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Claims  |
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What is claimed is:
1. A catheter button comprising a non-metallic button body portion having a
central opening extending therethrough, a metallic marker integral with
said body portion, and coupling means for integrally holding the metallic
marker on the exterior of the button body.
2. A catheter button of claim 1 wherein said body portion includes an
exterior annular groove wherein said marker is integrally held.
3. The catheter button of claim 2, wherein said metallic marker includes a
central opening coaxial with the central opening of the button body.
4. The catheter button of claim 1, wherein the button body additionally
includes at least one suture hole extending through said body portion and
substantially parallel to said central opening.
5. The catheter button of claim 4, wherein said metallic marker includes a
central opening and one or more suture holes arranged around said central
opening of said metallic marker.
6. The catheter button of claim 5, wherein the metallic member includes a
different number of holes than the number of suture holes in said button
body.
7. The catheter button of claim 2, wherein said metallic marker is a cap
having a circumferential flange integrally held in the exterior annular
groove of the button body.
8. The catheter button of claim 2, wherein said metallic marker is a
metallic ring integrally held in the exterior annular groove of the button
body.
9. The catheter button of claim 7, wherein said metallic cap additionally
comprises an integral metallic hollow stem extending coaxially with the
central opening of the button body and in the opposite direction from the
circumferential flange of the cap.
10. The catheter button of claim 1, further comprising a hollow stem
portion integral with and extending from the body portion and through
which the central opening also passes.
11. The catheter button of claim 10, wherein the metallic marker is a
metallic sleeve integral with and surrounding the stem portion.
12. The catheter button of claim 1, wherein said non-metallic body portion
is of substantially hemispherical shape.
13. The catheter button of claim 1, wherein said non-metallic body portion
is a flat, disk shape.
14. The catheter button of claim 10, wherein said stem portion has an inner
diameter which decreases from the outer end of said stem toward the inner
end of said stem, in a conical funnel-like shape.
15. The catheter button of claim 1 wherein the central opening has an
initial diameter which is substantially identical to the outside diameter
of a surgical tube the end of which is to be secured by said button, and
the central opening includes an interior step down at which its internal
diameter decreases abruptly to approximately equal the interior diameter
of such tube.
16. The catheter button of claim 15 wherein the length of the central
opening from the bottom of the button body to the step down is not less
than the initial diameter of the central opening.
17. The catheter button of claim 1, wherein the maximum diameter of said
button is about 3 cm.
18. The catheter button of claim 1 wherein said non metallic button body
comprises nylon.
19. The catheter button of claim 1, wherein said metallic marker comprises
a material selected from the group consisting of stainless steel, nickel,
tungsten, aluminum, brass, copper, silver, gold and gold copper alloy.
20. The catheter button of claim 1, wherein said non-metallic body portion
and said metallic marker are integrally fastened together with adhesive.
21. A catheter button comprising a non-metallic body button body and a
hollow, substantially nonelastic stem portion extending from and integral
with said button body portion wherein a central opening extends through
said body portion and said hollow stem, said stem portion having an outer
continuous wall structure and an inner diameter which decreases from the
outer end of said stem toward the inner end of said stem, in a conical,
funnel-like shape.
22. The catheter button of claim 21, wherein the central opening has an
initial diameter which is substantially identical to the outside diameter
of a surgical tube the end of which is to be secured by said button, and
the central opening includes an interior step down at which its internal
diameter decreases abruptly to approximately equal the interior diameter
of such tube.
23. The catheter button of claim 22, wherein the length of the central
opening from the bottom of the button body to the step down is not less
than the initial diameter of the central opening.
24. The catheter button of claim 21, wherein the maximum diameter of said
button is about 3 cm.
25. The catheter button of claim 21, wherein said non metallic body portion
is of substantially hemispherical shape.
26. The catheter button of claim 21, wherein said non metallic body portion
is of a flat, disk shape.
27. The catheter button of claim 21 wherein said non metallic button body
and stem comprise nylon.
