U.S. patent application number 10/996147 was filed with the patent office on 2005-04-28 for medical puncturing device.
This patent application is currently assigned to Maersk Medical A/S. Invention is credited to Delzac, Marc, Larsen, Bjorn Gullak, Mathiasen, Orla, Nielsen, Jan Willum, Teisen-Simony, Claude.
Application Number | 20050090784 10/996147 |
Document ID | / |
Family ID | 22360747 |
Filed Date | 2005-04-28 |
United States Patent
Application |
20050090784 |
Kind Code |
A1 |
Nielsen, Jan Willum ; et
al. |
April 28, 2005 |
Medical puncturing device
Abstract
The invention relates to a medical puncturing device comprising
a rigid needle being at one end adapted for facilitating the
puncturing and comprising at the opposite end a hub, the hub
comprising a handle part and a shield part being pivotable in
relation to the handle part and further comprising locking means on
the shield part and the handle part, the locking means being
adapted to interlock the shield and the handle part in a pivoted
position of the shield part where the rigid needle is covered by
this.
Inventors: |
Nielsen, Jan Willum;
(Roskilde, DK) ; Larsen, Bjorn Gullak; (Roskilde,
DK) ; Mathiasen, Orla; (Roskilde, DK) ;
Delzac, Marc; (Roskilde, DK) ; Teisen-Simony,
Claude; (Frederiksberg, DK) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Assignee: |
Maersk Medical A/S
|
Family ID: |
22360747 |
Appl. No.: |
10/996147 |
Filed: |
November 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10996147 |
Nov 23, 2004 |
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10017789 |
Dec 13, 2001 |
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6840922 |
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10017789 |
Dec 13, 2001 |
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09115340 |
Jul 14, 1998 |
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6355021 |
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Current U.S.
Class: |
604/263 |
Current CPC
Class: |
A61M 25/0631 20130101;
A61M 5/3216 20130101; Y10S 128/919 20130101; A61M 2005/1581
20130101; A61M 2005/1585 20130101 |
Class at
Publication: |
604/263 |
International
Class: |
A61M 005/00 |
Claims
1-10. (canceled)
11. An infusion device comprising: a housing; a soft cannula
extending from the housing, said soft cannula having an outer tip;
a puncturing device adapted to be connected to said housing, said
puncturing device comprising a rigid needle being adapted to extend
through the cannula and beyond the outer tip thereof when the
puncturing device is connected to said housing, said rigid needle
being at one end adapted for facilitating puncturing and including
at the opposite end a hub; said hub having a hinge, a handle part
and a single shield part with a first end and a second free end,
said first end of the shield part being pivotably connected to the
handle part by means of said hinge, whereby said second free end is
pivotable with respect to said hinge; said shield part being
adapted to cover the rigid needle when pivoted with respect to said
hinge, the second free end of the shield part extending beyond said
one end of the rigid needle; and said hub further having a locking
mechanism on the shield part and the handle part, the locking
mechanism being adapted to interlock the shield and the handle part
in a pivoted position of the shield part when the puncturing device
is disconnected from the housing and the shield part is pivoted to
cover at least a portion of the rigid needle.
12. The infusion device as claimed in claim 11, wherein the shield
part comprises a recess for accommodating the rigid needle.
13. The infusion device as claimed in claim 11, wherein the shield
part has an essentially U-shaped cross section.
14. The infusion device as claimed in claim 11, wherein the locking
mechanism on the handle part comprises two arms having on their
opposed sides barbs adapted to interlock with the corresponding
locking mechanism of the shield part.
15. The infusion device as claimed in claim 14, wherein the edges
of the barbs are tapered so as to facilitate the insertion into the
corresponding locking mechanism of the shield part.
16. The infusion device as claimed in claim 15, wherein the hub is
formed as a single part and where the hinge between the handle part
and the shield part is an area with a reduced rigidity.
17. The infusion device as claimed in claim 15, wherein the hub is
made of a plastics material.
