U.S. patent application number 12/757941 was filed with the patent office on 2011-10-06 for acupuncture needle delivery system.
Invention is credited to John Dumitru Stan.
Application Number | 20110245857 12/757941 |
Document ID | / |
Family ID | 44114224 |
Filed Date | 2011-10-06 |
United States Patent
Application |
20110245857 |
Kind Code |
A1 |
Stan; John Dumitru |
October 6, 2011 |
ACUPUNCTURE NEEDLE DELIVERY SYSTEM
Abstract
An acupuncture needle and delivery system that facilitates the
sanitary insertion and handling of the acupuncture needle in all
orientations, and that does not impede the performance of the
various post-insertion procedures of the sort commonly used by
acupuncture practitioners. In a fully assembled pre-use state, the
device includes an acupuncture needle having a filiform shaft and
an enlarged head portion, an insertion tube accommodating at least
the filiform shaft of the acupuncture needle to protect the
filiform shaft from contamination, a stabilization sleeve slidably
engaging the outer surface of the insertion tube, and retainer
means for releasably securing the acupuncture needle within the
insertion tube.
Inventors: |
Stan; John Dumitru;
(Vancouver, CA) |
Family ID: |
44114224 |
Appl. No.: |
12/757941 |
Filed: |
April 9, 2010 |
Current U.S.
Class: |
606/189 |
Current CPC
Class: |
A61H 39/083
20130101 |
Class at
Publication: |
606/189 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 1, 2010 |
CA |
2,698,955 |
Claims
1. An acupuncture needle delivery system, comprising in a fully
assembled pre-use state: an acupuncture needle having a filiform
shaft and an enlarged head portion; an insertion tube having an
axial length that is less than the axial length of the acupuncture
needle, said insertion tube being adapted to accommodate at least
the filiform shaft of the acupuncture needle to protect the
filiform shaft from contamination; a stabilization sleeve slidably
engaging the outer surface of the insertion tube; and retainer
means for releasably securing the acupuncture needle within the
insertion tube.
2. The acupuncture needle delivery system of claim 1, wherein the
axial length of said insertion tube is between roughly 2 mm and 5
mm less than the axial length of said acupuncture needle.
3. The acupuncture needle delivery system of claim 1, wherein the
axial length of said stabilization sleeve is between roughly 1/4 to
1/2 of the axial length of said insertion tube.
4. The acupuncture needle delivery system of claim 1, wherein said
retainer means comprise a removable resilient wedge inserted
between an inner wall of said insertion tube and the enlarged head
portion of said acupuncture needle.
5. The acupuncture needle delivery system of claim 1, wherein said
retainer means comprise adhesive affixed to the end of said
insertion tube adjacent the enlarged head portion of said
acupuncture needle.
6. A method of introducing an acupuncture needle into a body to be
treated, said method comprising the steps of: providing the
acupuncture needle delivery system according to claim 1;
positioning the insertion tube at a predetermined sensitive point
on the skin of a patient to be treated; sliding the stabilization
sleeve down to abut the skin of the patient; releasing the
acupuncture needle within the insertion tube by removing or
destroying the retainer means; setting the filiform shaft of said
acupuncture needle into or through the dermal layer of the skin;
removing said insertion tube to permit the further insertion of
said acupuncture needle; optionally grasping said stabilization
sleeve while further inserting said acupuncture needle to a
predetermined target depth; and optionally removing or discarding
said stabilization sleeve.
7. The method of claim 6, wherein the step of optionally removing
or discarding said stabilization sleeve is performed prior to the
step of positioning the insertion tube at a predetermined sensitive
point on the skin of a patient to be treated.
Description
TECHNICAL FIELD
[0001] The present disclosure relates to acupuncture and more
particularly to acupuncture needles and to delivery systems and
methods for the sanitary insertion and handling thereof during the
performance of acupuncture treatments.
