U.S. patent number 3,921,632 [Application Number 05/498,079] was granted by the patent office on 1975-11-25 for implant device.
Invention is credited to Frank M. Bardani.
United States Patent |
3,921,632 |
Bardani |
November 25, 1975 |
Implant device
Abstract
A tubular member has a central longitudinal axial bore
therethrough, a pointed elongated annular concavely bevelled
implanting end and a charging end. The implanting and charging ends
communicate with the bore. A first plunger having a solid pointed
elongated annular concavely bevelled implanting end is adapted to
be removably inserted in the bore for slidable movement therein.
When the first plunger is completely inserted in the bore of the
tubular member the implanting ends are aligned to form a
complimentary substantially continuous, pointed, elongated, annular
concavely bevelled penetration surface. The first plunger is
slidably moveable in the bore of the tubular member from a first to
a second position at which insertion of the first plunger in the
bore is complete. Means are optionally provided for aligning the
implanting ends at only the second position.
Inventors: |
Bardani; Frank M. (Rye,
NY) |
Family
ID: |
23979522 |
Appl.
No.: |
05/498,079 |
Filed: |
August 16, 1974 |
Current U.S.
Class: |
604/891.1;
604/60; 424/423 |
Current CPC
Class: |
A61M
37/0069 (20130101) |
Current International
Class: |
A61M
31/00 (20060101); A61M 5/00 (20060101); A61M
005/00 (); A61M 031/00 () |
Field of
Search: |
;128/221,217,264,218D,214.4,347,2B,218P,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Michell; Robert W.
Assistant Examiner: Opitz; Rick
Attorney, Agent or Firm: Simon, Esq.; Morton S.
Claims
What is claimed is:
1. An implant device comprising:
a. a tubular member having a central longitudinal axial bore
therethrough, a pointed elongated annular concavely bevelled
implanting end, and a charging end, each of said ends communicating
with said bore;
b. a plunger having a solid, pointed, elongated annular concavely
bevelled end, said plunger being removeably inserted in said bore
and slideably movable therein along the longitudinal axis of said
tubular member from a first position to a second position at which
maximum insertion of the plunger into the bore is obtained and the
implanting end of the tubular member and the pointed end of the
plunger are aligned to form a complimentary substantially
continuous pointed elongated annular concavely bevelled penetration
surface; and
c. means for aligning said implanting end and said pointed end,
said means for aligning being only one semicircular projection on
the charging end of the tubular member, said first projection
extending for a distance in the axial direction whereby a pill
receiving trough is formed for facilitating introduction of an
implant dosage form into the bore of the tubular member, and a
second semi-circular projection on the plunger, the first and
second projections being complimentary and alignable at only the
second position, alignment of the first and second projections
serving to simultaneously align said implanting end and said
pointed end, said first projection being an extension of the
charging end and having a first shoulder and a second shoulder,
said plunger having a head portion the diameter of which is larger
than the diameter of bore of the tubular member, said second
projection being an extension of the head portion of the plunger
and having a third shoulder and a fourth shoulder, said plunger
being movable within said bore from the first position to the
second position only when the first and second shoulders are
aligned opposed to and in sliding contact respectively with the
third and fourth shoulders.
2. The device as claimed in claim 1 further including an insertion
limiting stop member on said tubular member for limiting the
maximum depth of penetration of the implanting end of the tubular
member.
3. The device as claimed in claim 2 wherein the stop member is
fixed in position on the tubular member.
4. The device as claimed in claim 2 wherein the stop member is
adjustable in position on the tubular member.
5. The device as claimed in claim 4 wherein said stop member has a
longitudinal axial bore adapted to receive said tubular member for
slidable movement therein further including gripping means for
releasably frictionally fixing the stop member in a selected
position on said tubular member.
6. The device as claimed in claim 4 wherein the stop member has a
first longitudinal axial bore, the tubular member is disposed
within, and slidably movable along the axis of, said first
longitudinal axial bore, said stop member having an internally
threaded second bore communicating with the first longitudinal
axial bore, and a complimentary threaded set screw in said second
bore threadable into frictional engagement with the tubular member
to fix the position of the stop member on the tubular member.