18. The infusion device as claimed in claim 15, wherein gripping
means are provided on the shield part and the handle part, said
gripping means being adapted to lock the hub to the housing.
19. The infusion device as claimed in claim 11, wherein the locking
mechanism on the shield part comprises two side flanges adapted to
interlock with the corresponding locking mechanism of the handle
part.
20. The infusion device as claimed in claim 19, wherein the edges
of the flanges are tapered so as to facilitate the insertion into
the corresponding locking mechanism of the handle part.
21. The infusion device as claimed in claim 11, wherein the shield
part comprises an operating handle, the operating handle thereby
being pivotable with respect to the handle part of the hub.
22. The infusion device as claimed in claim 11, wherein the hub is
formed as a single part and where the hinge between the handle part
and the shield part is an area with a reduced rigidity.
23. The infusion device as claimed in claim 11, wherein the hub is
made of a plastics material.
24. The infusion device as claimed in claim 11, wherein gripping
means are provided on the shield part and the handle part, said
gripping means being adapted to lock the hub to the housing.
25. The infusion device as claimed in claim 11, wherein gripping
means are provided on the shield part and the handle part, said
gripping means being adapted to lock the hub to the housing,
wherein the shield part comprises an operating handle, the
operating handle being pivotable with respect to the handle part of
the hub, and wherein pressing the handle part against the operating
handle will release the gripping means and thereby the puncturing
device from the housing.
26. An infusion device comprising: a housing; a cannula extending
from said housing; a hub adapted to be removably connected to said
housing, said hub and said housing connected at least partially by
a pair of projecting arms, each arm having a barb portion, said
arms extending from said hub; a needle having a first end mounted
in said hub, said needle adapted to extend through said cannula,
and a shield hingedly connected to said hub, wherein said shield is
pivotable to cover at least a portion of said needle when said hub
is removed from said housing.
27. The infusion device of claim 26 wherein said shield bends said
needle when said shield is pivoted to cover at least a portion of
said needle.
28. The infusion device of claim 26 wherein said housing further
comprises a medication bore within the housing for leading
medication to said cannula.
29. The infusion device of claim 26 wherein said housing further
comprises a cavity formed within said housing and connected to said
cannula.
30. The infusion device of claim 26 wherein said hub and said
shield are integrally molded together.
31. The infusion device of claim 26 wherein said hub is
substantially rectangularly shaped.
32. The infusion device of claim 26 wherein said shield has a
substantially U-shaped cross section.
33. An infusion device comprising: a hub comprising: a handle
having a needle mounted thereto and a pair of retaining arms
extending from said handle; an elongated shield extending from said
handle and rotatable relative to said handle; and an infusion
housing releasably engaged by said arms, said housing having a
cannula extending therefrom, wherein at least a portion of said
needle extends through said housing and said cannula.
34. The infusion device of claim 33 wherein said shield is hingedly
connected to said handle.
35. The infusion device of claim 33 wherein said shield is
rotatable to cover at least a portion of said needle.
36. The infusion device of claim 33 wherein said handle and said
shield are integrally molded together.
37. The infusion device of claim 33 wherein said shield further
comprises a pair of flanges along at least a portion of said
shield, said flanges being adapted to engage said arms when said
shield covers at least a portion of said needle.
38. The infusion device of claim 33 wherein said handle is
substantially rectangularly shaped.
39. The infusion device of claim 33 wherein said shield has a
substantially U-shaped cross section.
40. The infusion device of claim 33 wherein said hub is formed from
a plastics material.
41. The infusion device of claim 33 wherein said infusion housing
further comprises a cavity.
42. The infusion device of claim 33 wherein said handle is
configured to be retained within an inserter device.
43. An infusion device comprising: a housing; a cannula extending
from said housing for delivery of medication through said cannula;
and a hub removably connected to said housing, said hub comprising:
a needle having a first end extending at least partially through
said cannula when said hub is connected to said housing; a handle
fixedly attached to an opposing end of said needle; and a shield
hingedly connected to said handle, and adapted to cover at least a
portion of said needle after said hub is removed from said
housing.
