U.S. patent application number 09/478552 was filed with the patent office on 2002-01-24 for tissue mapping injection device.
Invention is credited to MILLER, ERIC C..
Application Number | 20020010439 09/478552 |
Document ID | / |
Family ID | 22357637 |
Filed Date | 2002-01-24 |
United States Patent
Application |
20020010439 |
Kind Code |
A1 |
MILLER, ERIC C. |
January 24, 2002 |
TISSUE MAPPING INJECTION DEVICE
Abstract
A tissue mapping injection device suitable for use during a
lymphatic breast mapping procedure is provided. The device includes
a housing having an elongated body portion extending distally
therefrom. A plunger is slidably positioned within the housing. A
connector rod is secured to the forward end of the plunger and
extends distally through the elongated body portion. The plunger
and the connector rod define a fluid delivery channel. A plurality
of needles are secured to the distal end of the connector rod. Each
of the needles is constructed from a shape memory material and
defines a fluid injection channel which communicates with the fluid
delivery channel. The plunger is movable from a retracted position
wherein the needles are positioned within the elongated body
portion to an advanced position wherein the needles extend
outwardly from the distal end of the elongated body portion.
Inventors: |
MILLER, ERIC C.; (Los Gatos,
CA) |
Correspondence
Address: |
LAWRENCE A CRUZ ESQ
UNITED STATES SURGICAL CORPORATION
150 GLOVER AVENUE
NORWALK
CT
06856
|
Family ID: |
22357637 |
Appl. No.: |
09/478552 |
Filed: |
January 6, 2000 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60114824 |
Jan 6, 1999 |
|
|
|
Current U.S.
Class: |
604/272 |
Current CPC
Class: |
A61B 17/3478 20130101;
A61B 2090/3908 20160201; A61M 2025/0086 20130101 |
Class at
Publication: |
604/272 |
International
Class: |
A61M 005/32 |
Claims
What is claimed is:
1. A surgical instrument for injecting a fluid into tissue
comprising: a housing; a hollow elongated body portion having a
longitudinal axis extending distally from the housing; an actuator
assembly including a plunger slidably positioned within the
housing, the plunger defining a fluid delivery channel; and at
least one needle having an injection tip operatively connected to
the plunger, the at least one needle defining a fluid injection
channel which communicates with the fluid delivery channel, the
needle being formed from shape memory material and being movable in
response to movement of the plunger from a deformed position
located within the elongated body portion to a relaxed position
located externally of the elongated body portion, wherein in the
relaxed position, the injection tip extends outwardly from the
elongated body portion to define a predetermined angle with respect
to the longitudinal axis of the elongated body portion.
2. A surgical instrument according to claim 1, wherein the
predetermined angle is about ninety degrees.
3. A surgical instrument according to claim 1, wherein the at least
one needle includes four needles, each of the four needles, in the
relaxed position, curving outwardly from the longitudinal axis of
the elongated body portion into one of four planar quadrants
surrounding target tissue.
4. A surgical instrument according to claim 3, wherein the
predetermined angle is about ninety degrees.
5. A surgical instrument according to claim 1, wherein the plunger
is slidable within the housing between advanced and retracted
positions, wherein when the plunger is in the retracted position,
the at least one needle is in the deformed position, and when the
plunger is in the advanced position, the at least one needle is in
the relaxed position.
6. A surgical instrument according to claim 5, wherein the at least
one needle includes four needles, each of the needles in the
relaxed position, curving outwardly from the longitudinal axis of
elongated body portion into one of four planar quadrants
surrounding target tissue.
7. A surgical instrument according to claim 6, wherein the
predetermined angle is about ninety degrees.
8. A surgical instrument according to claim 1, wherein the at least
one needle includes eight needles each of the needles in the
relaxed position, curving outwardly from the longitudinal axis of
the elongated body portion into one of four planar quadrants
surrounding target tissue.
9. A surgical instrument according to claim 8, wherein four of the
needles have injection tips positioned in a first vertical plane
and the other four needles have injection tips positioned in a
second vertical plane which is spaced from the first vertical
plane.
10. A surgical instrument according to claim 9, wherein the
predetermined angle is about ninety degrees.
11. A surgical instrument according to claim 5, further including a
biasing member supported within the housing, the biasing member
being positioned to urge the plunger to the retracted position.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority from U.S. provisional
application Ser. No. 60/114,824, filed Jan. 6, 1999, which is
hereby incorporated by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates generally to a surgical
instrument for injecting a fluid into tissue and, more particularly
to a surgical instrument for injecting an imaging radio label
material into breast tissue for the detection of breast
carcinoma.
