U.S. patent application number 09/778201 was filed with the patent office on 2002-08-08 for needle enclosing safety catheter.
Invention is credited to Cook, Daniel J..
Application Number | 20020107483 09/778201 |
Document ID | / |
Family ID | 25112591 |
Filed Date | 2002-08-08 |
United States Patent
Application |
20020107483 |
Kind Code |
A1 |
Cook, Daniel J. |
August 8, 2002 |
NEEDLE ENCLOSING SAFETY CATHETER
Abstract
A catheter and needle system includes a solid piercing needle, a
catheter, and a needle tip enclosure, as well as a method of
utilization. The solid needle reduces the possibility of
transmitting infectious agents to a user otherwise resulting from
accidental needle punctures. The system has two configurations, a
first for inserting the assembly into a patient, and a second for
withdrawing and disposing of the piercing needle. The catheter has
means for receiving, delivering and viewing fluids at the insertion
site. The needle and enclosure operate cooperatively to enable
medical procedures to be conducted without hinderance, and to
automatically cleanse and enclose the piercing portion of the
needle upon withdrawal. The system also provides for the safe
withdrawal of the needle without the need to disturb the catheter
once it is inserted.
Inventors: |
Cook, Daniel J.; (Richmond
Heights, MO) |
Correspondence
Address: |
THOMPSON COBURN, LLP
ONE FIRSTAR PLAZA
SUITE 3500
ST LOUIS
MO
63101
US
|
Family ID: |
25112591 |
Appl. No.: |
09/778201 |
Filed: |
February 6, 2001 |
Current U.S.
Class: |
604/164.01 |
Current CPC
Class: |
A61M 2005/325 20130101;
A61M 25/0618 20130101; A61M 5/3273 20130101 |
Class at
Publication: |
604/164.01 |
International
Class: |
A61M 005/178 |
Claims
What is claimed is:
1. A catheter and needle assembly comprising: a catheter having a
body defining an interior passageway with a distal and a proximal
opening, a solid needle having a shaft and a distal tip, a needle
tip enclosure at the catheter's proximal opening, said enclosure
containing a cavity therethrough; said needle shaft having a length
sufficient to extend through the enclosure cavity and the catheter
passageway so that said needle tip emerges at the catheter distal
opening, said passageway and needle being cooperatively structured
to provide a flow channel in the catheter passageway for bodily
fluids; and said needle being of a size which permits it to be
withdrawn from the catheter such that the needle tip enters the
enclosure cavity through a distal orifice of the enclosure, said
needle tip being shaped to prevent egress of the needle tip from
the cavity through a proximal orifice, and said enclosure, upon
passage of the needle tip into the cavity through the distal
orifice, preventing reemergence of the needle tip from the distal
orifice, thereby trapping the needle tip in the needle tip
enclosure.
2. The catheter and needle assembly of claim 1 wherein at least a
portion of the longitudinal extent of the catheter body is
transparent for viewing said interior passageway.
3. The catheter and needle assembly of claim 1 wherein at least a
portion of the needle tip enclosure is transparent for viewing said
cavity.
4. The catheter and needle assembly of claim 1 wherein said flow
channel is an open volume within the interior passageway that is
unoccupied by the needle shaft.
5. The catheter and needle assembly of claim 1 wherein said flow
channel is formed by a longitudinal groove in the needle.
6. The catheter and needle assembly of claim 1 wherein said
catheter body has an aperture proximate the distal opening for
entry of bodily fluids to the interior passageway.
7. The catheter and needle assembly of claim 1 wherein said needle
tip is of a greater width in at least one direction transverse to
its longitudinal extent than the width of the needle shaft in said
transverse direction.
8. The catheter and needle assembly of claim 7 wherein said
enclosure proximal orifice is of a lesser width than the maximum
width of the needle tip in said one transverse direction.
9. The catheter and needle assembly of claim 1 further including a
vent from the enclosure cavity.
10. The catheter and needle assembly of claim 1 wherein a
transverse cross-section of the needle tip substantially
corresponds to a transverse cross-section of the enclosure
cavity.
11. The catheter and needle assembly of claim 1 wherein the
transverse cross-section of the enclosure cavity substantially
corresponds to the transverse cross-section of the catheter
interior passageway.
