U.S. patent application number 10/630883 was filed with the patent office on 2004-02-05 for methods and devices for defining and marking tissue.
Invention is credited to Burbank, Fred H., Foerster, Seth A., Ritchart, Mark A., Zerbouni, Elias A..
Application Number | 20040024304 10/630883 |
Document ID | / |
Family ID | 23192532 |
Filed Date | 2004-02-05 |
United States Patent
Application |
20040024304 |
Kind Code |
A1 |
Foerster, Seth A. ; et
al. |
February 5, 2004 |
Methods and devices for defining and marking tissue
Abstract
In order to later identify the location of a biopsy or surgery,
various means and methods for permanently and non-surgically
marking selected tissue in the human body are used. Later
visualization of the markers is readily accomplished using
state-of-the-art imaging systems.
Inventors: |
Foerster, Seth A.; (San
Clemente, CA) ; Burbank, Fred H.; (San Juan
Capistrano, CA) ; Ritchart, Mark A.; (Murrieta,
CA) ; Zerbouni, Elias A.; (Baltimore, MD) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
23192532 |
Appl. No.: |
10/630883 |
Filed: |
July 30, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10630883 |
Jul 30, 2003 |
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10213638 |
Aug 7, 2002 |
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10213638 |
Aug 7, 2002 |
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09954646 |
Sep 18, 2001 |
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09954646 |
Sep 18, 2001 |
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09776125 |
Feb 2, 2001 |
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09776125 |
Feb 2, 2001 |
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08858389 |
May 19, 1997 |
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6228055 |
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08858389 |
May 19, 1997 |
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08308097 |
Sep 16, 1994 |
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Current U.S.
Class: |
600/407 |
Current CPC
Class: |
A61B 10/0283 20130101;
A61B 90/39 20160201; A61B 2090/3908 20160201; A61B 2017/00004
20130101; Y10T 24/4501 20150115; A61B 10/0275 20130101; A61B
2090/3987 20160201 |
Class at
Publication: |
600/407 |
International
Class: |
A61B 005/05 |
Claims
What is claimed is:
1. A device for marking a particular tissue area within a human
body to identify said particular tissue area for a later diagnostic
or therapeutic procedure, comprising: a discrete marker element; an
apparatus for remotely delivering said marker element from outside
the human body to the particular tissue area using an aided
visualization device; said apparatus including a member having a
distal region and a proximal region, said member being adapted to
extend through said human body and to receive a deployment actuator
connector which extends axially therealong, said connector
comprising a distal portion which extends distally of the member
and a proximal portion which extends proximally of the member, the
proximal portion being attached to a deployment actuator and the
distal portion being attached to said marker element, wherein
actuation of said deployment actuator is transmitted from the
proximal portion of the connector to the distal portion thereof to
cause release and deployment of said marker element; a
predetermined failure point in the distal region of said deployment
actuator connector, wherein once the distal region of said member
is positioned at said selected tissue location, the deployment
actuator may be actuated to pull the marker element against the
distal region of said member, said member distal region being
adapted to function as a forming die to cause the marker element to
bend until it encounters a stop designed into said member distal
region, such that the marker element is reconfigured to a desired
shape, the proximal portion of said connector being adapted to be
severed from the distal portion at said predetermined failure point
upon the further actuation of said deployment actuator after
abutment of the marker element against said stop, thereby releasing
and implanting said marker element; and said apparatus further
comprising a cutting tip for piercing said human body; wherein said
marker element is adapted to become entirely implanted in said
particular tissue area, such that no part of the marker element
extends outside of said body.
15. A device as recited in claim 1, and further comprising a
plurality of marker elements adapted to assume a plurality of
shapes, wherein each shape denotes a different selected tissue
location or event.
16. A device as recited in claim 1, wherein said device is adapted
to be employed in combination with a medical instrument which
transports said device to said selected tissue location responsive
to positional control by a guidance system.
17. A device for marking a particular tissue area within a human
body to identify and particular tissue area for a later diagnostic
or therapeutic procedure, comprising: a discrete marker element; an
apparatus for remotely delivering said marker element from outside
the human body to the particular tissue area, using an aided
visualization device; said apparatus including a member having a
distal region and a proximal region, said member being adapted to
extend through said human body and to receive a deployment actuator
connector which extends axially therealong, said connector
comprising a distal portion which extends distally of the member
and a proximal portion which extends proximally of the member, the
proximal portion being attached to a deployment actuator and the
distal portion being attached to said marker element, wherein
actuation of said deployment actuator is transmitted from the
proximal portion of the connector to the distal portion thereof to
cause release and deployment of said marker element: wherein said
device is adapted to be employed in combination with a medical
instrument which transports said device to said selected tissue
location responsive to positional control by a guidance system;
said medical instrument drawing a vacuum to isolate and retain
tissue at the selected location and said marking device being
adapted to deploy said marker element into said retained
tissue.
35. A device as recited in claim 1, wherein the marker element has
a width of less than 0.1 inches.
36. A device as recited in claim 1, wherein the marker element has
a width at its distal end within a range of 0.035-0.045 inches.
37. A device as recited in claim 1, wherein the particular tissue
area comprises a lesion within the body, and no part of the marker
element extends outside of said lesion.
43. A device as recited in claim 38, wherein said device is adapted
to be employed in combination with a medical instrument which
transports said device to said selected tissue location responsive
to positional control by a guidance system.
