U.S. patent application number 17/033325 was filed with the patent office on 2021-01-14 for catheter assembly with segmented stabilization system.
The applicant listed for this patent is ARROW INTERNATIONAL LLC. Invention is credited to Robert J. Anderson, Joshua J. GALGANO, Hanjun KIM.
Application Number | 20210008347 17/033325 |
Document ID | / |
Family ID | 1000005107813 |
Filed Date | 2021-01-14 |
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United States Patent
Application |
20210008347 |
Kind Code |
A1 |
GALGANO; Joshua J. ; et
al. |
January 14, 2021 |
CATHETER ASSEMBLY WITH SEGMENTED STABILIZATION SYSTEM
Abstract
A catheter assembly with segmented or step-wise deployment
stabilization system includes a base or handle, puncture needle
extending from the handle, and a deployment mechanism or mechanisms
to selectively extend from the distal end of the needle for first
length a hollow stabilizing component and as a second step to a
second further length a stabilizing guide wire element. The hollow
stabilizing component has some degree of flexibility as does the
guide wire to minimize chance of damage to surrounding tissue. The
user can feel resistance and have the opportunity to retract either
component and attempt redeployment without a retraction of the
puncture needle and a second poke of the patient's skin. In the
example for peripheral venous catheterization, the system reduces
the probability of blood vessel puncture. The deployment mechanism
can have a guiding system which ensures the proper sequence of
deployment.
Inventors: |
GALGANO; Joshua J.; (Silver
Spring, MD) ; KIM; Hanjun; (Pittsburgh, PA) ;
Anderson; Robert J.; (North Liberty, IA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ARROW INTERNATIONAL LLC |
Morrisville |
NC |
US |
|
|
Family ID: |
1000005107813 |
Appl. No.: |
17/033325 |
Filed: |
September 25, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14782422 |
Oct 5, 2015 |
10786653 |
|
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PCT/US2014/033012 |
Apr 4, 2014 |
|
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17033325 |
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61808982 |
Apr 5, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/09 20130101;
A61M 25/0606 20130101; A61B 17/3403 20130101; A61M 2025/0681
20130101; A61M 25/0662 20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 25/09 20060101 A61M025/09 |
Claims
1. An apparatus designed for facilitating subcutaneous insertion of
a catheter comprising: a hollow needle assembly comprising a hollow
needle having a longitudinal axis and a distal end; and a hollow
stabilizing component assembly comprising a hollow stabilizing
component having a longitudinal axis and a distal end, the hollow
stabilizing component coaxial to and selectively movable between a
retracted position along the longitudinal axis of the needle to a
deployed position extended past the distal end of the needle;
wherein the needle is configured to provide subcutaneous access and
the hollow stabilizing component is configured to provide a first
support and guide section extendible from the needle.
2. The apparatus of claim 1, further comprising an additional
stabilizing component selectively movable between a retracted
position along the longitudinal axis of the hollow stabilizing
component to a deployed position extended from the distal end of
the hollow stabilizing component so that the needle is operable to
provide subcutaneous access, wherein the hollow stabilizing
component providing a first support and guide section extendible
from the needle, and the additional stabilizing component providing
a second support and guide section from the needle.
3. The apparatus of claim 1, further comprising a hollow
stabilizing component deployment device for manual movement of the
hollow stabilizing component over a range.
4. The apparatus of claim 2, further comprising an additional
stabilizing component deployment device for manual movement of the
additional stabilizing component over a range.
5. The apparatus of claim 2, wherein the hollow stabilizing
component is slideable inside the needle and the additional
stabilizing component is slideable inside the hollow stabilizing
component.
6. A method for facilitating subcutaneous insertion of a cannula
comprising: advancing subcutaneously a distal end of a puncture
needle; and extending a distal end of a hollow stabilizing
component beyond the needle.
7. The method of claim 6, further comprising extending an
additional stabilizing component beyond the extended hollow
stabilizing component.
8. The method of claim 7, wherein the additional stabilizing
component comprises a guide wire.
9. The method of claim 7, further comprising using a proximal
hollow stabilizing component deployment device and a proximal guide
wire deployment device to extend the hollow stabilizing device
along the needle and the guide wire through and out of the hollow
stabilizing component.
10. The method of claim 9, further comprising positioning a
catheter sheath over the needle prior to subcutaneous insertion,
and sliding the sheath forward over the hollow stabilizing
component and the stabilizing guide wire.
11. The method of claim 10, further comprising removing the needle,
the hollow stabilizing component, and the stabilizing guide wire
while leaving the catheter sheath.
12. The method of claim 6, applied to peripheral venous
catheterization.
13. The method of claim 12, further comprising confirming entry
into a peripheral vein or artery through providing a fluid pathway
from the extended distal end of the hollow stabilization component
proximally to a collection chamber at or near a proximal end of the
needle, and allowing visual observation of blood in the chamber by
the user.
14. The method of claim 9, wherein the deployment devices are
coordinated to require step-wise deployment of at least the hollow
stabilizing component to its extended position and then the guide
wire.
15. The method of claim 14, further comprising allowing retraction
of the guide wire and then the hollow stabilizing component in
reverse order from extension.
16. The method of claim 8, wherein the needle is substantially
rigid and the hollow stabilizing component and guide wire have a
degree of flexibility.
17. The method of claim 16, wherein combined length of extension of
the hollow stabilizing component and the guide wire is
approximately equal to length of a catheter sheath to be emplaced
by guiding over the needle, hollow stabilizing component, and guide
wire.
18. An apparatus for supplemental stabilization during placement of
a catheter sheath with a catheterization needle and guide wire
comprising: an intermediate stabilizing component comprising a
flexible tube that is extendable past a distal end of the needle
and through which the guide wire can be further extended.
19. The apparatus of claim 18, further comprising manually operated
members that allow a user to selectively deploy the intermediate
stabilizing component and the guide wire.
20. The apparatus of claim 19, wherein the manually operated
members comprise sliders that move in a system of slots which
control step-wise extension and retraction of the hollow
stabilizing component and guide wire.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation patent application of
U.S. patent application Ser. No. 14/782,422 filed on Oct. 5, 2015
and published as U.S. Patent Application Publication No.
2016/0045715, which is a National Stage application of
PCT/US2014/033012 filed Apr. 4, 2014 and published as WO
2014/165783, which claims the benefit of U.S. Provisional
Application No. 61/808,982 filed Apr. 5, 2013, the disclosures of
which are herein incorporated by reference in their entirety.
FIELD OF INVENTION
[0002] The present invention relates generally to the field of
catheters and methods of using the same. More particularly, but not
exclusively, it is a method for facilitating the insertion of a
peripheral intravascular catheter into a vein or artery by using a
hollow stabilizing component through which another component, one
example being a thin guide wire, is passed. Subsequently, the
method allows for a catheter sheath to pass over the hollow
stabilizing component and any additional components such as a thin
guide wire, emplacing the catheter within the patient's vessel.
RELATED ART
[0003] Peripheral intravascular catheters are ubiquitous in
hospitals and medical centers throughout the world. Many of these
devices are wasted due to failure to properly cannulate or thread
the catheter into the vein. Furthermore, the procedure varies in
difficulty depending on the condition of the patient. For example,
patients suffering from dehydration or other illnesses typically
lack straight and/or plump superficial veins which are ideal for
peripheral vessel cannulation. Such substandard veins are difficult
to find, and maneuvering a needle within them is arduous. However,
arterial line catheters currently used in practice are easier to
place/cannulate through the aid of a guide wire that passes through
the needle upon entering the blood vessel. The Seldinger technique,
as it is called and is known in this field of endeavor, uses the
guide wire to position itself within the vessel after which it acts
as a support for the catheter sheath to be slid over it. With the
catheter fixed and in place, the guide wire is then removed. The
catheter is then available for use.
[0004] Applying the Seldinger technique to a peripheral intravenous
catheter can be advantageous in facilitating catheter insertion.
However, there are several barriers that must be overcome. First,
vein, as compared to arterial, walls are thin, only a few cells
thick at points, and the force used to maneuver the guide wire may
result in puncturing both sides of the vein, thus wasting the
catheter and destroying usefulness of the vein distal to the
attempt site for catheterization. Next, a metal guide wire is
typically used in arterial catheters. Such a guide wire used in a
peripheral intravenous catheter may not be flexible enough to
effectively maneuver within a vein. It may also puncture a blood
vessel wall, particularly veins. Finally, difficulties arise in
administering any intravenous catheter or guide wire due to failure
to easily locate the veins due to their flexible structure. As
veins move in response to pressure exerted near them, multiple
attempts to properly insert the catheter may be necessary, which in
turn provides further pain and discomfort to the patient. Because
of these barriers, few devices have successfully been able to
cannulate thin and winding veins as well as such arteries.
