U.S. patent application number 14/572299 was filed with the patent office on 2015-04-09 for needle and related methods.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Malka S. BERNDT.
Application Number | 20150099967 14/572299 |
Document ID | / |
Family ID | 38819708 |
Filed Date | 2015-04-09 |
United States Patent
Application |
20150099967 |
Kind Code |
A1 |
BERNDT; Malka S. |
April 9, 2015 |
NEEDLE AND RELATED METHODS
Abstract
An optical spectroscopic injection needle assembly. According to
one embodiment, the assembly may include an injection needle, a
light source, a spectrometer, a computer and an indicator. The
injection needle, in turn, may include a hollow outer needle, a
hollow inner needle, a pair of optical fibers, an inner catheter,
an outer catheter, an inner hub and an outer hub. The proximal end
of the outer needle may be fixedly mounted within the distal end of
the inner catheter. The distal end of the inner hub may be fixedly
mounted on the proximal end of the inner catheter, the proximal end
of the inner hub being suited for connection to a syringe. The
inner needle, as well as the distal ends of the optical fibers, may
be positioned within the outer needle and may be held in place by
an optical bonding material. The proximal ends of the optical
fibers may extend from a side arm of the inner hub, one fiber may
be coupled to the light source, the other fiber may be coupled to
the spectrometer. The inner catheter and the outer needle may be
slidably mounted within the outer catheter to permit the outer
needle to be selectively extended or retracted from the distal end
of the outer catheter. The outer hub may be fixedly mounted on the
proximal end of the outer catheter. In use, as the outer needle may
be inserted into a tissue, the tissue may be illuminated and the
reflected light may be detected and compared to standards for
various tissue types. The results of the comparison may then be
indicated.
Inventors: |
BERNDT; Malka S.;
(Lexington, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed,
Inc.
|
Family ID: |
38819708 |
Appl. No.: |
14/572299 |
Filed: |
December 16, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14155516 |
Jan 15, 2014 |
8942790 |
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14572299 |
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11825929 |
Jul 10, 2007 |
8666479 |
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14155516 |
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60819586 |
Jul 10, 2006 |
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Current U.S.
Class: |
600/424 |
Current CPC
Class: |
A61M 25/0084 20130101;
A61B 34/20 20160201; A61B 2017/00048 20130101; A61B 17/3478
20130101; A61B 5/0084 20130101; A61B 5/0075 20130101; A61M 5/158
20130101; A61B 2090/373 20160201; A61B 2017/00061 20130101; A61B
2034/2055 20160201; A61B 1/07 20130101 |
Class at
Publication: |
600/424 |
International
Class: |
A61B 19/00 20060101
A61B019/00; A61B 5/00 20060101 A61B005/00; A61B 1/07 20060101
A61B001/07; A61M 5/158 20060101 A61M005/158 |
Claims
1-25. (canceled)
26. A method of evaluating a tissue, the method comprising the
steps of: inserting a first hollow needle into an insertion site of
a body part to a first depth, the first hollow needle extending
distally from the distal end of a first catheter and having a sharp
distal end adapted for insertion into the body part, the first
hollow needle including a tubular member disposed within a lumen of
the first hollow needle, the tubular member having a longitudinal
bore, wherein each of the first catheter and the tubular member is
configured to directly contact and allow fluid to flow from the
longitudinal bore of the first catheter to the longitudinal bore of
the tubular member; and injecting a material through the tubular
member and into the body part.
27. The method of claim 26, wherein the first hollow needle is
axially fixed relative to the tubular member.
28. The method of claim 26, wherein the tubular member is a second
hollow needle.
29. The method of claim 28, wherein the second hollow needle has a
distal-facing distal end face, the distal-facing distal end face of
the second hollow needle and a distal-facing distal end face of the
first hollow needle lying along a common plane.
30. The method of claim 26, wherein a bonding material is disposed
within the first hollow needle.
31. The method of claim 30, wherein the bonding material includes
epoxy.
32. The method of claim 30, wherein a distal end of the bonding
material includes a distal face configured to lie flush with the
distal end of the needle.
33. The method of claim 26, wherein the first hollow needle has a
proximal end, the proximal end being fixedly mounted within the
longitudinal bore of the first catheter.
34. The method of claim 26, wherein a second catheter includes a
proximal end, a distal end, and a longitudinal bore, the first
catheter being slidably mounted in the second catheter.
