Surgical needle abstract
A surgical needle including a cannula, hook-wire and reinforcement
member for use in the manual location and marking of a lesion in
a mass of soft tissue. The cannula rigidly supports the hook-wire
during insertion into the soft tissue, and has a substantially cylindrical,
hollow shaft and a cutting point located at an insertion end. The
surgical needle further includes an anchor for restrainably locating
the hook-wire proximate the lesion which is capable of springedly
assuming a substantially acute angle relative to the remainder of
the hook-wire. Reinforcement minimizes the potential for breakage
of the hook-wire within the mass of soft tissue, after extension
of the hook-wire beyond the insertion end of the cannula; in which
the hook-wire is substantially D-shaped and closely approximates
the diameter of the substantially cylindrical, hollow shaft; maximizing
the structural size and integrity of the hook-wire to minimize the
occurrence of breakage.
Surgical needle claims
What is claimed is:
1. A surgical needle for use in the location and marking of a lesion
in a mass of soft tissue, said surgical needle comprising:
cannula means for manual insertion into the mass of soft tissue,
said cannula means having a substantially cylindrical shaft defining
a substantially hollow void region within said shaft, a cutting
point located at an insertion end and a second end opposite said
insertion end, said cannula means having a longitudinal axis;
hook-wire means positioned within said cylindrical shaft of said
cannula means for flexibly marking the lesion in the mass of soft
tissue, said hook-wire means including a hook-wire member;
said cannula means further serving to rigidly support said hook-wire
means during insertion into the mass of soft tissue, said hook-wire
means being capable of telescopically extending out of said cannula
means at and beyond said insertion end;
said hook wire means further including anchoring means for restrainably
locating said hook-wire member proximate the lesion in the mass
of soft tissue, said anchoring means including a hook member, said
hook member being capable of springedly assuming a substantially
acute angle relative to said hook-wire member upon extension of
said hook-wire means from said cannula means, said cannula means
being wholly removable from said anchoring means following location
and marking of the lesion by said hook-wire means;
said hook member overlaying at least a portion of said hook-wire
member, said portion comprising a hook overlay region; and
reinforcement means for minimizing the potential for breakage of
said hook-wire means within the mass of soft tissue after extension
out of and beyond said insertion end of said cannula means, said
reinforcement means including said hook member and at least said
hook overlay region of said hook-wire member, each having substantially
D-shaped cross-sections including a substantially flat side and
a substantially cylindrical side opposite said substantially flat
side,
said substantially D-shaped cross-sections serving to maximize
that portion of said substantially hollow void region within said
shaft, which may be occupied simultaneously by said hook overlay
region and said hook member prior to said extension of said hook-wire
means,
said reinforcement means further including said hook overlay region
and said hook member each having widths, defined at said substantially
flat side of each and substantially perpendicular to said longitudinal
axis, closely approximating the diameter of said substantially hollow
void region, so as to further maximize the structural size and integrity
of said hook overlay region and hook member, to minimize the occurrence
of breakage therebetween, and
said hook member and said hook overlay region, each having said
D-shaped cross-sections juxtaposed to one another at their respective
flat sides, prior to said extension, and further meeting at a fold-point
projectable out of and beyond said insertion end of said cannula
means.
2. The invention according to claim 1 wherein said reinforcement
means further comprises stress relocation means for relocating physical
stress which may occur upon the assertion of forces along said hook-wire
member, to a position displaced from said fold-point, between said
hook overlay region and hook member, so as to further minimize the
occurrence of breakage at said fold-point.
3. The invention according to claim 2 wherein said stress relocation
means comprises a weld bonding portions of said two overlapped D-shaped
cross-sections of said hook overlay region and hook member to each
other, thereby forming a region, to accommodate said physical stresses,
isolated from said fold-point.
Surgical needle description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to surgical equipment
and, in particular, to a surgical needle inserted into a mass of
soft tissue for location and marking of a lesion using various radiographic
techniques to later assist a doctor in locating the lesion during
surgery.
2. Background Art
Localization needles have long been used in localizing and marking
lesions in a mass of soft tissue, such as breasts, prostrates, livers,
and muscle tissue to assist doctors in surgery (exploratory and
otherwise). These localization needles are manually inserted into
the mass of soft tissue while a doctor observes its location and
progress through various radiographic techniques including, for
instance, mammography, computerized tomography (CAT scan), fluoroscopy,
standard x-ray, ultrasound and magnetic resonance imaging (MRI).
