U.S. patent application number 17/240484 was filed with the patent office on 2021-08-12 for tip cap assembly for closing an injection system.
The applicant listed for this patent is Becton Dickinson France. Invention is credited to Franck Carrel, Lionel Maritan.
Application Number | 20210244892 17/240484 |
Document ID | / |
Family ID | 1000005540967 |
Filed Date | 2021-08-12 |
United States Patent
Application |
20210244892 |
Kind Code |
A1 |
Maritan; Lionel ; et
al. |
August 12, 2021 |
Tip Cap Assembly for Closing an Injection System
Abstract
A tip cap assembly adapted to close a fluid passageway of a
distally projecting tip of an injection system, said tip cap
assembly including an elastomeric inner cap having a frustoconical
protrusion extending proximally and having a proximal face; a rigid
outer cap which is securely disposed around said elastomeric inner
cap; the proximal face of the frustoconical protrusion having a
diameter at least greater than the diameter of the fluid passageway
of the injection system.
Inventors: |
Maritan; Lionel; (Bresson,
FR) ; Carrel; Franck; (Saint Jean de Vaulx,
FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton Dickinson France |
Le Pont de Claix |
|
FR |
|
|
Family ID: |
1000005540967 |
Appl. No.: |
17/240484 |
Filed: |
April 26, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15028950 |
Apr 13, 2016 |
11013865 |
|
|
PCT/EP2014/071950 |
Oct 14, 2014 |
|
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17240484 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/5086 20130101;
A61M 5/3134 20130101; A61M 5/347 20130101; A61M 5/3202 20130101;
A61M 2005/3104 20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32; A61M 5/34 20060101 A61M005/34; A61M 5/50 20060101
A61M005/50 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 15, 2013 |
EP |
13306414.7 |
Claims
1. A tip cap assembly adapted to close a fluid passageway of a
distally projecting tip of an injection system, said tip cap
assembly comprising: an elastomeric inner cap having a
frustoconical protrusion extending proximally, said frustoconical
protrusion having a proximal-most face; and a rigid outer cap which
is securely disposed around said elastomeric inner cap, the rigid
outer cap comprising a frustoconical protrusion that extends from a
proximal portion of the rigid outer cap, wherein a radial recess
defined by an outer ring extends around at least a portion of the
frustoconical protrusion of the rigid outer cap.
2. The tip cap assembly according to claim 1, wherein the radial
recess extends around an entire circumference of the frustoconical
protrusion of the rigid outer cap.
3. The tip cap assembly according to claim 1, wherein the outer
ring comprises a thread provided on an outer surface of the outer
ring.
4. The tip cap assembly according to claim 1, wherein an inner
surface of the frustoconical protrusion of the rigid outer cap
comprises at least one ridge.
5. The tip cap assembly according to claim 1, wherein the radial
recess is configured to permit radial deformation of the
frustoconical protrusion of the rigid outer cap.
6. The tip cap assembly according to claim 1, further comprising a
stress-limiting element for allowing said elastomeric inner cap to
be substantially deformed when the assembly closes said fluid
passageway.
7. The tip cap assembly according to claim 1, wherein the
elastomeric inner cap and the rigid outer cap comprises a holding
element to secure said elastomeric inner cap into said rigid outer
cap.
8. The tip cap assembly according to claim 7, wherein said holding
element comprises a shoulder provided into the rigid outer cap, and
a radial rim provided onto the elastomeric inner cap, said
elastomeric inner cap being proximally blocked by the contact
between said radial rim and said shoulder.
9. The tip cap assembly according to claim 7, wherein said holding
element comprises at least one abutment surface provided into the
rigid outer cap, and a distal face provided onto the elastomeric
inner cap, said elastomeric inner cap being distally blocked by the
contact between said abutment surface and said distal face.
10. An injection system comprising a longitudinal barrel, a
distally projecting tip provided with a fluid passageway extending
therethrough, a distal surface and a lateral surface, wherein said
injection system further comprises a tip cap assembly according to
claim 1.
11. A tip cap assembly adapted to close a fluid passageway of a
distally projecting tip of an injection system, said tip cap
assembly comprising: an elastomeric inner cap having a
frustoconical protrusion extending proximally, said frustoconical
protrusion having a proximal-most face; and a rigid outer cap which
is securely disposed around said elastomeric inner cap, the rigid
outer cap comprising at least one window defined in an outer
surface of said rigid outer cap.
12. The tip cap assembly according to claim 11, wherein two windows
are defined in the outer surface of said rigid outer cap.
13. The tip cap assembly according to claim 11, wherein the at
least one window extends through said rigid outer cap.
14. The tip cap assembly according to claim 11, wherein the at
least one window extends circumferentially around the outer surface
of said rigid outer cap.
15. The tip cap assembly according to claim 11, wherein the at
least one window includes a first longitudinal rib on a first side
of the at least one window and a second longitudinal rib on an
opposing second side of the at least one window.
16. The tip cap assembly according to claim 11, further comprising
a stress-limiting element for allowing said elastomeric inner cap
to be substantially deformed when the assembly closes said fluid
passageway.
17. The tip cap assembly according to claim 11, wherein the
elastomeric inner cap and the rigid outer cap comprises a holding
element to secure said elastomeric inner cap into said rigid outer
cap.
18. The tip cap assembly according to claim 17, wherein said
holding element comprises a shoulder provided into the rigid outer
cap, and a radial rim provided onto the elastomeric inner cap, said
elastomeric inner cap being proximally blocked by the contact
between said radial rim and said shoulder.
19. The tip cap assembly according to claim 17, wherein said
holding element comprises at least one abutment surface provided
into the rigid outer cap, and a distal face provided onto the
elastomeric inner cap, said elastomeric inner cap being distally
blocked by the contact between said abutment surface and said
distal face.
20. An injection system comprising a longitudinal barrel, a
distally projecting tip provided with a fluid passageway extending
therethrough, a distal surface and a lateral surface, wherein said
injection system further comprises a tip cap assembly according to
claim 11.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/028,950 filed Apr. 13, 2016, which is the
United States national phase of International Application No.
