U.S. patent number 3,882,845 [Application Number 05/424,927] was granted by the patent office on 1975-05-13 for methods and devices for reducing lumen constriction.
This patent grant is currently assigned to Investors In Ventures, Inc.. Invention is credited to Louis Bucalo.
United States Patent |
3,882,845 |
Bucalo |
May 13, 1975 |
Methods and devices for reducing lumen constriction
Abstract
A method and device for reducing constriction of the lumen of a
tubular organ during healing subsequent to an operation. A device
such as an implant is introduced into a tubular organ at least at
the region thereof where surgical procedures are performed with the
implant being capable of supporting the tubular organ at this
latter region in such a way that it will prevent the tubular organ
from becoming constricted due to compressive forces resulting from
the formation of scar tissue. Preferably the implant extends along
the interior of the tubular organ not only at the region where scar
tissue forms but also in opposite directions beyond this region
with the implant having a construction which will permit pumping
action of the tubular organ to continue while the tubular organ is
supported to oppose the action by the scar tissue which tends to
contract the tubular organ.
Inventors: |
Bucalo; Louis (Holbrook,
NY) |
Assignee: |
Investors In Ventures, Inc.
(New York, NY)
|
Family
ID: |
23684467 |
Appl.
No.: |
05/424,927 |
Filed: |
December 17, 1973 |
Current U.S.
Class: |
128/843;
623/23.64; 285/115 |
Current CPC
Class: |
A61F
6/24 (20130101) |
Current International
Class: |
A61F
6/00 (20060101); A61F 6/24 (20060101); A61b
019/00 () |
Field of
Search: |
;128/1R,334R,334C,348,350,374,33R ;3/1,DIG.1 ;285/103,115,116
;138/103,118 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Allansmith, Jour. Thorac. Surg., Vol. 44, No. 2, August 1962, pp.
258-263..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Steinberg & Blake
Claims
What is claimed is:
1. In a surgical method to be performed at the region of a tubular
body organ, the steps of performing surgical procedures at the
region of the tubular body organ for obtaining access to the
interior thereof, so that subsequent to the surgical procedure scar
tissue will form at the latter region during healing of tissue at
said region, and introducing into the tubular body organ after
access is obtained thereto by the surgical procedures a tubular
implant which is longer than said region, the implant having an
intermediate portion for opposing constriction by scar tissue which
forms at said region and for performing a specific function for
which the implant is designed and a pair of opposed elongated
flexible portions extending in opposite directions beyond the
intermediate portion and while being substantially less rigid than
said intermediate portion and bendable with respect thereto also
having sufficient rigidity to support the wall of the tubular organ
in the interior thereof for opposing constriction and preventing
kinking of the tubular organ in opposite directions beyond the
intermediate portion of the implant while providing beyond the
intermediate portion of the implant in the lumen of the tubular
organ a clearance sufficient to permit fluid to flow through the
tubular organ, and introducing the implant into the tubular organ
with the intermediate portion thereof situated at the region where
scar tissue forms while locating said elongated flexible portions
at regions extending along the interior of the tubular organ in
opposite directions beyond opposed ends of the intermediate portion
situated at said region where scar tissue forms.
2. In a method as recited in claim 1, and wherein the tubular organ
is of the type which pumps a body fluid by a contracting and
expanding action such as a peristaltic action, and situating said
elongated portions of the implant along the interior of the tubular
organ in such a way that while the tubular organ is supported by
said elongated portions of the implant the latter will not inhibit
the pumping action of the tubular organ.
3. In a method as recited in claim 1 and including the step of
introducing as at least part of the implant a material which is
capable of being absorbed at a rate enabling the latter material to
contribute to internal support of the tubular body organ opposing
constriction thereof during healing while subsequent to healing the
latter material will dissapear.
4. In a method as recited in claim 3 and wherein the material which
is capable of being absorbed holds together parts of the implant
for facilitating introduction thereof.
5. In a method as recited in claim 3 and wherein the implant
includes a valve while the tubular organ is a vas deferens, and the
material which is capable of being absorbed extends beyond the
valve in opposite directions from the area where scar tissue grows
into an area where scar tissue does not grow.
6. In a method as recited in claim 1 and including the step of
situating around the exterior of the implant a means for promoting
the ingrowth of tissue.
7. An implant to be introduced into a tubular organ after surgical
procedures are performed to give access to the interior of the
tubular organ at a region along the tubular organ where scar tissue
will form during healing subsequent to the introduction of the
implant into the tubular organ, said implant having a length which
is greater than the length required to occupy the interior of the
tubular organ at the region thereof where the scar tissue
subsequently grows and said implant including elongated tubular
means for permitting a body fluid to flow along the interior of the
tubular organ through the implant, said tubular means having a
rigidity sufficiently great to support the tubular organ and oppose
substantial constriction thereof by the scar tissues the implant
further including a pair of elongated flexible means of
substantially greater flexibility than said tubular means connected
with and extending in opposite directions beyond opposed ends of
said tubular means for extending therefrom respectively beyond said
opposed ends into regions of the tubular organ beyond the region
where scar tissue subsequently grows, said pair of elongated
flexible means while being bendable nevertheless having sufficient
rigidity to support the wall of the tubular organ and permit
curving thereof without kinking at regions beyond the region where
scar tissue subsequently grows, and said pair of flexible means
each having a cross section adapted to occupy only part of the
cross section of the lumen of the tubular organ for leaving therein
a clearance extending longitudinally along the lumen sufficiently
great for fluid to flow therethrough.