BACKGROUND
[0002] Acupuncture is gaining wide acceptance as a medical
treatment for a variety of health conditions, and has become widely
integrated into health care systems throughout North America. By
way of general overview, acupuncture involves the insertion of a
filiform needle (at least the shaft of which is typically
constructed of medical grade stainless steel) to a target depth
below the dermis of the skin at a predetermined sensitive point,
and the performance of various additional procedures selected to
stimulate a positive change in the health condition of a patient.
These additional procedures may, for example, involve heating the
needle with a heat source (commonly known as "moxibustion"),
applying electrical stimulation to the needle, such as by attaching
the needle to a milliamp or microamp stimulator, and/or the use of
various manual manipulative techniques such as thrusting, angling
and vibrating the needle.
[0003] To minimize patient discomfort, the acupuncture needle is
typically first quickly "set" through the dermal layer of the
patient's skin, and then further inserted through the skin into the
body of the patient to a target depth of up to several centimetres,
depending upon the application and on the region of the body being
treated. In many cases, the acupuncture treatment may be preformed
on a recumbent patient that has been positioned so as to facilitate
the practitioner's access to the predetermined sensitive point.
However, in some instances, such as when patients have circulatory
or neurological limitations, this is not possible and the
acupuncture needle must be set and inserted horizontally, or even
from below.
[0004] Great care must be taken to maintain sterility of the
acupuncture needle throughout the entire acupuncture treatment
process in order to protect both the patient and the practitioner
from possible contamination, and acupuncture needle delivery
techniques have accordingly evolved over the years from simple free
hand insertion and manipulation to the use of insertion
tube-assisted delivery systems intended to assist with the
maintenance of sanitary conditions (and in some instances to
facilitate consistent setting of the acupuncture needle). As is
discussed further below, the use of an insertion tube surrounding
the needle shaft facilitates sanitary pre-use initial handling and
setting of an acupuncture needle by a practitioner. Once the needle
has been set, the insertion tube is generally discarded in order to
permit the further insertion and manipulation of the needle at the
target depth.
[0005] Additional sanitary challenges often arise, however, during
the further insertion and manipulation of the acupuncture needle at
the target depth, particularly in situations where the practitioner
is inserting the needle into scarred, dense, or fibrous tissue
(such as in intra-articular insertions in, for example, the knee).
In these situations and others, such as where, for example, the
needle has a thickness of 0.22 mm or less and a needle length is 35
mm or shorter, or a thickness of 0.22 mm or greater and a length
that is 50 mm or longer, the needle is prone to bowing or bending
during further insertion and manipulation.
[0006] Any such bowing or bending interferes with the
practitioner's ability to accurately insert and manipulate the
needle, and requires the practitioner to attempt to compensate by
initiating time consuming and/or difficult compensatory movements.
In many cases, suitable compensation for the bowing or bending of
the needle is not easily achievable, and in some cases may not be
achievable at all by even the most skilful practitioner unless the
practitioner stabilizes the shaft of the needle using a cotton swab
or simply his/her fingers. These stabilization techniques
compromise the sterility of the needle, and increase the risk of
infection.
[0007] To address this need for stabilization (and the resulting
potential for contamination), acupuncture needle assemblies and
delivery systems that additionally provide a grip element have been
proposed. However, all known acupuncture needle assemblies and
delivery systems that additionally provide a grip element to
facilitate stabilization of the needle during insertion and
manipulation fail to adequately address the need for such
stabilization when the needle is inserted horizontally or from
below the predetermined sensitive point, or fail to adequately
accommodate the performance of various stimulative procedures. In
addition, many of the known needle assemblies and delivery systems
are relatively difficult to manufacture and to use.
