U.S. patent application number 16/814544 was filed with the patent office on 2021-01-07 for passive safety i.v. blood collection catheter.
This patent application is currently assigned to MMI, LLC. The applicant listed for this patent is MMI, LLC. Invention is credited to Donald L. Millerd.
Application Number | 20210000401 16/814544 |
Document ID | / |
Family ID | |
Filed Date | 2021-01-07 |
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United States Patent
Application |
20210000401 |
Kind Code |
A1 |
Millerd; Donald L. |
January 7, 2021 |
PASSIVE SAFETY I.V. BLOOD COLLECTION CATHETER
Abstract
Apparatus and methods for a single, handheld device that
provides for both insertion of a catheter and collection of a
fluid. Some embodiments further include a needle that assists in
the insertion of the catheter into a blood vessel, and which
includes a retraction feature that protects the user from an
accidental needle stick when the device is ready for disposal.
Still further embodiments include a protective cover that prevents
a user from accidentally being stuck by a second needle used for
the introduction of the patient's blood into a collection
device.
Inventors: |
Millerd; Donald L.; (San
Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MMI, LLC |
San Diego |
CA |
US |
|
|
Assignee: |
MMI, LLC
San Diego
CA
|
Appl. No.: |
16/814544 |
Filed: |
March 10, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15280040 |
Sep 29, 2016 |
10758167 |
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16814544 |
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14068630 |
Oct 31, 2013 |
9456775 |
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15280040 |
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61874771 |
Sep 6, 2013 |
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Current U.S.
Class: |
1/1 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61M 5/178 20060101 A61M005/178; A61B 5/154 20060101
A61B005/154; A61M 25/00 20060101 A61M025/00; A61M 5/32 20060101
A61M005/32; A61M 25/06 20060101 A61M025/06 |
Claims
1-49. (canceled)
50. A method for automatically retracting a needle from a catheter,
comprising: providing a first hollow needle extending in a distal
direction from the lumen of a catheter; providing a flowpath from
the first hollow needle to a second hollow needle, the second
hollow needle being aligned with a second axis that is laterally
displaced from the first axis of the first hollow needle; extending
the tip of the second hollow needle through an aperture in a
slidable cover; retracting the first hollow needle from the lumen
in a proximal direction along the first axis; and automatically
sliding the cover along the second axis during said retracting.
51. The method of claim 50 which further comprises separating the
first hollow needle from the catheter before said retracting.
52. The method of claim 50 wherein said automatically sliding the
cover is to a position that is proximal of the tip.
53. The method of claim 50 wherein said extending is in a proximal
direction.
54. The method of claim 50 which further comprises automatically
locking the cover in a position after said automatically
sliding.
55. The method of claim 50 wherein the flowpath is flexible.
56. The method of claim 50 wherein said automatically sliding the
cover is by pushing the cover with the retracting first hollow
needle.
57. The method of claim 50 wherein said automatically sliding the
cover is by expanding a coiled spring.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of priority to U.S.
Provisional Patent Application Ser. No. 61/874,771, filed Sep. 6,
2013, incorporated herein by reference.
FIELD OF THE INVENTION
[0002] Various embodiments of the present invention pertain to
methods and apparatus for injecting medicaments into a patient and
also taking a blood sample from a patient, and including
embodiments having a needle retractable to within a guarded chamber
after usage.
BACKGROUND OF THE INVENTION
[0003] Fluid access into the vasculature of a patient may be
necessary for any of several different reasons. Such access may be
necessary in order to place medicaments within the patient's
circulatory system, or to remove blood or other fluids from the
patient for subsequent analysis. For either reason, such access is
generally established with the vasculature of the patient, such as
a vein. When an infusion protocol is involved that requires
periodic injections, an established fluid access site that can be
repetitively used for a sequence of different injections may be
required. Establishing such an access site, however, can be
problematic.
[0004] Often, such access is established by a needle extending
through the lumen of a catheter, such that both the tip of the
needle and the tip of the catheter are located within the patient's
vein. The needle is subsequently withdrawn, and the infusion or
injections occur after a reservoir and tubing are attached to the
luer of the catheter. In yet other situations, it is desirable to
obtain blood or other bodily fluid from the patient for subsequent
analysis. In such cases the blood may be drawn through a hollow
needle inserted into the patient's vasculature or by connection of
a blood collection reservoir to an existing, inserted catheter.
[0005] Currently, these two functions of introduction of a
medicament into the patient, and withdrawal of blood from the
patient, are performed in a series of multiple operations by a
medical professional, using a plurality of different devices. The
current requirement for multiple steps in a procedure using
multiple devices provides multiple opportunities for error and
multiple risks to the patient. Further, the use of multiple devices
requires the clinic administrator to maintain an inventory of many
separate devices. Such an inventory is not just expensive, but by
itself leads to further risk to the patient if the wrong devices
are stocked or used.
[0006] Yet further risks are incurred by the medical practitioner,
since the devices used for introduction of a medicament or
withdrawal of patient blood each can include sharp tipped needles.
Since these needles are exposed to the patient's blood, there is a
possibility of the medical practitioner being accidentally stuck by
a used needle, with the subsequent exposure of the practitioner to
the ailment of the patient.
[0007] What is needed are devices that address one or more of the
aforementioned issues. Various embodiments of the present invention
do this in novel and unobvious ways.
SUMMARY OF THE INVENTION
[0008] Various aspects of different embodiments of the present
invention pertain to the combination of catheter placement for
repeat usage, with patient fluid collection at the time of initial
placement of the catheter.
[0009] Yet other embodiments include aspects directed toward safety
features that protect a medical professional from being pierced
accidentally by the needle used to introduce the catheter into the
patient's circulatory system.
[0010] Yet other embodiments include aspects directed toward
protection of the medical professional from being accidentally
pierced with a needle used to place the patient's blood within a
collection vial.
[0011] One aspect of the present invention pertains to an apparatus
for collecting blood in a container and connecting to intravenous
tubing. Some embodiments include a main body including a collection
cavity adapted and configured to receive therein an end of a
separate container. Other embodiments include a first hollow
needle, and a second hollow needle. Still further embodiments
include a catheter assembly having a body and a hollow lumen, the
catheter body being adapted and configured for attachment to the
intravenous tubing. The catheter body includes a one-way valve that
prevents flow of blood through the lumen when the first needle is
separated from the lumen.
[0012] Another aspect of the present invention pertains to an
apparatus for collecting blood in a container and connecting to
intravenous tubing. Some embodiments include a main body defining
an interior including a collection cavity. Other embodiments
include a first retractable needle having a first sharp tip, the
first needle being movable from a first extended position in which
the first sharp tip is exterior to the main body for insertion into
a blood vessel to a second retracted position in which the first
sharp tip is within the interior. Yet other embodiments include a
second needle having a second sharp tip extending into the
collection cavity. Still further embodiments include a catheter
assembly having a body defining a hollow lumen, the catheter body
being adapted and configured for attachment to the intravenous
tubing. The first needle and the main body are readily separable
from the catheter assembly, the first needle automatically
withdrawing to the second position after separating the first
needle from the catheter assembly.
[0013] Yet another aspect of the present invention pertains to a
method for obtaining a sample of blood in a container from the
circulatory system of a biological unit. Some embodiments include
providing a hand-held device defining an interior including a
collection cavity and including first and second hollow needles in
fluid communication with each other, and a catheter surrounding the
first needle. Yet other embodiments include inserting the first
needle and the surrounding catheter into the circulatory system.
Still other embodiments include placing the container in the
collection cavity and inserting the second needle into the
container, either before or after inserting the first needle into
the circulatory system. Other embodiments include establishing
fluid communication from the first needle to the container,
separating the first needle and the catheter; and automatically
withdrawing the first needle into the interior by the
separating.
[0014] It will be appreciated that the various apparatus and
methods described in this summary section, as well as elsewhere in
this application, can be expressed as a large number of different
combinations and subcombinations. All such useful, novel, and
inventive combinations and subcombinations are contemplated herein,
it being recognized that the explicit expression of each of these
combinations is unnecessary.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Some of the figures shown herein may include dimensions.
Further, some of the figures shown herein may have been created
from scaled drawings or from photographs that are scalable. It is
understood that such dimensions, or the relative scaling within a
figure, are by way of example, and not to be construed as
limiting.
[0016] FIG. 1 is a perspective, exploded line drawing of an
apparatus according to one embodiment of the present invention.