8. An implant as recited in claim 7 and wherein said implant
carries at its exterior a means for promoting the ingrowth of
tissue.
9. An implant as recited in claim 7 and wherein the pair of
elongated means support the tubular organ while permitting
contraction and expansion thereof so that the tubular organ can
carry out a pumping action.
10. An implant as recited in claim 9 and wherein each of the
elongated means has at least a pair of opposed edge regions for
engaging the interior surface of the tubular organ while leaving on
opposite sides of each edge region free spaces in the tubular
organ.
11. An implant as recited in claim 10 and wherein each of said
elongated means has the configuration of an elongated strip.
12. An implant as recited in claim 10 and wherein each of the
elongated means has a central region extending centrally along the
interior of the tubular organ and a plurality of ribs projecting
from the central region and having the edge regions which engage
the inner surface of the tubular organ.
13. An implant as recited in claim 10 and wherein each elongated
means is of a V-shaped cross section.
14. An implant as recited in claim 9 and wherein each of said
elongated means is made of a flexible material of a substantially
U-shaped cross section.
15. An implant as recited in claim 9 and wherein each of said
elongated means is made of a flexible material having a
substantially spiral-shaped cross section.
16. An implant as recited in claim 9 and wherein each of said
elongated means is in the form of a plurality of elongated
filaments extending from said tubular portions and free to move
inwardly toward and outwardly away from each other.
17. The combination of claim 7 and wherein the implant is in the
form of a control means adapted to be introduced into a tubular
organ for acting on fluid therein, said control means having a
central control region and a pair of elongated tubular portions
extending in opposite directions from said central control region
and having a length great enough to extend through and beyond a
region where scar tissue will form into a region where scar tissue
will not form, each of said tubular portions having along at least
part of its length a section which is flexible to enable the
tubular organ to bend, so as to prevent kinking thereof, while at
the same time capable of opposing constriction of the tubular organ
during healing thereof.
18. The combination of claim 17 and wherein the flexible sections
of said tubular portions are respectively situated next to the
central region.
19. The combination of claim 7 and wherein said implant includes a
flexible tubular wall extending along the entire length of the
implant.
20. The combination of claim 17 and wherein said flexible section
of each tubular portion is in the form of a series of
convolutions.
21. The combination of claim 17 and wherein the flexible section of
each tubular portion is situated at an outer end region thereof
distant from the central control region.
22. The combination of claim 17 and wherein the flexible sections
of said tubular portion are each in the form of coil springs fixed
to and extending from the remainder of the tubular portions.
23. The combination of claim 17 and wherein each tubular portion
has a solid wall portion next to the central control region and
beyond said solid wall portion an elongated free end portion which
is cut through along a spiral to form a spring from the part of
each tubular portion which extends beyond its solid wall
portion.
24. The combination of claim 17 and wherein the flexible sections
of said tubular portions are respectively in the form of elongated
tapered free end portions of each tubular portion situated distant
from the central control region and having a tapered as well as a
convoluted configuration.
Description
BACKGROUND OF THE INVENTION
The present invention relates to implanting methods and implants
capable of reducing constriction of a tubular organ of a living
being as a result of the formation of scar tissue.
As is well known, when an implant is to be introduced into a
tubular organ of a living being such as a human being, surgical
procedures are necessarily performed at the region of the tubular
organ so as to provide access to the interior thereof. After
obtaining this access to the interior of the tubular organ, an
implant is conventionally introduced into the tubular organ, and
then surgical procedures are performed in order to close the
incision or the like which is formed in order to have access to the
interior of the tubular organ. As a result of these surgical
procedures scar tissue or fibroblasts will form during the healing
process. It has been found that such scar tissue will exert
compressive forces on the tubular organ which may tend to contact
the tubular organ so that the interior volume thereof becomes
constricted.
Thus, it is essential to carry out the surgical procedures in
connection with introducing the implant into the tubular organ at a
given region which extends through a given distance along the
tubular organ, and along this latter distance the scar tissue will
form, generating forces which are directed inwardly toward the
lumen for reducing the interior cross section of the tubular organ,
sometimes to such an extent that it becomes completely closed. In
the event that the implant is shorter than the region along which
the scar tissue grows, the tubular organ may becoome closed or
nearly closed at a region upstream or downstream or both upstream
and downstream of the implant.
The above problem is encountered at various parts of the body where
tubular organs are situated. For example one type of implant is a
vas value to be introduced into a vas deferens for reversibly
interrupting the flow of sperm-carrying fluid therethrough. If the
implant in this case does not extend along the interior of the vas
throughout and beyond the range where scar tissue forms along the
exterior of the vas, the vas will become constricted due to the
formation of the scar tissue to such an extent that even when the
vas valve is open an inadequate flow of sperm-carrying fluid will
result.
A further example of regions where the above problem is encountered
is in connection with tubular body conduits such as blood vessels.
