U.S. patent application number 11/447980 was filed with the patent office on 2006-12-14 for insertion device and method.
This patent application is currently assigned to Sensors for Medicine and Science, Inc.. Invention is credited to Casey J. O'Connor, Steven J. Walters.
Application Number | 20060282042 11/447980 |
Document ID | / |
Family ID | 37055942 |
Filed Date | 2006-12-14 |
United States Patent
Application |
20060282042 |
Kind Code |
A1 |
Walters; Steven J. ; et
al. |
December 14, 2006 |
Insertion device and method
Abstract
The present invention provides an insertion device and method
for implanting a biosensor into a patient subject. In one
embodiment, a biosensor is stored in the instrument's hydration
chamber which enables the biosensor to maintain proper hydration
and sterilization prior to insertion. The instrument further
includes a plunger that travels along a channel within the support
device. After the biosensor is placed into the channel, the user
pushes the plunger causing the biosensor to move through the
channel and a hollow tube and into the patient subject. The present
invention also provides for packaging and storing a biosensor and
insertion device so that the biosensor is hydrated and sterile
prior to insertion.
Inventors: |
Walters; Steven J.;
(Ellicott City, MD) ; O'Connor; Casey J.;
(Gaithersburg, MD) |
Correspondence
Address: |
ROTHWELL, FIGG, ERNST & MANBECK, P.C.
1425 K STREET, N.W.
SUITE 800
WASHINGTON
DC
20005
US
|
Assignee: |
Sensors for Medicine and Science,
Inc.
Germantown
MD
|
Family ID: |
37055942 |
Appl. No.: |
11/447980 |
Filed: |
June 7, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60688371 |
Jun 8, 2005 |
|
|
|
Current U.S.
Class: |
604/164.01 ;
604/15; 604/38 |
Current CPC
Class: |
A61B 5/14503 20130101;
A61M 37/0069 20130101; A61B 17/3468 20130101; A61B 5/14532
20130101; A61B 5/6849 20130101 |
Class at
Publication: |
604/164.01 ;
604/015; 604/038 |
International
Class: |
A61M 5/178 20060101
A61M005/178; A61F 13/20 20060101 A61F013/20 |
Claims
1. An instrument for inserting a biosensor into a subject, said
instrument comprising: a support device, wherein said support
device contains at least one channel; a plunger, wherein said
plunger is slidable within said channel; a compartment, said
compartment having a top end and a bottom end and wherein said
compartment stores at least one of said biosensors; a plug, wherein
said plug is insertable into the top end of the compartment; a
hollow tube, wherein said hollow tube is attached to and extends
from one end of said support device, and wherein said channel,
plunger and hollow tube are configured such that said biosensor can
be expelled through said channel and hollow tube by said plunger
and into said subject.
2. The instrument of claim 1, wherein said compartment is a
hydration compartment which is configured to contain hydration
fluid for hydrating said biosensor.
3. The instrument of claim 2, wherein said hydration fluid is at
least one selected from the group consisting of: saline solution,
inorganic salts, buffer salts, preservatives, antimicrobial agents,
antibiotics, anti-inflammatory drugs, pharmacological compounds,
ionic surfactants, nonionic surfactants, thickening agents,
antioxidants, vitamins, and saccharides.
4. The instrument of claim 1, wherein said compartment contains a
breakable floor.
5. The instrument of claim 1, wherein said plug includes a slot
through which hydration fluid enters the compartment.
6. The instrument of claim 1, wherein said plug is made of a porous
material allowing fluid to enter said compartment.
7. The instrument of claim 1, wherein said plug is made of solid
material and creates a fluid-tight friction fit within the walls of
said compartment.
8. The instrument of claim 1, wherein said plug contains a hollow
chamber for containing hydrating fluid.
9. The instrument of claim 8, wherein said plug contains a
breakable bottom, wherein said breakable bottom breaks upon the
application of pressure by the user and releases said hydrating
fluid into the compartment.
10. The instrument of claim 1, wherein said support device is made
of a porous material allowing fluid to enter said compartment.
11. The instrument of claim 1, wherein said support device further
comprises a first element that identifies the backward most
position of the plunger within the channel.
12. The instrument of claim 1, wherein said support device further
comprises a second element identified when the plunger and
biosensor are positioned within the channel such that biosensor is
positioned at the distal end of the hollow tube.
13. The instrument of claim 1, wherein said support device further
comprises a third element that identifies the forward most position
of the plunger within the channel.
14. The instrument of claim 11, wherein said first element is a
ramp that is configured to engage an extension arm extending from
said plunger.
15. The instrument of claim 12, wherein said second element is a
ramp that is configured to engage an extension arm extending from
said plunger.
16. The instrument of claim 13, wherein said third element is a
ramp that is configured to engage an extension arm extending from
said plunger.
17. The instrument of claim 1, wherein said plunger contains at
least one extension arm.
18. The instrument of claim 1, wherein a hydration compartment can
be located opposite the extension arm.
19. The instrument of claim 1, wherein said plug is substantially
t-shaped and is configured to slidably engage the walls of said
compartment.