One type of needle, termed a "Kopans" needle, utilizes
a single flexible hook-wire in marking the lesion. The hook-wire
is introduced into the soft tissue sheathed within a rigid cannula.
Once the localization needle is proximate the lesion, the doctor
telescopically extends the flexible hook-wire out from the rigid
cannula into the mass of soft tissue. A portion of the flexible
hook-wire was previously fashioned into a hook, such that the hook-wire
can be anchored proximate the lesion to aid in the location of the
lesion during surgery. The exposed hook-wire is then often taped
to the exposed skin of the patient.
Another type of localization needle is disclosed in U.S. Pat. No.
5031634 to Simon. Simon discloses a biopsy needle guide device
containing two hook-wires within a cannula interconnected such that
the hook-wires--which telescope through the side wall of the cannula,
can be engaged and disengaged from the soft tissue to provide for
readjustability. Each of the two hook-wires have D-shaped cross-sections,
which together almost fill the cannula.
One shortcoming of the Kopans localization needle is its propensity
to fracture while a doctor attempts to anchor it within the soft
tissue. Such breakage results in a portion of the hook-wire remaining
within the soft tissue, which then must be removed through difficult
and costly surgery. Another shortcoming of the Kopans localization
needle is the difficultly in locating the hook-wire during surgery
due to its small diameter.
One further shortcoming of the prior art Simon needle is its non-severable
construction, which forces the cannula to remain seated within the
soft tissue unit completion of the surgical location process.
It is thus an object of the present invention to provide a surgical
needle for the location and marking of lesion within a mass of soft
tissue, which is reinforced so as to minimize the occurrence of
breakage.
It is an associated object of the present invention to provide
a more easily locatable hook-wire member to aid in location during
surgery.
It is thus a further object of the present invention to provide
a surgical needle having a removable cannula, which can be removed
after location of the lesion with the soft tissue and deployment
of the hook-wire--one which resists breakage typically occurring
at the hook-wire fold-point
These and other objects of the present invention will become apparent
in light of the present specification, claims and drawings.
SUMMARY OF THE INVENTION
The present invention comprises a surgical needle for use in the
manual location and marking of a lesion in a mass of soft tissue.
The surgical needle comprises cannula means, hook-wire means, anchoring
means and reinforcement means, which, in combination, substantially
minimize the occurrence of breakage of the hook-wire means during
insertion, anchoring and surgery.
The cannula means rigidly supports the hook-wire means during insertion
and initial location of the surgical needle into and within the
mass of soft tissue, providing a substantially cylindrical shaft
with a substantially hollow void region, a cutting point located
at an insertion end and a second end opposite said insertion end.
The hook-wire means comprises a hook-wire member used for flexibly
marking the lesion in the mass of soft tissue. The hook-wire means,
which is initially positioned within the substantially cylindrical
shaft of the cannula means, telescopically extends out of the cannula
means at and beyond the insertion end. The cannula means is wholly
removable from the mass of soft tissue and from the located hook-wire
means following location and marking of the lesion by the hook-wire
means.
The surgical needle further comprises anchoring means for restrainably
locating the hook-wire member proximate the lesion in the mass of
soft tissue. The anchoring means includes a hook member capable
of springedly assuming a substantially acute angle relative to the
remainder of the hook-wire member upon extension of the hook-wire
means from the cannula means. Prior to extension, the hook member
overlays at least a portion of the remainder of the hook-wire member
which portion comprises a hook overlay region.
The surgical needle further includes reinforcement means for minimizing
the potential for breakage of the hook-wire means within the mass
of soft tissue after upon the hook-wire means being extended out
of and beyond the insertion end of the cannula means. The reinforcement
means are integrated into that portion of the hook member overlaying
the hook-wire member and at least the hook overlay region of the
hook-wire member.
In a preferred embodiment, the reinforcement means includes the
hook-wire member and the hook overlay region each having a substantially
D-shaped cross-section including a substantially flat side and a
substantially cylindrical side opposite the substantially flat side.
The substantially D-shaped cross-section serves to maximize the
space which may be occupied simultaneously by the hook overlay region
and the hook member within the substantially hollow void region
prior to extension of the hook-wire means. In another preferred
embodiment the entirety of the hook-wire means has a substantially
D-shaped cross-section; substantially the same cross-sectional configuration
as that of the hook-member and hook overlay region.
In this embodiment, the reinforcement means further includes the
hook overlay region and hook member each having widths closely approximating
the diameter of the substantially hollow void region, so as to further
maximize the structural size and integrity of the hook overlay region
and hook member to minimize the occurrence of breakage therebetween.