28. The catheter button of claim 21 wherein the button body additionally
includes at least one suture hole extending through said body portion
substantially parallel to said central opening.
29. A catheter button comprising a non-metallic button body portion, a
hollow stem portion extending from and integral with said button body
portion and a central opening extending through said body portion and said
hollow stem, wherein the central opening has an initial diameter which is
substantially identical to the outside diameter of a surgical tube, the
end of which is to be secured by said button, and the central opening
includes an interior step down at which its internal diameter decreases
abruptly to approximately equal the interior diameter of such tube.
30. The catheter button of claim 29, further comprising a metallic marker
integral with said body portion.
31. The catheter button of claim 30, wherein said body portion includes an
exterior annular groove wherein said marker is integrally held.
32. The catheter button of claim 31, wherein said metallic marker includes
a central opening coaxial with the central opening of the button body.
33. The catheter button of claim 30, wherein the button body additionally
includes at least one suture hole extending through said body portion
substantially parallel to said central opening.
34. The catheter button of claim 33, wherein said metallic marker includes
a central opening and one or more suture hole arranged around said central
opening of said metallic marker.
35. The catheter button of claim 34, wherein the metallic member includes a
different number of holes than the number of suture holes in said button
body.
36. The catheter button of claim 31, wherein said metallic marker is a cap
having a circumferential flange integrally held in the exterior annular
groove of the button body.
37. The catheter button of claim 31, wherein said metallic marker is a
metallic ring integrally held in the exterior annular groove of the button
body.
38. The catheter button of claim 36, wherein said metallic cap additionally
comprises an integral metallic hollow stem extending coaxially with the
central opening of the button body and in the opposite direction from the
circumferential flange of the cap.
39. The catheter button of claim 30, wherein the metallic marker is a
metallic sleeve integral with and surrounding the stem portion.
40. The catheter button of claim 29, wherein the button body portion is of
substantially hemispherical shape.
41. The catheter button of claim 29, wherein the button body portion is of
a flat, disk shape.
42. The catheter button of claim 30, wherein said metallic marker comprises
a material selected from the group consisting of stainless steel, nickel,
tungsten, aluminum, brass, copper, silver, gold and gold copper alloy.
43. The catheter button of claim 30, wherein said non-metallic body portion
and said metallic marker integrally fastened together with adhesive. |
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Claims |
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Description |
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BACKGROUND
The present invention relates to so called catheter buttons for securing
the exterior end or ends of a tube surgically inserted in body tissue, and
more particularly to catheter buttons of various shapes and configurations
integral with a marking means visible on X-ray images or the like, such as
a metallic cap or ring. The buttons may further include a stem portion for
facilitating use with such tubes.
Catheter buttons are sometimes known as catheter retainers, as disclosed
for example in Edwards U.S. Pat. No. 4,360,025. They have also been called
catheter support devices or catheter anchoring devices, as disclosed for
example in Jacobs U.S. Pat. No. 4,397,641. In still other embodiments they
have been called catheter stabilization pads, as disclosed for example in
Kamen U.S. Pat. No. 4,563,177.
Catheter buttons having at least one hole for anchoring a surgical tube
have been well known. Additionally, catheter buttons having various
geometric shapes are also well known. For example, plastic buttons of
spherical, hemispherical or circular, flat disk shapes with an opening for
supporting a surgical tube are known. For example, hemispherical buttons
are shown in "Brachytherapy Update - 1986," Hilaris, B. S. and Nori, D.,
Editors, Memorial Sloan-Kettering Cancer Center, New York, Mar. 22, 1986,
p. 153. In the case of a circular flat disk, buttons are known to have
more than one opening. Such buttons somewhat resemble ordinary shirt
buttons. Additionally, metallic marking elements such as flat metallic
discs, an flanged discs having an internal stem, the flange and stem of
which extend upwardly away from the patient's skin, separate from a button
body, have been used in conjunction with a separate non-metallic button
body. See again, Hilaris et al., supra.
