U.S. patent application number 16/251411 was filed with the patent office on 2019-05-23 for self-anchoring catheters and methods of use.
The applicant listed for this patent is PAVmed Inc.. Invention is credited to Lishan Aklog, Brian deGuzman.
Application Number | 20190151620 16/251411 |
Document ID | / |
Family ID | 56078513 |
Filed Date | 2019-05-23 |
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United States Patent
Application |
20190151620 |
Kind Code |
A1 |
Aklog; Lishan ; et
al. |
May 23, 2019 |
Self-Anchoring Catheters and Methods of Use
Abstract
Catheters for percutaneous applications are disclosed. The
catheter according to example embodiments may comprise a
substantially straight section, an anchoring section positioned
proximal to the substantially straight section. The anchoring
section can have a curvature for providing longitudinal traction
with a tissue to anchor the catheter to the tissue and a pathway
extending through the catheter for transporting fluids. The pathway
may comprise a first section and a second section in fluid
communication with each other, where the first section extends
through the length of the straight section, and the second section
extends through the anchoring section and has a curvature which
mimics the curvature of the anchoring section.
Inventors: |
Aklog; Lishan; (New York,
NY) ; deGuzman; Brian; (Paradise Valley, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PAVmed Inc. |
New York |
NY |
US |
|
|
Family ID: |
56078513 |
Appl. No.: |
16/251411 |
Filed: |
January 18, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14956141 |
Dec 1, 2015 |
10252034 |
|
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16251411 |
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62085838 |
Dec 1, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0021 20130101;
A61M 25/0009 20130101; A61M 25/04 20130101 |
International
Class: |
A61M 25/04 20060101
A61M025/04; A61M 25/00 20060101 A61M025/00 |
Claims
1. A method for forming a catheter comprising: coupling a straight
section of a catheter with a shaping member having a curved portion
with a pre-determined curvature, the straight section having a
flexible portion capable of being shaped into the pre-determined
curvature and a pathway extending through the straight section,
wherein the pathway mimics the curvature of the shaping member;
shaping the flexible portion of the straight section to assume the
pre-determined curvature; and wherein the flexible portion of the
straight section retains the pre-determined curvature upon removing
the straight section from the shaping member.
2. The method of claim 1, wherein the shaping member is a rigid
insert for shaping the flexible portion.
3. The method of claim 1, wherein the shaping member stays with the
anchoring portion during catheter insertion.
4. The method of any one of claim 1, wherein the shaping member is
a jacket for shaping the flexible portion.
5. A method for forming a catheter comprising: providing an
elongated tube having pathway extending therethrough and a flexible
portion; engaging a shaping member provided with curved
configuration to the flexible portion of the tube to provide the
flexible portion with a shape approximating the configuration of
the member; and allowing the flexible portion to retain the curved
configuration of the member upon removing the member.
6. The method of claim 5, wherein the member is a rigid insert for
shaping the flexible portion.
7. The method of claim 5, wherein the member stays with the
flexible portion during catheter insertion.
8. The method of any one of claim 5, wherein the member is a jacket
for shaping the flexible portion.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional application of U.S.
application Ser. No. 14/956,141 filed on Dec. 1, 2015, which claims
the benefit of and priority to U.S. Provisional Patent Application
No. 62/085,838, entitled "Self-Anchoring Catheters and Methods of
Use", filed on Dec. 1, 2014, each of which is incorporated herein
by reference in their entireties.
TECHNICAL FIELD
[0002] Example embodiments relate generally to catheters, more
particularly, to percutaneous catheters. The present disclosure
relates, in particular, to the use of a curved anchoring section
for anchoring catheters within tissues without the need of
additional devices or dressings.
BACKGROUND
[0003] A wide variety of catheters can be inserted into patients
for short-term and long-term use. These catheters can be inserted
into different types of anatomic structures including vascular
structures (e.g. veins, arteries, cardiac chambers), body cavities
and spaces (e.g. thoracic, pericardial, peritoneal, epidural,
thecal) and visceral organs (e.g. stomach, intestines, bladder).