PCT/EP2014/071950 filed Oct. 14, 2014, and claims priority to
European Patent Application No. 13306414.7 filed Oct. 15, 2013, the
disclosures of each of which are hereby incorporated in their
entirety by reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention generally relates to an injection
system such as a syringe, as well as a tip cap assembly for
securely closing the distal tip of the injection system.
Description of Related Art
[0003] In this application, the distal end of a component or
apparatus must be understood as meaning the end furthest from the
hand of the user and the proximal end must be understood as meaning
the end closest to the hand of the user, with reference to the
injection system intended to be used with said component or
apparatus. As such, in this application, the distal direction must
be understood as the direction of injection with reference to the
injection system, and the proximal direction is the opposite
direction, i.e. the direction towards the hand of the user.
[0004] Current medicine uses a wide range of injection systems to
deliver fluids into the body of patients. For example, such
injection systems may include auto-injectors, medical pens or
syringes. Conventional syringes are widely used because of their
common availability, ease of use and limited cost. They usually
comprise a longitudinal barrel with an open proximal end and a
substantially closed distal end including a distally projecting
tip. The fluid intended to be injected can be stored into the
syringe barrel, and in this case, the open proximal end is closed
by a stopper in sliding fluid-tight engagement within the barrel
and actuated by a plunger rod. The tip is provided with a fluid
passageway extending therethrough to allow the injection of the
fluid when a distal pressure is applied on the plunger. The tip can
be provided with an attached needle or can be of a luer type,
meaning needle-free. Syringe barrels are typically made of glass or
plastic. Glass is preferably chosen for its chemical neutrality and
low gas permeability whereas plastic is preferably chosen for its
resistance to shocks.
[0005] Almost all fluids can be injected with a syringe. For
example, a fluid can be a pharmaceutical solution such as a drug, a
vaccine, vitamins or dietary minerals. Syringes are also useful to
inject diagnostic solutions, cosmetic fluids, including gels such
as hyaluronic acid or silicone compositions. The injection can be
performed in every part of the body including skin, hypodermis,
muscle and veins, depending on the application.
[0006] Usually, syringes are provided empty and filled with a fluid
immediately before the injection, but now syringes are more and
more provided prefilled with the fluid to inject, ready to be used,
leading to several advantages. First of all, prefilled syringes
reduce the number of steps required to perform an injection, which
is particularly valuable in emergency medicine. Furthermore,
prefilled syringes reduce the risk of human error on the quantity
or the quality of the fluid to be injected. Indeed, the
administration of a wrong dose or undesired medicine may impede
medical treatments efficacy and cause death or severe injuries on
treated patients. Additionally, prefilled syringes reduce the risk
of contamination linked with the transfer of fluids from multidose
vials into empty syringes, such contamination also leading to
impede medical treatments efficacy. Finally, prefilled syringes are
particularly useful to store fluids which are difficult to
transfer. For example, it is appropriate to use such syringes when
viscous liquids or gels are employed for cosmetic applications, or
when pharmaceutical compositions are employed for anesthetic
applications.
[0007] During the time between the filling of the syringe and its
use, needle-free syringes are equipped with a tip cap to close the
distally extending tip. Indeed, as fluids are stored in the
prefilled syringe for an extended period of time, typically from 6
to 18 months before injection, the injection system must be kept
perfectly sealed during this period. The quality of the sealing
between the tip cap and the syringe is very important as a
deficient sealing could damage the nature or the purity of the
fluids, leading to wastage of valuable fluids, potential
unacceptable risks for the patients and potential unacceptable
risks for the medical staff according to the nature of the
pharmaceutical compositions stored inside the syringes.
[0008] Moreover, the syringe should be opened easily when required
and the tip cap should be removed without excessive effort. But it
is well known that sticking phenomenon can occur when a tip cap is
plugged on the tip of a syringe. Indeed, it has been observed that
when two materials are compressed together over an extended period
of time, such phenomenon of sticking could occur and prevent a fast
and easy opening of a prefilled syringe. Consequently, a tip cap
difficult to open would lead to the rejection of the prefilled
syringes before use and would constitute an unacceptable economic
loss. This could also lead to the death or severe injury of
patients requiring an immediate injection.
[0009] Finally, the outside surface of the syringe tip needs to be
preserved from contaminants, such as dust or micro-organisms, which
could migrate from the tip to the fluid passageway. Indeed, if
these contaminants are injected with the pharmaceutical fluid to a
patient, it would trigger an inappropriate immune response, lessen
the treatment efficacy and decrease the patient's trust into his
treatment.
SUMMARY OF THE INVENTION
[0010] Therefore, it is an object of the invention to provide a tip
cap ensuring an improved and sustainable sealing of the syringe
tip. It is further an object of the invention to provide a tip cap
that can be easily unplugged from the syringe tip. It is another
object of the invention to maintain the syringe tip sterility
during storage.
[0011] A first aspect of the invention is a tip cap assembly
adapted to close the fluid passageway of a distally projecting tip
of an injection system, said tip cap assembly including: [0012] an
elastomeric inner cap having a frustoconical protrusion extending
proximally, said frustoconical protrusion having a proximal face,
and [0013] a rigid outer cap which is or can be securely disposed
around said elastomeric inner cap, the proximal face of the
frustoconical protrusion having a diameter at least greater than
the diameter of the fluid passageway of the injection system.
[0014] Due to the frustoconical protrusion of the elastomeric inner
cap, the contact between said elastomeric inner cap and the
distally projecting tip is limited to the small distal surface of
said tip. Indeed, the proximal face of the elastomeric inner cap is
essentially perpendicular to the rotational axis of the cone from
which the frustoconical protrusion is derived. The surface of the
proximal face may be flat or may show a slight curvature radius,
the center of which being situated on said rotational axis.
Moreover, the diameter of the proximal face of the frustoconical
protrusion of the elastomeric inner cap at least greater than the
diameter of the fluid passageway does not allow the frustoconical
protrusion to penetrate the fluid passageway of the distally
projecting tip. This significantly reduces or cancels the sticking
phenomenon that may happen after an extended period of storage and
therefore allows a quick and easy removal of the tip cap assembly
from the injection system. The proximal face of the frustoconical
protrusion may be the most proximal face of the elastomeric inner
cap.