[0017] FIG. 2 is a cross sectional view of the apparatus of FIG. 1,
as represented with a drawing from a shaded CAD model, and in a
first mode of operation.
[0018] FIG. 3 is a cross sectional representation of a portion of
the apparatus of FIG. 2.
[0019] FIG. 4 is an enlarged cross section of a portion of the
apparatus of FIG. 2.
[0020] FIG. 5 is an enlarged cross section of a portion of the
apparatus of FIG. 2.
[0021] FIG. 6 is a cross sectional view of the apparatus of FIG. 2
in a second mode of operation.
[0022] FIG. 7 is a cross sectional view of the apparatus of FIG. 2
in a third mode of operation.
[0023] FIG. 8 is a cross sectional view of the apparatus of FIG. 2
in a final, used position, and ready for disposal.
[0024] FIG. 9A shows a top plan view of an apparatus according to
another embodiment of the present invention.
[0025] FIG. 9B shows a side elevational view of the apparatus of
FIG. 9A.
[0026] FIG. 10 is a perspective, exploded line drawing of the
device of FIG. 9.
[0027] FIG. 11A is a top, partially see-thru CAD representation of
the embodiment of FIG. 10, assembled, and in a first mode of
operation.
[0028] FIG. 11B is a side elevational cross-sectional view of the
apparatus of FIG. 11A.
[0029] FIG. 12A is a top, partially see-thru CAD representation of
the embodiment of FIG. 10, assembled, and in a second mode of
operation.
[0030] FIG. 12B is a side elevational cross-sectional view of the
apparatus of FIG. 12A.
[0031] FIG. 13A is a top, partially see-thru CAD representation of
a portion of the embodiment of FIG. 10, assembled, and in a third
mode of operation.
[0032] FIG. 13B is a side elevational cross-sectional view of the
apparatus of FIG. 13A.
[0033] FIG. 14A is a top, partially see-thru CAD representation of
the embodiment of FIG. 10, assembled, and in a final, used
position, and ready for disposal.
[0034] FIG. 14B is a side elevational cross-sectional view of the
apparatus of FIG. 14A.
[0035] FIGS. 15A, 15B, and 15C are top perspective, top plan, and
cross sectional line drawings, respectively, of the luer body of
FIG. 10.
[0036] FIGS. 16A and 16B are top rear and top front perspective
line drawings, respectively, of the holder top of FIG. 10.
[0037] FIGS. 16C, 16D, and 16E are top plan, side elevational, and
cross sectional line drawings, respectively, of the apparatus of
FIG. 16A.
[0038] FIGS. 17A, 17B, and 17C are top rear, side elevational, and
cross sectional line drawings, respectively, of a portion of the
needle assembly of FIG. 10.
[0039] FIGS. 18A and 18B are top rear and top front perspective
line drawings, respectively, of the collection adapter body of FIG.
10.
[0040] FIGS. 18C and 18D are side elevational and side cross
sectional line drawings, respectively, of the apparatus of FIG.
18A, with FIG. 18D being a cross sectional representation of FIG.
18C as taken along the centerline of FIG. 18C.
[0041] FIGS. 19A and 19B are top rear and top front perspective
line drawings, respectively, of the sliding disc member of FIG.
10.
[0042] FIGS. 19C and 19D are side elevational and top plan views,
respectively, of the apparatus of FIG. 19A, with FIG. 19D being the
view looking down from line 19D-19D of FIG. 19C.
[0043] FIGS. 19E and 19F are front end and rear end views,
respectively, of the apparatus of FIG. 19A.
[0044] FIGS. 20A and 20B are rear elevational and top rear
perspective line drawings, respectively, of the holder body of FIG.
10.
[0045] FIGS. 20C and 20D are side elevational and cross sectional
line drawings, respectively, of the apparatus of FIG. 20A.
[0046] FIGS. 21A and 21B are top rear and top front perspective
line drawings, respectively, of an alternative to the sliding disc
member of FIG. 10.
[0047] FIGS. 21C and 21D are side elevational and top plan views,
respectively, of the apparatus of FIG. 21A, with FIG. 21D being the
view looking down from line 21D-21D of FIG. 21C.
[0048] FIGS. 21E and 21F are front end and rear end views,
respectively, of the apparatus of FIG. 21A.
ELEMENT NUMBERING
[0049] The following is a list of element numbers and at least one
noun used to describe that element. It is understood that none of
the embodiments disclosed herein are limited to these nouns, and
these element numbers can further include other words that would be
understood by a person of ordinary skill reading and reviewing this
disclosure in its entirety.
TABLE-US-00001 10 collection vessel 11 first position .sup. 12'
movement toward second position 12 second position 20 apparatus
21.1 main body 21.2 collection cavity 22 cap 24 holder top .1
collection valve guide .2 collection valve slot 25 window 26 holder
body 27 cylindrical receptaclel; wall .1 distal guide and stop;
groove .2 2.sup.nd complementary feature .3 proximal guide and
stop; groove .4 pocket 28 fingers 29 collector aperture 30 IV
catheter assy 32 flexible lumen 34 luer body 35 locking feature 36
eyelet 37 eyelet receptacle 38 valve, 1-way or 2-way 39 valve
receptacle 40 needle assembly 42 cannula, sharp tipped 44 a adapter
45 flat or flattened area; groove 46 spring .1 spring guide .2
ridges .3 recess 47 centerline; axis 48 tube .1 tube guide .2 tube
port .3 tube port .4 tube holder 50 collection valve assy. 51
locking tabs; guiding ear 52 cannula 54 b adapter body 55 body
guided member 56 sheath .1 sheath coupling 57 centerline; axis 58
filter 59 filter receptacle 60 sliding disk member 61 leg 62
protrusion; 1.sup.st complementary feature 63 cover 64 flexible
hinge member; ear 65 shoulder wings 66 cannula aperture
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0050] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention
relates. At least one embodiment of the present invention will be
described and shown, and this application may show and/or describe
other embodiments of the present invention. It is understood that
any reference to "the invention" is a reference to an embodiment of
a family of inventions, with no single embodiment including an
apparatus, process, or composition that should be included in all
embodiments, unless otherwise stated. Further, although there may
be discussion with regards to "advantages" provided by some
embodiments of the present invention, it is understood that yet
other embodiments may not include those same advantages, or may
include yet different advantages. Any advantages described herein
are not to be construed as limiting to any of the claims. The usage
of words indicating preference, such as "preferably," refers to
features and aspects that are present in at least one embodiment,
but which are optional for some embodiments.
[0051] The use of an N-series prefix for an element number (NXX.XX)
refers to an element that is the same as the non-prefixed element
(XX.XX), except as shown and described. As an example, an element
1020.1 would be the same as element 20.1, except for those
different features of element 1020.1 shown and described. Further,
common elements and common features of related elements may be
drawn in the same manner in different figures, and/or use the same
symbology in different figures. As such, it is not necessary to
describe the features of 1020.1 and 20.1 that are the same, since
these common features are apparent to a person of ordinary skill in
the related field of technology. Further, it is understood that the
features 1020.1 and 20.1 may be backward compatible, such that a
feature (NXX.XX) may include features compatible with other various
embodiments (MXX.XX), as would be understood by those of ordinary
skill in the art. This description convention also applies to the
use of prime ('), double prime (''), and triple prime (''')
suffixed element numbers. Therefore, it is not necessary to
describe the features of 20.1, 20.1', 20.1'', and 20.1''' that are
the same, since these common features are apparent to persons of
ordinary skill in the related field of technology.
[0052] Although various specific quantities (spatial dimensions,
temperatures, pressures, times, force, resistance, current,
voltage, concentrations, wavelengths, frequencies, heat transfer
coefficients, dimensionless parameters, etc.) may be stated herein,
such specific quantities are presented as examples only, and
further, unless otherwise explicitly noted, are approximate values,
and should be considered as if the word "about" prefaced each
quantity. Further, with discussion pertaining to a specific
composition of matter, that description is by example only, and
does not limit the applicability of other species of that
composition, nor does it limit the applicability of other
compositions unrelated to the cited composition.
[0053] Various references may be made to one or more processes,
algorithms, operational methods, or logic, accompanied by a diagram
showing such organized in a particular sequence. It is understood
that the order of such a sequence is by example only, and is not
intended to be limiting on any embodiment of the invention.
[0054] This document may use different words to describe the same
element number, or refer to an element number in a specific family
of features (NXX.XX). It is understood that such multiple usage is
not intended to provide a redefinition of any term herein. It is
understood that such words demonstrate that the particular feature
can be considered in various linguistical ways, such ways further
not necessarily being additive or exclusive.