They are used for various purposes including infusion of substances
(e.g. fluids, medications, blood products, nutritional), withdrawal
of blood or other bodily fluids for diagnostic or therapeutic
purposes (e.g. drainage, decompression), monitoring of physiologic
parameters (e.g. pressure, temperature) and as a conduit through
which therapeutic or diagnostic instruments are passed.
[0004] Catheters commonly used for percutaneous applications
include Percutaneous Venous Catheters (PVCs) and Central Venous
Catheters (CVCs). PVCs are inserted through the skin into a
peripheral vein, usually in the arm, and are the most common means
of delivering fluids or medications into patients. CVCs are
inserted through the skin into a central vein and usually remain in
place for a long period of time, especially when the reason for
their use is longstanding. PVCs and CVCs are secured into positions
utilizing various means. For example, CVCs are sometimes inserted
in more critical locations, and the catheters are sutured to the
skin and frequently have eyelets, suture guides or other features
to facilitate suturing. Other catheters are secured using simple or
elaborate taping schemes. There are a wide variety of proprietary
catheter anchoring devices being marked which uses a variety of
adhesives, straps and other mechanisms.
[0005] Catheter dislodgment is an issue for a variety of reasons.
Inadvertent dislodgement of certain catheters such as CVCs, chest
tubes, large arterial sheaths and others can lead to serious
complications including air embolism, pneumothorax, hemorrhage or
even death. Furthermore, replacing dislodged catheters can expose
patients to additional discomfort, interfere with the therapeutic
regimen or other care and lead to complications from the
reinsertion procedure. The economic burden resulting from dislodged
catheters or the various efforts and protocols necessary to prevent
dislodgement can be significant.
[0006] Accordingly, there is a need for catheters that can be
anchored to the skin without a need for suturing, elaborate taping
and/or additional anchoring devices.
SUMMARY
[0007] Devices, systems and methods for anchoring a catheter are
disclosed herein. According to embodiments illustrated herein,
there is provided a catheter capable of self-anchoring without the
use of additional anchoring instruments. The catheter may include a
substantially straight section, an anchoring section positioned
proximal to the substantially straight section, where the anchoring
section can have a curvature for providing longitudinal traction
with the tissue to anchor the catheter to a tissue. The catheter
may further include a pathway extending through the catheter for
transporting fluids or through which instruments may be inserted
into a patient, where the pathway can include a first section and a
second section in fluid communication with each other. The first
section can extend through the length of the straight section, and
the second section extends through the anchoring section and having
a curvature which mimics the curvature of the anchoring
section.
[0008] In some embodiments, there is provided a catheter system
including a straight section having a flexible portion capable of
assuming a pre-determined curvature configured to provide traction
with a tissue. The system may also include a shaping member with a
curved section having the pre-determined curvature for shaping the
flexible portion of the straight section into the pre-determined
curvature, and a pathway extending through the length of the
straight section for transporting fluids to and from the tissue,
wherein when the shaping member is coupled to the flexible portion
the flexible portion assumes the shape of the pre-determined
curvature and the pathway may mimic the pre-determined
curvature.
[0009] In some embodiments, there is provided a method for
operating a self-anchoring catheter. The method may include
inserting a catheter into a tissue, the catheter having a
substantially straight section, an anchoring section positioned
proximal to the substantially straight section and a pathway
extending through the straight section, the anchoring section
having a curvature for providing longitudinal traction with a
tissue to anchor the catheter to the tissue and the pathway
configured to mimic the curvature of the anchoring section. The
method may also include advancing the catheter in a rotating
fashion, until the anchoring section gains traction with the
tissue, and anchoring the catheter using the traction created
between the anchoring section and the tissue.
