U.S. patent application number 17/162894 was filed with the patent office on 2021-05-20 for archflo midline catheter.
This patent application is currently assigned to Medical Components Inc.. The applicant listed for this patent is Medical Components Inc.. Invention is credited to Michael ANSTETT, Michael PALKO, Rose ROWAN, John TIMKO.
Application Number | 20210146095 17/162894 |
Document ID | / |
Family ID | 1000005371125 |
Filed Date | 2021-05-20 |
United States Patent
Application |
20210146095 |
Kind Code |
A1 |
PALKO; Michael ; et
al. |
May 20, 2021 |
ARCHFLO MIDLINE CATHETER
Abstract
A midline catheter is provided. The midline catheter includes a
shaft defining a lumen, the shaft having a distal end and a
proximal end. The distal end includes two or more opposing notches
thereon, each of the notches having an open notch distal end and an
opposing notch proximal end formed as an arch. The catheter may
also include written indicia thereon to indicate that it is a
midline catheter and/or is power injectable or
non-power-injectable.
Inventors: |
PALKO; Michael; (Perkasie,
PA) ; ANSTETT; Michael; (New Port Richey, FL)
; ROWAN; Rose; (Mantua, NJ) ; TIMKO; John;
(Rochester Hills, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medical Components Inc. |
Harleysville |
PA |
US |
|
|
Assignee: |
Medical Components Inc.
Harleysville
PA
|
Family ID: |
1000005371125 |
Appl. No.: |
17/162894 |
Filed: |
January 29, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15836054 |
Dec 8, 2017 |
|
|
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17162894 |
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62435887 |
Dec 19, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/583 20130101;
A61M 2205/584 20130101; A61M 25/0068 20130101; A61M 2025/0008
20130101; A61M 2025/0073 20130101; A61M 25/0097 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00 |
Claims
1. A midline catheter comprising: a shaft defining a lumen, said
shaft having a distal end and a proximal end wherein said distal
end includes two or more opposing notches thereon, each of said
notches having an open notch distal end and an opposing notch
proximal end formed as an arch; wherein an interior of the shaft is
undivided between the proximal end of the shaft and the proximal
end of each of the two or more opposing notches; wherein said
distal end includes a radiused edge circumferentially disposed
thereon.
2. The midline catheter of claim 1 wherein each of said arches are
formed in the shaft of the midline catheter.
3. The midline catheter of claim 1 wherein the radiused edge is
configured to reduce mechanical irritation during an insertion and
a dwell period.
4. The midline catheter of claim 1 wherein said catheter is sized
as 3F single, 4F single, or 4F double.
5. The midline catheter of claim 1 wherein a length of the catheter
is 10 cm.
6. The midline catheter of claim 1 wherein a dimension of each of
said notches is from 0.020 inches to 0.025 inches wide and 0.038
inches by 0.042 inches in length.
7. The midline catheter of claim 6 wherein the dimension of each of
said notches is 0.022 inches wide and 0.040 inches in length.
8. The midline catheter of claim 1 wherein a dimension of the
radius of the radiused edge is from 0.007 inches to 0.010
inches.
9. The midline catheter of claim 8 wherein the dimension of the
radius is 0.008 inches.
10. The midline catheter of claim 1 wherein the interior of the
shaft between the proximal end of each of said notches is
substantially circular.
11. A midline catheter comprising: a shaft defining a lumen, the
shaft having a distal end and a proximal end; the distal end
includes at least two opposing notches, with each notch of the at
least two opposing notches having an open notch distal end and an
opposing notch proximal end formed as an arch; wherein an interior
of the shaft between the proximal end of each of the at least two
opposing notches is substantially circular; wherein the distal end
includes a radiused edge circumferentially disposed thereon.
12. The midline catheter of claim 11 wherein each of the arches are
formed in the shaft of the midline catheter.
13. The midline catheter of claim 11 wherein the radiused edge is
configured to reduce mechanical irritation during an insertion and
a dwell period.
14. The midline catheter of claim 11 wherein the catheter is sized
as 3F single, 4F single, or 4F double.
15. The midline catheter of claim 11 wherein the interior of the
shaft is undivided between the proximal end and the proximal end of
each of said notches.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/836,054, filed on Dec. 8, 2017, which
claims the benefit of priority to U.S. Provisional Application No.
62/435,887, filed on Dec. 19, 2016, the entirety of each of which
is hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to vascular access and more
particularly to midline catheters.
BACKGROUND OF THE INVENTION
[0003] Peripheral intravenous catheters (PIV) typically remain in
place or "dwell" from a few hours to four days. For longer
therapies, PIVs are serially replaced or an extended use (extended
dwell) IV catheter is inserted. The most popular extended dwell IV
catheter is the peripherally inserted central catheter (PICC). The
end or tip or the catheter is generally positioned in the lower
one-third of the cavo-atrial junction. PICC insertions require a
highly skilled nurse or physician for insertion as they may employ
a variety of special components including a complicated,
large-gauge, peel-away introducer and/or fine-gauge wires that are
inserted into the vein.
[0004] Multiple complications can arise from the placement of a
PICC line ranging from simple bruising to significant tissue
damage, In all cases, a post-procedural chest X-Ray is used to
indicate whether or not the catheter is appropriately positioned in
the superior vena cava. Sometimes, the catheter tip is found to
reside either in the jugular vein, in the right atrium of the
heart, or malpositioned elsewhere. In the event of improper
catheter tip placement, the PICC must be manipulated into proper
position, removed or pulled back into a sub-optimal, non-central
position. Repositioning of a PICC line can be both difficult and
costly, as it often requires the use of a Fluoroscope for X-Ray
imaging guidance. Failure to reposition a poorly placed catheter
tip can result in complications such as abnormal heart rhythms,
vessel damage, or, rarely, a perforation of the superior vena cava
or other central vessels. Many physicians are hesitant to order a
PICC line for these same reasons.