[0055] Various embodiments of the invention disclosed herein
combine the basic elements of both an IV catheter and a blood
collector and then expands upon those features resulting in a fully
automatic/passive safety product that seamlessly shields the user
against needle stick injuries in one simple step. Immediately upon
separation of the catheter luer from the main body, both cannula
sharps are simultaneously and automatically shielded within the
collection holder. This renders the device unusable and safe for
proper disposal. As used herein, the term "proximal" refers to
proximity to the user, and with regards to FIG. 2 or 9, to the
right of the drawing. The word "distal" refers to a direction
generally opposite of the proximal direction
[0056] FIG. 1 presents an exploded view of an apparatus 20
according to one embodiment of the present invention. Apparatus 20
provides a single device that can be used as part of a catheter for
the intravenous delivery of medicaments, but also provide an
interface through which the patient's blood can be collected. In
still further embodiments, the apparatus includes a needle that is
useful for puncturing a vein of a patient, and also for providing a
flow of the patient's blood into a separate collection vessel such
as a standard collection tube (not shown).
[0057] FIG. 1 shows an apparatus 20 having an IV catheter 30,
needle assembly 40, collection valve 50, and latching disk 60. The
catheter 30, needle 40, valve 50, and disk 60 are contained within
a cap 22, holder top 24, and holder body 26.
[0058] Apparatus 20 can be seen in a side elevational cross
sectional view in FIG. 2. The holder top 24 and holder body 26 in
one embodiment are molded plastic pieces that are joined together
by any suitable process, including as examples, by way of snap fit,
by adhering with a glue, by ultrasonic welding, or the like.
Although holder top 24 and holder body 26 are shown as two separate
pieces, it is understood that various embodiments of the present
invention contemplate these two components being combined into a
single main body 21.1, and still further contemplates those other
embodiments in which the various structural features of holder top
24 and holder body 26 are redistributed among two or more different
separate pieces, but which still function as a main body 21.1 when
assembled. The catheter assembly 30, needle assembly 40, and
collection valve assembly 50 are all preferably supported by the
holder top 24, as will be described.
[0059] FIG. 2 shows a view of apparatus 20 in which protective cap
22 has been removed. It is understood that cap 22 provides for safe
handling of the sterile, exposed needle 42 and catheter 32 during
storage and handling. The opened proximal end of cap 22 fits over
the distal-most end of holder top 24 in a manner that provides not
only for safe handling and storage, but also for easy, ready
removal by a medical professional. Preferably, cap 22 covers lumen
32 and luer 34.
[0060] Placed on the distal-most end of holder top 24 is an
intravenous catheter assembly 30. Assembly 30 includes a hollow
luer body 34 that includes a flexible lumen 32 extending in a
distal-direction. Lumen 32 is preferably attached to an inner
surface of luer body 34 by way of an eyelet 36. Luer body 34 also
supports an internal one-way valve 38 that is located generally in
the middle of the length of body 34. In some embodiments, valve 38
is a 1-way valve, whereas in other embodiments it is a 2-way valve.
Preferably, valve 38 permits cannula 42 to be extended through the
valve dome, without leakage. Upon withdrawal of cannula 42, the
dome of valve 38 substantially seals to a fluid-tight state.
[0061] The proximal end of body 34 includes an inner diameter that
establishes a friction fit over a pair of forward-extending fingers
28 that are part of holder top 24 (shown in FIG. 4). In some
embodiments, luer body 34 also includes a plurality of ridges on
one or more outer surfaces that assist the medical practitioner in
handling of catheter assembly 30.
[0062] FIGS. 2 and 4 include cross sectional views of a needle
assembly 40. Needle assembly 40 preferably includes a beveled,
sharp-tipped needle 42 that is fixed to the internal surfaces of a
shuttling adapter 44. Cannula 42 is adapted and configured to
extend within flexible lumen 32 of catheter 30. The tip of cannula
42 extends beyond the end of flexible lumen 32. During insertion of
needle 42 and lumen 32 into the vein of a patient, needle 42
provides a stiffening function that maintains the cylindrical shape
of lumen 32, preventing buckling of lumen 32 during insertion of
the needle 42 and catheter 30 into the vein of the patient.
[0063] As best seen in FIG. 4, needle assembly 40 further includes
a spring 46 that is located between opposing, facing shoulders of
adapter 44 and holder top 24. FIG. 4 shows needle assembly 40
inserted fully within catheter assembly 30, with the resultant
maximum compression of spring 46. Preferably, spring 46 is a coil
spring, although it is appreciated that various devices and methods
can be used to bias apart adapter 44 and the forward shoulder of
holder top 24. It can also be seen in FIG. 4 that cannula 42
extends through the distal-most end of valve 38, and thus provides
fluid communication from the tip end aperture of needle 42, to the
proximal-most opened end of adapter body 44.
[0064] Referring to FIG. 4, a disk leg 61 operating as a guide for
adapter 44 can be seen (leg 61 preferably not being engaged with
adapter 44). A first latching mechanism between disk 60 and holder
top 24 establishes the relative locations of needle assembly 40 and
disk 60. A second latching mechanism establishes the relative
positions of disk 60 and holder body 26. Disk 60 sits in a relaxed
position between the holder top and holder body with a slight
interference fit. In a manner that will be described later, leg 61
of disk 60 maintains radial alignment within the holder body 24 and
acts as a guide to needle assembly 40 in a forwardmost position,
with spring 46 under near-maximum compression, during a first mode
of operation of apparatus 20.
[0065] FIG. 5 shows an enlarged sectional view of a portion of
apparatus 20. A latching disk 60 can be seen located within a
generally cylindrical aperture 29 of holder body 26. Disk 60 is
preferably a single, molded piece having a forwardly-extending leg.
Various features of disk 60 are adapted and configured to provide a
first latching between disk 60 and retractable need assembly 40,
and a second latching between disk 60 and either holder top 24 or
holder body 26.
[0066] Collection valve assembly 50 is attached to internal support
ribs of holder top 24. Disk 60 includes a small, central aperture
that loosely fits around an outer diameter of a shoulder of adapter
54. Thus, disk assembly 60 is free to move relative to adapter body
54, and body 54 is held fixed by holder top 24. A flexible tube 48
provides fluid communication from adapter 44 and cannula 42 to one
end of adapter body 54.
[0067] Referring briefly to FIG. 2, it can be seen that adapter 54
establishes a centerline 57 generally within the center of chamber
21.2 of holder body 26. Adapter body 44 and cannula 42 establish a
second centerline 47 that is generally parallel to, and offset
from, centerline 57. However, it is understood that yet other
embodiments of the present invention contemplate relative
arrangements of the centerlines of needle assembly 40 and
collection valve assembly 50, including non-parallel arrangements
(in which centerline 57 and aperture 29 of holder body 26 would be
angled upward, away from the patient, referring to FIG. 2) and also
those embodiments in which centerlines 47 and 57 are not offset
(such as when the two axes are generally aligned).
[0068] Referring again to FIG. 5, it can be seen that adapter 54
supports a cannula 52 that extends rearward toward the proximal
opening 29 of holder body 26. A conical barb at the proximal end of
adapter body 54 further support a flexible sheath 56 that generally
surrounds and seals cannula 52 to adapter body 54. Preferably,
sheath 56 is fabricated from a flexible material, such as a
silicone rubber, and can therefore easily be compressed and
collapsed around cannula 52. The proximal-most end of cannula 52
preferable includes a beveled, sharp tip for puncturing a
collection vessel, as will be described later.
[0069] FIG. 5 further shows that adapter body 54 supports a porous
filter 58 that provides a purging function for the interior volume
of cannula 42, adapter body 44, tube 48, and adapter body 54. The
proximal end of disk 60 includes a protrusion 62 that is shown in
FIG. 6 as being held against a forward ledge of holder body 26.
[0070] Apparatus 20 operates in several different modes. FIG. 1 is
an exploded view of a storage mode of operation, in which catheter
assembly 30 is located at the distal-most end of holder top 24,
with full compression of spring 46. Further, in this storage mode,
sheath 56 is unpunctured, and maintains the sterility of the
internal flowpath of assembly 20.
[0071] FIG. 2 represents apparatus 20 in a first mode of operation.