[0004] 2. Background of Related Art
[0005] Breast carcinoma is the most common cancer and the second
leading cause of cancer-related death in women living in the United
States. The incidence of breast cancer is increasing by about three
percent per year. Recent studies show that one in eight women in
the United States will develop breast cancer. Early detection
lowers mortality and prolongs life expectancy of those having
breast cancer.
[0006] Presently, standard screening tests for early detection of
breast cancer include breast self-examination, breast examination
by a physician, and mammography. In general, physical examination
alone will detect, at best, only sixty to eighty percent of breast
masses, whereas mammography will detect eighty to ninety percent of
breast masses in women not having dense breasts. In women having
dense breasts, mammography has a false-negative rate of twenty-five
to forty-five percent, and has a positive predictive value of only
thirty percent. Only one in every four to six biopsies performed to
confirm or rule out malignancy of suspicious lesions detected
during mammograms will be malignant. Thus, the majority of biopsies
prove to be unnecessary, i.e., the lesion is benign. Considering
that the economic cost as well as the physical and psychological
stress of undergoing a biopsy is high, the need for a noninvasive
and accurate technique to better discriminate between benign and
malignant mammographic abnormalities which require biopsy is
clearly present.
[0007] One such technique being developed for noninvasively and
accurately discriminating between malignant and benign mammographic
abnormalities is Lymphatic Breast Mapping ("LBM"). During an LBM
procedure, a quantity of radioactive tracer or dye is injected into
and around a tumor. Because of the tracer's biochemistry, the tumor
will collect more of the tracer than does normal healthy tissue.
Thus, when the radioactive tracer decays and emits gamma rays, a
higher number of these gamma rays will originate from tumor sites
than from equal volumes of healthy tissue. The tracer distribution
and gamma ray emission can be identified using a scintillation
camera to enable doctors to identify the presence or absence of
cancer.
[0008] Accordingly, a need exists for a surgical instrument for
injecting a radioactive tracer into body tissue at precise
locations adjacent a tumor.
SUMMARY
[0009] In accordance with the present disclosure, a tissue mapping
injection device is disclosed that is capable of injecting an
imaging radio label material or dye into the body at a location
encompassing target tissue. The injection device includes a
housing, an elongated body portion coupled to and extending
distally from the housing, an actuator assembly slidably supported
within the housing from a retracted to an advanced position, and at
least one needle coupled to the distal end of the actuator
assembly. The actuator assembly includes a plunger which is
slidably positioned along a cylindrical bore formed within the
housing. An engagement member is coupled to or monolithically
formed with the plunger and is positioned to be engaged by the
thumb of a surgeon. The plunger has a first end which extends
distally from one end of the housing in a direction opposite to the
elongated body portion. The plunger defines a fluid delivery
channel and includes a distal end adapted to receive a fluid
delivery hose.
[0010] A connector rod is coupled to and extends from the plunger
through the elongated body portion. The connector rod also defines
a fluid delivery channel which communicates with the plunger
delivery channel. The needles are connected to the distal end of
the connector rod and are formed from a shape memory material. Each
of the needles defines an injection delivery channel which
communicates with the fluid delivery channel of the connector rod.
In a relaxed state, the needles curve outwardly at a predetermined
angle relative to the longitudinal axis of the elongated body
portion. In one embodiment, four needles are secured to the distal
end of the connector rod. Each of the needles is substantially
identically shaped in its relaxed state.
[0011] In use, when the plunger is in the retracted position, the
needles are positioned within elongated body portion and are
deformed by the body portion to a substantially straight
configuration. When the plunger is moved to the advanced position,
the needles are moved distally out of the distal end of the
elongated body portion. The needles are no longer deformed by the
elongated body portion and thus, return to the relaxed state
curving outwardly from the longitudinal axis of the body portion.
Since each of the needles is similarly shaped, the tips of the
needles lie in a common plane and extend into four quadrants
surrounding a target tissue. Each of the needles is spaced
approximately 90.degree. from adjacent needles. Fluid can be
injected into the tissue surrounding the target tissue via the
delivery channels in the plunger and the injection channel formed
in the needles.