Thus, it is known that in connection with surgical procedures or
wounds resulting from injuries or the like it is necessary to
splice separated portions of such a conduit together. This
procedure may conventionally be performed by connecting the severed
ends of a body conduit together while situating in the interior of
the conduit a tubular structure which extends across the severed
ends which are surgically connected to each other. In this case
also where the implant does not extend through and beyond the
region where scar tissue subsequently grows, the body conduit will
become undesirably consticted as a result of the formation of the
scar tissue, and the flow of body fluid will be undesirably
constricted, creating problems similar to those which are
encountered in connection with various types of sclerosis such as
arteriosclerosis and arteriolosclerosis.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide an implanting method and implant whch will avoid these
problems.
In particular, it is an object of the present invention to provide
an implanting method and implant capable of supporting a tubular
organ at the interior thereof in such a way that the tubular organ
will not become undesirably constricted due to formation of scar
tissue.
Also it is an object of the present invention to provide an
implanting method and implant which will prevent kinking of a
tubular organ so that flow of a fluid therethrough will not be
prevented by kinks which might otherwise form.
In addition it is an object of the present invention to provide an
implanting method and implant which will enable a tubular organ to
continue to carry out its normal pumping action such as a
peristaltic action, while at the same time the tubular organ is
supported at its interior in such a way that it will not become
undesirably constricted by the formation of scar tissue.
Yet another object of the present invention is to provide in the
case of vas valve implants, a method and apparatus for reliably
preventing any possibility of sperm bypassing the valve along the
exterior thereof.
When surgical procedures are performed such as in connection with
introduction of an implant into a tubular organ, there is a region
along the exterior of the tubular organ where scar tissue will grow
during healing. According to the invention the implant has a length
sufficiently great to enable it to extend through and beyond the
region of the tubular organ where scar tissue forms at the exterior
of the latter, with the implant being capable of supporting the
tubular organ in such a way that it will not become constricted due
to the formation of scar tissue.
The implant of the invention preferably extends not only along the
interior of the tubular organ at an operative region where scar
tissue forms, but also in opposite directions beyond the operative
region into non-operative regions of the tubular organ where scar
tissue does not grow, the implant having a pair of elongated
flexible means which extend in opposite directions into the latter
non-operative regions in such a way that these regions connot kink
but instead remain flexible and are capable of contracting and
expanding to perform a pumping action such as a peristaltic action,
so that kinking of the tubular organ is prevented and constriction
due to formation of scar tissue is also avoided.
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 illustration of the problem which is solved
by the present invention;
FIG. 2 schematically illustrates a solution to the problem with the
method and implant of the invention;
FIG. 3 illustrates a specific type of solution to the problem, in
accordance with the invention;
FIG. 4 is a schematic longitudinal sectional elevation of a
specific vas valve implant and implanting method of the invention,
including a sperm barrier;
FIGS. 5-7 are respectively transverse sections taken along lines
5--5, 6--6, and 7--7 of FIG. 4 in the direction of the arrows;
FIG. 8 illustrates how an arrangment as shown in FIG. 6, for
example, enables the pumping action to continue;
FIGS. 9-12 respectively illustrate different possible embodiments
of elongated means which may be used with and form part of implants
of the invention, to carry out the method of the invention;
FIG. 13 is a fragmentary schematic longitudinal sectional
illustration of yet another embodiment of a method and implant of
the invention;
FIG. 14 is a transverse section taken along line 14--14 of FIG. 13
in the direction of the arrows;
FIGS. 15-21 respectively illustrate various embodiments of the
invention, in connection with tubular organ implants, in schematic
longitudinal sectional elevations;
FIG. 22 is a longitudinal schematic sectional elevation of yet
another embodiment where structure is placed around the exterior of
the tubular organ;
FIG. 23 shows yet another embodiment of the invention where a
temporary support is provided to oppose constriction of the tubular
organ;
FIG. 24 illustrates a further embodiment of the invention where a
cluster of dissolvable particles oppose constriction of a
lumen;
FIG. 25 is a schematic illustration of a method according to which
it is possible to manufacture a further embodiment of an implant
according to the invention;
FIG. 26 illustrates the implant resulting from the method of
manufacture shown in FIG. 25 situated in a tubular body organ;
and
FIG. 27 is a schematic fragmentary illustration of a sperm barrier
utilized with vas valve implants and implanting methods according
to the invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to FIG. 1, the problem solved by the present invention is
illustrated therein. Thus, FIG. 1 schematically illustrates part of
an elongated tubular body organ 20. This tubular body organ may be
a vas deferens, a blood vessel or any tubular body conduit for
conveying a body fluid. It is assumed that an implant 22 is to be
situated in the tubular organ 20 in the manner illustrated
schematically in FIG. 1 which shows the previously formed incision
closed at 23. This implant 22 will have a tubular construction
enabling a body fluid to flow through the organ 20 after the
implant 22 is introduced. Thus in the case of a vas deferens, the
implant 22 may have a valve structure for reversibly interrupting
the flow of sperm-carrying fluid, or in the case of a blood vessel
which has been ruptured or severed for any reason, the implant 22
will be in the form of a simple splicing tube situated in the
interior of the organ 20 extending across the parts of the tubular
organ 20 which are connected together. The implant has at its
exterior a means 25 for promoting the ingrowth of tissue.