12. The catheter and needle assembly of claim 1 wherein the
enclosure cavity includes a blocking member that prevents
reemergence of the needle tip by obstructing a portion of the
enclosure cavity once the needle tip is sufficiently far into the
enclosure cavity.
13. The catheter and needle assembly of claim 12 wherein the
blocking member is biased towards the enclosure cavity, and removal
of the needle from the vicinity of the blocking member allows the
blocking member to move in response to the bias to obstruct a
portion of the enclosure cavity.
14. The catheter and needle assembly of claim 12 wherein the
obstructing of a portion of the enclosure cavity by the blocking
member is selectively controllable.
15. The catheter and needle assembly of claim 12 wherein the
blocking member is seated in a receiving indentation in an interior
wall of the enclosure cavity when obstructing a portion of the
enclosure cavity.
16. The catheter and needle assembly of claim 1 wherein said needle
and enclosure with enclosed needle tip is detachable from said
catheter.
17. A method of inserting a catheter and needle assembly comprising
the steps of: providing a catheter and needle assembly which
includes; a catheter having a body defining an interior passageway
with a distal and a proximal opening, a solid needle having a shaft
and a distal tip, a needle tip enclosure at the catheters proximal
opening, said enclosure containing a cavity therethrough; said
needle shaft having a length sufficient to extend through the
enclosure cavity and the catheter passageway such that said needle
tip emerges at the catheter distal opening when in a first
configuration; said passageway and needle being cooperatively
structured to provide a flow channel for bodily fluids in the
catheter passageway when in said first configuration; said needle
being of a size to permit withdrawal from the catheter such that
the needle tip can enter the enclosure cavity through a distal
orifice of the enclosure, said needle tip being shaped to prevent
egress of the needle tip from the cavity through a proximal orifice
of the enclosure, and said enclosure, upon passage of the needle
tip into the cavity through the distal orifice, prevents
reemergence of the needle tip from the distal orifice; wherein said
catheter and needle assembly is in a second configuration when said
needle tip is withdrawn from the catheter into the enclosure and is
prevented from reemergence; disposing said catheter and needle
assembly in said first configuration and inserting the catheter and
needle assembly into a patient; and then shifting said catheter and
needle assembly, following insertion, from said first configuration
into said second configuration.
18. The method according to claim 17 including the additional step
of: detaching the needle and enclosure with enclosed needle tip
from the catheter, which is left inserted.
19. A method of inserting a catheter and needle assembly comprising
the steps of: providing a catheter and needle assembly which
includes; a catheter having a body defining an interior passageway
with a distal and a proximal opening, a solid needle having a shaft
and a distal tip, a needle tip enclosure at said proximal opening,
said enclosure containing a cavity therethrough, wherein at least a
portion of said enclosure is transparent for viewing into the
cavity; said needle shaft having a length sufficient to extend
through the enclosure cavity and the catheter passageway so that
said needle tip emerges at said distal opening when in a first
configuration; said passageway and needle being cooperatively
structured to provide a flow channel in said passageway for bodily
fluids when in said first configuration; said needle being of a
size which permits it to be withdrawn from the catheter such that
said needle tip can enter said cavity through a distal orifice of
the enclosure, said needle tip being shaped to prevent egress of
the needle tip from said cavity through a proximal orifice of the
enclosure, and said enclosure, upon passage of said needle tip into
the cavity through the distal orifice, prevents reemergence of said
needle tip through the distal orifice; wherein said catheter and
needle assembly is in a second configuration when said needle tip
is withdrawn from the catheter into said enclosure and is prevented
from reemergence; disposing said catheter and needle assembly in
said first configuration and inserting said catheter and needle
assembly into a patient; inspecting said transparent portion of the
housing for the presence of blood in the enclosure cavity; shifting
said catheter and needle assembly, after determining blood is
present in the enclosure cavity, from said first configuration into
said second configuration.
20. The method according to claim 19 including the additional step
of: detaching the needle and the enclosure with enclosed needle tip
from the catheter, which is left inserted.