[0010] In some embodiments, there is provided a method for
manufacturing a catheter. The method may include inserting a
straight section of the catheter into a shaping member having a
curved portion with a pre-determined curvature, the straight
section having a flexible portion capable of being molded into the
pre-determined curvature. The method may also include shaping the
flexible portion of the straight section to assume the
pre-determined curvature, and removing the straight section from
the shaping member, wherein the flexible portion of the straight
section retains the pre-determined curvature.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Illustrative, non-limiting example embodiments will be more
clearly understood from the following detailed description taken in
conjunction with the accompanying drawings.
[0012] FIG. 1A illustrates a catheter with a helical shaped
self-anchoring section;
[0013] FIG. 1B and FIG. 1C illustrate a catheter with a rigid
insert for shaping a portion of the catheter;
[0014] FIG. 1D and FIG. 1E illustrate a catheter with a jacket for
shaping a portion of the catheter;
[0015] FIG. 2A and FIG. 2B illustrate a catheter system having a
helical shaped self-anchoring section and an insertion needle for
assisting the insertion of the catheter system;
[0016] FIG. 2C and FIG. 2D illustrate a catheter with a flexible
anchoring portion and a rigid insertion needle capable of
straighten the flexible anchoring portion;
[0017] FIG. 2E and FIG. 2F illustrate a catheter system with a
flexible anchoring section and a rigid insertion needle;
[0018] FIG. 2G and FIG. 2H illustrate a catheter system with a
flexible anchoring section inserted into a vessel layer;
[0019] FIGS. 3A-3F illustrate a catheter system having a helical
shaped self-anchoring section being inserted into anatomic
structures;
[0020] FIG. 4A illustrates a central vascular catheter having a
helical shaped self-anchoring section;
[0021] FIGS. 4B and 4C illustrate a central vascular catheter
having a helical shaped self-anchoring section being inserted into
an anatomic structure;
[0022] FIG. 5A illustrates a thoracic catheter having a helical
shaped self-anchoring section;
[0023] FIG. 5B illustrates a thoracic catheter having a helical
shaped self-anchoring section being inserted into an anatomic
structure;
[0024] FIG. 6A and FIG. 6B illustrate catheters having threaded
self-anchoring sections;
[0025] FIG. 7A and FIG. 7B illustrate a catheter having a threaded
self-anchoring section being inserted into an anatomic
structure;
[0026] FIG. 8A illustrate a central vascular catheter having a
threaded self-anchoring section; and
[0027] FIG. 8B illustrate a central vascular catheter having a
threaded self-anchoring section being inserted into an anatomic
structure.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0028] Various exemplary embodiments will be described more fully
hereinafter with reference to the accompanying drawings, in which
some example embodiments are shown. The present inventive concept
may, however, be embodied in many different forms and should not be
construed as limited to the example embodiments set forth herein.
Rather, these example embodiments are provided so that this
disclosure will be thorough and complete, and will fully convey the
scope of the present inventive concept to those skilled in the art.
In the drawings, the sizes and relative sizes of layers and regions
may be exaggerated for clarity. Like numerals refer to like
elements throughout.
[0029] It will be understood that when an element is referred to as
being "connected" or "coupled" to another element, it can be
directly connected or coupled to the other element or intervening
elements may be present. In contrast, when an element is referred
to as being "directly connected" or "directly coupled" to another
element, there are no intervening elements present. Other words
used to describe the relationship between elements should be
interpreted in a like fashion (e.g., "between" versus "directly
between," "adjacent" versus "directly adjacent," etc.).
[0030] Unless otherwise defined, all terms (including technical and
scientific terms) used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
inventive concept belongs. It will be further understood that
terms, such as those defined in commonly used dictionaries, should
be interpreted as having a meaning that is consistent with their
meaning in the context of the relevant art and will not be
interpreted in an idealized or overly formal sense unless expressly
so defined herein.
[0031] Embodiments of the present disclosure generally provide
self-anchoring catheters and catheter systems for percutaneous
applications. The various embodiments of the present disclosure can
be used for infuse or withdraw fluids from bodily tissues, and to
provide short or long term venous accesses.