44. The infusion device of claim 43 wherein said handle is
configured to be retained within an inserter device.
45. The infusion device of claim 43 wherein said handle is
substantially rectangularly shaped.
46. The infusion device of claim 43 wherein said shield engages
said handle when said shield is positioned to cover at least a
portion of said needle.
47. The infusion device of claim 43 further comprising retaining
means extending from said handle.
48. The infusion device of claim 47 wherein said retaining means
are a pair of opposing legs.
49. The infusion device of claim 47 wherein said retaining means is
configured to retain said hub against said housing.
50. The infusion device of claim 47 wherein said hub is adapted for
placement and engagement with said housing down a center line of
said housing.
51. The infusion device of claim 43 wherein said shield has a
substantially U-shaped cross section.
52. The infusion device of claim 43 wherein said hub is formed from
a plastics material.
53. The infusion device of claim 43 wherein said shield bends said
needle when said shield at least partially covers said needle.
54. The infusion device of claim 43 wherein said infusion housing
further comprises a cavity.
55. The infusion device of claim 43 wherein said housing further
comprises a medication bore within the housing for leading
medication to said cannula.
56. A medical puncturing device comprising: a hub having a pair of
retaining members for removable attachment of said hub to an
infusion device; a shield portion extending rearwardly from said
retaining members of said hub in a first position; and a needle
extending from said hub, wherein said needle is adapted to extend
though a cannula of said infusion device; wherein said shield may
be pivoted into a position where at least a portion of said needle
is covered.
57. The medical puncturing device of claim 56 wherein said shield
is locked with said hub when said shield is covering at least a
portion of said needle.
58. The medical puncturing device of claim 56 further comprising a
handle portion upstanding from said first portion.
59. The medical puncturing device of claim 58 wherein said handle
portion is substantially rectangularly shaped.
60. The medical puncturing device of claim 58 wherein said handle
portion is configured to be retained within an inserter device.
61. The medical puncturing device of claim 56 wherein said shield
has a substantially U-shaped cross section.
62. The medical puncturing device of claim 56 wherein said pair of
retaining members is configured to retain said hub against said
infusion device.
63. The medical puncturing device of claim 56 wherein said shield
bends said needle when said shield is pivoted to said position
wherein at least a portion of said needle is covered.
64. A medical puncturing device comprising: a handle defining a
needle retaining portion, said needle retaining portion being
substantially rectangular in cross section and having a needle
extending therefrom, said needle having a second end for puncturing
the skin of a patient; a shield flexibly connected to said handle,
a portion of said shield extending rearwardly from said handle in a
first position and away from said needle, said portion being
substantially U-shaped in cross section; and a pair of protrusions
extending from said shield, said protrusions adapted for retention
of said shield with said handle when said shield is in a position
covering at least a portion of said needle.
65. The medical puncturing device of claim 64 wherein said handle
portion is configured to be retained within an inserter device.
66. The medical puncturing device of claim 64 wherein said shield
has a substantially U-shaped cross section.
67. The medical puncturing device of claim 64 wherein said shield
extends substantially perpendicularly to said needle in said first
position.
68. The medical puncturing device of claim 64 wherein said shield
bends said needle when said shield is pivoted into a position
covering at least a portion of said needle.
69. The medical puncturing device of claim 64 wherein said
protrusions are elongated an extend along at least a portion of
said length of said shield.
70. A medical puncturing device comprising: a substantially
rectangularly shaped handle having a pair of retaining arms
extending therefrom, said arms being adapted to removably connect
said device to an infusion set; a needle having a first end mounted
in said handle and a second end extending downward from said
handle; and a shield pivotally connected to said handle, said
shield having a portion extending substantially rearwardly in a
first position to allow connection of said device to an infusion
set; wherein said shield pivots with respect to said handle wherein
said shield covers at least a portion of said needle.
71. The medical puncturing device of claim 70 wherein said handle
is substantially rectangularly shaped.