[0015] For example, the elastomeric inner cap has globally the
shape of a cylinder and the rigid outer cap has a globally tubular
shape provided with a distal transversal wall. For example, the
elastomeric inner cap is received within the rigid outer cap so
that the outer wall of the elastomeric inner cap is at least
partially in contact with the inner wall of the rigid outer cap, in
particular with the inner wall of a tubular part of the rigid outer
cap. The elastomeric inner cap may be received with friction within
the rigid outer cap.
[0016] Due to its elastomeric nature, the elastomeric inner cap has
the capability of being deformed when it is submitted to pressure,
for example when a distal pressure is applied. For example, when
the elastomeric inner cap has the global shape of a cylinder, it
may be deformed radially outwardly under the effect of a
longitudinal pressure, for example a distal pressure or a proximal
pressure.
[0017] In aspects of the disclosure, the tip cap assembly is
provided with stress-limiting means, also referred to as a
stress-limiting element, allowing said elastomeric inner cap to be
substantially deformed when the assembly closes said passageway,
for example when a distal pressure is exerted on the elastomeric
inner cap by the syringe tip. In particular, the stress-limiting
means allow at least part of the elastomeric inner cap to be
deformed radially outwardly, although the elastomeric inner cap is
received within the rigid outer cap. The deformation of the
elastomeric inner cap ensures an optimal sealing of the fluid
passageway and the syringe tip. However, the rigid outer cap could
be deformed by the stress transmitted by the elastomeric inner cap
over an extended period of storage, and such deformed rigid cap
might lead to a deficient sealing. The stress-limiting means avoids
the unintended deformation of the rigid outer cap by limiting the
amount of stress transmitted to the rigid outer cap by the
deformation of the elastomeric inner cap when it closes said
passageway, for example when distal pressure is exerted on the
elastomeric inner cap, and contributes to maintain the optimal
sealing over an extended period of time.
[0018] In aspects of the disclosure, these stress-limiting means
include at least one window and more preferably two diametrically
opposed longitudinal windows provided onto said rigid outer cap.
For example, the window(s) are provided on a tubular wall of the
rigid outer cap. These windows accommodate the elastomeric material
from the elastomeric inner cap resulting from the deformation
caused by both the closing of the passageway and the insertion of
the elastomeric cap into the rigid outer cap, for example when the
diameter of the elastomeric cap is greater than the internal
diameter of the rigid cap. In particular, the windows allow the
elastomeric inner cap to be deformed radially outwardly. In
particular, when located on a tubular wall of the rigid outer cap,
the window(s) may receive some part of the elastomeric inner cap
which is deformed radially outwardly.
[0019] In aspects, these stress-limiting means further include a
distal opening provided into said rigid outer cap to accommodate
the distal deformation of the elastomeric inner cap when the tip
cap assembly closes said the fluid passageway, for example when the
elastomeric inner cap is submitted to distal pressure. The distal
opening may be provided in the distal transversal wall of the rigid
outer cap.
[0020] In aspects of the disclosure, the elastomeric cap and the
outer rigid cap include holding means, also referred to as a
holding element, intended to secure said elastomeric inner cap into
said rigid outer cap.
[0021] In aspects of the disclosure, said holding means include a
shoulder provided into the rigid outer cap and a radial rim
provided onto the elastomeric inner cap, the elastomeric inner cap
being proximally blocked by the contact between the distal rim and
said shoulder. The shoulder and the radial rim therefore form
proximal blocking means, also referred to as a proximal blocking
element, for blocking the proximal movement of the elastomeric
inner cap with respect to the rigid outer cap.
[0022] In aspects of the disclosure, said holding means further
include at least one abutment surface provided into the rigid outer
cap, and a distal face provided onto the elastomeric inner cap,
said elastomeric inner cap being distally blocked by the contact
between the abutment surface and the distal face. The abutment
surface and the distal face therefore form distal blocking means,
also referred to as a distal blocking element, for blocking the
distal movement of the elastomeric inner cap with respect to the
rigid outer cap.
[0023] The shoulder, the radial rim, the abutment surface and the
distal face form altogether locking means, also referred to as a
locking arrangement, both in proximal and in distal translation of
the elastomeric inner cap with respect to the rigid outer cap.
[0024] In aspects of the disclosure, the length L1 defined between
an abutment surface and the shoulder of the rigid outer cap is
greater than the length L2 defined between the distal face and the
radial rim of said elastomeric inner cap, L1 and L2 being measured
along a longitudinal axis of the tip cap assembly. A gap is
therefore left between the rigid outer cap and the elastomeric
inner cap: the presence of such a gap simplifies the assembling of
the tip cap assembly and allows an optimal and sustainable closure,
even with non-standard syringes.
[0025] A second aspect of the disclosure is an injection system
including a longitudinal barrel, a distally projecting tip provided
with a fluid passageway extending therethrough, a distal surface
and a lateral surface, where the injection system further includes
a tip cap assembly according to the first aspect of the
disclosure.
[0026] A third aspect of the disclosure is an injection system
including a longitudinal barrel having a distally projecting tip
and a tip cap assembly, said distally projecting tip being provided
with a fluid passageway extending therethrough, a distal surface
and a lateral surface, said tip cap assembly including an
elastomeric inner cap including a frustoconical protrusion and a
rigid outer cap which can be securely disposed around said
elastomeric inner cap, said assembly being configured so that, when
said tip cap assembly closes said passageway, said frustoconical
protrusion contacts said distally projecting tip only at the distal
surface.
[0027] In aspects of the disclosure, the rigid outer cap is
provided with a sterility skirt intended for a circumferential
sealing of the lateral surface of said distally projecting tip when
said assembly closes said fluid passageway. This sterility skirt
maintains sterile the distal tip of the syringe during storage and
thus the content of the injection system.
[0028] In aspects of the disclosure, the sterility skirt is further
provided with at least one annular ridge. For example, the annular
ridge is provided on the inner wall of the sterility skirt. The at
least one annular ridge may enhance the sealing provided between
the sterility skirt and the lateral surface of the distally
projecting tip.
[0029] In aspects of the disclosure, the injection system is
provided with a collar securely engaged around said distal tip,
having an inner thread and a distal rim, and wherein said rigid
outer cap is provided with an outer thread able to cooperate with
the thread of the collar to close said passageway.