21. A method of inserting a catheter and needle assembly comprising
the steps of: providing a catheter and needle assembly which
includes; a catheter, a solid needle having a shaft and a needle
tip, and a needle tip enclosure; said catheter forming a hollow
conduit with a distal opening, a proximal opening, and an aperture,
said openings and aperture in fluid communication with an open
volume within said conduit, said aperture in the vicinity of said
distal opening, said open volume extending continuously between
said openings; said needle sized to slide within said conduit so
that said shaft extends through but does not obstruct said conduit
open volume and said needle tip emerges from and forms a seal with
said distal opening when said catheter and needle assembly is in a
first configuration; said enclosure containing a cavity and having
a distal orifice, a proximal orifice, and a transparent window
providing visual inspection of said cavity, said distal orifice
sized to allow passage of said needle shaft and said needle tip and
said proximal orifice sized to allow passage of said needle shaft
but not of said needle tip; disposing said catheter and needle
assembly in said first configuration wherein, said enclosure distal
orifice is joined to said catheter proximal opening so that said
catheter open volume and said enclosure cavity are in fluid
communication; and said needle shaft passes through said catheter
open volume and said enclosure cavity without obstruction of
continuous fluid communication therethrough; and then inserting
said catheter and needle assembly sufficiently far into a blood
vessel of a patient so that blood enters said catheter open volume
through said aperture; inspecting said cavity for blood entering
from said catheter open volume; and confirming correct insertion of
said catheter by viewing the presence of blood within said
cavity.
22. The method according to claim 21 wherein said enclosure further
includes a needle tip retaining device for preventing reemergence
of said needle tip after said needle tip enters into said enclosure
cavity.
23. The method according to claim 22 including, upon confirming
said catheter is correctly inserted, the additional steps of:
withdrawing said needle through said catheter and said enclosure
until said needle tip enters and is retained within said enclosure;
and detaching said needle and enclosure with retained needle tip
from the catheter, which is left inserted.
24. The method as set forth in claim 23 wherein the enclosure is
moved distally simultaneous with proximal movement of the
needle.
25. The method as set forth in claim 23 wherein movement of the
needle with respect to the enclosure includes a wiping action,
thereby cleaning the needle as it is withdrawn.
26. A method of inserting a catheter and needle assembly comprising
the steps of: providing a catheter and needle assembly which
includes; a catheter, a solid needle having a needle tip, and an
enclosure; said catheter having an aperture formed in the vicinity
of its distal end, said aperture in fluid communication with an
open volume within said catheter; said enclosure at a proximal end
of said catheter, said enclosure containing a cavity in fluid
communication with said open volume within said catheter, said
enclosure being at least partially transparent for viewing said
cavity; inserting said catheter and needle assembly sufficiently
far into a blood vessel of a patient so that blood enters said
catheter open volume through said aperture; viewing said cavity for
blood entering said cavity from said catheter open volume; and
confirming correct insertion of said catheter by viewing blood
within said cavity.
27. A catheter and needle assembly comprising: a catheter having a
body defining an interior passageway with a distal and a proximal
opening, a needle having a shaft and a distal tip, a flash chamber
in fluid communication with the interior passageway of the
catheter, said needle and flash chamber being relatively movable
with respect to each other; said needle shaft having a length
sufficient to extend through the flash chamber and the catheter
passageway so that said needle tip emerges at the catheter distal
opening, said passageway and needle providing a flow channel for
bodily fluids to the flash chamber; and said needle being of a size
which permits it to be withdrawn from the catheter.
28. The catheter and needle assembly of claim 27 wherein at least a
portion of the flash chamber is transparent.
29. The catheter and needle assembly of claim 27 wherein appearance
of bodily fluids in the flash chamber occurs upon placement of the
distal end of the catheter in a vein of a human body.
30. The catheter and needle assembly of claim 27 wherein the needle
and flash chamber are configured to minimize the total body fluid
volume in the flash chamber.
31. The catheter and needle assembly of claim 27 wherein the flash
chamber is movable distally away from a user of the assembly after
the needle is inserted in a blood vessel of a human body so as to
position blood contained in the flash chamber away from the hand of
a user holding the proximal portion of the catheter and needle
assembly.
32. A catheter and needle assembly comprising: a catheter having a
body defining an interior passageway with a distal and a proximal
opening, a solid needle having a shaft and a distal tip, said
needle shaft having a length sufficient to extend through the
catheter passageway so that said needle tip emerges at the catheter
distal opening, said passageway and needle being cooperatively
structured to provide a flow channel in the catheter passageway for
bodily fluids; and said needle being of a size which permits it to
be withdrawn from the catheter, said catheter body having an
aperture proximate the distal opening for entry of bodily fluids to
the interior passageway.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
BACKGROUND OF THE INVENTION
[0003] Numerous medical procedures involve the insertion of
intravenous devices into patients with varying medical conditions.