20. The instrument of claim 1, wherein said plug is shaped to
cradle said biosensor.
21. The instrument of claim 1, wherein said support device contains
ridges to allow for ergonomic gripping of said instrument.
22. The instrument of claim 1, wherein said support device contains
at least one slot allowing an extension arm extending from said
plunger to be moved back and forth along said support device.
23. The instrument of claim 1, wherein said plunger is made of a
guide wire.
24. The instrument of claim 1, wherein said plunger is made of
plastic.
25. The instrument of claim 1, wherein said hollow tube is a
needle.
26. The instrument of claim 1, wherein the distal end of said
hollow tube is beveled.
27. The instrument of claim 1, wherein said plunger is a
stylet.
28. The instrument of claim 1, wherein said plunger has a beveled
distal end matching a beveled end of said tube.
29. The instrument of claim 1, wherein said channel further
comprises a first breakable barrier and second breakable
barrier.
30. The instrument of claim 29, wherein said first and second
breakable barriers form part of the compartment for containing said
biosensor and said hydration fluid.
31. The instrument of claim 30, wherein the compartment is sealed
by a plug.
32. The instrument of claim 30, wherein said plug is configured to
secure said biosensor in said compartment.
33. A method for inserting a biosensor into a subject comprising
the steps of: providing an instrument for inserting a biosensor
into a subject comprising a support device containing at least one
channel, a plunger slidable within said channel, a compartment that
stores at least one biosensor, a plug configured to secure said
biosensor in said compartment, and a hollow tube which is attached
to and extends from a distal end of said support device; moving
said plunger to a first position of said support device to allow a
biosensor to enter said channel of said support device; pushing
said plug into said compartment contained in said support device to
secure said biosensor within said channel of said support device;
moving said plunger toward a second position of said support device
to indicate to the user that said biosensor has traveled through
said hollow tube and is about to enter said subject; moving said
plunger to a third position of said support device to indicate to
the user that said biosensor has exited said hollow tube and
entered said subject.
34. The method of claim 33, wherein said biosensor is initially
located within said compartment.
35. The method of claim 33, wherein said biosensor enters said
channel by gravity.
36. The method of claim 33, wherein ramps lock said plunger at said
positions.
37. A method for loading a biosensor into an insertion device
comprising the steps of: providing an instrument for inserting a
biosensor into a subject comprising a support device containing at
least one channel, a plunger slidable within said channel, a
compartment that stores at least one biosensor, a plug configured
to secure said biosensor in said compartment, and a hollow tube
which is attached to and extends from a distal end of said support
device; moving said plunger to a first position of said support
device to allow room for said biosensor to be placed in the distal
end of the hollow tube of said support device; placing said
biosensor inside said distal end of said hollow tube; moving said
plunger through said channel to a second position of said support
device to allow said biosensor to travel through said channel and
enter said compartment; moving said plunger to a third position of
said support device to allow said biosensor to be secured between
said plug and said plunger.
38. The method of claim 37, wherein said biosensor rests against a
distal end of said plunger when said plunger moves to said second
position.
39. The method of claim 37, wherein said biosensor enters said
compartment by gravity.
40. A package assembly for storing a biosensor and apparatus for
inserting a biosensor into a subject comprising: a package body
shaped to contain at least one insertion instrument within a cavity
of said package body; a sterile barrier sealed to said package
body, wherein said sterile barrier contains at least one septum
which allows said cavity to be filled with fluid, and wherein said
barrier is sealed to said body so as to prevent fluid from leaking
from said cavity.
41. The package assembly of claim 40, wherein said package body is
composed of plastic.
42. The package assembly of claim 40, wherein said sterile barrier
is at least one selected from the group consisting of: plastic,
paper or aluminum foil.
43. The package assembly of claim 40, wherein said septum prevents
fluid from leaking out of said cavity.
44. The package assembly of claim 40, wherein said package body is
shaped to secure said instrument.
45. The package assembly of claim 40, wherein said instrument is
secured to said package body by friction fitting.
46. The package assembly of claim 40, wherein said septum is
configured to be pierced by a syringe.
47. The package assembly of claim 40, wherein said package assembly
further comprises side walls extending form a front portion of said
package body.
48. The package assembly of claim 47, wherein said side walls
further comprise flap portions that can be engaged together.
49. The package assembly of claim 48, wherein said package assembly
wherein said side walls and flap portions enable the package
assembly to stand vertically.
50. The package assembly of claim 48, wherein said flap portions
further comprise slotted clasps.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of provisional
application No. 60/688,371, filed Jun. 8, 2005, and incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the invention
[0003] The present invention relates generally to the insertion of
subcutaneous biosensors and, more specifically, to a device and
method for implanting a biosensor at a selected site within the
body of a patient.