However, these prior art buttons suffer from many disadvantages. A primary
disadvantage is the necessity to handle two small separate pieces, i.e., a
button body and a metallic marker, in the surgical theater, especially
where many such combinations may be used to secure multiple flexible
tubular implants in a single tissue site. Metallic buttons or markers are
used because they can be readily identified in X-ray photographs, but it
is undesirable to have the metallic markers next to the skin because they
cause excessive skin loss due to electron scattering by radiation from
radioactive material used in cancer therapy. A further disadvantage of the
metallic buttons having stems, is that crimping of the stem to hold the
tube within the button is difficult.
BRIEF SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to provide new and
even more useful catheter buttons.
It is an additional object of this invention to provide a non-metallic
catheter button body which integrally includes a metallic marker element.
Still further, it is an object of the present invention to provide a
non-metallic catheter button having an integral stem portion.
It is yet another object of the present invention to provide a non-metallic
catheter button comprising an integral stem portion, which button is also
integral with a metallic marker element.
It is another object of the present invention to provide non-metallic
catheter buttons of various geometric shapes.
In accordance with the foregoing objects, the present invention comprises a
non-metallic catheter button body having a variety of geometric shapes,
having integrally secured therewith a metallic marker element, to anchor a
catheter or surgical tube in the body with less pain to the patient while
providing an X-ray visible marker, which button substantially reduces the
loss of patient's skin from scattered electrons resulting from bombardment
by radiation from radioactive material. The non-metallic button body may
further include an integral non-metallic stem portion to facilitate the
crimping of the stem, anchoring of tubes in the body, and insertion of
ribbons of radioactive material therein.
BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding and further features of the advantageous
catheter button system of the resent invention, reference is made to the
following drawings of various embodiments of the invention, wherein:
FIG. 1 is a partially schematic isometric view of a partially spheric
non-metallic catheter button body of the present invention also including
an integral non-metallic stem;
FIG. 1A is a partially schematic isometric view of the non-metallic button
body illustrated in FIG. 1 further integral with a metallic marker cap as
illustrated in FIG. 2, below;
FIG. 2 is a partially schematic isometric view of a metallic marker cap for
use in integral combination with a non-metallic button body in accordance
with the present invention;
FIG. 3 is a partially schematic axial cross-sectional view of a partial
spheric non-metallic button body of the present invention including an
integral stem having a funnel entry internal profile, as well as a stepped
central opening for receiving the end of a flexible surgical needle or
tube;
FIG. 4 is a top view of the non-metallic button body illustrated in FIG. 3;
FIG. 5 is an axial cross-sectional view of the metallic marker cap
illustrated in FIG. 2;
FIGS. 5A-5H, inclusive, illustrate various embodiments of the metallic
marker cap previously illustrated in FIGS. 2 and 5, additionally showing a
multiplicity of different openings through the top surface of the cap for
the purpose of serving as indicia of a specific flexible surgical needle
or tube implant;
FIG. 6 shows an axial cross-sectional view of a ring-shaped metallic marker
for use in integral combination with one of the non-metallic button bodies
of the present invention;
FIG. 7 shows a top view of the metallic ring marker illustrated in FIG. 6;
FIG. 8 shows a partially schematic axial cross-sectional view of a flanged
cap metallic marker member including an integral metallic stem extending
in the direction opposite from the cap flange, which marker is for use in
integral combination with one of the non-metallic button bodies of the
present invention;
FIG. 9 is a bottom view of the flanged metallic cap with stem illustrated
in FIG. 8;
FIG. 10 is a partially schematic axial cross-sectional view of an
hemispheric non-metallic button body of the present invention including an
integral stem extending away from the top of the button body;
FIG. 10a is a top view of the button body illustrated in FIG. 10;
FIG. 11 is a partially schematic axial cross-sectional view of a flat-disk
non-metallic button body of the present invention integrally including a
non-metallic stem extending coaxially from one face thereof, that stem
having the interior funnel-entry shape and the stepped central opening for
receiving the end of a flexible surgical needle or tube implant;
FIG. 11A shows a top view of the non-metallic button body illustrated in
FIG. 11;
FIG. 12 is a partially schematic axial cross-sectional view of a flat
disk-type non-metallic button body of the present invention integrally
including a non-metallic stem portion axially extending from one face
thereof;
FIG. 12A is a top view of the non-metallic button body illustrated in FIG.