35. The method of claim 34, further comprising: extending the first
needle and the first catheter relative to and distally of the
second catheter.
36. The method of claim 34, further comprising: placing a syringe
in fluid communication with the tubular member, wherein the syringe
includes material.
37. The method of claim 34, wherein inserting a first hollow needle
includes inserting a first hollow needle transorally.
38. A method of evaluating a tissue, the method comprising the
steps of: (a) inserting a hollow needle into an insertion site of a
body part to a first depth, the first hollow needle extending
distally from the distal end of a first catheter and including a
tubular member disposed within a lumen of the first hollow needle,
the tubular member having a longitudinal bore, wherein a proximal
end of the tubular member is positioned to allow fluid to flow from
the first catheter to the longitudinal bore of the tubular member;
(b) illuminating the body part at the first depth; and (c)
detecting the light reflected from the illuminated body part at the
first depth.
39. The method of claim 38, further comprising: repeating steps (a)
through (c) for other depths or other insertions sites.
40. The method of claim 38, wherein the body part is illuminated
using light transmitted through fiber optics located radially
outward from the tubular member.
41. A method of treating a tissue, the method comprising the steps
of: (a) inserting a needle into an insertion site of a body part
within a digestive tract to a first depth; (b) illuminating the
body part at the first depth; (c) detecting the light reflected
from the illuminated body part; (d) comparing the detected light to
a standard of a known composition; and (e) indicating the results
of the comparison.
42. The method of claim 41, further comprising: repeating steps (a)
through (e) for other depths or other insertions sites until a
predetermined type of tissue is located.
43. The method of claim 42, further comprising: injecting a
material through the tubular member and into the predetermined type
of tissue.
44. The method of claim 41, wherein step (b) is performed using
light transmitted through fiber optics disposed within the needle,
and step (c) is performed using a light detector operatively
coupled to the fiber optical fibers.
45. The method of claim 41, wherein the first hollow needle
including a tubular member disposed within a lumen of the first
hollow needle, the first hollow needle including fiber optics
disposed within the first hollow needle and radially outward from
the tubular member, for transmitting light to an object and for
collecting light reflected from the object.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 U.S.C.
119(e) of U.S. Provisional Patent Application Ser. No. 60/819,586,
filed Jul. 10, 2006, the disclosure of which is incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to injection needles
and relates more particularly to an injection needle incorporating
visualization.
[0003] Nearly half of all Americans suffer from heartburn at least
once a month. Heartburn occurs when stomach fluids and acids escape
from the stomach and enter into the esophagus, irritating the
esophagus. Normally, a muscular ring called the lower esophageal
sphincter (LES) acts as a valve between the esophagus and the
stomach to allow food to pass from the esophagus into the stomach
while keeping stomach fluids and acids from escaping from the
stomach into the esophagus. In those instances in which the LES
fails to keep stomach fluids and acids in the stomach, heartburn
occurs.
[0004] For some people who suffer from heartburn, the heartburn is
severe enough or frequent enough to disrupt their daily activities
and/or their sleep. Such a condition is called gastroesophageal
reflux disease (GERD). In some people who have GERD, the LES
relaxes more than it should and/or at the wrong times.
[0005] In addition to causing frequent and/or severe heartburn,
GERD can cause other health problems. For example, the fluids and
acids that reflux into the esophagus can lead to inflammation of
the esophagus (esophagitis) or ulcers. In severe cases, this damage
can scar the esophageal lining and narrow it, causing a stricture
which may make it hard or painful for the patient to swallow. In
certain cases, this may lead to a condition called Barrett's
esophagus, where the lining of the esophagus changes and may over
time lead to cancer of the esophagus.
[0006] Many people can get relief from GERD symptoms by changing
their diet and/or using appropriate medications. Some of the
medications available for managing GERD symptoms include common
antacids as well as drugs that slow down the production of stomach
acids, such as proton pump inhibitors and H.sub.2 receptor
antagonists.
[0007] It should be noted, however, that medications of the type
described above merely address symptoms of GERD and do not address
the condition's mechanical etiology. Thus, GERD symptoms often
recur after drug withdrawal. In addition, while medications may
effectively treat the acid-induced symptoms of GERD, they do not
treat alkaline reflux, which may result in esophageal mucosal
injury.
