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Patent 2234997 Summary

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(12) Patent: (11) CA 2234997
(54) English Title: ANTI-CORING NEEDLE
(54) French Title: AIGUILLE ANTI-OBTURATION
Status: Deemed expired
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61M 5/32 (2006.01)
(72) Inventors :
  • MARINACCI, ROBERT A. (United States of America)
  • PEARSON, WILLIAM R. (United States of America)
  • SPADY, DAVID E. (United States of America)
  • DALLING, N. LAWRENCE (United States of America)
(73) Owners :
  • MERIDIAN MEDICAL TECHNOLOGIES, INC. (United States of America)
(71) Applicants :
  • MERIDIAN MEDICAL TECHNOLOGIES, INC. (United States of America)
(74) Agent: LAVERY, DE BILLY, LLP
(74) Associate agent:
(45) Issued: 2006-08-15
(86) PCT Filing Date: 1996-10-10
(87) Open to Public Inspection: 1997-04-24
Examination requested: 2001-08-22
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1996/015787
(87) International Publication Number: WO1997/014461
(85) National Entry: 1998-04-16

(30) Application Priority Data:
Application No. Country/Territory Date
08/545,148 United States of America 1995-10-19

Abstracts

English Abstract





A hypodermic needle comprising a tubular, elongated, generally cylindrical
wall (12) defining an internal longitudinal bore (14)
extending longitudinally therethrough along a longitudinal axis. The
longitudinal bore has forward and rearward openings (16, 18). The
cylindrical wall is constructed and arranged to form a forward pointed end
(20) and a rearward pointed end (22). The rearward pointed end
is defined by an annular end surface (24) forming the rearward end of said
cylindrical wall. The rearward pointed end terminates in the most
rearward point (26) lying in an imaginary plane (28) disposed perpendicularly
to the longitudinal axis (x). The annular rearward end surface
defines an imaginary plane (32) inclined with respect to the imaginary plane
perpendicular to the longitudinal axis. The cylindrical wall
(12) has a laterally facing opening (34) spaced from the rearward opening of
the longitudinal bore, and the longitudinal bore is restricted
at a position between the rearward opening and the laterally facing opening.


French Abstract

L'invention concerne une aiguille hypodermique comprenant une paroi tubulaire allongée, généralement cylindrique (12) délimitant un lumen longitudinal traversant interne (14) s'étendant le long d'un axe longitudinal. Le lumen longitudinal a des ouvertures avant et arrière (16)(18). La paroi cylindrique est réalisée et agencée pour former une extrémité pointue avant (20) et une extrémité pointue arrière (22). L'extrémité pointue arrière est délimitée par une surface annulaire terminale (24) formant l'extrémité arrière de la paroi cylindrique. L'extrémité pointue arrière (24) se termine par une pointe (26), située dans un plan imaginaire (28), perpendiculaire à l'axe longitudinal (x). La surface d'extrémité annulaire arrière définit un plan imaginaire (32), incliné par rapport (au) plan imaginaire perpendiculaire à l'axe longitudinal. La paroi cylindrique (12) a une ouverture latérale (34) espacée de l'ouverture arrière du lumen longitudinal et le lumen longitudinal est resserré en une position entre l'ouverture arrière et l'ouverture faisant face latéralement.

Claims

Note: Claims are shown in the official language in which they were submitted.





WHAT I S CLAIMED IS:

1. A hypodermic needle, comprising a tubular,
elongated, generally cylindrical wall defining an
internal longitudinal bore extending longitudinally
through the cylindrical wall along a longitudinal axis,
said longitudinal bore having forward and rearward
openings; said cylindrical wall forming a forward pointed
end and a rearward pointed end, said rearward pointed end
terminating in an annular end surface having a
rearwardmost point lying in a first imaginary plane
disposed perpendicularly to said longitudinal axis, said
annular rearward end surface defining a second imaginary
plane inclined with respect to said first imaginary
plane; said cylindrical wall having a laterally facing
opening spaced from the rearward opening of said
longitudinal bore; and said longitudinal bore being
restricted at a position between said rearward opening
and said laterally facing opening.
2. The hypodermic needle according to claim 1, wherein
said laterally facing opening is generally in
longitudinal alignment with said rearwardmost point.

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02234997 1998-04-16
WO 97/14461 PCT/US96/15787
ANTI-CORING NEEDhE


The present invention relates to


hypodermic needles, and more particularly, to the


type of hypodermic needles that have a rearward end


adapted to establish fluid communication with a


medicament prior to an injection operation.