[0005] In between the PIV and PICC is a mid-length (midline)
catheter which is designed for a moderate extended dwell period of
between six and thirty days. Midline catheters are peripheral
infusion devices inserted via the antecubital fossa with the tips
terminating in either the basilic, cephalic, or brachial vein,
distal to the shoulder, at or below the axillary line. Most
technicians consider the basilic vein to be optimal due to the
diameter of the vein.
[0006] As midline catheters are intended for extended use (e.g. up
to 30 days), maintaining patency of the catheter is a concern.
Therefore, what is needed is a midline catheter that has enhanced
patency that will increase dwell time by minimizing events that may
lead to catheter occlusion due to blood clots and/or suctioning to
the vessel wall.
BRIEF SUMMARY OF THE INVENTION
[0007] The foregoing needs are addressed by the midline catheter in
accordance with the invention.
[0008] In one aspect of the invention a catheter with enhanced
patency is provided. This is accomplished by shortening the lumen
from 20 cm (as in a standard midline catheter) to 10 cm to reduce
the mechanical vessel irritation from shoulder movement.
[0009] In another aspect of the invention the catheter includes a
distal end that includes a radiused edge, which reduces the
mechanical vessel irritation during insertion from shoulder
movement during dwell. Unlike conventional midline catheters the
midline catheter in accordance with the invention includes a
non-trimmable distal tip.
[0010] In another aspect of the invention the distal end of the
catheter includes opposing notches at the distal end that reduces
the likelihood of catheter occlusion due to blood clots or
suctioning to the vessel wall.
[0011] In another aspect of the invention the notches include an
arched portion positioned on and cut into the shaft of the
catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] For a better understanding of the invention, and to show how
the same may be carried into effect, reference will now be made, by
way of example, to the accompanying drawings, in which:
[0013] FIG. 1 is a perspective view of the midline catheter in
accordance with the invention showing the distal tip.
[0014] FIG. 2 is a perspective view of the midline catheter in
accordance with the invention showing the distal tip.
[0015] FIG. 3 is a perspective side view of the midline catheter in
accordance with the invention showing the radiused edge of distal
tip and the arched notch.
[0016] FIG. 4 is a perspective view depicting a hub and luer of a
catheter.
DETAILED DESCRIPTION OF THE INVENTION
[0017] The midline catheter in accordance with the invention
advantageously reduces mural thrombus formation along with a higher
potential of extended utility for blood return. Referring now to
FIGS. 1-3, the midline catheter 10 in accordance with the invention
includes catheter shaft 12, catheter lumen 14 and distal tip 16.
Proximal end 49 is operably coupled to a luer 52, extension, clamp,
ID tag and hub 50.
[0018] Distal tip 16 includes a pair of opposing notches 18, 20
thereon. Notches 18, 20 each include a distal end 22 and a proximal
end 24. Proximal end 24 is formed as an arch in the sidewall of
catheter shaft 12. The arch shape is advantageous in that it
eliminates corners that might encourage clots to form. Notches 18,
20 enhances the patency of catheter 10 by preventing occlusion of
lumen 14. Notches 18, 20 increase the open, patent area of the
catheter allowing for partial occlusion while still remaining
patent. Those of skill in the art will appreciate that more than
two opposing notches may be positioned at the distal tip of the
catheter depending on the size of the catheter and depending on the
dimensions of the notch. The dimensions of each of the opposing
arches are approximately 0.020 inches to 0.025 inches wide and
0.038 inches by 0.042 inches in length. Preferably the dimensions
are 0.022 inches wide and 0.040 inches in length. Those of skill in
the art will also appreciate that the dimensions of the notches 18,
20 may vary according to need and size of the catheter.
[0019] In addition, the distal end 22 of midline catheter 10 in
accordance with the invention advantageously includes a radius 26
circumferentially disposed on the distal end 22 for reducing
mechanical irritation during insertion and dwell periods. The
radius may be from 0.007 inches to 0.010 inches and preferably
0.008 inches.
[0020] The midline catheter 10 in accordance with the invention may
include a 3F single, 4F single and 4F double sized catheter. The
catheter may have a length of approximately 10 cm to prevent the
catheter from reaching the shoulder region which in turn reduces
mechanical vessel irritation from shoulder movement.
[0021] After implantation it is difficult to determine whether a
catheter is a PICC or a midline without referring to documentation
regarding the implantation procedure. Therefore, it is anticipated
that the hub 50 and luer 52 may include printed indicia thereon to
clearly identify it as a "midline" catheter and/or whether or not
the catheter is "power injectable." Such indicia may include a
symbol, words and may additionally include a color such as yellow,
red, green, etc. Those of skill in the art will appreciate that the
printed indicia may also be printed on the catheter shaft.
[0022] Those of skill in the art will also appreciate that the
catheter 10 may be power injectable or may be inserted
manually.
[0023] Although the invention has been illustrated and described
with respect to one or more implementations, equivalent alterations
and modifications will occur to others skilled in the art upon the
reading and understanding of this specification and the annexed
drawings. In addition, while a particular feature of the invention
may have been disclosed with respect to only one of several
implementations, such feature may be combined with one or more
other features of the other implementations as may be desired and
advantageous for any given or particular application. Thus, the
breadth and scope of the present invention should not be limited by
any of the above described embodiments. Rather, the scope of the
invention should be defined in accordance with the following claims
and their equivalents.
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