[0008] In any event, because GERD is a chronic condition, it may be
necessary for a patient to take medications for the rest of his
life in order to continue to obtain relief from GERD symptoms.
However, for many patients, the expense and the psychological
burden of a lifetime of medication dependence, as well as the
uncertainty of long-term effects of some newer medications and the
potential for persistent mucosal changes despite symptomatic
control, make surgical treatment an alluring alternative to a
medicinal approach. As can readily be appreciated, however,
surgical intervention, often in the form of anti-reflux surgery, is
a major undertaking and includes its own set of risks.
[0009] Fortunately, a minimally invasive technique has been devised
for treating GERD. This technique, which is more fully disclosed in
U.S. Pat. Nos. 6,238,335, 6,251,063, 6,351,064 and 6,695,764, all
of which are incorporated herein by reference, typically involves
first inserting an endoscope down through the patient's mouth and
into the esophagus in proximity to the LES. Then, the distal end of
a device commonly referred to as "an injection needle" is inserted
through a working channel of the endoscope, and a needle at the
distal end of the injection needle is inserted into the muscle of
the LES. Then, a special solution is dispensed through the
injection needle and into the muscle of the LES. The solution
includes a biocompatible polymer that forms a soft, spongy,
permanent implant in the sphincter muscle that helps the LES to
keep stomach fluids and acids from backing up into the
esophagus.
[0010] Typically, an injection needle of the type referred to above
comprises a hollow needle, a flexible inner catheter, a flexible
outer catheter, an inner hub and an outer hub. The proximal end of
the hollow needle is typically fixedly mounted within the distal
end of the flexible inner catheter. The inner hub is typically
fixedly mounted on the proximal end of the inner catheter and is
adapted to convey fluids to the inner catheter from a needleless
syringe or the like. The inner catheter and the hollow needle are
typically slidably mounted within the outer catheter so that one
may extend the hollow needle out of the distal end of the outer
catheter when one wishes to make an injection and retract the
hollow needle into the outer catheter when not making an injection.
The outer hub is typically fixedly mounted on the proximal end of
the outer catheter and is adapted to engage the inner hub so as to
limit the distal movement of the needle and the inner catheter
relative to the outer catheter. Examples of injection needles are
disclosed in the following patents, all of which are incorporated
herein by reference: U.S. Pat. No. 6,770,053; U.S. Pat. No.
6,585,694; U.S. Pat. No. 6,423,034; U.S. Pat. No. 6,401,718; U.S.
Pat. No. 6,336,915; U.S. Pat. No. 5,785,689; U.S. Pat. No.
4,946,442; and U.S. Pat. No. 4,668,226.
[0011] Typically, certain measures are taken to promote proper
placement of the distal tip of the injection needle in the targeted
tissue. For example, where the injection needle is delivered to the
patient via the working channel of an endoscope, the endoscope is
typically additionally equipped with a light and a camera so that
one can view, in real-time, the environs of the distal end of the
endoscope; in this manner, the targeted penetration site may be
identified. In addition, to promote a proper penetration depth of
the needle into the targeted tissue, the needle is typically
dimensioned to extend from the distal end of the inner catheter by
a length corresponding to the desired penetration depth. However,
as can be appreciated, tissue thicknesses vary from patient to
patient. Moreover, because tissue is easily compressed and because
tissue may be penetrated by the inner catheter as well as by the
needle, the depth of needle penetration cannot always be controlled
by dimensioning the needle in the above manner. For this reason,
fluoroscopy is often employed to provide live X-ray images of the
injected solution that indicate if the needle has been inserted too
far through the tissue.
[0012] In addition to being used in the above fashion to treat
GERD, injection needles are also useful in injecting other
treatment materials, such as drugs, treatments for bleeding,
etc.
SUMMARY OF THE INVENTION
[0013] According to one aspect of the invention, there is provided
an injection needle that may comprise (a) a first catheter, said
first catheter comprising a proximal end, a distal end and a
longitudinal bore; (b) a first hollow needle, said first hollow
needle being designed to extend distally from said distal end of
said first catheter, said first hollow needle comprising a distal
end adapted for insertion into an object; (c) a tubular member,
said tubular member comprising a longitudinal bore, said tubular
member being disposed within said first hollow needle, said
longitudinal bore of said tubular member being in fluid
communication with said longitudinal bore of said first catheter;
and (d) fiber optics which may be located within said first hollow
needle for transmitting light to an object and for collecting light
reflected from the object.