Cap 22 has been removed, exposing the sharp tip of cannula 42 and
the exterior of flexible lumen 32. The medical practitioner has
access to hold the exterior of luer body 34, as well as the ability
to hold the exterior of holder top 24 and holder body 26. The
medical practitioner places the sharp tip of cannula 40 relative to
a vein of a patient, and inserts the cannula 42 and flexible lumen
32 within the vein of the patient.
[0072] In a second mode of operation, the medical practitioner can
bring a standard collection vessel 10 (not shown) through aperture
29 and into the opened proximal chamber 21.2 of holder body 26. The
proximal end of body 26 includes a generally cylindrical chamber
21.2. The interior dimensions of the proximal end of holder body 26
are slightly greater than the outer diameter of the collection
vessel. Therefore, the collection vessel enters aperture 29, and
the face of the collection vessel can be brought into contact with
the proximal end of sheath 56.
[0073] Preferably, the end of the collection vessel 10 is soft
enough such that the medical practitioner can push the collection
vessel against sheath 56 and the sharp tip of cannula 52. By
continuing to push the collection vessel toward adapter 54, the
sharp tip of cannula 52 penetrates the end of collection vessel 10,
and enters the interior of the collection vessel. However, the
flexible sheath 56 does not enter the collection vessel, and
instead is compressed in buckling along cannula 52 and toward
adapter body 54.
[0074] Once the tip of cannula 52 extends within the empty volume
of collection vessel 10, fluid communication is established from
the interior of the collection vessel through cannula 52 and
adapter body 54, through tube 48, and into the interior flow
passage of needle assembly 40. Since needle assembly 40 is exposed
to blood within the patient's vein, blood can begin to flow through
needle assembly 40 and tube 48, through collection valve assembly
50, and into collection vessel 10.
[0075] In order to prevent any hydraulic lockup, the interior of
collection vessel 10 can be established at a pressure less than the
pressure of the blood within the vein, or a suitable fluid
induction device can be used. Still further, any trapped air within
needle assembly 40, tube 48, and valve assembly 50 can escape
through porous filter 58. However, filter 58 is preferably of a
type in which the porosity of the filter is maintained only so long
as the filter does not contact blood (such as a Porex.RTM.
material). Upon contact with the blood, the filter media loses
porosity, such that there can be no further leakage of either
trapped air or blood through the filter. As blood flows through
tube 48, it can be seen by the medical practitioner through a
transparent window 25 within holder top 24.
[0076] The medical practitioner maintains collection vessel 10
within holder body 26 and in fluid communication with the vein of
the patient until sufficient blood has been collected. Multiple
collection vials maybe used. After the medical professional has
collected sufficient blood, the compression is relieved and the
collection vessel 10 is withdrawn. The adapter 44 assembly still
remains in a distal position, under spring load, until the luer
assembly 30 has separated from the Holder Top 24. The relationship
between the luer body 34, holder top legs 28 and adapter 44
receiving flats 45 prevent movement. Once the user advances the
catheter luer assembly in a distal direction beyond legs 28, there
is nothing to prevent them from flexing outward. This outward
flexing releases adapter 44 so it can move in a proximal direction,
retracting toward the proximal end of holder body 26. Needle
assembly 40 can move rearward toward a receiving pocket on the end
of disk 60. Both disk 60 and needle assembly 40 therefore move
toward the proximal end of the body holder. The beginnings of this
movement can be first seen in FIG. 6. The full seating of the
needle assembly in the receiving pocket of disk 60 can be seen in
FIG. 7 Cannula 42 of needle assembly 40 retracts within flexible
lumen 32 of catheter assembly 30. However, the medical practitioner
advances the catheter assembly 30 into the patient's vein, with the
result that lumen 32 remains in fluid communication with the
patient's vein. However, as needle assembly 40 retracts, the end of
the needle assembly retracts past flexible valve 38, which acts as
a one-way valve, and thereby closes and prevents any escape of the
patient's blood.
[0077] FIGS. 7 and 8 show the remaining retraction of needle
assembly 40 within holder body 26. As the assembly of the disk and
needle retract, tube 48 begins to extend. FIG. 7 shows the
completed and full retraction of needle assembly 40 relative to
disk 60. FIG. 8 shows the completed and full retraction of the disk
relative to holder 26. The aft face of disk 60 is biased by spring
46 to sit against a ledge or shoulder surrounding aperture 29 of
holder body 26 and locks into place preventing any further
movement. Tube 48 is shown in its position of maximum extension
from the end of adapter 44 to the end of adapter 54. The sharp tip
of cannula 42 is fully contained within holder top 24.
[0078] In some embodiments, the relationship between adapter 44 and
disk 60 is generally for guiding disk 60 to its full proximal
position. Various embodiments do not include features that
pre-stage activation upon insertion of a collection Tube 10. The
disk 60 statically stays positioned in the holder top 24 by a
simple interference fit having a reverse draft. Multiple collection
tubes can be used without activation since activation (retraction
of the needle assembly 40 and disk 60) does not occur until the
catheter luer assembly 30 has separated from the holder 24.
[0079] FIGS. 9-20 pertain to an apparatus 120 according to another
embodiment of the present invention. FIG. 9A and FIG. 9B show top
and side external views, respectively, of device 120. A main body
121.1 has a protective cap 122 on one end, and an aperture 129
defined on the opposite end, the aperture being adapted and
configured to accept a collection vessel. Although what will be
shown and described is an embodiment configured to accept a vessel
such as an evacuated, cylindrical vessel, the present invention
further contemplates those embodiments in which the aperture is
adapted and configured to accept any shape, size, or type of
collection vessel, and further included those embodiments adapted
and configured to accept tubing-like components that are in fluid
communication with a collection reservoir.
[0080] FIG. 10 presents an exploded view of an apparatus 120
according to one embodiment of the present invention. Apparatus 120
provides a single device that can be used as part of a catheter for
the intravenous delivery of medicaments, but also provide an
interface through which the patient's blood can be collected. In
still further embodiments, the apparatus includes a needle that is
useful for puncturing a vein of a patient, and also for providing a
flow of the patient's blood into a separate collection vessel such
as a standard collection tube (not shown).
[0081] FIG. 10 shows an apparatus 120 having an IV catheter 130,
needle assembly 140, collection valve 150, and latching disk 160.
The catheter 130, needle 140, valve 150, and disk 160 are contained
within a cap 122, holder top 124, and holder body 126.
[0082] Apparatus 120 can be seen in a top elevational view in FIG.
11A and a side elevational cross sectional view (taken along the
centerline of FIG. 11A) in FIG. 11B. The holder top 124 and holder
body 126 in one embodiment are molded plastic pieces that are
joined together by any suitable process, including as examples, by
way of snap fit, by adhering with a glue, by ultrasonic welding, or
the like. The catheter assembly 130, needle assembly 140, and
collection valve assembly 150 are all preferably supported by the
holder top 124, as will be described.
[0083] FIGS. 11A and 11B show views of apparatus 120 in which
protective cap 122 has been removed. It is understood that cap 122
provides for safe handling of the sterile, exposed needle 142 and
catheter 132 during storage and handling. The opened proximal end
of cap 122 fits over the distal-most end of holder top 124 in a
manner that provides not only for safe handling and storage, but
also for easy, ready removal by a medical professional. Preferably,
cap 122 covers lumen 132 and luer body 134, and the tip of cannula
142.
[0084] Placed on the distal-most end of holder top 124 is an
intravenous catheter assembly 130. Assembly 130 includes a hollow
luer body 134 that includes a flexible lumen 132 extending in a
distal-direction. Lumen 132 is preferably attached to an inner
surface of luer body 134 by way of an eyelet 136. Luer body 134
also supports an internal valve 138 within a receptacle 139 that is
located generally in the middle of the length of body 134 (luer
body 134 also being shown in FIG. 15). The proximal end of body 134
includes an inner diameter that establishes a friction fit over a
pair of forward-extending fingers 128 that are part of holder top
124 (also shown in FIGS. 14A and 14B). In some embodiments, luer
body 134 also includes a plurality of ridges on one or more outer
surfaces that assist the medical practitioner in handling of
catheter assembly 130. The placement of luer body 134 over fingers
128 causes the tips of these fingers to be pressed firmly within
corresponding flats 145 of body 144 (as seen in FIG. 17). The inner
surface of luer body 134 fits over fingers 128 and compresses them
into flats 145 so as to firmly hold needle assembly 140 in place,
and able to resist a force exerted on needle assembly 140 by spring
146 (as will be discussed later). Luer body 134 includes one or
more locking features 135 that are adapted and configured for
connection to another medical device.