In any case, in order to introduce the implant 22, surgical
procedures will be performed at the region 24 of the body tissue
which surrounds the tubular organ 20 and which is indicated by the
dot-dash line. This region 24 may be considered an operating or
operative region where an incision is formed so as to give access
to the interior of the tubular organ 20. It is in this region 24
that scar tissue forms during healing of the tissue surrounding the
tubular organ 20 after the implant 22 has been introduced. As may
be seen from FIG. 1, the incision area 24 where scar tissue forms
extends beyond the ends of the implant 22. Thus, after the incision
is made and closed subsequent to the introduction of the implant 22
into the tubular organ 20, the tissue heals at the region 24.
During healing the tissue swells and fibroblast growth takes place
during healing. This fibroblast or scar tissue is very tough and
grows rapidly. Upon healing, the scar tissue presses radially
inwardly against the wall of the tubular organ 20, as indicated by
the arrows 26, causing constriction and collapse of the wall of the
tubular organ 20, particularly at locations just beyond the ends of
the implant 22. Thus, this radial inwardly directed pressure
resulting from the formation of the scar tissue may close and seal
the tubular organ 20 for a period which may last for many months
and even years. In the case of a vas deferens, such unforeseen
closure thereof may go unnoticed for such a long period of time,
whereas in the case of a blood vessel, any appreciable constriction
of this type will create serious problems such as those encountered
with sclerosis conditions.
Referring now to FIG. 2, the principles of the present invention
are illustrated therein. Thus, FIG. 2 shows an elongated body organ
20 which may be the same as that illustrated in FIG. 1. FIG. 2 also
shows the region 24 which may be considered the surgical or
operative area, whereas non-surgical regions are indicated beyond
the region 24 where the scar tissue grows. FIG. 2 also illustrates
an implant 27 replacing implant 22 shown in FIG. 1.
According to the invention the implant 27 has connected thereto a
pair of elongated means 28 which extend in opposite directions from
the intermediate part of the implant which is designed to perform a
specific function such as reversibly interrupting the flow of
sperm-carrying fluid or forming a splice between severed portions
of a blood vessel. The pair of elongated means 28 which thus form
implant extensions are sufficiently long to extend beyond the area
24 into the non-surgical areas 30 where scar tissue does not grow.
These elongated means 28 may have any one of several constructions
referred to in detail below, according to which they are capable of
supporting the tubular organ 20 in the interior such a way that
inward constriction of the tubular organ cannot occur in the manner
described above in connection with FIG. 1.
A specific example of the present invention which has been used in
practice is illustrated in FIG. 3. In FIG. 3 the tubular organ 20
is a vas deferens which in the illustrated example receives a
two-piece vas valve 32 through incision 35. This two-piece vas
valve has a left section 34 joined to a right section 36, as viewed
in FIG. 3. One of the advantages of the two-piece vas valve 32 is
that the incision required for such a vas valve can be made
extremely small so that the surgical area 38 in the case of FIG. 3
is limited as compared to conventional surgical areas in connection
with gaining access to the interior of a tubular organ. Thus,
because the valve 32 is made in the separate sections 34,36, an
extremely short incision will enable the separate sections 34 and
36, to be independently introduced while they are separate from
each other, and thereafter they can be joined together. In this way
the extent to which the surgical operations must extend
longitudinally along the tubular organ 20 is reduced, and the
length of the sections 34 and 36 after they are joined to each
other is such that the assembled vas valve 32 extends throughout
the region 38 and beyond the latter into the non-surgical areas 40
where the opposed free end regions of the sections 34 and 36 are
situated in areas of the tubular organ 20 which are free of the
trauma resulting from the surgical procedures at the region 38.
Actual experience with this type of implant has demonstrated that
immediately after introduction of the implant, when it is
maintained open until healing is completed, and throughout the
healing period, a full uninterrrupted flow of sperm-carrying fluid
is maintained, as demonstrated by actual sperm counts taken under
the above conditions. In contrast, with an arrangement as shown in
FIG. 1 where the implant 22 is in the form of a vas valve, the
sperm count is greatly reduced as compared to that which is
acheived with the arrangement of FIG. 3, demonstrating that the
scar tissue substantially restricts the tubular organ 20 at the
regions thereof located just beyond the implant 22. Thus, by
resorting to the implanting method and implant of the invention, as
demonstrated in FIG. 2 for a general case, it is possible to avoid
the above problems.
Referring to FIG. 4, a specific application of the present
invention is illustrated therein. Thus, FIG. 4 shows a pair of
sections 42 of a vas which has been cut through between these
sections so as to receive the implant 44 which in the illustrated
example is a vas valve having intermediate its ends the valve
assembly 46 capable of opening and closing the elongated tubular
means 48 which is rigid and which extends into the lumen of the
sections 42 in the manner illustrated schematically in FIG. 4. This
structure carries at its exterior a tissue-ingrowth means 50 for
promoting the ingrowth of tissue at the exterior of the elongated
tubular means 48. In accordance with the features of the present
invention the space between the vas sections 42 is filled with a
barrier means 200 surrounding and covering the part of the valve
assembly 46 which is situated in this space. The barrier means 200
is in the form of any jelly or other relatively thick highly
viscous substance such as a medical silicone paste. Thus if it
should happen that any sperm should travel along the exterior of
the implant and reach the space between the vas sections 42, such
sperm will be incapable of travelling through the space between the
vas sections 42 from one of these sections to the other because the
thick paste or jelly which forms the barrier means 200 will present
the sperm an obstacle through which the sperm cannot travel. In
this way bypassing of the valve by sperm is reliably avoided.
