U.S. patent number 3,826,241 [Application Number 05/298,024] was granted by the patent office on 1974-07-30 for implanting method.
This patent grant is currently assigned to Investors in Ventures, Inc.. Invention is credited to Louis Bucalo.
United States Patent |
3,826,241 |
Bucalo |
July 30, 1974 |
IMPLANTING METHOD
Abstract
A method for implanting artificial devices in the bodies of
living creatures such as human beings. The device is initially
embedded in tissue of the living creature where the device is
permitted to remain until ingrowth of tissue into intimate contact
with the exterior surface of the device is completed. Then the
device is removed while retaining thereon a layer of the tissue
which has grown into contact with the device, and the device with
this layer of tissue thereon is then implanted in the body at the
location where the device is to be used in the body with tissue at
this latter part of the body engaging the tissue which has
previously grown onto the device, so that the possibility of
rejection of the device is reduced.
Inventors: |
Bucalo; Louis (Holbrook,
NY) |
Assignee: |
Investors in Ventures, Inc.
(New York, NY)
|
Family
ID: |
23148681 |
Appl.
No.: |
05/298,024 |
Filed: |
October 16, 1972 |
Current U.S.
Class: |
128/843; 433/173;
128/898; 606/153; 623/1.1 |
Current CPC
Class: |
A61L
27/306 (20130101); A61F 2/2476 (20200501); A61F
2310/00568 (20130101); A61F 2240/001 (20130101); A61F
2/24 (20130101); A61C 8/00 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61L 27/00 (20060101); A61L
27/30 (20060101); A61C 8/00 (20060101); A61F
2/00 (20060101); A61f 001/24 (); A61b 019/00 () |
Field of
Search: |
;3/1,DIG.3
;128/1R,334R,92C,92CA,419P ;32/1A |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Steinberg & Blake
Claims
What is claimed is:
1. In a method for implanting in the body of a living creature such
as a human being an artificial implant device which has an exterior
surface which is impervious to the growth of tissue so that tissue
cannot grow into the device beyond the exterior surface thereof,
the steps of initially embedding the device in tissue of the living
creature at a location different from a predetermined location at
which the device is ultimately to be located and remain, while
exposing only the exterior surface of the device to the tissue and
permitting the device to remain in the tissue in which it is
initially embedded until ingrowth of tissue into intimate contact
only with the exterior surface of the device is completed, then
removing the device from the location at which it was initially
embedded while retaining only at the exterior of the device tissue
which has grown into contact only with the exterior surface of the
device, and then surgically obtaining access to said predetermined
location and implanting the device with the tissue thereon only at
the exterior surface thereof at said predetermined location with
the tissue at the exterior of the device engaging tissue located at
said predetermined location, and then surgically closing off access
to said predetermined location so that at said predetermined
location tissue of the body need only become united with tissue of
the same body, whereby the possibility of rejection of the device
is reduced.
2. A method as recited in claim 1 and including the step of
preliminarily locating at the exterior surface of the device, prior
to initial embedding thereof, a means which will permit the
ingrowth of tissue.
3. A method as recited in claim 1 and wherein the tissue is
initially embedded at a part of the body where a relatively large
volume of tissue is readily accessible from the exterior of the
body.
4. A method as recited in claim 3 and wherein the part of the body
where the device is initially embedded is a buttock.
5. A method as recited in claim 1 and wherein said predetermined
location is the interior of a body cavity which is lined with
tissue placed in engagement with the tissue preliminarily grown
onto the device and retained thereon when the device is removed
from the location at which it is initially embedded.
6. A method as recited in claim 5 and wherein the cavity is the
interior of a vas deferens of human male and the device is a
valve.
7. A method as recited in claim 6 and wherein wire is preliminarily
wound onto the exterior of the valve prior to initial embedding
thereof for promoting ingrowth of tissue.
8. A method as recited in claim 1 and wherein the device is a
valve.
9. A method as recited in claim 1 and wherein the device is
implanted at said predetermined location immediately subsequent to
removal of the device from the location at which it was initially
embedded.