44. A device for marking a particular tissue area within a human
body to identify said particular tissue area from a later
diagnostic or therapeutic procedure, comprising: a discrete marker
element; and an apparatus for remotely delivering said marker
element from outside the human body to the particular tissue area,
using an aided visualization device, the apparatus including a
member having a distal region and a proximal region, said member
being adapted to extend into said human body, wherein said distal
region is adapted to retain and deploy said marker element and said
proximal region is linked to said distal region, so that
predetermined marker deployment functions may be communicated from
said proximal region to said distal region; said member being
adapted to receive a deployment actuator connector which extends
axially therealong, said connector comprising a distal portion
which extends distally of the member and a proximal portion which
extends proximally of the member, said proximal portion being
attached to a deployment actuator and said distal portion being
attached to said marker element, wherein actuation of said
deployment actuator is transmitted from the proximal portion of the
connector to the distal portion thereof to cause release and
deployment of said marker element; a predetermined failure point in
the distal region of said deployment actuator connector, wherein
once the distal region of said member is positioned at said
selected tissue location, the deployment actuator may be actuated
to pull the marker element against the distal region of said
member, said member distal region being adapted to function as a
forming die to cause the marker element to bend until it encounters
a stop designed into said member distal region, such that the
marker element is reconfigured to a desired shape, the proximal
portion of said connecting means being adapted to be severed from
the distal portion at said predetermined failure point upon the
further actuation of said deployment actuator after abutment of the
marker element against said stop, thereby releasing and implanting
said marker element; wherein said marker element is adapted to
become entirely implanted in said particular tissue area, such that
no part of the marker element extends outside of said body.
45. A device as recited in claim 16, wherein said medical
instrument draws a vacuum to isolate and retain tissue at the
selected location and said marking device is adapted to deploy said
marker element into said retained tissue.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to methods and devices for marking
and defining particular locations in human tissue, and more
particularly relates to methods and devices for permanently
defining the location and margins of lesions detected in a human
breast.
[0002] It is desirable and often necessary to perform procedures
for detecting, sampling, and testing lesions and other
abnormalities in the tissue of humans and other animals,
particularly in the diagnosis and treatment of patients with
cancerous tumors, pre-malignant conditions and other diseases or
disorders. Typically, in the case of cancer, when a physician
establishes by means of known procedures (i.e. palpation, x-ray,
MRI, or ultrasound imaging) that suspicious circumstances exist a
biopsy is performed to determine whether the cells are cancerous.
Biopsy may be an open or percutaneous technique. Open biopsy
removes the entire mass (excisional biopsy) or a part of the mass
(incisional biopsy). Percutaneous biopsy on the other hand is
usually done with a needle-like instrument and may be either a fine
needle aspiration (FNA) or a core biopsy. In FNA biopsy, very small
needles are used to obtain individual cells or clusters of cells
for cytologic examination. The cells may be prepared such as in a
Papanicolaou (Pap) smear. In core biopsy, as the term suggests, a
core or fragment of tissue is obtained for histologic examination
which may be done via a frozen section or paraffin section. The
chief difference between FNA and core biopsy is the size of the
tissue sample taken. A real time or near real time imaging system
having stereoscopic capabilities, such as the stereotactic guidance
system described in U.S. Pat. No. 5,240,011, is employed to guide
the extraction instrument to the lesion. Advantageous methods and
devices for performing core biopsies are described in the
assignee's co-pending patent application Ser. No. 08/217,246, filed
on Mar. 24, 1994, and herein incorporated by reference.
[0003] Depending upon the procedure being performed, it is
sometimes desirable to completely remove suspicious lesions for
evaluation, while in other instances it may be desirable to remove
only a sample from the lesion. In the former case, a major problem
is the ability to define the margins of the lesions at all times
during the extraction process. Visibility of the lesion by the
imaging system may be hampered because of the distortion created by
the extraction process itself as well as associated bleeding in the
surrounding tissues. Although the lesion is removed and all fluids
are continuously aspirated from the extraction site, it is likely
that the process will "cloud" the lesion, thus impairing exact
recognition of its margins. This makes it difficult to ensure that
the entire lesion will be removed
[0004] Often, the lesion is merely a calcification derived from
dead abnormal tissue, which may be cancerous or pre-cancerous, and
it is desirable to remove only a sample of the lesion, rather than
the entire lesion, to evaluate it. This is because such a lesion
actually serves to mark or define the location of adjacent abnormal
tissue, so the physician does not wish to remove the entire lesion
and thereby lose a critical means for later re-locating the
affected tissue. One of the benefits to the patient from core
biopsy is that the mass of the tissue taken is small. However,
oftentimes, either inadvertently or because the lesion is too
small, the entire lesion is removed for evaluation, even though it
is desired to remove only a portion. Then, if subsequent analysis
indicates the tissue to be malignant (malignant tissue requires
removal, days or weeks later, of tissue around the immediate site
of the original biopsy), it is difficult for the physician to
determine the precise location of the lesion, in order to perform
necessary additional procedures on adjacent potentially cancerous
tissue. Additionally, even if the lesion is found to be benign,
there will be no evidence of its location during future
examinations, to mark the location of the previously removed
calcification so that the affected tissue may be carefully
monitored for future reoccurrences.
[0005] Thus, it would be of considerable benefit to be able to
permanently mark the location or margins of such a lesion prior to
or immediately after removing or sampling same. Making prior to
removal would help to ensure that the entire lesion is excised, if
desired. Alternatively, if the lesion were inadvertently removed in
its entirety, marking the biopsy site immediately after the
procedure would enable reestablishment of its location for future
identification.
[0006] A number of procedures and devices for marking and locating
particular tissue locations are known in the prior art. For
example, location wire guides, such as that described in U.S. Pat.
No. 5,221,269 to Miller et al, are well known for locating lesions,
particularly in the breast. The device described by Miller
comprises a tubular introducer needle and an attached wire guide,
which has at its distal end a helical coil configuration for
locking into position about the targeted lesion. The needle is
introduced into the breast and guided to the lesion site by an
imaging system of a known type, for example, x-ray, ultrasound, or
magnetic resonance imaging (MRI), at which time the helical coil at
the distal end is deployed about the lesion. Then, the needle may
be removed from the wire guide, which remains in a locked position
distally about the lesion for guiding a surgeon down the wire to
the lesion site during subsequent surgery. While such a location
system is effective, it is obviously intended and designed to be
only temporary, and is removed once the surgery or other procedure
has been completed.
