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FIELD OF THE INVENTION
The present invention is concerned with holding and guiding instruments and
devices used by physicians and surgeons to localize specific anatomical
sites or diseased tissues in the body and is particularly directed to
angulator devices for the precise positioning and percutaneous insertion
of needles and wires and catheters for biopsy examination and aspiration
purposes.
BACKGROUND OF THE INVENTION
In many clinical situations, before a proper diagnosis can be made and
effective therapy instituted, it is necessary to identify a localized
focus of disease deep within specific organs or tissues in the body;
obtain a sample of tissue from the diseased region; and evaluate it
histologically. Typical examples are the presence of a small mass in the
breast of a woman or a nodule in the lung. In order to accurately diagnose
and then effectively treat the disease, the breast mass or lung nodule, it
often becomes necessary for a surgeon to excise a portion of the diseased
tissue for microscopic examination and analysis. Thus, it is often
necessary to insert long needles or wires, typically from four to eight
inches in length, through the skin into the diseased region of the body,
to include not only the breast or lung, but also deep seated organs such
as the liver, kidney, and bony skeleton. Such needles are typically guided
to their target tissue by any of a variety of imaging systems including
X-ray fluoroscopy, computerized tomography, ultrasound, magnetic resonance
and the like.
Generally, percutaneous insertion of objects such as needles, wires and
catheters are employed to obtain biopsy specimens of the diseased tissues;
drain abscesses; sample body fluids; and introduce medication or contrast
agents into the body. The insertion of hollow needles, of various bore
diameters and lengths, may also be the first step towards non-surgical
placement of larger-bore catheters into the body of the subject by
conventionally known means.
Precise positioning of the object to be surgically inserted, typically a
small-bore needle, is simple in principle but is often difficult in
practice. Initially, an appropriate and safe skin entry site is chosen;
the site sterilized; and then infiltrated with a local anesthetic. The
needle is then advanced into the tissues; its direction and depth checked
repeatedly by one or more imaging systems; and adjustments made if
necessary. The imaging system displays the internal target as well as the
needle shaft and allows the surgeon to carefully aim the needle towards
the target even though the target tissue may be small and deep seated. The
ongoing and recurring problem, however, lies in the fact that it may be
extremely difficult for the surgeon to maintain the needle at the exact
angle required relative to the target tissue within the patient's body. In
routine practice, the needle is inserted by hand and advanced part-way
towards the estimated position of the target tissue site. The patient then
is moved in and out of the viewing position of the particular imaging
system to determine whether the needle is accurately aimed towards the
target site; or whether the needle direction needs to be adjusted; and/or
to determine how much further the needle should be advanced to reach the
target tissue. This procedure may have to be repeated a number of times
before completion.
The operator commonly improvises some support for the needle during this
viewing period of time, often with a folded towel; or a stack of sterile
swab pads; or some similar temporary arrangement, in order to maintain the
needle in the inserted position until its relationship to the target
tissue can be verified. This problem is compounded if the desired point of
entry through the skin of the patient is on an oblique or vertical aspect
of the body surface. It is often difficult to maintain the desired angle
of entry in such instances and it is common for the surgeon to withdraw
the needle and reinsert it at a different angle or aspect several times
before the correct relationship to the target tissue is attained.
It is therefore commonly recognized that a device which would allow the
surgeon to position a needle at the chosen skin entry site and to maintain
the requisite angle of insertion into the tissue of the patient would be
an extraordinarily useful and advantageous device. Such an article would
not only allow for precise positioning of the needle to be inserted, but
would also support the needle after initial insertion while its position
within the body is being verified by the imaging system. It would also
eliminate the requirement that the surgeon or surgical assistant
physically grasp and maintain the inserted needle in position during the
entirety of the verification procedure. Such a device would not only
provide freedom, convenience and accuracy for the surgeon during the
procedure, but also would provide greater comfort for the patient as well.
SUMMARY OF THE INVENTION
A self-supporting angulator for precise percutaneous insertion of an object
into the body of a subject is provided, this angulator comprising a base
plate; at least one primary member rotatably joined to the base plate; at
least one secondary member rotatably joined to the base plate at an angle
substantially radial to the axis of the primary member, this secondary
member being positionable adjacent to the primary member at a plurality of
different angles of intersection; means for coupling the rotatable
secondary member to the rotatable primary member at a desired angle of
intersection; and means for holding the object to be inserted disposed
upon at least one of the rotatable members.