72. The medical puncturing device of claim 70 wherein said handle
is adapted so a user can grasp said handle together with said
infusion set.
73. The medical puncturing device of claim 70 wherein said handle
is configured to be retained within an inserter device.
74. The medical puncturing device of claim 70 wherein said shield
has a substantially U-shaped cross section.
75. The medical puncturing device of claim 70 wherein said pair of
retaining arms is configured to retain said device against said
infusion set.
76. The medical puncturing device of claim 70 wherein said shield
bends said needle when said shield is pivoted into a position
covering at least a portion of said needle.
77. A medical puncturing device comprising: a handle defining a
needle retaining portion; a needle fixedly attached to said needle
retaining portion and configured for insertion through an infusion
housing; a shield hingedly connected to said handle, a portion of
said shield extending rearwardly from said handle in an unlocked
position; and a pair of gripping arms positioned on one of said
shield and said handle for removable connection of said device to
said infusion housing; wherein said shield is adapted to engage
said gripping arms and cover at least a portion of said needle.
78. The medical puncturing device of claim 77 wherein said handle
is substantially rectangularly shaped.
79. The medical puncturing device of claim 77 wherein said handle
is configured to be retained within an inserter device.
80. The medical puncturing device of claim 77 wherein said handle
tapers inwardly from a base of said handle toward a distal end
thereof.
81. The medical puncturing device of claim 77 wherein said handle
includes an generally cylindrical inner wall structure integrated
within a substantially rectangularly-shaped outer wall
structure.
82. The medical puncturing device of claim 77 wherein said shield
has a substantially U-shaped cross section.
83. The medical puncturing device of claim 77 wherein said pair of
gripping arms is configured to retain said device against said
infusion housing.
84. The medical puncturing device of claim 77 wherein said pair of
gripping arms is mounted on said handle.
85. The medical puncturing device of claim 77 wherein said shield
may be pivoted to cover at least a portion of said needle.
86. The medical puncturing device of claim 85 wherein said shield
bends said needle when said shield is pivoted to cover said
needle.
87. The medical puncturing device of claim 77 wherein said handle
and said shield are integrally molded together.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to a medical puncturing device
e.g. for use in connection with the insertion of a soft cannula
where the soft cannula e.g. forms part of a infusion device for
subcutaneous delivery of a medication or a therapeutic fluid by
means of an external infusion system and more particularly to a
medical puncturing device capable of being discarded without the
danger of causing unintended harmful injuries to persons
afterwards.
[0002] The medical puncturing device will in the following be
explained in connection with the field of subcutaneous infusion
devices. Such infusion devices are generally known in the art for
delivering a medication or a therapeutic fluid to a subcutaneous
site in a patient. Such devices commonly comprise a soft tubular
cannula extending from a housing adapted to receive the desired
medication via means, e.g. disconnectable means, for suitable
connection to further components of the infusion system. The
possibility of disconnecting the infusion set from the further
parts of the infusion system is provided in order to improve the
user comfort. In order to place the soft cannula at a subcutaneous
delivery site, a medical puncturing device comprising a rigid
needle and a handle is used. The rigid needle is inserted through
the hollow soft cannula and extends beyond the outer tip of this.
The soft cannula is inserted into the subcutaneous fat layer of the
patient together with the rigid needle, which is afterwards
withdrawn leaving the soft cannula at the infusion site. In order
to provide such disconnectable medical puncturing device and still
maintain a fluid-tight sealing towards the interior of the housing
and the tubular cannula that prevents contamination of the infusion
site, such devices are commonly provided with a self-sealing
penetrable septum on the housing. Upon withdrawal of the needle
from the septum this provides a fluid-tight sealing towards the
interior of the housing. The septum and the needle further provides
a fluid-tight sealing between the housing and the connector means
when medication or therapeutic fluid is delivered to the patient
from the external infusion system. Subcutaneous infusion devices of
this generally known type are known from e.g. U.S. Pat. No.
