U.S. patent number 3,815,578 [Application Number 05/359,429] was granted by the patent office on 1974-06-11 for method of inserting an implant into a portion of a tubular organ whose mucous lining has been partially removed.
This patent grant is currently assigned to Investors In Ventures, Inc.. Invention is credited to Louis Bucalo.
United States Patent |
3,815,578 |
Bucalo |
June 11, 1974 |
METHOD OF INSERTING AN IMPLANT INTO A PORTION OF A TUBULAR ORGAN
WHOSE MUCOUS LINING HAS BEEN PARTIALLY REMOVED
Abstract
An implant to be introduced into a cavity of a living body, as
well as a tool and method for implanting. The tool is a reamer for
removing a layer of mucosa which lines the lumen of a tubular body
organ which is to receive the implant. The implant carries at a
part of its exterior a structure for promoting the ingrowth of
tissue, and with the use of the tool mucosa is removed only at the
part of the tubular organ which is to be in engagement with the
structure for promoting the ingrowth of tissue after the implant is
introduced into the tubular organ. The implant carries at the
region of the structure for promoting the ingrowth of tissue a
fastening structure of hook-shaped configuration for hookig into
the tissue of the tubular organ from the interior thereof to
maintain the tubular organ in engagement with the implant, securely
connected thereto, while the tissue has an opportunity to grow into
intimate contact with the exterior of the implant.
Inventors: |
Bucalo; Louis (Holbrook,
NY) |
Assignee: |
Investors In Ventures, Inc.
(New York, NY)
|
Family
ID: |
23413753 |
Appl.
No.: |
05/359,429 |
Filed: |
May 11, 1973 |
Current U.S.
Class: |
128/843; 606/153;
606/159 |
Current CPC
Class: |
A61B
17/11 (20130101); A61F 6/24 (20130101); A61F
6/22 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61F 6/00 (20060101); A61F
6/22 (20060101); A61F 6/24 (20060101); A61B
17/03 (20060101); A61m 019/00 () |
Field of
Search: |
;128/1R,33R,304,305,310,311,334R,334C ;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Steinberg & Blake
Claims
What is claimed is:
1. In a method for introducing into the lumen of a tubular organ of
a living being an implant which carries at least at part of its
exterior a means for promoting the ingrowth of tissue into intimate
contact with the exterior surface of the implant, the steps of
cutting the tubular organ at least up to the lumen thereof so as to
give access to the lumen, removing a layer of mucosa from the
interior of the lumen at least at the part thereof which will be
situated at the means for promoting ingrowth of tissue when the
implant is subsequently introduced into the lumen, and then
introducing the implant into the lumen so that the tissue of the
tubular organ engages the means for promoting the ingrowth of
tissue without interposition of a mucosa layer between the tissue
and the means for promoting the ingrowth of tissue.
2. In a method as recited in claim 1 and wherein the implant has an
exterior surface area which does not carry means for promoting the
ingrowth of tissue, the removal of the layer of mucosa being
carried out only at that part of the lumen which will be situated
at the means for promoting the ingrowth of tissue when the implant
is subsequently introduced into the lumen, so that an exterior
surface area of the implant which does not carry the means for
promoting the ingrowth of tissue will be engaged by a layer of
mucosa.
3. In a method as recited in claim 1 and wherein the layer of
mucosa is removed by reaming.
4. In a method as recited in claim 1 and including the additional
step of fastening the tubular organ to the implant so that the
tissue of the tubular organ which engages the means for promoting
the ingrowth of tissue will have an opportunity to grow into said
means for additionally securing the tubular organ to the
implant.
5. In a method as recited in claim 1 and wherein the tubular organ
is a vas deferens while the implant is a valve having tubular
extensions received in the lumen of the vas deferens and carrying
at least at part of the exterior surface thereof said means for
promoting the ingrowth of tissue which is engaged by the tissue of
the vas deferens.