[0004] 2. Discussion of Related Art
[0005] Biosensors have been increasingly used to monitor physical
characteristics of human and animal subjects. Such biosensors can
be placed underneath the skin of a subject and used to measure, for
example, blood glucose levels. An example of such a biosensor can
be found in U.S. Pat. No. 6,330,464, the disclosure of which is
incorporated herein by reference. There, an optical-based biosensor
is disclosed which is capable of detecting the presence or amount
of analyte in blood. Of course, such biosensors must be compatible
with human and animal tissue and must maintain their integrity
within moisture-rich environments. Oftentimes, the exterior of the
biosensors are made of materials sensitive to the drying effects of
air and must be constantly hydrated in order to maintain device
integrity. For example, U.S. Pat. No. 6,330,464 discloses optical
based sensors with fluorescent indicator molecules distributed
throughout a matrix layer coated on the exterior surface of the
sensor body. Of course, the biosensors must also be kept sterilized
prior to insertion into the subject in order to avoid
infection.
[0006] Certain insertion devices are known in the art for
implanting sensors subcutaneously into subjects. For example, U.S.
Pat. No. 4,787,384 discloses a system and device for implanting a
solid identification marker underneath the animal's skin that
allows scientists to mark a given animal for tracking or testing
purposes. However, this system has several disadvantages. First,
the system contains at least one projection extending into the
hollow tube that is configured to trap the marker in place by
friction fitting. Such a projection could damage the coating of a
biosensor, especially in the case where the exterior surface of the
biosensor is coated with an indicator chemistry and the like. Also,
the disclosure of U.S. Pat. No. 4,787,384 does not teach or suggest
providing for consistent hydration of the marker for the period
prior to insertion. Accordingly, the disclosure provides no means
of hydrating a biosensor.
[0007] Insertion devices for implanting sensors are also described
in, among others, U.S. Pat. Nos. 6,936,006, 5,074,318 and
5,002,548.
[0008] What is desired, therefore, is a system and method to
overcome at least some of the disadvantages of the prior art and to
effectively store and insert sterilized biosensors into subjects
while preserving biosensor integrity.
SUMMARY OF THE INVENTION
[0009] In one aspect, the present invention provides an insertion
device having a support device including a channel that houses a
slidable plunger. The plunger has an extension arm that is attached
to the plunger and extends outside of the support device through a
slot allowing the user to slide the plunger back and forth within
the channel. In one embodiment, the user can monitor the position
of the plunger by viewing the location of the extension arm
relative to a plurality of ramps located on the support device.
[0010] The insertion device in accordance with one aspect of the
present invention also provides a hydration storage compartment for
the storage of the biosensor preferably in a sterile, hydrating
environment. In one embodiment, the hydrating compartment includes
a plug that resides above the biosensor which enables the biosensor
to be securely maintained within the hydrating compartment. In
another embodiment, the biosensor is sandwiched between the plug
and plunger as it resides in the hydration storage compartment. In
a preferred embodiment, the plug contains a slot that allows fluid
to enter and exit the hydration storage compartment so that the
biosensor is properly hydrated during storage and prior to
insertion into the patient.
[0011] The insertion device according to one aspect of the
invention also includes a hollow tube having dimensions that allow
the plunger and biosensor to travel within the hollow tube. In one
embodiment, a distal end of the hollow tube is configured such that
it can be inserted into the skin of the subject. Also in accordance
with this embodiment, the plunger, biosensor and hollow tube are
configured such that the biosensor can be driven out of the distal
end of the hollow tube by the plunger and into the desired location
in the subject.
[0012] In another aspect, the present invention provides at least
one method for inserting the biosensor into the subject. In the
preferred method, the user places his/her thumb, for example, on
the extension arm and moves the extension arm in proximity to the
first ramp, which allows the biosensor to be located in the channel
of the hollow tube. The user then pushes the plug down toward the
channel to secure the biosensor into the channel. The user then
pushes the plunger toward the distal end of the apparatus by using
the extension arm to a position in proximity to the second ramp.
The user then continues to push the plunger over the third ramp
indicating to the user that the biosensor has exited the distal end
of the hollow tube and has entered the subject.
[0013] In another aspect, the present invention provides a package
assembly for storing the insertion device so that the insertion
device and biosensor remain sterile and properly hydrated prior to
use. In a preferred embodiment, the package assembly containing the
insertion device is sealed with a sterile barrier allowing the
insertion device and biosensor to be sterilized. In another
embodiment, the sterile barrier contains a septum through which
hydrating fluid is permitted to enter the sealed, sterilized
package assembly, thereby allowing the insertion device and
biosensor to be hydrated. In an additional embodiment, the package
includes flaps and slotted clasps extending from the back of the
package which enables the package to stand vertically. The vertical
orientation of the package advantageously allows the sterile
hydrating fluid to penetrate the hydration chamber and bathe the
biosensor prior to use without leaking from the package cavity.
[0014] The above and other features and advantages of the present
invention, as well as the structure and operation of preferred
embodiments of the present invention, are described in detail below
with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings, which are incorporated herein and
form part of the specification, help illustrate various embodiments
of the present invention and, together with the description,
further serve to explain the principles of the invention and to
enable a person skilled in the pertinent art to make and use the
invention. In the drawings, like reference numbers indicate
identical or functionally similar elements.
[0016] FIG. 1a shows an exploded view of the insertion device in
accordance with one aspect of the present invention.
[0017] FIG. 1b shows a top view of the insertion device of FIG.
1a.