Analogous issues can exist in other catheterizations or placement
of cannula or sheaths. A few examples are central venous catheters,
arterial sheaths, and venous cord introducer sheaths.
[0005] Ultrasound or other supplemental tools or equipment are
sometimes used with a separately handled puncture needle for
catheterization. This requires a specific skill set and the
overhead and added complexity of such sometimes costly
equipment.
[0006] As is well known in the art, tens and even hundreds of
millions of catheters are placed per year. Sometimes multiple
sticks of the placement needle are required to get proper
placement. It is particularly difficult with infants, children, the
obese, or the ill. It is not simply a matter many times of slight
positioning. It can result in blown veins or arteries. Therefore,
the sheer numbers and failed attempts can result in expenditure of
resources such as discarding incorrectly placed catheters as well
as health professional's time. There is room for improvement in
this technical field.
SUMMARY OF THE INVENTION
[0007] It is therefore a primary objective, feature, advantage, or
aspect of the present invention to improve over or solve problems
and deficiencies in the present state of the art. Other objects,
features, aspects, and advantages of the invention are an apparatus
and method which include one or more of:
[0008] a. promotes improved sub-dermal placement of the catheter or
the like;
[0009] b. deters misplacement, puncturing, or other damage to blood
vessels including peripheral veins and arteries;
[0010] c. can be facilitated at least in some forms by one hand
operation;
[0011] d. is noncomplex;
[0012] e. is economical;
[0013] f. can be made portable, even hand-sized;
[0014] g. reduces wasted catheters and related instrumentation;
[0015] h. can save user time including presents a low-learning
curve for its use;
[0016] i. lowers the probability of punctured through the desired
location particularly in peripheral blood vessels;
[0017] j. avoids mistakes and sudden forceful movements at the
sub-dermal location;
[0018] k. does not require other tools or equipment;
[0019] l. decreases likelihood of repeated vein punctures to
patient and associated pain.
[0020] In one aspect of the invention, an apparatus comprises a
hollow needle for penetrating skin and placement of its distal end
in an intended internal position in a patient, including but not
limited to a peripheral blood vessel. A hollow stabilizing
component is slideable along the needle (inside or outside) from a
retracted position to an extended position past the distal end of
the needle.
[0021] The benefit of such an arrangement is that instead of simply
subcutaneous puncturing to gain access to inside a patient (human
or animal), and then either trying to deploy a catheter sheath or
something similar or using simply a guide wire through the needle
lumen and extend it out to assist, a tubular stabilizing member can
be extended from the distal end of the puncture needle. That
tubular member can serve as a catheter sheath guide. It can also
accommodate a subsequent member sliding out along and out its
hollow interior. This can provide a number of different possible
functional benefits.
[0022] In one example, the secondary member is a stabilizing member
such as a second hollow stabilizing component or tube of slightly
smaller diameter than the first hollow stabilizing component. There
could be further extensions from that combination.
[0023] In another example, the secondary stabilizing component
could be what will be called a guiding element or guide wire.
Instead of being hollow, it can be wire shaped. In one example,
instead of more conventional metal guide wires such as might be
used with the Seldinger technique, the guide wire could be plastic.
It could be more flexible and less likely to puncture a blood
vessel than a metal guide wire.
[0024] In a further example, a guiding element or wire is slideable
through the hollow stabilizing component from a retracted position
to an extended position past the distal end of the hollow
stabilizing component.
[0025] Another aspect of the invention involves an actuator or
mechanism proximal to stabilizer and guide wire components to
control their step-wise deployment. In use, in a home position the
stabilizer component and guide element are retracted. The distal
end of the needle penetrates the skin to an intended internal
position. The actuator allows the user to deploy at least the
hollow stabilizer tube to its extended position. The actuator then
allows the user to deploy the guide element to an extended position
past the distal end of the extended hollow stabilizing component as
a second step. This promotes proper placement of the extended guide
element and deters misplacement or damage to internal tissues or
vessels. Subsequently a catheter sheath or the like can be slid
over and past the distal end of the needle, over the extended
portion of the hollow stabilizing component and then over the
extended portion of the guide element in its extended portion past
the extended distal end of the stabilizing component, again
promoting proper placement and deterring damage. The actuator
allows retraction in a reverse manner. It can be in a two-step
process.
[0026] The actuator or deployment mechanism does not have to be
integrated with any housing or body associated with the needle,
hollow stabilizing component, or a further stabilizing component.
On the other hand, it can be integrated. In that aspect, the entire
system can be integrated in basically one tool or instrument. For
intravascular catheterization, it can be hand held size and even
operable one-handed.
[0027] In another aspect of the invention, the hollow stabilizing
component is essentially sized for coaxial sliding within the lumen
of the needle. The guiding element is sized for coaxial sliding
within the lumen of the hollow stabilizing member. Thus, the
slightly larger diameter needle can penetrate the skin, the hollow
stabilizing member and guide element can be stored in retracted
position in the lumen of the needle. The two step deployment of the
stabilizing component and then the guiding element can occur. In
one aspect, the outer diameter of the stabilizing component is
slightly less than the inside diameter of the lumen of the needle
in which it slides. This can allow blood or fluid entering the
distal end of the needle to flow between the exterior of the
stabilizing component and lumen of the needle. This can allow, as
an optional feature, backflow of blood or fluid into a flash
chamber that can give the user a visual indication of whether the
needle has been placed in a desired position. An example would be a
backflow of blood from a blood vessel to give the user high
assurance of proper placement in the blood vessel.
[0028] In another aspect of the invention, the actuator comprises a
handheld body or handle, a cavity longitudinal through at least a
portion of the handle, a manually manipulatable control for
deployment of the stabilizer component from retracted to extended
position and vice versa, and a manually operated control for
independent actuation of the guide wire or element from a retracted
to a fully extended position and vice versa. In one example, the
actuating controls are slide elements. A guide in the actuator body
or handle allows slideable movement of both controls for a first
stage deployment. Both the hollow stabilizing component and guiding
element could be moved from fully retracted positions proximal to
the distal end of the needle to a first extended position extended
from the distal end of the needle.
[0029] An example of the guide would be a slot arrangement or
system in the body/handle. In one example, the controls and guiding
structure in the actuator handle comprise essentially a key and
slot arrangement. The first step deployment allows a single pushing
forward of sliders (keys) along a first slot basically aligned with
the longitudinal axis of the needle. A transitional slot transverse
to that first slot would allow a second slider to be moved to a
second spaced apart but parallel slot that extends farther distally
to allow the second step deployment of just the guiding element.
The slot arrangement can allow the actuating body or handle to be
held in one hand, and a thumb or finger of the user control both
steps with that one hand with high assurance of the correct order
of deployment. It can also give tactile feedback regarding whether
each or any of the components being introduced through the skin is
deemed to be moving to the desired location inside the patient's
body.
[0030] Another aspect of the invention comprises an apparatus,
including in any of the forms described above, further including a
catheter sheath that can be installed over the needle prior to
introduction of the needle into the patient. It can be separated
from the apparatus once high assurance of desired placement of the
deployed needle, hollow stabilizing component, and guiding element
are confirmed.
[0031] In another aspect of the invention, the apparatus and
catheter combination described above are further combined with a
connection between the catheter and either a supply of fluid or a
container for receiving fluid from the location of the distal end
of the catheter in the patient's body. The apparatus deploying the
needle, stabilizing component, and guiding element would be removed
once the catheter sheath is in place in the patient. The catheter
sheath would have a connection to tubing or the like. That tubing
can be connected in fluid communication with other components.
Examples of the same would be a container to receive blood from a
blood vessel for further use. Another example would be a supply of
intravenous fluids, including pharmaceuticals, to the patient.
[0032] These and other objects, features, aspects, and advantages
of the present invention will become more apparent with reference
to the accompanying specification and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1A is a perspective view of an assembled version of a
first exemplary embodiment according to the present invention.
[0034] FIG. 1B is an exploded view of FIG. 1A.
[0035] FIGS. 1C, 1D, and 1E are enlarged exploded views of certain
components of FIG. 1B.
[0036] FIG. 2 is a highly diagrammatic view of the catheter of FIG.
1A placed in a peripheral vein of a patient and connected to either
an output or input storage bag or container via a tubular
connection.
[0037] FIG. 3A is similar to FIG. 1A but shows the apparatus in a
first position (stabilizing component and guide wire in home or
fully retracted positions) with the needle in place in a peripheral
vein.
