers can slip
on the smooth surface, particularly when wet, and risk puncturing
the patient incorrectly or at least not as accurately as desired.
An incorrectly positioned needle puncture, which misses the vein or
goes through it, can be painful and cause bleeding.
OBJECTS OF THE INVENTION
[0013] It is therefore an object of the present invention to
develop a safety catheter and needle that develops a vacuum to draw
blood into the flash back chamber when the needle is used on trauma
patients having low blood pressure.
[0014] It is yet another object of the present invention to develop
such a safety catheter and needle that provides protection against
accidental needle sticks during needle and catheter assembly and
shipping.
[0015] A further object is to provide a needle that also protects
against accidental sticks upon opening of the needle package,
removal of the needle from the package, and pre-use manipulation of
the needle and catheter.
[0016] Another object is to provide a catheter and needle that also
provides recapping structure to allow the operator to place an
otherwise separate cap over the needle after its withdrawal from
the patient.
[0017] Yet another object is to provide a single cap structure that
provides both pre-use capping and post-withdrawal capping of the
needle.
[0018] A still further object of the invention is to provide a
catheter and needle housing that is less subject to slipping in the
hands of a user while still being predominantly transparent and
generally cylindrical for easy use and grasping.
[0019] Another object is to provide a safety catheter that is
stronger, and less subject to accidental breakage in use, than
prior catheters and needles.
[0020] An additional object is to provide a safety catheter that
meets the prior objects while providing a safety catheter that is
convenient, easy and economical to manufacture, assemble, and ship,
slim yet sturdy, and easy to use and dispose of properly and
safely.
[0021] There are other objects that will become apparent as the
specification proceeds.
SUMMARY OF THE INVENTION
[0022] The foregoing objects and advantages are attained by our
invention of an improved safety needle, preferably a catheter
needle, that has an outer housing and an inner needle housing
slidably mounted in the outer housing. The inner needle housing
includes a catheter mounting end opposite the junction of the
needle housing and the outer housing. Preferably, a removable cap,
which is preferably frusto-conical, has one end mountable about the
catheter mounting end and another end mountable on the outer
housing. The cap can be mounted on the inner needle housing to
protect against needle sticks during shipping of the inner needle
housing and assembly of the catheter on the needle and the inner
housing within the outer housing. The cap can then be reversed and
mounted on the outer housing to protect against needle sticks
during packaging, shipment, and pre-insertion manipulation of the
catheter. Preferably, after withdrawal of the needle, the cap can
be remounted on the outer housing to provide protection against
accidental sticks after use of the needle and during disposal.
[0023] The outer housing may include a plunger penetrating the
outer housing on the side of the outer housing opposite the needle.
The plunger is slidably mounted in the outer housing to draw a
vacuum within the outer housing. Alternatively, the plunger may be
omitted and the plunger passage blocked with a plug.
[0024] The outer housing may also include a gripping friction
surface which preferably results from embossing a trademark or
suitable indicia on the outer surface of the outer housing. The
inner needle housing may also include ribs or columns on the
periphery of the needle housing to strengthen it while minimizing
material use and providing grasping surfaces on the needle
housing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The preferred embodiments of the applicants' invention are
depicted in the following drawings in which:
[0026] FIG. 1 is an exploded isometric view of the major components
of the preferred catheter embodiment having a plunger, a separable
needle cap, and an embossed trademark/friction surface on the outer
housing;
[0027] FIG. 2 is a partial plan view of the catheter needle of FIG.
1 after assembly and showing the plunger in partial cutaway within
the housing;
[0028] FIG. 3 is a partial cross-sectional view through section
line 3-3 of FIG. 2, showing the indicia embossing of the outer wall
of the outer housing;
[0029] FIG. 4 is a cross-sectional view of the preferred plunger
catheter showing the narrow end of the cap mounted on the inner
needle housing to cover the needle during shipment and
assembly;
[0030] FIG. 5 is a cross-sectional view of the preferred plunger
catheter showing the cap being removed from the inner needle
housing after assembly of the inner needle housing within the outer
housing of the catheter;
[0031] FIG. 6 is a cross-sectional view of the preferred plunger
catheter showing the cap inverted from the orientation of FIG. 5
and mounted on the outer housing to cover the catheter and needle
during packaging, shipment, removal from the packaging by the user,
and pre-use manipulation of the catheter;
[0032] FIG. 7 is a cross-sectional view of the preferred plunger
catheter showing removal of the cap from the outer housing prior to
insertion of the needle and catheter into the patient;
[0033] FIG. 8 is a cross-sectional view of the preferred plunger
catheter showing the withdrawal of the needle from the patient and
automatic sheathing of the needle within the inner needle
housing;
[0034] FIG. 9 is a cross-sectional view of the preferred plunger
catheter showing the cap mounted once again on the outer housing to
further protect the inner housing and needle within the inner
housing; and
[0035] FIG. 10 is a cross-section view of the preferred catheter
without the plunger and with a flash back plug abutting and thus
blocking the plunger passage in the back of the outer housing.