[0007] Other devices are known for marking external regions of a
patients skin. For example, U.S. Pat. No. 5,192,270 to Carswell,
Jr. discloses a syringe which dispenses a colorant to give a visual
indication on the surface of the skin of the point at which an
injection has or will be given. Similarly, U.S. Pat. No. 5,147,307
to Gluck discloses a device which has patterning elements for
impressing a temporary mark in a patients skin, for guiding the
location of an injection or the like. It is also known to tape or
otherwise adhere a small metallic marker, e.g. a 3 millimeter
diameter lead sphere, on the skin of a human breast in order to
delineate the location of skin calcifications (see Homer et al, The
Geographic Cluster of Microcalcifications of the Breast, Surgery,
Gynecology, & Obstetrics, December 1985). Obviously, however,
none of these approaches are useful for marking and delineating
internal tissue abnormalities, such as lesions or tumors.
[0008] Still another approach for marking potential lesions and
tumors of the breast is described in U.S. Pat. No. 4,080,959. In
the described procedure, the skin of the portion of the body to be
evaluated, such as the breasts, is coated with a heat sensitive
color-responsive chemical, after which that portion of the body is
heated with penetrating radiation such as diathermy. Then, the
coated body portion is scanned for color changes which would
indicate hot spots beneath the skin surface. These so-called hot
spots may represent a tumor or lesion, which does not dissipate
heat as rapidly because of its relatively poor blood circulation
(about {fraction (1/20)} of the blood flow through normal body
tissue). This method, of course, functions as a temporary
diagnostic tool, rather than a permanent means for delineating the
location of a tumor or lesion.
[0009] A method of identifying and treating abnormal neoplastic
tissue or pathogens within the body is described in U.S. Pat. No.
4,649,151 to Dougherty et al. In this method, a tumor-selective
photosensitizing drug is introduced into a patient's body, where it
is cleared from normal tissue faster than it is cleared from
abnormal tissue. After the drug has cleared normal tissue but
before it has cleared abnormal neoplastic tissue, the abnormal
neoplastic tissue may be located by the luminescence of the drug
within the abnormal tissue. The fluorescence may be observed with
low intensity light, some of which is within the drug's absorbance
spectrum, or higher intensity light, a portion of which is not in
the drug's absorbance spectrum. Once detected, the tissue may be
destroyed by further application of higher intensity light having a
frequency within the absorbance spectrum of the drug. Of course,
this method also is only a temporary means for marking the abnormal
tissue, since eventually the drug will clear from even the abnormal
tissue. Additionally, once the abnormal tissue has been destroyed
during treatment, the marker is destroyed as well.
[0010] It is also known to employ biocompatible dyes or stains to
mark breast lesions. First, a syringe containing the colorant is
guided to a detected lesion, using an imaging system. Later, during
the extraction procedure, the surgeon harvests a tissue sample from
the stained tissue. However, while such staining techniques can be
effective, it is difficult to precisely localize the stain. Also,
the stains are difficult to detect fluoroscopically and may not
always be permanent.
[0011] Additionally, it is known to implant markers directly into a
patient's body using invasive surgical techniques. For example,
during a coronary artery bypass graft (CABG), which of course
constitutes open heart surgery, it is common practice to surgically
apply one or more metallic rings to the aorta at the site of the
graft. This enables a practitioner to later return to the site of
the graft by identifying the rings, for evaluative purposes. It is
also common practice to mark a surgical site with staples, vascular
clips, and the like, for the purpose of future evaluation of the
site.
[0012] A technique has been described for the study of pharyngeal
swallowing in dogs, which involves permanently implanting steel
marker beads in the submucosa of the pharynx (S. S. Kramer et al, A
Permanent Radiopaque Marker Technique for the Study of Pharyngeal
Swallowing in Dogs, Dysphagia, Vol. 1, pp. 163-167, 1987). The
article posits that the radiographic study of these marker beads
during swallowing, on many occasions over a substantial period of
time, provides a better understanding of the pharyngeal phase of
degluitition in humans. In the described technique, the beads were
deposited using a metal needle cannula having an internal diameter
slightly smaller than the beads to be implanted. When suction was
applied to the cannula, the bead sat firmly on the tip. Once the
ball-tipped cannula was inserted through tissue, the suction was
broken, thereby releasing the bead, and the cannula withdrawn.
[0013] Of course, this technique was not adapted or intended to
mark specific tissue sites, but rather to mark an entire region or
structure of the body in order to evaluate anatomical movements
(i.e. swallowing motions). It also was not intended for use in
humans.
[0014] Accordingly, what is needed is a method and device for
non-surgically implanting potentially permanent markers at the
situs of a lesion or other abnormal tissue, for the purpose of
defining the margins of a lesion before it is removed and/or to
establish its location after it has been removed. The markers
should be easy to deploy and easily detected using state of the art
imaging techniques.
SUMMARY OF THE INVENTION
[0015] This invention solves the problems noted above by providing
an implantable device which is particularly adapted to mark the
location of a biopsy or surgery for the purpose of identification.
The device is remotely delivered, preferably percutaneously.
Visualization of the marker is readily accomplished using various
state of the art imaging systems. Using the invention, it is
possible to permanently mark the location or margins of a lesion or
other tissue site, prior to removing or sampling same. The markers
function to provide evidence of the location of the lesion after
the procedure is completed, for reference during future
examinations or procedures.
