U.S. patent application number 14/187983 was filed with the patent office on 2014-06-19 for retrofitted neural injection system and related methods.
This patent application is currently assigned to Custom Medical Applications. The applicant listed for this patent is Nicholas Sandor Racz. Invention is credited to Nicholas Sandor Racz.
Application Number | 20140171915 14/187983 |
Document ID | / |
Family ID | 40133016 |
Filed Date | 2014-06-19 |
United States Patent
Application |
20140171915 |
Kind Code |
A1 |
Racz; Nicholas Sandor |
June 19, 2014 |
RETROFITTED NEURAL INJECTION SYSTEM AND RELATED METHODS
Abstract
Various embodiments may include methods of manufacture of a
retrofitted neural injection system. Various embodiments may
include acquiring an injection needle comprising a hollow cannula
with an open distal end. Then, forming an at least one side port in
the hollow cannula proximate to the distal end. Then, sealing the
open distal end of the hollow cannula with a bio-compatible sealant
so as to eliminate fluid communication between the inside and the
outside of the hollow cannula via the distal end. In some
embodiments, the bio-compatible sealant may be comprised of a
thermosetting material. In some embodiments, the bio-compatible
sealant may be comprised of a cured epoxy resin. In some
embodiments, the bio-compatible sealant may be comprised of an
aliphatic polymer. In some embodiments, the bio-compatible sealant
may be comprised of an polyfluorocarbon.
Inventors: |
Racz; Nicholas Sandor;
(Coppell, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Racz; Nicholas Sandor |
Coppell |
TX |
US |
|
|
Assignee: |
Custom Medical Applications
Farmers Branch
TX
|
Family ID: |
40133016 |
Appl. No.: |
14/187983 |
Filed: |
February 24, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12139233 |
Jun 13, 2008 |
8690832 |
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14187983 |
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60943824 |
Jun 13, 2007 |
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Current U.S.
Class: |
604/513 ;
604/164.06; 604/272 |
Current CPC
Class: |
A61M 5/3291 20130101;
A61B 17/3401 20130101; A61M 25/0009 20130101; Y10T 29/49716
20150115 |
Class at
Publication: |
604/513 ;
604/272; 604/164.06 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A neural injection system comprising: an at least partially
hollow cannula with a sharp distal end, wherein said sharp distal
end has a port comprising biocompatible sealant, wherein said port
was formerly open; wherein said hollow cannula is defined by a
first inside diameter, a first outside diameter, a first length,
and at least one side port in fluid communication between the
inside and the outside of the hollow cannula; wherein said side
port is located coaxially at a predetermined distance from the
distal end; and wherein fluid communication between the inside and
the outside of the hollow cannula via the distal end is eliminated
by a hermetic seal.
2. The system of claim 1, wherein the neural injection system
comprises a stylet.
3. The system of claim 2, wherein the stylet is releasably secured
within a first portion of said hollow cannula.
4. The system of claim 2, wherein the stylet is fixedly secured
within a first portion of said hollow cannula.
5. The system of claim 2, wherein the stylet is capable of sliding
within said hollow cannula.
6. The system of claim 2, wherein the stylet extends up to the
distal end of said first length of said hollow cannula.
7. The system of claim 2, wherein the stylet extends beyond the
distal end of said first length of said hollow cannula.
8. The system of claim 2, wherein the stylet is hollow and has at
least one side port.
9. The system of claim 8, wherein the side port of said stylet is
in fluid communication with said side port of the hollow
cannula.
10. The system of claim 9, wherein the neural injection system
comprises a rigid bend in the hollow cannula proximate to the
distal end.
11. The system of claim 10, further comprising an agent for
delivery to said individual.
12. A method of treatment of an individual in need thereof
comprising: locating a site for treatment in said individual;
adjusting the neural injection system of claim 4 such that said
system is positioned relative to said individual at a desired
insertion point and orientation; inserting at said site at least a
portion of said neural injection system; maneuvering the distal end
of the neural injection system inside said individual proximate to
the site; and treating said individual.
13. A kit comprising the neural injection system of claim 4 and at
least one agent.
Description
FIELD OF INVENTION
[0001] The present invention generally relates to injection systems
and related methods of manufacture and use.