Description
BACKGROUND OF THE INVENTION
The present invention relates to the implanting of devices in the
bodies of living creatures such as human beings.
As is well known, it is advisable and necessary under certain
conditions to introduce an artificial implant device into the body
of a living creature such as a human being. Such devices may take
many different forms. For example pacemakers may be implanted to
control the operations of the heart. An artificial heart itself may
be implanted. Artificial bones or parts of bones, including
artificial teeth, may be implanted. Valves may be implanted to
control the flow of body fluids.
One of the major problems encountered when dealing with implants is
that in many cases the body rejects the implant. Although great
care may be exercised in the choice of the materials used for the
device which is to be implanted, the number of different materials
which are known to be compatible with human tissue is extremely
small, and when a compatible material, such as gold, is used, the
costs are extremely high.
A further problem encountered in connection with implants is the
reliability of the anchoring of the implant of the desired
location. After a given device has been implanted it may
undesirably move from its initial location. Furthermore, where a
seal is required between the exterior surface of the implanted
device and the tissue of the body, as is the case with valves, for
example, such a seal can not always be reliably achieved.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide a method for avoiding the above drawbacks.
In particular, it is an object of the present invention to provide
an implanting method which will greatly reduce the possibility of
rejection of the implanted device.
In particular, it is an object of the present invention to provide
a method according to which a wide variety of devices can be
treated in such a way that they are rendered highly acceptable to
the tissue of the body so as to be retained reliably in the
body.
In addition, it is an object of the present invention to provide a
method of this type which is easy to perform at a relatively low
cost and without any particular danger to the individual who is to
receive the implant.
Yet another object of the present invention is to provide a method
which enables implanting of a device in such a way that not only is
the possibility of rejection greatly reduced but in addition the
device will be reliably anchored at the desired location in a
manner which will reliably avoid undesirable movement of the device
and leakage of body fluids along the exterior of the device.
According to the method of the invention the device which is to be
implanted is initially embedded in tissue of the body which is
ultimately to receive the device, with this latter tissue being
located at a part of the body different from the predetermined
location which ultimately receives the device. The embedded device
is permitted to remain in the tissue in which it is initially
placed for a length of time sufficient to permit ingrowth of tissue
into intimate contact with the exterior surface of the device. Then
the device is removed from the body while retaining on the device a
layer of the tissue which has grown into contact with the exterior
surface of the device. This device with the layer of tissue which
has grown thereon is then implanted in the body at the
predetermined location where tissue of the body is placed directly
in contact with the tissue previously grown onto the device so that
it is only required for the tissue at the ultimate location of the
device to become united with tissue already grown onto the device
in the same body in which the device is ultimately implanted, thus
reducing the possibility of rejection.
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 schematic representation of a first step in the method
of the invention;
FIG. 2 is a schematic illustration of a stage in the method
subsequent to that illustrated in FIG. 1;
FIG. 3 illustrates a device after it has been removed from a body
with tissue remaining on the device; and
FIG. 4 is a schematic representation of the manner in which a
device in the condition shown in FIG. 3 is implanted at its
ultimate location in the body.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to FIG. 1, there is illustrated therein the device 10
which is to be implanted in the body of a living creature such as a
human being. In the illustrated example this device 10 is a valve,
but it is to be understood that any artificial device may be
treated according to the present invention, such as pacemakers,
artificial organs, artificial bones or parts thereof, teeth,
etc.
FIG. 1 schematically represents a part 12 of the body of a human
being, this part 12 being composed of a body of tissue 14 covered
with exterior skin 16. The tissue 14 is preferably located at a
part of the body where a relatively large amount of such tissue is
readily accessible at the exterior skin 16. For example a buttock
is particularly suitable for this purpose.