In this embodiment, the hook member and hook overlay region each
have their D-shaped cross-sections juxtaposed to one another at
their respective flat sides prior to extension from the cannula
means; further meeting at a fold-point projectable out of and beyond
the insertion end of the cannula means.
In one embodiment of the surgical needle, the reinforcement means
further comprises stress relocation means for relocating physical
stress which may occur upon the exertion of forces along the hook-wire
member. This stress relocation means is positioned proximate to
but displaced away from the original, previously worked fold-point
so as to further minimize the occurrence of breakage at the relatively
fragile fold-point. In this embodiment, the stress relocation comprises
a weld capable of bonding portions of the two overlapped D-shaped
cross-sections to each other, thereby forming a region to accommodate
the physical stresses at a position isolated from the fold-point.
In an alternative preferred embodiment, the reinforcement means
solely comprises stress relocation means for relocating physical
stresses which may occur upon the exertion of forces along the hook-wire
member, to a position proximate to yet distanced from the fold-point.
In this embodiment the hook-wire need not be of substantially D-shaped
cross-section and thus, the stress relocation may be accomplished
by welding portions of the hook-wire member to each other thereby
forming a relocated region to accommodate the physical stresses
isolated from the fold-point.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 of the drawings is an elevated side view of a prior art
Kopans biopsy localization needle;
FIG. 2 of the drawings is a top view of a prior art Kopans biopsy
localization needle;
FIG. 3 of the drawings is a cross-sectional elevated front end
view of a prior art Kopans biopsy needle illustrating the substantially
cylindrical cross-sections of the hook-wire member which prevents
the Kopans hook-wire from having a width closely approximating the
diameter of the void region of the cannula;
FIG. 4 of the drawings is an enlarged fragmentary view of a prior
art Kopans biopsy needle illustrating a stress fracture which may
occur at the fold-point, on either the inside or outside of the
fold-point, upon assertion of forces along the needle;
FIG. 5 of the drawings is an elevated side view of the hook-wire
means of applicants' surgical needle showing, in particular, the
hook member of the anchoring means assuming a substantially acute
angle relative to the remainder of the hook-wire member, with relocation
of the potential bend region away from the original hook fold-point;
FIG. 6 of the drawings is an enlarged elevated side view of the
hook-wire means of applicants' surgical needle showing, in particular,
the result of forces exerted along the hook-wire member, to prompt
bending at a position displaced away from the fragile hook fold-point;
FIG. 7 of the drawings is an enlarged elevated side view of FIG.
6 showing, in particular, a weld capable of bonding portions of
the hook member and hook overlay region, to create a new bending
region to accommodate exerted stresses, one which is isolated from
the fold-point;
FIG. 8 of the drawings is a bottom plan view of applicants' surgical
needle showing, in particular, a portion of the cannula means having
the hook-wire means partially enshrouded therein, prior to extension;
FIG. 9 of the drawings is an enlarged perspective view of applicants'
surgical needle showing, in particular, the hook-wire means telescopically
extending out of the cannula means at and beyond its insertion end;
FIG. 10 of the drawings is a front, cross-sectional view of applicants'
surgical needle of FIG. 8 taken along line 10--10 and looking in
the direction of the arrows, particularly, showing the substantially
D-shaped cross-section of the hook member and hook overlay region
in one preferred embodiment of the invention; and
FIG. 11 of the drawings is a front, cross-sectional view of applicants'
surgical needle of FIG. 8 taken along line 11--11 and looking in
the direction of the arrows, particularly showing, the remainder
of the hook-wire means as having a substantially D-shaped cross-section,
with substantially the same width as the hook overlay region.
DETAILED DESCRIPTION OF THE DRAWINGS
While this invention is susceptible of embodiment in many different
forms, several specific embodiments are shown in the drawings and
will herein be described in detail, with the understanding that
the present disclosure is to be considered as an exemplification
of the principles of the present invention and is not intended to
limit the invention to the embodiments illustrated.