6. In a method as recited in claim 5 and wherein each of said
tubular extensions of the valve has an elongated free end portion
extending beyond the means for promoting ingrowth of tissue, and
the removal of the layer of mucosa being carried out only where the
means for promoting the ingrowth of tissue is situated so that the
free end portions of the tubular extensions of the valve are
engaged by mucosa layers.
7. In a method as recited in claim 1 and wherein the tubular organ
is a vas deferens while the implant is a valve having tubular
extensions extending in opposite directions from an intermediate
part of the valve and respectively carrying means for promoting the
ingrowth of tissue, the cutting of the vas deferens being carried
out with removal of an elongated portion of the vas deferens
extending up to the lumen thereof so as to leave at the vas
deferens a continuous portion thereof extending between free ends
of the lumen into which the tubular extensions are respectively
inserted, the step of deflecting the continuous portion of the vas
deferens outwardly away from the lumen thereof while drawing the
free ends of the lumen toward each other to locate the free ends of
the luman directly next to the intermediate portion of the valve
while forming from the continuous portion of the vas deferens a
pair of flaps which remain integral with each other and which are
situated one beside the other extending laterally away from the
lumen, and fastening said flaps to each other so that the free ends
of the vas will remain at the intermediate portion of the valve
while the tissue of the vas grows into the means for promoting the
ingrowth of tissue.
Description
BACKGROUND OF THE INVENTION
The present invention relates to implants to be introduced into the
bodies of living beings, as well as to tools and methods utilized
in connection with the introduction of such implants.
Although it is known to introduce into the body of a living being,
such as a human being, artificial implants such as valves for
reversibly interrupting the flow of a fluid in a tubular body
organ, one of the most serious problems encountered in connection
with such implants is that of securely maintaining the implant at
the desired location in the body cavity. Because the implant is
located in a body of living tissue, particular problems are
encountered because while it is essential to secure the implant in
the body of living tissue, at the same time it is necessary for
nourishment to reach the living tissue, and living tissue has the
property of adapting itself to forces which it encounters in such a
way that peculiar problems are encountered in the securing of an
implant in the interior of a body cavity. Furthermore, problems are
encountered in connection with securely mounting an implant of this
type in such a way that the flow of a body fluid can be reliably
controlled. For example, in the case of a valve, it is essential to
secure the valve in the body cavity in such a way that fluid cannot
flow along the exterior of the valve, thus defeating the purpose of
the valve.
Moreover, the physicians and surgeons who introduce the implant
must have a considerable amount of skill in order to securely
situate the implant at the desired location in a reliable manner
according to conventional techniques. This required skill is
relatively rare, so that with many surgeons the implant is situated
in a body cavity without the assurance of a reliable securement of
the implant.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide not only an implant but also a tool and method for
implanting, all of which will contribute to elimination of the
above drawbacks.
Thus, one of the primary objects of the present invention is to
provide an implanting method according to which an exceedingly
secure connection of the implant to the body cavity in the interior
thereof will be achieved in a simple highly reliable manner which
does not require a great amount of skill on the part of the
individual who introduces the implant.
Also, it is an object of the present invention to provide an
implanting method which will assure a reliable ingrowth of tissue
into intimate contact with the exterior surface of the implant, to
achieve not only a secure connection of the implant but also to
prevent body fluid from flowing along the exterior of the
implant.
Yet another object of the present invention is to provide a tool
which is easy to manipulate and which places the body tissue in a
condition which will contribute greatly to the reliability of the
securement of the implant in the body cavity.
Furthermore, it is an object of the present invention to provide an
implant which itself has a construction which greatly contributes
toward the security of the connection of the implant to the body
organ in the interior thereof.
According to the method of the invention the implant carries at its
exterior a fastening means which hooks into the tissue of the body
organ from the interior thereof for reliably maintaining the
implant at the desired location in the body cavity. Also in
accordance with the invention a layer of mucosa is removed from the
inner surface of the body organ which receives the implant at that
part of the inner surface which becomes situated next to a means
for promoting the ingrowth of tissue into intimate contact with the
exterior surface of the implant, the implant being provided with
such a means prior to its introduction into the body cavity.