[0038] FIGS. 3B, 3C, and 3D are plan views from different
perspectives of the apparatus of FIG. 3A in its first position (all
extendable components retracted).
[0039] FIG. 3E is a sectional view taken along line 3E-3E of FIG.
3D.
[0040] FIGS. 3F and 3G are back and front elevation views
respectfully of FIG. 3C.
[0041] FIG. 3H is an enlarged isolated view taken along line 3H of
FIG. 3E.
[0042] FIGS. 3I-M are enlarged isolated views of portions of FIG.
3E.
[0043] FIGS. 4A-4H are identical to FIGS. 3A-3H except the
apparatus is in a second position namely where manually actuatable
sliders move the coaxial hollow stabilizing component and guide
wire from home or fully retracted positions to extended positions
past the distal end of the needle along the vein.
[0044] FIGS. 5A-5H are identical to FIGS. 4A-4H except the device
is in a third position where the dedicated slider controlling the
guide wire is manipulated to its dedicated separate slot and moved
to fully extend the guide wire past the extended position of the
hollow stabilizing member along the vein.
[0045] FIG. 6 is similar to FIGS. 3A, 4A, and 5A, but shows the
catheter sheath moved away from the actuator handle away from its
original or home position and along all of the needle, the extended
portions of the stabilizing component and guide wire.
[0046] FIG. 7 is similar to FIG. 6 but shows the actuating
apparatus (handle, needle, stabilizing component, and guide wire)
removed from the catheter so that the catheter is left emplaced in
the vein and so that the catheter can be used for any purpose.
[0047] FIG. 8A is a diagrammatic illustration of a second exemplary
embodiment according to the present invention.
[0048] FIG. 8B shows the embodiment of FIG. 8A in a starting or
home position with two manual controls on a handle in position
where a hollow stabilizing member and coaxial guide wire are in
retracted or home positions relative the needle and the handle.
[0049] FIG. 8C shows a first step deployment of a hollow
stabilizing component from the distal end of the needle.
[0050] FIG. 8D shows a second step deployment of a guide wire from
the hollow stabilizing component.
[0051] FIG. 9A is a diagrammatic view of the third exemplary
embodiment according to the present invention. It is essentially
the same as FIG. 8A but adds a manual control and longitudinal
extendibility of a needle relative to the handle.
[0052] FIG. 9B is a partially exploded view of the embodiment of
FIG. 9A showing extension of the hollow stabilizing component and
guide wire from a longitudinally moveable needle.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION
Overview
[0053] For a better understanding of the invention, below is a
description in more detail of examples of several forms the
invention can take. It is to be understood these are neither
inclusive nor exclusive of all such possible forms and
configurations.
[0054] Frequent reference will be made to the appended drawings.
Reference numerals will be used to refer to certain parts and
locations within the drawings. The same reference numbers apply to
all the drawings unless otherwise indicated.
[0055] These exemplary embodiments will be described primarily in
the context of use with peripheral venous catheterization. It is to
be understood, however, that it can be applied in any context in
analogous ways. In other words, it is not limited to peripheral
venous catheterization. Examples of other possible uses include but
are not limited to any other catheterization of analogous uses. As
is appreciated by those in this technical field, intravascular
catheterization is but one species of catheterization.
Exemplary Embodiment One
[0056] With primary reference to FIGS. 1-7 and any subparts, an
apparatus according to a first exemplary embodiment can include a
hand held body or handle 12, and sliders or slideable controls 54
and 64 that slide within a slot arrangement in handle 12.
[0057] A coaxial combination of needle 14, what is called a hollow
stabilizing component or HSC 50, and a flexible thin guide element
or wire 60 are operatively mounted relative to handle or body 12
along a longitudinal axis (see FIG. 1B). As shown in FIG. 1A, a
catheter sheath and hub 13 are slid over and backward or proximally
from the distal end of needle sub-assembly 14 prior to use of
apparatus 10. Catheter subassembly 13 is thus left in place after
apparatus 10 guides it into place and is removed.
[0058] In this embodiment, the length and diameter of handle sub
assembly 12 is approximately three inches long by a half of an inch
diameter. The slide controls 54 and 64 extend to different radial
heights relative to body 12 as shown in FIG. 1A. The length of the
slots in which slide controls 54 and 64 are coordinated such that,
in retracted position, hollow stabilizing member 50 and guide wire
60 are fully retracted from the distal tip of needle 40 of needle
sub-assembly 14 (when in fully retracted position). In this
example, full extension of HSC (hollow stabilizing component) 50
and then guide wire 60 will be approximately equal to a length of
the catheter assembly 13.
Catheter and Needle
[0059] Catheter assembly 13 and needle sub-assembly 14 can be
conventional as would be appropriate for the given application for
the apparatus. Both could be obtained commercially off the shelf.
For example, needle sub-assembly 14 could be a metal, beveled
distal end, hollow needle or trocar for peripheral venous
catheterization. But it could be the type for other forms of
catheterization. Typically this is 18-22 gauge as well as lesser
used gauge sizes. Gauge size would be selected based on application
(e.g. peripheral venous catheterization versus others) and based on
diameter of the coaxial guide wire and coaxial hollow stabilizing
component. Catheter tube, cannula or sheath 30 would have an
internal lumen diameter that would closely fit over the exterior of
needle sub-assembly 14 but be slideable inside it. Thus, hollow
stabilizing component 50 would have a slightly smaller outside
diameter than the inside diameter of the aluminum needle
sub-assembly 14 and be slideable therein (including in this example
having space allowing blood to flow therebetween). The distal end
31 of catheter sheath 30 could be blunted (e.g. to avoid
inadvertent vessel puncture). These catheter sheaths are typically
quite thin and have a degree of flexibility.
[0060] Once the device of FIG. 1A is in place, catheter sub
assembly 13 can be slid forward on needle sub-assembly 14, HSC 50
and/or guide wire 60 can be extended, and then everything removed
to leave just catheter sub assembly 13 in place. Normal utilization
of that properly placed catheter can proceed such as is well-known
in the art. One example is diagrammatically shown in FIG. 2.
Further description of use of catheter 13 will not be set
forth.
Handle
[0061] FIGS. 1B and 1C illustrate construction and components of
each subassembly. Handle or body 20 can be made out of a number of
different materials. Moldable plastic is one. Others are possible.
A cavity extends between distal open end 21 to proximal open end
24. As illustrated in FIG. 1B, a flash chamber 25 is succeeded by
constriction 26 which is succeeded by a proximal chamber 27 between
those open ends. A cap 22 with through bore 23 holds in place
proximal end 42 of needle 40 of needle sub-assembly 14 and mounts
to distal end 21 of body 20. It can be connected by adhesive,
fasteners (such as screws), or other techniques.
[0062] Flash chamber 25 is optional but can provide a collection
space for blood flowing back from a pierced blood vessel. A side
port 18 has an opening 29 in fluid communication with flash chamber
25. A transparent or partially transparent container 19 could be
pre-connected to side port 18 and collect spill-over blood out of
flash chamber 25. This can provide a visual indicator to the user
that the needle has accessed a blood vessel. One example of such a
flash connection 19 to side port 18 would be a piece of transparent
plastic surgical grade tubing with its distal end closed off.
Optionally, that distal end could be bent over and glued to the
side of body 20 to provide a U-shape visual "flash chamber". As
will be appreciated by those skilled in the art, flash chamber 25
is in the interior end handle 20. There could be a window or a
light transmissive (transparent or translucent) section of handle
20 that would allow the user to visually see blood filling into
chamber 25. In such situations a side port and added flash vessel
outside handle 20 may not be needed.
[0063] However, to the extent side port 18 is utilized, the vessel
container for visually seeing a flash of blood that flows through
flash chamber 25 and outside port 18 could be such things as a
short section of light transmissive surgical tubing or the like,
some sort of light transmissive container or bag, or something
similar. Furthermore, it could either be a closed volume of space
(like a closed end length of tube) or it could have a limited
liquid space but either have an air vent or a valve that could
release air or blood from that space. There are many ways in which
the user could visually identify a flash of blood coming back. A
further potential example would be some sort of bracket along
handle 20 that would attach a short length of tubing or other
visually perceivable container space for a flash chamber outside
the handle body. Additionally, a side port 18 could simply connect
to a collection container or some other system for either
collecting fluid from the subcutaneous site of the needle or
possibly infuse fluid from a source outside of handle 20 through
side port 18 and down needle 40 and out its distal end 41.