Hypodermic needles have several


applications. In most such applications the


hypodermic needle has a forward end adapted to


l0 penetrate the skin of an individual, and a rearward


end adapted to communicate with a liquid medicament


source so that the medicament is permitted to travel


from the source, through a central longitudinal bore


in the needle, and into the flesh of the individual.


In many of the applications for hypodermic


needles, it is necessary for the rearward end of the


needle to puncture a seal in order to establish


fluid communication with the medicament source. For


example, one application exists in the field of


automatic injection devices, wherein a liquid


medicament is sealed within a tubular container,


preferably made of glass, having a synthetic rubber


seal closing off a forward end thereof. During an


injection operation, the rearward end of the needle


punctures the seal to establish fluid communication


with the medicament, and a stressed spring assembly


is released so as to cause the forward end of the


needle to project outwardly from the forward end of


automatic injector body and into the flesh of an


individual while such fluid communication is


maintained. A plunger rearwardly confines the


medicament within the container and is driven by the


released spring assembly towards the forward end of


the container and functions to force the medicament


through the needle and into the flesh of the


1

CA 02234997 2005-08-04
individual. Such automatic injection devices are
disclosed, for example, in U.S. Patent Nos.
5,391,151; 5,102,393; and copending U.S. Patent
Application No. Docket 106,-
A problem associated with the
aforementioned arrangements in which the rearward
end of the needle must puncture a rubber or other
type of seal in order to establish fluid
to communication with a medicament is that it is
possible for the rearward end of the needle to core
out or dislodge a small particle from the seal.
This can lead to problems associated with the needle
establishing fluid communication with the
medicament. For example, where a-synthetic rubber
seal is used, a synthetic rubber particle may become
lodged in the needle's rearward end and
significantly reduce the amount of medicament flow
through the needle. While certain types of "anti-
coring" rubber materials, such as natural rubber,
have been used, such materials are not compatible
with as many types of medicaments in comparison with
synthetic rubber.
To obviate the aforementioned problems,
there has been proposed a hypodermic needle in which
a second, lateral opening is provided in the
cylindrical side wall of the needle, towards the
rearward end of the needle. The purpose of
providing a second opening is to enable fluid to
flow freely through the needle even in the event
that the rearward opening is plugged with a rubber
particle. However, this configuration does not
address the potential for a relatively small rubber
particle from entering the rearward end of the
needle and becoming lodged within the bore of the
2

CA 02234997 1998-04-16
WO 97/14461 PCT/US96/15787
needle at, or downstream from, the lateral second


opening, thus impeding fluid flow through the


needle. It also does not address another problem


which may arise when a lateral second opening is


rovided. More s ecificall
p p y, rather than a particle


becoming completely dislodged from the rubber seal,


in some instances the particle may become tethered


to the seal at the point of puncture. In such


instances, it is possible for the tethered particle


l0 to be drawn partially into the second, lateral


opening so as to partially block the longitudinal


passage through the needle and thereby reduce flow


through the needle. It may also be possible for a


dislodged particle to partially enter the second,


lateral opening and thereby reduce flow through the


needle.


It is an object of the present invention


to provide a hypodermic needle that overcomes the


problems noted above. In accordance with the


present invention, there is provided a hypodermic


needle comprising a tubular, elongated, generally


cylindrical wall defining an internal longitudinal


bore extending longitudinally through the


cylindrical wall along a longitudinal axis. The


longitudinal bare has forward and rearward openings.