5,522,803 to Teissen-Simony and U.S. Pat. No. 5,545,143 to
Fischell.
[0003] The use of a medical puncturing device comprising a rigid
needle may lead to some disadvantages during use of such device,
viz. the potential danger of unintended exposure to the needle tip
after the needle has-been discarded.
[0004] A medical puncturing device of a type providing some remedy
for these disadvantages is disclosed in U.S. Pat. No. 5,533,974.
This previously known device comprises a rigid needle and a
protector housing wherein a biasing element, a cam and a gripping
element are provided in order to lock the protector housing in
relation to the needle at the pointed tip of this.
[0005] A further device is disclosed in U.S. Pat. No. 5,279,591.
This previously known device comprises a rigid needle and a
protector housing wherein a resilient spring means is provided to
block the needle tip upon sliding the protector housing to the
needle tip.
[0006] A still further device is disclosed in WO 9305840. This
previously known device comprises a rigid needle and a protector
housing wherein a resilient guard element is provided to block the
pointed needle tip upon sliding the protector housing to the needle
tip. Means for limiting the sliding movement are provided hereby
ensuring the position of the protector housing.
[0007] Although these previously known medical puncturing devices
to some extent give a satisfactory result with respect to the
prevention of unintended and harmful needle sticks they all have a
complicated construction requiring a cumbersome assembling
process.
[0008] For this reason there is a need for improvements in the
field of medical puncturing devices, the improvements relating to
providing a medical puncturing device having satisfactory
properties particularly with respect to providing a medical
puncturing device which can be dismantled and discarded without the
risk of causing any injuries, and at the same time being of a
simpler construction requiring less effort in the manufacturing
process.
[0009] The infusion needle according to the invention remedies the
above mentioned disadvantages and provides further advantages which
will become apparent from the following description.
SUMMARY OF THE INVENTION
[0010] In order to provide remedy for the above mentioned
disadvantages a medical puncturing device has been developed, said
medical puncturing device comprising a rigid needle being at one
end adapted for facilitating the puncturing and comprising at the
opposite end a hub, the hub comprising a handle part and a shield
part being pivotable in relation to the handle part and further
comprising locking means on the shield part and the handle part,
the locking means being adapted to interlock the shield and the
handle part in a pivoted position of the shield part where the
rigid needle is covered by this.
[0011] By these features a simple construction is obtained which
provides a reliable function as to preventing the risk of causing
any injuries upon dismantling and discarding of the device.
[0012] In a preferred embodiment the shield part comprises a recess
for accommodating the rigid needle. This can conveniently be
obtained by configuring the shield part with an essentially
U-shaped cross section.
[0013] The locking means on the handle part preferably comprises
two arms having on their opposed sides barbs adapted to interlock
with the corresponding locking means of the shield part. The
locking means on the shield part preferably comprises two side
flanges adapted to interlock with the corresponding locking means
of the handle part. The flanges or the barbs are preferably tapered
to facilitate the insertion of these into the corresponding locking
means of the handle part and the shield part, respectively.
[0014] In order to facilitate the handling, the shield part
preferably comprises an operating handle.
[0015] The hub is conveniently configured as a single part where
the transition area between the handle part and the shield part is
an area with a reduced rigidity, e.g. an area with a reduced
material thickness. The medical puncturing device according to the
invention is preferably manufactured from a plastics material, e.g.
by a moulding process.
[0016] In a convenient embodiment the hub is prior to pivoting of
the shield part adapted to grip around a body, e.g. an infusion
device where a soft cannula belonging to this is to be inserted
into a human body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a perspective view of a medical puncturing
device;
[0018] FIG. 2 is a side view of the medical puncturing device shown
in FIG. 1;
[0019] FIG. 3 is a rear end view of the medical puncturing device
shown in FIG. 2;
[0020] FIG. 4 is a front end view of the medical puncturing device
shown in FIG. 2;
[0021] FIG. 5 is a bottom view of the medical puncturing device
shown in FIG. 1;
[0022] FIG. 6 is a top view of the medical puncturing device shown
in FIG. 1;
[0023] FIG. 7 is a sectional view after the line 7-7 in FIG. 5;
[0024] FIG. 8 is a perspective view showing the medical puncturing
device where the shield part is pivoted to a locked position;
[0025] FIG. 9 is a side view showing the shield part pivoted to a
locked position;
[0026] FIG. 10 is a perspective view where the medical puncturing
device is mounted on an infusion device, and
[0027] FIG. 11 is a sectional view after the line 11-11 in FIG.