7. The device as claimed in claim 2 wherein said stop member is
substantially hour-glass shaped.
8. The device as claimed in claim 2 wherein said stop member 7 also
serves as a finger hold.
9. The device as claimed in claim 1 further including means on the
tubular member for facilitating gripping of the device.
10. The device as claimed in claim 1, wherein said implanting end
and said pointed end are substantially ellipsoidal.
11. The device as claimed in claim 1 wherein the first projection
is a cutout of the charging end of the tubular member and the
second projection is a cutout of the head portion of the plunger.
Description
The present invention relates to an improved device for
administration of drugs. More particularly, the invention relates
to an improved device for subcutaneous introduction of drug
implants, preferably in pellet form.
Techniques and devices for introducing solid medicaments beneath
the skin are known to the art. Medical use of drug implants was
initiated as early as 1861, see Howard Jones, N., J. Hist. Med. 2,
201 (1947). Implants have advantageously been used for
administration of hormones, such as testosterone, estradiol and
other drugs, where slow, constant release and continuous absorption
of a drug for prolonged time periods is desired. The long lasting
effect of a drug implant frees the patient from the need to take
multiple periodic parenteral or oral doses. Implant therapy is
often in the long run more economical. Moreover, where a dosage
regimen is critical use of implants eliminates the possibility of
missed doses. Though clinical use of pellet implants has declined
with the development of oral dosage forms, it nevertheless remains
a valuable medical tool in for example, drug absorption studies.
Surface area of an implant is readily determined and controlled.
Moreover, the effective area of a pellet in contact with body
tissues can be measured before and after implantation by simple
direct inspection of the implant.
As stated heretofore, devices for subcutaneous introduction of
implants are disclosed in the prior art. One such device comprises
an injector needle, having a central longitudinal axial bore and a
sharp bevelled end, a first plunger having a sharp bevelled end and
a second plunger having a blunt end. The first plunger and the
second plunger are each removably insertable within the bore of the
injector needle. The technique employed with this prior art device
is as follows:
The area wherein the pellet is to be inserted is anesthesized with
a local anesthetic. A small incision is made in the skin to permit
free passage of the injector needle. The first plunger is inserted
into the bore of the injector needle, then the injector needle,
with the first plunger in place, is inserted into the subcutaneous
tissue. When insertion of the injector needle is complete the first
plunger is withdrawn from the bore. A drug pellet is then
introduced into the injector bore and gently forced down the bore
and into the subcutaneous tissues with the blunt end of the second
plunger. Once the pellet is fully inserted, the injector with the
second plunger seated in the bore is simultaneously withdrawn. The
incision is then closed with sutures, a clip, or an adhesive
bridge, etc.
The aforementioned prior art device has, however, not proven
successful since it suffers from several major defects. First, a
preliminary surgical incision is required before the device can be
employed. Second, if upon insertion into the subcutaneous tissues
the injector needle with first plunger in place is not properly
oriented, that is to say, the bevelled sharp end of the first
plunger is not in alignment with the bevelled sharp end of the
injector needle, insertion of the device will result in
considerable tearing of the tissues.
The device of the present invention constitutes an improvement over
the above described prior art device. Use of the present device
obviates the need for preliminary surgical incision. The instant
device makes a clean incision. No stitching or sutures are
generally thereafter required. Furthermore, in the device of the
present invention, means are provided for preventing improper
orientation of the sharp end of the injector needle and the sharp
end of the first plunger whereby disadvantageous tearing of the
skin and tissues is avoided.
The present invention will now be described in greater detail with
reference to the accompanying drawings in which like elements are
assigned the same numerical designation.
In the drawings:
FIG. 1 is a plan view, partially in section, of a preferred
embodiment of the instant invention;
FIG. 2 is a top plan view showing the complimentary positioned ends
respectively of the tubular member and first plunger of FIG. 1;
FIG. 3 is a cross-sectional view taken along the line 3--3 of FIG.