[0018] FIG. 1c shows a side cutaway view of the insertion device of
FIG. 1a.
[0019] FIG. 2 shows the insertion device of FIG. 1 and illustrates
the biosensor in the hydration storage compartment in accordance
with one aspect of the present invention.
[0020] FIG. 3 shows the insertion device of FIG. 1 and illustrates
plunger extension positioned such that the biosensor is permitted
to move into the channel in accordance with one aspect of the
present invention.
[0021] FIG. 4 shows the insertion device of FIG. 1 and illustrates
the positioning of the biosensor in the channel in accordance with
one aspect of the present invention.
[0022] FIG. 5 shows the insertion device of FIG. 1 and illustrates
the positioning of the biosensor toward the distal end of the
hollow tube in accordance with one aspect of the present
invention.
[0023] FIG. 6 shows the insertion device of FIG. 1 and illustrates
the biosensor being ejected from the end of the hollow tube in
accordance with one aspect of the present invention.
[0024] FIG. 7a illustrates a front view of a sterile package
assembly for storing an insertion device in accordance with another
aspect of the present invention.
[0025] FIG. 7b illustrates a front view of a sterile package
assembly for storing an insertion device with a sterile barrier
layer and septum in accordance with another aspect of the present
invention.
[0026] FIG. 7c illustrates a side view of the sterile package
assembly for storing an insertion device in accordance with another
aspect of the present invention.
[0027] FIG. 7d illustrates a rear view of the sterile package
assembly for storing an insertion device in accordance with another
aspect of the present invention.
[0028] FIG. 7e illustrates a clasp assembly of the sterile package
assembly for storing an insertion device in accordance with another
aspect of the present invention.
[0029] FIG. 8 shows a side cutaway view of an insertion device in
accordance with another embodiment of the present invention.
[0030] FIGS. 9a and 9b show the hydration chamber of the insertion
device having a breakable floor in accordance with another
embodiment of the present invention.
[0031] FIGS. 10a and 10b show the channel of the insertion device
having first and second breakable barriers in accordance with
another embodiment of the present invention.
[0032] FIG. 11 shows the plug of the insertion device as being
hollow and having a breakable bottom in accordance with another
embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0033] The present invention includes an apparatus and method for
implanting a biosensor (such as, for example, a biosensor for
measuring the presence or amount of blood glucose levels or other
analytes of interest) in a patient subject. The present invention
also includes an apparatus for packaging and storing the instrument
and biosensor so as to ensure hydration and sterility prior to
use.
[0034] Referring to FIGS. 1a, 1b and 1c, in one embodiment of the
present invention, the apparatus 100 includes a hollow tube 102
having an entrance and exit opening. The hollow tube 102 is
supported by a support device 104. In a preferred embodiment, the
support device 104 contains a biosensor hydration storage
compartment 110 which is configured to store the biosensor 118 and
hydrating solution.
[0035] A plunger or core 108 is located within the support device
104 and is configured to slide within a channel 106 in the support
device 104. The channel 106 is preferably a circular channel but
also may be configured to have different shapes, such as, for
example, square, rectangle or triangle. The plunger 108 is also
configured to slide within the hollow tube 102. The channel 106 is
preferably concentric with the hollow tube 102. The plunger 108 in
one embodiment has a forward and backward position relative to the
support device 104. The plunger 108 may include an extension or arm
108a which allows a user of the apparatus 100 to move the plunger
108 forward and backward in the apparatus 100 along the
longitudinal axis of the channel 106 and hollow tube 102. A slot
116 or the like may be provided in the support device 104 for
allowing the extension 108a to move freely along the support device
104.
[0036] In one embodiment, the present invention may include one or
more elements that facilitate limiting the motion of the plunger
108 and identifying the location of the plunger 108 along the
channel 106 and hollow tube 102. As shown in FIGS. 1a, 1b and 1c,
the present invention may include any or all of ramps 112a, 112b
and 112c provided on the support device 104. The ramps 112a, 112b
and 112c are configured to contact the extension arm 108a in order
to limit the motion of the plunger 108 and indicate to the user the
location of the biosensor 118 within the channel 106 and hollow
tube 102. For example, in one embodiment, ramp 112c indicates the
backward most location of the plunger 108 and, in a preferred
embodiment, acts as a stop to prevent further backward movement of
the plunger 108, as reflected in FIGS. 3 and 4. Ramp 112b also may
be used, in accordance with one embodiment, to indicate that the
biosensor is located at the distal end of the hollow tube 102, as
illustrated in FIG. 5. Ramp 112a also may be used, in accordance
with one embodiment, to indicate that the biosensor has been
ejected from the end of the hollow tube 102 and into the patient
subject, as illustrated in FIG. 6.
[0037] In accordance with a preferred embodiment, the support
device 104 may include a biosensor hydration storage compartment
110 with hydration storage compartment plug 113 which is configured
to be inserted into the storage compartment 110 and positioned
adjacent to the channel 106. The hydration storage compartment plug
113 may have one or more slot openings 113a allowing hydration
fluid to enter the hydration storage compartment 110. The plug 113
secures the biosensor 118 within the apparatus 100 hydration
storage compartment 110 while the biosensor 118 is bathed in
hydration fluid. In accordance with another aspect of the present
invention, the hydration chamber may also receive one or more
sterilization fluids, such as, for example, Cidex sterilization
fluid.