[0008] By way of example, U.S. Pat. No. 5,624,460 to Yoo describes
an acupuncture needle assembly that includes a "guide pipe" (i.e.
an insertion tube) and a paper, rubber or foamed resin "grip pipe"
that is located within the guide pipe and that immediately
surrounds the needle shaft about 3-5 mm from the end portion of the
needle head. As with a conventional insertion tube-assisted
delivery system, the guide pipe facilitates the sanitary pre-use
initial handling and setting of the needle, and is discarded once
the needle has been set. A practitioner may then grasp the grip
pipe to stabilize the needle during the acupuncture stimulus, and
use the grip pipe to withdraw the needle from the patient after
use.
[0009] However, since the Yoo grip pipe is formed of paper, rubber
or foamed resin, and since it immediately surrounds the shaft of
the needle, which has an internal diameter that is smaller than
that of the handle or upper "grip portion" of the needle itself,
the Yoo grip pipe cannot readily be removed from the needle during
use, and would accordingly impede procedures requiring a
practitioner to heat or electrify the needle. For example, the
moxibustion technique known as "sparrow pecking" requires a
practitioner to heat the acupuncture point and needle with an
external heat source to stimulate circulation and immune function.
It is important in performing this technique to bring the heat
source to the point were the heat is intense but tolerable in a
"coming and going" process (i.e. in a "pecking" manner), and to
achieve this the heat source must be brought as close as possible
to the needle and to the skin to generate a strong heat reaction.
Since the Yoo grip pipe is immediately associated with the needle
shaft and cannot readily be removed, it may have an insulatory
effect between the needle and the heat source (and may itself melt
or burn if brought too close to the heat source), and thereby limit
the effectiveness of this type of procedure. Additionally, in some
scenarios, the treatment target depth may require the needle to be
inserted up to 90% or so of its overall length. Since the Yoo
needle assembly does not provide for removal of the grip pipe
during use, the grip pipe also limits the depth to which a
practitioner may insert the Yoo needle.
[0010] Published U.S. patent publication Ser. No. 11/292,025 to
Teichert et al. (U.S. Patent Publication No. 2007/0129744), the
disclosure of which is hereby fully incorporated by reference,
describes an acupuncture needle guide assembly that comprises an
acupuncture needle with a shaft and a needle handle, a guiding tube
(i.e. an insertion tube) accommodating the acupuncture needle
before use and providing guidance for setting the acupuncture
needle, a holding tube being arranged within the guiding tube and
providing a cover for the needle shaft, and a destructible or
detachable connector fixing the holding tube between the needle
handle and an inner wall of the guiding tube until the connector is
removed or broken. The holding tube has an inner diameter that is
greater than the diameter of the needle shaft, and preferably has
an inner diameter that is greater than the outer diameter of the
needle handle in order to permit the holding tube to be removed
from the needle after insertion thereof into the body. In use, the
assembly is first positioned on the skin of the patient to be
treated, and the acupuncture needle is then released by removing or
breaking the connector. Upon removal or destruction of the
connector, the holding tube drops down the shaft of the needle
towards the tip thereof under the effect of gravity, and is
manually gripped by the practitioner after the guiding tube is
withdrawn to facilitate stabilization during the further insertion
and manipulation of the needle.
[0011] Although the "loose" fit of the holding tube vis-a-vis the
needle of the Teichert et al. assembly permits the holding tube to
be removed during use and thereby addresses some of the
shortcomings of the Yoo assembly, the inability of a practitioner
to control the position of the holding tube after the connector is
removed or broken, but prior to removal of the guiding tube, makes
it generally unsuitable for use in horizontal orientations, or in
situations where the needle must be set and inserted from below the
predetermined sensitive point.
[0012] There accordingly exists a need for an improved acupuncture
needle and delivery system that facilitates the sanitary insertion
and handling of the acupuncture needle in all orientations, and
that does not impede the performance of the various post-insertion
procedures of the sort that are commonly used by acupuncture
practitioners to stimulate a positive change in the health
condition of a patient. Since the need for stabilization of the
needle shaft is situation dependant, provision of an improved
acupuncture needle and delivery system in which the implementation
of the stabilizing feature is optional and does not commit the
practitioner to a predefined insertion process would also be
beneficial.