[0032] FIG. 1 illustrates a catheter 100 in accordance with various
embodiments of the present disclosure. Referring to FIG. 1, the
catheter 100 can include a hub 102 section and a pathway 108
extending through the length of the catheter 100. The hub 102, as
illustrated, may be positioned at a proximal end of the catheter
100 and designed to be connected to a wide variety of instruments,
such as but not limited to, an infusion source, a withdrawal
mechanism, a monitoring device or serve as a portal of entry for
diagnostic or therapeutic instruments. To that end, the hub 102 may
be of any shape or dimension so long as it can be attached to the
desired instrument.
[0033] The catheter 100 may also include a catheter or body section
104 configured for communicating with anatomic structures. The
catheter section 104 can be directly connected to the hub 102 where
a first section 108a of the pathway 108 may extend through the
entire length of the catheter section 104. The overall length of
the catheter section 104 can vary to better accommodate the
insertion of the catheter 100 into different types of anatomic
structures. In some embodiments, the catheter section 104 may
further include a tip located at a distal end 112, where the
catheter section 104 and the distal tip 112 can be placed at
desired locations for transporting (i.e., delivering or
withdrawing) fluids. In some embodiments, the catheter section 104
may be substantially straight in nature for overcoming multiple
layers of tissues of an anatomic structure. The catheter section
104 can then place the distal tip 112 at the desired locations,
where fluids can be delivered or withdrawn at the distal tip 112
and then through the pathway 108. To better assist the insertion
and anchoring of the catheter at the various types of anatomic
structures, the catheter section 104 may be constructed to be
rigid, semi-rigid or flexible and may possess one or more lumens
designed for different types of venous applications. In general,
the catheter 100 and its various components may be made from any
material that is biocompatible, including, but not limited to,
plastic, metal or ceramic.
[0034] In some embodiments, as shown in FIG. 1, for anchoring the
catheter 100 at a surgical site, the catheter 100 can include an
anchoring section 106 designed to secure the catheter 100 onto a
tissue without using sutures, tapes or additional anchoring
apparatuses. The anchoring section 106 may be designed to be
directly connected the hub section 102, or in some embodiments, a
proximal catheter section 116 may be placed between the anchoring
section 106 and the hub section 102, where the proximal catheter
section 116 may be substantially straight in nature and the length
of the section 116 can vary to better accommodate the anchoring and
insertion of the catheter into different anatomic structures.
Fluids can be transported through the entire length of the catheter
100, from the hub 102 to the distal tip 112, via the pathway 108
which extends through the entire anchoring section 106.
[0035] Referring to FIG. 1, to anchor the catheter 100 at a tissue
site, the anchoring section 106, in some embodiments, can be curved
to assume a corkscrew like helical configuration, designed to
anchor into tissue structures. This helical structure can include a
plurality of turns spaced apart at certain pitch designed to create
a traction force with surrounding tissue. Each turns of the helical
structure can in general have a width 106w that is substantially
similar to the diameter 104w of the catheter section 104 or the
rest of the catheter 100 for that matter. Dimensions and pitch
distances of the anchoring section 106 can be configured to
optimize the traction between the helical turns and the tissue
body. For example, the diameter or width 106d of the helical
portion can be substantially larger than the opening created by the
catheter section 104 when the catheter is initially inserted into
the tissue, thereby ensuring the turns of the helical anchoring
section 106 can be securely pushed against the surrounding tissues.