[0038] In accordance with a preferred embodiment, the biosensor 118
is capable of being exposed to sterilizing gas, such as ethylene
oxide (ETO) gas, while present within the apparatus 100 and
hydration storage compartment 110.
[0039] The support device 104 of the present invention may be
constructed of any suitable material such as, for example, an
injected molded plastic. The hollow tube 102 may be constructed of
a suitable, substantially rigid material such that the hollow tube
may be inserted into the skin of the patient subject. In one
embodiment, the hollow tube 102 is a needle or the like. In another
aspect of the present invention, the hollow tube 102 has a distal
end which may be beveled or tapered to facilitate insertion into
the patent subject. The support device 104 also may have multiple
ridges 114 positioned on the bottom surface for ergonomic feel
during use.
[0040] The plunger 108 can be a guide-wire, plastic injected molded
piece, stylet, or the like and preferably includes a beveled or
tapered distal end 108b (See FIGS. 1a, 1b and 1c). In one
embodiment, the beveled or tapered distal end of the plunger
matches the beveled or tapered distal end of the hollow tube 102.
This configuration may help to prevent unwanted coring of body
tissue during the insertion process.
[0041] FIG. 2 illustrates the insertion device according to one
embodiment of the present invention where the biosensor 118 is
securely positioned within the hydration compartment 110 by plug
113. When the extension 108a is positioned in proximity to the
third ramp 112a, the plunger 108 will serve as a "floor" for the
biosensor hydration storage compartment 110, trapping the biosensor
118 in this location when the plug 113 is secured above the
biosensor 118.
[0042] FIG. 3 illustrates the insertion device according to one
embodiment of the present invention wherein the plunger extension
108a is positioned in the backward most position in proximity to
first ramp 112c. The plunger may be moved to this position by the
user by sliding extension 108a in proximity to the first ramp 112c.
At this backward most position, the distal end of the plunger 108
moves beyond the location of the hydration storage compartment 110.
In this position, the biosensor 118 no longer has the plunger 108
as a "floor" and, as a result, moves into the channel 106 in front
of the distal end of plunger 108, as illustrated in FIG. 4. In one
embodiment, also illustrated in FIG. 4, the hydration storage
compartment plug 113 is then pushed downward, ensuring that the
biosensor 118 is firmly positioned within the circular channel 106
and ready for travel along the circular channel 106 and hollow tube
102 and into the subject.
[0043] Referring to FIG. 5, the extension 108a is illustrated in an
advanced position toward the second ramp 112b. In this position,
the distal end of plunger/core 108 contacts the biosensor 118 and
pushes the biosensor 118 through the circular channel 106 and into
the hollow tube 102. When the extension 108a reaches the second
ramp 112b, this alerts the user that the biosensor 118 is at the
end of the hollow tube 102. At that point, the distal end of the
plunger 108 is at its pre-insertion position 102a within the hollow
tube 102.
[0044] FIG. 6 illustrates the insertion device according to one
embodiment of the present invention wherein the plunger extension
108a positioned in the forward most position in proximity to the
third ramp 112a. As the extension 108a is moved by the user from
the second ramp 112b to the third ramp 112a, the plunger 108
continues its movement toward the distal end of the hollow tube 102
thereby causing the biosensor 118 to be ejected into the patient
subject. In one embodiment, as the plunger 108 moves toward the
distal end of the hollow tube 102, the support device 104 will move
in the opposite direction. This is accomplished, for example, when
the thumb (resting on the extension 108a) and the forefinger
(resting on the ridges 114) move in opposite directions. The
plunger extension 108a will come in contact with the end of the
slot 116 in the support device 104 that will act as a stop when
moving the biosensor 118 toward the distal end of the hollow tube
102, signifying ejection of the biosensor 118. In accordance with
another aspect of the present invention, the plunger 108 may be
restricted from moving in the backward direction thereby ensuring
the biosensor 118 is fully ejected from the apparatus 100. The tip
of the hollow tube 102 is preferably then removed from the
subject.
[0045] Referring back to FIG. 1a, in accordance with one
embodiment, the biosensor 118 may be loaded into the hydration
storage compartment 110 of the apparatus 100 with the extension
108a positioned in proximity to the third ramp 112a. When the
biosensor 118 is loaded into the apparatus 100, the hydration
storage compartment plug 113 traps the biosensor 118 in the
hydration storage compartment 110. The plug 113 remains secured
within the walls of the hydration storage compartment 110, in one
embodiment, by virtue of friction fitting or other equivalent
methods known in the art. In accordance with another embodiment of
the present invention, the biosensor may be loaded into the
hydration storage compartment 110 when the plunger extension 108a
is in the back position in proximity to first ramp 112c. In this
embodiment, the plug 113 is fully inserted into the hydration
chamber 110 thereby securing the biosensor within the channel
106.