In accordance with the invention, a pair of elongated means 52 are
connected with the tubular means 48 at the opposed end regions
thereof. These elongated means 52 may have a press fit into the
interior of the tubular means 48. As is apparent from FIGS. 5-7,
the elongated means extending from each end of the tubular means 48
has a central region 54 extending along the axis of the lumen and a
plurality of ribs 56 projecting radially from the central region
54. Each elongated means 52 is made of a flexible plastic material
compatible with human tissue. Thus, in the illustrated example each
elongated means 52 has the cross section of a cross. The ribs 56
terminate in outer edge regions which extend along the inner
surface of the tubular organ 42. Moreover, as is apparent from a
comparison of FIGS. 5-7 and as is illustrated in FIG. 4, each
elongated means 52 tapers so as to terminate in a small tip
situated distant from the tubular means 48. As a result of the use
of such elongated means 52, the tubular organ 42 will be supported
at its interior against constriction resulting from growth of scar
tissue, inasmuch as the total length of the implant, between the
outer tips of the elongated means 52, is considerably longer than
the region where scar tissue will grow, this region being occupied
at least partly by the rigid tubular means 48. Because of the
flexibility of the elongated means 52, the tubular organ can bend
without kinking, so that it cannot become closed by kinking. At the
same time, the elongated means 52 has a strength sufficient to
prevent inward constriction of the tubular organ at those parts
thereof where scar tissue grows and where the thicker parts of the
elongated means 52 are located at the region of the ends of the
tubular means 48.
Moreover, it will be noted that free hollow spaces are left in the
interior of the tubular organ on opposite sides of each of the
ribs. This is a further important feature of the invention as may
be seen from a comparison of FIGS. 6 and 8. A tubular organ such as
a vas deferens or other tubular organs function to pump a body
liquid along the interior of the tubular organ by an action such as
a peristaltic action during which the tubular organ forms
contractions which move longitudinally along the tubular organ.
Because of the construction of the elongated means 52 it is
possible for tubular organ to contract into the spaces between the
ribs 56, assuming a configuration as illustrated schematically in
FIG. 8, and thus the pumping action can proceed so that the body
fluid can be pumped even though the tubular organ is supported at
its interior against undesirable constriction from the growth of
scar tissue. Thus, FIG. 6 may be considered as showing the tubular
organ in a substantially open condition while FIG. 8 may be
considered as showing a peristaltic constriction which the organ
assumes for carrying out a pumping action.
The above-described configuration of the elongated means 52 is
highly desirable but is not essential. Thus, FIG. 9 shows an
elongated means 60 of V-shaped configuration situated in a tubular
organ 62. FIG. 10 shows an elongated means 64 in the form of a
simple strip having only a pair of opposed edge regions next to the
inner surface of the tubular organ 66. FIG. 11 shows an elongated
means 68 also made of a flexible plastic sheet material and having
a substantially U-shaped cross section so that while it supports
the tubular organ 70 against contraction from scar tissue
nevertheless the flexiblity of the elongated means 68 permits a
pumping action to take place as described above. FIG. 12 shows an
elongated means 72 also made of a flexible plastic material, as is
the case with the above embodiments of the elongated means of the
invention, but in this case the elongated means 72 is of a
spiral-shaped cross section. Thus, the tubular organ 74 will also
be prevented by such a construction from collapsing due to the
inward radial pressure of scar tissue while at the same time it is
possible for the elongated means 72 to yield and expand as a result
of peristaltic action or the like. Any of the embodiments of FIGS.
9-12 may be substituted for that of FIGS. 5-8 and connected in the
same way to tubular valve portions 48.
A further possible embodiment of the invention is illustrated in
FIGS. 13 and 14 where a tubular means 76 corresponding to any of
the tubular means described above is shown in a tubular organ 78.
This tubular means 76 fixedly carries at its interior in the region
of its opposed ends a ring 80 fixed to free ends of elongated
extremely fine filaments or wires 82 which project freely beyond
the tubular means 76 at each of the ends thereof, only one of these
ends being shown in FIG. 13. The extent to which the bundle of
filaments or wires 82, which are flexible, extend beyond the
tubular means 76 at each of the ends thereof is sufficient to
locate these filaments or wires well beyond the region where scar
tissue will grow. Only a small number of filaments 82 are shown for
the sake of clarity. Such bundles of filaments or wires are capable
of moving inwardly toward each other and spreading apart from each
other so that they also will prevent constriction due to scar
tissue while at the same time enabling traveling contractions to
occur in connection with the pumping action.