[0064] Handle body 20 not only is configured to have a space
between the outside diameter of the HSC 15 and the inner diameter
of needle 40 (to allow blood to backflow into flash chamber 25),
but also needle body 40 is fixed to cap 22, which is in turn fixed
over flash chamber 25 of handle body 20.
[0065] As shown in FIG. 3J, proximal end of needle 40 should be
secured or fixed to a counter-sunk partial bore by having a flared
proximal end 46 that would then be secured in place by an
interference fit or adhesively connected plug 45. Other ways of
securement to cap 22 are possible. This arrangement would seal or
be a barrier from blood moving back between the exterior needle 40
and the passageway through cap 22.
[0066] The short section (e.g. one inch of clear plastic surgical
tubing 19) could receive blood through the passageway of opening 29
and allow visual confirmation of placement of distal end of needle
40 in a blood vessel. If the "flash" of blood stops or slows, the
user can back up the distal end of the needle or withdraw it and
reposition it until confirmation is made. Tube 19 can have a closed
distal end. Because of size, makeup of components, and materials,
the entire assembly 10 can be made economically and thus be
disposable.
[0067] The shape, size, and function of handle subassembly 12
includes being able to operate apparatus 10 by holding handle body
20 in one hand. Sliders 15 and 16 are operatively mounted in handle
body 12 as well as operatively connected to HSC tube 50 and guide
wire 60 which are coaxially positioned along the longitudinal axis
of needle 40. What would be called a lock and key system includes a
slot arrangement formed in handle body 20. Two longitudinal slots
are coordinated with HSC tube 50 and guide wire 60 for a two-step
deployment. The operator can push on slider 64 which would move
slider 54 concurrently until slider 54 reaches the distal end of
first slot 70. This is the first step deployment of HSC tube 50
beyond the distal end of needle 30. A transitional slot 71 allows
the user to transition slider 64 to the second slot 72 in handle
20. By correlation of the length of slider 54 versus slider 64
longitudinally, and the point of attachment in length of both HSC
tube 50 and guide wire 60 to those slider plates 57 and 67 of
sliders 54 and 64 determines how far the distal ends of HSC tube 50
and guide wire 60 can be extended relative the distal end of needle
30. Furthermore, the slot system 70, 71, and 72 ensures that the
correct order of deployment occurs. The slots also guide the user
in operation which can be by grasping handle body 20 underneath and
wrapping four fingers around it with needle 40 extending outwardly
between the first finger and the thumb and then using the thumb to
slide slider plates 57 and 67. This can be done in either direction
for two-step deployment outwardly and two-step retraction. Slide
control 54 and 64 can be made of different materials including
plastics similar to body 20.
[0068] Materials for handle or body 20 and other components can be
of a variety of types. One example would be any biocompatible or
surgical grade plastic that could be formed in a manner needed or
desired. Its properties would have sufficient durability and
rigidity for the described purposes.
Needle
[0069] Needle subassembly 14 (FIG. 1C) can include a standard
catheterization metal needle 40 with sharp beveled edge 41 and open
proximal end 42. As indicated in FIG. 1B, catheter subassembly 13
could be slid over needle 40. Catheter subassembly 13 can include
what might be called a hub 36 including a luer, threaded, or other
connection for connection to another tube to some type of
collection or infusion system 17 (see FIG. 2). This is conventional
in the art. A transitional section and conical nose 35 would
receive the proximal end of catheter sheath 30 and hold it in
position. The sheath distal end 30 would fit over needle body 40 to
almost the beveled end 41 when in beginning or home position. It
would be available then to slide forwardly on needle body 40 into
final interior position in a user's blood vessel while leaving hub
36 exterior above the hand to connect up to the system 17 of FIG. 2
as appropriate.
Hollow Stabilizer Component (HSC)
[0070] Hollow stabilizer component ("HSC") subassembly 50 (FIG. 1D)
would include flexible tube 50 having opposite open distal and
proximal ends 51 and 52. The tube of HSC 50 would fit into and be
secured within a through-bore 66 in a carriage portion 55 of slide
control 54. A plate or slider portion 57 extends from sliding
carriage 55 and is available for the user to manually move.
[0071] The tube of HSC 50 can be secured or fixed into through-bore
56 by any number of techniques. One would be adhesive. Another
would be interference-fit. There could also be an enlarged chamber
around through-bore 56 that could allow injection of adhesive or
installation of some sort of retention member.
[0072] In this embodiment, some characteristics of the tube of HSC
50 are as follows. Its length is approximately half the length of
cannula 36 of the catheter subassembly 13. Its lumen diameter is
slightly bigger than the outside diameter of needle body 40. It is
made of a plastic material that has some degree of flexibility yet
has sufficient rigidity to be pushed by slide control 54 from its
proximal end through needle body 40, out distal end 41 of needle
body 40 and, for example, into the lumen of a blood vessel. It can
experience some resistance to that movement and retain its general
longitudinal shape, however, it can flex. This can help, for
example, HSC 50 to bounce off or deflect instead of puncture,
and/or otherwise follow the lumen of the blood vessel. The material
has been selected for this embodiment to do so even for the
relatively thin peripheral veins associated with peripheral venous
catheterization. Some veins can be only a few cells thick. The
material deters puncturing of even such thin walled vessels. An
example of the material is polyurethane. The polyurethane tubing
could be selected to have a degree of flexibility. For example, it
could be more flexible than the rigid metal needle 40. By further
example, it could be less flexible than plastic guide wire 60,
including the exemplary commercially available fishing line
mentioned previously. The designer can select the degree of
flexibility based on the material properties of the polyurethane.
In this exemplary embodiment, HSC 50 would have a degree of
flexibility that is not as much as the plastic guide wire 60 but is
sufficient to allow some flexure so that it promotes following a
blood vessel once deployed out of properly placed needle. It would
then add sufficient rigidity to both guide the guide wire 60 along
its distal end and out into that blood vessel as well as later
guide catheter sheath 30 over it. Other materials with analogous
properties are possible.
[0073] As previously mentioned, the outer diameter of HSC tube 50
will be selected to be smaller than the internal diameter of needle
40 so that it can slide therein and allow blood to move backwards
approximately to flash chamber 25. The length of HSC tube 50 is
selected to be in retracted position just proximal of the distal
tip of needle 40 (see FIG. 3H). And, as mentioned, the proximal end
of HSC tube 50 would be fixed to slider 15. The material for HSC
tube 50 in this embodiment is selected to have a degree of
longitudinal rigidity but a degree of flexibility such that when it
exits needle 40 it can deflect relatively easily, including thin
walled peripheral veins. On the other hand, it provides a degree of
stiffness or support over which catheter sheath 30 can be slid or
manipulated.
[0074] In this embodiment HSC tube 50 is made of polyurethane. An
example could be Dow Pellethane 2363, with a durometer 40-65 Shore
D.
[0075] It should be understood, however, that variations to these
material properties are possible. Additional material properties
such as puncture resistance, chemical resistance, potential
strength, color, and the like can be selected as according to need
or desire. The material is biocompatible and meets all requirements
for catheterization. It is strong enough to hold and guide the
catheter sheath with a high enough modulus not to break.
Guide Wire
[0076] Guide wire 60 can be essentially a conventional guide wire
used with Seldinger technique catheterization. Its length is from a
proximal connection to slider 16 to essentially the same distal
location and just proximal of the distal end of needle 40 when in
home position (see FIGS. 3H and 3E). Guide wire 60 slides through
the lumen of HSC tube 50.
[0077] Some of its functions are to provide structural support for
the catheter cannula beyond the distal end of needle 40 for a
portion of the way to its final intended position while having a
degree of flexibility to bend to follow the blood vessel. Guide
wire 60 in this example is made of a plastic monofilament. An
example of the material is nylon or nylon based monofilament. One
example is fused fishing line under the brand name Fireline Crystal
from Berkley Fishing, Spirit Lake, Iowa (USA).
[0078] Its distal end 61 can be blunted or rounded to prevent
inadvertent puncture of a vessel wall distal to the puncture
needle. It proximal end is connected to disc 68 by adhesion, sonic
welding, tying, or otherwise. When disc 68 is seated in the
proximal end of carriage body 65 of slider 16 and plug 69 inserted
over disc 68, this fixes guide wire 60 to slider 16 so that it can
accept longitudinal force on guide wire 60 to deploy it. In this
embodiment, the diameter of guide wire 60 fits within the lumen HSC
tube 50 and slides therein. It has been selected to deter the risk
of puncturing even the relatively thin blood vessels used for
peripheral venous catheterization as well as have flexibility to
follow the blood vessel once needle 40 appropriately penetrates it.