BRIEF DESCRIPTION OF THE FIGURES
The present invention may be more easily and fully understood when taken in
conjunction with the accompanying drawing, in which:
FIG. 1 is an overhead view of a preferred embodiment of an angulator device
in a folded, collapsed state shown without a coupling bracket;
FIG. 2 is a cross-sectional view of the folded embodiment illustrated
within FIG. 1 along the axis A A';
FIG. 3 is a perspective view of a preferred combined coupling bracket and
needle holder comprising part of the present invention;
FIGS. 4a-4c are frontal views of the components comprising the coupling
bracket and needle holder illustrated by FIG. 3;
FIG. 5 is a perspective view of the preferred embodiment illustrated by
FIGS. 1-5 in the fully erect, self-supporting state;
FIG. 6 is a detailed perspective view of the combined coupling bracket and
needle holder on the primary and secondary members of the embodiment
illustrated by FIG. 5;
FIG. 7 is an overhead view of the combined coupling bracket and needle
holder on the primary and secondary members of the embodiment illustrated
by FIG. 5;
FIG. 8 is a perspective view of another embodiment comprising the present
invention in the fully erect, self-supporting state;
FIG. 9 is a perspective view of another embodiment comprising the present
invention in the fully erect, self-supporting state; and
FIG. 10 is a perspective view of another embodiment of the present
invention in the fully erect, self-supporting state.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is an erectable and collapsable, self-supporting
angulator device for the precise positioning, holding and percutaneous
insertion of an object such as a needle into the tissues of the body. In
preferred embodiments, the angulation device is provided as a compact,
presterilized, biocompatible, and disposable article of manufacture which
improves the accuracy of needle placement (and similar objects) for a
variety of medical purposes. The angulation devices are compatible with
all presently known imaging systems; are inexpensive; and substantially
reduce both the operating time for and patient discomfort during the
insertion procedure.
The preferred embodiment of the present invention is illustrated in a
variety of different views and in both erected and collapsed states by
FIGS. 1-7 respectively. The preferred design is shown in the folded or
collapsed state by FIGS. 1 and 2 in which the angulator 10 comprises a
semi-circular base plate 12, a short, arched primary member 14, and a
longer, arched secondary member 16 positioned adjacent thereto. The base
plate 12 is preferably formed of a flexible, resilient material which can
be sterilized, is biocompatible, and disposable. It is usefully configured
as a semi-circular disc 18 whose center has been perforated by an
semi-oval shaped aperture 20. The primary member 14 is preferably arched
in configuration from one end 22 to the other end 24 and is attached to
the base plate 12 by rotatable joining means such as flexible hinges 26
and 28 respectively. While hinges 26, 28 are the preferred means of
rotatable juncture, all joining means which allow the primary member 14 to
rotate after being attached to the surface 18 of the base plate 12,
regardless of specific position or mode of attachment, are suitable for
use with the present invention.
The secondary member 16 is also preferably arched in configuration and
desirably has a curvature parallel to the arched configuration of the
primary member 14 such that two concentric arches are formed. The adjacent
arched secondary member 16 has two ends 30 and 32, only one of which is
rotatably joined to the base plate 12 at a location substantially radial
to, and preferably at a right angle to, the axis of the primary member 14.
As shown in FIGS. 1 and 2, the end 30 is rotatably joined to the surface
of the semi-circular disc 18 via the flexible hinge 34. Other rotatable
joining means for attaching the secondary member 16 to the base plate 12
may be substituted and employed as desired. It is also highly desirable
that the underside 17 of the base plate 12 be coated with a non-toxic,
biocompatible adhesive 38 as is illustrated in the cross-sectional view
along the axis A A' of FIG. 2.
It will be noted and appreciated that while the primary member 14 and the
secondary member 16 are preferably configured as concentric, arched
elements, a variety of other shapes and configurations are also useful in
varying degrees. Clearly, the members 14, 16 may alternatively be linear,
sinusoidal, multisided with or without parallel sides, saw-toothed, or
irregularly shaped--although these are generally considered to be less
desirable than the simpler and more convenient arch configuration.
Similarly, there is no requirement or necessity that either the primary
member 14 or the secondary member 16 be comprised of a single construct or
structure; to the contrary, each member may be composed of a plurality of
elements joined together to form an integral unit. Morever, it is expected
that a variety of different materials of varying tensile strength,
flexibility, resiliency, and elasticity may be utilized to give one or
more specific configurations which are deemed to be useful or necessary
under specific conditions or test circumstances.