A "Kopans" prior art surgical localization needle 10
is shown in FIGS. 1 through 4 of the drawings. The Kopans surgical
localization needle 10 comprises flexible, cylindrical hook-wire
11 cannula 12 and hook portion 13. The hook is formed when portion
13 of hook-wire 11 is bent over portion 14 of hook-wire 11 which
hook serves to restrainably locate hook-wire 11 within the mass
of soft tissue. As described above, the Kopans surgical localization
needle 10 is inserted into a mass of soft tissue with hook-wire
11 contained within cannula 12. Hook-wire 11 is capable of telescopic
extension out of cannula 12 such that it can be restrainably located
proximate a lesion within the mass of soft tissue. Due to the overlap
of portions 13 and 14 of hook-wire 11 and the cylindrical cross-sections
thereof, the diameter of hook-wire 11 must be sufficiently small
such that both portions of hook-wire 11 can fit one on top of the
other, within hollow shaft 12a of cannula 12. As can be seen with
reference to FIG. 3 the small diameter required to fit hook-wire
11 within cannula 12 given its cylindrical cross-section results
in a substantial amount of unutilized space within hollow shaft
12a of cannula 12. More importantly though, the small diameter makes
hook-wire 11 more fragile and more difficult to electronically locate
within the mass of soft tissue during surgery.
The hook in the Kopans localization needle 10 is often formed by
bending portion 13 of hook-wire 11 over portion 14 of hook-wire
11 in a looping motion, such that there is substantial elliptical
displacement between portion 13 and portion 14 of hook-wire 11 upon
completion. The process of bending hook-wire 11 stresses, region
15 thus creating a weak "preworked" fragile area within
hook-wire 11 where breakage would then be more apt to occur. This
"looping" into the desired shape by cold working surgical
stainless steel hook-wire 11 tends to prompt stress fracturing,
as shown in FIG. 4 more at the folded region than at other locations
along hook-wire 11. Due to the smaller diameter of cylindrical hook-wire
11 such that both components of it can fit within cannula 12 and
the stress fracturing problem, the possibility of breakage due to
torque or linear forces about fold region 15 increases; potentially
resulting in portion 13 separating from portion 14 of hook-wire
11 within the mass of soft tissue.
After telescopic extension of hook-wire 11 out of cannula 12 and
into the mass of soft tissue and removal of the cannula, the practitioner
may pull on the external end of hook-wire 11 to restrainably locate
hook-wire 11 proximate the lesion. The force created by the manual
pulling of hook-wire 11 may be represented by arrow 20. Inasmuch
as hook-wire 11 is surrounded by soft tissue during the assertion
of force 20 the soft tissue will exert force 21 upon portion 13
of hook-wire 11. Force 21 can often result in further bending and
elliptical displacement of portion 13 about region 15; with the
resulting torque about region 15 in turn, causing a severing or
fracture of portion 13 from portion 14 of hook-wire 11.
Applicants' surgical needle 100 is shown in FIGS. 5 through 11
of the drawings. Surgical needle 100 which is also used in the
location and marking of a lesion in a mass of soft tissue, includes
cannula means 101 hook-wire means 102 anchoring means 121 and
reinforcement means. Surgical needle 100 is utilized by the doctor
in the same manner described above, however, due to its structural
features and mode of operation, the potential for breakage of hook-wire
means 102 is substantially minimized and the ability to locate hook-wire
means 102 within the mass soft tissue is increased.
As shown in FIGS. 8 and 9 cannula means 101 which rigidly supports
hook-wire means 102 can be manually inserted into a mass of soft
tissue. Cannula means 101 has a substantially cylindrical shaft
with a substantially hollow void region, cutting point 104 located
at the insertion end of cannula means 101 and a second end 105 opposite
the insertion end. Cannula means 101 which in a preferred embodiment
is fabricated of surgical stainless steel, is inserted into the
mass of soft tissue with cutting point 104 leading the penetration.
During insertion, hook-wire means 102 is positioned within the
cylindrical shaft of cannula means 101. Hook-wire means 102 flexibly
marks the lesion in the mass of soft tissue under the guidance of
a medical practitioner who views the progress of cannula means 101
(and hook-wire means 102 disposed therein) toward the lesion within
the mass of soft tissue through various radiographic techniques.
As cannula means 101 approaches and becomes proximate to the lesion,
a doctor may telescopically extend hook-wire means 102 out of cannula
means 101 at and beyond insertion end 104 thus locating and marking
the lesion by hook-wire means 102. A doctor may then remove cannula
means 101--which had served to rigidly support hook-wire means 102
during insertion into the mass of soft tissue and location therewithin--from
the mass of soft tissue, thus leaving only hook-wire means 102 disposed
within the mass of soft tissue. In a preferred embodiment, hook-wire
means 102 will be of sufficient length such that a portion of hook-wire
means 102 remains exposed outside the mass of soft tissue, and outside
the patient. This exposed portion may be taped to the skin of the
patient for stabilization.