It should be appreciated that the length provided to the anchoring
section 106, in some embodiments, should be sufficient to optimize
traction, and that although a helical design is provided, other
geometric designs can be implemented, so long as such a design
permits that anchoring section to be advanced to secure the device
in place. In some embodiments, for a 1 mm diameter PVC, the
anchoring section 106 can have about two to six turns, the helix
diameter can be about two to six times the catheter diameter (e.g.,
about two to six mm), and the pitch between the turns can be about
two to four mm. During an anchoring process, as the catheter 100 is
inserted into a tissue, the catheter 100 may be rotated clockwise
or counter-clockwise until the anchoring section 106 can be placed
substantially underneath at least one layer of tissue (i.e., a
layer of skin), such that the plurality of helical turns can
generate a traction force sufficient with the tissue to resist a
longitudinal displacement of the catheter 100. Leaving at least one
helical turn proximal to the anchoring tissue allow the catheter
100 to not only resist dislodgement from a traction force but also
prevents the catheter 100 from advancing further into the patient
from a pushing force. It should be appreciated that the anchoring
section 106 can be of any shape or dimension so long as it can
create sufficient traction forces with the surrounding tissues to
resist against dislodgement. In some embodiments, once the catheter
100 is secured in place, fluids can be transported through the
pathway 108, where a second portion 108b of the pathway 108 may be
designed to mimic the curvatures of the helical portion, such that
fluids flows through each turns within the helical portion. The
second section 108b of the pathway 108 can be entirely housed
within the turns of the helical portion and in direct communication
with the first section 108a of the pathway 108. The anchoring
section 106 as shown in FIG. 1 effectively allows tissues to be
lodged between each turns of the helical portion, thereby
optimizing the traction force between the catheter 100 with the
surrounding tissues. Furthermore, the length and diameter of the
helical portion, as well as the number of turns and the pitch
distance between turns, can be optimized to better anchoring the
catheter in different anatomic structures. It should be appreciated
that although only one anchoring section is provided, to the extent
that certain applications are contemplated, the device can be
provided with multiple anchoring sections. The availability of
multiple anchoring sections can assist in securing the device
across an area with different tissues. For example, a catheter may
include two or more anchoring sections for anchoring the catheter
in two different anatomic layers (e.g., skin and fascia). The
helical corkscrew like configuration of the anchoring section 106
can be formed in a variety of ways. In order to serve its anchoring
role, the anchoring section 106 may be configured to resist
straightening during application of a traction force. As such, the
anchoring section 106 may be designed to possess some rigidity. In
some embodiments the entire catheter 100 may be substantially
rigid, in which case the helical anchoring portion 106 can be
created as part of a single piece by shape molding that segment
using common techniques (e.g. bending around a mandrel, heat
shaping or fabricating it in that shape from the onset). In some
embodiments where the distal straight portion of the catheter 104
is substantially flexible, the device can be constructed from a
single piece by treating the helical portion in such a way to
render it more rigid or by altering the material as it is being
created (e.g. during an extrusion). In some embodiments, the
catheter 104 can be created from multiple parts which render the
distal straight portion substantially flexible and the proximal
helical portion more rigid. For example, a relatively rigid insert
120, as illustrated in FIG. 1B and FIG. 1C, may be applied to the
anchoring section 106 (which may be flexible) to create a helical
shaped portion. Or as illustrated in FIGS. 1D and 1E, a jacket 122
with a helical shape can be applied to the anchoring portion 106 of
the catheter to render the anchoring portion 106 more rigid and
also shape the anchoring section 106 into a helical
configuration.
[0036] For the purpose of better assisting the initial insertion
into a tissue, the catheter 100 can be equipped with a distal tip
112 that may be sharp and pointed and designed to penetrate
tissues. Or, in some embodiments, an integrated needle or an
insertion kit can be used to firstly penetrate the tissue and then
guide the catheter 100 to the desired anatomic location. FIGS. 2A
and 2B are diagrams illustrating an insertion needle 200 designed
to be integrated with the catheter 100 for an initial penetration
into a tissue. Referring to FIG. 2A, the insertion needle 200 can
include a proximal needle hub 202 that is connectable to the hub
section 102 of the catheter 100. The proximal needle hub 202 can be
connected to a substantially straight needle section 204, where the
needle section 204 may be of a diameter that is less than the
diameter of the pathway 108, such that the needle section 204 can
be inserted through the pathway 108. The needle section 204 can
further include a distal tip 206 that may be sharp and pointed and
designed to pierce through tissues. Now referring to FIG. 2B, in
some embodiments, a catheter system 220 can have the catheter 100
integrated with the insertion needle 200 for percutaneous
applications. In use, the entire needle section 204 can be fed
through the catheter 100 at the catheter's hub section 102, as
illustrated in FIG. 2B, where the length of the insertion needle's
200 needle section 204 can be optimized such that when inserted
through the catheter 100, the distal tip 206 of the needle section
204 protrudes out of the catheter 100 just slightly. To accomplish
this integration with the catheter 100 while still be able to
pierce through tissues (i.e., skins and vessels), the integration
needle 200 can consists of shape memory metal such as nitinol or
spring metal, which possesses the necessary flexibility to travel
through the helical configuration, yet also stiff enough to
penetrate various anatomic structures.