BACKGROUND OF THE INVENTION
[0002] Needles and needle systems are used extensively in a wide
variety of procedures which are performed in various fields of
medicine, such as cardiology, radiology, urology, interventional
pain management, and internal medicine. The use of needles and
needle systems in invasive procedures in various medical fields has
become routine due, in part, to the ability of needles to pass
through most tissues without causing significant destruction to the
tissues. Conventional needles have an orifice or a port at the
distal tip of the needle. Distal tips of needles are more liable to
clog as the tip of the needle is used for penetration of tissue to
access the site of treatment. Additionally, there exists a greater
chance of leakage of the agent being delivered, using conventional
needles. Needles with orifices located along the length of the
needle are routinely used for aspiration purposes as well as for
delivering anesthesia. Specifically, a variety of needles having
side ports are used for delivery of spinal anesthesia. This
configuration reduces the chance of the inability to deliver
anesthesia due to clogging of the opening at the needle tip.
[0003] A very successful embodiment of a needle with an opening at
the distal end portion and with a side port is disclosed in U.S.
Pat. No. 5,817,074 ("the '074 patent"). The '074 patent discloses a
stellate ganglion sympathetic block needle having a side port
positioned at a predetermined distance from the opening a the
distal tip. The stellate ganglion sympathetic block needle allows
for an effective stellate ganglion sympathetic block even if the
needle is placed such that the needle distal opening is under the
anterior longitudinal ligament, which results in the needle distal
opening being, constricted, thereby interfering with the injection
of the anesthesia. When this interference occurs, the side port of
the stellate ganglion sympathetic block needle allows directional
injection onto the surface of the anterior longitudinal ligament in
order to spread onto the surface of the longus coli muscle toward
the stellate ganglion, thereby achieving an effective stellate
ganglion sympathetic block. This invention has found wide
applicability; however, certain procedures might prefer a needle
with a blocked distal tip and only side port(s) for the
administration of therapeutic, diagnostic or prophylactic agents
while retaining the sharp point of the distal tip to maneuver and
penetrate certain tissues to access treatment sites.
[0004] Needles with a blocked tip (distal end) and an open side
portal are used for procedures such as thoracentesis, which
involves inserting the needle through the thoracic cage into the
pleural space between the lung and the chest wall to draw off fluid
for diagnostic or therapeutic purposes. Thoracentesis needles
generally consist of an orifice free, sharp conical end and a
circular side hole for draining fluid. However, these needles are
pre-made with an enclosed end, making them much more expensive than
traditional open-ended beveled needles to manufacture.
[0005] Accordingly, it would be desirable to create a neural
injection system that is primarily composed of a traditional
open-ended needle system, which is common and inexpensive, and
retrofit such a needle to provide a sharp-tipped, open side port,
closed distal end, neural injection system.
SUMMARY OF THE INVENTION
[0006] The summary of the invention is not intended to represent
each embodiment or every aspect of the present invention.
[0007] Various embodiments may include a neural injection system
comprising: an at least partially hollow cannula with a sharp
distal end, wherein said distal end has a port comprising
biocompatible sealant; wherein said distal end has a port, and said
partially hollow cannula is defined by a first inside diameter, a
first outside diameter, a first length, and at least one side port
in fluid communication between the inside and the outside of the
hollow cannula, located coaxially at a predetermined distance from
the distal end, wherein the port at the distal end is sealed to
eliminate fluid communication between the inside and the outside of
the hollow cannula via the distal end.
[0008] Further, various embodiments may include a method of
treatment for an individual in need thereof comprising locating a
site for treatment in the individual; adjusting the neural
injection system described above; such that the system is
positioned relative to the individual at a desired insertion point
and orientation; inserting at the site at least a portion of the
neural injection system described above; maneuvering the distal end
of the neural injection system inside the individual proximate to
the site; and treating the individual.
[0009] Another embodiment may include a method of retrofitting a
needle comprising acquiring an injection needle comprising a hollow
cannula with an open distal end; forming at least one side port in
the hollow cannula proximate to the distal end so as to permit
fluid communication between the inside and the outside of the
hollow cannula via the side port; and sealing the open distal end
of the hollow cannula with a sealant so as to eliminate fluid
communication between the inside and the outside of the hollow
cannula via the distal end.
[0010] Various embodiments may also include a system for delivering
an agent in vivo in an individual in need thereof comprising: means
for locating a site for delivery in the individual; means for
adjusting the neural injection system described above; such that
the system is positioned relative to the individual at a desired
insertion point and orientation; means for inserting at said site
at least a portion of the neural injection system of claim 1; means
for maneuvering the distal end of the neural injection system
inside the individual proximate to the site; and means for
delivering said agent.