[0016] More particularly, a device is provided for marking tissue
within a human body to identify a selected location for a
diagnostic or therapeutic procedure. The device comprises a marker
element and an apparatus for remotely delivering the marker element
from outside the human body to the selected tissue location. Since,
with remote delivery (e.g. percutaneously) direct visual access is
not possible, an aided visualization device is used, such as an
imaging system, an endoscope, or the like. Deployment of the marker
element is such that it becomes implanted in the tissue.
[0017] The delivery apparatus preferably includes a member, which
may comprise a tube, such as a needle, cannula, or trocar, of any
known type for delivering medications, surgical equipment, or other
items to the interior of a patient's body. The member may also be
the body of an optical instrument such as an endoscope,
laparoscope, or arthroscope. In the preferred embodiment, a biopsy
needle or gun, such as is often used to extract tissue for
examination in a biopsy procedure, is used in conjunction with the
marking device, comprising a portion of the delivery apparatus, in
order to provide a means for entering the patient's body and
positioning the marker element at the selected tissue location.
However, in other embodiments, the marking device is self
contained, having a means itself for obtaining entry to the body,
and being guided by a commercially available guidance system, such
as a stereotactic guidance system.
[0018] The aforementioned member or tube, which typically comprises
a cannula or needle having a lumen, has a distal end portion or
region and a proximal end portion or region, and is adapted to
extend through the body. The distal region is adapted to retain and
deploy the marker element and the proximal region is linked to the
distal region, so that predetermined marker deployment functions
may be communicated from the proximal region to the distal region.
In some embodiments, these deployment functions are communicated by
means of the marker elements themselves travelling through the
lumen for deployment from the distal region. In other embodiments,
an actuator extends axially through the lumen to communicate
deployment functions to the marker element held on or by the distal
region. The apparatus is preferably guided to the selected tissue
location, i.e. the site of the detected lesion or other
abnormality, using a stereotactic guidance system or similar
imaging system.
[0019] Several alternative embodiments of the marking device are
disclosed. In one embodiment, the distal region of the tube
includes a forming die, which is adapted to form each marker
element into a predetermined shape, preferably a helix, as the
marker element is deployed from the lumen. In a number of
alternative embodiments, a mechanism, such as a mandrel, is used to
push the marker elements through the tube. The marker elements may
comprise a preformed spring having a predetermined shape, which is
compressed into a linear position within the tube lumen. Upon
deployment from the lumen, the spring is adapted to expand and
assume its predetermined shape to such an extent that the energy of
its expansion is sufficient to implant the marker element into the
tissue at the selected tissue location. In some embodiments,
implantation is accomplished because the marker elements have a
plurality of attachment elements, each having a tip end (sometimes
sharpened) which expands outwardly with sufficient energy to embed
and anchor itself into the tissue at the selected tissue location.
In other embodiments, the marker element has blunt, rather than
sharpened edges, but is adapted to expand sufficiently upon exiting
from the tube that its edges press radially against the selected
tissue, thereby wedging and implanting the marker element.
[0020] In yet another embodiment of the invention, the tube lumen
is adapted to receive a deployment actuator connector, or center
wire, which extends axially through the lumen. The connector
includes a distal portion which extends distally of the tube and a
proximal portion which extends proximally of the tube. The proximal
portion is attached to a deployment actuator, such as a pull ring,
while the distal portion is attached to the marker element. On the
connector, proximal to the distal portion, is a predetermined
failure point which is adapted to be the weak point on the
connector by failing fast under tension. In operation, once the
tube distal region has been positioned at the selected tissue
location, the deployment actuator is actuated in a proximal
direction to pull the marker element against the distal region of
the tube. The tube distal region thus functions as a forming die to
cause the marker element to bend until it abuts the tube distal
region at its junction with the distal portion of the connector,
such that the marker element is reconfigured to a desired shape.
The proximal portion of the connector is adapted to be severed from
the distal portion at the predetermined failure point upon the
application of continued tension on the deployment actuator after
abutment of the marker element against the tube distal region,
thereby releasing and implanting the marker element.
[0021] Another important feature of the invention is the ability to
utilize marker elements having a plurality of shapes. In some
embodiments, these shapes may be created merely by utilizing
different sized material stock or different cross sections. This
shape diversity permits the adoption of a system wherein each shape
denotes a different selected tissue location or event.
[0022] In a preferred embodiment of the invention, the device is
adapted to be employed in combination with a medical instrument
which transports the device to the selected tissue location
responsive to positional control by a guidance system. The medical
instrument preferably draws a vacuum to isolate and retain tissue
at the selected location in a tissue receiving port. The marking
device is adapted to deploy the marker element into the retained
tissue.
[0023] In another aspect of the invention, a marker element is
provided for marking tissue within a human body to identify a
selected location for a diagnostic or therapeutic procedure. The
marker element, which is preferably comprised of a biocompatible,
implantable, and substantially radiopaque material, is adapted to
be deployed to the selected tissue location percutaneously by a
delivery instrument, so as to become implanted in the tissue.
[0024] A number of different marker element configurations and
materials may be employed. Materials may include stainless steel,
titanium, and the like, as well as non-metallic materials, such as
polymers, salts, and ceramics, for example. In some embodiments,
the marker element may actually be formed into a desired shape by a
forming die in the delivery instrument, while in other embodiments,
it may comprise a spring which radially expands upon exit from the
delivery instrument to embed itself in the tissue.
[0025] In yet another aspect of the invention, a method for
permanently marking tissue in a human body to identify a selected
location for a diagnostic or therapeutic procedure is disclosed,
which comprises actuating a delivery instrument, having a tube with
a distal region, to a position wherein the tube extends through the
human body and the distal region is at the selected location. A
marker element is then deployed from the tube distal region to the
selected tissue location so that it becomes anchored in the
tissue.
[0026] These and other aspects and advantages of the present
invention are set forth in the following detailed description and
claims, particularly when considered in conjunction with the
accompanying drawings in which like parts bear like reference
numerals.