Its length between distal and proximal ends 61 and 62 is selected
so that it slides within lumen 53 of HSC 50 by pushing its distal
end 62 with second slide control 64. It can be held in place inside
64 by threading it through bore 66 and adhering it with glue, tying
it, or otherwise affixing it to disk 68 that would seat within a
depression in the proximal end of slide 64. A plug member 69 can
interference fit or be glued into that depression over disk 68 to
further hold it in position.
[0079] Guide wire 60, sometimes referred to as guide element, can
be made of other materials. Other plastics are possible. Metal is
also possible. Distal end 61 can be rounded or blunted regardless
of the material.
Assembly
[0080] Assembly of apparatus 10 can proceed as follows. The distal
end 61 of guide wire 60 can be threaded into opening 56 in slider
carriage 55 and then threaded through the lumen of HSC tube 50. The
plates 57 and 67 of sliders 15 and 16 would be aligned in the same
plane and then that whole combination inserted in proximal open end
of handle body 20. The coaxial distal ends 51 and 61 of HSC tube 50
and guide wire 60 would move through internal proximal chamber 27
in handle 20, and then into constriction 26; which is right along
longitudinal axis of handle 20. The smaller diameter of
constriction 26 would guide the HSC/guide wire combination through
flash chamber 25 and out the distal open end of handle body 20
right along its longitudinal axis.
[0081] FIGS. 1C-1E illustrate an assembly of needle 40 to cap 22
(see also FIG. 3J), HSC tube 50 to slider 54 (see also FIG. 3L) and
guide wire 60 to slider 64 (see also FIG. 3M), respectively. FIG.
1B then shows those subassemblies and their relationship to handle
body 20. In both FIGS. 1B and 1C, the commercially available
catheter sheath 30/hub34/35/36 is shown to illustrate how it can be
slid proximally on needle body 40 and essentially loaded for use on
implement 10. As can be appreciated, the methods by which needle 40
is attached to cap 22 in a fixed relation, and likewise for HSC
tube 50 to slider 54 and wire 60 to slider 64 can vary. As
illustrated in FIGS. 3J, 3L and 3M, handle 20 can be created to
have recesses, voids, slots, or other features that would
facilitate such connections. For a few examples, a counter-sink
bore in cap 22 could receive a plug 45 for a flared proximal end 46
of needle 40 to hold it in place in cap 22. As indicated at FIG.
3L, a void or other slot could allow some sort of a locking member
or injected adhesive to hold the proximal end of HSC tube 50 and
slider 54. Configuration of holding the proximal end of guide wire
60 and slider 64 is indicated at FIG. 3M. Additionally, there could
be barriers, seals, gaskets or the like installed along that
longitudinal axis. For example, FIG. 3K shows a counter-sink 58
could exist in body 20 in which a gasket or seal could be placed to
prevent fluid or blood from communicating in the chamber 27. A
similar gasket could be placed over the proximal end of HSC tube 50
and around guide wire 60 (see the location of reference numeral 59
in FIG. 3L) to prevent blood or fluid from back flowing between
guide wire 60 and the lumen of HSC 50 back and out of that proximal
end of HSC 50. Other features could be integrated in instrument
10.
[0082] Needle 40 is fixed into cap 22 and held by adhesive,
interference fit or other technique. That combination can then be
brought up so that the center longitudinal bore 23 in cap 22 fits
over the coaxial distal ends 51 and 61 of HSC tube 50 and guide
wire 60 to align it with the lumen of needle 40. Cap 22 and affixed
needle 40 can then be fastened to the distal end 21 of body 20.
Plates 57 and 67 of sliders 15 and 16 would be aligned along main
longitudinal slot 70 and pushed proximally until in position
similar to FIG. 1A.
[0083] Catheter assembly 13 would be threaded onto the distal end
31 of needle body 40 and moved distally until hub 36 comes near or
abuts cap 22. In that position (see FIG. 1A), distal end 41 of
sheath 30 is just proximal of distal end 41 of needle 40.
Essentially the catheter assembly 13 is loaded onto needle 40
before entering the patient. Flash tube 19 could be connected to
side port 18 and, if desired, its closed end bent over and glued to
the side of body 20.
[0084] As can be appreciated, by reverse movement, either slider 16
and its affixed guide wire 60 could be withdrawn from the whole
assembly and/or slider 15 and HSC tube 50 by pushing sliders 15
and/or 16 out the back or proximal end of slot 70.
[0085] In this example, the relative dimensions of the handle,
needle, HSC, and guide wire, compared to that of the catheter, are
predesigned as follows. In home or fully retracted position for HSC
tube 50 and guide wire 60, both are coaxial and proximal of the
distal end 41 of needle 40. But when fully deployed, where slider
15 is slid to the extreme distal end of slot 70 and slider 16 is
transitioned over and moved to the extreme distal position of slot
72, the combined distance of extension of HSC tube 50 and guide
wire 60 will be approximately the same as the length of catheter
sheath 30. Thus, when the catheter assembly is slid forward when
apparatus 10 is deployed to fully extended state, distal end 31 of
catheter sheath 30 would be at or near the extended distal end 61
of guide wire 60. Sheath 30 would follow over the extended portion
of HSC tube 50 and then the extended portion of guide wire 60 to
that position so that it has both support and guidance by those two
stages after sheath 30 leaves needle 40.
[0086] In this example, the extension of HSC tube 50 from the
distal end of the needle is approximately 0.660 inches. The
extension of guide wire 60 past the distal end of the extended HSC
tube is 0.739 inches. Cumulatively that is 1.454 inches. This would
approximately match the length of the catheter sheath 30. The
design of the connection points of the proximal ends of HSC 50 and
guide wire 60 to their respective sliders 15 and 16, as well as the
length of slots 70 and 72, would be coordinated to accomplish this
result. While this precise arrangement is not necessarily required,
in this example it is selected such that upon full deployment of
guide wire 60 and HSC 50 (FIG. 5A), catheter sheath 30 need only
then be slid a short distance forward to pass distal end of needle
40 and then the user would have both the extended section of HSC 50
and guide wire 60 to guide that sheath to a fully extended distal
end of guide wire 60. This can guide and support that sheath to an
intended location. It is to be understood that the Figures are not
precisely to scale regarding the relationship of length of sheath
30 fully extended lengths of HSC 50 and guide wire 60. But, the
enlargement of FIG. 6 illustrates that principal.
[0087] Slots 70 and 72 are substantially parallel to the
longitudinal axis of body 20 and needle 40. The connection of HSC
tube 50 and guide wire 60 and the internal chambers in handle 50
are also along that longitudinal axis.
[0088] The configuration of sliders 15 and 16 relative to slots 70,
71 and 72 ensure there is no error in the order of deployment. The
first step would be to combine sliding of slider plates 64 and 54
along slot 70 (starting from the home position of FIG. 3A once the
distal end of needle 40 is deemed properly positioned in vein
11).
[0089] The distal end of slot 70 provides certainty to the user
that HSC tube 50 is fully deployed to its extended position. At
that point, the pre-designed geometry of sliders 15 and 16 does the
following. The length of slider 54 aligns slider 64 with transition
slot 71. The user simply pushes slider 64 sideways through
transition slot 71 into slot 72. The length of slider 54 is too
long to pass through transition slot 71 so it cannot be
inadvertently or even intentionally moved out of slot 70. After
slider 64 is moved to slot 72, slider plate 64 can be pushed
forward to actuate the second step extension deployment--movement
of guide wire 60 distally and out of HSC tube 50.
[0090] FIG. 1B indicates how the components are assembled and how
the combination of slots 70, 71 and 72 are formed in handle 20.
Slide controls 54 and 64 are guided by those slots as will be
described further below.
Operation
[0091] Typically, apparatus 10 is placed in the user's palm with
sliders 15 and 16 up or towards the user. Distal end 41 of needle
40, fixed in the end of handle 20, is then directed to a desired
entry point at the patient's skin. It has been found that moving
needle 40 forward into the skin at approximately a 45.degree. angle
can be beneficial. Once in that position, handle 20 can be dropped
to a shallower entry angle (perhaps approximately
20.degree.-30.degree.). relative to the skin or to vein 11. The
angle can be dropped if initial vein puncture is successful after
visual confirmation in flash chamber/connector 25/19. This can be
beneficial for subsequent deployment of HSC tube 50 and guide wire
60 via sliders 15 and 16.