According to the first step of the method of the invention an
incision 18 is made through the skin 16 into the tissue 14 so as to
form in the tissue 14 a pocket 20 by stretching the tissue and skin
16 at the region of the incision 18 in the manner shown
schematically in FIG. 1. The pocket 20 is of course made somewhat
larger than the device 10 so that through the incision 18 the
device 10 can be readily introduced into the pocket 20. Then the
incision 18 is closed and sutures may be applied for this purpose,
so that the device 10 remains embedded in the tissue 14 as
indicated schematically in FIG. 2. The device 10 can remain in this
condition shown in FIG. 2 in the body of an individual without
creating any particular problems or any particular discomfort, and
during a period of time which may be on the order of two or three
months, the ingrowth of the tissue 14 will take place into intimate
contact with the exterior surface of the device 10. For this
purpose, an individual may go to a hospital for no more than
overnight stay, so that the surgeon can embed the device 10 in the
tissue 14. Then the individual may leave the hospital and go about
his business in a usual manner for a period of two or three months,
until ingrowth of tissue has been completed.
In order to promote ingrowth of tissue it is possible to situate at
the exterior of the device 10, prior to embedding thereof in the
tissue 14, a means 22 which will promote the ingrowth of tissue. In
the example illustrated in FIG. 1 this means takes the form of one
or more strands of gold wire wound around the valve 10 at the
exterior thereof to form a large number of interstices through
which the tissue will grow into intimate contact with the exterior
surface of the device 10. Other structures may be used to form the
means 22 for promoting the ingrowth of tissue. For example any
layer of porous material such as gold sprayed onto the exterior
surface of the device 10 in a suitable evacuated atmosphere may be
used.
After the period required for completion of ingrowth of tissue has
elapsed, the individual returns to the hospital and the surgeon
will remove the device 10 from the tissue 14 in which it was
initially embedded. At this stage of the method of the invention
the surgeon is careful to leave on the device 10 a layer 24 of the
tissue which has grown into intimate contact with the exterior
surface of the device 10. In the particular example shown in the
drawings where a valve is used for the device 10, an operating
component 26 of the valve may be left exposed so that the valve can
be opened and closed. However, when dealing with other types of
devices such exposure of part of the device may not be required. It
is to be noted that in accordance with the invention any of the
artificial devices which are to be implanted have exterior surfaces
which are impervious to tissue so that tissue cannot grow into the
device beyond the exterior surface thereof.
Immediately subsequent to the removal of the device 10 from the
tissue 14 with the layer 24 of ingrown tissue remaining on the
device 10, only at the exterior surface thereof, the surgeon will
introduce the device 10 into the part of the body where the device
is to remain. Thus, FIG. 4 shows by way of example, in a schematic
manner, a vas deferens 28 initially formed in a wall portion
thereof with a slit 30 through which the device 10 with the ingrown
tissue 24 thereon is introduced in the manner shown in FIG. 4.
With this method the inner tissue 32 which lines the cavity formed
by the interior of the vas 28 directly engages only the ingrown
tissue 24 from the very same individual in which the device 10 is
implanted. It is thus required that the tissue 32 become united
only with tissue 24, and since the tissue 32 and the tissue 24 are
from the same individual the possibility of rejection is very
greatly reduced. In addition, the uniting of the tissue 32 with the
tissue 24 by ingrowth of the tissue 32 into intimate union with the
tissue 24 reliably anchors the device 10 at the desired location
and in the case of a valve reliably prevents any leakage past the
valve at the exterior thereof. Of course, in the case of a valve
care is taken to maintain the ends 36 and 38 of the valve open so
that the flow of fluids can readily be controlled by opening and
closing of the valve.
Of course, after the device 10 is removed with the tissue 24
remaining thereon, the second incision which is made is again
closed so that the part 12 of the body where the tissue 14 is
located will heal up readily.
It is emphasized that the method of the invention is illustrated
above in connection with a valve only by way of example. The method
of the invention is applicable to all types of devices which are to
be implanted in the body of a living creature such as a human
being. For example in FIG. 4 the tubes connected to the device may
be arteries connected to an artificial heart. As was pointed out
above pacemakers may be treated in the manner indicated above so as
to be reliably retained in the body without any possibility of
rejection. Furthermore the method of the invention may be practiced
with any artificial materials or devices such as a section of
artificial bone which is to be introduced, a tooth which is to be
implanted in gums, or even tubes, plates, or the like which are to
be used to repair injuries to any body cavities.
* * * * *