[0046] As described above, the ramps 112a, 112b and 112c may be
provided on the surface of the support device 104 to limit the
movement of the extension 108a and plunger 108 and to signal to the
user the location of the plunger 108 within the channel 106. For
example, the third ramp 112a may be provided toward the distal end
of the support device 104 to temporarily lock the plunger/core 108
in place during loading, assembly, shipment and storage of the
apparatus 100.
[0047] In the preferred embodiment, referring to FIG. 3, the first
ramp 112c, may be a ribbon protruding from the surface of the
support device 104, preventing the extension 108a from moving
beyond the backward most position. For example, in one embodiment,
the first ramp 112c may be a ribbon of material fixed into and
extending from the support device 104 at the backward most position
of the extension 108a and arching back toward the rear of the
support device 104, as shown in FIG. 3. The first ramp 112c thereby
becomes an obstacle to movement for the extension 108a and plunger
108, and also indicates to the user the location of the plunger 108
and biosensor 118. The first ramp 112c need not be a ribbon, but
may be configured as any of a number of protrusions extending from
the support device 104 preventing the extension 108a from moving
beyond its backward most position. The protrusions can be made of
any material known in the art, including, for example, plastic
and/or metal. The first ramp 112c may also be a part of the support
device 104, whereas a plastic mold of the support device 104 could
include such a protrusion.
[0048] In one embodiment of the invention, as illustrated in FIGS.
5 and 6, the second and third ramps 112b and 112a can be created
using a ribbon of material extending from the support device 104 in
proximity to the distal end of the support device 104. The ribbon
creating the second and third ramps 112b and 112a, in one
embodiment, is configured in such a way so as to allow the
extension 108a to come to a stop at the second ramp 112b, but to
allow the extension to ride up the second ramp 112b, over the
ribbon body, and down the third ramp 112a, temporarily securing the
extension 108a and plunger 108 in a set position after the
biosensor 118 has been expelled. The ribbon can be configured in
such a way so as to allow the user to move the extension 108a back
up the third ramp 112a, over the ribbon body, and down the second
ramp 112b. The second and third ramps 112b and 112a need not be
created by a ribbon, but may be any of a number of protrusions
extending from the support device 104. The protrusions can be made
of any material known in the art, including plastic and/or metal.
The protrusions forming second and third ramps 112b and 112a may
made as integral parts of the support device 104 or may be affixed
to the support device 104 by known means, such as an adhesive.
[0049] In other embodiments, the ramps 112a, 112b and 112c need not
be protrusions, but may be notches or the like in the support
device 104, which are configured to engage the extension 108a at
set positions and indicate to the user the location of the plunger
108 and biosensor 118.
[0050] The hydration storage compartment 110 is preferably sized to
house only one biosensor, but the invention is not meant to be
limited to such an embodiment. In alternative embodiments (not
shown), the hydration storage compartment 110 may be constructed to
hold multiple biosensors. In still other embodiments, the support
device 104 may be configured to have multiple hydration storage
compartments 110 along the surface of support device 104.
[0051] The hydration storage compartment 110 can be fabricated from
a porous material or include holes to allow liquid to pass into the
chamber from the outside, such as through slot 113a in plug 113. In
one embodiment, it is intended that the biosensor 118 be placed
within the hydration storage compartment 110 of the apparatus 100
prior to packaging, as illustrated in FIG. 2. In this embodiment,
it is desired that the biosensor 118 be treated, hydrated,
sterilized or the like, after the biosensor 118 is inserted into
the hydration storage compartment 110. Therefore, any number of
hydration methods known in the art can be used to ensure that fluid
enters the hydration storage compartment 110.
[0052] In another embodiment of the present invention, referring to
FIGS. 9a and 9b, the hydration storage compartment 110 contains
hydrating fluid and a breakable floor 120. In this embodiment, the
breakable floor 120 prevents the biosensor 118 and fluid from
entering the channel 106 prior to use of the device. In this
embodiment, the hydration storage compartment 110 is defined by the
walls of the device 115, the breakable floor 120, and the plug 113.
The plug 113, in one embodiment, is non-porous and creates a
fluid-tight seal within the compartment 110, thereby preventing the
fluid from leaking outside the compartment 110. In this embodiment,
the user moves the plunger extension 108a back to the first ramp
112c and applies pressure to the plug 113 so that the biosensor 118
breaks through the breakable floor 120 and enters the channel 106
along with the hydrating fluid. The breakable floor 120 can be made
of any number of materials known in the art that can hold fluid and
break open upon suitable pressure without fragmenting, such as
aluminum foil, rubber and/or plastic.
[0053] In another embodiment of the present invention, referring to
FIGS. 10a and 10b, the biosensor 118 and fluid are placed within a
hydration chamber 126 which is defined by the channel 106 at a
bottom end, side walls including a first breakable barrier 122 and
a second breakable barrier 124 located within the channel 106, and
the plug 113 at the top. The plug 113 secures the biosensor and
seals the fluid within the channel 106 prior to insertion. In this
embodiment, the plunger extension 108a begins at the position
located at the first ramp 112c and, when moved forward, the distal
end of the plunger 108 pierces the first breakable barrier 122, and
forces the biosensor 118 to break through the second breakable
barrier 124 as the biosensor 118 travels down the hollow tube 102
and into the subject. This occurs while the plunger extension 108a
moves past the second ramp 112b to the third ramp 112a. In this
embodiment, the biosensor 118 and fluid can be loaded into the
channel 106, with the plug 113 acting as the roof of this hydration
chamber 126, securing the biosensor 118 and preventing the fluid
from escaping the chamber 126 prior to use. The breakable barriers
can be made of any number of materials known in the art that can
hold fluid and break open upon suitable pressure without
fragmenting, such as aluminum foil, rubber and/or plastic.