[0011] Yet another embodiment may be a kit comprising the neural
injection system described above; and at least one agent, where the
agent may be a therapeutic agent, a diagnostic agent or a
prophylactic agent.
[0012] The foregoing has outlined rather broadly the features and
technical advantages of the present invention in order that the
detailed description of the invention that follows may be better
understood. Additional features and advantages of the invention
will be described hereinafter which form the subject of the claims
of the invention.
BRIEF DESCRIPTION OF THE FIGURES
[0013] The foregoing summary as well as the detailed description of
the preferred embodiment of the invention will be better understood
when read in conjunction with the appended drawings. It should be
understood, however, that the invention is not limited to the
precise arrangements and instrumentalities shown herein. The
components in the drawings are not necessarily to scale, emphasis
instead being placed upon clearly illustrating the principles of
the present invention. Moreover, in the drawings, like reference
numerals designate corresponding parts throughout the several
views.
[0014] The invention may take physical form in certain parts and
arrangement of parts. For a more complete understanding of the
present invention, and the advantages thereof, reference is now
made to the following descriptions taken in conjunction with the
accompanying drawings, in which:
[0015] FIG. 1 is an illustration of a traditional injection system
found in the prior art;
[0016] FIG. 2 is an illustration of an embodiment of a retrofitted
neural injection system; and
[0017] FIGS. 3 is an illustration of an embodiment of a retrofitted
neural injection system with a rigid bend in the cannula.
DETAILED DESCRIPTION OF THE INVENTION
[0018] The principles of the present invention and their advantages
are best understood by referring to FIGS. 1-3 of the drawings, like
numerals being used for like and corresponding parts of the various
drawings.
[0019] Although the invention has been described with reference to
specific embodiments, these descriptions are not meant to be
construed in a limiting sense. Various modifications of the
disclosed embodiments, as well as alternative embodiments of the
invention will become apparent to persons skilled in the art upon
reference to the description of the invention. It should be
appreciated by those skilled in the art that the conception and the
specific embodiment disclosed may be readily utilized as a basis
for modifying or designing other structures for carrying out the
same purposes of the present invention. It should also be realized
by those skilled in the art that such equivalent constructions do
not depart from the spirit and scope of the invention as set forth
in the appended claims.
[0020] In the following descriptions and examples, specific details
are set forth such as specific quantities, sizes, etc., to provide
a thorough understanding of the present invention. However, it will
be obvious to those skilled in the art that the present invention
may be practiced without such specific details. In many cases,
details concerning such considerations and the like have been
omitted inasmuch as such details are not necessary to obtain a
complete understanding of the present invention and are within the
skills of persons of ordinary skill in the relevant art. It is
therefore contemplated that the claims will cover any such
modifications or embodiments that fall within the true scope of the
invention.
[0021] The following definitions and explanations are meant and
intended to be controlling in any future construction unless
clearly and unambiguously modified in the following examples or
when application of the meaning renders any construction
meaningless or essentially meaningless. In cases where the
construction of the term would render it meaningless or essentially
meaningless, the definition should be taken from Webster's
Dictionary, 3.sup.rd Edition.
[0022] The term "attached," or any conjugation thereof describes
and refers the at least partial connection of two items.
[0023] Exemplary, non-limiting embodiments of medical instrument,
neural injection systems, and the like that can be modified
according to various teachings include, but are not limited to,
U.S. Pat. No. 6,949,087; U.S. Pat. No. 6,855,132; U.S. Pat. No.
6,558,353; U.S. Pat. No. 6,547,769; U.S. Pat. No. 6,387,163; U.S.
Pat. No. 6,245,044; U.S. Pat. No. 5,871,470; U.S. Pat. No.
5,865,806; U.S. Pat. No. 5,836,914; U.S. Pat. No. 5,817,074; U.S.
Pat. No. 5,800,445; U.S. Pat. No. 5,730,749; U.S. Pat. No.
5,669,882; U.S. Pat. No. 5,628,734; U.S. Pat. No. 5,573,519; U.S.
Pat. No. 5,571,091; U.S. Pat. No. 5,480,389; U.S. Pat. No.
5,466,225; U.S. Pat. No. 5,336,191; U.S. Pat. No. 5,312,360; U.S.
Pat. No. 5,304,141; U.S. Pat. No. 5,250,035; U.S. Pat. No.
5,242,410; U.S. Pat. No. 5,106,376; U.S. Pat. No. 4,994,034; U.S.