12;
FIG. 13 is a partially schematic axial cross-sectional view of a flat
disk-type non-metallic button body of the present invention illustrating
the circumferential groove for integrally holding a metallic marking
member;
FIG. 13A is a top view of the non-metallic button body illustrated in FIG.
13;
FIG. 14 is a partially schematic axial cross-sectional view of a
super-hemispheric non-metallic button body of the present invention also
illustrating the circumferential groove for integrally retaining a
metallic marker member therewith;
FIG. 14A is a top view of the non-metallic button body of FIG. 14;
FIG. 15A is a partially schematic isometric view of an hemispheric
non-metallic button body of the present invention, like that illustrated
in FIG. 14;
FIG. 15B is a partially schematic isometric view of a metallic ring marking
member of the present invention as illustrated in FIGS. 6 and 7;
FIG. 15 is a partially schematic isometric view of an hemispheric
non-metallic button body of the present invention integral with a metallic
ring marker member;
FIGS. 16 and 17 show partially schematic axial cross-sectional views of
metallic crimper/marker sleeves in accordance with the present invention;
FIGS. 16A and 17A show end views of the metallic crimper/marker sleeves of
FIGS. 16 and 17, respectively;
FIGS. 16B and 17B show the metallic crimper/marker sleeves of FIGS. 16 and
17, respectively integrally positioned on the integral stem portions of
partially spheric non-metallic button bodies according to the present
invention;
FIG. 18 shows a prior art non-metallic hemispheric button body not having
any external groove;
FIG. 19 shows a prior art metallic marker member having a flat bottom
surface and flanged edge and integral metallic stem extending in the same
direction from the plane of the flat bottom surface as the flanged edge;
FIGS. 20 and 20A show axial cross-sectional and top views, respectively, of
a prior art disk catheter button member.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in FIGS. 1, 1A and 2, one preferred embodiment of the catheter
button 10 of the present invention basically comprises a non-metallic
hemispherically shaped button body portion 16 having an integral stem
portion 12 and an integral metallic marker cap 14, as shown in FIGS. 2 and
5. An opening 11 extends through the stem portion 12 and the
hemispherically-shaped button body portion 16. Openings 18 are arranged
around the stem 12 and extend from and through the hemispherically-shaped
body portion 16. The openings 18 and the opening 11 formed through the
stem portion 12 are in a substantially parallel relationship to each
other. The hemispherically-shaped body portion 16 further includes an
annular exterior groove 20.
The metallic marker cap 14 comprises a flat circular surface 26 having an
integral annular flange or lip 24. The cap 14 further includes a central
opening 22 and peripheral suture holes 28 disposed around the central
opening 22. The opening 22 has a diameter large enough to fit over the
stem portion 12. The peripheral suture holes 28 are located to correspond
with the suture holes 18 in the button body 10. Furthermore, the annular
lip 24 of the cap 14 is formed to fit tightly in the annular groove 20 of
the hemispherically-shaped button body portion 16.
When assembled, the cap portion 14 and button body portion are integrally
connected in intimate contact as shown in FIG. 1A. As can be appreciated
from FIGS. 5A through 5H, the number of suture holes 28 in the cap 14 is
not limited to the number of corresponding openings 18 in the button body.
Any number of such holes or openings may be utilized and thereby function
as identification marks for a particular implant. Any number of openings
may be utilized and arranged in any number of different combinations to
serve as distinct identification for any catheter or surgical tube which
is secured by such a button. Preferably, the openings 28 are arranged at
least at 45.degree. from each other about the outer periphery of the cap
around the stem , thereby allowing for as many as eight openings as shown
in FIG. 5A. As an example of identification, as shown in FIG. 5D, the cap
portion 14 may have five openings, which are arranged 45.degree. from each
other. Of course any random or organized pattern of such indicia openings
may be used as desired.