BRIEF DESCRIPTION OF THE DRAWING
[0027] FIG. 1 is a cross-sectional view of a biopsy instrument
embodiment as described in co-pending patent application Ser. No.
08/217,246, configured to be utilized as a preferred instrument for
use in conjunction with the inventive tissue marking device;
[0028] FIGS. 2 and 3 are cross-sectional views illustrating the
sequential steps in the operation of the biopsy instrument
embodiment needed to capture tissue targeted for marking;
[0029] FIG. 4 is a cross-sectional view of one embodiment of a
tissue marking device constructed in accordance with the principles
of the invention, illustrating the device in a first position in
preparation for delivering a marker to tissue targeted for
marking,
[0030] FIGS. 5, 6, 7, and 8 are cross-sectional views similar to
FIG. 4, illustrating sequentially the delivery of a marker to the
targeted tissue;
[0031] FIGS. 9, 10, and 11 are schematic cross-sectional views of
an alternative embodiment of a tissue marking device constructed in
accordance with the principles of the invention, illustrating
sequentially the delivery of a marker to the targeted tissue;
[0032] FIG. 12 is a schematic cross-sectional view illustrating a
third alternative embodiment of a tissue marking device constructed
in accordance with the principles of the invention;
[0033] FIG. 13 is a schematic cross-sectional view illustrating a
fourth alternative embodiment of a tissue marking device
constructed in accordance with the principles of the invention;
[0034] FIG. 14 is a schematic cross-sectional view illustrating a
fifth alternative embodiment of a tissue marking device constructed
in accordance with the principles of the invention;
[0035] FIG. 15 is a schematic cross-sectional view illustrating a
sixth alternative embodiment of a tissue marking device constructed
in accordance with the principles of the invention;
[0036] FIG. 16 is a schematic cross-sectional view illustrating a
seventh alternative embodiment of a tissue marking device
constructed in accordance with the principles of the invention;
[0037] FIG. 17 is a front elevation view of an alternative marker
element embodiment;
[0038] FIG. 18 is a perspective view of another alternative marker
element embodiment;
[0039] FIG. 19 is a front elevation view of yet another alternative
marker element embodiment; and
[0040] FIG. 20 is a front elevation view of still another
alternative marker element embodiment.
DETAILED DESCRIPTION OF THE INVENTION
[0041] Now with more particular reference to the drawings, FIGS.
4-8 illustrate sequentially the deposit of a marker into a desired
tissue location, utilizing a preferred embodiment of the invention.
Specifically, the marking instrument 10 comprises a marker element
12 which includes an umbrella end comprising a pair of attachment
members or wings 14 and 16, and a center wire 18. All three wires
14, 16 and 18 are joined at the distal end 20 of the center wire
18, preferably by welding. At the proximal end 22 of the center
wire is a deployment actuator or pull ring 24, which is preferably
attached by welding or brazing.
[0042] To place the marker element 12 at a desired location, a
biopsy needle or gun is preferably used, though other known
delivery means could be used as well. For example, the
stand-mounted biopsy instrument described in U.S. patent
application Ser. No. 08/117,246, previously incorporated by
reference into this application, is a preferred instrument for
introducing the marker element into the body of a patient. One
embodiment of such an instrument 26 is partially illustrated in
FIGS. 1-3. The biopsy instrument 26 includes a housing 28. A hollow
outer piercing needle 38 is attached to the housing 28 at location
34. A distal end of the hollow outer piercing needle 38 includes a
point 40. Hollow outer piercing needle 38 also includes a tissue
receiving port or bowl 42 (FIGS. 2 and 3). A cannular inner cutter
44 is movably positioned coaxially within the hollow outer piercing
needle 38 and housing 28. A vacuum line 46 supplies vacuum to ports
50 in the bottom of the receiving bowl 42.
[0043] Operation of the biopsy instrument to facilitate the
placement of a tissue marker is illustrated sequentially in FIGS.
1-3. FIG. 1 illustrates the distal end point 40 of the hollow outer
piercing needle 38 in position to pierce a target tissue 51. The
initial position of the point 40 with respect to the tissue area
being marked is determined by the overall position of the biopsy
instrument with respect to the patient. For example, the entire
biopsy instrument may be mounted on a commercially available
stereotactic guidance system (not shown) commonly used in the
medical field for accurate positioning of a variety of medical
devices with respect to a patient. A detailed description of such a
motorized biopsy needle positioner, i.e. stereotactic guidance
system, is given in U.S. Pat. No. 5,240,011, issued on Aug. 31,
1993 to Michael Assa, which is hereby incorporated herein by
reference. The suspect lesion within tissue 51 is to be targeted
and marked according to the instructions provided with the
stereotactic guidance system. As shown in FIG. 1, the stereotactic
guidance system has positioned the biopsy instrument 26 such that
the distal end point 40 is immediately adjacent to the surface of
the tissue 51. Once the point 40 is adjacent the specific lesion to
be marked, the needle 38 is fired into the lesion such that the
point 40 traverses through the lesion, thereby placing the tissue
receiving bowl 42 in the center of the lesion.
[0044] As shown in FIG. 2, after the hollow outer piercing needle
38 has been positioned at the precise location within the tissue 51
at which it is desired to mark tissue, the cutter 44 is moved
proximally of the housing 28 to provide an entry access for the
tissue marker delivery system.
[0045] As shown in FIG. 3, a vacuum source attached to vacuum line
46 is actuated, thereby generating a region of low pressure at the
vacuum ports 50 to facilitate the prolapse of tissue 51a
immediately adjacent to the tissue receiving port 42 into the
hollow interior of hollow outer piercing needle 38.