[0014] In another embodiment of the invention, an optical
spectroscopic injection needle assembly may comprise (a) an
injection needle, which may comprise (i) a first catheter, said
first catheter having a proximal end, a distal end and a
longitudinal bore; (ii) a first hollow needle, said first hollow
needle designed to extend distally from said distal end of said
first catheter, said first hollow needle comprising a distal end
adapted for insertion into an object; (iii) a tubular member, said
tubular member comprising a longitudinal bore, said tubular member
being disposed within said first hollow needle, said longitudinal
bore of said tubular member being in fluid communication with said
longitudinal bore of said first catheter; and (iv) fiber optics
which may be located within said first hollow needle, in one
embodiment, for transmitting light to an object and for collecting
light reflected from the object; (b) means, optically coupled to
the fiber optics, and adapted to serially illuminate an object at a
plurality of wavelengths; (c) means, optically coupled to the fiber
optics, provided to detect the light reflected from the illuminated
object at said plurality of wavelengths; (d) means for comparing
the detected light to appropriate standards; and (e) means for
indicating the results of said comparison.
[0015] In another embodiment of the invention, a method of treating
a tissue may comprise the steps of (a) providing the aforementioned
optical spectroscopic injection needle assembly; (b) inserting the
first hollow needle into an insertion site of a body part to a
first depth; (c) illuminating the body part at said first depth, in
one embodiment, using light transmitted through said fiber optics
from said serially illuminating means; (d) detecting the light
reflected from the illuminated object at said first depth using
said detecting means; (e) comparing the detected light to
appropriate standards; (f) indicating the results of said
comparison; (g) if needed, repeating steps (b) through (f) for
other depths or other insertions sites until a desired tissue is
located; and (h) injecting a material through the tubular member
and into the desired tissue.
[0016] For purposes of the present specification and claims,
various relational terms like top, bottom, proximal, distal, upper,
lower, front, and rear are used to describe the present invention
when said invention is positioned in or viewed from a given
orientation. It is to be understood that, by altering the
orientation of the invention, certain relational terms may need to
be adjusted accordingly.
[0017] Various objects, features and advantages of the present
invention will be set forth in part in the description which
follows, and in part will be obvious from the description or may be
learned by practice of the invention. In the description, reference
is made to the accompanying drawings which form a part thereof and
in which is shown by way of illustration various embodiments for
practicing the invention. The embodiments will be described in
sufficient detail to enable those skilled in the art to practice
the invention, and it is to be understood that other embodiments
may be utilized and that structural changes may be made without
departing from the scope of the invention. The following detailed
description is, therefore, not to be taken in a limiting sense, and
the scope of the present invention is best defined by the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings, which are hereby incorporated
into and constitute a part of this specification, illustrate
various embodiments of the invention and, together with the
description, serve to explain the principles of the invention. In
the drawings wherein like reference numerals represent like
parts:
[0019] FIG. 1 illustrates a partly schematic side view, broken away
in part, of one embodiment of an optical spectroscopic injection
needle assembly constructed according to the teachings of the
present invention, the assembly being shown with its needle in a
retracted position;
[0020] FIG. 2 illustrates a partly schematic side view, broken away
in part, of the optical spectroscopic injection needle assembly of
FIG. 1, the assembly being shown with its needle in an extended
position;
[0021] FIG. 3 illustrates an enlarged fragmentary longitudinal
section view of the distal end of the optical spectroscopic
injection needle assembly of FIG. 1, the assembly being shown with
a needle in an extended position;
[0022] FIG. 4 illustrates a fragmentary side view, partly in
section, of the proximal end of the optical spectroscopic injection
needle assembly of FIG. 1;
[0023] FIG. 5 illustrates an enlarged section view taken along line
1-1 of FIG. 2;
[0024] FIG. 6 illustrates an enlarged section view of an alternate
needle assembly for use in the injection needle of FIG. 1; and
[0025] FIGS. 7(a) and 7(b) are enlarged distal end and fragmentary
top views, respectively, of the fiber optic assembly illustrated in
FIG. 6.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0026] Referring now to FIGS. 1 through 5, there are shown various
views of one embodiment of an optical spectroscopic injection
needle assembly constructed according to the teachings of the
present invention, said optical spectroscopic injection needle
assembly being represented generally by reference numeral 11.