[0036] This description of the preferred embodiment utilizes
spacial orienting terms such as "back" and "outer." It is to be
understood that these terms are used for convenience of description
and not themselves limiting or requiring a particular location in
space.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0037] Referring now to FIG. 1, the applicant's preferred plunger
safety needle, generally 10, has a plunger rod 12 and plunger 14, a
needle mounting cylinder 16, a needle 18, a catheter 20, an inner
needle housing 22, an outer handle housing 24, and a cap 26. The
plunger rod 12 consists of an "X" shaped plunger beam 28 extending
perpendicularly from a planar plunger end cap 30. The plunger beam
28 slidably penetrates the open end 31 of a cylindrical flash back
chamber 32 on the interior of the needle mounting cylinder 16; and
the needle 18 is mounted on the end of the needle mounting cylinder
16 opposite the open end 31 of the flash back chamber 32.
[0038] The needle mounting cylinder 16 slidably penetrates an open
passage 34 in the needle housing 22. In turn, the needle housing
22, the needle mounting cylinder 16, plunger rod 12, and plunger 14
are mounted within the generally cylindrical interior wall 36 of
the outer handle housing 24. The plunger beam 28 of the plunger rod
12 slidably penetrates and abuts the "X" shaped plunger passage 38
cooperatively provided by the mating upper 40 and lower 42 halves
of the handle housing 24 when sonically welded together with the
needle housing 22 and the associated structure assembled within the
handle housing 24.
[0039] The plunger rod 12 is thus slidably mounted in the plunger
passage 38 to slidably penetrate the cylindrical flash back chamber
32 within the needle mounting cylinder 16. In turn, the
substantially cylindrical needle housing 22 slidably penetrates a
housing passage 44 provided within the interior wall 36 of the
handle housing 24.
[0040] The catheter 20 has a skin penetration tube 46 coaxially
extending from an expanded catheter hub 48. The catheter hub 48
mounts on the catheter mount 50 extending from the needle housing
22, and the cap 26 is mountable on the needle housing 22 or the
handle housing 24 as explained below.
[0041] Referring now to FIG. 2, the plunger beam 28 has a resilient
plunger 14 mounted within and slidably abutting the interior wall
52 of the needle mounting cylinder 16. Thus, when the plunger cap
30 is drawn away from the handle housing 24 and air cannot enter
through the needle 18 (not shown in FIG. 2) into the interior
vacuum space 54 within the needle mounting cylinder 16, the plunger
14 slides within the mounting cylinder 16 in the same direction and
simultaneously draws a vacuum in the interior vacuum space 54. If
the needle 18 has penetrated the vein of a patient (not shown) when
the vacuum is drawn in the interior vacuum space 54, blood is urged
to flow from the vein, through the needle, and into the vacuum
space 54.
[0042] The outer surface of the handle housing 24 includes
trademark indicia 56. With reference to FIG. 3, the indicia 56
projects from the outer surface of the housing 24. The raised
indicia 56 not only can identify the product and convey information
about the product 10 but also can provide a surface that is more
likely to cause greater friction in the hands of a user and less
likely to result in slippage when in use. This is particularly
helpful in an emergency, when sweaty palms and other fluids,
including blood, etc., may otherwise render the outer surface of
the handle housing 24 quite slippery. The preferred indicia 56 are
cut into the molds for the needle housing 24 so that the indicia 24
are included into the transparent housing 24 automatically when
molded. Other surface alteration or scoring may also be
utilized.
[0043] Referring now to FIG. 4, the cap 26 is frusto-conical and
thus has a larger somewhat cylindrical end 58 opposite a narrower
somewhat cylindrical end 60. The cap is made out of resilient
material, and its narrower end 60 is mountable on the narrowed cap
mounting hub 62 on the needle housing 22. The cap mounting hub 62
is intermediate the wider needle mounting housing central body 64
and the narrower raised column guard hub 66. When mounted on the
hub 62, the cap 26 thus provides a protective shield around the
needle 18 extending from the needle housing 22 when the needle
mounting cylinder 16 is placed within the needle housing 22 as
shown in FIG. 1. In this manner, the partial needle assembly 99
(consisting of the needle housing 22, needle mounting cylinder 16,
needle 18, and cap 26) can be shipped or moved from one assembling
or manufacturing area to another with significantly reduced risk of
any accidental needle stick to an assemblers, handlers, etc.
[0044] With reference now to FIG. 5, the cap 26 is readily removed
by an operator. The partial needle assembly 99 can then be further
assembled into the handle housing 24 as shown in FIG. 1.