[0085] FIG. 16 show various views of a portion of a main body
according to one embodiment of the present invention. In this
embodiment, the main body includes a holder top 124 that provides a
variety of functions with a variety of different features. These
functions and features will be described, but it is understood that
the present invention contemplates those embodiments in which one
or more of these functions and features are not included.
[0086] Holder top 124 includes a distal end having a pair of
distally extending fingers 128 that provide for capture of needle
assembly 140 as discussed herein. The proximal end of holder top
124 defines an aperture that is adapted and configured to receive
therein the distal end of the holder body 126. Further, the open
proximal end of holder top 124 includes a pair of distal guide/stop
grooves 127.1 arranged on generally opposite sides. These grooves
127.1 coact with corresponding ears 164 of sliding disk member 160
as will be described later. The open end of holder top 124 further
includes a guiding feature 127.2 that is generally complementary in
shape to a corresponding guiding feature 162 of sliding disk member
160, as will be discussed later.
[0087] Holder top 124 includes an outer shape adapted and
configured to provide a hand hold for the medical professional. As
best seen in FIG. 16B, holder top 124 has a width that decreases in
the distal direction, and further has a height that decreases in
the distal direction. This curving shape, which reduces from
proximal to distal end, provides a secure hold of apparatus 120
within the hand and fingers of a medical professional.
[0088] Holder top 124 receives within it a collection valve
assembly 150, this assembly 150 being seen in side view on FIGS.
11B, 12B, 13B, and 14B. Holder top 124 includes a guide 124.1 that
receives within it a correspondingly-shaped guided member 155 of
body 154 (as seen in FIGS. 18A and 18B). This guiding chamber 124.1
extends generally above needle assembly 140 and leg 161.
[0089] In apparatus 120, holder top 124 provides for the internal
placement of a needle assembly 140 and collection valve assembly
150 having cannula axes 147 and 157, respectively, that are
generally parallel and vertically displaced from one another (as
best in FIG. 11B). However, other embodiments of the present
invention are not so limited. For example, yet other embodiments
include a collection valve assembly having a cannula axis that is
tilted relative to the cannula axis of the first needle, such that
the collection cavity 121.2 is tilted upward, toward the face of
the user during usage. Such embodiments further contemplate needle
assemblies 140 that retract generally into the interior of main
body 121.2, but not necessarily into the collection cavity. Still
further, although FIGS. 11A and 11B show cannula axes 147 and 157
being parallel and displaced, yet other embodiments contemplate the
axes being coincident. In such embodiments, it is contemplated that
the first and second cannulas 142 and 152 can be unitary, such that
both the needle assembly 140 and the cannula 152 retract from a
first, ready-to-use position to a second, used position, after
removal of catheter assembly 130 or actuation of some other
retraction-causing feature.
[0090] Referring to FIGS. 16C and 16E, it can be seen that holder
top 124 includes a slot 124.2 that is adapted and configured to
receive within it a corresponding guiding ear or locking tab 151 of
adapter body 154 (as best seen in FIGS. 18A and 18B). The coaction
of slot 124.2 and tab 151 provides for alignment of holder body 154
relative to holder top 124 (and therefore alignment with needle
assembly 140). Referring to FIG. 18B, it can be seen that tab 151
in some embodiments provides a unidirectional, snap fit. Tab 151
has an angled, expanding leading edge to assist in temporary
expansion of guide 124.1 during assembly, yet also includes a
squared-off trailing edge that makes holder body 154 resistant to
accidental disassembly and removal, the outermost diametral
portions of ear 151 being in interference with portions of body 124
after the entire tab 151 is contained within slot 124.2, such that
the temporarily expanded holder top 124.1 snaps back into
place.
[0091] FIG. 11B shows a cross sectional view of a needle assembly
140. Needle assembly 140 preferably includes a beveled,
sharp-tipped needle 142 that is fixed to the internal surfaces of a
shuttling adapter 144. Cannula 142 is adapted and configured to
extend within flexible lumen 132 of catheter 130. The tip of
cannula 142 extends beyond the end of flexible lumen 132. During
insertion of needle 142 and lumen 132 into the vein of a patient,
needle 142 provides a stiffening function that maintains the
cylindrical shape of lumen 132, preventing buckling of lumen 132
during insertion of the needle 142 and catheter 130 into the vein
of the patient.
[0092] FIG. 17 show additional views of the adapter body 144 of
needle assembly 140. Body 144 includes a front cylindrical cavity
to which cannula 142 is attached, and which establishes a
centerline 147 of cannula 142. Body 144 further includes a
plurality of ridges 146.1 that assist in aligning and guiding an
end of spring 146 (as can be seen in FIG. 11B). Body 144 further
includes a shoulder 146.2 that receives an end 148.2 of spring 146,
and against which spring 146 exerts a load.
[0093] The proximal end of body 144 is adapted and configured to
receive within it an end of tube 148. FIG. 17C shows an internal
cylindrical cavity 148.2 that receives the end of tube 148. As tube
148 exits from body 144, the tube makes a right angle turn through
tube holding feature 148.4. It can be seen that feature 148.4
includes a generally semi-cylindrical shape that receives the outer
diameter of the tube. However, this cylindrical shape is opened to
the proximal end of body 144 by a V-shaped pair of upper and lower
walls. As best seen in FIG. 17C, these angularly-shaped walls
narrow down to a minimum distance that is large enough to permit
tube 148 to be squeezed past these walls during assembly, but small
enough to prevent the assembled and inserted, right-angled tube
from escaping the semi-cylindrical aperture. The placement of tube
holding feature 148.4 on a side of body 144 provides for less
impedance by tube 148 on the retraction on needle assembly 140, by
placing the sharpest turn radius of tube 148 held firmly within
body 144. Therefore, very little of the spring force is consumed by
any requirement to make a sharp bend in tube 148 as it retracts
(referring to FIGS. 13A and 14A).
[0094] As best seen in FIG. 11B, needle assembly 140 is acted upon
by a spring 146 that is located between the shoulder 146.2 of
adapter 144 and a recess 146.3 of holder top 124 (as best seen in
FIG. 16E). FIG. 4 shows needle assembly 140 inserted fully within
catheter assembly 130, with the resultant maximum compression of
spring 146. Preferably, spring 146 is a coil spring, although it is
appreciated that various devices and methods can be used to bias
apart adapter 144 and the forward shoulder of holder top 124. It
can also be seen in FIG. 4 that cannula 142 extends through the
distal-most end of valve 138, and thus provides fluid communication
from the tip end aperture of needle 142, to the proximal-most
opened end of adapter body 144. Tube 148 continues the path of
fluid communication from adapter body 144 to adapter body 154, as
will be discussed later.
[0095] Some embodiments of the present invention further include a
sliding member 160 that can provide a plurality of functions with
an apparatus 120. As one example, and as best seen in FIGS. 11A and
11B, sliding member 160 includes a cover 163 that includes an
aperture 166 through which second needle 152 extends. Further, FIG.
11A shows that extending distally and on the bottom side of sliding
member 160 is a leg 161 that fits generally underneath and guides
the distal end of needle assembly 140. Still further, sliding
member 160 includes a pair of outwardly extending ears 164 that
coact with the main body to prevent sliding member 160 from moving
distally forward from the first position 111, shown in FIGS. 11A
and 11B. Sliding member 160 further defines a pocket 127.4 that
provides placement of needle assembly 140 in both the partially
retracted and fully retracted states (as seen in FIGS. 13B and 14B,
respectively). Still further, the ears 164 of sliding disk 160
coact with main body 121.1 to prevent distal-direction movement of
the cover 163 in the final, used configuration (as shown in FIGS.
14A and 14B).
[0096] Referring to FIGS. 11B and 19D, a disk leg 161 operating as
a guide for adapter 144 can be seen (leg 161 preferably not being
engaged with adapter 144). A first latching mechanism between disk
160 and holder top 124 establishes the relative locations of needle
assembly 140 and disk 160 in the first, ready to use position 111.
A second latching mechanism establishes the relative positions of
disk 160 and holder body 126, in the final, used second position
112. Disk 160 sits in a relaxed position between the holder top and
holder body with a slight interference fit. In a manner that will
be described later, leg 161 of disk 160 maintains radial alignment
within the holder body 124 and acts as a guide to needle assembly
140 in a forwardmost position 111, with spring 146 under
near-maximum compression, during a first mode of operation of
apparatus 120.
