U.S. patent number 3,880,137 [Application Number 05/464,637] was granted by the patent office on 1975-04-29 for two-piece implants.
This patent grant is currently assigned to Louis Bucalo, Investors In Ventures, Inc.. Invention is credited to Louis Bucalo.
United States Patent |
3,880,137 |
Bucalo |
April 29, 1975 |
Two-piece implants
Abstract
An implant for a living being. A tubular organ such as a vas
deferens is divided into a pair of separate portions having free
ends adjacent each other. The implant has a pair of parts which are
separately introduced into the lumens of the separate portions of
the tubular organ while the parts of the implant remain accessible
at the free ends of these separate portions of the tubular organ.
These parts which are thus accessible are then joined together to
render the implant operative without excessive stretching of the
tubular organ so that excessive slack is not produced therein. The
tubular organ may be a vas deferens while the implant is a vas
valve capable of reversively blocking flow in the vas deferens and
having the separate parts one of which is constituted by a tubular
component and the other of which is constituted by the remainder of
the vas valve, these parts being united after being introduced into
the lumens to provide the assembled vas valve.
Inventors: |
Bucalo; Louis (Holbrook,
NY) |
Assignee: |
Bucalo; Louis (Holbrook,
NY)
Investors In Ventures, Inc. (New York, NY)
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Family
ID: |
26988022 |
Appl.
No.: |
05/464,637 |
Filed: |
April 26, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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332019 |
Feb 12, 1973 |
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Current U.S.
Class: |
128/843;
606/153 |
Current CPC
Class: |
A61B
17/11 (20130101); A61F 6/24 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61F 6/00 (20060101); A61F
6/24 (20060101); A61B 17/03 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1R,274,33R,334C
;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Steinberg & Blake
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
The present application is a division of copending application Ser.
No. 332,019, filed Feb. 12, 1973 and entitled "Two-Piece Implants
and Implanting Methods."
Claims
What is claimed is:
1. An implant to be introduced into a tubular organ of a living
being after the tubular organ has been divided into a pair of
separate portions having free ends situated adjacent each other,
said implant comprising a pair of parts one of which is to be
introduced into the lumen of one of the separate portions and the
other of which is to be introduced into the lumen of the other of
the separate portions of the tubular organ, said parts remaining
accessible at free ends of said separate portions of the tubular
organ, and means operatively connected with said parts of the
implant for connecting them to each other at the region of the free
ends of the separate portions of the tubular organ for operatively
connecting said parts of said implant to each other and render the
implant operative after the parts thereof have been separately
implanted, the tubular organ being a vas deferens and the implant
being a vas valve, and said parts being respectively constituted by
a tubular component which forms one of the parts and the remainder
of the vas valve, said means for connecting said parts to each
other including male and female tapered mating portions of said
parts which fit together with a tight wedge fit, said one part of
said vas valve being an elongated tubular component having a female
portion of said means and terminating at said female portion of
said means in an outwardly directed flange which forms a
barrier.
2. The combination of claim 1 and wherein said barrier is formed
with openings passing therethrough.
3. An implant to be introduced into a tubular organ of a living
being after the tubular organ has been divided into a pair of
separate portions having free ends situated adjacent each other,
said implant comprising a pair of parts one of which is to be
introduced into the lumen of one of the separate portions and the
other of which is to be introduced into the lumen of the other of
the separate portions of the tubular organ, said parts remaining
accessible at free ends of said separate portions of the tubular
organ, and means operatively connected with said parts of the
implant for connecting them to each other at the region of the free
ends of the separate portions of the tubular organ for operatively
connecting said parts of said implant to each other and render the
implant operative after the parts thereof have been separately
implanted, the tubular organ being a vas deferens and the implant
being a vas valve, and said parts being respectively constituted by
a tubular component which forms one of the parts and the remainder
of the vas valve, said means for connecting said parts to each
other including male and female tapered mating portions of said
parts which fit together with a tight wedge fit, said parts being
respectively formed with bores extending along the entire length of
said parts, and a pair of mandrels to be situated in said bores
filling the latter during introduction of said parts into lumens of
the separate portions of the vas deferens, to prevent blocking of
said bores during introduction of the parts into the lumens,
respectively, so that after the parts are thus introduced into the
lumens said mandrels may be removed to provide unobstructed bores
in said parts of said valve.