[0092] By referring to FIGS. 3-8 and any subparts, operation of
apparatus 10 of FIGS. 1A-1C can be further understood. In initial
home position, slide controls 54 and 64 are pushed back proximally
in handle body 20 (see FIG. 3A). Slide controls 54 and 64 can be
serially moved beyond the proximal end body 20 individually or
together which would remove the respectfully attached HSC 50 and
guide wire 60 subassemblies if desired. But starting with the
position shown in FIG. 3A, the user could visually direct distal
needle end 41 towards a peripheral vein of a patient. As indicated
in FIG. 3A, a typical angle of attack can be around 45 degrees
although other angles are possible. By manipulation and experience,
the goal would be for beveled needle tip 41 to penetrate the vein
into the vein's lumen.
[0093] In this embodiment, the flash chamber option could help the
user confirm proper needle placement. As indicated at FIG. 3H, a
slight gap exists between the outside of HSC body 50 and the
interior diameter of needle 40. Blood, under the patient's blood
pressure, can flow in that space back into flash chamber 25.
Opening 29 inside port 18 is in fluid communication. A visually
transparent collection vessel (U-shaped closed end length of
tubing) would allow the user to see a "flash" or small volume of
blood would be indicative of the needle being properly placed in
the peripheral vein.
[0094] FIGS. 3B-3M show various views of the assembly 10 in that
first starting position. Other features are as follows. FIGS. 3H-3M
show in enlarged fashion the general relationship between
components include the gap between lumen of needle 40 and the
outside diameter of HSC 50 all the way from distal end 41 of needle
40 in flash chamber 25. FIGS. 3B-3D, as well as FIGS. 3F and 3G
show additional views of how sliders 54 and 64 relate to the other
components when the device is in this fully retracted position.
[0095] The constriction 26 between flash chamber 25 and the
proximal chamber 27 provides a stabilizing support for HSC tube 50
before it passes into and through the larger flash chamber 25. A
similar size constriction in cap 22 does the same.
[0096] It should be noted that there can be some gap or space
between guide wire 60 and the internal wall of the lumen of HSC
tube 50 through which blood might move proximally and into handle
20. Some sort of O-ring or other sealing technique might be
utilized to prevent the same. However, since guide wire 60 must
slide in HSC tube 50, it may be acceptable that the sizes of these
two components might be so close that blood would not tend to
travel all the way back in the handle 20.
[0097] FIGS. 4A-4H show the intermediate position. Importantly, as
shown in FIG. 4A, after the user pushes both slide controls 54 and
64 forward to where the distal end of slot 70 is a mechanical stop
against further distal longitudinal movement, the narrower slide
control 64 aligns with transition slot 71 (see ghost lines for
slide 64 in FIG. 4A). This movement extends HSC tube 50 further
into the blood vessel from the needle tip to provide a first length
of guide and support for catheter cannula 30. The flexibility of
tube 50 exiting from rigid needle 40 allows it to deflect or tend
to follow the lumen of the blood vessel. In this position with a
thumb or single finger, the operator can simply move a slide
control 64 through transition slot 71 into second longitudinal slot
72 (see solid lines for slider 64 in FIG. 4A). The user should be
able to feel resistance when advancing HSC 50 and guide wire 60. If
resistance is felt, either can be retracted and needle angle
adjusted for another attempt at deployment of either or both. FIG.
4B-4H illustrate position of sliders 54 and 56 from different
viewpoints relative this first step of deployment. Cross section
FIG. 4E and enlargement FIG. 4H give more details regarding the
interior relationships.
[0098] FIGS. 5A-H shows the third (fully extended) position. Slide
control 64 is pushed until the end of slot 72 (which functions as a
mechanical stop). As shown in FIG. 5A, guide wire 60 then extends
further out of HSC tube 50 an additional distance down the blood
vessel. Its flexibility receives guidance from tube 50 and tends to
follow, without puncturing or leaving, the blood vessel. FIGS.
5B-5H are similar to FIGS. 4B-4H but show the second step
deployment and thus the full extended deployment of both guide wire
60 and HSC 50 as well as the relationship to the internal
components and positioning of slide controls 54 and 64. It is to be
noted that in this example the lateral height of slider 64 is
greater than the lateral or radial height of slider 54 from the
longitudinal axis of apparatus 10. This helps promote the correct
sequence in sliding of sliders 64 and 54. When in position 3A, the
user should always push on rear-most slider 64 so sliders 64 and 54
can move together forwardly or distally in slot 70. It is to be
understood, however, that the implement does allow individual and
thus sequential deployment if desired.
[0099] The operator thus, with one hand or a thumb and single
finger, can achieve a two-step deployment shown in FIGS. 3A, 4 and
5A. Thereafter, as indicated in FIG. 6, the user can manually push,
slide, thread or otherwise manipulate the catheter sub-assembly 13
distally. The catheter cannula 30, typically a thin wall flexible
tube (such as known in the art), will follow the outside of the
needle and then the extended portion of HSC tube 50 and then the
extended portion of guide wire 60. In this embodiment, the length
of cannula 30 will be enough that it can be pushed to the end of
the extended guide wire 60 while leaving a hub portion 34/35/36
outside the patient and available for connection for other use.
[0100] As shown in FIG. 7, the last step would be to hold the
cannula/catheter subassembly 13/30 in that slid down position but
withdraw the remainder of apparatus 10. What would be left is the
cannula/catheter subassembly 13/30. As can be appreciated,
withdrawal of all but the catheter can proceed in a reverse order
to deployment. Slider 64 would be pushed approximately in slot 72
to transition slot 71 and then behind slider 54. Then slider 54 can
be pushed distally to push both back. This two-step retraction
would then gently allow retraction first of the more flexible and
thinner guide wire 60 and then both guide wire 60 and HSC 50 back
into needle 40. Then, body 20 can be moved away from the skin
penetration site to withdraw the needle 40 and thus the entire
assembly 10 except that catheter hub 34/35/36 would be held to
leave it in its position to leave its distal end of sheath 30 in
its emplaced position that had been guided out that far by the
extended deployment of HSC 50 and guide wire 60.
Exemplary Embodiment Two
[0101] FIG. 8A diagrammatically depicts an alternative embodiment
10' of that previously described. It utilizes a similar handle,
fixed needle (not shown but would be mounted to the front of body
20' along the axis of the bore through body 20'), and deployable
HSC and guide wire by slide controls on the handle. Needle 40' can
be similar to needle 40 previously described. The main differences
are as follows.
[0102] The U-shape slide control 54' is connected to a carriage
that slides within an internal bore in handle 20'. An HSC tube 50'
(the same or similar to HSC 50 previously described) is attached to
slider 54'. By sliding 54' distally along handle body 20', HSC tube
50' can be moved out distally of the distal end of needle 40' or
brought back inside it.
[0103] A rectangular second slider 64' has a carriage inside that
same internal bore of handle 20' and is attached to guide wire 60'.
It can independently extend or retract guide wire 60' by sliding
action along body 30'.
[0104] As shown in FIG. 8B, when rectangular slide 64' is slid
proximal on handle 20' and slide 54' (and basically nested around
it), HSC 50' and guide wire 60' (both coaxial within tube 50')
would be retracted proximally from the distal end of and into the
lumen of needle 40'.
[0105] A user can step-wise deploy HSC tube 50' by selectively and
independently sliding U-shaped slider 54' distally or forwardly on
body 20'. There could be a mechanical stop on body 20' or otherwise
(such as the end of a slot) to regulate how far forward it can go.
For example, it could extend approximately the same proportional
length as described regarding embodiment one.
[0106] Once rectangular slide 64' is then slid forward and nested
into forwardly-slid U-shape slide 54', guide wire 60' would be
deployed as a second step and beyond the distal end of deployed,
extended HSC tube 50'. By the nesting relationship, slider 64'
would reach a mechanical stop inside the U-shape of slider 54'.
[0107] As with embodiment one, a catheter sheath (not shown) can be
preloaded on needle 40' (not shown) and utilized in a similar
fashion. As can be appreciated, this is but one further example of
a combination of a puncture needle and a first stabilizing hollow
component that can be manually activated to deploy past the
needle's distal end. It further gives but one additional example of
how a second stabilizing component, in this example the guide wire
60 can further extend it. Other variations are possible.
Exemplary Embodiment Three
[0108] FIGS. 9A and B show, in similar form to FIGS. 8A and 8B, a
further alternative embodiment 10'' of the invention. It functions
essentially like the embodiment of FIGS. 8A and 8B with the
following additional feature.
[0109] This embodiment shows that further deployable and
retractable members are possible. In one example, an additional
slider 44' could be connected to some other type of sheath or
cannula that could be slid over hollow stabilizing component 50'
and selectively moved forwardly or distally. It could simply be a
catheter sheath.