Pat. No. 4,973,313; U.S. Pat. No. 4,629,450; U.S. Pat. No.
4,317,445; U.S. Pat. No. 4,308,875; U.S. Pat. No. 4,230,123; U.S.
Pat. No. 3,856,009; U.S. Pat. No. 3,565,074; and, U.S. Pat. No.
2,922,420, the contents of which are hereby incorporated by
reference as if they were presented herein in their entirety. In
general, any catheter may be used with the various embodiments of
the present invention.
[0024] A "fluid" is a continuous, amorphous substance whose
molecules move freely past one another and that has the tendency to
assume the shape of its container, for example, a liquid or a
gas.
[0025] Any agent that can be injected through a needle can be
delivered using the inventive method. Typical agents might include
drugs, small molecules, pharmaceutical agents, diagnostic agents,
biological molecules, proteins, peptides, antibodies,
polynucleotides, RNA, DNA, viruses, cells, and combinations
thereof. Agents may range in size from small organic molecules to
macromolecules such as DNA to intact cells. The agent to be
delivered to the injection site may be therapeutic (e. g.,
chemotherapeutic drug, antibiotic), prophylactic (e. g., vaccine),
or diagnostic (e. g., contrast agent for magnetic resonance
imaging, labeled metabolite).
[0026] Drugs include any compound useful in the treatment or
prevention of a disease. In a particularly preferred embodiment,
the drug is an antibiotic, anti-viral agent, anesthetic, steroidal
agent, anti-inflammatory agent, anti-neoplastic agent, antigen,
vaccine, antibody, decongestant, antihypertensive, sedative, birth
control agent, progestational agent, anti-cholinergic, analgesic,
anti-depressant, anti-psychotic, p-adrenergic blocking agent,
diuretic, cardiovascular active agent, vasoactive agent,
non-steroidal anti-inflammatory agent, nutritional agent, etc. A
combination of drugs may be used in the present invention. The drug
may also be delivered in various forms, for example, the drug may
be encapsulated, or the drug may be in a time release form.
[0027] Therapeutic prophalytic or diagnostic agents to be delivered
may also include biological molecules such as proteins, peptides,
polynucleotides, and oligonucleotides. Examples of proteins or
peptides include insulin, cytokines, growth factors,
erythropoeitin, antibodies, antibody fragments, etc.
Polynucleotides may be delivered for gene therapy and anti-sense
therapy.
[0028] In addition to drugs, small molecules, and biological
molecules, the invention may be used to deliver viruses and cells.
Particularly preferred viruses and cells are those that are
therapeutic. Viruses with altered genomes may be used in gene
therapy as vectors to introduce a foreign gene into the patient's
cells.
[0029] Further, agents used for delivery with the inventive method
disclosed herein may also include cells. Any type of cell or
mixture of cells may be transplanted using the inventive
method.
[0030] The term "medicament(s)" means and refers to all types of
fluidic substances that have a beneficial, desired or therapeutic
effect. Non-limiting examples of medicaments suitable for use in
the invention methods include anesthesia, biologically active
agents, such as small molecule drugs, proteinaceous substances,
polynucleotides or nucleic acids (e.g., heterologous DNA, or RNA)
and vectors, liposomes, and the like, containing such nucleic acids
or polynucleotides, as well as liquid preparations or formulations
thereof.
[0031] The term "medical instrument" means and refers to any item,
instrument or structure capable of connecting to a catheter, such
as, but not limited to a stimulation device, tubing, piping, a
medicament delivery system, a meter, a liquid repository (e.g., an
I.V. bag), a syringe, or the like.
[0032] The term "normal insertion procedure" means and refers to a
typical surgical or insertion procedure as disclosed in Heavner et
al., "Sharp Versus Blunt Needle: A Comparative Study of Penetration
of Internal Structures and Bleeding in Dogs", 2003, World Institute
of Pain, Pain Practice, 3:3, 226-231.
[0033] The term "stylet" means and refers to a small poniard.
Stylets of the preset invention are capable of being hollow, but
such is not required.
[0034] Other than in the operating examples, or where otherwise
indicated, all numbers expressing quantities of ingredients or
reaction conditions used herein are to be understood as modified in
all instances by the term "about".
[0035] Various embodiments include a retrofitted neural injection
systems and related methods of manufacture and use with at least
one benefit of enhanced injection characteristics, increased
operational efficiency, reduced cost per unit, reduced incidence of
injury through intraneural or intravascular injection, reduced
incidence of injury through pricking or piercing, or the like.