[0046] Now again referring to FIGS. 48, the marking instrument 10
includes a tube 54. The center wire 18 runs axially through a lumen
56 of the tube 54, with the pull ring 24 being attached to the
proximal end of the center wire 18, proximally of the tube 54. The
distal end 20 of the center wire extends distally of the tube 54
and is joined to attachment members 14 and 16, as described
above.
[0047] In operation, the tube 54 of the marking instrument is
inserted into the patient's body in the direction of the arrow 58,
as shown in FIG. 4, until the distal end 20 of the center wire 18
approaches the desired location, adjacent to or in the abnormal
tissue or lesion. Because direct visual access to the targeted
tissue is impossible, an aided visualization device, such as the
stereotactic guidance system described above, is used to guide the
distal portion of the making instrument to the targeted tissue.
Then, if the biopsy instrument shown in FIGS. 1-3 is utilized to
deploy the markers, the targeted tissue 51a (FIG. 5) is vacuumed
into the tissue receiving port 42. Referring particularly to FIG.
5, once the distal end 20 of the center wire reaches the targeted,
vacuumed tissue, the ring 24 is pulled away, from the tissue in the
direction of the arrow 60. This action deploys the marker
attachment members 14 and 16 as they are forced into a die formed
in the tip 62 of the tube. This die may take any desired form,
depending upon the desired deployed configuration of the attachment
members 14, 16.
[0048] With reference to FIG. 6, tension continues to be applied to
the ring 24, in the direction shown by the arrow 64, until the
distal end of the marker is fully deployed. Forcing the attachment
members into the die 62 causes them to extend outwardly, as
illustrated, into the tissue. Their outward energy anchors the
marker element 12 in the tissue for permanent implantation. The
tips 66 and 68 of the attachment members may be configured to be
less traumatic as an implant, or may alternatively be sharpened to
provide a more secure grip. At full deployment, the width of the
umbrella end of the marker element is preferably about 0.035 to
0.045 inches, though other sizes may be utilized within the scope
of the invention.
[0049] Now referring to FIG. 7, even after the attachment members
14 and 16 have been fully deployed, the pull ring 24 is pulled to
further increase tension in the direction of the arrow 70, until
the center wire 18 is sheared at a point of weakness or detent 72
(see FIGS. 4-6) which is established in the center wire 18
proximally of the tip 20. Once failure has occurred, the pull ring
24 and the proximal portion 18' of the center wire may be discarded
as they are severed from the marker element 12 and remaining distal
portion 18" of the center wire.
[0050] Finally, with reference to FIG. 8, to finish placing the
marker element 12, the tube 54 is withdrawn in the direction of the
arrow 74, as illustrated. The marker element is thereby permanently
secured to locate the lesion site for future examination by known
imaging methods.
[0051] In the preferred embodiment, the marker element 12 is
fabricated of stainless steel. However, many other biocompatible,
radiopaque, implantable materials may be used for the marker
element 12 as well, including, for example, titanium, tantalum, or
nickel-titaniun alloys. Additionally, while a 3-pronged umbrella
end is shown and described, any number of prongs may be used, if
desired.
[0052] While it is preferred that the marker element 12 be deployed
using the biopsy instrument described and shown in FIGS. 1-3, any
instrument capable of delivering the element percutaneously may be
utilized. Such instruments, for example, may include the hand-held
biopsy gun described in U.S. Pat. No. Re. 34,056, entitled "TISSUE
SAMPLING DEVICE" and issued to Lindgren et al. All of these types
of instruments include a tube (typically a cannula or needle) which
is adapted to enter the body, and would be capable of delivering
the marker element. It is also within the scope of the invention to
deliver the marker element through any tube which has access to the
body or using optical medical instruments, such as endoscopes,
arthroscopes, or laparoscopes, in which case the marker element is
delivered to the desired tissue site from outside the body of the
patient, through the body of the instrument.
[0053] Now with reference to FIGS. 9-11, an alternative embodiment
of a marking instrument 10a is shown, which is identical to the
instrument 10 in all respects not shown or described herein.
Portions of the instrument 10a corresponding to portions of the
instrument 10 are designated by corresponding reference numerals
followed by the letter a.
[0054] The FIG. 9 embodiment is substantially similar to the FIG. 4
embodiment, in that the marking instrument includes a tube 54a
which has a lumen 56a, and may utilize a cannula, needle, or
imaging instrument (i.e. endoscope, laparoscope, or the like) for
access to a delivery site within the body and to aid in delivery.
Again, as is the case for all succeeding embodiments, it is
preferred that the tube 54a utilize the hollow outer piercing
needle 38 of the biopsy instrument shown in FIGS. 1-8, though any
other instrument which is capable of delivering a marker
percutaneously or through a body orifice from a location outside
the patient's body may be utilized. A center wire 18a runs
longitudinally through the lumen 56a. At the proximal end of the
center wire 18a is a deployment actuator or pull ring 24a. At the
distal end of the center wire is the marker element 12a.
[0055] A primary difference between the FIG. 4 and FIG. 9
embodiments is that the FIG. 9 marker element 12a is preferably a
generally "U" shaped element resembling a surgical ligating clip,
having tips 66a and 68a, which is captured by the distal looped end
20a of the twisted center wire. In operation, once the tips 66a and
68a of the marking element 12a reach the targeted tissue, the ring
24a is pulled rightwardly in the direction of the arrow 76 (FIG.
10). This action retracts the base portion 78 of the marker element
12a into a forming recess 80 (FIG. 9), wherein the recessed tube
wall 82 forces prongs 86 and 88 together until tips 66a and 68a of
the prongs 86 and 88, respectively, contact or nearly contact one
another (FIG. 10). At this point, increasing tension applied to the
pull ring 24a causes the wire 18a to fail at a point of weakness or
detent (not shown) provided in the center wire at or near its tip
end 20a, thereby releasing the marker into the target tissue, as
illustrated in FIG. 11.