It will be noted also that there are no restrictions or limitations
regarding the means of rotatably joining each primary member and secondary
member to the surface of the base plate. Not only are the means for
rotatably joining each member of no significant interest or value, but
neither are the precise locations, dimensions, and proximate distant
relationships of any meaningful concern to the invention as a whole. Since
each primary member and secondary member may be configured in a variety of
shapes, it is clear that the individual construction and configuration may
provide one, two, or more ends by which to join the respective member to
the surface of the base plate. Accordingly, so long as at least one end of
a primary member is rotatably joined to the base plate and at least one
end of a secondary member is also rotatably joined to the base plate, that
embodiment is deemed to be within the scope and definition of the present
invention.
The other criterion for all embodiments comprising this invention require:
that the secondary member be positioned on the base plate at an angle
substantially radial (and preferably 90.degree.) to the axis of the
corresponding primary member; and that the rotatably joined secondary
member extend sufficiently in length to be positioned adjacent to the
rotatable primary member at one, and preferably at a plurality of
different angles of intersection. Thus, so long as the primary member and
the adjacent secondary member are not substantially parallel to one
another over the surface of the base plate, that positioning and
construction will cause and angular intersection between the primary
member and the secondary member sufficient to be within the definition of
the present invention.
The other component parts of the present invention include the means for
coupling the rotatable secondary member to the rotatable primary member at
a desired angle of intersection; and means for holding the object to be
inserted (the needle) preferably along the common isocentric axis
perpendicular to the intersection angle formed by the two rotatable
members. In preferred embodiments of the present invention, the means for
coupling the members and the means for holding the object to be inserted
are combined into a signle article of manufacture such as appears in FIG.
3. As shown therein, a slidable, combined coupling bracket and object
holder 50 is seen retaining an elongated needle 52. The preferred combined
coupling bracket and needle holder 50 of FIG. 3 is preferably constructed
as an integral unit from three components, a 2-part front plate, a 3-part
middle plate, and a single part rear plate as appears in FIGS. 4a, 4b, and
4c respectively. The 2-part front plate 60 of FIG. 4a is substantially
planar and is composed of an L-shaped arm section 62 and elongated center
section 63, separated by a narrow space 66 from the other elongated
half-section 64; a narrow slit 65; and a pair of clips 68a and 68b. The
narrow space 66 between the half-section 63 and the half-section 64 forms
a retention groove for the needle 52 or another object to be inserted.
The middle plate 70 of FIG. 4b is a 3-part planar construction composed of
an L-shaped arm portion 72 and fusable portion 73 separated by a short
narrow slit 75 from the other fusable portion 74; an arched broad space
76; and a fusable curved support portion 78. The arched broad space 76 is
an open channel configured to accommodate the width and thickness of the
primary member 14 which is to be slid through the space 76 and maintained
in place by the fusable curved support 78.
The rear plate 80 of FIG. 4c is also substantially planar and is composed
of an L-shaped arm segment 82; two fusable segments 84a and 84b separated
by a narrow slit 85; and a retaining segment 88.
Assembly of the unit is made by attaching the fusable segments 84a and 84b
(by fusion, adhesive or other means) to the corresponding rear surfaces of
fusable portions 74 and 73; which, in turn, are themselves joined on their
front surfaces to the rear surfaces of portions 63 and 64 respectively.
The curved support 78 is also joined to the rear surfaces of sections 63
and 64 towards their lower ends. If properly done, this mode of assembly
for the 3-part middle plate 70 with respect to the 2-part front plate 60
and single part rear plate 80 causes the narrow slits 85, 75, and 65 to be
in alignment--thereby forming a narrow slot 55 (of reduced length in the
middle plane) through the entirety of the combined bracket and holder 50.
In addition, it is preferred that a spring 54 be attached to both the
L-shaped arm segment 82 and the L-shaped arm portion 72 to maintain a
constant tension force between the respective parts. The properly aligned
and assembled unit is the combined coupling bracket and object holder 50
illustrated by FIG. 3.
To assemble the angulator device 10, the combined coupling bracket and
object holder 50 is mounted on the primary arched member 14 by tilting the
retaining segment 88 backward to admit the primary member 14 into the
arched broad space 76 of the middle plate 70. The primary member 14 is
supported and held within the space 76 by the curved support 78 such that
a sliding movement is facilitated. The free end of the secondary member 16
is then slid into the slot 55 of the coupling bracket 50. The spring
tension thus locks arm 72 against the top edge of the secondary member 16;
which in turn, is locked against the top edge of the primary member 14;
which is pressed down onto the curved support 78.