[0030] In aspects of the disclosure, the rigid outer cap is
provided with a proximal abutment surface contacting the distal rim
of the collar when said tip cap assembly closes said
passageway.
[0031] A fourth aspect of the disclosure is a tip cap assembly
adapted to close the fluid passageway of the distally projecting
tip of an injection system. The tip cap assembly includes an
elastomeric inner cap having a distal portion and a proximal
portion and a rigid outer cap adapted to be securely disposed
around the elastomeric inner cap. The proximal portion of the
elastomeric inner cap includes a frustoconical protrusion and a
proximal face having a diameter greater than the diameter of the
fluid passageway of the injection system.
[0032] In aspects of the disclosure, the tip cap assembly further
includes a stress-limiting means to accommodate deformation of the
elastomeric inner cap when the assembly closes the fluid
passageway. The stress-limiting means may include at least one
window in the rigid outer cap and, preferably, two diametrically
opposed longitudinal windows. Alternatively or in addition, the
stress-limiting means may include a distal opening in the rigid
outer cap.
[0033] In aspects of the disclosure, the elastomeric cap and the
outer rigid cap each include at least one engagement surface,
wherein contact of the engagement surface of the elastomeric inner
cap with the engagement surface of the rigid outer cap secures the
elastomeric inner cap to the rigid outer cap. The engagement
surface of the rigid outer cap may include a shoulder, and the
engagement surface of the elastomeric inner cap may include a
radial rim, wherein the radial rim contacts the shoulder at least
when a proximal pressure is applied to the elastomeric inner cap.
Alternatively or in addition, the engagement surface of the rigid
outer cap may include at least one abutment surface, and the
engagement surface of the elastomeric inner cap may include a
distal face, wherein the at least one abutment surface contacts the
distal face at least when a distal pressure is applied to the
elastomeric inner cap. In the aspect where the rigid outer cap
includes a first engagement surface including a shoulder and a
second engagement surface including an abutment surface and the
elastomeric inner cap includes a first engagement surface including
a radial rim and a second engagement surface including distal face,
the length L1 defined between the abutment surface and the shoulder
of the rigid outer cap may be greater than the length L2 defined
between the distal face and the radial rim of the elastomeric inner
cap.
[0034] In aspects of the disclosure, the outer rigid cap may
include a distal portion, a central portion, and a proximal
portion. The at least one stress-limiting means, preferably a
longitudinal window, may be located in the distal portion of the
outer rigid cap and the proximal section may have a frustoconical
shape. The outer rigid cap may further include internal and/or
external reinforcement means, also referred to as reinforcement
elements. The reinforcement means may be longitudinal or
circumferential ribs.
[0035] In aspects of the disclosure, the elastomeric inner cap may
include a distal portion and a proximal portion. The distal portion
may be essentially cylindrical with a flat distal face and the
proximal portion may comprise a frustoconical protrusion. The
diameter of the proximal portion may be less than the diameter of
the distal portion. The proximal portion of the elastomeric inner
cap may also include a circular bump.
[0036] In aspects of the disclosure, the elastomeric cap may adopt
three different configurations: a free configuration when it is not
assembled with the rigid cap, a first stressed configuration when
it is assembled into the rigid cap to form the tip cap assembly and
a second stressed configuration due to the distal pressure applied
by the distally projecting tip when the tip cap assembly closes the
fluid passageway of an injection system.
[0037] In the second stressed configuration, the distal end of the
elastomeric inner cap is received in the distal portion of the
outer rigid cap and the proximal portion of the elastomeric inner
cap is received in the central portion of the outer rigid cap. The
outside diameter of the distal portion of the elastomeric inner cap
may be greater than the inside diameter of the distal portion of
the outer rigid cap and/or the outside diameter of the proximal
portion of the elastomeric inner cap may be greater than the inside
diameter of the central portion of the outer rigid cap in order to
enhance contact between the engagement surfaces of the outer rigid
cap and the elastomeric inner cap.
[0038] In the third stressed configuration, the elastomeric inner
cap is further compressed between the rigid inner cap and the
distally projecting tip of the injection system.
[0039] In both the second and the third stressed conditions, the
stress-limiting means acts to reduce the stress placed on the rigid
outer cap due to the compression of the elastomeric inner cap.
[0040] A fifth aspect of the disclosure is an injection system
including a longitudinal barrel, and a distally projecting tip
having a fluid passageway extending therethrough, a distal surface,
and a lateral surface, wherein the injection system further
includes a tip cap assembly as described above.
[0041] In aspects of the disclosure, when the tip cap assembly
closes the fluid passageway, the frustoconical protrusion only
contacts the distal surface of the distally projecting tip.
[0042] In aspects of the disclosure, the rigid outer cap may
further include a sterility skirt that provides a circumferential
seal between the lateral surface of the distally projecting tip and
the rigid outer cap when the tip cap assembly closes the
passageway. The sterility skirt may include at least one annular
ridge.
[0043] In aspects of the disclosure, the injection system may
further include a collar securely engaged around the distal tip.
The collar may have an inner thread and a distal rim. In this
aspect, the rigid outer cap includes an outer thread adapted to
cooperate with the inner thread of the collar in order to close the
passageway. The rigid outer cap may further include a proximal
abutment surface that contacts the distal rim of the collar when
the tip cap assembly closes the passageway. This engagement of the
proximal abutment surface and the distal rim of the collar prevents
rotational movement of the tip with respect to the injection system
to avoid damage to the tip cap assembly and assures correct
positioning of the tip cap with regard to the collar to signal the
user that a seal has been formed.
[0044] A sixth aspect of the disclosure is an injection system
including a longitudinal barrel, a distally projecting tip and a
collar provided with an inner thread. The collar is securely
engaged around the distally projecting tip and the distally
projecting tip has a lateral surface and a fluid passageway
extending therethrough. The injection system further includes a
tip-cap assembly including an elastomeric inner cap and a rigid
outer cap that is or can be securely disposed around the
elastomeric inner cap. The rigid outer cap of the tip cap assembly
includes an outer thread intended to be screwed with the inner
thread of the collar, a frustoconical extension and a radial recess
between the outer thread and the frustoconical extension. The
frustoconical extension is intended to ensure a circumferential
sealing of the distally projecting tip around the lateral surface
in order to act as a sterility skirt when the tip-cap assembly
closes the passageway of the projecting tip.