Furthermore, according to yet another feature of the invention the
body cavity is manipulated in such a way that it will not be
subject to undesirable slack which could contribute to faulty
operation of the implant.
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 side elevation of a tool according to the invention
shown schematically in FIG. 1 during use of the tool, with a handle
of the tool being fragmentarily illustrated in FIG. 1;
FIG. 2 fragmentarily illustrates an implant, FIG. 2 illustrating
the relationship between the tool and the implant, in accordance
with the present invention;
FIG. 3 is a transverse section of the tool of FIG. 1 taken along
line 3--3 of FIG. 1 in the direction of the arrows, the tool being
shown by itself in FIG. 3;
FIG. 4 is a schematic longitudinal sectional elevation of a human
vas deferens showing an implant of the invention stituated in the
vas deferens after it has been worked on by the tool of FIG. 1,
with the implant of FIG. 4 having a special construction in
accordance with the invention for fixing the vas deferns to the
implant;
FIG. 5 is a transverse section of the implant of FIG. 4 taken along
line 5--5 of FIG. 4 in the direction of the arrows;
FIG. 6 is a fragmentary elevation of another embodiment of an
implant which will accomplish the same results as that of FIGS. 4
and 5;
FIG. 7 is a developed view of a sheet from which the fastening
means of FIG. 6 is made;
FIG. 8 is a fragmentary sectional elevation of the fastening means
of FIG. 6 and 7 showing in greater detail how it is mounted on the
implant;
FIG. 9 is a schematic illustration of how part of a vas deferens is
cut away prior to introduction of the implant, in accordance with a
further feature of the present invention; and
FIG. 10 is a schematic representation of how the vas deferens is
treated after it has the condition shown in FIG. 9 so as to further
contribute to the security of the mounting of the implant in the
vas deferens.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to FIG. 1, there is illustrated therein a tool 12
according to the present invention. This tool 12 is in the form of
a reamer having an elongated shank 14 provided with an elongated
reaming portion 16. The reaming edges of the elongated shank
portion 16 are schematically illustrated in FIG. 1. As is apparent
from FIG. 3, the reaming edges 18 of the shank portion 16 project
so as to be able to remove material which in the illustrated
example is a layer of mucosa which lines the lumen of the vas
deferens 20 which is schematically illustrated in FIG. 1.
The tool 12 has at the shank 14 not only the reaming portion 16 but
also an elongated tapered portion 22 which has a smooth exterior
surface and which generally tapers so that at its end distant from
the reaming portion 16 the portion 22 has a diameter smaller than
the portion 16. At this end the portion 22 is followed by a
subsequent smooth-surfaced portion 24 of the shank 14 which is of a
constant diameter substantially smaller than that of the portion
16, and this portion 24 terminates in a substantially pointed tip
26, shown most clearly in FIG. 1. Thus, after the vas 20 is severed
so that an elongated free end portion thereof, as illustrated in
FIG. 1, is accessible, the physician or surgeon will introduce into
the vas the shank 14 of the tool 12. For convenience in handling,
the reaming portion 16 is fixed at its end distant from the portion
22 to a handle 28 which can be grasped for ease of manipulation of
the tool. The tip 26 and the portion 24 serves to guide the tool in
the interior along the lumen 30 of the vas 20, and when the right
end of the handle 28 engages the free end of the vas 20, the
reaming portion 16 will be situated as illustrated in FIG. 1 so
that by rotation of the reamer, which is manually rotated by manual
turning of the handle 28, it is possible to remove from the
interior of the vas 20 a layer of mucosa along the portion R of the
vas, as illustrated in FIG. 1.