1, and
FIG. 4 is a plan view, partially in section, of the tubular member
of FIG. 1 with the second plunger in place, and shown after
delivery of a drug pellet.
Referring now to FIG. 1: Injector needle or tubular member 1 has a
longitudinal axial bore 2 therethrough, a pointed elongated annular
concavely bevelled implanting end 3 and a charging or inlet end
portion 4. Bore 2 communicates with end 3 and with inlet end
portion 4. A finger hold 5 which can also serve as an insertion
limiting stop member is mounted on tubular member 1. A first
plunger 6 comprised of solid rod portion 7, head portion 8 and a
pointed elongated annular concavely bevelled end 9 is removably
insertable in bore 2 of tubular member 1 for slidable movement
therein along the longitudinal axis of said tubular member 1 from a
first position to a second position. As shown in FIGS. 1 and 2, end
3 of tubular member 1 and end 9 of first plunger 6 are elongated
and annular, more particularly they are substantially ellipsoidal.
As is more clearly shown in FIGS. 2 and 4 ends 3 and 9 can be
aligned to present a complimentary elongated annular concave
surface. Means are provided on the first plunger 6 and on the
tubular member 1 to ensure that this complimentary alignment of
ends 9 and 3 occurs only at one position, viz. the second position
referred to above.
As shown in FIG. 1 and 4, end portion 4 of tubular member 1 has a
cutout forming a troughlike lip or projection 11 having shoulders
13 and 13' . Head portion 8 of first plunger 6 has a complimentary
semicylindrical lip or projection 12 having shoulders 14 and 14' .
As is clear from FIG. 3 lips or projections 11 and 12 will mesh in
only one position, that is when shoulders 13 and 13' respectively
are aligned opposed to and in contact with shoulders 14 and 14' .
Moreover, rod portion 7 of first plunger 6 can only be inserted
within bore 2 of tubular member 1 to the second position when
projections 11 and 12 are positioned so that shoulders 13 and 13'
are aligned with respect to shoulders 14 and 14' . When so aligned
shoulders 14 and 14' can be slidably moved along opposing
juxtaposed shoulders 13 and 13' from the first position to the
second position at which point only ends 9 and 3 are in alignment
as shown in FIGS. 1 and 2.
When at the second position, complimentary aligned ends 9 and 3
present a substantially continuous pointed elongated annular
concavely bevelled tip. Providing the device of the present
invention with such a tip accounts for certain significant
advantages over prior art straight bevelled tips. The device of the
instant invention readily penetrates the skin and underlying
subcutaneous tissue. No preliminary surgical incision is required.
Less pain and tissue damage is occasioned and the need for surgical
sutures to close the puncture is generally obviated.
Finger hold 5 is provided on tubular member 1. Hold 5 optionally
functions to limit the maximum depth of penetration of end 3 of
tubular member 1 to the distance between point 10 of end 3 and
shoulder portion 21 of body 15. As shown in FIGS. 1 and 4 body 15
is preferably hour-glass shaped so as to provide a convenient
gripping surface for the fingers. One end of hour-glass shaped body
15 is unitary with shoulder portion 21. Hold 5 can be fixed in
position on or unitary with tubular member 1. Alternatively, it can
be adjustable in position along tubular member 1. This optional
adjustability feature of hold 5 enables it to be positioned at any
one of a plurality of points along the longitudinal axis of tubular
member 1 thereby permitting regulation of the maximum depth of
penetration of end 3 into the subcutaneous tissues.