Among these medical conditions are a number of diseases that also
present a risk of infection to the medical practitioner providing
care. The insertion of intravenous devices generally requires the
use of a sharp implement, which conventionally has been a hollow
bore needle, for piercing the skin to allow insertion of a hollow
catheter. The distal end of the catheter must be inserted into, but
not through, a blood vessel. Normally, proper placement of the
catheter is confirmed by visual observation of a "flash-back" of
blood that passes through the hollow needle into a stationary flash
chamber located at the proximal end of the catheter assembly, where
it is visualized. Once the catheter has been inserted to the proper
position within the blood vessel, the sharp implement needs to be
withdrawn and properly discarded. The acts of withdrawal and
disposal pose the greatest threat to the health of the
practitioner, since the implement remains sharp enough to pierce
skin and is potentially carrying an infectious agent. With the
prior art designs, the hollow needle and flash chamber contain a
rather large amount of potentially infectious blood, with the
result that inadvertent skin puncture of the practitioner can lead
to significant transference of infectious agent from the patient to
the practioner.
[0004] A system for providing protection from the risk of infection
during withdrawal and disposal of a piercing instrument must
accommodate various operational constraints. A primary constraint
is to minimize interference with the execution of the medical
procedure prior to withdrawal and disposal. Accordingly, the system
should minimize or eliminate additional steps and preferably should
not significantly alter the steps performed without the system.
Medical care often occurs in stressful and hurried situations and
hence, ease of use is a second constraint. Preferably, the system
should not compel the practitioner to carry out any but the most
minimal actions to accomplish safe withdrawal and disposal.
Additional constraints include cost and ease of construction,
compatibility with existing equipment, and adaptability of use
across variations in patients and insertion locations.
[0005] A very desirable benefit of such systems would be reduction
in the risk of accidental infection. Risk of infection can be
reduced by, inter alia, automatic operation, encapsulation of the
piercing implement, and a reduction in the fluid and tissue volume
associated with piercing instrument removal -- since greater volume
potentially increases the amount of the infectious agent present.
Risk can also be reduced by quick operation. If the system is
effective simultaneously with, or at least immediately subsequent
to withdrawal, exposure of the piercing instrument is minimized, as
is the risk of accidental infection.
[0006] Numerous approaches to providing a safer withdrawal and
disposal system have been employed, though two general categories
of systems predominate. One category of system deploys a secondary
sheath between a needle and a catheter to envelope the needle upon
withdrawal from the piercing site, prior to complete withdrawal of
the secondary sheath and needle from the catheter. This category of
system is relatively sizable and complex, yet still poses a risk of
reemergence of the needle. Preventing reemergence may necessitate
even more apparatus. Withdrawal is also generally associated with
emission of a significant amount of body fluid with this category
of system, among other adverse consequences. The second category of
system involves affixing a point guard about the tip of the
piercing instrument after withdrawal. This approach often requires
substantial complexity and substantial additional actions to
implement. What's more, with this second category of system, better
execution of one desirable benefit, such as secure encapsulation of
a piercing instrument, is often exchanged for a poorer execution of
another desirable benefit, such as automatic operation.
[0007] As mentioned above, most prior approaches utilize a hollow
needle (in fluid communication with a stationary flash chamber
having a relatively large volume) for piercing. Hollow needle and
flash chamber assemblies, however, present a risk of exposure to
the body fluids they contain when the needle is withdrawn. In fact,
research reveals that the risk of infection from a hollow needle is
many times greater than that from a solid needle. This difference
probably arises from the large reservoir of blood within the hollow
needle and flash chamber assembly, that then becomes the source of
inoculation when inadvertent needle stick injuries occur. Solid
needles, on the other hand, have no such reservoir for inoculation.