Description
BACKGROUND OF THE INVENTION
The present invention relates to implants for living beings.
In particular, the present invention relates to implants which are
designed to be received in the lumens of tubular organs.
When an implant such as a vas valve is to be introduced into the
lumen of a tubular organ such as a vas deferens, it is customary to
divide the tubular organ such as the vas deferens into a pair of
separate portions which have free ends adjacent to each other. The
surgeon will then introduce the implant, such as a vas valve, first
into the lumen of one of the separate portions of the tubular organ
and then into the lumen of the other of the separate portions of
the tubular organ. Because the parts of the implant which are
respectively received in these lumens of the separate portions of
the tubular organ are relatively long, it is necessary for the
surgeon to stretch the tubular organ and distend it to an
undesirable extent in order to be able to effectively introduce the
implant into the lumens of the separate portions of the tubular
organ. The result of these procedures is that a considerable amount
of slack is introduced into the tubular organ resulting sometimes
in prevention of reestablishment of flow when an implant such as a
valve is placed in its open position.
A further problem which is encountered with an implant which is in
the form of a valve is that it is cometimes difficult for the
physician to know from the exterior of the valve when it is in its
open position and when it is in its closed position.
In addition, when the implant is a valve, it sometimes happens that
the openings at the opposed free ends of the valve become blocked
by substances situated in the lumen of the vas deferens or the
like, so that even when the valve is open to reestablish flow
through the tubular organ, such flow cannot be reliably
established.
In this latter connection, it sometimes happens that even during
introduction of the implant into the lumen, substances in the lumen
itself flow into the interior of the implant blocking the interior
of the implant and preventing flow therethrough in an undesirable
manner.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide an implant which will avoid the above drawbacks.
In particular, it is an object of the present invention to provide
an implant which will avoid the necessity of excessive distension
of the tubular organ during introduction of the implant into the
lumen thereof.
A more specific object of the present invention is to provide an
implant in the form of a vas valve which can be introduced into a
tubular organ formed by a vas deferens in such a way that excessive
distension of the latter will not be required.
It is also an object of the present invention to provide a vas
valve which can be introduced into the vas deferens in a manner
which will avoid blocking of the interior of the valve.
Furthermore, it is an object of the present invention to provide a
vas valve which can reliably reestablish flow through the valve
whenever desired even if it should happen that the outer free ends
of the valve become blocked.
Yet another object of the present invention is to provide a vas
valve which can be reliably placed without difficulty in open and
closed positions.
Yet another object of the present invention is to provide a vas
valve which will reliably prevent movement of sperm along the
exterior of the valve so that only movement of sperm through the
interior of the valve is assured when the valve is placed in an
open position.
According to the method of the invention, the tubular organ which
is to receive the implant is cut through so as to form a pair of
portions having free ends situated adjacent each other, and then a
two-part implant has its respective parts introduced separately
into the lumens of the separate portions of the tubular organ with
the two parts of the implant accessible at the free ends of these
separate portions. These separate parts of the implant are then
joined to each other so as to render the implant operative and so
as to complete the assembly thereof, and through this expedient it
becomes possible to introduce the implant without excessive
distension of the tubular organ.