[0027] Assembly 11 may include an injection needle 13, a light
source 15, a spectrometer 17, a computer 19 and an indicator
21.
[0028] Injection needle 13 may comprise a hollow outer needle 31.
Outer needle 31 may include an elongated, unitary, tubular member
of uniform diameter, made of stainless steel or the like, outer
needle 13 may be shaped to include a blunt proximal end 33, a
beveled distal end 35 and a longitudinal bore 37. Outer needle 31
may be dimensioned to be, for example, a 22 gauge extra thin walled
hypodermic needle having a bevel of 18 degrees.
[0029] Injection needle 13 may also comprise a hollow inner needle
41. Inner needle 41 may be positioned within bore 37 of outer
needle 31. Inner needle 41 may be an elongated, unitary, tubular
member of uniform diameter, made of stainless steel or the like.
Inner needle 41 may be shaped to include a blunt proximal end 43, a
beveled distal end 45 and a longitudinal bore 47. Inner needle 41
may be dimensioned to be, for example, a 25 gauge extra thin walled
hypodermic needle having a bevel of 18 degrees. Inner needle 41 may
be dimensioned so that blunt proximal end 43 and beveled distal end
45 lie flush with blunt proximal end 33 and beveled distal end 35,
respectively, of needle 31. As will be discussed further below,
longitudinal bore 47 of inner needle 41 may be used to convey
fluids, such as a solution of implant material where injection
needle 13 is used to inject such a solution into the LES muscle of
a GERD patient. (Alternatively, injection needle 13 may be used to
inject therapeutic and diagnostic agents.)
[0030] Injection needle 13 may further comprise a pair of optical
fibers 49-1 and 49-2, the distal ends (not shown) of optical fibers
49-1 and 49-2 may be inserted into longitudinal bore 37 of needle
31. In the present embodiment, fibers 49-1 and 49-2 may be
identical to one another and may be 0.22 NA, step index multimode
fibers optimized for the VIS-NIR range, each of fibers 49-1 and
49-2 may include a silica-based core 50 of 100 micron diameter, a
silica-based cladding 51 of 110 micron diameter, and a polyimide
buffer 52 of 125 micron diameter. The distal ends (not shown) of
fibers 49-1 and 49-2 may be beveled and lie flush with distal end
35 of needle 31. The proximal ends 53-1 and 53-2 of fibers 49-1 and
49-2, respectively, may extend proximally beyond proximal end 33 of
needle 31 and may be coupled to connectors 55-1 and 55-2,
respectively. Examples of connectors suitable for use as connectors
55-1 and 55-2 include SMA 905 connectors.
[0031] Injection needle 13 may further comprise a spacer 56, spacer
56 being positioned within bore 37 of outer needle 31. Spacer 56,
which may be made of a suitable medical grade plastic or the like,
may include an elongated, unitary, solid member that is
appropriately dimensioned to keep fibers 49-1 and 49-2 spaced apart
at a desired distance. Spacer 56 has a distal end 57 and a proximal
end 58. Preferably, distal end 57 is beveled and lies flush with
beveled distal end 35 of needle 31. In the present embodiment,
proximal end 58 is blunt and lies flush with blunt proximal end 33
of needle 31; however, it should be understood that proximal end
58, if flexible, could extend proximally beyond blunt proximal end
33 of needle 31.
[0032] Injection needle 13 may further comprise a bonding material
59, which may comprise an optical bonding material, such as an
optical epoxy or like material. Optical bonding material 59 is
provided to fill the remaining spaces within bore 37 of outer
needle 31 and to bond together the various components positioned
within bore 37. The distal end 60 of optical bonding material 59 is
shaped to lie flush with beveled distal end 35 of needle 31.
[0033] Injection needle 13 further comprises an inner catheter 61.
In the present embodiment, inner catheter 61 may include an
elongated, unitary, flexible member, for example, made of a
suitable medical grade plastic, inner catheter 61 being shaped to
include a proximal end 63, a distal end 65 and a longitudinal bore
67. Proximal end 33 of needle 31 may be disposed within bore 67 of
inner catheter 61 and may be securely retained therewithin by a
tubular band 69 crimped around the outside of catheter 61 against
needle 31, with distal end 35 of needle 31 extending distally a
short distance from distal end 65 of catheter 61.