[0056] Referring now to FIG. 12, a second alternative embodiment of
a marking instrument 10b is shown, which is identical to the
instrument 10 in all respects not shown or described herein.
Portions of the instrument 10b corresponding to portions of the
instrument 10 are designated by corresponding reference numerals
followed by the letter b.
[0057] The FIG. 12 embodiment is substantially similar to the FIG.
4 embodiment, in that the marking instrument includes a tube 54b
which has a lumen 56b, and may utilize a cannula, needle, or
imaging instrument (i.e. endoscope, laparoscope, or the like) for
access to delivery site within the body and to aid in delivery.
[0058] There are two primary differences between the embodiments of
FIGS. 4 & 9 and that of FIG. 12. First, in the FIG. 12
embodiment, a plurality of marker elements 12b (two are shown,
though any number may be employed) may be preloaded into the tube
54b, each comprising a pre-formed spring which is deployed through
the tube's distal region 90 in an axial direction. Second, the
nature of the deployment mechanism utilizes a compressive rather
than tensile force. It may further be noted that, though end
deployment of the marker elements in the FIG. 12 embodiment is
illustrated, they may be similarly deployed radially through a side
port (not shown) in tube 54b, or at any other angle, to accommodate
delivery through an existing instrument (i.e. cannula, needle,
endoscope, laparoscope, or the like). In being deployed radially,
the distal region 90 is not used for passage of the marker element
and could be utilized to house a piercing element (not shown)
similar to that shown in FIGS. 1-3. Armed with the piercing
element, this marker delivery system would not be dependent on a
positioning system as described in FIGS. 1-3 for placement at the
tissue site and could be used alone in conjunction with a
commercially available stereotactic or other guidance system. This
concept may be applied to all subsequent embodiments except that
illustrated in FIG. 16.
[0059] Still with reference to FIG. 12, each marker element or
spring 12b preferably includes a center coil 92 from which a pair
of attachment members 94 and 96 extend, and is adapted to
automatically attach itself to the target tissue by utilizing its
own stored energy. Thus, in operation, each spring 12b is held in a
compressed position within the tube 54b. When it is desired to
deploy the marker, a mandrel 98 is preferably utilized to push the
spring 12b through the center lumen 56b and out through the distal
open end 90 of the tube. Once the spring exits the tube, stored
energy causes the attachment members 94 and 96 to expand outwardly,
as shown. As this expansion occurs, the tips 102 and 104 of the
attachment members 94 and 96, respectively, anchor themselves into
the tissue to permanently secure the marker element in the desired
location. As with the FIG. 4 embodiment, the tips 102 and 164 may
be blunt to be less traumatic as an implant, or may alternatively
be sharpened or barbed to provide a more secure grip. Once a spring
has been deployed, the instrument may be repositioned to the next
desired location for the immediate deployment of another marker
until the supply in the tube 54b is exhausted, eliminating the need
to remove and re-load the marking instrument 10b between each
deployment.
[0060] Again in this embodiment, the spring 12b may be fabricated
of any known biocompatible, implantable, radiopaque material,
though stainless steel is preferred. Additionally, the forces
required to deploy the attachment members on the spring may be
customize by varying the spring filar, dimensions, material, and/or
the number of coils in the torsional part of the spring.
[0061] FIG. 13 illustrates another alternative embodiment of the
marking instrument 10, which is identical to the instrument 10b of
FIG. 12 in all respects not shown or described herein. Portions of
the instrument 10c corresponding to portions of the instrument 10b
of FIG. 12 are designated by corresponding reference numerals
followed by the letter c.
[0062] In actuality, the FIG. 13 embodiment is substantially
identical to that of FIG. 12, except for the shape of each spring
12c, and is employed in precisely the same manner. Thus, to deploy
a marker element 12c, the mandrel 98c is utilized to push the
spring 12c through the center lumen 56c and out through the distal
open end 90c of the tube. As in the FIG. 12 embodiment, the marker
element travels in the direction of the arrow 100c, until the
attachment members 94c and 96c extend outwardly sufficiently to
anchor themselves to the target tissue. Also, the FIG. 13
embodiment is similar to the FIG. 12 embodiment in that the
instrument may be repositioned to immediately deploy another marker
element without re-loading, and marker elements may be deployed
radially through a side port in tube 54c (not shown), or any other
angle, to accommodate delivery through an existing instrument (i.e.
cannula, needle, endoscope, laparoscope, or the like).
[0063] FIG. 14 shows still another alternative embodiment of the
marking instrument 10, which is also substantially identical to the
instrument 10b of FIG. 12 in all respects not shown or described
herein. Portions of the instrument 10d corresponding to portions of
the instrument 10b of FIG. 12 are designated by corresponding
reference numerals followed by the letter d.
[0064] Again, the FIG. 14 embodiment is substantially identical to
those of FIGS. 12 and 13, except for the shape of the marker
element or spring 12d. A marker element 12d is deployed preferably
using a mandrel 98d or the like to push the spring 12d through the
center lumen 56d until it exits through the open end 90d of the
tube. As in the FIGS. 12 and 13 embodiments, the marker element
travels in the direction of the arrow 100d, until the tips 102d and
104d extend outwardly sufficiently to anchor themselves to the
target tissue.
[0065] In practice, a radiologist or other operator of the
equipment can use a marker shaped like marker 12b, as shown in FIG.
12, during one biopsy, then use a differently shaped marker, such
as the marker 12c in the FIG. 13 embodiment, or the marker 12d in
the FIG. 14 embodiment, during a subsequent biopsy procedure. The
differently shaped markers permit the distinction between different
biopsy procedures during future imaging procedures, as well as
between biopsy sites which may be close in proximity, thereby
improving the information available to the radiologist and thus the
ability to monitor or diagnose the patient's future condition more
precisely.