The implant of the invention includes a pair of components adapted
to be separately introduced into the lumens of the separate
portions of the tubular organ, and these components carry a means
for connecting them to each other after they are respectively
introduced into the lumens of the separate portions of the tubular
organ so as to render the implant operative. Thus, in the specific
case of a vas valve, the implant which is formed by the vas valve
is composed of a pair of parts one of which includes a simple
tubular part and the other of which includes the remainder of the
vas valve, and these components carry a means such as male and
female mating tapered portions which can be placed one in the other
with a wedge fit so that they will remain assembled and render the
implant operative after its separate components have been
separately introduced into the lumens of the separate portions of
the vas deferens.
BRIEF DESCRIPTION OF DRAWINGS
The invention is illustrated by way of example in the accompanying
drawings which form part of this application and in which:
FIG. 1 is a longitudinal sectional elevation schematically
illustrating a vas deferens with an implant of the invention
situated therein;
FIG. 2 is an end view of the vas valve of FIG. 1 as seen from the
right of FIG. 1;
FIG. 3 is a fragmentaty sectional elevation illustrating the
connecting means carried by the separate components of the vas
valve for connecting them to each other;
FIG. 4 is a fragmentary side elevation of one end region of the vas
valve, the other end region having the same construction;
FIG. 5 is a transverse sectional elevation of the structure of FIG.
4 taken along line 5--5 of FIG. 4 in the direction of the
arrows;
FIG. 6 is a schematic illustration of the introduction of an
implant into a tubular organ;
FIG. 7 shows in elevation a mandrel to be used with one of the
components of FIG. 1;
FIG. 8 is an illustration of another mandrel to be used with the
other of the components of the vas valve of FIG. 1;
FIG. 9 is a fragmentary side elevation of one end of the vas valve
of FIG. 1 showing a further addition thereto; and
FIG. 10 is a transverse section of the structure of FIG. 9 taken
along line 10--10 of FIG. 9 in the direction of the arrows.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to FIG. 1, the implant 10 of the invention is in the form
of a vas valve in the illustrated example. This valve includes a
pair of parts 12 and 14. The part 12 is in the form of an elongated
tube made of any suitable material which is compatible with the
body, while the part 14 includes the rest of the vas valve. Thus,
the part 14 includes the valve housing 16 carrying in its interior
the rotary valve member whose stem is connected to the turnable
element 18 at the exterior of the valve. This element 18 is turned
for the purpose of opening and closing the valve. In addition, the
part 14 includes the tubular element 20 which is integral with and
extends to the right from the housing 16, as illustrated in FIG. 1.
This tubular part 20 may be located at the test side of the valve
while the part 12 may be located at the urethral side.
The tubular part 12 is formed at the region of its free end which
is distant from the part 14 with a longitudinally extending slot 22
extending completely across the tubular part 12 inwardly from the
left free end thereof, as viewed in FIG. 1, through the distance
indicated in FIG. 1. In the same way, the tubular part 20 is formed
with an elongated slit 24 extending completely across the part 20
and inwardly from the right free end thereof through a distance
such as that indicated at the right in FIG. 1.
In addition, the part 12 terminates at its right end in a barrier
flange 26 formed, as shown in FIG. 2, with four peripheral
V-notches 28 displaced by 90.degree. with respect to each other
about the periphery of the flange 26 so as to promote the ingrowth
of tissue into these notches and thus provide a secure lodging of
the part 12 in the vas deferens which forms the tubular organ in
the illustrated example.
A means is provided for fastening the parts 12 and 14 to each other
after they are respectively introduced into the lumens of the
separate portions of vas deferens which are illustrated in FIG. 1.
Thus, before the implant 10 is situated in the tubular organ, this
organ is transversely cut through so as to be divided into a pair
of separate portions. Thus it will be seen that the vas deferens
illustrated in FIG. 1 includes the elongated left portion 30 and
the elongated right portion 32, these portions respectively
terminating in the free ends 34 and 36 which are adjacent each
other. As may be seen from FIG. 6, after the vas deferens
illustrated has been cut through, its separate portions 30 and 32
need only be deflected to an extremely small extent so as to be
capable of receiving the implant of the invention. The part 30
which is angularly positioned approximately as shown in FIG. 6 will
separately receive the tubular part 12 of the vas valve, this part
being first covered at its exterior with a filamentary material
such as gold wire 38. This wire may be wound around the exterior of
the tubular part 12 and may also take the form of a suitable braid.