[0045] In aspects of the disclosure, the frustoconical extension of
the rigid outer cap may be provided with at least one annular
ridge, preferably three.
[0046] A seventh aspect of the disclosure is a tip-cap assembly
adapted to close the fluid passageway of the distally projecting
tip of an injection system. The tip-cap assembly includes an
elastomeric inner cap which has a distal face and a radial rim, and
a length L2 defined as the distance between the distal face and the
radial rim. The tip-cap assembly further includes a rigid outer cap
which is or can be securely disposed around the elastomeric inner
cap, with a shoulder and at least one abutment surface, and a
length L1 defined as the distance between the at least one abutment
surface and the shoulder. The elastomeric inner cap is distally
blocked by the contact between the distal face and the at least one
abutment surface, and proximally blocked by the contact between the
radial rim and the shoulder. The length L1 is greater than the
length L2 in order to allow a limited translation of the
elastomeric inner cap within the rigid outer cap.
BRIEF DESCRIPTION OF THE DRAWINGS
[0047] The present invention will now be described in greater
detail based on the following description and the appended
drawings, in which:
[0048] FIG. 1A is a side view of a syringe without a tip cap;
[0049] FIG. 1B is a perspective view of a syringe without a tip
cap;
[0050] FIG. 1C is a cross-section view of a syringe without a tip
cap;
[0051] FIG. 2A is a side view of the syringe of FIGS. 1A-1C closed
by a tip cap assembly of an abstract of the present disclosure;
[0052] FIG. 2B is a perspective view of the syringe of FIGS. 1A-1C
closed by a tip cap assembly of an aspect of the present
disclosure;
[0053] FIG. 2C is a cross-section view of the syringe of FIGS.
1A-1C closed by a tip cap assembly of an aspect of the present
disclosure;
[0054] FIG. 3A is a side view of the rigid outer cap of the tip cap
assembly of FIGS. 2A and 2B;
[0055] FIG. 3B is a cross-section view of the rigid outer cap of
the tip cap assembly of FIGS. 2A and 2B;
[0056] FIG. 3C is another cross-section view of the rigid outer cap
of the tip cap assembly of FIGS. 2A and 2B;
[0057] FIG. 3D is a perspective view of the rigid outer cap of the
tip cap assembly of FIGS. 2A and 2B;
[0058] FIG. 3E is a cross-section perspective view of the rigid
outer cap of the tip cap assembly of FIGS. 2A and 2B;
[0059] FIG. 4A is a side view of the elastomeric inner cap of the
tip cap assembly of FIGS. 2A and 2B;
[0060] FIG. 4B is a perspective view of the elastomeric inner cap
of the tip cap assembly of FIGS. 2A and 2B;
[0061] FIG. 5 is the theoretical superimposition of the rigid outer
cap of FIGS. 3A, 3B and 3C on the elastomeric inner cap of FIGS. 4A
and 4B;
[0062] FIG. 6A is a cross-section view of a tip cap assembly
according to an aspect of the present disclosure.
[0063] FIG. 6B is a cross-section view of a tip cap assembly
according to another aspect of the present disclosure;
[0064] FIG. 7 is a cross-section view of a tip cap assembly mounted
on the syringe of FIGS. 1A, 1B and 1C;
[0065] FIG. 8 is a perspective view of the syringe of FIGS. 1A-1C
closed by a tip cap assembly according to an aspect of the present
disclosure; and
[0066] FIG. 9 is a perspective view of the syringes of FIGS. 1A-1C
closed by a tip cap assembly according to another aspect of the
present disclosure.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0067] For purposes of the description hereinafter, the terms
"upper", "lower", "right", "left", "vertical", "horizontal", "top",
"bottom", "lateral", "longitudinal", and derivatives thereof shall
relate to the invention as it is oriented in the drawing
figures.
[0068] FIGS. 1A-1C show an injection system 10 in the form of a
luer syringe according to an aspect of the disclosure. The present
disclosure could be used with any other types of injection systems,
such as a pen, or an infusion system, provided they include a
distally projecting tip. For sake of clarity, the present
disclosure will only be described with a luer syringe 10. The
syringe 10 includes a longitudinal barrel 11 having a longitudinal
axis A, a proximal flange 12 and a distally projecting tip 13. The
distally projecting tip 13 includes a fluid passageway 14 extending
therethrough, a distal surface 15 and a lateral surface 16 (see
FIG. 1C) which is substantially tubular. A collar 20 is securely
engaged around the tip 13, for example by clipping, screwing or
welding. In another aspect (not shown), the collar 20 is molded
with the longitudinal barrel with which it forms only one part. The
collar 20 is provided with an inner thread 21 and a distal rim 22.
The syringe 10 is further provided with a stopper and a plunger
rod, not shown in FIGS. 1A-1C.
[0069] As shown in FIGS. 2A-2C, the syringe 10 may be sealingly
closed by a tip cap assembly 30. This tip cap assembly 30 includes
a rigid outer cap 40 which receives an elastomeric inner cap
50.
[0070] The rigid outer cap 40 will now be described with references
to FIGS. 3A-3E.
[0071] The rigid outer cap 40 includes an essentially tubular wall
41 having a longitudinal axis A' and defining a cavity 41a open on
both distal and proximal ends. The tubular wall 41 includes three
different portions: a distal portion 42, a central portion 43 and a
proximal portion 44.
[0072] The distal portion 42 has an essentially tubular shape and
includes a distal opening 42a and two longitudinal windows 42b (see
FIG. 3E, only one visible in FIGS. 3A and 3B), diametrically
opposed, in the example shown. Each window 42b is enclosed on its
outside by two longitudinal ribs 42c and one distal radial rib 42d
and on its inside by two abutment surfaces 42e and a shoulder 42f.
In other aspect (not shown), one, three or four abutment surfaces
42e are provided into the rigid cap 40. A length L1, measured along
axis A', is defined between the abutment surfaces 42e and the
shoulder 42f and consists in the longitudinal dimension of the
longitudinal windows 42b. The shoulder 42f is located between the
distal portion 42 and the central portion 43. In other aspects (not
shown), the distal portion 42 includes one, three or four windows
42b.