[0036] Various embodiments includes a retrofitted neural injection
system include an at least partially hollow cannula. The cannula is
defined by a first inside diameter, a first outside diameter, a
first length, a side port located coaxially along the cannula for
fluid communication between the inside and the outside of the
hollow cannula, and a sealed distal end. In some embodiments, the
system also includes a stylet, wherein the stylet is capable of
being releasably locked in a first position within the hollow
cannula and extends up to a first length of the hollow cannula. In
some embodiments, the hollow cannula proximate to the distal end
includes a rigid bend so as to facilitate placement of the distal
end adjacent to a target site.
[0037] Various embodiments also includes methods and devices that
are designed for injection of minute amounts of fluid medicaments
into tissue or a body wall, for example, an interior body wall. The
therapeutic amount of the medicament to be administered according
to the invention method will vary depending upon the therapeutic
goal to be accomplished, the size and age of the subject, the
pharmacokinetics of the injectate, and the like.
[0038] Various embodiments are designed for treatment of a target
tissue(s) at a target site. In an embodiment, treatment of a tissue
may be at least one of probing, ablation, stimulating, or the like.
In general, treatments capable with various embodiments can be any
treatment common in the art and should not be limited by the
present disclosure.
[0039] A cannula associated with various embodiments may be a
cylindrical structure extending from a proximal end to a distal
end. The length from the proximate end to the distal end, traveling
along the length of the cannula is known as the first length. In
various embodiments where a bend in the cannula exists, the first
length may be longer than the linear distance from the proximate
end to the distal end. In an embodiment, the cannula is of a
generally constant circumference. The cannula is capable of being
differentiated by an inside diameter and an outside diameter. In an
embodiment, an outside diameter is between about 0.0355 to about
0.03600 mm and an inside diameter is between about 0.0230 to about
0.0245 mm. In an alternate embodiment, an outside diameter between
about 0.0205 to 0.280 mm and an inside diameter between about
0.0155 to 0.0170 mm. In various embodiments, an inside diameter and
an outside diameter are capable of being any desired length and any
particular length should not be construed as a limitation on the
scope of the appended claims.
[0040] In various embodiments, a distal end of the at least
partially hollow cannula may take various shapes. In an embodiment,
the distal tip may be the traditional beveled angular plane shape.
In another embodiment, the distal tip is squared with the
perpendicular of the lengthwise plane of the cannula. In another
embodiment, the distal tip forms a partial bevel, wherein the
leading portion of the shaped tip is of a traditional bevel form
and the remainder of the tip is formed in a non-beveled shape, such
as a stair step. Regardless of the shape of the distal end of the
cannula, the distal end of the cannula should be capable of being
sealed by a material so as to close the original open distal end of
the cannula.
[0041] In various embodiments, a sealant is applied to provide a
hermetic seal at the distal end of the at least partially hollow
cannula. The seal may be used to block all fluid flow through the
formerly open distal end of the cannula. In various embodiments,
the sealant may be applied in a moderate amount so that the cutting
and leading action of the distal tip is not encumbered by a buildup
of sealant on the distal tip. In various embodiments, the sealant
may be applied in a moderate amount so that the side port is not
encumbered or blocked. In some embodiments, the sealant is composed
of a bio-compatible material, such as a thermosetting polymer like
an epoxy resin. Aliphatic polymers such as polyethylene or
polypropylene may be applied in a liquid form and cooled to a solid
state on the distal end of the hollow cannula or in monomer form
and cured on the surface of the hollow cannula so as to provide a
thin yet resistant film across the open end of the distal end.
Another sealant that may be used would be one comprised of a
polyfluorocarbon to increase the "slipperiness" of the leading
surface. Other sealant materials that may be used are known to
those familiar in the medical arts.
[0042] In various embodiments, a connector may be about the
proximal end of the cannula. A connector may be used as an
attachment means for attaching the cannula and an optional further
medical instrument. The connection(s) at the proximal end may be
any type of connection common in the art, such as, for example, and
not by way of limitation, a luer lock connector, a threaded
attachment, an interference fit attachment, a clamp, a system
utilizing a dowel, two or more of the aforesaid in combination, or
the like.
[0043] A stylet of various embodiments may extend through at least
a portion of the hollow portion of the cannula. In some
embodiments, a stylet may be characterized by an outside diameter
and a length extending from a proximal end to the distal end,
representing the first length. The outside diameter, in various
embodiments, is smaller than the first inside diameter of the
cannula. In some embodiments, the stylet comprises a side port an
is at least partially hollow. In an embodiment, the stylet and the
cannula define a passageway for passage of at least one
medicament.