[0012] In an alternate embodiment, eight needles are secured to the
distal end of the connector rod. The eight needles form two sets of
four needles, wherein each needle has a substantially identical
configuration in the relaxed state as the other needles in that set
of needles. When the needles are advanced out of the distal end of
the elongated body portion, the tips of the first set of needles
lie in a first plane and the tips of the second set of needles lie
in a second plane spaced from the first plane. Each of the needles
of each set of needles extends into one of the four quadrants
surrounding a target tissue and is spaced approximately ninety
degrees from adjacent needles.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Various preferred embodiments of the injection device for
Lymphatic Breast Mapping are described herein with reference to the
drawings, wherein:
[0014] FIG. 1 is a perspective view of one embodiment of the
injection device in a non-deployed condition;
[0015] FIG. 2 is a perspective view with parts separated of the
injection device shown in FIG. 1;
[0016] FIG. 3 is a side view of the injection device shown in FIG.
1 with parts removed in a non-deployed condition;
[0017] FIG. 4 is an enlarged view of the indicated area of detail
shown in FIG. 4;
[0018] FIG. 5 is a side view of the injection device shown in FIG.
1 with parts removed and in a deployed condition;
[0019] FIG. 6 is a perspective view of the distal end of the
injection device shown in FIG. 1 in the deployed condition;
[0020] FIG. 6A is an alternate embodiment of the distal end of the
injection device shown in FIG. 1 in the deployed condition;
[0021] FIG. 7 is a cannula suitable for use with the injections
device shown in FIGS. 1 and 6A;
[0022] FIG. 8 is a side cross-sectional view of the injection
device shown in FIG. 1 in a non-deployed condition passing through
the cannula shown in FIG. 7 with the cannula extending partially
into body tissue; and
[0023] FIG. 9 is a side cross-sectional view of the injection
device shown in FIG. 1 in a deployed condition passing through the
cannula shown in FIG. 7 with the cannula extending partially into
body tissue.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0024] Preferred embodiments of the presently disclosed injection
device will now be described in detail with reference to the
drawings, in which like reference numerals designate identical or
corresponding elements in each of the several views.
[0025] FIGS. 1-4 illustrate the injection device shown generally as
10. Briefly, injection device 10 includes a housing 12, an
elongated body portion 14, and an actuator assembly 16. Housing 12
has a pair of radially extending fingers 18 configured to be
engaged by the fingers of a surgeon. Elongated body portion 14 is
fixedly secured to one end 20 of housing 12 and extends distally
therefrom. Actuator assembly 16 includes a plunger 22 which is
slidably positioned within housing 12 and extends distally from the
other end 24 of housing 12 in a direction opposite to body portion
14. An engagement member 26 is secured to plunger 22 at a location
to be grasped by the thumb of a surgeon while the surgeon's fingers
grip radially extending fingers 18. Alternately, engagement member
26 can be monolithically formed with plunger 22.
[0026] Referring to FIG. 2, housing 12 includes a pair of molded
housing half-sections 12a and 12b which are secured together via
known techniques, e.g., adhesives, ultrasonic welding, screws,
etc., to form the housing. End 20 of housing 12 includes a slot 28
configured and dimensioned to receive an annular flange 30 formed
at the proximal end of body portion 14. Housing 12 also includes a
cylindrical bore 32 and a void 34. Cylindrical bore 32 is
dimensioned to slidably receive plunger 22 (FIG. 1). A shoulder 36
is formed at one end of cylindrical bore 32 to limit the extent of
longitudinal movement of plunger 22 along bore 32 within housing
12. Void 34 reduces the amount of material required to manufacture
the housing and, thus reduces the cost of manufacturing the
housing.
[0027] Plunger 22 of actuator assembly 16 is preferably formed from
molded half-sections 22a and 22b which are secured together using
known techniques, e.g., adhesives, ultrasonic welding, screws, etc.
Plunger 22 defines a fluid delivery channel 38. A first end 40 of
plunger 22 includes an annular rib 42 to facilitate attachment of a
fluid supply line 44 (FIG. 3) to the plunger. A second end 46 of
plunger 22 has a slot 48 formed therein dimensioned to receive a
flange 50 formed at a proximal end of connector rod 52 to secure
connector rod 52 in a longitudinally fixed position with respect to
plunger 22. The second end 46 of plunger 22 also includes an
annular flange 45 dimensioned to engage a biasing member 47
positioned in the forward end of cylindrical bore 32. Biasing
member 47, which is preferably a coil spring, is positioned between
annular flange 45 of plunger 22 and shoulder 36 of housing 12 to
urge the plunger to a retracted position. The proximal end of
cylindrical bore 32 also includes a shoulder 49 to retain plunger
22 within cylindrical bore 32.