[0097] Sliding member 160 is also shown in FIG. 19. Sliding member
160 includes a disk-shaped proximal end 163 that includes within it
a generally centered aperture 166. A pair of flexibly hinged
members or ears 164 extends generally outward on opposing sides of
member 160. A leg 161 extends distally from the inner face of cover
163, and has a generally curved shape to it as seen in FIGS. 19E
and 19F. Sliding member 160 further includes a semi-cylindrical
wall 127 that defines therein a pocket 127.4.
[0098] Flexible ears 164 coact with complementary-shaped distal and
proximal guide/stop grooves 127.1 and 127.3, respectively. These
guide/stop grooves include a short length in the axial direction
adapted and configured to receive the distal end of the ear, and
provide guidance of the ear during sliding contact. The guide/stop
grooves further include a distalmost endwall that is adapted and
configured to coact with the corresponding ears to prevent distal
motion beyond a first distalmost position (when the apparatus 120
is ready to be used) and a second distalmost position (after the
device has been used, and the collection container withdrawn).
[0099] Distal guide/stop 127.1 can be seen in FIGS. 16A, 16B, and
16C. Proximal guide/stop 127.3 can be seen formed into holder body
126 in FIGS. 20B, 20C, and 20D. Ears 164 of sliding member 160
coact with proximal grooves 127.1 to limit the distalmost travel of
member 160 in the first position (as can be seen in FIG. 12A).
However, ears 164 are adapted and configured to not interfere with
the sliding motion of member 160 from the first position toward the
second position. In the fully extended and final position (as seen
in FIG. 14A), ear 164 coacts with groove 127.3 to stop movement of
member 160 in a distal direction after sliding member 160 is fully
in the second position 112.
[0100] Sliding member 160 further includes a guiding feature 162
that has a shape complementary to a guiding feature 127.2, the
latter being shown in FIG. 20B and FIG. 16A. Complementary-shaped
features 162 and 127.2 coact to guide sliding member 160 within the
main body 121.1 of apparatus 120 (as also seen in FIG. 14B). The
guiding feature 162 in some embodiments fulfills a second function
as a leg 161 that fits under and generally close to the bottom of
adapter body 144 (as seen in FIGS. 11B and 12B). The curved shape
of this leg further assists in guiding adapter body 144 into pocket
127.4, as needle assembly 144 retracts from the first position 111
into the second (and intermediate) position 112' (as seen in FIG.
13B). It is understood that in some embodiments the needle
body-guiding function of leg 161 and the sliding member-guiding
function (relative to main body 121.1) of guiding feature 162 can
be accomplished simultaneously with the tongue-like structure shown
in FIG. 19B. However, yet other embodiments contemplate
configurations of the sliding member 160 in which these two guiding
functions are performed separately on a sliding member, and still
further contemplate those embodiments in which these functions are
accomplished not on the sliding member but on other structure of
the apparatus 120.
[0101] FIGS. 11 and 12 show views of a portion of apparatus 120. A
latching disk 160 can be seen located within a generally
cylindrical aperture 129 of holder body 126. Disk 160 is preferably
a single, molded piece having a forwardly-extending leg. Various
features of disk 160 are adapted and configured to provide a first
latching between disk 160 and retractable need assembly 140, and a
second latching between disk 160 and either holder top 124 or
holder body 126.
[0102] Collection valve assembly 150 is attached to internal
support ribs of holder top 124. Disk 160 includes a small, central
aperture that loosely fits around an outer diameter of a shoulder
of adapter 154. Thus, disk assembly 160 is free to move relative to
adapter body 154, and body 154 is held fixed by holder top 124. A
flexible tube 148 provides fluid communication from adapter 144 and
cannula 142 to one end of adapter body 154.
[0103] Referring briefly to FIG. 11B, it can be seen that adapter
154 establishes a centerline 157 generally within the center of
chamber 121 of holder body 126. Adapter body 144 and cannula 142
establish a second centerline 147 that is generally parallel to,
and offset from, centerline 157. However, it is understood that yet
other embodiments of the present invention contemplate relative
arrangements of the centerlines of needle assembly 140 and
collection valve assembly 150, including non-parallel arrangements
(in which centerline 157 and aperture 129 of holder body 126 would
be angled upward, away from the patient, referring to FIG. 2) and
also those embodiments in which centerlines 147 and 157 are not
offset (such as when the two axes are generally aligned).
[0104] It can be seen that adapter 154 supports a cannula 152 that
extends rearward toward the proximal opening 129 of holder body
126. A conical barb at the proximal end of adapter body 154 further
support a flexible sheath 156 that generally surrounds and seals
cannula 152 to adapter body 154. Preferably, sheath 156 is
fabricated from a flexible material, such as a silicone rubber, and
can therefore easily be compressed and collapsed around cannula
152. The proximal-most end of cannula 152 preferable includes a
beveled, sharp tip for puncturing a collection vessel, as will be
described later.
[0105] Adapter body 154 supports a porous filter 158 that provides
a purging function for the interior volume of cannula 142, adapter
body 144, tube 148, and adapter body 154. The proximal end of disk
160 includes a protrusion 162 that is shown in FIG. 6 as being held
against a forward ledge of holder body 126.
[0106] FIG. 18 show various views of an adapter body 154 according
to one embodiment of the present invention. Body 154 includes a
proximal end having a coupling feature 156.1 that is inserted into,
and seals around, the open end of flexible sheath 156. Adjacent to
coupling 156.1 is a cylindrical collar that closely fits within
aperture 166 of sliding disk member 160. Adjacent to this centering
collar is a receptacle 159 that receives within it filter 158.
Referring to FIG. 18D, it can be seen that receptacle 159 includes
an aperture in the bottom that provides fluid communication to the
flowpath extending along centerline 157, this flowpath beginning at
the tip of needle 142 and extending to the tip of needle 152, and
further into the collection reservoir when the collection reservoir
is in place. By way of this secondary flowpath to filter 158, any
trapped air within the main flowpath can be released through the
filer. Once the filer cavity fills with blood, the blood coacts
with the filter media to block any outward flow from receptacle
159. FIG. 18D also shows that the flowpath upstream of receptacle
159 leads to a tube port 148.3 that receives an end of flexible
tube 148. The other end of the flexible tube is received within the
tube port 148.2 that can be seen in FIG. 17.
[0107] Referring to FIGS. 18 and 11B, it can be seen that tube 148
extends from port 148.3 and wraps around the distalmost nose of
body 154, and is supported by one or more guiding tube guiding
features 148.1. FIG. 11B shows the tube extending between the
guiding features 148.1 and flash window 125. Preferably, the
portion of tubing proximate to flash window 125 is transparent. The
tube then extends aft (i.e., toward the right in FIG. 11B), around
the body 154, and past the shoulder wings 165 of sliding disk
member 160 (see FIGS. 19B and 19D), and extends finally in a distal
direction toward tubing guide 148.4 and into tube port 148.2 of
first needle body 144. With this forward-backward-forward again
path of tube 148 in the first position, the lower portion of the
tube is free to extend aft (i.e., in FIG. 14B to the right) in the
second position 112, and thus not impede the retracting motion of
needle assembly 140. As best seen in FIG. 14A, it can be seen that
tube 148 in the second position extends generally toward one side
of the centerline 147, with the end of tube 148 being received
within tube holding feature 148.4 of adapter 144.
[0108] Apparatus 120 operates in several different modes. FIG. 10
is an exploded view of a storage mode of operation, in which
catheter assembly 130 is located at the distal-most end of holder
top 124, with full compression of spring 146. Further, in this
storage mode, sheath 156 is unpunctured, and maintains the
sterility of the internal flowpath of assembly 120.
[0109] FIGS. 11A and 11B represent apparatus 120 in a first mode of
operation, and with sliding member 160 and needle assembly 140 in a
first position 111. Cap 122 has been removed, exposing the sharp
tip of cannula 142 and the exterior of flexible lumen 132. The
medical practitioner has access to hold the exterior of luer body
134, as well as the ability to hold the exterior of holder top 124
and holder body 126. The medical practitioner places the sharp tip
of cannula 140 relative to a vein of a patient, and inserts the
cannula 142 and flexible lumen 132 within the vein of the
patient.
[0110] In the first mode of operation, the medical practitioner can
bring a standard collection vessel 110 (not shown) through aperture
129 and into the opened proximal chamber 121 of holder body 126.
The proximal end of body 126 includes a generally cylindrical
chamber 121. The interior dimensions of the proximal end of holder
body 126 are slightly greater than the outer diameter of the
collection vessel. Therefore, the collection vessel enters aperture
129, and the face of the collection vessel can be brought into
contact with the proximal end of sheath 156.