In connection with FIGS. 13 and 14, the filaments 82 may be held
together in any suitable way if necessary to facilitate insertion
thereof. Thus, the surgeon may hold the filaments together with a
finger. However, if desired, the filaments may be embedded in a
body of gelatin which dissolves subsequent to insertion. Also the
filaments 82 may be made of the same material as known dissolving
sutures so that after healing is completed the filaments will be
absorbed and entirely disappear.
Referring to FIG. 15, the implant illustrated therein in the
tubular body organ 20 which may be the vas deferens is in the form
of an elongated valve means 84 having a central valve section 86
and a pair of elongated tubular portions 88 respectively extending
in opposite directions from the central valve section 86 through
the area 90 where scar tissue subsequently grows into the areas 92
where scar tissue does not grow. These elongated tubular portions
88 each have next to the central valve section 86 a section 94
which is flexible so that in this way kinking of the tubular organ
will be avoided, while beyond these flexible sections 94 each
tubular portion 88 has a section 96 carrying a tissue-ingrowth
means 98 such as a suitable wire wound around the cylindrical free
end portion 96 which extends into the area where scar tissue does
not grow. The flexible portions 94 are fully capable of opposing
constriction due to formation of scar tissue. They are formed by
circular convolutions so that each section 94 has a construction
similar to a bellows and while made of metal is nevertheless thin
enough to flex to prevent kinking. The material used for the
tubular portion as well as the remainder of the valve is any
material compatible with the human body, such as gold, for
example.
After obtaining access to the interior of a tubular body organ for
any reason, an implant of the invention, illustrated in FIG. 16,
for example, may be introduced only to prevent constriction of the
lumen. In the embodiment of FIG. 16 the elongated implant 100 has a
single elongated continuous tubular portion 102 which is flexible
along its entire length and formed of convolutions so as to have
the bellows-type of construction referred to above in connection
with sections 94. In this case the entire exterior surface of the
elongated flexible tube 102 carries the tissue-ingrowth means 104
which may be in the form of a suitable filament wound around the
tube 102 as illustrated in FIG. 16.
FIG. 17 shows an embodiment of the invention where the control
means formed by the implant is not a valve (FIGS. 3, 4, and 15) or
a tube (FIG. 16) but instead has a central control region 106 to
act on the fluid differently in different positions, as shown, for
example, in U.S. Pat. No. 3,742,933. However, in this case the
elongated tubular portions 108 which are of constant diameter and
which are substantially rigid are located next to the central
control region 106 and carry the tissue-growth means 112 while
beyond these portions 108 the elongated tubular portions are each
provided with the flexible bellows-type of construction 114
according to which the circular convolutions are arranged as
illustrated.
With the embodiment of FIG. 18 the central control means 106 is
shown in a position different from FIG. 17 and the elongated
tubular portions 120 carry the tissue-ingrowth means 122 so that
except for the convoluted outer free end portions 114 the
embodiment of FIG. 18 is identical with that of FIG. 17. According
to FIG. 18 a pair of elongated coil springs 124 are pressed at
their inner ends onto free ends of the portions 120 so that these
coil springs, also made of any suitable wire which is compatible
with the human body, such as gold wire, for example, will permit
the tubular organ to flex, thus avoiding kinking thereof, while at
the same time these coil springs are capable of opposing any
tendency for the organ to become constricted due to formation of
scar tissue.
In the embodiment of FIGS. 17 and 18, the central control region
106 has its rotary body 110 formed with a through-bore 117 which
extends along the axis of the body 110 and with a U-bore 118 which
bypasses the bore 117. In the position of FIG. 17 the V-bore 118
provides communication between the tubular portions 108 while the
bore 117 is closed. In the position of FIG. 18 the bore 117
provides communication between the tubular portions 120 while the
V-bore 118 is closed. These bores 117 and 118 may carry at their
surfaces suitable chemicals or other deposits for acting on the
body fluid in any desirable manner, or only one of the bores may
have such a coating at its inner surface while the other bore is
uncoated. In this way without acting to regulate the fluid flow in
any way it is possible to influence the body fluid in different
ways.
According to the embodiments of the invention which is illustrated
in FIG. 19, the control means formed by implant 124 is also in the
form of a valve means or other means for acting on the body fluid
and adapted to be introduced into a tubular organ, as illustrated.
In this case also the control means 124 has the central control
region 126 and the pair of substantially rigid elongated tubular
portions 128 respectively carrying the tissue ingrowth means 130
and extending along the region where scar tissue will normally
grow. However, in this case the walls which form tubular portions
128 extend along the entire length of the implant between the
opposed ends thereof but beyond the region which carries the tissue
ingrowth means 130. Where these walls extend beyond the scar tissue
region they have been cut through with a suitable tool along a
spiral path so as to form in this way elongated spring extensions
132 which are integral with and extend from the solid wall sections
128. These sections 132 will perform in the same way as the springs
122 described above in connection with FIG. 18.
FIG. 20 illustrates an embodiment of the invention where in the
illustrated tubular body organ 20 there is introduced an implant in
the form of a control means 134 having the central control region
136 and the pair of elongated tubular portions 138 respectively
extending in opposite directions from the central valve sections
136 and carrying the tissue ingrowth means 140. According to this
embodiment a pair of elongated cylindrical highly porous cylinders
142 of a material such as that used for dissolving sutures are
intially situated in the interior of the tubular portions 138 and
extend freely beyond the latter through a distance as illustrated
in FIG. 20. These cylinders 142 do not appreciably oppose the flow
of a body fluid and are capable also of supporting the tubular
organ 20 against constriction during healing but at the same time
they are capable of being absorbed into the system while they
dissolve so that eventually they will disappear leaving subsequent
to complete healing only the valve means 134 without the plugs 142.