[0054] In another embodiment, as shown in FIG. 11, the plug 113 can
be configured to have a hollow chamber for containing the hydration
fluid. In this embodiment, the plug 113 may be designed in such a
way as to have a breakable bottom 130 so that fluid can be released
to hydrate the biosensor 118 when the user applies pressure to the
plug. That is, in various configurations, the plug 113 can rest
atop the biosensor 118 before use. When the user applies pressure
to the plug 113, the floor 130 of the plug 113 bursts open,
releasing the fluid stored within the plug 113, bathing the
biosensor 118 with hydrating fluid in the process. Accordingly, the
breakable floor 130 can be made of any number of materials known in
the art that can hold fluid and break open upon suitable pressure
without fragmenting, such as aluminum foil, rubber and/or plastic.
The plug 113 in accordance with this embodiment can be used in
conjunction with the apparatus 100 in accordance with any of the
embodiments discussed above.
[0055] Referring to FIG. 8, in another embodiment, the biosensor
118 can be loaded into the hydration storage compartment 110
located on the underside of the apparatus 100 opposite the
extension arm 108a. This can be accomplished, for example, with a
plug 113 designed to cradle the biosensor 118. In other words, for
any and all embodiments, the plug can be designed in a multitude of
ways depending on the needs that arise from the configuration and
location of the storage compartment 110 on the apparatus 100. In
this embodiment, it would be desirable to have the plug 113 shaped
to cradle the biosensor 118 for easy loading of the biosensor 118
from the underside of the apparatus 100, thereby lowering the risk
of having the biosensor 118 fall to the floor during biosensor 118
loading. In an alternative embodiment for loading the biosensor
into the apparatus 100, the apparatus 100 can be flipped so that
the storage compartment 110 is on top and the user can load the
biosensor 118 into the compartment 110 and secure the biosensor 118
with the plug 113. The user can then flip the apparatus 100 back so
that the storage compartment 110 is on the bottom, and ready for
the insertion process to take place.
[0056] In this arrangement, the plunger 108 would serve as a "lid"
to the hydration storage compartment 110 as opposed to a "floor" as
described in other embodiments. Here, the plug 113 would serve as
the "floor", thereby trapping the biosensor 118 in the hydration
storage compartment 110. Similar to the other embodiments described
above, once the distal end of the plunger 108 passes the hydration
storage compartment 110 when extension 108a is located in proximity
to the first ramp 112c, the biosensor 118 no longer has a
restriction to entering into the channel 106 and in front of the
distal end of plunger 108. Once in this position, the apparatus 100
can be rotated sufficiently (i.e. flipped so that the hydration
storage compartment 110 is on top of the apparatus 100) to allow
the biosensor to fall into the circular channel 106 by gravity. The
plug 113 could then be pushed toward the channel 106 to secure the
biosensor 118 into the channel 106.
[0057] Also referring to FIG. 8, the biosensor can be loaded into
the apparatus 100 from either end. In one embodiment, the biosensor
118 can be loaded into the distal end of the hollow tube 102 when
the extension 108a is in proximity to the second ramp 112b. The
apparatus 100 can then be turned vertically so that once the
biosensor 118 is inserted into the hollow tube 102 gravity causes
the biosensor 118 to rest against the distal end of plunger 108
when within the tube 106. The extension 108a can then be moved
backward to the first ramp 112c, indicating to the user that the
biosensor is in proximity to the hydration storage compartment 110.
The user can then lower the apparatus 100 horizontally so that the
biosensor 118 can fall by gravity into the hydration storage
compartment 110 which resides in a position such that it is at the
bottom of the apparatus 100 (as shown in FIG. 8). The extension
108a can then be moved to the third ramp 112a prior to insertion,
securing the biosensor 118 between the plunger 108 and plug 113.
The biosensor 118 can be hydrated in a substantially similar way as
described above including pores or slot openings in the support
device 104, plug 113 or chamber 110.
[0058] In accordance with another aspect of the present invention,
referring to FIGS. 7a-7e, a package assembly is provided for
storing the insertion device. FIG. 7a illustrates a package
assembly 700 according to one embodiment in an unfolded and loaded
configuration. In particular, the package assembly 700 includes a
package assembly body 714 that has an apparatus cavity 709
configured to hold the apparatus 100 containing the biosensor 118
in the hydration storage compartment 110. The cavity 709, in a
preferred embodiment, is also configured to hold a sufficient
volume of fluid so that the fluid can enter the hydration storage
compartment 110 and bathe the biosensor 118, as illustrated in FIG.