[0044] In various embodiments, the material of construction may
permit the stylet so as to bend within the hollow cannula to
conform generally to its internal shape. In some embodiments, the
material of construction of the flexible stylet may be of a polymer
material. In some embodiments, the material will be made of a
biocompatible material. Examples of such embodiments include
materials such as polyethylene, polypropylene, and
polyfluorocarbons. In some alternative embodiments, the material of
construction may be of a metallic material. Examples of embodiments
include steel alloys, titanium alloys, and aluminum. In various
embodiments, the stylet exhibits elastic deformation in regards to
insertion and removal from the cannula.
[0045] In various embodiments, the stylet may be capable of being
inserted into the cannula so that the distal tip of the stylet may
be position within the cannula at any point. In an embodiment, the
distal end of the stylet may be positioned so that the distal end
of the stylet is equivalent with the distal end of the cannula in
relation to the proximate end of the cannula. In an alternate
embodiment, the distal end of the stylet may extend past the distal
end of the cannula. In an alternate embodiment, the distal end of
the cannula may extend past the distal end of the stylet.
[0046] Various embodiments may fixedly connect, releasably connect,
or leave unconnected the flexible stylet and the cannula. In
another embodiment, the stylet is capable of sliding within the
cannula. In another embodiment, the stylet is releasably secured
within the cannula by a locking mechanism, such as, but not limited
to a luer lock, an interference fit, a snap, screw threads, or the
like. In an embodiment of a luer lock system, internal male luer
threads are located in or about the stylet adjacent to receive and
engage a cannula having female luer threads thereon. In other
embodiments, the luer lock is reversed. In another embodiment, the
stylet is welded to or otherwise fixedly connected to the
cannula.
[0047] A side port in various embodiments may be a port extending
from the exterior of the hollow cannula to the interior of the
hollow cannula or the flexible stylet. The shape of the side port
may vary. In an embodiment, a port may be circular. In another
embodiment, a port may be ovular. In an another embodiment, a port
may be a quadrangular port, such as a rectangle or a square. In an
another embodiment, the port is triangular. It can be seen by one
skilled in the art that the shape of the port may be formed in any
shape sufficient to permit fluid aspiration.
[0048] A side port in various embodiments may be further
characterized by the associated edge of the port on the cannula or
stylet. In an embodiment, a port may have a slightly inwardly
beveled edge extending from the exterior surface of the hollow
cannula to the interior surface. In an alternate embodiment, a port
may have a slightly outwardly beveled edge extending from the
interior surface of the hollow cannula to the exterior surface. In
an embodiment, the degree of bevel may be used to change the
pressure of the medicament as it enters the target tissue,
facilitate a change in the degree of spread of the medicament, and
allow for a smooth surface as the cannula is inserted to the target
tissue.
[0049] Further embodiments may comprise a cannula or stylet with
multiple ports arranged in any orientation about the shaft. In an
embodiment, a stylet may comprise, in application, a side port
across a cannula and a side port across the stylet. In various
embodiments, the side ports may be positioned such that reasonable
alignment of the side ports occurs at a desired position of the
stylet within the cannula such that a medicament may pass from
across the reasonably aligned side ports.
[0050] Various embodiments may include a wire or other means of
conveying stimulation to a target tissue. In an embodiment, the
wire may extends along the cannula from about the proximal end to
about the distal end of the distal tip. In another embodiment, the
wire may be integral (attached to) with the cannula. In another
embodiment, the wire may extend along the outside of the cannula.
In another embodiment, a wire may extend along, through, or is
integral with the stylet.
[0051] Design consideration that may be implemented with various
embodiments include, but are not limited, to designing the wire and
connector such that they may be utilized as a "plug and use" type
of arrangement. A plug and use arrangement is beneficial because it
reduces the complexity of the device and reduces loose wires. In an
embodiment, the wire may be formed into the connector such that
when the connector is connected to another medical instrument, the
wire is able to communicate with the instrument. However, any
connection common in the art that would allow the wire to
communicate with a medical instrument may be contemplated within
various embodiments.