[0034] Injection needle 13 may further comprise an outer catheter
71. In the present embodiment, outer catheter 71 may include an
elongated, unitary, flexible member, for example, made of a
suitable medical grade plastic, outer catheter 71 may be shaped to
include a proximal end 73, a distal end 75 and a longitudinal bore
77. Outer catheter 71 may be appropriately dimensioned to receive
inner catheter 61 coaxially within bore 77, with inner catheter 61
and outer catheter 71 may be slidable relative to one another. In
this manner, as will be discussed further below, outer needle 31,
as well as the various components housed therewithin, may be
alternately extended distally from outer catheter 71, as when
making an injection, and retracted into outer catheter 71, as when
not making an injection.
[0035] Injection needle 13 may further comprise an outer hub 81. In
one embodiment, outer hub 81 comprises an elongated, unitary,
tubular, rigid member, for example, made of a suitable medical
grade plastic, outer hub 81 may be shaped to include a distal stem
portion 83, an intermediate shoulder portion 85, and a proximal
collar portion 87. Stem portion 83 may have has an outer profile
that is generally cylindrical and further may comprise a pair of
opposing flattened surfaces 89-1 and 89-2 that extend
longitudinally. Shoulder portion 85 may have an outer profile that
is generally conical, tapering outwardly from stem portion 83 to
collar portion 87. Collar portion 87, which may be generally
cylindrical in outer profile, may be shaped to include embossed
indicia 91-1 and 91-2, the purpose of which will be discussed
further below. A longitudinal bore may be provided in outer hub 81,
said longitudinal bore comprising a first portion 93, a second
portion 94, a third portion 95, a fourth portion 96, and a fifth
portion 97. First portion 93 may extend proximally from distal end
99 of hub 81 to second portion 94. Second portion 94, which may be
smaller in diameter than first portion 93, may comprise an internal
flange 101 provided in stem portion 83. Flange 101 may be
appropriately dimensioned so that proximal end 73 of catheter 71,
which is freely received in first portion 93, may be securely
retained within outer hub 81. Outer hub 81 may be insert-molded
around proximal end 73 of outer catheter 71, with internal flange
101 being sized to frictionally engage catheter 71 in a highly
retentive manner. Third portion 95, which may extend between second
portion 94 and fourth portion 96, may be greater in diameter than
each of first portion 93 and second portion 94. Fourth portion 96,
which may be located within shoulder portion 85 and which may
extend between third portion 95 and fifth portion 97, may be
greater in diameter than each of third portion 95 and fifth portion
97. A washer 103 may be fixedly mounted within fourth portion 97,
washer 103 having a generally oval aperture 104, the purpose of
which will be described below. If desired, outer hub 81 may be
insert-molded around washer 103. Fifth portion 97, which may be
smaller in diameter than fourth portion 96 but may be greater in
diameter than third portion 95, may extend proximally from fourth
portion 96 to proximal end 105 of hub 81.
[0036] Injection needle 13 may further comprise an inner hub 111.
In the present embodiment, inner hub 111 may include an elongated,
unitary, tubular, rigid member, for example, made of a suitable
medical grade plastic, inner hub 111 being shaped to include a
distal stem portion 113, an intermediate neck portion 115 and a
proximal body portion 117. Stem portion 113, which may be generally
cylindrical in outer profile, except for a pair of opposing
flattened surfaces 118 that may extend longitudinally, may be
shaped'to include a slotted distal section 119 and a tubular
proximal section 120. Distal section 119 may have a bifurcated barb
121 at its distal end. Proximal end 63 of inner catheter 61 may be
fixedly mounted within slotted distal section 119 of stem portion
113 by a friction fit. (If desired, slotted distal section 119 may
be provided with serrations to help grip inner catheter 61.)
Tubular proximal section 120 may be shaped to include a
longitudinal bore 122 and a pair of proximal notches 124-1 and
124-2 along its outer surface. Stem portion 113 may be partially
inserted into outer hub 81, with barb 121 being appropriately sized
relative to aperture 104 of washer 103 so that barb 121 may be
inserted through aperture 104 during assembly of injection needle
13 but, thereafter, cannot easily be withdrawn proximally through
aperture 104. In addition, tubular proximal section 120 may be
dimensioned relative to aperture 104 of washer 103 so that, when
stem portion 113 and aperture 104 are properly aligned
rotationally, proximal section 120 may be moved back and forth
through aperture 104 and so that, when stem portion 113 is fully
inserted into outer hub 81 (with notches 124-1 and 124-2 disposed
within aperture 104), stem portion 113 may be rotated 90 degrees
relative to aperture 104, thereby preventing proximal section 120
from being moved translationally relative to outer hub 81.