In this way also it is possible to oppose constriction due to
formation of scar tissue while leaving the tubular organ in its
initial condition except for the implant 134.
In the embodiment of the invention which is illustrated in FIG. 21
there is a control means 134 identical with the control means 134
of FIG. 20 and carrying the tissue ingrowth means 140 in exactly
the same way at the tubular portions 138. However, in this case
instead of cylinders 142, elongated tapered convoluted tubular
extensions 144 are provided. These extensions have inner
cylindrical hollow portions 146 which are received in the interior
of the portions 138 as illustrated. These tapered portions 144
which thus also have the circular convolutions forming a bellows
type of construciton will provide the required flexing to prevent
kinking but at the same time opposing any tendency of construction
due to formation of scar tissue.
According to the embodiment of the invention which is illustrated
in FIG. 22, the control means 148 is also shown as situated in a
tubular body organ 150 extending between the parts thereof into
which the tubular portions 152 of the control means extend as
illustrated. These tubular portions carry the tissue-ingrowth means
154 in the form of a porous matrix or of a wire, for example, wound
around the exterior of the tubular portions 152. These portions 152
extend through and beyond the area where scar tissue will form so
as to oppose any tendency for constriction to take place. However,
with this embodiment after the implant is introduced the surgeon
will wind a springy wire 156 of gold, platinum, or other material
which is compatible with the human body around the exterior of the
vas 150 so as to achieve a construction as illustrated in FIG. 22.
With this located the springs 156 form a means located around the
exterior of the tubular organ to permit the latter to flex without
kinking. According to the embodiment of the invention which is
illustrated in FIG. 23, any tubular organ 160, such as any blood
vessel, for example, may be repaired as by having a severed portion
interconnected through the sutures 162. However, prior to
interconnecting the severed portions of the tubular organ 160 the
elongated implant 164 is introduced. This implant 164 in this case
is formed in its entirety of an elongated cylindrical tube of a
material capable of being dissolved and absorbed into the system
such as the material used for dissolving sutures. Thus the
elongated tube 164 is introduced into the tubular organ 160 so that
it will assume a position as indicated in FIG. 23. With this
construction the tubular organ will resume its initial condition
after healing with the entire implant 164 disappearing completely.
It is to be noted that the elongated tube 164 will support the
tubular organ against constriction while permitting the required
body fluid to flow through.
Of course, as was pointed out above in connection with FIGS. 13 and
14, the filaments 82 may be situated in a body of gelatin or other
material which will dissolve so as to facilitate introduction of
the filaments 82, and in this case these filaments 82 will be
located in a material such as that used to form the implant 164 of
FIG. 23, and in fact the arrangement of FIG. 23 may be used in
combination with the arrangement of FIGS. 13 and 14 for the purpose
of holding the filaments 82 properly during insertion of the
implant.
According to the embodiment of the invention which is shown in FIG.
24, the tubular body organ 160 may be identical with that of FIG.
23. After it has been cut through for any reason, the ends may be
held together upon closing of the tubular organ by sutures 162, as
pointed out above in connection with FIG. 23. However, in this case
the implant 166 is composed of a cluster of particles which have an
irregular configuration. These particles may have a shape and size
similar to that of large particles of sand, except that the
particles which form the cluster 166 are made of a material which
will be absorbed into the body upon dissolving, as is known in
connection with dissolvable sutures, for example. The body fluid
flows in the direction of the arrow 168. At the right end of the
cluster 166 is located a filter 170 which is made of a number of
elongated fibers of dissolvable material such as dissolvable suture
material, these fibers being pressed together so as to form the
filter 170 through which the fluid also can flow. The filter 170 is
placed by the surgeon at the location shown in FIG. 24 where it
remains simply by friction, and as a result the particles 166 are
prevented from flowing away from the region shown in FIG. 24. where
they serve to support the interior of the tubular organ 160 against
constriction due to the formation of scar tissue. It will be noted
that the cluster of particles 166 is distributed along the interior
of the tubular organ 160 through a distance which extends not only
through the region where scar tissue grows but also substantially
beyond this region. Thus, after the tubular organ has been opened
for any reason and is to be reclosed the surgeon will introduce one
portion of the cluster of particles 166 in the right part 160a and
the other portion in the left part 160b of the tubular organ 160,
as viewed in FIG. 24, so that upon closing of the tubular organ by
the sutures 162, for example, the continuous cluster of particles
166 will be formed. Because of their size and irregular
configuration these particles while capable of reliably supporting
the tubular organ against constriction due to the growth of scar
tissue nevertheless will permit the fluid to flow freely through
the tubular body organ in the direction shown by the arrow 168.
FIG. 26 illustrates yet another embodiment of an implant according
to the invention, schematically shown in FIGS. 26 in the interior
of a tubular body organ, while FIG. 25 schematically illustrates a
stage in the method of manufacture of the implant of FIG. 26.