[0037] During a catheter anchoring process, the catheter 100 can be
firstly inserted through a layer of skin and into an appropriate
anatomic structure with the integrated needle 200 until the
anchoring section 106 (i.e., helical portion) reaches the skin
entry point. The catheter 100 can then be rotated until all or most
of the anchoring section 106 became submerged underneath the skin.
Subsequently, the catheter 100 can be covered with a simple
dressing, where the dressing and additional treatment of the entry
point can be performed to prevent inadvertent rotation of the
catheter 100. In this manner, for at least the reason that the
diameter of the helical portion is substantially larger than the
entry opening in the skin, the anchoring section 106 can resist
dislodgement in longitudinal direction. In some embodiments,
removing the catheter 100 can include removing the dressing,
rotating the catheter 100 in the opposite direction of the
insertion rotation until the helical portion is completely outside
the tissue body and then slide the remaining distal straight
catheter section 104 out of the patient.
[0038] In some embodiments, as shown in FIG. 2C and FIG. 2D, the
helical anchoring portion 106 of the catheter 100 may be fabricated
so that it is stiff enough to resist straightening under traction
forces but flexible enough and possesses shape memory so that it
may be straighten when a rigid insertion needle 230 is advanced
through the catheter's 100 lumen. In this embodiment, the catheter
100 and insertion needle 230 assemble 240 may be provided to an
operator just as a traditional device would. The portion of the
catheter with helical shape memory (e.g., anchoring portion 106)
can be indicated by a different color or other markings so that the
operator can know where the helical portion begins during the
insertion process. As illustrated in FIG. 2D, when a rigid
insertion needle 230 is inserted through the anchoring section 106,
the anchoring section 106 may be flexible enough to assume a
substantially straight shape. FIG. 2E and FIG. 2F illustrate an
exemplary embodiment of the catheter system presented in FIG. 2C
and FIG. 2D. As illustrated in FIG. 2E, the anchoring section 106
may be sufficiently flexible to assume other geometrical
configurations, and the anchoring section 106 may be marked in a
distinct color so an operator may know where the section 106 begins
and ends. In some embodiments, as illustrated in FIG. 2F, a rigid
insertion needle 230 may be applied to the catheter 100 to straight
out the anchoring section 106.
[0039] During a catheter anchoring process, as shown in FIG. 2G and
FIG. 2H, the straight catheter/needle assemble 240 may be inserted
through a layer of skin 242 and into an appropriate anatomic
structure until the marked, but current straightened, helical
portion 106 is near the skin entry point. When the needle 230 is
removed and no longer straightening the helical portion 106, this
portion 106 takes its helical configuration based on shape memory.
The helical portion 106 can then inserted through the skin 242
using the same rotational motion.
[0040] In some embodiments, the catheter system 220 as shown in
FIG. 2B can be conveniently deployed in anatomic structures where
blood vessels lay closely or far away from the skin layer. Firstly,
a blood vessel can be identified through direct visualization,
palpation or using some imaging modality. Subsequently, catheters
such as peripheral vascular catheters (PVCs) integrated with
anchoring sections that are similar to the anchoring section 106
described in FIG. 1 can be used for percutaneous applications.