[0037] Neck portion 115, which may be generally cylindrical in
outer profile, may be shaped to include a longitudinal bore 127,
bore 127 being aligned with bore 122 of proximal section 120. Neck
portion 115 may be appropriately dimensioned to serve as a stop to
limit insertion of inner hub 111 into outer hub 81.
[0038] Proximal body portion 117, which may be generally
rectangular in outer profile, may be shaped to include an
unbranched distal portion, i.e., a first arm 131, and a branched
proximal portion, i.e., second and third arms 133 and 135,
respectively. First arm 131 may be shaped to include a bore 137,
bore 137 being aligned with bore 127 of neck portion 115. Embossed
indicia 139-1 and 139-2 may be provided on opposing surfaces of
first arm 131, indicia 139-1 and 139-2 being provided to be
alignable with indicia 91-1 and 91-2, respectively, to indicate the
rotational alignment of inner hub 111 to outer hub 81, such as when
one wishes to prevent longitudinal movement of inner hub 111
relative to outer hub 81. Second arm 133, which is substantially
coaxial with first arm 131, may be shaped to include a bore 141,
bore 141 being aligned with bore 137 of first arm 131. The proximal
end of second arm 133 may be shaped to include an externally
threaded connector 143 adapted for use with a needle-less syringe
or the like. Third arm 135, which may lie off-axis with first arm
131, may be shaped to include a bore 145, bore 145 communicating
with bore 137. A flexible strain relief 150 is coaxially mounted
over the free end of third arm 135.
[0039] Injection needle 13 may further comprise a sheath 151.
Sheath 151 may be an elongated, unitary, flexible, tubular member,
for example, a length of furcation tubing. Sheath 151 may be shaped
to include a proximal end 153 and a distal end 155, proximal end
153 being bifurcated into arms 154-1 and 154-2 to hold the proximal
ends of optical fibers 49-1 and 49-2, respectively. Distal end 155
of sheath 151 may be fixedly mounted within strain relief 150.
[0040] Light source 15, which may be a conventional,
variable-wavelength light source (e.g., tunable laser, lamp with
filters, etc.) of the type used to illuminate objects with one or
more of ultraviolet, visible and infrared light for purposes of
performing optical spectroscopy, may be coupled to connector 55-2
to provide light to optical fiber 49-2.
[0041] Spectrometer 17, which may be a conventional spectrometer,
may be coupled to connector 55-1 to detect the light from optical
fiber 49-1. Spectrometer 17 may also be electrically coupled to
computer 19, which, in one embodiment, compares the detected
spectrum to standards from objects whose composition is known
(e.g., fat tissue, muscle tissue, blood, etc.). The results of the
comparison from computer 19 may then be transmitted to indicator
21. Indicator 21 may take the form of a computer monitor, a
printer, one or more light signals (e.g., a green light turned on
for targeted objects, a red light turned on for other objects), one
or more audio signals (e.g., a bell rung for targeted objects, a
buzzer actuated for other objects), or the like.