The cylindrical wall is constructed and arranged to


form a forward pointed end and a rearward pointed


end. The rearward pointed end terminates in an


annular end surface having a rearwardmost point


lying in an imaginary plane disposed perpendicularly


to the longitudinal axis. The annular rearward end


surface defines an imaginary plane inclined with


respect to the imaginary plane perpendicular to the


,E longitudinal axis. The cylindrical wall has a


laterally facing opening spaced from the rearward


3

CA 02234997 1998-04-16
WO 97/14461 PCT/US96/15787
opening of the longitudinal bore, and the
longitudinal bore is restricted at a position
between the rearward opening and the laterally
facing opening.
i
These and other objects, features, and
advantages of the present invention will become
apparent from the following description and the
appended claims, taken in conjunction with the
accompanying drawings.
I0 BRIEF DESCRIPTION OF TiiE DRAWINGS
FIGURE 1 is a longitudinal sectional view
of the hypodermic needle according to the principles
of the present invention;
FIGURE 2 is an enlarged longitudinal
sectional view of the rearward portion of the
hypodermic needle in accordance with the principles
of the present invention;
FIGURE 3 is a plan view of the rearward
portion of the hypodermic needle of the present
invention, rotated 90° about the longitudinal axis
with respect to FIGURE 2;
FTGURE 4 is a transverse sectional view
taken through the line 4-4 in FIGURE 1;
FIGURE 5 is a transverse sectional view
taken through the line 5-5 in FIGURE 1;
FIGURE 6 is a longitudinal sectional view
showing the hypodermic needle in accordance with the
present invention, being utilized in conjunction
with a dental cartridge assembly of an automatic
injector assembly in accordance with the principles
of the present invention.
4

CA 02234997 1998-04-16
WO 97114461 PCT/US96/15787
ET~Ih~;D DESCRIPTION OF THE DRAWINGB
Referring now, more particularly, to the


' drawings, there is shown in FIGURE 1 a hypodermic


needle, generally indicated at 10, in accordance


' 5 with the principles of the present invention. The


hypodermic needle comprises a tubular, elongated,


generally cylindrical wall 12 defining an internal


longitudinal bore 14 extending longitudinally


therethrough along a longitudinal axis (indicated at


x in FIGURE 2). The longitudinal bore 14 has a


forward opening 16 and a rearward opening 18.


Preferably, the cylindrical wall 12 is made from


type 304 stainless steel. The cylindrical wall has


a forward pointed end, generally indicated at 20


formed by an angular grind. The cylindrical wall


also has a rearward pointed end, generally indicated


at 22, also formed by an angular grind. The


rearward pointed end 22 is defined by and terminates


in an annular end surface 24. As shown more clearly


in FIGURE 2, the rearward pointed end 22 terminates


in a rearwardmost point 26 lying in an imaginary


plane, indicated at 28, disposed perpendicularly to


the longitudinal axis x. The annular rearward end


surface 24 defines an imaginary plane, indicated at


32, inclined with respect to the imaginary plane 28


perpendicular to the longitudinal axis x.


The cylindrical wall 12 has a laterally


facing opening 34 spaced from the rearward opening


18 of the longitudinal bore 14. As can be


appreciated from the figures, the lateral opening 34


is in longitudinal alignment with the rearwardmost


point 26. The cylindrical wall 12 is crimped or


otherwise extended inwardly into the longitudinal


bore 14 to form a restriction 38
which restricts


,


the longitudinal bore 14 at a position between the


5

CA 02234997 1998-04-16
WO 97J1446i PCT/LJS96/15787
rearward opening 18 and the laterally facing opening
34.
w
As shown in FIGURE 3, the lateral opening
34 is defined by an oblong surface, generally
indicated at 40, defining a beveled edge surrounding
the opening 34. The surface 40 defining the beveled
edge converges as it approaches the longitudinal
axis of the hypodermic needle.
From FIGURES 2 and 3, it can be
appreciated that the more forwardly disposed portion
42 of surface 40 is inclined at a smaller angle with
respect to the longitudinal axis x in comparison
with the rearward portion 44 of surface 40. While
the forwardly disposed surface portion 42 is
I5 substantially flat and forms an angle 8, preferably
in the range of about 28° ~1° with respect to the
longitudinal axis, the rearward portion 44 is
substantially arcuate so as to define an imaginary
circle having a maximum radius R of .0060 inches.
The imaginary plane 32 defined by the
annular end surface 24 forms an angle a with respect
to the imaginary plane 28. Angle a is preferably
about 30° ~1°. The rearwardmost point 26 is
disposed at a distance g from the center of the
restriction 38. Preferably, the distance g is
approximately .030 inches. The rearwardmost point
26 is disposed at a distance h from the closest edge
forming the lateral opening 34. Preferably, the
distance h is approximately .052 ~.002 inches. The
longitudinally rearwardmost and longitudinally
forwardmost portions of the surface 40 forming the
lateral opening 34 are spaced by a distance i.
Preferably, the distance i is approximately .024
~.003 inches. The crimped or inwardly extending
surfaces forming the restriction 38 are separated by
6

CA 02234997 1998-04-16
WO 97/14461 PCT//1JS96/15787
a distance j. Preferably, the distance j is


approximately .005 + .001 to - .002 inches. The


thickness of the cylindrical wall is designated by


reference character t. Preferably the thickness t


is about .0050 + .0010 to -.0015 inches.