Thus, by way of the use of this filamentary material it is possible
to promote the ingrowth of tissue into intimate contact with the
exterior surface of the tubular part 12, so as to greatly reduce
the possibility of travel of sperm along the exterior of the
tubular component 12.
In the same way, with the separate portion 32 of the vas deferens
situated somewhat as illustrated in FIG. 6, it is possible for the
surgeon to introduce the other part 14 into the lumen of the
separate portion 32. This part 14 also carries at the exterior of
the tubular extension 20 the filamentary material 40 in the form a
gold wire or braid which covers the exterior surface of the tubular
portion 20, and it will be noted that this material is extended all
the way up to the part of the housing 16 which engages the vas
deferens, and the braid or wire 38 also extends all the way up to
the part of the flange 26 which engages the vas deferens. Thus, the
ingrowth of tissue will also be promoted into intimate contact with
the exterior surface of the part 20 and the part of the housing 16
adjacent to the part 20 in order to reduce the possibility of
travel of sperm along the exterior of the part 14.
These parts 12 and 14 of the implant carry a means 42 for
interconnecting these parts with each other after they have been
introduced into the lumens of the separate portions 30 and 32 of
the tubular organ. This connecting means 42 is shown in detail in
FIG. 3. Thus in accordance with the illustrated example the tubular
part 12 has at the region of the flange 26 a female component 44
which is hollow and tapered at its interior, while the part 14 has
a mating male component 46 which has at its exterior a taper which
matches that of the interior of the female component 44. Thus, with
this construction after the two parts of the valve are respectively
received in the lumens of the separate portions 30 and 32, the male
component 46 and the female component 44 of the connecting means 42
are joined together with the male part 46 received with a tight
wedge fit in the female part 44, so that in this way the valve is
rendered operative.
As a result of this feature the extent to which the tubular organ
must be distended is greatly reduced so that there is very little
if any slack which will produce undesirable curvature of the
tubular organ preventing in some cases the desired reestablishment
of flow through the tubular organ. Thus, by dividing the implant
into two parts which are joined to each other after the parts are
respectively received in the lumens of the separate portions of the
tubular organ, it is possible to join these parts together in such
a way that the extent to which the tubular organ must be stretched
and displaced from its initial location is very greatly
reduced.
According to a further feature of the invention, prior to
introducing the part 12 into the lumen of the portion 30 of the vas
deferens, the mandrel 48 shown in FIG. 7 is situated in the
interior of and fills the longitudinal bore of the part 12 so that
this bore will not become blocked by or receive any of the material
within the portion 30 of the vas deferens. In the same way a second
mandrel 50 is situated in and completely fills the tubular part 20
at the bore of the latter so that this bore cannot become blocked
during introduction of the part 14 into the lumen of the separate
portion 32 of the vas deferens. For this purpose it is to be noted
that the part 18 is turned so as to situate the valve in its open
position, and the mandrel 50 is long enough to extend through the
bore of the rotary valve member as well as through the male part 46
of the connecting means and of course through the entire length of
the tube 20 all the way up to the right end of the latter.
In this connection it is to be noted that after completion of the
implanting procedures even if it should happen that the free ends
of the tubular part 12 and 20 which are distant from each other
become blocked, it will nevertheless be possible for the semen and
other fluids to enter into the bores of the tubular parts 12 and 20
through the slots 22. Thus, after the implant has been introduced
into the tubular organ, the valve will, after a certain period of
time, be turned to its closed position. For this purpose the rotary
part 18 carries a cross pin 52 received in suitable slots of a
rotary wrench 54 shown in phantom lines in FIG. 1. The part 18
fixedly carries a springy detent 56 capable of being received
either in the recess 58, at the periphery of an upper flange of the
housing 16, when the valve is in its open position as illustrated,
or in a detent recess 60 displaced 90.degree. from the recess 58.