Thus, referring to FIG. 25, an inner filament 172 of very fine wire
or other suitable material is wound in one direction around a
suitable mandrel 174 which may be made of a material such as
aluminum, for example. The fine filament 172 may be made of a
springy material so that it forms an elongated coil spring wound
around the mandrel 174. The opposed ends of the wire 172 are
wrapped around inner free ends of a plurality of barbs 176 also
made of any suitable metal, for example, and distributed about the
axis of the mandrel 174 as illustrated. Any desired number of barbs
176 may be situated at each end region of the wire 172 as
illustrated. In this way the barbs 176 are held on the mandrel 174
assembled with the wire 172.
Then, an outer fine filament 178, which may be identical with the
material of the filament 172 is wound around and against the coil
172 but the convolutions of the filament 178 are wound in a
direction opposite to the direction of winding of the convolutions
of the filament 172. In this way the convolutions of the two wound
filaments 172 and 178 will engage each other while being inclined
in opposite directions to define a plurality of apertures. It is to
be understood that this construction is illustrated schematically
only for the sake of clarity. Actually the windings will be located
closer to each other and the pitch of the convolutions will be much
sharper so that the inclination of the convolutions will be more
pronounced than illustrated. The ends of the outer wound filament
178 will also be wrapped around the inner axially extending ends of
the barbs 176 so as to contribute to the security of the assembly
of the components shown in FIG. 25.
This latter assembly is then placed in a suitable evacuated chamber
where in a known way a metal, preferably gold, is vapor-deposited
over the entire assembly so as to form a coating on the exterior
surfaces of the springy filaments 172 and 178 and the barbs 176.
When using a vapor-deposited material such as gold, te structure is
rendered compatible with the human body. At the same time, the part
of the deposited metal situated at the intersecting portions of the
coils and barbs serve as welds to fasten these components together
at the locations where they engage each other.
After vapor deposition has been carried out in the above manner the
mandrel 174, which may be made of a material such as aluminum, as
pointed out above, is melted away, leaving the coated assembly of
wound springy filaments 172 and 178 together with the barbs 176.
The resulting implant 180 which iis illustrated in FIG. 26 thus
includes an elongated tubular foraminous wall constituted by the
intersecting coil spring filaments 172 and 178 which are coated
with a metal as described above, with this foraminous tubular wall
carrying at the region of its ends the barbs 176 which have their
pointed ends directed outwardly away from the axis of the tube and
toward a central plane which is normal to the tube.
Thus, with this construction when the tubular organ 182 is cut
through for any reason so as to have access to the interior
thereof, before the ends 184 of the tubular organ are again placed
in engagement with each other, the implant 180 is introduced. The
barbs 176 will act in a highly effective manner to dig into the
tissue of the tubular organ 172 so as to hold the ends 184 butting
against each other to achieve healing in a highly effective manner
without the use of sutures. At the same time the foraminous wall
which is constituted by the springs 172 and 178 has a sufficient
rigidity to oppose constriction of the lumen of the tubular organ.
It will be noted that the length of the implant 180 is such that it
extends through and substantially beyond the trauma area 186 where
scar tissue will grow. Moreover, because of the springy nature of
the foraminous tubular wall it will prevent kinking of the tubular
organ.
In addition, one of the great advantages achieved with this
particular embodiment of the invention resides in the fact that the
foraminous tubular wall constituted by the coated springs 172 and
178 itself forms a tissue-ingrowth means since the tissue will
readily grow through and fill the tiny spaces formed between the
oppositely directed coil springs. Thus, an extremely secure joinder
of the implant into the wall of the tubular organ which grows
through and around the foraminous wall of the implant is achieved,
so that particularly outstanding results will follow from this
particular embodiment of the invention.
Referring to FIG. 27, there is illustrated therein an embodiment of
the invention according to which the barrier means 200 of FIG. 4 is
used by itself with a vas implant since this feature need not
necessarily be combined with the other features of the invention.
Thus FIG. 27 shows a pair of spaced vas sections 204a and 204b
between which is located the central valve assembly 202 of a vas
valve which is implanted in the manner illustrated in FIG. 27 with
the elongated tubular parts 206a and 206b of the valve being
covered with a suitable tissue ingrowth means and extending along
the interiors of the lumens of the vas section 204a and 204b. Thus,
this arrangement is identical with that of FIG. 4 except that the
valve need not have the components 52. The space between the vas
sections 204a and 204b is filled with the barrier means 200 which
is precisely the same as the barrier means 200 described above in
connection with FIG. 4. Thus with the embodiment of FIG. 27, even
if it is decided not to use the elements 52 of FIG. 4, nevertheless
this embodiment will achieve the advantage of preventing the sperm
from bypassing the valve along the exterior thereof since the sperm
will be incapable of travelling through the thick substance 200, as
described above in connection with FIG. 4.
It is apparent, therefore, that with the above described methods
and devices of the invention it becomes possible to carry out
surgical procedures in such a way that the formation of scar tissue
will not undesirably cause constriction of a tubular body organ,
with the added advantages of preventing kinking of the body organ
and permitting a pumping action such as a peristaltic action to
take place.
* * * * *