The implant which is to be introduced into the vas is in the
illustrated example a valve 32 which is fragmentarily illustrated
in FIG. 2 and which is of a previously proposed constuction. This
valve 32 has the intermediate housing portion 34 in which a valve
member is situated to be moved in order to open and close the valve
32. For this purpose the movable part of the valve has a stem 36
which projects beyond the intermediate portion 34 and which can be
turned so as to open and close the valve.
At the intermediate portion 34 the valve 32 has a pair of
oppositely directed tubular extensions 38 and 46. Extension 38 is
shown in FIG. 2 extending to the right from the intermediate
portion 34. This tubular extension 38 serves as the inlet or outlet
for the valve when the valve is in its open position. As is
illustrated in FIG. 2, the tubular extension 38 terminates in an
elongated outer free end portion 40 which is formed with a slot 42
in order to prevent plugging of the open end of the tubular
extension 38.
Between the intermediate portion 34 and its smooth-surfaced
elongated free end portion 40, the tubular extension 38 carries a
means 44 for promoting the ingrowth of tissue. It is to be
understood that the tubular extension 46 which is only
fragmentarily illustrated in FIG. 2 as extending from the left from
the intermediate portion 34 will have a construction identical with
the tubular extension 38. Thus, both the extensions 38 and 46 have
a means 44 for promoting the ingrowth of tissue. This means 44 in
the illustrated example is of a filamentary construction and takes
the form of fine wire which is wound around the tubular extension
38 and which is made of a material which is compatible with the
human body. This is of course true of all of the materials used for
the implant. This fine wire used for the means 44 for promoting the
ingrowth of tissue can be gold or platinum, for example. However,
the means 44 may also take the form of any suitable porous matrix
such as porous metal compatible with the human body and sputtered
onto the surface of the extension 38 in an evacuated atmosphere.
Any of these constructions are possible for the pair of means 44
respectively carried by the extensions 38 and 46 in order to
promote the ingrowth of tissue. It is to be noted that this means
44 extends along the tubular extension 38 through the distance R
which is the same distance R along the interior of the vas 20 from
which the layer of mucosa is removed by the reamer 12. Thus, the
extension 38 has a total length L, and the layer of mucosa is
removed only along a distance corresponding to the distance R along
the extension 38, so that when the implant is introduced into the
vas, the elongated free end portion 40 will extend beyond the
region from which the layer of mucosa has been removed by the
reamer 12. Thus, the length of the reaming portion 16 is carefully
selected to correspond to the distance through which the means 44
extends along the extension 38, and when this extension 38 is
introduced into the vas, only that part of the lumen from which the
layer of mucosa has been removed will engage the means 44. The
remainder of the interior lining of the lumen beyond the means 44
will retain the mucosa layer, so that a layer of mucosa will indeed
engage the elongated portion 40.
The extension 46 is treated in precisely the same way as the
extension 38. Thus, the other free end of the vas which is not
illustrated in FIG. 1 also has a layer of mucosa removed by the
tool 12 in precisely the same way so that when the extension 46 is
introduced into the other part of the vas only the part of the
lumen from which the layer of mucosa has been removed will engage
the means for promoting the ingrowth of tissue which is carried by
the extension 46. The elongated free end portion thereof which
extends beyond the means for promoting ingrowth of tissue will
engage the mucosa lining, as described above in connection with the
extension 38.
Thus, referring to FIG. 4, it will be seen that the valve 32 is
illustrated with its opposed extensions 38 and 46 respectively
situated in the lumens of the pair of the pair of separated vas
portions 20 and 50 which have been separated from each other by
cutting through the vas prior to introduction of the implant 32.
The vas portion 20 is shown with the mucosa layer 48 extending from
the right end of the means 44 carried by the extension 38 for
promoting ingrowth of tissue, so that the elongated free end
portion 40 is in engagement with the mucosa lining 48. In the same
way, the free end portion 40 of the extension 46 engages the mucosa
lining 52 of the vas portion 50, this lining 52 extending only up
to the means 44 which is carried by the extension 46.