[0066] FIG. 15 illustrates yet another alternative embodiment of
the marking instrument 10, which is also substantially identical to
the instrument 10b of FIG. 12 in all respects not shown or
described herein. Portions of the instrument 10e corresponding to
portions of the instrument 10b of FIG. 12 are designated by
corresponding reference numerals followed by the letter e.
[0067] In this embodiment, each marker element 12e is deployed
distally through the open distal region 90e of the tube 54e by a
mandrel 98e, much as in the previous embodiments shown in FIGS. 12,
13, and 14. The primary difference, however, between this
embodiment and the previous embodiments is that, while the marker
elements in the previous embodiments rely largely on the barbed
nature of the spring to secure themselves in the tissue, in this
embodiment, the springs are secured simply because of their
significant expansion upon exit from the tube. This embodiment
particularly lends itself to marking the boundaries of a biopsy or
other desired site by defining the perimeter of the site. The
expansion of the spring 12e causes the blunt edges 102e and 104e to
press outwardly against the selected tissue, thereby wedging the
spring securely into position.
[0068] An advantage of this embodiment is that, because of the
tight compression of the springs 12e within the tube 54e, a larger
number of markers can be inserted therein simultaneously, thereby
permitting the deployment of more markers without having to pause
and disengage to re-load.
[0069] Another advantage the FIG. 15 embodiment provides is the
ability to deploy springs adapted to expand to a number of
different sizes all from the same lumen. Lager sized springs would
require more coils within a given lumen than smaller sized springs
(not shown).
[0070] It should be noted that the springs need not be limited to
the configuration illustrated, but could include any spring of any
configuration which expands to secure its position. While stainless
steel is presently preferred, any other biocompatible, implantable,
and radiopaque material could be used alternatively. Also as in the
previous embodiments, marker elements may be similarly deployed
radially through a side port in tube 54e (not shown), or any other
angle, to accommodate delivery through an existing instrument (i.e.
cannula, needle, endoscope, laparoscope, or the like).
[0071] Still another alternative embodiment of the marking
instrument 10 is shown in FIG. 16. In this embodiment, the marking
instrument 10f comprises a tube 54f. Wire segments 106 of any
desired length are preloaded into the lumen 56f, which runs along
substantially the entire length of the tube 54f Once the needle is
properly positioned, the marker elements 12f are deployed by
pushing them out of the tip of the needle, through the side exit
port 108. A curved portion 110 of the lumen 56f comprises a die
portion, and is adapted to form the wire segments 106 into helical
marker elements 12f as they pass therethrough, pushed by a mandrel
(not shown) or other known means from the tip of the needle through
the exit port 108. The nature of the curve or curves in the die
portion 110 and preformed curves imparted into the wire segments
determine the final shape (which resembles a partial or whole
helix) and dimensions of the marker element.
[0072] This embodiment is versatile in that it is capable of
continuously deploying any number of marker elements without the
necessity of re-loading, since all that is required is a continuous
feed of wire segments into the proximal region of the tube 54f.
Furthermore, differently sized and shaped helixes may be delivered
in the same procedure by utilizing marker wires of different
diameters and/or preformed curves, which approximate different
helical shapes as they pass through the die portion. Thus, loading
a plurality of different sized wires into the needle yields a
plurality of different shaped markers.
[0073] Of course, as with the previous embodiments, although
stainless steel is presently preferred, many different types of
biocompatible, implantable, and radiopaque materials could be
utilized within the scope of the invention. Also as in the previous
embodiments, marker elements may be similarly deployed at different
angles to accommodate delivery through an existing instrument (i.e.
cannula, needle, endoscope, laparoscope, or the like).
[0074] Unlike previous embodiments, FIG. 16 preferably incorporates
a piercing element 112 enabling this marker to be delivered without
the aid of the positioning system described in FIGS. 1-3 for
placement at the tissue site. This embodiment could be used alone
in conjunction with a commercially available stereotactic or other
(i.e. ultrasonic) guidance system.
[0075] Though a number of different embodiments of the conceptual
invention have been described and shown, it is considered to be
within the scope of the invention for the marking elements and
delivery instruments to take on many other forms. For example,
embolization coils like that illustrated in FIG. 17 and designated
with reference numeral 12g are well known in the medical field for
placement into vessels such as veins and arteries in order to block
off fluid flow abnormalities (such as fistulas and arteriovenous
malformations). These coils have been made of various materials,
including stainless steel, platinum, and gold, and are wound into
configuration similar to that of a light bulb filament. They are
generally placed into the body using a catheter or trocar system.
The inventors in the present application have discovered that such
coils may indeed also be used as marker elements, for permanent
implantation in target tissue, in a manner similar to that
described previously with respect to FIGS. 1-16.
[0076] Marker elements of many other materials and configurations
may be used as well. For example, one such multi-appendaged
jack-shaped marker 12h is illustrated in FIG. 18. Additionally,
small beads 12i (FIG. 19) of calcium carbonate or other radiodense
materials, which are highly visible by mammographic imaging, could
be deployed as marker elements. One such application would be to
place a plurality of such beads or pellets (each having a diameter
of about 500.mu.) around the entirety of a breast lesion prior to
the extraction procedure, which would then serve as guides to
ensure that all of the margins had been removed. During subsequent
imaging procedures, they would function to denote the location of
the previous biopsy for reference purposes.
[0077] Referring now to FIG. 20, yet another alternative marker
element 12j, which is of a woven construction, is illustrated.
Other such marker materials may include adhesives and epoxies which
would be injected at the biopsy site. Biodegradable polymers and
other plastics could also be used, as long as they are
biocompatible, implantable, and visible using an imaging
system.
[0078] While this invention has been described with respect to
various specific examples and embodiments, it is to be understood
that the invention is not limited thereto and that it can be
variously practiced within the scope of the following claims.
* * * * *