[0045] With the cap 26 removed, the next manufacturer can install
the catheter 20 by sliding it over the needle 18 so that the
catheter hub 48 mounts on the catheter mount 50. The catheter mount
50 has a cylindrical mounting body 71 with diametrically opposed
catheter hub engaging arms 72, 74 extending radially outwardly from
the mounting body 71. The catheter hub 48 has a radially extending
detent or undercut 76 penetrating the cylindrical interior wall 78
of the catheter hub 48.
[0046] Referring now to FIG. 6, the catheter hub 48 mounts on the
catheter mount 50 and is retained in place on the mount 50 by the
radially extending arms 72, 74, which penetrate the radially
extending undercut 76 in the catheter hub 48. The catheter hub 48
is made of resilient material and is held in place by the arms 72,
74 until the operator forces the catheter 20 off of the mount 50
until it is fully separated from the needle housing 22.
[0047] Still referring to FIG. 6, the larger end 58 of the cap 26
has an internal radial rib or lip 68. The handle housing 24 has a
mating radial detent 70 on the needle end 61 of the handle housing
24 opposite the plunger end cap 30 (not shown in FIG. 6). The
larger end 58 of the cap 26 is mounted on the needle end 61 so that
the cap's internal rib 68 abuts the radial detent 70 in the housing
24. In this manner, the protective cap 26 is mounted on the handle
housing 24 to extend from the housing 24 and surround the needle 18
and catheter 20. The protective cap 26 once again provides a
protective sheath around the needle 18 and catheter 20 to minimize
accidental needle sticks during (i) further packaging, shipment,
and handling of the packaging, (ii) opening of the packaging, and
(iii) pre-use manipulation of the catheter 10 prior to actual use
to puncture the skin of a patient.
[0048] Referring now to FIG. 7, when the operator is ready to use
the needle 18 and catheter 20, the cap 26 may be pulled off of the
handle housing 24 (not shown). The operator may now insert the
needle 18 and catheter 20 into the patient as described in the '718
and '725 patents.
[0049] Referring back to FIG. 5, the raised column guard hub 66,
which is exposed upon removal of the cap 26, provides significant
strength with minimum material between the cap mounting hub 62 and
catheter mounting hub 50 on the needle housing 22. The operator can
readily grasp this area 66 of the needle housing to hold the
housing 22 when withdrawing the needle 18 from the patient (not
shown). In this operation, the handle housing (not shown in FIG. 5)
can be drawn away from the patient with one hand while grasping the
guard hub 66 and holding it in place as (i) the needle 18 is drawn
out of the patient, (ii) the mounting hub 50 separates from the
catheter hub 48 as shown in FIG. 7, (iii) the needle 18 slides out
of the catheter 20 as also shown in FIG. 7, and (iv) the needle 18
is drawn into the needle housing 22 as shown in FIG. 8. This
operation is described in greater detail in the '718 and '725
patents.
[0050] Now that the operator has completed use of the needle 18,
the operator can, as shown in FIG. 9, slide the large end 58 of the
cap 26 over the needle housing 22 to yet again engage the radial
detent 70 and secure the cap 26 on the handle housing 24. The same
cap 26 thus provides yet another level of protection against
subsequent needle sticks. This cap-remounting procedure also
provides the clinician, particularly one who is accustomed to
manual capping of needles after use, with a greater level of
comfort and security in using the safety needle 10. It also reduces
the likelihood that the cap 26 will be left behind on the street or
any other accident or trauma location.
[0051] Referring now to FIG. 10, the cap 26, indicia 56, (FIG. 1)
on the housing 24, mounting hub 50, and catheter hub 48 described
above may also be used on a safety needle not having a plunger at
all. This type of catheter is preferably for use with patients
having sufficient blood pressure. This non-plunger needle 100 has a
resilient plug 102 mounted within the mounting cylinder 16 to
extend therefrom and abut the generally planar interior end 104 of
the needle housing 24. The plug 102 thus abuts the "X" shaped
plunger passage 38 and prevents the flow of blood from the flash
back chamber 32 through the plunger passage 38.
[0052] The protective cap 26, plunger rod 12 and catheter hub 48
are preferably made from polypropylene. The plug 102 is made from
rubber, and the handle housing 24 and needle mount 16 are made from
high impact polystyrene. The needle is made of steel. The catheter
20 is made from radiopaque Teflon, and the needle housing 22 is
made from ploycarbonate.
[0053] It can thus be seen that the applicants have invented a
safety catheter and needle that is safer than prior art catheters
and needles and yet convenient, economical, and easy to assemble
and manufacture. It provides numerous significant advantages over
the prior art, and it does so at minimal cost.
[0054] While in the foregoing the applicants have described their
preferred embodiments, it is to be understood that the scope of the
invention is to be determined by reference to the following
claims.
* * * * *