The combined bracket and object holder 50 is constructed to be slidable
over the entirety of the arched primary member 14 and/or the arched
secondary member 16. Since the L-shaped arm segment 82 of the rear plate
is directly aligned with the L-shaped arm section 62 of the front plate
while the L-shaped arm portion 72 of the middle plate remains depressed by
the spring tension, the application of a compression force (by finger
pressure) between the outer L-shaped arms 82 and 62 above and the arm 72
below will cause a widening of the horizontal gap 90 between the upper and
lower portions of the middle plate. This will release the tension between
the L-shaped arm 72 of the middle plate against the secondary member 16;
and the tension of the secondary member 16 against the primary member 14;
and the tension of the primary member 14 against the curved support 78.
This release of tension will free the primary and secondary members to be
set at any desired angle relative to the base plate. Once the desired site
on each member 14 and 16 is achieved, the compression force is removed and
tension force restored by the spring 54 is sufficient to close the gap 90
between the upper and lower sections of the middle plate 70. The unit 50
is thus secured at this position on each of the members indefinitely.
The erected, self-supporting angulator device 10 complete with combination
coupling bracket and needle holder 50 is illustrated by FIGS. 5, 6, and 7.
The primary member 14 rotatably joined to the surfae 18 of the base plate
12 has been elevated and the combination coupling bracket and needle
holder 50 slidably mounted on the thickness of the support member 14.
Clearly, the thickness of the primary member 14 passes through the broad
space 76 of the middle plate 70. By compressing the L-shaped arm 72
towards the L-shaped arms 62 and 82 of the bracket 50, the gap 90 is
widened and the bracket 50 then can be slided over the entirety of the
primary member 14 until another desired position is achieved. The
secondary member 16 has also been elevated from the folded state and the
end 32 inserted into and passed through the slot 55 of the coupling
bracket 50. As shown by FIGS. 5, 6, and 7, as the coupling bracket and
needle holder 50 is slid over the surface of the primary member 14, the
secondary member 16 will also rotate conform to any desired position on
the arch; and thus maintain a variety of different angles of intersection
with the primary member. In a similar fashion, the coupling bracket 50 can
be slid over the secondary member 16 and the primary member 14 will
follow. It is clear, therefore, that with each change of position for the
coupling bracket and needle holder 50 on the primary member 14, there will
be a different angle of intersection achieved for the members 14 and 16
over a range of substantially 180.degree. in any direction.
In its intended use with human or animal subjects, it is expected that the
base plate 12 will be positioned on the skin of the subject at an
insertion site overlying the tissue to be localized and/or examined. The
center of the apertue 20 typically, will be positioned such that the
needle point is situated directly over the planned site of skin
penetration. The adhesive 38 will maintain the general position of the
angulator device 10 on the skin of the subject without discomfort to the
patient. The flexibility of the base plate material allows for movement
through breathing or involuntary muscle contraction for the subject
without loss of positioning for the angulator. Once the base plate has
been attached to the skin surface, the L-shaped arms 82 and 62 are
squeezed against the L-shaped arm section 72. The combination coupling
bracket and needle holder 50 can now be moved along both arched members in
any direction between 0.degree. and 180.degree. (preferably between
30.degree.-150.degree.) relative to the skin surface and then secured into
place. As a convenience, angle degree markings can be printed on the
surface of the primary and secondary members to serve as reference points
as seen in FIG. 6. Once secured into position, the needle retained by
clips 68a and 68b can be checked using the imaging system for the desired
precise location and angle of insertion. Any necessary adjustments can be
made before the needle or other object is advanced into the tissues along
the preselected axis. Once it is decided to advance the needle into the
tissues of the subject, the angulator will continue to aim and hold the
needle securely while it is being advanced into the tissues; since biopsy
needles and the like are generally from 4 to 8 inches in length, the
needle may be advanced into the tissues until approximately 31/2 inches of
the needle's shaft remain exposed to view. If deeper penetration is
desired, this may then be accomplished by releasing the needle from the
coupling bracket and folding the arched members 14, 16 and coupling
bracket 50 flat against the skin of the patient. The needle is then held
in position by the tissues themselves and it may then be advanced further
until the desired degree of penetration is achieved. The base plate and
collapsed arched members will not interfere with the surgeon's hands while
the biopsy or aspiration samples are being taken; or while any other
surgical function or procedure is being carried out. After the surgical
procedure has been completed, the angulator device 10 may be easily peeled
off the skin and discarded either before or after the needle has been
withdrawn from the tissues.