Hook-wire means 102 comprises hook-wire member 110 preferably
formed of surgical stainless steel, anchoring hook member 121 hook
overlay region 103 and various reinforcement means. Anchoring means
hook member 121 with hook point 124 restrainably locates hook-wire
means 102 in the mass of soft tissue. Anchoring means hook member
121 which--upon extension of hook-wire means 102 from cannula means
101--is capable of springedly assuming a substantially acute angle
relative to the remainder of hook-wire means 102 shown in FIGS.
5 through 9. Hook member 121 overlays at least a portion of the
remainder of hook-wire member 110 at hook overlay region 103.
Surgical needle 100 further comprises reinforcement means which
minimizes the potential for breakage of hook-wire means 102 within
the mass of soft tissue after extension out of and beyond insertion
end 104 of cannula means 101. The reinforcement means includes hook
member 121 (overlaying hook overlay region 103) and hook overlay
region 103 each having substantially D-shaped cross-sections as
shown in FIGS. 9 through 11. As shown in FIGS. 9 and 10 the substantially
D-shaped cross-sections of hook member 121 and hook overlay region
103 include substantially flat sides 121a and 103a respectively,
with substantially cylindrical sides opposite thereto at 121b and
103b, respectively.
The substantially D-shaped cross-sections, as shown in FIG. 10
serve to maximize the space which may be occupied simultaneously
by hook member 121 and hook overlay region 103 within the substantially
hollow void region of cannula means 101. In FIG. 10 it can further
be seen that due to the substantially D-shaped cross-section, the
widths of hook member 121 and hook overlay region 103 may closely
approximate the diameter of the substantially hollow void region
of cannula means 101 so as to further maximize the structural size
and integrity of at least hook member 121 and hook overlay region
103 if not the entirety of hook-wire means 102 thus minimizing
the occurrence of breakage over the Kopans needle having cylindrical
cross-section hook-wire 11 utilizing a smaller diameter wire 11
such that hook-wire 11 could fit within cannula 12.
In another preferred embodiment of surgical needle 100 the entirety
of hook-wire means 102 including hook-wire member 110 has a substantially
D-shaped cross-section, which may have the same width as hook overlay
region 103 and hook member 121. However, given that the width constraint
is determined by the simultaneous occupation of cannula means 101
by both hook member 121 and hook overlay region 103 hook-wire member
110 the portion of hook-wire means 102 extending beyond such portions,
could also be cylindrical in cross-section.
In one preferred embodiment, the reinforcement means further comprises
stress relocation means 130 comprising a bonding weld which relocates
physical stress which may occur upon the assertion of forces along
hook-wire means 102. As shown FIG. 7 stress relocation means 130
is positioned proximate to and extending from fold-point 122 between
hook member 121 and hook overlay region 103 so as to further isolate
any region where bending can occur, to minimize the occurrence of
breakage at fold-point 122. Stress relocation means 130 functions
such that if excessive forces are exerted upon hook-wire means 102
rather than prompt breakage at fragile fold-point 122 hook-wire
means 102 may be bent back at region 123 not previously preworked
to form a fold, as shown in FIGS. 6 and 7; thus preventing severing
of a portion of hook-wire means 102.
In the preferred embodiment, stress relocation means 130 may comprise
a weld between at least a portion of hook member 121 and hook overlay
region 103 capable of bonding portions of overlapped substantially
D-shaped cross-sections 121 and 103 to each other, thus protecting
fold-point 122 by forming region 123 to accommodate the physical
stresses, a region which is isolated from fold-point 122. Thus,
any torque caused by a doctor anchoring hook-wire means 102 would
occur at region 123 which never having been previously subjected
to any type of cold worked or other bending, to render hook-wire
means 102 capable of resisting more forces without fracturing.
In another embodiment, surgical needle 100 may have a hook-wire
member of cylindrical cross-section, as in the prior art (shown
in FIG. 3), but still have reinforcement means comprising stress
relocation means 130. The inclusion of stress relocation means 130
would still substantially minimize the occurrence of breakage in
surgical needle 100; even without components of the hook-wire member
having substantially D-shaped cross-sections.
The foregoing description and drawings merely explain and illustrate
the invention and the invention is not limited thereto except insofar
as the appended claims are so limited, as those skilled in the art
who have the disclosure before them will be able to make modifications
and variations therein without departing from the scope of the invention. |