SUMMARY
[0013] This summary is not an extensive overview intended to
delineate the scope of the subject matter that is described and
claimed herein. The summary presents aspects of the subject matter
in a simplified form to provide a basic understanding thereof, as a
prelude to the detailed description that is presented below.
Neither this summary nor the following detailed description
purports to define or limit the invention; the invention is defined
only by the claims.
[0014] In embodiments of the present subject matter, there is
provided an acupuncture needle delivery system comprising, in its
fully assembled pre-use state, an acupuncture needle having a
filiform shaft and an enlarged head portion, an insertion tube
having an axial length that is less than the axial length of the
acupuncture needle, the insertion tube being adapted to accommodate
at least the filiform shaft of the acupuncture needle to protect
the filiform shaft from contamination, a stabilization sleeve
slidably engaging the outer surface of the insertion tube, and
retainer means for releasably securing the acupuncture needle
within the insertion tube.
[0015] Preferably, the axial length of the insertion tube is
between roughly 2 mm and 5 mm less than the axial length of the
acupuncture needle, and the axial length of the stabilization
sleeve is between roughly 1/4 to 1/2 of the axial length of the
insertion tube.
[0016] Also provided is a method of introducing an acupuncture
needle into a body to be treated, the method comprising the steps
of: providing the acupuncture needle delivery system according to
the present disclosure; positioning the insertion tube at a
predetermined sensitive point on the skin of a patient to be
treated; sliding the stabilization sleeve down to abut the skin of
the patient; releasing the acupuncture needle within the insertion
tube by removing or destroying the retainer means; setting the
filiform shaft of the acupuncture needle into or through the dermal
layer of the skin; removing the insertion tube to permit the
further insertion of the acupuncture needle; optionally grasping
the stabilization sleeve while further inserting the acupuncture
needle to a predetermined target depth; and optionally removing or
discarding the stabilization sleeve.
[0017] Since the stabilization sleeve is slidably engaged around
the outer surface of the insertion tube, it may readily be
discarded prior to or at any point during the acupuncture treatment
process, thereby providing the option to use the stabilization
sleeve in circumstances where stabilization is desired or required,
while avoiding possible interference that may be caused by the
presence of a stabilization sleeve during the performance of the
various post-insertion procedures of the sort that are commonly
used by acupuncture practitioners. The slidable engagement of the
stabilization sleeve around the outer surface of the insertion tube
also enables the sanitary insertion and handling of the acupuncture
needle in all orientations.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] For a fuller understanding of the nature and advantages of
the disclosed subject matter, as well as the preferred mode of use
thereof, reference should be made to the following detailed
description, read in conjunction with the accompanying drawings. In
the drawings, like reference numerals designate like or similar
steps or components.
[0019] FIG. 1 is an exploded perspective view of an acupuncture
needle and delivery system in accordance with an embodiment of the
presently disclosed subject matter;
[0020] FIG. 2 is an acupuncture needle and delivery system in
accordance with an embodiment of the presently disclosed subject
matter, shown in the fully assembled pre-use state thereof;
[0021] FIG. 3 is an enlarged sectional view of FIG. 2, taken along
line A-A of FIG. 2; and,
[0022] FIGS. 4A-4G are each a perspective view setting forth a
sequence of phases of setting and inserting an acupuncture needle
using an acupuncture needle and delivery system in accordance with
an embodiment of the presently disclosed subject matter.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0023] Specific embodiments of the disclosed apparatus and method
will now be described with reference to the drawings. Nothing in
this detailed description is intended to imply that any particular
component, feature, or step is essential to the invention.