10.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0028] From FIG. 1 a preferred embodiment of the medical puncturing
device appears. The device comprises a rigid needle 1 mounted in a
needle hub 2. The needle is at the end opposite the needle hub 2
pointed or tapered so as to facilitate puncturing e.g. by the
insertion of a soft cannula. The needle hub comprises a handle part
3, which is at one side connected to a shield part 4 via a hinge 5
formed as a material area with a reduced thickness. The shield part
4 has the shape of a half tube 6 having at the edges at both sides
flanges 7,8. The shield part 4 comprises a pivoting handle 17. At
the opposite side of the needle hub 2 in relation to the needle
connection point the needle hub 2 comprises two arms 9,10 having
barbs 11,12 at their opposed sides 15,16.
[0029] From FIG. 2 the puncturing device appears in a side view
more clearly showing the transition area 5 where the shield part 4
is pivoted in relation to the handle part 3 by a pivoting action on
the pivoting handle 17 by one hand while holding the handle part 3
with the other hand.
[0030] From FIG. 3 and FIG. 4 which are rear and front end views,
respectively, the locking elements on the shield part and the
handle part appear more clearly. Upon pivoting of the shield part
in relation to the handle part these locking elements are caused to
interact.
[0031] FIG. 5 and FIG. 6, which are bottom and top views,
respectively, illustrate the locking elements in further
detail.
[0032] From FIG. 7 the fastening site 14 for the rigid needle in
the hub becomes apparent. The rigid needle is preferably secured in
the correct position by a press fit connection or by gluing or
welding.
[0033] From FIG. 8 and FIG. 9 it appears that the barbs 11,12 are
co-operating with the flanges 7,8 of the shield part in order to
interlock the shield part in the pivoted position. The deformed
material in the transition area 5 together with the bend needle
provide a biasing effect between the flanges 7,8 and the barbs
11,12. The needle hereby closely abuts on the side of the half tube
6 ensuring that unintended contact with the needle is avoided. This
becomes especially clear in FIG. 9 where a part of the hub is cut
away.
[0034] From FIG. 10 and FIG. 11 a field of use for the puncturing
device appears. The puncturing device is inserted into an infusion
device 18 for subcutaneous delivery of medication to a patient.
This infusion device comprises a housing 19 in which a cavity 20 is
provided and where a bore 21 leads medication from a pump or the
like via a connector 25 to the cavity 20 where a soft cannula 22 is
provided in fluid contact with the cavity 20 and where a further
bore 23 covered with a self-sealing septum 24 is provided opposite
the soft cannula 22. The puncturing device is inserted through the
self-sealing septum 24, the cavity 20 and the soft cannula 22 and
extends beyond the outer tip of the soft cannula. The puncturing
device is held in place in relation to the connector 25 by means of
barbs 26,27 on the shield part. When pressing the handle part 3
againts the pivoting handle 17 the barbs will release from their
gripping position on the downward facing side of the connector 25
and the puncturing device may be retracted from the infusion set.
The soft cannula is placed in an operational position, i.e. in a
subcutaneous infusion site, by penetrating the skin and tissue of
the patient by means of the puncturing device and afterwards
retracting the puncturing device through the soft cannula, the
cavity and the self-sealing septum. The puncturing device is not
intended for further use and should therefore be folded and brought
into a locked position as shown in FIG. 8 and FIG. 9 prior to
discarding hereby ensuring that unintended harmful injuries caused
by an exposed needle are avoided.
* * * * *