[0110] However, an alternative possibility exists. Second U-shaped
slider 44' could be connected to a carriage that slides in the same
slot/bore as the carriage portions of slider 64' and 54' of FIG.
9A. Slider 44' could have puncture needle 40' fixed to it. Thus,
the additional feature of this embodiment is that needle 40' could
be independently moved forward relative to handle 20'. Slider 54'
(U-shaped) can also. Slider 44' can provide a mechanical stop to
forward motion of slider 54'. Finally rectangular slider 64' could
also be independently moved forward with slider 54' being its
mechanical stop.
[0111] Each of sliders 44', 54' and 64' could likewise be moved
rearwardly (proximally) along handle 20' in reverse order. In such
an arrangement, guided deployment of the needle relative to the
handle is possible by the finger of the operator sliding slide
control 44'. One or two stabilizing components (whether or not
hollow stabilizing component 50' and stabilizing wire 60') could be
further extended from resulting position of needle 40'.
[0112] This would also align with the optional possibility that the
needle could be attached to either the rear-most slider 64' or
middle slider 54'. As previously mentioned, at least one of the
stabilizing components could potentially be slid over the needle
and outwardly. Any catheterization sheaths would then be loaded on
that outermost stabilizing component that slid outward to its final
position. A slideable needle would require design of relative
length and position of each of slideable needle 40', HSC 50' and
guide wire 60' and their respective slide controls 44', 54', and
64' so that once needle 40' is fully extended, HSC 50' could be
extended beyond it, and that wire 60' could be extended beyond HSC
50'.
[0113] Optionally, housing 20 or 20' could include features that
would keep the entire device 10, 10' or 10'' in a home or starting
position. For example, some sort of cap, bracket, retainer, or the
like could be placed over the proximal end of body 20 or 20' to
prevent any of the components from sliding out the end regardless
of its orientation of handle 20 or 20'. Similarly, some sort of a
cap, retainer, or otherwise could be placed over the distal end of
the needle to prevent any of the extendible members from extending
until that member is removed or released. Still further, packaging
of an assembled apparatus 10 could hold all the elements in that
starting position. Once the packaging is removed, it is then
manipulatable as described.
[0114] Further features of the embodiment 10'' of FIGS. 9A and B
are set forth below. Some or all can be applied in analogous
fashion to embodiments 10 and 10'.
[0115] A method for incorporating a guide wire device into a
peripheral intravenous catheter is described herein. The method
embodies three specific steps that incorporate the Seldinger
technique of using a support system within the vein to support the
catheter, while circumventing the described limitations. Each step
will be represented by a relevant feature of the specially designed
catheter device 10''. First, a needle will be used to pierce
through the vein and establish one level of support. Next, a small,
thin hollowed tube, referred to as the hollow stabilizing component
("HSC"), will be directed through the needle in the same manner as
the arterial catheter guide wire to provide a second layer of
support not found in the usual Seldinger technique. The HSC will be
shorter than the normal guide wire, but still long enough so that
it can be easily moved a distance past the inserted needle into the
targeted vein. The HSC must be small enough to fit within 18-22
gauge needles, as well as lesser-used gauge sizes. The final step
involves a guide wire element that can fit within the HSC and be
extended further into the vein from the HSC tube's opening. This
final guide wire, referred to as a thin stabilizing guide wire,
will be made of a material that can support the weight of the
catheter as it is slid over the three components. A stabilizing
guide wire made from durable metal machined to the appropriate
length and diameter to fit within the HSC while being rigid enough
to support the catheter sheath may be utilized, yet we must be
cautious with a metal guide wire due to the thin nature of vein
walls. Alternate materials with similar strength properties may be
used as well. The peripheral venous sheath would then be slid into
the vein over the hollow stabilizing component and subsequently the
thin stabilizing guide wire. Like the arterial catheter, once the
sheath has been installed, all three stabilizing components
(needle, HSC, thin stabilizing guide wire) would be easily removed,
leaving the catheter fixed in the vein. As will be appreciated by
those skilled in the art, any of the apparatus described herein
could be utilized with a guide wire 60 that is not metal. The
Seldinger technique conventionally uses a metal guide wire. On the
other hand, use of a metal guide wire is not precluded with these
embodiments.
[0116] FIGS. 9A and 9B show perspective views of the assembled
catheter assembly 10'' with a segmented stabilization system. The
catheter assembly is used primarily, but not exclusively, in
accessing peripheral veins and arteries for the administration of
various drugs and fluids. The present method allows deployment of
the catheter components by one operator. The catheter of the
present method allows a catheter to pass over a stable shaft that
is segmented in order to preserve the integrity of the accessed
vessel. The catheter assembly includes an outer housing 20' with an
interior containing a catheter (not shown), a needle assembly
40'/44', an HSC assembly 50'/54', and a thin stabilizing guide wire
assembly 60'/64'. The outer housing 20' may be made of plastic,
acetal, or other materials known in the art. The outer housing 20'
has a housing hollow which can contain all necessary sliding
assemblies. The catheter assembly remains in a constrained position
until the operator, who is most often a physician or registered
nurse, takes action. After performing standard preparatory
procedures well known in the art, the operator first performs step
one, piercing the vessel with the needle 40'. This is done by the
operator pushing needle deployment piece 44' forward with one or a
number of fingers. Needle 40' is usually of a gauge size between 18
and 22. Next, the operator performs the second step, passing HSC
50' through needle 40'. This step is performed by the operator
pushing the HSC deployment piece 54' forward with one or a number
of fingers. Guide wires are frequently used to navigate vessels
before catheter sheaths are passed over said guide wires, but the
HSC 50' hollow design provides support and guidance for the actual
guide wire. Likewise, said hollow design allows for the third step
performed by the operator. In the third step, the operator pushes
forward the thin stabilizing guide wire deployment piece 64' with
one or a number of fingers to pass the thin stabilizing guide wire
60' through the HSC 50', extending the thin stabilizing guide wire
60' past the HSC 50' and into the vessel. Thin stabilizing guide
wire 60' may be one of a plurality of materials. Each possible
material must be strong enough to support the passage of the
catheter sheath over it. In an exemplary embodiment of the present
invention, the thin stabilizing guide wire 60' may be highly
flexible until it is exposed to the temperature of human blood for
a specific period of time. One material could be nitinol which is
configured to increase rigidity upon exposure to temperatures on
the order of in vivo human blood. After exposure for said specific
period of time, the material may become more rigid. These
properties would allow the thin stabilizing guide wire 60' to
easily pass through fragile vessels without damaging vessel walls.
Then, once the operator advances the thin stabilizing guide wire
60' to its desired location by pushing the thin stabilizing guide
wire deployment piece 64', the thin stabilizing guide wire 60'
would become rigid enough to support a catheter sheath.
[0117] In another exemplary embodiment, the thin stabilizing guide
wire 60' may be made of a swellable polymer. Such a material would
allow the thin stabilizing guide wire 60' to be thin and rigid in a
dry state. The material would then increase in diameter with
exposure to a solution such as human blood. In the present
invention, the swellable polymer would be rigid when initially
traveling through the first vessel wall, so the wall may be
pierced, but flexible enough not to punch through the second,
opposing wall of the vessel. Over a specific period of time, the
swellable polymer would increase in diameter to match the diameter
of the HSC 50', which would be substantial enough for a catheter to
pass over it in the right location. The specific period of time
would be such that the operator would have enough time to position
the thin stabilizing guide wire 60' in the desired location.
[0118] While the thin stabilizing guide wire 60' may be made of
metal or a swellable polymer as in the exemplary embodiments, it is
not constrained to only those materials. The thin stabilizing guide
wire 60' may be a material that does not change properties at all
when coming into contact with human blood. It may simply be a
machined metal or polymer with just enough rigidity and strength as
to not damage vessel walls but still allow a catheter to pass over
it in a secure and stable manner. Likewise, the polymer would have
a high enough modulus of elasticity that it will not break during
normal use even at the small diameters required. One example would
be radiopaque polyurethanes, which have been used extensively in
catheter designs. Any material used in the thin stabilizing guide
wire 60', as in any component of the catheter assembly with a
segmented stabilization system, will be safe for contact within the
human body. Furthermore, any material used as the thin stabilizing
guide 60' wire may be coated with a material that facilitates its
passage through the HSC 50' and into the blood vessel without
swelling to an extent to occlude the vessel thereby preventing the
sliding of the catheter over the thin stabilizing guide wire 60'.
Such a material may be, but is not limited to, a polymer such as
mannose. The HSC 50' may also be coated with such a material to
facilitate its passage through the needle 40' and into the blood
vessel. To further facilitate the easy sliding of assembly
components, tolerances well known in the art must be maintained to
ensure a sliding, not sticking fit between the HSC 50', thin
stabilizing guide wire 60', and needle 40'.