Referring to FIGURE 4, which is a


sectional view taken through the line 4-4 in


FTGURE 1, it can be appreciated that the outer


diameter for the major portion of the cylindrical


wall 12 is a dimension k, which is preferably about


.016 - .0165 inches (27 gauge). As can also be


appreciated from FIGURE 4, the cylindrical wail 12


has an inner diameter 1, which is preferably between


about .0075 and .0090 inches.


Referring now to FIGURE 5, which is a


sectional view taken through the line 5-5 in


FIGURE 1, it can be appreciated that surfaces 46


forming the side surfaces leading to the forwardmost


point 48 of the hypodermic needle are inclined by an


2o angle a with respect to an imaginary plane 50


through axis x, as shown. In FIGURE 1, it can be


seen.that the forwardmost point 48 is disposed on


the opposite side of the needle (i.e., out of


longitudinal alignment) with respect to rearwardmost


point 26.


FIGURE 6 is a longitudinal sectional view


of the hypodermic needle of the present invention


shown in cooperation with a dental cartridge


assembly of an automatic injector. The dental


cartridge assembly, generally indicated at60


includes a glass container 62, a forwardly disposed


rubber sealing disc 64, a metallic clamp ring 66,


and a needle hub assembly 68. The clamp ring 66 is


crimped around the forward end of the glass


container 62 so as to enable the rubber sealing disc


7

CA 02234997 1998-04-16
WO 97114461 PCT/US96/15787
64 to form a forward seal for medicament 70
contained within the glass container 62. The needle
hub assembly 68 is fixed to the needle to at a '
position 72 by an epoxy or any conventional fashion.
During an injection operation, the needle hub
assembly 68 is caused to ride rearwardly with
respect to the glass container 62 into the position
shown in FIGURE 6. During this movement of the
needle hub assembly 68, the rearward pointed end 22
l0 of the hypodermic needle 10 is caused to puncture
the rubber sealing disk 64. The specifics of the
injector device of this type can be more fully
appreciated from co-pending U.S. Patent Application
No. 08/280,884, hereby incorporated by reference,
and the aforementioned incorporated U.S. Patent No.
5,202,393 and U.S. Patent Application No. Docket
106.
As shown in FIGURE 6, the puncturing force
of the hypodermic needle 10 has created a tethered
rubber particle 76. Such tethered particle 76 will
ordinarily be formed on a side of the needle
opposite the rearwardmost point 26. The lateral
opening 34 is preferably positioned generally on the
same side of the needle as the rearwardmost point
and most preferably the lateral opening 34 and
rearwardmost point 26 are in longitudinal alignment
with one another so that the tethered particle 76
will not interfere with the opening 34.
In many instances, the particle will be
captured within the rearward opening 18 of the
hypodermic needle, as generally indicated in the
dashed line configuration 80, rather than being _
tethered as with tethered particle 76. Where the
particle 8o becomes lodged in the rearward opening
18, the particle remains at such position, rather
8

CA 02234997 1998-04-16
WO 97/14461 PCTlUS96/15787
than being permitted to float within the medicament


and perhaps find its way to the laterally facing


opening 34, wherein it may block the bore 14 and


severely restrict flow of medicament through the


' 5 needle. The restriction 38 is provided in the


cylindrical wall 12 in order to prevent any further


forward travel of the particle through the bore 14


so that the particle does not become lodged within


the bore at a more downstream position wherein it


may completely prevent fluid flow. With the


rearward opening 18 now substantially blocked by the


particle, the medicament will flow into the bore 14


via the opening 34.


It should also be noted that the oblong


shape of lateral opening 34 minimizes the likelihood


of complete blockage thereof by a dislodged


particle. In addition, the surface 40 and opening


34 are shaped so that they will not cause any


further coring of the seal 64. More specifically,


the arcuate rearward portion 44 (preferably defining


an imaginary circle having a maximum radius of .0060


inches) is shaped such that the portion of the


rubber seal 64 surrounding the puncture hole, and


that slides along the exterior periphery of the


cylindrical wall 12 as the rearward portion of the


needle is moved through the seal 64, will be readily


and smoothly accommodated. In addition, the gently


sloping forward portion 42 (preferably forming an


angle of about 28 1 with respect to the


longitudinal axis x) will gently expand the portions


of seal 64 surrounding the puncture hole as such


portions ride forwardly along the portion 42 as the


needle is further extended into the container,


without any rough or sharp edges of the needle


cutting or biting into the seal 64.