In a preferred embodiment, as illustrated in FIGS. 1 and 2, two suture hole
openings 18 are arranged on opposite sides of the stem 12. The openings 18
allow the button 10 to be fastened securely in place. Of course, any
number of openings may be utilized to fasten the button 10.
The non-metallic button bodies of the present invention typically have
diameters of not greater than about 3 cm and the flat disk button bodies
typically have thicknesses of not greater than about 0.4 cm. The diameter
of the integral metallic marker rings or caps is similarly typically not
greater than about 1 cm. A central opening in the button body is designed
to fit snugly over the outside circumference of the end of the catheter or
surgical implant tube, and the interior of the central opening is
preferably stepped down to a diameter approximately equal to the inside
diameter of the complimentary catheter or implant tube. The depth of the
central opening from the bottom of the non-metallic button body to the
desired step down is preferably at least about the length of the outside
diameter of the complimentary catheter or surgical implant tube to be
secured by the button. This insures that the button body will remain on
the exposed end of the catheter or implant tube. Those flexible catheter
or implant tubes typically have outside diameters of not greater than
about 0.5 cm, and typically have inside diameters of not more than about
0.3 cm, although larger tubes may be used.
FIGS. 3, 10-13 and 14, respectively, show various embodiments of the
advantageous non-metallic button bodies of the present invention. The more
elementary forms of such button bodies are illustrated in FIGS. 13 and 14.
In FIG. 13 non-metallic button body 10 comprises a flat disk of material
having central opening 22 and peripheral suture openings 28 with external
groove 20 in the circumference of the button body and intersecting the
upper flat face thereof. FIG. 13A shows a top view of the advantageous
non-metallic button body of FIG. 13.
FIG. 14 shows a super-hemispherically shaped non-metallic button body
otherwise comparable to the flat disk button body illustrated in FIG. 13.
This super-hemispherically shaped button body 10 also has central opening
22, peripheral suture holes 28 and circumferential groove 20 which
intersects the upper flat surface. FIG. 14A is a top view of the
advantageous non-metallic button body of FIG. 14.
The non-metallic button bodies illustrated in FIGS. 12 and 10,
respectively, illustrate a more complex form of the advantageous
non-metallic button bodies of the present invention wherein an integral
non-metallic stem portion extends coaxially from the top face of the
button body 10. It is through that stem portion 12 that central opening 22
extends. The stem portion of the bottom body is typically no longer than
the diameter of the bottom body and preferably is long enough to
facilitate the crimping functions described herein. One of the functions
of the stem portion 12 is to fit over a longer length of the exposed end
portion of a catheter or surgical implant tube so that stem 12 may be
crimped thereby even more positively gripping the flexible tubular member
therein. Additionally, the integral stem catheter buttons of FIGS. 12 and
10, respectively, also include the peripheral circumferential groove 20
which intersects the upper face of the button body 10. FIG. 12A shows a
top view of the advantageous non-metallic button body of FIG. 12, and FIG.
10A shows a top view of the advantageous non-metallic button body of FIG.
10.
The non-metallic button bodies illustrated in FIGS. 11 and 3, respectively,
illustrate an even more unique button body having an integral stem member
12 extending coaxially from the upper face of the button body wherein the
internal surface 40 of stem 12 is funnel-shaped having a larger diameter
at the open end of the stem portion 12 which decreases in size toward the
central region of the axis of the button body at which point the diameter
of the central opening is approximately equal to the inside diameter of a
flexible catheter or surgical implant tube with which the button is to be
used. Still further, the advantageous button bodies of FIGS. 11 and 3,
respectively, show the preferred step-down feature 42 wherein the diameter
of the central opening 22 steps down from a diameter substantially the
same as the outside diameter of the complimentary catheter or surgical
implant tube to the central diameter which, as stated above, is
substantially the same as the inside diameter of the complimentary
catheter or surgical implant tube. As indicated above, herein, that step
down 42 is located at a distance from the bottom of the button body of at
least about the length of the outside diameter of the complimentary
cathether or surgical implant tube.