FIGS. 3A-3C illustrate the catheter 100 being anchored in an
anatomic structure 300 where the thickness of the subcutaneous
tissue layer 302 is sufficiently large to anchor a substantial
portion of the anchoring section 106 within. For such anatomic
structures, during a catheter anchoring process, to reach a vessel
layer 304, the catheter system 220, where the insertion needle 200
is integrated within the catheter 100, may need to firstly pierce
through a layer of skin 306 and a layer of subcutaneous tissue 302
using the sharp distal needle tip 206. Referring to FIG. 3A, the
catheter system 220 can then be rotated to induce the anchoring
section 106 through the initial entry site and into the
subcutaneous tissue 302. Once at least a substantial portion of the
anchoring section 106 can be positioned within the subcutaneous
tissue layer 302, the insertion needle 200 can be withdrew from the
catheter system 220 by pulling the needle 200 out of the catheter
100 at the hub section 102. Illustrated in FIG. 3B is the catheter
100 inserted into the vessel layer 304 after the insertion needle
200 has been removed from the catheter system 220. Referring now to
FIG. 3C, the catheter 100 can be securely anchored at the
subcutaneous tissue layer 302 where the distal tip 112 is in
contact with the vessel layer to infuse or withdraw fluids.
[0041] Similarly, as illustrated in FIGS. 3D-3F, the catheter
system 220 can be readily deployed in an anatomic structure where
the thickness of the subcutaneous tissue layer 308 may be
insufficient to anchor the anchoring section 106. Referring now to
FIG. 3D, after the distal end 112 and a portion of the catheter
section 104 has penetrated through the subcutaneous tissue 308
layer to reach the vessel layer 310, the catheter system 220 may be
rotated to induce a horizontal motion to the catheter section 104
until a substantial portion of the anchoring section 106 can be
position within the vessel layer 310. The helical portion of the
anchoring section 106 can create a traction force with the vessel
layer 310, effectively securing the catheter 100 with in the vessel
layer 310. FIG. 3E illustrate the catheter 100 being inserted into
the vessel layer 310 with the insertion needle removed. Referring
now to FIG. 3F, after the catheter 100 is securely anchored in
place, the anchoring section 106 may be entirely or partially
anchored into the vessel layer 310 depending on the topography of
that particular anatomic structure.
[0042] It should also be appreciated that the helical configuration
can also be used on central vascular catheters as illustrated in
FIG. 4A. Similar a traditional central vascular catheter, catheter
400 as illustrated in FIG. 4A can possess a proximal hub section
402 with one or more ports 404 and a catheter portion with one or
more lumens 418. The catheter portion can include a substantially
straight proximal section 406, a helical anchoring section 408 and
a distal section 410. Similar to the peripheral vascular catheter
200, the helical anchoring section 408 can also be rigid or
semi-rigid, and an insertion of the central vascular catheter 400
can be facilitated with an insertion needle or an insertion kit. In
some embodiments, the central vascular catheter 400 can be inserted
into an anatomic structure to reach a blood vessel as illustrated
in FIGS. 4B and 4C. An insertion kit can be used to assist the
access to vessel 412, where a finder needle and a guide wire can be
used to advance the straight proximal section 406 off the catheter
400 into position. Subsequently, the catheter 400 can advance over
the wire until the helical anchoring section 408 reaches the skin
414. The catheter 400 can then be rotated until the helical
anchoring section 408 is completely under the skin 414. In general,
the subcutaneous tissue layer 416 will be thick enough such that
the helical anchoring section 408 will not enter the vessel 412.
Furthermore, to prevent inadvertent rotations, the catheter 400 can
be optionally covered with sterile dressings as necessary.
[0043] In some embodiments, the helical configuration can also be
used on thoracic catheters or chest tubes, as illustrated in FIGS.