When the springy detent 56 is in the recess 60 the valve is closed.
Thus by providing these detent recesses and the springy detent
member 56 it is possible for the operator to reliably locate the
valve either in its open or closed position without any
difficulty.
It will be noted from FIGS. 7 and 8 that the mandrels 48 and 50 are
respectively provided with handles 62 and 64. After the part 12 has
been situated within the lumen of the separate portion 30 of the
vas deferens, the mandrel 48 is removed, and the handle 62 is
provided to facilitate the introduction and removal of the mandrel
48 from the tubular part 12. In the same way, after the part 14 has
been received in the lumen of the separate portion 32 of the vas
deferens, the mandrel 50 is removed, and the handle 64 facilitates
the introduction and removal of the mandrel 50 from the part
14.
It is to be noted that the slots 22 and 24 may be replaced by a
series of lateral openings 66 illustrated in FIGS. 4 and 5. Thus,
instead of longitudinally extending slots as illustrated in FIG. 1,
it is possible to provide the free ends of the valve each with a
plurality of openings 66 as shown in FIGS. 4 and 5 at the free end
of the tubular part 20, and thus with this construction also if it
should happen that the free end of the tubular extension becomes
blocked nevertheless it will be possible for fluid to enter through
the lateral openings 66. Thus, this construction of FIGS. 4 and 5
is also included at the left end portion of the part 12 instead of
the slot 22, if desired. Therefore, either with the slots 22 and 24
or with the lateral openings 66 it is possible when the valve is
placed in its open position to reestablish flow through the tubular
organ in a highly reliable manner even if it should happen that the
free ends of the tubular organ becomes blocked.
Thus, the vas valve 10 will initially remain in its open position
until a sufficient time has elapsed for the implant to become
properly lodged in the tubular organ with ingrowth of tissue
occurring and with no possible build up of pressure within the
tubular organ. Then the valve may be placed in its closed position
so as to block the flow, and thus reliably prevent conception. In
this connection it is to be noted that the ingrowth of tissue at
the filamentary material at the exterior of the valve greatly cuts
down any possibility of travel of sperm along the exterior of the
valve. This prevention of travel of sperm along the exterior of the
valve is greatly enhanced by the presence of the barrier 26.
However, if it should be desired at any future time to reestablish
the flow of fluid through the vas deferens, the valve can be
returned to its open position, and then by reason of the slots 22
and 24 or the openings 66 a reliable reestablishment of flow is
assured. Furthermore, because of the minimal distension of the
tubular organ during the introduction of the implant, according to
the method of the invention, utilizing a two-part implant which has
its parts connected to each other after they are received in the
tubular organ, as described above, there is no possibility of
formation of loops or other undesirable configurations in the
tubular organ resulting from undesirable slack therein, so that in
this way also a reestablishment of flow is assured and the
possibility of undesirable growths or the like which could result
from such slack is also reliably avoided.
In order to further prevent blocking of the interior of the vas
valve, further measures are taken in accordance with further
features of the invention.
Thus, upon cutting through the vas to provide the separated
portions 30 and 32 shown in FIG. 6, it will be found that lumen is
covered with a layer of mucosa. In accordance with a further
feature of the present invention a suitable reamer which is not
illustrated is introduced into the lumen of the portion 30 of the
vas so as to remove from the inner surface the lining of mucosa at
least through a length equal to that which will subsequently be
occupied by the left portion of the valve as illustrated in FIG. 1.
The same operations are then performed with the right portion 32 of
the vas deferens so that in the latter also the inner lining of
mucosa is removed at least through a length sufficient to
accommodate the right portion of the valve as illustrated in FIG.