[0073] The central portion 43 has an essentially tubular shape and
includes on the inside a plurality of longitudinal rims 43a linked
with a shoulder 43b. On the outside, a ring 43c including a
proximal abutment surface 43d is linked with two longitudinal ribs
43e and the longitudinal ribs 42c. The longitudinal ribs 43e only
extend along part of the central portion 43 while the longitudinal
ribs 42c, enclosing the windows 42b, extend along both the distal
portion 42 and part of the central portion 43. The shoulder 43b is
located between the central portion 43 and the proximal portion
44.
[0074] The proximal portion 44 has an extension having the shape of
a truncated cone or frustoconical extension 44a. The frustoconical
extension 44a includes a proximal opening 44b and three annular
ridges 44c. On the outside, an outer thread 44d extends from the
ring 43c of the central portion 43 and is separated from the
frustoconical extension 44a by a radial recess 44e. In another
aspect (not shown), the rigid cap 40 is not provided with an outer
thread 44d and the proximal portion 44 only includes a
frustoconical extension 44a with ridges 44c. This aspect can then
be used with a syringe 10 that is not provided with a collar
20.
[0075] The rigid outer cap can be made of a rigid polymer such as
polypropylene, polyethylene, polyvinylchloride, polystyrene,
polycarbonate or a copolymer such as acrylonitrile butadiene
styrene or styrene acrylonitrile.
[0076] The elastomeric inner cap 50 will now be described with
reference to FIGS. 4A and 4B. It includes a distal portion 51 and a
proximal portion 52 both having a longitudinal axis A''. The distal
portion 51 has an essentially cylindrical shape and a flat distal
face 53. The proximal portion 52 includes a frustoconical
protrusion 54 having the shape of a truncated cone, a proximal face
55 essentially perpendicular to the axis A'' and a circular bump
56. The proximal portion 52 has a smaller average diameter than the
distal portion 51 and a radial rim 57 is located at the connection
between the proximal portion 52 and the distal portion 51.
Preferably the cone angle a of the truncated cone forming the
frustoconical protrusion 54 ranges from 40.degree. to 60.degree.
relative to axis A'', more preferably is 50.degree. relative to
axis A''. The length L2 of the distal portion 51, measured along
axis A'', is defined between the radial rim 57 and the flat distal
face 53. In the aspect of FIGS. 4A and 4B, the proximal face 55 is
essentially flat. In other aspects (not shown), the proximal face
55 has a curvature radius, the center of which being situated on
the axis A''. The diameter of the proximal face 55 is preferably
greater than the diameter of the fluid passageway 14 of the distal
tip 13. As appears from FIGS. 4A and 4B, the proximal face 55 is
the most proximal face of the elastomeric inner cap 50.
[0077] The elastomeric cap 50 is able to adopt three different
configurations: a free configuration when it is not assembled with
the rigid cap 40, a first stressed configuration when it is
assembled into the rigid cap 40 to form the tip cap assembly 30 and
a second stressed configuration due to the distal pressure applied
by the distally projecting tip 13 when the tip cap assembly 30
closes the fluid passageway 14 of an injection system 10, as will
be explained later.
[0078] Suitable materials for the elastomeric cap 50 of the
invention include natural rubber, acrylate-butadiene rubber,
cis-polybutadiene, chloro or bromobutyl rubber, chlorinated
polyethylene elastomers, polyalkylene oxide polymers, ethylene
vinyl acetate, fluorosilicone rubbers,
hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene
terpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene
rubber, silicone rubbers, styrene-butadiene rubbers,
tetrafluoroethylene propylene copolymers,
thermoplastic-copolyesters, thermo-plastic elastomers, or the like
or a combination thereof.
[0079] The superposition of cross-sectional views of the
elastomeric inner cap 50 (FIGS. 4A-4B) and the rigid outer cap 40
(FIGS. 3A-3E) is shown as a theoretical view in FIG. 5, as the
represented shape of the elastomeric inner cap 50 on this Figure is
that of its free configuration and therefore overlaps (at circular
bump 56) the shape of the rigid outer cap 40. The distal portion 51
of the elastomeric inner cap 50 is intended to be received in the
distal portion 42 of the rigid cap 40, and the proximal portion 52
of the elastomeric inner cap 50 is intended to be received in the
central portion 43 of the rigid cap 40. In the theoretical view of
FIG. 5, the axis A' of the rigid cap 40 is superposed with the axis
A'' of the elastomeric inner cap 50 and the length L1 included
between the abutment surface 42e and the shoulder 42f is slightly
greater than the length L2 of the distal portion 51 of the
elastomeric inner cap 50. In another aspect (shown in FIG. 7), the
length L1 is equal to the length L2 of the distal portion 51. In a
last aspect (not shown), the length L1 is slightly smaller in
comparison to the length L2. Finally, the circular bump 56 of the
elastomeric inner cap 50 has a diameter slightly greater than the
internal diameter of the central portion 43 of the rigid cap
40.
[0080] A tip cap assembly 30 ready to be used, with the elastomeric
inner cap 50 assembled into the rigid cap 40, is shown in FIGS. 6A
and 6B. The elastomeric inner cap 50 is maintained inside the rigid
cap 40 and is in its first stressed configuration: its distal
portion 51 is enclosed between the abutment surface 42e and the
shoulder 42f of the rigid cap 40 and its longitudinal axis A'' is
superposed with the longitudinal axis A' of the rigid cap 40. The
elastomeric inner cap 50 is distally blocked by the contact between
its distal face 53 and the abutment surfaces 42e of the rigid cap
40, and proximally blocked by the contact between its radial rim 57
and the shoulder 42f of the rigid cap 40. In the embodiment of
FIGS. 6A and 6B, the length L1 is greater than the length L2 and a
gap G exists between the rigid cap 40 and the elastomeric cap 50
which allows a limited translation of the elastomeric cap 50 within
the rigid cap 40. In the embodiments where L1 is equal to or
smaller than L2, the abutment surfaces 42e of the rigid cap 40
contact directly the distal face 53 of the elastomeric inner cap 50
while the shoulder 42f of the rigid cap 40 contacts the radial rim
57 of the elastomeric cap 50. Consequently, the radial rim 57
contacts the shoulder 42f at least when a proximal pressure is
applied on the elastomeric inner cap 50, while the abutment
surfaces 42e contact the distal face 53 at least when a distal
pressure is applied on the elastomeric inner cap 50. The abutment
surfaces 42e and the shoulder 42f of the rigid cap 40, together
with the distal face 53 and the radial rim 57 therefore form
holding means to secure the elastomeric inner cap 50 within the
rigid cap 40.