Where the inventives button body includes both the step-down feature and an
integral stem, the stem may also function to be crimped upon and hold a
ribbon of radioactive material in place with the inserted implant tube.
The other features of the advantageous non-metallic catheter button of FIG.
11 are substantially the same as the features described in conjunction
with FIG. 13, while the other features of the button body illustrated in
FIG. 3 are substantially the same as the other features illustrated in
conjunction with FIG. 14. FIG. 4 is a top view of the advantageous
non-metallic button body of FIG. 3, and FIG. 11A is a top view of the
advantageous non-metallic button body of FIG. 11.
The advantageous funnel-shaped interior of the stem portion of the
non-metallic catheter buttons of FIGS. 3 and 11 respectively, provides
means for much more easily threading a ribbon of radioactive treatment
seed material into a catheter or surgical implant tube whose exterior end
is secured by a catheter button. In the present invention, the open end of
the funnel-shaped opening 40 of the stem portion has an inside diameter
which is typically some 2 to 4 times the ordinary inside diameter of the
catheter or surgical implant tube secured by the button. Thus, it is very
substantially more easy to thread a ribbon of radioactive treatment
materials into the end of a catheter or implant tube whose exterior end is
secured with the advantageous funnel-stemmed catheter button of the
present invention. Furthermore, the aforementioned desirable step down
feature insures that once such a ribbon enters the central opening of the
button body, the end surface of the catheter or surgical implant tube does
not impair entry of the ribbon into the catheter or implant tube per se.
Previously, the threading of such ribbons into the external ends of a
catheter or implant tube was accomplished by using a portable
double-funnel device having funnel cones on each end of an axial passage,
which passage itself was no greater than about the inside diameter of the
catheter or implant tube into which a ribbon was to be fed. One of the
double funnel ends was placed over the external end surface of the end of
the catheter or implant tube, while the ribbon sought to be threaded
therein was then inserted into the other double funnel cone, and hopefully
the technician was able to hold the double funnel device sufficiently
still vis-a-vis the exposed end of the catheter or implant tubes for long
enough during the attempted threaded process so that threading of the
ribbon into the catheter or implant tube per se was actually achieved.
The advantageous button bodies of the present invention having the integral
funnel-shaped stem member eliminate the need for the portable
double-funnel threading device, and eliminate the frustration of
attempting to hold such a device still on the exposed end of a catheter or
implant tube. Furthermore, the use of the advantageous button of the
present invention is more comfortable for the patient because there is a
much diminished tendency for the catheter or implant tube to be moved
substantially within the body tissue during the ribbon threading process,
whereas the use of the former double funnel device presented a substantial
possibility of axial movement of the catheter or implant tube within the
patient's tissue.
The metallic marker cap element previously discussed and illustrated in
FIGS. 2 and 5, respectively, is but one embodiment of the advantageous
metallic marker member portion of the integral button body/marker
combination of the present invention. In FIGS. 6 and 7 a ring-shaped
metallic marker member is illustrated. FIG. 6 shows the cylindrical height
of the ring and its thickness in axial cross-section, while FIG. 7 is a
top view illustrating the circumference, thickness and diameter of such a
ring.
Just as the circumferential flange 24 of the metallic marker cap member
illustrated in FIGS. 2 and 5 is designed to fit very snugly in
circumferential groove 20 in the advantageous non-metallic button bodies
of the present invention, thereby integrally connecting such non-metallic
button bodies with such metallic marker caps, the ring-type marker 30 is
similarly designed to fit snugly in the external peripheral groove 20 on
any of the non-metallic button bodies of the present invention. Like the
metallic caps discussed earlier herein, the metallic marker ring 30 will
be easily visible in any X-ray photgraph of the portion of a patient's
body tissue into which a catheter or surgical implant tube has been
implanted and has the external end thereof secured by one of the
advantageous integral non-metallic button/metallic marker element
combinations of the present invention.