Moreover, when using a hollow needle with a catheter the user may
receive an incorrect "flashback" signal. The "flashback" signal is
the entry, or "flashing" , of blood into a viewing chamber (called
the flashback chamber) in the interior of the catheter and needle
system. The flash occurs when a blood vessel is entered and blood
can flow into the catheter interior. Hollow needles allow blood to
flow into the catheter interior even if only the needle, but not
the catheter, has entered the blood vessel. Hence, the user must
guess to what degree it is necessary to further insert the needle
and catheter, after observing the flashback, to ensure that the
catheter is correctly inserted. A system providing greater
certainty of correct catheter insertion is preferable.
SUMMARY OF THE INVENTION
[0008] The objectives of the present invention include:
[0009] The provision of an improved piercing system which entails a
minimum of hindrance to the optimum execution of a medical
procedure.
[0010] The provision of an improved piercing system that requires
minimum additional actions following the execution of a medical
procedure such as the insertion of a catheter.
[0011] The provision of an improved piercing system that requires
minimal alterations of the actions involved in the execution of a
medical procedure such as the insertion of a catheter.
[0012] The provision of an improved piercing system with ease of
use sufficient to curtail any additional demands on the medical
practitioner's attention.
[0013] The provision of an improved piercing system that requires
minimal additional actions by the medical practitioner to realize
the improvement in safety.
[0014] The provision of an improved system and method for catheter
insertion using a solid needle to reduce the possibility of
infection transference.
[0015] The provision of an improved piercing system that is
relatively inexpensive.
[0016] The provision of an improved piercing system of simplified
construction.
[0017] The provision of an improved piercing system compatible with
existing medical equipment.
[0018] The provision of an improved piercing system adaptable for
use across variations in patients and piercing locations.
[0019] The provision of an improved piercing system that reduces
the risk of accidental infection.
[0020] The provision of an improved piercing system that operates
automatically.
[0021] The provision of an improved piercing system that completely
encloses the penetrating elements of the piercing instrument.
[0022] The provision of an improved piercing system that reduces
the amount of fluids and tissue which accompany withdrawal of the
piercing instrument.
[0023] The provision of an improved piercing system that occurs
sufficiently fast to be in effect simultaneously with or at least
immediately after withdrawal of the piercing instrument.
[0024] The provision of an improved piercing system, comprised of a
catheter and needle, that gives visual confirmation only when the
catheter is correctly inserted, and not when just the needle is
correctly inserted.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a longitudinal partial
cross-section top plan view of a first embodiment of the present
invention in a first configuration.
[0025] FIG. 1B is a longitudinal cross-section top plan view of a
catheter portion of the first embodiment of the present invention
depicted in FIG. 1A.
[0026] FIG. 2 is a longitudinal partial cross-section top plan view
of two parts of the first embodiment of the present invention in a
second configuration.
[0027] FIG. 3 is a longitudinal cross-sectional elevation of the
first embodiment of the present invention, in the configuration of
FIG. 1A.
[0028] FIG. 3A is a cross-section view along line 3A-3A in FIG. 3
of a needle element of the first embodiment of the present
invention.
[0029] FIG. 4 is a longitudinal cross-sectional elevation of the
first embodiment of the present invention, in the second
configuration shown in FIG. 2.
[0030] FIG. 5 is a longitudinal cross-sectional elevation similar
to a portion of FIG. 3, illustrating a second embodiment of the
present invention.
[0031] FIG. 5A is a cross-sectional view along line 5A-5A of
portions of catheter and needle elements of the second embodiment
of the present invention.
[0032] FIG. 6 is a view along the longitudinal axis 12 in the
direction 12P of FIG. 1A, of a catheter and needle tip of a third
embodiment of the present invention. Similar reference characters
indicate similar parts throughout the several views of the
drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0033] In FIGS. 1A, 1B & 2-4 a first embodiment of a catheter
and needle assembly 10 of the present invention is shown in two
configurations. A first configuration for insertion of the catheter
and needle assembly is depicted in FIGS. 1A & 3. Two components
of the catheter and needle assembly, in a second configuration for
safe withdrawal and disposal following insertion, is depicted in
FIGS. 2 & 4.