[0081] Furthermore, the average diameter of the distal portion 51
of the elastomeric inner cap 50 is chosen to be slightly larger
than the inside diameter of the distal portion 42 of the rigid cap
40. As a result, the elastomeric inner cap 50 is tightened on its
diameter, is slightly deformed, and part of this elastomeric inner
cap 50 even protrudes further through the windows 42b of the rigid
cap 40 when assembled (as shown in FIG. 7). This deformation thus
enhances the contact area between the abutments surfaces 42e and
the distal face 53 of the elastomeric inner cap 50. Similarly, and
as shown in FIG. 5, the circular bump 56 of the proximal portion 52
has a diameter slightly larger than the inside diameter of the
central portion 43 of the rigid cap 40. Consequently, the proximal
portion 52 is tightened on its whole diameter, and the
frustoconical protrusion 54 is deformed over its length, thus
further extending toward the proximal portion 44 of the rigid cap
40. These deformations further contribute to maintain the
elastomeric inner cap 50 in the rigid cap 40. In the aspect where
L1 is smaller than L2 (not shown), the distal portion 51 of the
elastomeric cap 50 is tightened on its length and slightly
deformed.
[0082] Due to the specific shape of the rigid cap 40 and the
elastomeric inner cap 50, the assembly of the tip cap 30 can be
obtained by aligning the axis A' of the rigid cap 40 with the axis
A'' of the elastomeric inner cap 50, the proximal portion 52 of the
elastomeric inner cap 50 facing the distal opening 42a of the rigid
cap 40. A proximal pressure applied on the elastomeric inner cap
50, or a distal pressure applied on the rigid cap 40 allows the
introduction and the slight deformation of the elastomeric inner
cap 50 into the rigid cap 40. This operation can be facilitated by
lubrication of the elastomeric inner cap 50, lubrication of the
cavity 41a of the rigid cap 40, or both. In the aspect where L1 is
greater than L2, the gap G leads to a simpler assembling by
allowing a greater deformation of the elastomeric cap 50 and
permitting to have higher ranges of manufacturing tolerances. The
tip cap assembly 30 of the present aspect is therefore very fast to
assemble and the probability of an incorrect assembling is very
limited.
[0083] The tip cap assembly 30 is now ready to be connected with a
syringe 10 as shown in FIG. 7. The axis A', A'' of the tip cap
assembly are aligned with the axis A of the syringe 10, the
proximal opening 44b of the tip cap assembly 30 facing the distally
projecting tip 13 of the syringe 10. When the tip cap assembly 30
is provided with an outer thread 44d, a rotational movement is
required to screw the outer thread 44d into the inner thread 21 of
the collar 20 of the syringe 10. Before the end of the rotation,
the projecting tip 13 comes in contact with the proximal face 55 of
the elastomeric inner cap 50. In the aspect where L1 is greater
than L2, the elastomeric cap 50 is pushed against the abutment
surfaces 42e of the rigid cap 40 and then progressively compressed.
In the aspects where L1 is equal or smaller than L2, the
elastomeric cap 50 is already immobilized inside the rigid cap 40
and is directly compressed by the projecting tip 13. Thereafter,
the lateral surface 16 of the projecting tip 13 comes in contact
with the frustoconical extension 44a, which is progressively
deformed radially outwardly. At the end of the rotation, the
proximal abutment surface 43d of the tip cap assembly 30 comes in
contact with the distal rim 22 of the collar 20. Thus, the tip cap
assembly 30 is secured to the collar 20 and to the distally
projecting tip 13 as shown in FIGS. 2A, 2B and 7. The proximal
abutment surface 43d of the rigid cap 40 cooperates with the distal
rim 22 of the collar 20 to prevent any further rotational movement
that would damage the tip cap assembly 30. This cooperation also
ensures the correct positioning of the tip cap 30 with respect to
the collar 20 and provides the user with a tactile indication that
the syringe 10 is hermetically sealed. In another aspect (not
shown), the proximal abutment surface 43d is not present on the
ring 43c but integrated on the outer surface of the rigid cap
40.
[0084] In an aspect where the syringe 10 is not provided with a
collar 20 and the tip cap assembly 30 is consequently not provided
with an outer thread 44d or a ring 43c (not shown), the tip cap
assembly 30 is simply mounted on the distally projecting tip 13 by
a proximal movement.
[0085] As shown in FIG. 7, the elastomeric inner cap 50 does not
substantially penetrate the fluid passageway 14 since the diameter
of the proximal face 55 is at least greater than the diameter of
the fluid passageway 14. When the tip cap assembly 30 is plugged on
the tip, the elastomeric inner cap 50 is compressed between the
distally projecting tip 13 and the abutment surfaces 42e of the
rigid cap 40, which significantly deforms the proximal portion 52
of the elastomeric inner cap 50 in order to ensure the tight
sealing of the fluid passageway 14. Part of this deformation is
absorbed by the specific shape of the frustoconical protrusion 54
of the elastomeric cap 50, which contributes to limit both axial
and radial stress transmitted to the rigid cap 40. The deformation
of the elastomeric cap 50 is also partially allowed by the distal
opening 42a and the longitudinal windows 42b of the rigid cap 40,
as shown in FIG. 7, further reducing the amount of axial stress
transmitted to the rigid cap 40 through the abutment surfaces 42e.
The frustoconical protrusion 54 of the elastomeric inner cap 50 as
well as the distal opening 42a and the longitudinal windows 42b of
the rigid cap 40 therefore constitute stress-limiting means that
allow the elastomeric cap 50 to be substantially deformed when the
tip cap assembly 30 closes the passageway 14 of the syringe 10.