As has been set forth above, one of the important factors in
introducing an implant such as the implant 32 into the interior of
a body cavity such as the interior of the tubular organ 20 or 50 is
the reliable securing of the implant in its position in the
interior of the body cavity. Experience has shown that the tissue
of the vas portions 20 and 50 will very rapidly grow into the pair
of means 44 for promoting ingrowth of tissue, so that the tissue of
the vas portions 20 and 50 will come into intimate tight engagement
with the exterior surface of the extensions 38 and 46 at the
interstices or pores of the means 44 which promotes the ingrowth of
tissue. The removal of the mucosa lining at that part of the organ
which engages, at its inner surface, the means 44 contributes in a
highly remarkable manner to the rapid ingrowth of tissue in order
to achieve the secure connection between the living tissue and the
implant.
However, immediately after the implant has been introduced into the
lumen of the tubular organ, it is desirable to maintain the tubular
organ and the implant connected to each other until the tissue of
the organ has an opportunity to grow into the means 44. Thus, it is
possible to suture the vas portions 20 and 50 to each other in
order to maintain them in the position shown in FIG. 4 until the
tissue grows into the means 44 on the extensions 38 and 46.
However, such suturing has proved to be a problem since many
surgeons cannot perform the suturing in a fully effective manner.
Furthermore, such suturing requires an increased time for the
operating procedure, which is undesirable.
Therefore, according to a further feature of the invention the
implant 32 is provided with a fastening means 54 capable of
fastening the vas portions 20 and 50 onto the extensions 38 and 46
in a highly reliable manner which will maintain the implant in the
position shown in FIG. 4 until the tissue grows into the pair of
means 44, without requiring the inconvenient suturing or other
measures which may be used to retain the components in the position
shown in FIG. 4.
This fastening means 54 in the example of FIGS. 4 and 5 takes the
form of a plurality of hooks 56 circumferentially distributed about
each of the extensions 38 and 46, in the manner shown most clearly
in FIG. 5. Thus in the illustrated example there are four hooks 56
circumferentially distributed about the extension 38, and four
additional hooks 56 are of course circumferentially distributed
about the extension 44, in the manner shown in FIG. 5 according to
which the hooks are uniformly distributed angularly about each
extension. These hooks 56 are also made of a material which is
compatible with the human vas such as gold or platinum, for
example. The hooks 56 are of a substantially V-shaped configuration
and are each provided with one leg extending along the exterior
surface of the extension 38 or 46 and held onto the latter by the
windings of the wire which forms the means 44, as illustrated in
FIGS. 4 and 5. However, any other suitable mounting of the
fastening means on the tubular extensions can be used. For example
in the case where the means 44 takes the form of a porous matrix,
the hooks 56 are initially positioned in engagement with the
exterior surface of the tubular extensions and then the deposited
matrix will itself serve to fix the hooks 56 to the exterior
surface of each of the extensions 38 and 44.
It is to be noted that in addition to a leg which extends along and
is fixed to the exterior surface of each extension 38, each hook 56
has an outer inclined leg 58 which terminates in a pointed free
end. These inclined legs 58 of the hooks 56 are included in such a
direction that they permit each extension 38 and 46 to be
introduced into the lumen but will prevent removal of each
extension. Any attempt at removal will only result in further
digging of the hooks 58 into the tissue which forms the vas
portions 20 and 50. Thus, these hooks will serve to provide an
exceedingly secure connection between the vas portions 20 and 50
and the tubular extensions of the implant 32, so that there will be
sufficient opportunity for the tissue to grow into the pair of
means 44 to achieve the secure tight connection which will not only
securely maintain the implant in the position shown in FIG. 4 but
which will also reliably prevent any leakage of fluid along the
exterior of the valve.