[0052] Various embodiments may include insulation or at least one
form insulation about the cannula, stylet, or wire. As may be
appreciated by one of ordinary skill in the art, any material of
construction that provides electrical or thermal insulation could
be used such as, but not limited to, a plastic, a rubber, a metal,
a non-metal, or the like. In some embodiments, the insulation
covers the exterior of the hollow cannula along the entire first
length. In some embodiments, the insulation covers the exterior of
the hollow cannula until it reaches the rigid bend portion of the
hollow cannula. In some embodiments, the insulation covers an
exterior portion of the hollow cannula in between the hub and the
rigid bend portion.
[0053] Various embodiments may include insulation around the hollow
cannula, flexible stylet, or wire that is constructed of a material
that permits differentiation between the insulation and the hollow
cannula or flexible stylet material during real-time procedural
use. Numerous procedures, such as, but not limited to, fluoroscopic
guidance procedures, NMR procedures, X-ray procedures, direct
viewing procedures, or the like, may be used during a medical
procedure to determine the position of a retrofitted neural
injection system and the target location. In such embodiments, a
practitioner may choose an embodiment with an insulation coating
wherein the absorptive or reflective difference between the
insulation coating and the uninsulated portion of the retrofitted
neural injection system can be differentiated in real-time using
the selected real-time viewing system. For example, a particular
insulation may absorb the energy from a real-time viewing system
and show up as a dark segment whereas the uninsulated portion may
reflect the energy and appear to be a bright segment. In such
embodiments, the differentiation in reflectivity and absorption may
provide a method to determine the exact position of the shaped tip,
the distal tip, or the side portal of the retrofitted neural needle
in relation to the treatment site, given that the relative distance
from the insulation/non-insulation border.
[0054] Further modifications of embodiments of a retrofitted
injection system with a wire comprise the introduction of a probe
about the shaft or wire. Various probes capable of use with
embodiments include temperature probes, stimulation probes,
cameras, or the like.
[0055] Various embodiments may include methods of manufacture of a
retrofitted neural injection system. Various embodiments may
include acquiring an injection needle comprising a hollow cannula
with an open distal end. In some embodiments, the open distal end
is shaped in a beveled form. Then, forming a side port in the
hollow cannula proximate to the distal end so as to permit fluid
communication between the inside and the outside of the hollow
cannula via the newly formed side port. In some embodiments, a
plurality of side ports are formed. Formation of a side port in the
hollow cannula of the injection needle may be performed using any
number of methods known to ones of ordinary skill in the art. Then,
sealing the open distal end of the hollow cannula with a
bio-compatible sealant so as to eliminate fluid communication
between the inside and the outside of the hollow cannula via the
distal end. In some embodiments, the bio-compatable sealant may be
comprised of a thermosetting material. In some embodiments, the
bio-compatible sealant may be comprised of a cured epoxy resin. In
some embodiments, the bio-compatible sealant may be comprised of an
aliphatic polymer. In some embodiments, the bio-compatible sealant
may be comprised of an polyfluorocarbon. Handling, applying, and
curing the sealant may be performed using any number of techniques
known to one skilled in the art. In some embodiments, the sealant
does not hinder the penetrating or leading operation of the distal
end of the hollow cannula. Then, in some embodiments, the hollow
cannula is forcibly bent so as to impart a rigid bend. Then, in
some embodiments, a stylet is included. Then, in some embodiments,
a wire is included. Then, in some embodiments, insulation is
included.
[0056] Various embodiments may include methods of use of a
retrofitted injection system. An embodiment of a method may include
locating a site for treatment in a patient. Then, inserting into a
patient at least a portion of a retrofitted injection system
comprised of an at least partially hollow cannula being defined by
a first inside diameter, a first outside diameter, a first length,
a side port located coaxially along the hollow cannula for fluid
communication between the inside and the outside of the hollow
cannula, and a sealed distal end. In some embodiments, a stylet,
wherein the stylet is capable of being releasably locked in a first
position within the hollow cannula and extends up to a first length
of the hollow cannula, is included. In some embodiments, the hollow
cannula proximate to the distal end includes a rigid bend so as to
facilitate placement of the distal end about the treatment site.
Then, maneuvering the distal end of the retrofitted neural
injection system inside a patient proximate to the treatment site.
Then, treating the patient.
[0057] Further embodiments of a method may include stimulating a
tissue. Further embodiments of a method may include ablating at
least a portion of the tissue about a site. Other embodiments
comprise probing a tissue. And yet further embodiments of a method
may include preparing a patient for administering a medicament.
[0058] In an embodiment of an administration of a block, such as a
nerve block, the method may comprise preparing the patient. In an
embodiment, preparing the patient may comprise placing a patient in
a supine position or extended position, without a pillow, with the
patient's head in a neutral position.