[0042] To use assembly 11, for example, to inject implant material
into the lower esophageal sphincter of a patient, one may first
insert the distal end of an endoscope through the mouth of the
patient and then into the esophagus of the patient in the vicinity
of the lower esophageal sphincter. Placement of the distal end of
the endoscope in the vicinity of the lower esophageal sphincter may
be aided by real-time observation equipment loaded into a viewing
channel of the endoscope. Then, one may attach a
solution-containing syringe to connector 143 of injection needle 13
and may load the distal end of injection needle 13 into the working
channel of the endoscope, with needle 31 being placed in a
retracted position within outer catheter 71. Next, one may extend
needle 31 distally from outer catheter 71 by sliding inner hub 111
into outer hub 81 until neck portion 115 of inner hub 111 abuts
washer 103. One then may rotate inner hub 111 relative to outer hub
81 by 90 degrees (i.e., so that indicia 91-1 and 91-2 are aligned
with indicia 139-1 and 139-2, respectively) to keep inner hub 111
and outer hub 81 from sliding relative to one another. With needle
31 thus extended distally from outer catheter 71, one may begin to
insert needle 31 into a targeted area of the patient. (Visual
identification of the targeted area is preferably aided by the
real-time observation equipment of the endoscope.) As needle 31 is
inserted into the targeted area, light from light source 15 may be
transmitted to the penetrated depth of the targeted area using
optical fiber 49-2. The light reflected from the illuminated area
may then be collected by optical fiber 49-1, may be detected by
spectrometer 17, and may be analyzed by computer 19. The results of
the comparison may then be transmitted to indicator 21, which may
provide an indication (e.g., visual, aural, etc.) as to whether
needle 31 has been inserted into the area to an appropriate depth
(e.g., to the depth at which muscle tissue is located). As can be
appreciated, the aforementioned spectroscopic testing of the
illuminated area may be conducted continuously so that, as one
inserts needle 31 into the area to changing depths, one may obtain
virtually instantaneous feedback as to whether needle 31 is
positioned at the appropriate depth for the desired tissue type
within the targeted area. Once an indication has been made that
needle 31 has been inserted into the desired tissue type, one may
dispense the solution from the syringe into the tissue using
injection needle 13, the solution being conducted successively
through bores 141, 137, 127, 122, 67 and 47, respectively. After
the injection is complete, one may retract needle 31 into catheter
71 by rotating inner hub 111 relative to outer hub 81 by another 90
degrees (i.e., so that indicia 91-1 and 91-2 are 90 degrees out of
alignment with indicia 139-1 and 139-2) and by sliding inner hub
111 proximally away from outer hub 81 until barb 121 of distal.
portion 113 abuts washer 103. One then may remove injection needle
13 and the endoscope from the patient.
[0043] Referring now to FIG. 6, there is shown an enlarged section
view of an alternate needle assembly adapted for use in injection
needle 13, said alternate needle assembly being represented
generally by reference numeral 201.
[0044] Assembly 201 is similar in many respects to the needle
assembly of injection needle 13, assembly 201 including (i) an
outer needle 203 that is similar to outer needle 31, (ii) an inner
needle 205 that is similar to inner needle 41, and (iii) an optical
bonding material 207 that is similar to optical bonding material
59. However, assembly 201 differs from the needle assembly of
injection needle 13 in that, instead of including spacer 56 and
optical fibers 49-1 and 49-2, assembly may include fiber optic
assembly 211. Assembly 211, which is shown separately in FIGS. 7(a)
and 7(b), comprises a pair of optical fibers 213-1 and 213-2.
Fibers 213-1 and 213-2 may be similar in structure and composition
to optical fibers 49-1 and 49-2, respectively, each of fibers 213-1
and 213-2 comprising a core 215, a cladding 217 and a buffer 219.
Assembly 211 also may comprise a bundling sheath 221, bundling
sheath 221 designed to coaxially surround each of fibers 213-1 and
213-2 at their respectively distal ends and physically coupling
together fibers 213-1 and 213-2. In the present embodiment, sheath
221 may be made of a flexible material so that fibers 213-1 and
213-2 may assume an orientation within needle 203 similar to that
assumed by fibers 49-1 and 49-2 within needle 31.
[0045] In another embodiment (not shown), the light source and/or
the light detector may be positioned at or near the distal end of
the injection needle. For example, an LED or other light source may
be positioned at or near the distal end of the hollow needle, and a
light sensor may be located on. the outside of the hollow needle or
integrated into the wall of the hollow needle. Alternatively, the
needle itself could be an optical light guide, either to deliver
light or to receive light.
[0046] It should be noted that, although the endoscopic injection
needle assembly of the present invention has been described above
as being used to inject implant material into LES tissue, this
assembly is not limited to injecting implant materials nor is it
limited to injecting materials into LES tissue. For example, it may
include use as a needle to inject therapeutic and/or diagnostic
agents and implants.
[0047] The embodiments of the present invention described above are
intended to be merely exemplary and those skilled in the art shall
be able to make numerous variations and modifications to it without
departing from the spirit of the present invention. For example, it
should be understood that, instead of using one optical fiber to
illuminate an object and another optical fiber to collect the light
reflected from the object, one could use an arrangement that
includes a single optical fiber for both illumination and
collection. All such variations and modifications are intended to
be within the scope of the present invention as defined in the
appended claims.
* * * * *