[0111] Preferably, the end of the collection vessel 110 is soft
enough such that the medical practitioner can push the collection
vessel against sheath 156 and the sharp tip of cannula 152. By
continuing to push the collection vessel toward adapter 154, the
sharp tip of cannula 152 penetrates the end of collection vessel
110, and enters the interior of the collection vessel. However, the
flexible sheath 156 does not enter the collection vessel, and
instead is compressed in buckling along cannula 152 and toward
adapter body 154.
[0112] Once the tip of cannula 152 extends within the empty volume
of collection vessel 110, fluid communication is established from
the interior of the collection vessel through cannula 152 and
adapter body 154, through tube 148, and into the interior flow
passage of needle assembly 140. Since needle assembly 140 is
exposed to blood within the patient's vein, blood can begin to flow
through needle assembly 140 and tube 148, through collection valve
assembly 150, and into collection vessel 110.
[0113] In order to prevent any hydraulic lockup, the interior of
collection vessel 110 can be established at a pressure less than
the pressure of the blood within the vein, or a suitable fluid
induction device can be used. Still further, any trapped air within
needle assembly 140, tube 148, and valve assembly 150 can escape
through porous filter 158. However, filter 158 is preferably of a
type in which the porosity of the filter is maintained only so long
as the filter does not contact blood (such as a Porex.RTM.
material). Upon contact with the blood, the filter media loses
porosity, such that there can be no further leakage of either
trapped air or blood through the filter. As blood flows through
tube 148, it can be seen by the medical practitioner through a
transparent window 125 within holder top 124. The medical
practitioner maintains collection vessel 10 within holder body 126
and in fluid communication with the vein of the patient until
sufficient blood has been collected. Multiple collection vials
maybe used.
[0114] After the medical professional has collected sufficient
blood, the compression is relieved and the collection vessel 10 is
withdrawn. The Adapter 144 assembly still remains in a distal
position, and under spring load, until the Luer assembly 130 has
separated from the holder top 124. The relationship between the
luer body 134, Holder top Legs 128 and adapter 144 receiving flats
145 prevent movement.
[0115] Once the user advances the catheter luer assembly in a
distal direction beyond legs 128, there is nothing to prevent leg
128 from flexing outward. This outward flexing releases Adapter 144
so it can move in a proximal direction, retracting toward the
proximal end of holder body 126. Needle assembly 140 can move
rearward toward a receiving pocket on the end of disk 160, as seen
in FIGS. 12A and 12B. Luer assembly 130 has been removed from its
frictional fit over the ears 128 of body 124, thus relieving the
normal force applied between the flat 145 of body 144 and the tips
of fingers 128. As shown in FIGS. 12A and 12B, with the release of
the compression of the fingers into the grooves, needle assembly
140 begins to move from the first position 111 to the second
position 112. As shown in FIG. 12B, first needle adapter body 144
is free to move and be guided by the curvature of leg 161. Both
disk 160 and needle assembly 140 therefore move toward the proximal
end of the body holder.
[0116] The beginnings of this movement can be first seen in FIGS.
13A and 13B. Under the influence of the expanding spring 146,
needle body 144 has been urged into pocket 127.4 of sliding member
160 and into an intermediate second position 112'. As the
proximal-most end of adapter body 144 abuts the internal face of
pocket 127.4, the spring force is further exerted on sliding member
160 to move it toward the right. Adapter body 144 and sliding
member 160 are shown in an intermediate second position 112', which
is not a steady state location for the assembly as shown in FIG.
13B. In this position 112', there is still sufficient force being
exerted by spring 146 to continue urging apart sliding member 160
and main body 121.1. The full seating of the needle assembly 140 in
the receiving pocket 127.4 of disk 160 can be seen in FIG. 13B.
Cannula 142 of needle assembly 140 retracts inward toward the
interior of main body 121.1. The medical practitioner advances the
catheter assembly 130 into the patient's vein, with the result that
lumen 132 remains in fluid communication with the patient's vein.
However, as needle assembly 140 retracts, the end of the needle
assembly retracts past flexible valve 138, which acts as a one-way
valve, and thereby closes and prevents any escape of the patient's
blood from catheter 130.
[0117] FIGS. 14A and 14B show the remaining retraction of needle
assembly 140 within holder body 126 to the final, at rest second
position 112. As the assembly of the disk and needle retract, tube
148 begins to extend. FIGS. 13A and 13B show the intermediate
retraction of needle assembly 140 relative to disk 160. FIGS. 14A
and 14B show the completed and full retraction of the sliding disk
160 relative to holder 126. The aft face of disk 160 is biased by
spring 146 to sit against a ledge or shoulder surrounding aperture
129 of holder body 126 and locks into place preventing any further
movement. Tube 148 is shown in its position of maximum extension
from the end of adapter 144 to the end of adapter 154. The sharp
tip of cannula 142 is fully contained within holder top 124.
[0118] In some embodiments, the relationship between Adapter 144
and disk 160 is generally for guiding disk 160 to its full proximal
position. Various embodiments do not include features that
pre-stage activation upon insertion of a collection tube 110. The
disk 60 statically stays positioned in the holder top 124 by a
simple interference fit having a reverse draft. Multiple collection
Tubes can be used without activation since activation) retraction
of the needle assembly 140 and disk 160) does not occur until the
Catheter Luer assembly 130 has separated from the Holder 124.
[0119] FIG. 21 show various views of an alternative sliding disk
member 260 according to another embodiment of the present
invention. Sliding member 260 is substantially the same as sliding
member 160 previously described. However, member 260 includes a
cylindrical receptacle 227 that extends generally along the length
of leg 261. This cylindrically shaped receptacle is open on one
side (as best seen in FIGS. 21B and 21E), through which an end of
tube 148 can pass. Preferably, the axial length of receptacle 227
is greater than the length of body 144 of needle assembly 140.
Further, receptacle 227 preferably extends distally a sufficient
amount so that in the first position, the distal end wall of
receptacle 227 extends past the proximal end of body 144. This
substantially full length receptacle provides additional assurance
of proper guiding of assembly 140 in its transition from the first
position to the second position, as well as minimizing any possible
buckling of spring 148 as it expands going from the first position
to the second position.
[0120] Various aspects of different embodiments of the present
invention are expressed in paragraphs X1, X2, X3, X4, X5, X6, X7,
and X8 as follows:
[0121] X1. One aspect of the present invention pertains to an
apparatus for collecting blood in a container and connecting to
intravenous tubing, comprising a collection cavity adapted and
configured to receive therein an end of a readily separable
container; a first hollow needle having a first sharp tip, said
first needle being adapted and configured for insertion of the
first tip into a blood vessel; a second hollow needle having a
second sharp tip extending into the collection cavity; and a
catheter assembly having a body and a hollow lumen and receiving
said first needle within the lumen, the first sharp tip extending
from the distal end of the lumen, the catheter body having a
proximal end adapted and configured for attachment to the
intravenous tubing, said catheter body including a one-way valve;
wherein said first needle and said main body are readily separable
from said catheter assembly, and said one-way valve prevents flow
of blood through the lumen when said first needle is separated from
the lumen.
[0122] X2. Another aspect of the present invention pertains to an
apparatus for collecting blood in a container and connecting to
intravenous tubing, comprising a main body defining an interior
adapted and configured with a readily separable container; a first
retractable hollow needle having a first sharp tip, said first
needle being movable from a first extended position in which the
first sharp tip is exterior to said main body to a second retracted
position in which the first sharp tip is within the interior; a
second hollow needle having a second sharp tip, said second tip not
extending outside of said main body; and a catheter assembly having
a body and a hollow lumen and receiving said first needle within
the lumen, the catheter body having a proximal end adapted and
configured for attachment to the intravenous tubing; wherein said
first needle and said main body are readily separable from said
catheter assembly, said first needle automatically retracting to
the second position in response to separating said first needle
from said catheter assembly.
[0123] X3. Yet another aspect of the present invention pertains to
a method for obtaining a sample of blood in a container from the
circulatory system of a biological unit, comprising providing a
hand-held device defining an interior including a collection cavity
and including first and second hollow needles in fluid
communication with each other and a catheter surrounding the first
needle; inserting the first needle and the surrounding catheter
into the circulatory system; inserting the second needle into the
container; establishing fluid communication from the first needle
to the container; separating the first needle and the catheter; and
automatically retracting the first needle into the interior after
said separating.