[0034] Referring now to FIG. 1A, a first embodiment of a needle tip
enclosing catheter and needle assembly 10 in the first
configuration is depicted in partial cross-section. The catheter
and needle assembly has a longitudinal axis 12, with a proximal
direction 12P and a distal direction 12D. Directions referred to
hereafter as transverse are perpendicular to the longitudinal axis
12. It should be understood that in the FIGS. the catheter and
needle assemblies are depicted in straight linear configurations
for purposes of clarity only. Depending upon the application, the
catheter and needle assembly may have both flexible and inflexible
portions. Accordingly, axis 12, though depicted as a straight line,
may also be curvilinear in correspondence to the actual disposition
of assembly 10 when in use. In a case of curvilinear disposition,
directions 12P and 12D indicate relative directions along the
longitudinal extent of the catheter and needle assembly. The
direction 12P is along axis 12 pointing towards the proximal end of
the assembly, and the direction 12D is along axis 12 pointing
towards the distal end of the assembly.
[0035] FIG. 1B is a cross-section view of a catheter 20 employed in
the first embodiment. Catheter 20 has a proximal base 22 with a
plurality of flanges 24 that flare transversely. Base 22 adjoins a
transitional section 26 which connects to a conduit 28. Conduit 28
terminates in a distal tip 30. An opening 32 is formed in distal
tip 30.
[0036] Returning to FIG. 1A, catheter 20 is shown in relation to
the other parts of the assembly 10 when in the first configuration
for insertion into a blood vessel (not shown). An aperture 34
proximate tip 30 is in fluid communication with an interior
passageway 36 -- seen in FIG. 1B --of catheter 20. A catheter hub
38 securely mates with a needle tip enclosure 50 at a distal
enclosure adaptor 52. Enclosure 50 has an enclosure housing 54,
which includes a plurality of intermediate side tabs 56. A proximal
portion 58 of enclosure housing 54 has a proximal orifice 60 formed
therein. Proximal orifice 60 is in fluid communication with a
cavity 62. Cavity 62 runs longitudinally through enclosure housing
54 to a distal orifice 64.
[0037] Referring now to FIG. 2, a cross-section view of needle tip
enclosure 50 is depicted in the second configuration, following
successful insertion of catheter 20 into a blood vessel (not
shown). Within the cavity 62 is a blocking member 66, seen end-on.
When in the second configuration, the position of blocking member
66 obstructs movement through the cavity 62.
[0038] In FIG. 4, blocking member 66, forced by a spring 67 (or by
any other conventional device or material), crosses cavity 62 and
contacts an interior wall 68 of the enclosure housing 54. Housing
54 has first and second sides 70 and 72. In a proximal portion of
side 72 is a vent 74 from the cavity 62.
[0039] Referring again to FIG. 2, a solid piercing needle 80 and
enclosure 50 are depicted in the second configuration. The solid
needle 80 has a distal tip 82 and a shaft 84 (shown to be
semi-elliptical in cross-section--FIG. 3A), and is attached to a
proximal control elemental 86. In FIG. 3, needle tip 82 is seen to
have a proximal face 88 at the boundary between the tip 82 and the
shaft 84.
[0040] In operation, assembly 10 is initially in the first
configuration (shown in FIGS. 1A and 3) for inserting catheter 20
by piercing the skin with solid needle tip 82. In the first
configuration, enclosure adaptor 52 is fully engaged in hub 38,
needle 80 is at its farthest distal position in catheter 20 and
needle enclosure 50, and needle tip 82 emerges from the distal
opening 32 in readiness for piercing the skin of the patient.
During insertion, needle control element 86 is flush against the
enclosure 50 with needle shaft 84 passing throughout the enclosure
cavity 62 and the catheter interior passageway 36. Within cavity
62, needle shaft 84 confines the blocking member 66 to a first
position that is not obstructing cavity 62 as depicted in FIG. 3.