In still a further embodiment, the metallic marker members of the present
invention may comprise a cap-like structure as illustrated in FIGS. 8 and
9 wherein the cap-like structure not only includes cylindrical flange 24,
but also include an integral metallic stem 32. As with the other marking
member embodiments of the present invention, the peripheral flange 24 of
the metallic cap-with-stem 32 is designed to fit tightly within peripheral
groove 20 on any of the non-metallic marker bodies of the present
invention. When such an integral combination is used to secure the end of
a catheter or surgical implant tube implanted in body tissue, the metallic
stem 32 may be crimped to even more effectively secure the catheter button
of the present invention to the exposed end of the catheter or implant
tube, or to secure a ribbon of radioactive material in an implant tube,
depending upon the particular combination of features present in the
button body.
The use of the ring-type metallic marker member 30 is more specifically
illustrated in FIG. 15, and in exploded isometric FIGS. 15A and 15B,
respectively which show, isometric views of the relationships between an
hemispherical non-metallic button body of the present invention and an
integral ring-type metallic marker 30 in integral combination as shown in
FIG. 15.
It will be appreciated that any of the various ring-type, cap-type or
cap-with-stem type metallic marking members of the present invention may
be used in integral combination with any of the various flat disk, disk
with stem, or disk with funnel-shaped stem, or disk with stepped-down
central opening embodiments of the advantageous non-metallic button
members of the present invention. As explained several times above, each
of the aforementioned embodiments of the metallic marking member are
designed to fit tightly in the peripheral groove 20 on the exterior
circumference of the non-metallic button body at the upper surface of that
button body.
If desirable to further enhance the integral connection between the button
body and metallic marker any suitable adhesive may be used to connect
same.
It will be appreciated that any suitable means for integrally connecting
the metallic marker with the button body, including the aforementioned
snug fitting of a marker disc, ring, cap or flange on the exterior of the
button body, fitting of the marker within a peripheral groove on the
exterior of the body or either of such fittings together with a suitable
adhesive between the same, may be used, and all such means are herein
called coupling means.
Together, the integral combination of the non-metallic button body and the
metallic marker member provide a very useful new catheter button system.
It will be appreciated that the integral button body/marker combination
completely eliminates the need for separate handling of two rather small
pieces in the surgical theater. This greatly reduces surgery times when
many implants are being made to treat difficult and complicated cases.
Furthermore, the advantageous marking members of the present invention
provide a means for providing unique indicia for each of the exposed ends
of a large number of implants in a single tissue site. Still further, as
discussed above, the catheter buttons of the present invention with their
funnel stem feature provide a quick and accurate means of threading
radioactive ribbons into such implant tubes, thereby minimizing
unnecessary exposure of patient and doctor or technician during
radiological treatments via such implants. Still further, the advantageous
step down feature provides a further secure relationship between the
button body and the exposed end of an implant tube with which same is
used. And still further as explained above herein, the stem portions of
the button bodies of the present invention provide still another means for
frictionally connecting the button body to the exposed end of an implant
tube by crimping the stem onto the exposed end of the implant tube. This
array of advantageous features is achieved by the unique integral button
body/stem and button body/metallic marker member combinations of the
present invention.
Still another feature of the advantageous system of the present invention
is illustrated in FIGS. 16 and 17 which show axial cross-sectional views
of metallic sleeve members designed to fit integrally over the exterior of
the stem portion of the non-metallic button members of the present
invention. FIGS. 16A and 17A, respectively, show end views of such
metallic sleeve members. FIG. 16B shows a metallic sleeve like that
illustrated in FIGS. 16 and 16A in integral combination with a
non-metallic button body having an integral stem, such as the button body
illustrated in FIG. 3. Similarly, FIG. 17B illustrates the metallic sleeve
illustrated in FIGS. 17 and 17A in integral combination with another
embodiment of the advantageous non-metallic button bodies of the present
invention, like that illustrated in FIG. 10. Not only do such sleeve
portions function as metallic marking members in X-ray photographs, but
also, such metallic sleeves facilitate secure crimping of the stem portion
of the button bodies of the present invention against the exterior of an
implant tube whose exterior end is secured by one of the advantageous
catheter buttons of the present invention.