[0124] X4. Still another aspect of the present invention pertains
to an apparatus for collecting blood in a container, comprising a
main body including a collection cavity adapted and configured to
receive therein an end of a separable container; a first
retractable hollow needle slidable within said main body and having
a first sharp tip, said first needle having a first extended
position for insertion of the first tip into a blood vessel and a
second retracted position in which the first tip is protected by
said main body; a spring configured to urge said first needle into
the second position; a second hollow needle attached to said main
body and having a second sharp tip extending into the collection
cavity; and a catheter having a hollow lumen and receiving said
first needle within the lumen when said first needle is in the
first position.
[0125] X5. Still another aspect of the present invention pertain to
an apparatus for collecting blood in a container, comprising a main
body including a collection cavity adapted and configured to
receive therein an end of a separable container; a sliding member
guided to slide along a path within the collection cavity from a
first position to a second position and including a cover defining
an aperture; a first retractable hollow needle coupled to said main
body and having a first sharp tip, wherein in the second position
the first tip is protected within said main body; a second hollow
needle attached to said main body and having a second sharp tip
extending through the aperture in the first position into the
collection cavity; and a catheter having a hollow lumen and
receiving said first needle within the lumen when said first needle
is in the first position; wherein said first needle is separated
from said lumen in the second position, and said cover protects the
user from accidental contact with said second needle in the second
position.
[0126] X6. Yet another aspect of the present invention pertains to
an apparatus for collecting blood in a container, comprising a main
body including a collection cavity adapted and configured to
receive therein an end of a separable container; a first
retractable hollow needle slidable within said main body and having
a first sharp tip, said first needle having a first extended
position for insertion of the first tip into a blood vessel and a
second retracted position in which the first tip is protected
within said main body; a second hollow needle fixedly attached to
said main body and having a second sharp tip extending toward the
collection cavity; and a catheter having a hollow lumen and
receiving said first needle within the lumen when said first needle
is in the first position; wherein said first needle is distal to
said second needle in the first position, said first needle is
separated from said lumen in the second position, and which further
comprises a first needle body attached to said first needle,
wherein in the second position said first needle body is received
within the collection cavity.
[0127] X7. Still another aspect of the present invention pertains
to an apparatus for collecting blood in a container, comprising a
main body including a collection cavity adapted and configured to
receive therein an end of a separable container; a first
retractable hollow needle slidable within said main body and having
a first sharp tip, said first needle having a first extended
position for insertion of the first tip into a blood vessel and a
second retracted position in which the first tip is protected
within said main body, said first needle being oriented along a
first axis; a second hollow needle separate from said first needle
and attached to said main body and having a second sharp tip
extending into the collection cavity, said second needle being
oriented along a second axis that is non-coincident with the first
axis; and a catheter having a hollow lumen and receiving said first
needle within the lumen when said first needle is in the first
position; wherein said first needle is separated from said lumen in
the second position.
[0128] X8. Yet another aspect of the present invention pertains to
an apparatus for collecting blood in a container, comprising a main
body including a collection cavity adapted and configured to
receive therein an end of a separable container; a first
retractable hollow needle slidable within said main body and having
a first sharp tip, said first needle having a first extended
position for insertion of the first tip into a blood vessel and a
second retracted position in which the first tip is protected
within said main body; a second hollow needle separate from said
first needle and having a second sharp tip extending into the
collection cavity a flexible tube providing fluid communication
from said first needle to said second needle in the first position;
and a catheter having a hollow lumen and receiving said first
needle within the lumen when said first needle is in the first
position; wherein said first needle is separated from said lumen in
the second position.
[0129] Yet other embodiments pertain to any of the previous
statements X1, X2, X3, X4, X5, X6, X7, or X8 which are combined
with one or more of the following other aspects. It is also
understood that any of the aforementioned X paragraphs include
listings of individual features that can be combined with
individual features of other X paragraphs.
[0130] Which further comprises a transparent member permitting
visualization of the flow of blood to said second needle.
[0131] Which further comprises a second body coupled to said second
needle and providing fluid communication from said first needle to
said second needle, said second body including a gas purging valve
that permits the escape of gas contained in the fluid flowpath from
said first needle to said second needle.
[0132] Wherein said catheter body is coupled to said main body by a
frictional fit.
[0133] Wherein said first needle and said second needle are
unitary.
[0134] Wherein said first needle and said second needle are
non-unitary.
[0135] Which further comprises means for automatically retracting
said first needle.
[0136] Wherein said retraction means includes a spring.
[0137] Which further comprises means for preventing automatic
retraction of the first needle.
[0138] Wherein said preventing means includes a plurality of
fingers each received within a corresponding groove, said main body
including one of said fingers or said grooves and first needle body
including the other of said fingers or said grooves.
[0139] Wherein said preventing means includes a frictional fit
between said catheter body and said main body.
[0140] Wherein after said separating and during said retracting the
catheter remains inserted into the circulatory system.
[0141] Which further comprises blocking said retracting by said
placing.
[0142] Wherein said providing includes a cover of the collection
cavity, and which further comprises automatically locking the cover
to prevent access by the user to the second hollow needle.
[0143] Wherein said locking occurs automatically by said separating
and by removing the container from the collection cavity.
[0144] Which further comprises removing the container from the
cavity after said collecting.
[0145] Which further comprises collecting blood within the
container after said establishing and before said separating.
[0146] Wherein said establishing is by puncturing the container
with the second needle.
[0147] Wherein the device includes a pocket and said retracting is
into the pocket.
[0148] Wherein said retracting is into the collection cavity.
[0149] Wherein said first needle is supported by a needle body
having a ridge, said main body includes a recess, and said spring
urges the ridge apart from the recess.
[0150] Which further comprises a cover for the collection cavity,
and said spring is configured to urge said cover to a position
preventing access to said second hollow needle.
[0151] Wherein said spring is a coil spring.
[0152] Wherein said second needle has an axis, the collection
cavity has a first length along the axis, said second needle
extends into the cavity by a second length along the axis, and the
second length is less than the first length.
[0153] Which further comprises a flexible sheath surrounding the
second sharp tip.
[0154] Wherein said sliding member includes a flexible outwardly
extending ear, said main body includes a groove adapted and
configured to receive the ear therein, said ear and said groove
coacting to prevent movement of said sliding member relative to
said main body when said first needle is in the first position.
[0155] Wherein said sliding member includes a flexible outwardly
extending ear, said main body includes a groove adapted and
configured to receive the ear therein, said ear and said groove
coacting to prevent movement of said sliding member relative to
said main body when said first needle is in the second
position.
[0156] Wherein said sliding member includes an internal pocket,
said first needle is received within a first needle body, and said
first needle body is coupled to said main body in said first
position, and said first needle body is received within the pocket
in the second position.
[0157] Wherein said sliding member includes a first feature having
a cross sectional shape, said main body includes a second feature
having a shape complementary to the shape of the first feature, and
said first feature and said second feature coact to guide the
sliding of said sliding member along the path.
[0158] Wherein the cavity has an inner diameter and the cover has
an outer diameter substantially the same but less than the inner
diameter.
[0159] Which further comprises a cover slidable within the
collection cavity, said main body has a distalmost end, and said
first needle is located between the distalmost end and the cover in
the second position
[0160] Which further comprises a cover slidable within the
collection cavity from a first position in which an aperture of
said cover surrounds said first needle, to a second position in
which said cover closes the collection cavity and prevents access
to said second sharp tip.
[0161] Which further comprises a spring adapted and configured to
urge apart said main body and said first needle body.
[0162] Wherein said first needle body applies a force from said
spring to urge said cover to the second position.
[0163] Wherein the first axis and the second axis are parallel.
[0164] Wherein the first axis and the second axis are displaced
from one another.
[0165] Wherein the first axis and the second axis are not
parallel.
[0166] Wherein the second axis extends upward relative to the first
axis.
[0167] Wherein said tube is adapted and configured to provide fluid
communication from said first needle to said second needle in the
second position.
[0168] Wherein said main body includes a window, and said flexible
tube can be viewed through the window.
[0169] Wherein in the first position said first needle is generally
distal to said second needle, and in the second position said first
needle is generally adjacent to said second needle.
[0170] Wherein said first needle is received within a first needle
body, wherein said sliding member includes a receptacle for
receiving said hollow needle body, said receptacle at least
partially enclosing said hollow needle body in the first
position.
[0171] While the inventions have been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only certain embodiments have been shown and
described and that all changes and modifications that come within
the spirit of the invention are desired to be protected.
* * * * *