9

CA 02234997 1998-04-16
WO 97/14461 PCT/US96/15787
While the hypodermic needle of the present
invention has been described in conjunction with an
automatic injector, it should be appreciated that
this hypodermic needle has several other
applications in the medical industry, such as '
syringes.
It thus will be seen that the objects of
this invention have been fully and effectively
accomplished. It will be realized, however, that
the foregoing preferred specific embodiment has been
shown and described for the purpose of this
invention and is subject to change without departure
from such principles. Therefore, this invention
includes all modifications encompassed within the
spirit and scope of the following claims.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date 2006-08-15
(86) PCT Filing Date 1996-10-10
(87) PCT Publication Date 1997-04-24
(85) National Entry 1998-04-16
Examination Requested 2001-08-22
(45) Issued 2006-08-15
Deemed Expired 2013-10-10

Abandonment History

There is no abandonment history.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Registration of a document - section 124 $100.00 1998-04-16
Application Fee $300.00 1998-04-16
Maintenance Fee - Application - New Act 2 1998-10-13 $100.00 1998-09-28
Registration of a document - section 124 $100.00 1999-05-28
Maintenance Fee - Application - New Act 3 1999-10-11 $100.00 1999-09-27
Maintenance Fee - Application - New Act 4 2000-10-10 $100.00 2000-09-26
Request for Examination $400.00 2001-08-22
Maintenance Fee - Application - New Act 5 2001-10-10 $150.00 2001-09-20
Maintenance Fee - Application - New Act 6 2002-10-10 $150.00 2002-10-10
Maintenance Fee - Application - New Act 7 2003-10-10 $150.00 2003-10-03
Maintenance Fee - Application - New Act 8 2004-10-11 $200.00 2004-09-15
Maintenance Fee - Application - New Act 9 2005-10-10 $200.00 2005-09-12
Final Fee $300.00 2006-06-01
Maintenance Fee - Patent - New Act 10 2006-10-10 $250.00 2006-09-08
Maintenance Fee - Patent - New Act 11 2007-10-10 $250.00 2007-09-14
Maintenance Fee - Patent - New Act 12 2008-10-10 $250.00 2008-09-15
Maintenance Fee - Patent - New Act 13 2009-10-12 $250.00 2009-09-11
Maintenance Fee - Patent - New Act 14 2010-10-11 $250.00 2010-09-09
Maintenance Fee - Patent - New Act 15 2011-10-10 $450.00 2011-09-15
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
MERIDIAN MEDICAL TECHNOLOGIES, INC.
Past Owners on Record
DALLING, N. LAWRENCE
MARINACCI, ROBERT A.
PEARSON, WILLIAM R.
SPADY, DAVID E.
SURVIVAL TECHNOLOGY, INC.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 1998-07-31 1 3
Abstract 1998-04-16 1 60
Description 1998-04-16 10 409
Claims 1998-04-16 2 42
Drawings 1998-04-16 2 41
Cover Page 1998-07-31 1 56
Description 2005-08-04 10 408
Claims 2005-08-04 1 28
Representative Drawing 2006-07-13 1 4
Cover Page 2006-07-13 1 43
Fees 2002-10-10 1 40
Fees 1998-09-28 1 47
Fees 2004-09-15 1 36
Fees 2006-09-08 1 43
Assignment 1998-04-16 8 206
PCT 1998-04-16 4 163
Prosecution-Amendment 1998-04-16 1 18
Correspondence 1998-07-07 1 32
Assignment 1999-05-28 4 129
Prosecution-Amendment 2001-08-22 1 23
Prosecution-Amendment 2002-06-13 2 37
Fees 2003-10-03 1 34
Fees 2000-09-26 1 40
Fees 2001-09-20 1 38
Fees 1999-09-27 1 43
Prosecution-Amendment 2005-02-08 2 50
Prosecution-Amendment 2005-08-04 4 118
Fees 2005-09-12 1 32
Correspondence 2006-06-01 1 35
Fees 2007-09-14 1 43
Correspondence 2011-10-04 1 19
Fees 2008-09-15 1 44
Correspondence 2011-11-15 1 19
Fees 2011-11-08 1 47