Optional adjustability of the position of hold 5 on tubular member
1 can be attained by providing body 15 with releasable friction
gripping means for frictionally lockiing body 15 in a selected
fixed position on tubular member 1. Alternatively, tubular member 1
can be provided with an external male threaded surface and body 15
with internal complimentary female threads or vice-versa whereby
the position of hold 5 along the longitudinal axis of tubular
member 1 can be suitably adjusted by threading body 15 toward or
away from end 3. Alternatively, as shown in FIG. 4 hold 5 has a
longitudinal bore therethrough adapted to slidably receive tubular
member 1. A second internally threaded bore 23 is provided in body
15 and is adapted to receive therein complimentary threaded set
screw 22. Set screw 22 may be threaded into bore 23 to contact
tubular member 1 and frictionally fix the position of hold 5
thereon. Set screw 22 can be provided with a slotted head adapted
to receive a screwdriver to facilitate tightening of same. Other
means for providing optional adjustability of the position of hold
5 on tubular member 1 will readily suggest themselves to the
skilled artisan.
FIG. 4 illustrates a further embodiment of the device of the
present invention, blunt plunger 16. Plunger 16 is comprised of a
solid rod 17 having an enlarged head portion 18 at one end and a
blunt tip 19 at the other end. Like rod portion 7 of the first
plunger 6, rod 17 is adapted for removable insertion in bore 2 of
tubular member 1 for slidable movement therein along the
longitudinal axis of tubular member 1. Head portion 18 is larger in
diameter than the diameter of bore 2. Thus it serves as a stop
which limits the maximum extension of rod 17 within bore 2. As
shown in FIG. 4, blunt plunger 16 is preferably of sufficient
length so that when fully inserted within bore 2 of tubular member
1 blunt tip 19 of rod 17 extends beyond the tip 10 of end 3 of
tubular member 1. This facilitates complete removal of pellet 20
from bore 2.
Understanding of how the components of the device of the present
invention cooperate to achieve subcutaneous implant of a drug
pellet is best acquired by a consideration of how the device is
employed.
Rod portion 7 of the first plunger 6 is inserted within bore 2 of
tubular member 1 so that shoulders 13 and 13' of projection 11 of
tubular member 1 are aligned opposed to and in juxtaposition with
respect to shoulder 14 and 14' of projection 12 of head portion 8
of the first plunger 6. Rod portion 7 may then be slidably moved in
the direction of stop 5 to the second position at which point only
end 9 of the first plunger 6 and end 3 of tubular member 1 are
complimentarily aligned and form with one another a substantially
continuous, pointed, elongated, annular, concavely bevelled
surface. Hour-glass shaped body 15 of hold 5 is then grasped
between the pointer and index fingers with the thumb resting on
head portion 8 of the first plunger 6. Hand pressure is then
applied to drive the complimentarily aligned ends of tubular member
1 and first plunger 6 into the subcutaneous tissues. Hold 5
optionally serves to limit the depth of penetration and may
optionally be suitably adjusted prior to insertion of the device.
When the desired degree of penetration is achieved the device is
withdrawn slightly so as to leave in the subcutaneous tissues
adjacent the withdrawn tip 10 a pocket adapted to receive a
subsequently injected pellet. Thereafter first plunger 6 is
completely withdrawn from bore 2 of tubular member 1. A drug pellet
20 is placed on the troughlike lip or projection 11 then driven
into and seated within the previously prepared pocket in the
subcutaneous tissues by downward slidable movement of blunt plunger
16 in bore 2. Since blunt tip 19 of plunger 16 extends beyond tip
10 of tubular member 1 complete release of pellet 20 from the
device is assured. Once the pellet is seated the tubular member 1
and blunt plunger 16 are simultaneously withdrawn. No sutures are
generally required to close the puncture.
The device of the present invention can be readily fabricated out
of for example stainless steel, carbon steel, hyperchrome steel,
chromium, nickeloid, platinum, platinum iridium, gold or silver.
Other materials will readily suggest themselves to those skilled in
the art.
A further optional modification of the preferred embodiment of the
instant invention is the provision of a protective guard for point
10 of end 3 of the tubular member 1. The protective guard may be
rigid or plastic material. The guard is preferably a tubular sleeve
closed at one end and open at its other end and is adapted to
receive through the open end and encase and protect point 10 of end
3.
* * * * *