[0119] Once the operator has deployed the thin stabilizing guide
wire 60', the segmented stabilization system is in position within
the patient's vessel. The segments are made up of the needle 40',
the HSC 50', and the thin stabilizing guide wire 60'. The thin
stabilizing guide 60' wire passes through the HSC 50', which passes
through the needle 40'. In addition, the tip of the thin
stabilizing guide wire 60' should be a blunted, bullet-like tip to
prevent vein puncture through both sides of the vessel. Each
component remains anchored within the outer housing 20' of the
catheter assembly so no component could break free and travel
farther into the patient's vessel than intended. By entering the
vessel in a step-wise manner, sudden and forceful movements that
may puncture a vessel wall are avoided. The multi-step progression
allows the operator to an innovative method for performing the
final step, sliding the catheter sheath over the segmented
stabilization system and facilitating the administration of an
intravenous catheter into the patient's vessel, as shown in FIG. 2.
FIG. 1A illustrates how, prior to administration of the catheter
assembly, the catheter sheath can be positioned so that it faces
the handle 20' and covers the base of the needle 40' leaving the
sharp tip of the needle protruding out. The base of the catheter
sheath is fitted on the needle so that it is secure when
administering the needle 40' and the segmented stabilization system
into the patient's vessel. As known in the art, a portion of the
needle 40' is extended from the catheter sheath to facilitate
insertion into the vessel of the patient as illustrated in FIG. 3A.
The tip of the catheter sheath rests above the insertion as the
needle tip punctures and enters the vessel. The catheter sheath tip
would be bevel shaped to allow for the catheter sheath to enter the
vessel more easily and decrease the risk of pushing the assembly
out of the vein as the catheter sheath is advanced. Likewise, the
beveled tip of the catheter sheath facilitates insertion into the
vessel over the segmented stabilization system. The base of the
catheter sheath is standard with the prior art and can be fitted
with standard mechanisms such as a Luer lock or others.
Furthermore, the catheter may/should be made of a more flexible
material than currently used in the art of cannulation to allow for
easier threading into tortuous, small veins. Because the segmented
stabilization system is in place, the catheter sheath, which would
be difficult to navigate a vessel independently, easily follows the
correct path of the vessel.
[0120] It is understood that the various components of the catheter
assembly 10'' with the segmented stabilization system may be coated
by a material that allows easier passage through another component
or into the vessel. Such coatings may act as a lubricant to
facilitate entrance into the patient's vessel. Various barriers may
also be in place to prevent the thin stabilizing guide wire 60'
from contacting human blood before the appropriate time. For
example, the thin stabilizing guide wire 60' may have to pass
through a thin wall to enter the vessel so that blood does not
prematurely cause the thin stabilizing component 60' to reach its
final rigidity.
[0121] Once the catheter is passed over the segmented stabilizing
system, the segmented stabilizing system and its associated
assemblies are withdrawn from the patient's body, leaving only the
catheter sheath in the vessel. Withdrawing the segmented
stabilizing system may be achieved by the operator performing the
reverse order of the operations that put the HSC 50' and thin
stabilizing guide wire 60' in place. This means that in an
exemplary embodiment, the needle deployment piece 44', HSC
deployment piece 54', and thin stabilizing guide wire deployment
piece 64' are all pulled back by one or a number of fingers of the
operator to withdraw the thin stabilizing guide wire 60', HSC 50',
and needle 40'. Alternatively, a separate mechanism may be deployed
to remove the segmented stabilizing system. Once the segmented
stabilizing system is removed, the catheter sheath is clear of
obstructions and may remain in the patient's peripheral vessel for
a period of time sufficient for all necessary drugs and/or fluids
to be administered to the patient. The catheter sheath must be of
sufficient length for the volume of fluid and/or drugs to be
administered. It must also be of sufficient diameter to allow the
timely administration of said drugs and/or fluids.
[0122] In an exemplary embodiment, the length of the portion of
thin stabilizing guide wire 60' extending outside extended HSC 50'
is 1 inch, and the diameter of the thin stabilizing guide wire 60'
is 0.04 inch. It is appreciated that the thin stabilizing guide
wire deployment piece 64' may take a variety of different shapes,
and that each component of the thin stabilizing guide wire assembly
may be made of materials known in the art.
[0123] The HSC assembly incorporates an HSC 50', and an HSC
deployment piece 54'. Connection between the two pieces may be by
medical grade glue or other means known in the art. In one
exemplary embodiment, the outer diameter of the HSC 50' is 0.08
inch and the inner diameter is 0.04 inch. The length of the HSC 50'
is 0.70 inch. It is appreciated that the HSC deployment piece 54'
may take a variety of different shapes, and that each component of
the HSC assembly may be made of materials known in the art.
[0124] The needle assembly includes a needle 40', and a needle
deployment piece 44'. In an exemplary embodiment, needle 40' is
0.50 inches long, with an outer diameter of 0.13 inch and an inner
diameter of 0.08 inch. The needle 40' may have a beveled tip to
facilitate insertion. It is appreciated that each component of the
needle assembly may be made of a variety of materials known in the
art. It is also appreciated that all sizes of exemplary embodiments
may be scaled depending on the specific application of the
catheter.
Options and Alternatives
[0125] It will be appreciated that the invention can take many
forms and embodiments. Variations obvious to those skilled in the
art will be included within the invention which is defined solely
by the claims. Some of those options and alternatives have been
described previously. Below are some additional examples.
[0126] For example, the size, shape, configuration, and materials
for various components of the invention can vary according to the
desire.
[0127] Another example would be that deployment mechanisms or
actuators could be different for extension deployment versus
retraction. In the described embodiments they are the same. As
mentioned, one application is intravascular catheterization.
However, any subsequent placement of some sort of a sheath or
cannula may be possible. Additionally, the invention may have other
uses beyond those.
[0128] It is also to be understood that in one embodiment, a hollow
or tubular stabilizing component is deployable beyond distal end of
a puncture needle. This hollow or tubular stabilizing component may
provide a guide for a guide wire. It also could provide a guide for
a further tubular or hollow stabilizing component deployable beyond
the fully extended distal end of the first hollow stabilizing
component. Because the first hollow stabilizing component is
hollow, it can have other potential features or uses. Furthermore,
any of those extendible or deployable stabilizing components can be
concentric relative to each other in the sense that one or more can
be slidable along the puncture needle or over it. There can be more
than one and more than two additional extendible stabilizing
components.
[0129] Furthermore, in the embodiments having a guide wire inside a
hollow stabilizing component, they do not have to be deployed
together. Additionally, the guide wire does not necessarily have to
then be deployed before catheter sheath is placed. The operator
could decide that utilization of the first hollow stabilizing
component is sufficient. As described above, the slider 64 or other
deployment control could be left alone and only the hollow
stabilizer component control utilized for that purpose. Still
further, the user could decide to deploy in a first step both
hollow stabilizing component 50 and internal wire 60 so they both
are extended from the needle as in FIG. 4E. The operator could then
decide a further second step extension of wire 60 is not
needed.
[0130] A further example, the relative extendible lengths of any
stabilizing component or components can be matched to at least the
approximate length of the sheath 30 which will be guided over it or
them. But they do not have to be of equal or even correlated
length. For example, full extended HSC 50 and wire 60 could be
longer than the reach of catheter sheath 30 when pushed forwardly.
Or they could be shorter. However, it has been found it could be
beneficial that sheath 30 length is at least approximately equal to
combined length of the fully extended HSC 50 and wire 60. This
gives confidence to the user that there would be the supplemental
stabilization assistance and guidance to approximately the same
extended position from the distal end of the needle as the sheath
length.
[0131] Several examples of coatings or additions to the components
have been described. Others may be possible.
[0132] It has been found that a stabilizing component, at least a
second stabilizing component and especially if in wire form, would
have more flexibility than typical metal guide wires such as are
conventional with the Seldinger technique. Use of the term "wire"
herein is intended to not be limited to metal. One example of
higher flexibility wire is plastic. An example has been given. It
could be multi-filament, twisted, or composite, instead of
monofilament. Other materials and configurations are possible.
[0133] Several of the embodiments have an integrated apparatus 10.
It is to be understood that there could be forms where the
deployment mechanisms are not specifically integrated with the
components to place the catheter. It will be understood that this
disclosure, in many respects, is only illustrative. Changes may be
made in details, particularly in matters of shape, size, material,
and arrangement of parts.
* * * * *