Of course, the fastening means 54 may have other constructions. For
example, as is shown in FIG. 7, it is possible to provide a
fastening means 60 formed from a thin sheet of metal 62 which is
compatible with the tissue such as gold or platinum. Thus a fairly
thin sheet of gold or platinum, for example, may have stamped
therefrom sections having approximately the configuration shown in
FIG. 7. It will be noted that these sections have a free jagged
edge 64 which extends from a substantially rectangular portion 66,
with the free edge 64 extending between a pair of oppositely
inclined edge regions 68 which project from the substantially
rectangular portion 66. The length of the means 60 is such that it
can be wrapped at least once around the tubular extensions 38 and
46 in the manner shown in FIG. 6. The wire which is used to form
the means 44 can be wrapped around the cylindrical part 70 which is
formed from the rectangular portion 66 of the sheet 62. The
remaining part, because of the inclined edges 68 and the longer
length of the jagged edge 64 forms an outwardly flaring portion 72
terminating in the jagged edge 74 which is thus spaced from the
extension 38 and pointed toward the intermediate part 34 of the
implant 32, as shown in FIGS. 6 and 8. Thus, the wire which forms
the means 44 is securely wrapped around the cylindrical part 70
which is formed from the rectangular portion 62, and part of the
wire of the means 44 is also surrounded by the flaring portion 72
which terminates in the jagged edge 64. After the left portion of
the wire is wound, as viewed in FIG. 6, the means 60 can be wrapped
around the tubular extension 38, and then the remainder of the wire
can be wrapped to secure the means 60 in the position shown in
FIGS. 6 and 8. In the same way a means 60 is secured to the
extension 46.
Therefore, with the embodiment of FIGS. 6-8 when the implant is
introduced to the position shown in FIG. 4, the sharp points
situated along the jagged edge 64 will dig into the tissue in order
to provide an extremely secure mounting while retaining the implant
in position within the body cavity in a manner which permits the
tissue to grow freely into the means 44 which promotes the ingrowth
of tissue.
Thus, both of the embodiments 54 and 60 of a fastening means
according to the invention enable the implant to be introduced with
substantially no resistance into the interior of the tubular organ
but prevents removal of the implant once it has been situated in
the organ, enabling the tissue of the latter, particularly the part
from which the mucosa layer has been removed, to freely grow into
the interstices or pores of the means 44.
According to a further feature of the invention, a vas deferens 76
which is schematically shown in FIG. 9, has an elongated portion
cut away, this portion extending only up to the lumen 80, so that
the vas 76 is left with an elongated continuous portion 82 as
illustrated in FIG. 9. Then the tool 12 is introduced into the free
ends of the lumen which are connected by the portion 82 in order to
remove the mucosa layer as described above in connection with FIG.
1.
Thereafter, the implant is introduced, and this implant preferably
has a fastening means, such as the fastening means 54 or the
fastening means 60.
The elongated portion 82 of the vas is deflected away from the
lumen 80 so as to be formed into a pair of flaps 84, as shown in
FIG. 10, these flaps of course being integrally connected to each
other at their common end 86 which is distant from the vas 76. Then
the flaps 84 are simply sutured together.
The result of this feature of the invention is that in addition to
all of the advantages discussed above in connection with the other
embodiments, the method of FIGS. 9 and 10 will take up any slack
which might otherwise undesirably remain in the tubular organ such
as the vas deferens. In addition, if it should happen that any
sperm should be capable of traveling along the exterior of the
valve, this sperm would necessarily be required to traverse the
intermediate portion 34 of the implant 32. However, when the sperm
reaches one or the other of the flaps 84, the sperm encounters in
effect a path extending perpendicularly away from the lumen, and in
this way the possibility of any sperm continuing from one to the
other side of the implant is avoided to an even greater extent with
the arrangement of FIGS. 9 and 10.
It is thus apparent that with the above features of the invention
it becomes possible to secure an implant in the interior of a body
cavity in a highly reliable manner, while still making it possible
to eliminate any inconveniences in the manipulations which must be
performed by a surgeon. The features of the invention are of
particular value in connection with the introduction of a valve
into a vas deferens for reversibly preventing flow of
semen-carrying fluid.
* * * * *