5A and 5B. Referring to FIG. 5A, a thoracic catheter 500 can
possess the similar features of the vascular catheter 400 but to be
used in a pleural space 504 (i.e., lung) to evacuate air and fluid
or on occasion, infuse therapeutic agents. Due to the fact that the
tip of the catheter 500 often needs to be precisely positioned at a
specific surgical location (e.g. at the thoracic apex), the
catheter 500 may possess a particularly long helical anchoring
section 502 for gaining access to the desired surgical location
across the subcutaneous tissue 506 and the pleural space 504. The
insertion process can include firstly creating a small skin
incision, followed by creating a tunnel through the subcutaneous
tissue 506 and into the pleural space 504, then advance the
catheter (generally without a trocar) 500 through the small skin
incision, and rotate the catheter 500 until the helical shaped
anchoring section 502 can reside completely under the skin 502 and
the catheter tip is located at the proper position.
[0044] In some embodiments, the self-anchoring feature of the
percutaneous catheters may be formed by screw-like threads which
engages the skin and prevents dislodgement, as illustrated in FIGS.
6A and 6B. In many ways, this embodiment can be similar to that of
the helical configuration. The catheter 600 as shown in FIG. 6A can
include a proximal hub 602, a straight proximal section 504, a
threaded anchoring section 606 followed by a straight distal
section 608. Or as shown in FIG. 6B, the threaded anchoring section
606 can be contiguous with the proximal hub 602, eliminating the
straight proximal section 604 of the catheter 600, where the
threaded anchoring section 606 can be rigid, semi-rigid or
flexible. In some embodiments, the width, pitch and number of turns
of the threads can be optimized to facilitate a better engagement
with a wide range of skin thicknesses.
[0045] It should be appreciated that the threaded anchoring section
configuration can be applied to all percutaneous catheters
including the peripheral vascular catheters and the central
vascular catheters.
[0046] For example, FIGS. 7A and 7B are diagrams illustrating a
peripheral vascular catheter 700 having a threaded anchoring
section 702 in accordance with an embodiment of the present
disclosure. Referring to FIG. 7A, the anchoring section 702 can be
directly connected to a hub section 704 designed to function as an
infusion source or a withdrawal mechanism. The anchoring section
702 can be designed to have threads configured to anchor onto
tissues. As shown in FIGS. 7A and 7B and similar to the insertion
process illustrated in FIGS. 3A and 3B, after the catheter 700 has
been inserted through a layer of tissue 708 (i.e., skin) using an
insertion needle 706, the catheter 700 can be rotated to be entered
through the opening provided by the insertion needle 706, where the
anchoring section 702 can be threaded into the tissue layer 708,
thereby providing anchoring to the catheter 700.
[0047] In a similar fashion, central vascular catheters can also be
equipped with the threaded anchoring sections designed to provide
anchoring within tissues. FIGS. 8A and 8B are diagrams illustrating
a central vascular catheter 800 in accordance with embodiments of
the present disclosure. Referring to FIGS. 8A and 8B, the catheter
800 can include an anchoring section 802 equipped with threads
designed to anchor onto tissues, where the anchoring section 802
can be directly connected to a proximal hub section 804 designed to
be coupled to other instruments. In use, after an initial insertion
into a tissue, the catheter 800 can be rotated until the threaded
anchoring section 802 can be threaded into the tissue, thereby
providing anchoring to the catheter 800, as illustrated in FIG.
8B.
[0048] It should be appreciated that although described as being
helical in design or threaded in design, the self-anchoring portion
of the catheter can be one of a helical design, a threaded design,
any self-anchoring designs, or a combination thereof.
[0049] While the present disclosure has been described with
reference to certain embodiments thereof, it should be understood
by those skilled in the art that various changes may be made and
equivalents may be substituted without departing from the true
spirit and scope of the disclosure. In addition, many modifications
may be made to adapt to a particular situation, indication,
material and composition of matter, process step or steps, without
departing from the spirit and scope of the present disclosure. All
such modifications are intended to be within the scope of the
claims appended hereto.
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