Also in the first configuration, the proximal face 88 of needle tip
82 is disposed distally past aperture 34, to allow passage of
bodily fluids through aperture 34 and into an open space 90 within
interior passageway 36. The space 90 is the fraction of interior
passageway 36 and cavity 62 not occupied by needle shaft 84. Vent
74 is closed by a well-known air permissible plug 91 that allows
air to escape from housing 54 but prevents the escape of blood or
other body fluids. At least a portion of housing 54 is preferably
transparent to form a movable flashback chamber (space 90 and vent
74) which is visible to the user. When aperture 34 enters the blood
vessel, blood flows along space 90 into housing 54 where it is
visible to the user through the transparent portion (not depicted)
of housing 54. In contrast to prior approaches, the flow of blood
along space 90 does not occur immediately upon insertion of the
needle 80 into a blood vessel. The prior approaches use hollow
needles that allow blood flow through the hollow needle and into
the catheter and into a hollow flash chamber in the proximal
portion of the apparatus. These approaches allow the blood flow
into the catheter and flash chamber even if the needle is inserted
in the blood vessel, but the catheter is not. Hence, there is a
degree of uncertainty as to whether the catheter is correctly
inserted with the prior approaches. The solid needle 80, catheter
20, and aperture 34 of the present invention cooperate to allow
blood flow into space 90 only once the catheter 20 is correctly
inserted such that aperture 34 of catheter 20 has entered a blood
vessel. This "flashback" of blood indicates proper placement of
catheter 20. Inspection of the flash chamber allows the medical
practitioner inserting the catheter and needle assembly 10 to
visually determine if the assembly is correctly inserted, i.e., the
catheter tip containing aperture 34 has entered the blood
vessel.
[0041] After insertion of catheter 20, removal and disposal of
needle 80 will follow. Once the catheter and needle assembly 10 is
inserted into a blood vessel, needle enclosure 50 is moved distally
along direction 12D (FIG. 1A) while simultaneously needle 80 is
withdrawn proximally along direction 12P until needle tip 82 is
completely within enclosure 50. This movement of enclosure or
housing 50 distally relative to the proximal movement of needle 80
automatically disposes catheter 20 within the blood vessel. The
transition to the second configuration is complete when needle tip
82 is locked within enclosure 50 by blocking member 66 crossing
cavity 62. Needle 80 and enclosure 50 are usually then separated
from catheter 20, which is left inserted in the blood vessel. Also
the construction and operation of enclosure 50, as it moves
proximally along direction 12P from configuration 1 (shown in FIGS.
1A and 3) to configuration 2 (shown in FIGS. 2 and 4), in
cooperation with the construction of needle 80, automatically
effects a cleansing and encapsulation of needle 80.
[0042] Beginning from the first configuration (FIG. 1A, 3),
withdrawal is initiated by movement of needle 80 in the proximal
direction 12P relative to catheter 20 and enclosure 50. Proximal
orifice 60 is constructed to fit closely to, while still allowing
relatively unimpeded travel of, shaft 84. This close fit provides
at least two functional benefits. The first benefit is the
prevention of escape of needle tip 82 from enclosure 50 in the
direction 12P, since the needle tip cross-section is too great to
pass through proximal orifice 60. The second benefit, as a result
of the close fit of proximal orifice 60 to shaft 84, is a wiping
off of body fluids and tissue from shaft 84 as it passes through
proximal orifice 60. This wiping reduces the medical practitioner's
exposure to infectious agents along shaft 84 by limiting the
emission of fluids and tissues that accompanies the withdrawal of
needle 80. Once the needle tip 82 has left catheter 20, needle tip
82 enters cavity 62. As enclosure 50 moves distally and needle 80
simultaneously moves proximally, fluids in space 90 pass around tip
82 and remain within catheter 20 or exit into vent 74, as a result
of the relatively loose fit between the body of catheter 20 and
needle 80. Vent cap 91 prevents egress of fluids outside enclosure
50. This movement of fluids out of space 90 during the transition
from configuration 1 to configuration 2 minimizes the total fluid
held within enclosure 50 at the completion of catheter insertion.
This in turn minimizes the volume of potential contaminants to
which the practitioner is exposed.
[0043] Upon sufficient movement of the needle proximally into
cavity 62, needle tip 82 passes blocking member 66, thereby
releasing blocking member 66. Upon release, member 66 is moved by
spring 67 (or other suitable flexible material or structure) to the
position shown in FIG. 4 in which it blocks cavity 62, thereby
trapping tip 82 in enclosure 50. Alternatively, the housing
interior wall 68 may have a recess (not depicted) that the blocking
member 66 fits into for a more secure closure of cavity 62. The
presence of member 66 blocking cavity 62 is a barrier to the
reemergence of needle tip 82. When positioned across cavity 62,
blocking member 66 also tends to prevent passage of fluids and
tissues from cavity 62 and vent 74 through distal orifice 64. Also
during transition from configuration 1 to configuration 2 the total
volume of blood contained within the flash chamber of enclosure 50
has been minimized and positioned distally away from the
practitioner, thereby potentially decreasing the likelihood of
exposure. The operation of enclosure 50 is automatic upon removal
of the needle 80 and requires minimal additional or altered actions
by the medical practitioner. The movement of catheter 20 into the
blood vessel following catheter tip placement occurs automatically
during proximal movement of enclosure 50 along needle 80. Once
entirely removed, needle tip 82 is contained within enclosure 50,
and needle 80 and enclosure 50 can be discarded without exposing
the practitioner to contaminated needle tip 82.