It should be noted that the present invention as illustrated by the
preferred embodiments of FIGS. 1-7 has many desirable advantageous
features and uses which fall into any of three general categories: First,
the ease of use is apparent and highly desirable: The base plate of the
angulator device may be easily attached to the skin of the subject by
adhesive or other retention means and can be easily removed at the end of
any surgical procedure. The angulator may be mounted or positioned on any
horizontal, oblique, or even vertical skin surface. The angulator device
is foldable and may be erected for use in a matter of seconds. The design
and base are adaptable to almost any body contour and many envisioned
surgical procedures. The angulator device and preferred coupling bracket
will accept a variety of different objects of varying sizes, lengths and
diameters commonly in clinical use. The device frees the surgeon's hands
for other functions thereby often eliminating the need for an assistant.
Moreover, the angulator device allows the needle or other object to be
inserted to be easily disconnected from the remainder of the apparatus at
any time; and allows the remainder to be folded flat against the skin or
quickly removed entirely thereby eliminating obstacles and obstructions to
the surgical procedure itself.
Second, the accuracy provided by the angulator devices comprising the
present invention is clearly more precise and easily verified than any
other apparatus presently known to date: The needle or other object to be
inserted is held securely at precisely the exact angle of insertion
desired relative to the patient's body; the traditional balancing and
support attempts using towels, gauze pads, or other conveniences becomes
unnecessary and obsolete. The angle of insertion can be easily readjusted
when and if necessary without difficulty. The needle or object to be
inserted can be aimed at the desired target at the preferred angle of
inclination over a broad range of angles with great precision and
reliability. Angle degree scales may be provided along the surface of the
individual members as reference points. The needle to be inserted and the
angulator device (once attached to the skin of the patient) adjust and
move with the motions of the patient so that the needle position is
unaffectd with respect to the target tissue. Patient immobilization
requirements are therefore greatly reduced or in some instances, can be
eliminated altogether.
Third, the angulator and its uses are adaptable to all conventionally known
imaging systems: The angulator may be used with X-ray fluoroscopy,
computerized tomography, ultrasound, magnetic resonance and the like. If
desired, small radiopaque centering wires can be built into the base plate
of the device to identify the focal point at which the needle will enter
the skin. The angulator allows the patient to be moved into and out of any
imaging system without fear of disturbing or altering the position of the
needle. Morever, the surgeon's hands are kept out of the radiation field
when fluoroscopy or computerized tomography imaging systems are utilized.
Lastly, it is clear that in preferred formats, the angulator will be
prepared conveniently as a pre-sterilized article which is disposable and
constructed such that it may be erected and then subsequently collapsed
with a minimum of effort.
A non-exhaustive, representative showing of other useful embodiments of the
present invention in general are illustrated by FIGS. 8, 9 and 10
respectively. The embodiment of FIG. 8 shows the primary member 114 to be
an arched construct rotatably joined to the surface 18 of the base plate
12 only at one end 122. The manner of rotatable juncture is again via a
hinge 126, although any other means for rotatably joining the primary
member 114 to the base plate 12 is equally useful and suitable. All other
components of the angulator device are as previously described herein.
Another, perhaps less preferred, embodiment of the present invention is
seen in FIG. 9 in which the adjacently positioned secondary member 216 is
configured as an arched construct having two ends 230 and 232
respectively. Each end 230, 232 is rotatably joined to a substantially
circular base plate 212 containing a substantially oval shaped aperture
220 at the center. As before, the preferred means for rotatably joining
the secondary member 216 and the primary member 214 to the surface 218 of
the base plate 212 is via a series of hinges 226, 228, 234, and 236
respectively. Each of the other components comprising the embodiment of
FIG. 8 are as previously described herein.
Finally, the alternate embodiment shown by FIG. 10 illustrates the
situation wherein the primary member 314 is composed of two individual
arched elements 313, 315, each of which is rotatably joined at their
respective ends 322, 324 to the surface 318 of a circular base plate 312
having an oval aperture 320 at its center. Similarly, the adjacently
positioned secondary member 316 is composed of two individual arched
components 315, 317 whose respective ends are rotatably joined to the base
plate 312. In this embodiment also, a series of hinges 326, 328, 334, and
336 join each respective component end 322, 324, 330, and 332 to the
surface 318 of the base plate 312. Each of the other elements in this
embodiment are as previously described herein.
The present invention is not to be restricted in form nor limited in scope
except by the claims appended hereto.
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