The advantages of the system of the present invention become even more
clear when the presently claimed invention is compared to the primitive
catheter buttons or surgical tube securing devices which were previously
known, as discussed at the outset of this specification, some of which are
further illustrated in FIGS. 18-20. FIGS. 18, 20 and 20A, respectively
illustrate the two forms of catheter buttons typically used prior to the
advent of the present invention. FIG. 18 is a simple hemispherical
catheter button having a central opening and at least one suture hole,
while FIGS. 20 and 20A illustrate a simple flat disk catheter button
having at least a central opening and optionally having one or more suture
holes. Additionally, FIG. 19 shows a prior art metallic catheter button
wherein a peripheral flange as well as a central stem both extend axially
from the same side of the flat surface which comprises the bottom of that
metallic button. That metallic button was previously used with its flat
bottom surface in contact with a patient's skin, an arrangement which
further endangered the patient due to electron scattering initiated by
radiation from the radioactive materials used to treat the patient in the
implant tubes being secured by the buttons. In certain applications, such
as that illustrated in the Hilaris reference cited above herein, a
separate basic catheter button like that illustrated in FIG. 18 was used
along with a separate metallic catheter button like that illustrated in
FIG. 19 on the same exterior end of an implant tube to provide X-ray
marking as well as a means for securing the external end of the implant
tube.
However, none of those prior art devices, or even the occasional combined
use of separate prior art devices, in any way suggested the multiplicity
of advantages achieved by the presently claimed invention. Furthermore,
during the developments which resulted in the presently claimed invention
applicant has found that the processes by which the non-metallic button
bodies and the metallic marker members, respectively, are made, plays a
very substantial role in the successful combination of the two into a
truely integral non-metallic body/metallic marker combination. Previously,
non-metallic catheter buttons were typically made by punching the button
bodies from a sheet of molded plastic material such as nylon, and
thereafter drilling the desired holes therein. Applicant has discovered
that such procedures are not compatible size-wise and quality-wise with
the metallic marking members which are typically made by a different
manufacturer at a different site to different tolerances. Applicant has
found that it is greatly preferable for the advantageous non-metallic
button bodies of the present invention to be specifically molded to
provide very accurate control of tolerances so that the flange or ring
portion of the metallic marking member and the peripheral groove in the
complimentary non-metallic button body are precisely the same size to
provide the desired very tight for permanently integrally connecting the
two functional portions of the advantageous buttons of the present
invention. The manufacture of dies used in the molding process provides
the means for carefully controlling the tolerances of the resulting
non-metallic button bodies which successfully result in the presently
claimed invention.
While the non-metallic button bodies and integral stems of the present
invention may be made from known non-metallic materials including
ceramics, plastics or polymeric materials such as nylon and acrylics,
Zytel 330, a nylon manufactured by E. I. duPont de Nemours & Co., is
presently the most preferred material therefor. However, other forms of
nylon, and other polymeric material known under the tradename ALTEMP,
manufactured by General Electric Company, and Celcon, a crystalline
acetate copolymer based on trioxane, available from Celanese Corporation
of America, can be used. It is believed that a wide variety of suitable,
relatively inert, manmade polymer materials or other organic or inorganic
materials are suitable for use in manufacturing the non-metallic button
body portions of the presently claimed invention.
The metallic marker ring 30 or cap 14 is preferably made of stainless
steel. However, the cap 14 or ring 30 may comprise aluminum, brass,
copper, tungsten, nickel, silver, gold or gold copper alloys, or any other
suitable metallic material. Stainless steel and nickel are useful,
reasonably priced materials since they do not corrode or rust, and
additionally are non-toxic to body tissue and fluids.
While various embodiments of and materials for uses in the presently
claimed invention have been described in detail above herein, it will be
appreciated by those skilled in the art that certain modifications may be
made in those embodiments and their materials, shapes or sizes, which
modifications do not depart from the | | |