[0028] Referring also to FIGS. 3 and 4, connector rod 52 has a
longitudinal axis which is coaxial with the longitudinal axis of
plunger 22 and elongated body portion 14. Connector rod 52 extends
from end 46 of plunger 22 through elongated body 14 and defines a
fluid delivery channel 38' (See FIGS. 3 and 4) which communicates
with fluid delivery channel 38. A plurality of hollow needles 54
are secured to the distal end of connector rod 52. Each of the
needles defines an injection channel 56 in fluid communication with
delivery channel 38'. Each of needles 54 is constructed from a
shape memory material and includes a sharpened tip 58 having an
outlet orifice 59. Preferably, the shape memory material is Nitinol
although other shape memory materials may be used. In the relaxed
state, each needle curves outwardly such that a tangent extending
from needle tip 58 forms an angle of about ninety (90) degrees with
respect to the longitudinal axis of the elongated body 14.
Alternately, other needle configurations are envisioned, e.g.,
needle tip may extend outwardly at an angle of between about 10
degrees to about 150 degrees. The needles 54 are secured to
connector rod 52 such that when they are deployed from within
elongated body 14, the needles extend away from each other into
four planar quadrants surrounding target tissue. Preferably, the
needles are positioned at ninety degree intervals about the
longitudinal axis of the elongated body portion 14, although
different spacings are envisioned.
[0029] Referring to FIGS. 3 and 4, when plunger 22 is in its
retracted position, connector rod 52 and needles 54 are positioned
within elongated body 14. In this position, the inner wall of
elongated body 14 urges the needles from a normally curved
configuration to a substantially straight configuration.
[0030] Referring to FIG. 5, when engagement member 26 is moved
towards housing 12 in the direction indicated by arrow "A", plunger
22 is moved towards the distal end of cylindrical bore 32 against
the bias of spring 47. Longitudinal advancement of plunger 22
within cylindrical bore 32 causes corresponding longitudinal
advancement of connector rod 52 within elongated body portion 14.
As connector rod 52 is advanced, needles 54 are advanced in the
direction indicated by arrow "B" in FIG. 5 from a position within
elongated body portion 14 to a position extending outwardly from
the distal end of elongated body portion 14. As needles 54 exit the
distal end of body portion 14, the needles return to a relaxed
state wherein the needle tip 58 is pointed in a direction
substantially perpendicular to the longitudinal axis of the
elongated body portion 14. In the relaxed state, each of needle
tips 58 lies in the same vertical plane. See FIG. 6.
[0031] FIG. 6A illustrates an alternate embodiment of the injection
device. In the embodiment shown in FIG. 6A, the injection device
has eight needles. In the relaxed state, four of the needles 54
extend away from each other into four planar quadrants surrounding
target tissue and have tips 58 which lie in a first vertical plane
and, four of the needles 54' extend away from each other into four
planar quadrants surrounding target tissue and have tips 58' which
lie in a second vertical plane spaced from the first vertical
plane. By providing additional needles, radioactive tracer or dye
can be injected about the entire location of the target tissue.
[0032] Referring to FIGS. 7-9, during performance of a lymphatic
breast mapping procedure, a cannula 80 (FIG. 7) is inserted into
tissue via known techniques adjacent the location of the target
tissue 82. Next, the elongated body portion 14 of injection device
10 is inserted through cannula 80 in the direction indicated by
arrow "C" in FIG. 8 to a position in which the distal end of
elongated body portion 14 is located adjacent to the distal end 84
of cannula 80. Finally, actuator assembly 16 is actuated in the
manner discussed above to advance connector rod 52 and needles 54
in the direction indicated by arrows "D" and "E", respectively, in
FIG. 9, into or adjacent the target tissue. A radioactive tracer or
dye 90 can now be injected in and about the location of the target
tissue 82 via fluid supply line 44, fluid delivery channels 38 and
38' and injection channels 56.
[0033] It will be understood that various modifications may be made
to the embodiments disclosed herein. For example, although the
injection device has been disclosed as having four needles which
extend into four quadrants about the target tissue, a greater or
lesser number of needles may be provided. Moreover, the
configuration of the needles in the relaxed state may be different
than that disclosed. For example, the needle can have a
configuration in which the needle tip extends outwardly at an angle
of sixty (60) degrees with respect to the base of the needle.
Therefore, the above description should not be construed as
limiting, but merely as exemplifications of preferred embodiments.
Those skilled in the art will envision other modifications within
the scope and spirit of the claims appended thereto.
* * * * *