[0024] Referring now to FIGS. 1 to 3, an embodiment of an
acupuncture needle and delivery system in accordance with the
present disclosure is generally designated therein with reference
numeral 1, and comprises a needle 10, an insertion tube 20, a
stabilizing sleeve 30, and a retainer 40. Needle 10 is of generally
conventional construction for an acupuncture needle, and comprises
filiform shaft 12 and an enlarged head portion 14 to facilitate
handling by a practitioner/user. In preferred embodiments, the
shaft 12 and the head portion 14 are Ruined from medically approved
surgical stainless steel, or from other suitable heat- and
electricity-conducting materials known to those of skill in the
art, in order to accommodate moxibustion and/or electrical
stimulation procedures.
[0025] FIG. 1 illustrates the acupuncture needle and delivery
system in its fully assembled pre-use state, in which at least the
filiform shaft 12 of needle 10 is surrounded by insertion tube 20
in order to protect shaft 12 from contamination. The inner diameter
or insertion tube 20 is suitably selected with reference to the
diameter of head portion 14 of needle 10, and is sufficiently large
to permit needle 10 to freely slide through insertion tube 20 once
retainer 40 has been removed therefrom or destroyed, but not so
large as to permit needle 10 to bend or bow excessively under the
axial force applied by a user to head portion 14 during the
"setting" of needle 10 into or through the dermal layer of a
patient's skin.
[0026] The axial length of insertion tube 20 is similarly selected
with reference to the axial length of needle 10, such that at least
part of head portion 14 extends past the end of insertion tube 20
when the acupuncture needle and delivery system is in the fully
assembled pre-use state. The entire axial length of shaft 12 is
contained within insertion tube 20 in order to protect it from
contamination. In preferred embodiments, insertion tube 20 is
shorter than needle 10 by roughly the typical thickness of the
dermal layer of a patient's skin. Most preferably, the axial length
of insertion tube 20 is selected to be between 2 mm and 5 mm
shorter than the axial length of needle 10.
[0027] Insertion tube 20 may be formed from any suitable material
known to those of skill in the art, and in preferred embodiments is
formed from a plastic material, such as polyethylene, that may be
economically manufactured, and that may be sterilized without
degradation of the material during sterilization by
trade-recognized methods such as the use of gamma radiation or
ethylene oxide sterilization. In preferred embodiments, insertion
tube 20 has a circular cross-section in order to minimize the
amount of material required for manufacture. However, it will be
appreciated by those of skill in the art that insertion tube 20 may
be formed with a cross-section of any desired shape, such as, for
example, square or triangular. Most preferably, insertion tube 20
is formed from a transparent material in order to facilitate the
accurate "setting" of needle 10.
[0028] Stabilizing sleeve 30 circumferentially surrounds a portion
of insertion tube 20 when the acupuncture needle and delivery
system is in the fully assembled pre-use state, and has an inner
diameter that is selected with reference to the outer diameter of
insertion tube 20, such that stabilization sleeve 30 slidably
engages the circumferential outer surface of insertion tube 20 in a
snug manner that allows a user to easily slide stabilizing sleeve
30 up or down the outer surface of insertion tube 20 during use,
but that prevents stabilizing sleeve 30 from freely sliding by
itself (such as under the influence of gravity) relative to the
outer surface of insertion tube 20 in the absence of any external
force applied by a user. Stabilization sleeve 30 may be formed from
any suitable material such as paper or plastic, and in preferred
embodiments is formed from a resilient material that may be
economically manufactured, and that may be sterilized without
degradation during sterilization by trade-recognized methods such
as the use of gamma radiation or ethylene oxide sterilization. If
the cross-section of insertion tube 20 is selected to be a shape
other than circular, then the cross-sectional shape of
corresponding stabilization sleeve 30 is, of course, conformed
thereto. The thickness of the material comprising stabilization
sleeve 30 is selected such that the sleeve 30 maintains its shape
and form in the absence of external force applied by a user, but is
sufficiently pliable to easily collapse around shaft 12 of needle
10 when grasped by a user during the performance of a stabilization
technique.