Unintended deformation of the rigid cap 40 and in particular of its
distal portion 42, due to the stress resulting of the compression
of the elastomeric cap 50 over time, is therefore avoided: the
syringe can be kept perfectly sealed during storage time. Thanks to
the appropriate connection of the tip cap assembly with the
projecting tip 13, neither the nature nor the quality, for example
the purity, of the fluid stored inside the syringe is altered, even
after an extended period of storage. Wastage of valuable fluids is
therefore avoided, as well as unacceptable risks for patients and
medical staff that would be in contact with the fluid. The specific
geometry of the rigid cap 40, and in particular the distal opening
42a, the windows 42b, the abutment surfaces 42e, as well as the
specific geometry of the elastomeric inner cap 50 and in
particular, the frustoconical protrusion 54, therefore allow a
hermetical and sustainable sealing of the projecting tip 13 of the
syringe 10.
[0086] The rigid cap 40 is reinforced on its outside by the
longitudinal ribs 43e, the longitudinal ribs 42c and the distal
radial ribs 42d and on its inside by the longitudinal rims 43a and
the shoulder 43b, in order to resist against any deformation that
might result from the stress transmitted by the elastomeric inner
cap 50 when the tip cap assembly 30 closes the fluid passageway 14,
or by the user while manipulating the tip cap assembly.
Longitudinal ribs 43e, the longitudinal ribs 42c, the distal radial
ribs 42d, the longitudinal rims 43a and the shoulder 43b therefore
constitute reinforcement means.
[0087] In the aspect where L1 is greater than L2, the gap G between
the rigid cap 40 and the elastomeric cap 50 is also useful to be
compatible with different kinds of syringes showing unconventional
lengths of distally projecting tip 13, for example syringes that
have not been designed according to usual standards. As a result,
the tip cap assembly 30 according to this specific aspect can
provide an optimal and sustainable sealing even in the case of
non-standard syringes.
[0088] In the closed position shown in FIG. 7, the radial recess
44e allows a limited radial deformation of the frustoconical
extension 44a due to the contact with the lateral surface 16 of the
distally projecting tip 13. As a result, the frustoconical
extension 44a extends around and hermetically seals the distally
projecting tip 13, the three annular ridges 44c being in tight
contact with its lateral surface 16. This ensures the
circumferential sealing of the lateral wall 16 of the distal tip 13
and allows the sterile maintenance of the cavity 41a of the tip cap
assembly 30 and therefore the projecting tip 13 of the syringe 10.
In addition, the circumferential sealing of the lateral wall 16 of
the distal tip 13 is performed even when the distal tip 13 is not
perfectly circular. A distal tip 13 showing a limited asymmetry or
a ellipsoidal section resulting of manufacturing tolerances does
not deteriorate the sterility of the cavity 41a of the tip cap
assembly 30. The frustoconical extension 44a therefore acts as a
sterility skirt during the storage time of a prefilled syringe and
significantly limits or eliminates migration of contaminants from
the projecting tip to the fluid before and during the step of
injection to a patient. In other aspects (not shown), the sterility
skirt 44a is provided with at least one annular ridge 44c.
[0089] At the end of the storage time, immediately before injecting
the fluid stored to a patient, a limited effort is required to
unscrew the tip cap assembly 30 from the collar 20 and thus to open
the fluid passageway 14 of the syringe 10. Indeed, the specific
shape of the frustoconical protrusion 54 of the tip cap assembly 30
limits the area of contact between the elastomeric cap 50 and the
distally extending tip 13 to the distal surface 15, therefore
avoiding any contact between the elastomeric inner cap 50 and the
lateral surface 16 or the fluid passageway 14 of the distally
extending tip 13. This significantly reduces or cancels the
sticking phenomenon that may happen after an extended storage
period and therefore allows a quick and easy removal of the tip cap
assembly 30. The fluid passageway 14 is also maintained clean of
particles since the frustoconical protrusion 54 does not contact
directly the inside surface of the fluid passageway 14. During the
opening of a syringe 10, the frustoconical protrusion 54 of the
elastomeric inner cap 50 also creates a spring effect to the tip
cap assembly 30 which further contributes to an easy removal.
Finally, reinforcement means 43e, 42c, 42d, 43a and 43b allow for a
thinner tubular wall 41 of the rigid cap 40. The deformation of the
rigid cap 40 during the removal step is therefore limited, which
again ensures an easy removal. The tip cap assembly according to
the present disclosure therefore can reduce economic loss by
preventing discarding prefilled syringes before use. Furthermore,
injection can be done at very short notice and without excessive
effort. This could save patients requiring immediate treatment.
[0090] In another aspect shown in FIG. 8, the tip cap assembly 100
has the global shape of an elliptic cylinder and includes
elliptical reinforcement ridges 141 and 142 on the outer surface of
the rigid cap 140, the proximal portion (not visible) of the rigid
cap 140 being substantially cylindrical to fit within the syringe
collar 20 and all other features being similar to those previously
described for the tip cap assembly 30 of FIGS. 1-7. Comparing to
the circular cylinder tip cap assembly 30, the tip cap assembly 100
is easier to screw or remove from the syringe collar 20 as the
elliptical shape provides more contact surface to the user's
fingers, leading to a better gripping ability.
[0091] In another aspect shown in FIG. 9, the tip cap assembly 200
has globally the shape of an elliptical cylinder and the outer
surface of the rigid cap 240 is provided with longitudinal
reinforcement ridges 241 surrounding the windows 242 (only one
visible in FIG. 9), and two flat surfaces 243 placed between the
windows 242. The proximal portion (not visible) of the rigid cap
240 is substantially cylindrical to fit within the syringe collar
20 and all other features are similar to those previously described
for the tip cap assembly 30 of FIGS. 1-7. Comparing to the circular
cylinder tip cap assembly 30, the tip cap assembly 200 is easier to
screw or remove from the syringe collar 20 as the elliptical shape
provides more contact surface to the user's fingers, leading to a
better gripping ability.
[0092] In other aspects (not shown), the tip cap assembly 30 can be
provided with a tamper evidence feature, for example in the form of
breakable tabs between the collar 20 and the ring 43c of the rigid
cap 40. In other aspects (not shown), the tamper evidence features
also include a security ring provided on the collar 20.
[0093] Thanks to its unique structure, the tip cap assemblies
according to the present disclosure allows maintaining a perfect
sealing overtime, protecting the syringe tip from contamination
during storage time and providing an opening with limited
effort.
* * * * *