1. Thus, through this expedient of reaming out the mucosa linings
along the lumen portions where the vas valve is to be accommodated
there is a considerable reduction of possibility of blocking the
valve passages during introduction of the valve into the lumen of
the vas.
Furthermore, as is illustrated in FIGS. 4 and 5, according to a
further feature of the invention the exterior surfaces of the valve
at the region of its opposed ends is provided with a coating of
plastic 70. Thus, FIGS. 4 and 5 illustrate that embodiment where
the opposed ends are provided with the lateral openings 66 as
described above, but the plastic coating of FIGS. 4 and 5 can also
be utilized with the embodiment of FIG. 1 where the opposed ends of
the valve are provided with the slots 22 and 24. In the case of
FIGS. 4 and 5 the openings 66 are not covered by the plastic layer
70, and of course with the embodiment of FIG. 1 the slots 22 and 24
also would not be covered by the plastic coating. This plastic
coating 70 which is deposited in any suitable way on the exterior
surface of the valve at its opposed end regions as illustrated in
FIGS. 4 and 5 has the property of bonding itself intimately to the
exterior surface of the valve so that it will remain securely
connected thereto, and in addition the plastic coating will prevent
the vas from adhering at its lumen to the exterior surface of the
valve at the end regions thereof which are provided with the
plastic coating 70. This plastic coating may be made of any plastic
which will not adhere to the inner surface of the vas deferens. For
example Teflon may be used for the plastic layer 70 which will
prevent the vas from adhering to the outer end regions of the valve
so that in this way there is an assurance that the openings 66 will
remain free and clear to function properly whenever it is desired
to reestablish fluid flow. Of course the same results will be
achieved when the plastic coating is provided with the embodiment
of FIG. 1. While Teflon has been mentioned above, it is of course
possible to use any other plastic which is compatible with the
human body and which has the property of preventing the vas from
adhering to the surface of the plastic.
A further expedient for achieving results similar to those achieved
with the embodiment of FIGS. 4 and 5 is illustrated in FIGS. 9 and
10. Thus, referring to FIGS. 9 and 10 it will be seen that the end
of the valve which has the slot 24 has deposited thereon elongated
and circumferential beads 72. These beads 72 are made of a metal
which is different from the metal used for the valve. The
longitudinal and circumferential beads 72 are deposited in any
suitable way on the elongated free end portion of the valve which
is provided with the slot 24 shown in FIGS. 9 and 10, and of course
the opposed elongated end region of the valve which is provided
with slot 22 is also provided with these beads of metal 72. The
beads of metal 72 are made of any metal which is different from the
metal used for the valve. For example if the elongated end regions
of the valve are made of gold, then the beads 72 may be made of
platinum or nickel.
Of course, this deposition of beads of a dissimilar metal on the
exterior surface of the end regions of the valve can also be used
with the embodiment of FIGS. 4 and 5, in which case the beads will
not close any of the openings 66. It will be noted that the beads
do not close the slots 22 or 24.
As a result of the presence of the dissimilar metals there is an
automatic generation of microvoltages which have the effect also of
preventing adherence of the vas to the regions of the valve where
the dissimilar metals are located. Therefore by depositing on the
end regions of the valve beads 72 of a metal different from the
metal on which the beads are deposited there is an automatic
creation of microvoltages which will reliably prevent adhering of
the vas to the end regions of the valve. It is to be noted that the
beads 72 are shown at a considerable distance from each other in
FIGS. 9 and 10 for the sake of clarity. Actually the network of
longitudinal and circumferential beads will be denser than
illustrated in FIGS. 9 and 10.
Therefore, by way of these expedients it is possible on the one
hand to prevent the vas from adhering to the end regions of the
valve and on the other hand by reaming out the interior mucosa
linings initial blocking of the valve during introduction of the
latter into the lumen is also reliably prevented.
* * * * *