[0029] The axial length of stabilizing sleeve 30 is selected, in
part, with reference to the length of needle 10 and the intended
use thereof, and in part with reference to the typical width of a
human finger and thumb. By way of example, where a needle 10 is to
be inserted into scarred, dense or fibrous tissues (which typically
requires more significant stabilization than does a needle inserted
into softer tissues), a relatively long stabilizing sleeve 30 may
be preferred in order to enable the user to grasp the stabilizing
sleeve 30 more firmly, or between more than one finger and the
thumb. Conversely, where a needle 10 is long and is to be inserted
to a very deep target depth in soft tissue, a relatively short
stabilizing sleeve 30 (vis-a-vis the overall axial length of needle
10) may be selected. In preferred embodiments, the axial length of
stabilizing sleeve 30 is between roughly 1/4 to 1/2 of the axial
length of insertion tube 20.
[0030] Retainer 40 holds needle 10 in place within insertion tube
20 when the acupuncture needle and delivery system is in the fully
assembled pre-use state, and is removed or destroyed by a user when
the acupuncture needle and delivery system has been positioned over
a predetermined sensitive point on the skin of a patient in order
to enable the needle 10 to be set into or through the dermal layer
of the patient's skin. As is best seen in FIG. 3, retainer 40
comprises in preferred embodiments a removable wedge inserted in
the end of the insertion tube 20 adjacent head portion 14 of needle
10 to prevent movement thereof relative to insertion tube 20 until
retainer 40 is removed or destroyed. In the alternative, retainer
40 may comprise adhesives, handles, or connectors of any suitable
sort known to those of skill in the art.
[0031] By way of example and not limitation, several phases of a
typical use of the presently-disclosed acupuncture needle and
delivery system 1 to insert and stabilize needle 10 in the body of
a patient are illustrated in FIGS. 4A-4G. For ease of
understanding, FIGS. 4A-4G are oriented vertically, showing the
acupuncture needle and delivery system 1 in a generally vertical
orientation above the patient. It will, however, be readily
understood by those of skill in the art that the acupuncture needle
and delivery system 1 may readily be used to equal advantage in any
orientation, including horizontally or from below the patient. It
will also be readily appreciated by those of skill in the art that
FIGS. 4A-4G illustrate the insertion and stabilization of needle 10
in a case where stabilization is desired or required, and that in
cases where stabilization is not desired or required, stabilization
sleeve 30 may simply be removed and discarded prior to or at any
stage of use.
[0032] Turning now to FIG. 4A, acupuncture needle and delivery
system 1 is illustrated as held by practitioner 50 in its fully
assembled pre-use state, and positioned at a predetermined
sensitive point on the skin 60 of the body of a patient to be
treated. In FIG. 4B, stabilization sleeve 30 is slid down to abut
the skin 60, and in FIG. 4C, retainer 40 is removed or destroyed in
order to permit the relative movement of needle 10 within insertion
tube 20.
[0033] FIG. 4D illustrates the "setting" of needle 10 into or
through the dermal layer of skin 60 with a quick tap on head
portion 14 of needle 10 by practitioner 50, and FIG. 4E illustrates
the removal of insertion tube 20 to permit the further insertion of
needle 10. As shown in FIG. 4F, stabilization tube 30 is then used
by practitioner 50 to assist in the guidance of needle 10 to a
predetermined target depth, and finally, as illustrated in FIG. 4G,
stabilization tube 30 may optionally be removed and discarded.
[0034] The present description includes the best presently
contemplated mode of carrying out the subject matter disclosed and
claimed herein, and is made for the purpose of illustrating the
general principles of the subject matter and not be taken in a
limiting sense; the subject matter can find utility in a variety of
implementations without departing from the scope of the disclosure
made, as will be apparent to those of skill in the art from an
understanding of the principles that underlie the subject
matter.
* * * * *