7a. Typically, the volume of fluid necessary to bathe the biosensor
118 will be enough to fill the cavity surrounding the distal end of
the hollow tube 102 and up to the location of the third ramp 112a
when the device is in the package 700 and the package 700 is
standing in an upright position (as described below).
[0059] In one embodiment, the package assembly body 714 is shaped
to secure the apparatus 100 so that the apparatus 100 remains
substantially in place even if the package is otherwise moved. The
apparatus 100 may be secured in the package assembly body 714 in
any number of ways, including a friction fit mold. For example, as
shown in FIG. 7a, the package assembly body 714 is fashioned to
conform to the shape of the apparatus 100, allowing the apparatus
100 to remain secure within the package assembly 700. In one
embodiment, engagement elements 713 frictionally engage the
apparatus to secure it in place. The package assembly 700 can be
made of any suitable material known in the packaging arts, such as
plastic including, for example, thermoform plastic.
[0060] Referring to FIG. 7b, the package assembly 700 containing
the apparatus 100 is sealed with a sterile barrier 704 to maintain
the sterility of the apparatus and the biosensor 118. The sterile
barrier 704 can be made of any suitable material, such as, for
example, woven plastic (such as Tyvek.RTM.), paper or aluminum
foil. In accordance with a preferred embodiment of the invention,
the sterile barrier 704 is provided with a septum 702 which allows
the cavity 709 to be filled with hydration and/or sterilization
fluid while maintaining the sterility of the package and sterile
barrier 704. In one embodiment, saline is injected through the
septum 702 with, for example, a syringe. This allows the biosensor
118 to be hydrated while maintaining sterility within the package
700. The sterile barrier 704 is preferably attached to the face 712
of the package body 714 in such a way so as to create a fluid-tight
seal around the outer edge of the face 712 of the package body 714.
This can be accomplished with any number of glues or sealants known
to persons skilled in the art.
[0061] Any number of hydration fluids can be used, such as, for
example, one or more of the following: (1) inorganic salts such as
sodium chloride, potassium chloride, calcium chloride, or magnesium
chloride; (2) buffer salts such as phosphate, HEPES, carbonate, and
citrate; (3) preservatives such as EDTA; (4) antimicrobial agents
such as sodium azide, sulfites, and benzoates; (5) antibiotics,
anti-inflammatory drugs and other pharmacological compounds; (6)
ionic and nonionic surfactants; (7) thickening agents that can be
used to increase the viscosity of aqueous solutions such as
glycerol, polyethylene glycols, gelatin, agar and pectin; (8)
antioxidants such as BHT, BHA; (9) vitamins such as C and E,
flavonoids; and (10) Saccharides such as glucose, fructose, and
sucrose. This list should not be construed to be exhaustive, but is
meant to illustrate the vast array of fluids that could be used to
hydrate the biosensor.
[0062] In accordance with another aspect of the present invention,
the package 700 is designed to store the apparatus 100 in such a
way so as to allow constant hydration of the biosensor 118 while
the biosensor 118 is contained within the hydration storage
compartment 110. In one embodiment, as illustrated in FIG. 7c, the
package 700 stands vertically, allowing the sterile fluid to
penetrate the hydration chamber 110 and bathe the biosensor 118.
Fluid may penetrate the hydration chamber 110 in any number of
ways, including pores or slot openings in the support device 104,
plug 113 or chamber 110, as described above.
[0063] In one embodiment, the package assembly 700 is configured in
a vertical orientation by providing side walls 706 and 707 attached
to the package assembly body 714. Side walls 706 and 707 are shown
in FIG. 7a in a flat, unfolded configuration. Referring to FIGS.
7b-d, the side walls 706 and 707 are shown in a folded
configuration. Referring to FIG. 7d, in order to allow the sterile
package 700 to remain standing in accordance with one embodiment,
package flaps 706 are folded away from the plane created by the
face 712 of the package assembly 700 and sterile barrier 704. The
flaps 706 are folded so as to connect with one another via slotted
clasps 708, as illustrated in FIGS. 7d and 7e. This allows the
package 700 to stand vertically thereby ensuring that the
sterilization fluid collects in the cavity 709 so as to engulf the
hydration storage compartment 110 of the apparatus 100 and thereby
bathe the biosensor 118 prior to insertion into the subject.
[0064] While slotted clasps are illustrated as being formed from
portions of the side walls 706 and 707, the side walls can be
secured by other means. For example, the package assembly can be
provided with one or more back walls or clasps attached, for
example, to one or both of side walls 706 and 707. In another
embodiment, clasps are not formed from the side wall material but
are, instead, attached to the side walls in any known manner, such
as an adhesive.
[0065] Preferably, the apparatus 100, package 700, barrier 704,
septum 702 and other relevant parts are manufactured of such
materials that allow them to be readily disinfected and/or
sterilize by conventional means.
[0066] While various embodiments/variations of the present
invention have been described above, it should be understood that
they have been presented by way of example only, and not
limitation. Thus, the breadth and scope of the present invention
should not be limited by any of the above-described exemplary
embodiments, but should be defined only in accordance with the
following claims and their equivalents.
* * * * *