[0059] In an embodiment of administration of a medicament, while
standing on side of the body that is to be blocked, the physician
may tactilely locates the cricoid cartilage. In such an embodiment,
the neural injection system may be inserted in a position
approximately one finger breadth below the cricoid cartilage,
between the carotid sheath and the trachea on the side to be
blocked, while aiming slightly medially until bony contact is made
with the ventral lateral side of the body of the seventh cervical
vertebra. When the neural injection system is in said position, the
anesthesia may be injected.
[0060] In another embodiment, there may be methods for injecting a
medicament into tissue of a subject. The method may include
inserting the distal portion of an embodiment into the tissue of
the subject and causing a therapeutic amount of medicament to enter
multidirectionally from a distal end into the tissue.
[0061] FIG. 1 illustrates an embodiment of a traditional injection
system 1. The traditional injection system 1 is comprised of a
cannula 10. The cannula 10 is capable of being characterized as
having a first length as measured from the proximate end of a
stylet mating hub 44 to a distal opening 46 of the distal tip 40.
The distal tip 40 in this example is in a beveled shape at the end
of a hollow cannula shaft 34. A stylet mating hub 44, wherein a
stylet 20 may be insertedly attached to the cannula 10, is present
on the proximate end of the cannula 10. The stylet mating hub 44
possesses a stylet receiving notch 60 to fixedly engage a
corresponding tab 58 on a stylet 20.
[0062] FIG. 2 is an illustration of an embodiment of a retrofitted
neural injection system 2. The retrofitted injection system 2 is
comprised of similar components as the traditional injection system
1. Retrofitted neural injection system 2 is also comprised of a
side port 48, which in FIG. 2 is embodied in a small rounded hole.
Retrofitted neural injection system 2 is also comprised of a distal
opening 46 that is sealed closed. This permits fluid communication
between the inside and the outside of the hollow cannula shaft 34
only by the side port 48 instead of by the distal opening 46 as in
the traditional injection system 1.
[0063] FIGS. 3 is an illustration of an embodiment of a retrofitted
neural injection system 3 with a rigid bend in the cannula. The
retrofitted injection system 3 is comprised of similar components
as the traditional injection system 1 and retrofitted neural
injection system 2. Retrofitted neural injection system 3 is also
comprised of rigid bent portion 38 proximate to the side port 48,
which in FIG. 3 is embodied in a quadrangle hole. Retrofitted
neural injection system 3 is also comprised of insulation 36 along
part of the hollow cannula shaft 34.
[0064] As such, various embodiments of the present invent tion
generally compriuse methods of retrofitting a needle comprising
acquiring an injection needle comprising a hollow cannula with an
open distal end; forming at least one side port in the hollow
cannula proximate to the distal end so as to permit fluid
communication between the inside and the outside of the hollow
cannula via the side port; and sealing the open distal end of the
hollow cannula with a sealant so as to eliminate fluid
communication between the inside and the outside of the hollow
cannula via the distal end.
[0065] Various further embodiments therefore comprise a retrofitted
neural injection system comprising an at least partially hollow
cannula with a sharp distal end, wherein said distal end has a
port, and said partially hollow cannula is defined by a first
inside diameter, a first outside diameter, a first length, and at
least one side port in fluid communication between the inside and
the outside of the hollow cannula, located coaxially at a
predetermined distance from the distal end, wherein the port at the
distal end is sealed to eliminate fluid communication between the
inside and the outside of the hollow cannula via the distal
end.
[0066] Various further embodiments comprise a method of treatment
for an individual in need thereof comprising locating a site for
treatment in said individual; adjusting the retrofitted neural
injection system as described herein; such that said system is
positioned relative to said individual at a desired insertion point
and orientation; inserting at said site at least a portion of said
retrofitted neural injection system; maneuvering the distal end of
the retrofitted neural injection system inside said individual
proximate to the site; and treating said individual.
[0067] Although the present invention is described with several
embodiments, various changes and modifications may be suggested to
one skilled in the art. In particular, the present invention is
described with reference to certain polymers and materials and
methods of processing those materials, but may apply to other types
of processing or materials with little alteration and similar
results. Furthermore, the present invention contemplates several
process steps that may be performed in the sequence described or in
an alternative sequence without departing from the scope and the
spirit of the present invention. The present invention is intended
to encompass such changes and modifications as they fall within the
scope and the spirit of the appended claims.
* * * * *