[0044] Viewed in cross-section along line 3A-3A in FIG. 3, FIG. 3A
shows how the spatial relationships of catheter 20 and needle shaft
84 provide the space 90. In alternate embodiments (not depicted),
shaft 84 may occupy a lesser amount of the cross-sectional area of
catheter 20. In these embodiments, the space 90 will be a greater
fraction of the cross-sectional area of catheter 20, and space 90
may also extend around the sides or below needle shaft 84.
[0045] The transverse cross-section of catheter 20 and needle 80,
as well as the form of the needle tip 82, can differ both in size
and shape in various embodiments. Particular medical applications
will preferentially utilize specific configurations, including both
symmetrical and asymmetrical structures. The movable transparent
flash chambers can also differ in size, shape and topography in
various embodiments of the present invention when advantageous.
[0046] Referring now to FIGS. 5, a second embodiment of the present
invention is partially depicted in cross-section. Significant
modifications from the prior embodiment include: the form of a
needle tip 82A, the relation of tip 82A to a shaft 84A, and the
form of a proximal face 88A. The disposition of needle shaft 84A
within space 90 is also altered, in part, due to the modified
relation of tip 82A to shaft 84A. Needle shaft 84A having the
option, as depicted, of a relatively lesser cross-sectional area
than needle shaft 84 also contributes to its altered disposition
within space 90. FIG. SA shows both the transverse cross-section of
needle shaft 84A within the space 90, and the proximal portion 88A
of needle tip 82A. The axial position of needle shaft 84A is
approximately centered in relation to the distal tip 82A. The
embodiment depicted in FIGS. 5 & 5A is well suited for
providing an alternative option in medical circumstances, such as
pediatric care, where a catheter with a lesser width 92 is
desirable.
[0047] Referring now to FIG. 6, a third embodiment of the present
invention is depicted in an increased scale relative to FIG. 5.
FIG. 6 shows an alternative needle tip 82B which is differentiated
from needle tip 82A of FIGS. 5 & 5A by the presence of a needle
groove 94. Needle groove 94 extends longitudinally through the tip
82B and may also extend along a portion of the length of a shaft
84B, partially seen through a gap 96 formed by the sides of groove
94 and a catheter 20B. Catheter 20B is identical to the catheter 20
of the previous embodiments except for a lack of aperture 34.
Groove 94 is of sufficient depth to allow the flow of bodily fluids
through gap 96 between the boundaries of groove 94 and catheter
20B, into the open space 90. As depicted, the radius of shaft 84B
is greater than is the radius of tip 82B at the bottom of groove
94. Alternatively, the bottom of groove 94 may reach to a lesser
depth (not depicted), such that the radius of tip 82B at the bottom
of groove 94 is not less than the radius of the shaft 84B. An
additional alternative embodiment (not depicted) would continue
groove 94 along part or all of shaft 84B to further increase the
space 90 available for blood flow. A distal point 98 of needle tip
82B is seen to be off-centered, relative to the longitudinal axis
12. The distal point 98 may also be arranged to one side or the
other of groove 94 (not depicted) or centered (not depicted)
relative to the longitudinal axis 12. These variations in the
disposition of distal point 98 may also be optionally employed with
any of the other embodiments of the present invention.
[0048] A variety of physical mechanisms can serve as the blocking
member 66. Although only one example is depicted herein for
illustrative purposes, numerous variations in the construction of
the blocking member 66, variations in the means of biasing towards
a blocking position, as well as variations in the means of
effecting a blocking action upon needle withdrawal are within the
scope of the present invention. The various applicable mechanisms
are well known to those of skill in the art, and do not compromise
elements essential to the present invention.
[0049] In view of the above, it will be seen that the various
objects and features of the invention are achieved and other
advantageous results obtained. The examples contained herein are
merely illustrative and are not intended in a limiting sense.
* * * * *