U.S. patent number 3,877,462 [Application Number 05/407,991] was granted by the patent office on 1975-04-15 for ingrowth shroud and implanting method utilizing the same.
This patent grant is currently assigned to Inventors In Ventures, Inc.. Invention is credited to Louis Bucalo.
United States Patent |
3,877,462 |
Bucalo |
April 15, 1975 |
Ingrowth shroud and implanting method utilizing the same
Abstract
An implanting method according to which, in connection with the
implanting procedure, a shroud is connected to a body organ to
reinforce the latter in a manner which will prevent kinking of the
body organ. The shroud has in engagement with the body organ a
surface of sufficient porosity to promote the ingrowth of tissue
between the body organ and the shroud. The shroud may consist of a
bendable sheet material in the form of a filamentary mesh capable
of being placed around the body organ at the part of the latter
which receives the implant with the sheet material extending along
the body organ beyond the implant to prevent kinking of the body
organ at the region where it extends beyond the implant.
Inventors: |
Bucalo; Louis (Holbrook,
NY) |
Assignee: |
Inventors In Ventures, Inc.
(New York, NY)
|
Family
ID: |
23614393 |
Appl.
No.: |
05/407,991 |
Filed: |
October 19, 1973 |
Current U.S.
Class: |
128/843 |
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,335.5
;3/1,DIG.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Austenal Catalogue, 1964, pg. 65 (Item 6510)..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Steinberg & Blake
Claims
What is claimed is:
1. For use in connection with an implanting procedure, an elongated
implant adapted to be situated in the interior of a body organ with
said implant having opposed end regions beyond which the body organ
is adapted to extend, and ingrowth shroud means adapted to surround
the body organ at the region thereof where the implant is located,
said ingrowth shroud means being adapted to extend along the
exterior of the body organ beyond the opposed ends of the implant
for reinforcing the organ to prevent kinking thereof at the ends of
the implant, said ingrowth shroud means having, for engagement with
the organ, a surface of sufficient porosity to promote the ingrowth
of tissue between the organ and the ingrowth shroud means.
2. The combination of claim 1 and wherein the body organ is a vas
deferens while the implant is a valve adapted to be implanted in
the vas deferens to reversibly prevent the flow of sperm-carrying
fluid, said ingrowth shroud means being in the form of a bendable
mesh adapted to surround the vas deferens at the part thereof where
the valve is located and adapted to extend beyond opposed ends of
the valve.
3. For use in connection with an implanting procedure, an ingrowth
shroud consisting of a filamentary mesh sheet material means which
is flexible and bendable while having a relatively small degree of
resiliency so as to be bendable around and placed in engagement
with the exterior of an organ for reinforcing the latter, said
filamentary mesh sheet material means having a porosity sufficient
to promote the ingrowth of tissue between the organ and the sheet
material means, and said sheet material means having a dimension
along the organ sufficiently great to enable the sheet material
means to extend through substantial distances beyond opposed ends
of an implant situated in the organ with said sheet material means
having sufficient resistance to bending to prevent kinks from
forming in the organ at the ends of the implant without completely
eliminating the flexability of the organ, the filamentary sheet
material means having, for extending circumferentially around the
organ, a dimension great enough to enable end regions of the sheet
material means to overlap, the end regions of the sheet material
means which are adapted to overlap being formed with notches which
when the end regions overlap cooperate to define an opening through
which a part of an implant is adapted to extend.
4. In an implanting method, the steps of situating in an elongated
tubular organ an elongated implant which terminates in a pair of
opposed ends, and bending around and in engagement with the
exterior of the organ a filamentary mesh sheet material which is
flexible and bendable while being of a relatively small degree of
resiliency and which has dimensions great enough to extend
completely around the organ and along and through substantial
distances beyond the opposed ends of the implant, and situating the
sheet material at a location where it extends through substantial
distances beyond the opposed ends of the implant while bending the
sheet material to an extent according to which it completely
surrounds and engages the exterior surface of the organ for
reinforcing the latter, for providing some degree of bending of the
organ while preventing kinking thereof at the ends of the implant,
and for promoting ingrowth of tissue between the exterior organ and
the filamentary mesh sheet material.
5. In a method as recited in claim 4 and wherein end regions of the
sheet material are placed in overlapping relation extending
longitudinally along the organ during bending of the sheet
material.
6. In a method as recited in claim 4 and wherein the organ is a vas
deferens while the implant is a valve.
7. In a method as recited in claim 6 and wherein end regions of the
sheet material are placed in overlapping relation extending
longitudinally along the organ with the valve having a stem
extending through a wall of the organ and said end regions of the
implant being notched and receiving the stem in the notched end
regions.
Description
BACKGROUND OF THE INVENTION
The present invention relates to implanting methods and devices
used in connection with the implanting methods.
As is well known, most implants which are introduced into the
interior of a body organ of a living being are relatively rigid in
nature. On the other hand, the body organ is normally flexible, so
that the degree of flexibility of the body organ is necessarily
reduced by the implant therein. This loss of flexibility at the
exact part of the body organ which receives the implant in itself
creates no particular problem, but where the body organ extends
beyond the implant the flexibility of the body organ will tend to
form an undesirable kink in the body organ at the region where it
extends beyond an end of the implant. Furthermore, the flexibility
of the body organ is such that it may tend to deflect itself away
from the implant in an indesirable manner.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide a method and device which will avoid the above
drawbacks.
In particular, it is an object of the present invention to provide
a method and device which will prevent undesirable bending or
kinking of a body organ with respect to an implant.
Also it is an object of the present invention to provide a method
and device which will assure the security of the connection between
the body organ and the device of the invention.
In accordance with the invention the body organ is reinforced at
the part thereof which receives the implant by a shroud which is
placed around the body organ and which extends somewhat beyond the
ends of the implant along the body organ with this shroud having
sufficient resistance to bending to prevent kinking of the body
organ at the ends of the implant while at the same time avoiding a
complete inhibition of bending of the body organ. The shroud
preferably takes the form of a bendable sheet material in the form
of a filamentary mesh which can be placed around the body organ at
the region thereof which receives the implant with the open mesh
promoting ingrowth of tissue between the body organ and the sheet
material while at the same time the sheet material has the property
of giving to the body the capability of some bending at the region
where the body organ extends beyond the implant without, however,
giving to the body organ the capability of kinking at the ends of
the body organ.
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 fragmentary partly sectional elevation schematically
illustrating the method and structure of the present invention;
FIG. 2 is a sectional elevation taken along line 2--2 of FIG. 1 in
the direction of the arrows; and
FIG. 3 illustrates the ingrowth shroud of the invention prior to
utilizing the shroud in the method of the invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to the drawings and to FIGS. 1 and 2 in particular, there
is schematically illustrated therein, as an example of a body organ
to which the principles of the present invention are applied, a
part of a vas deferens 10 having an interior lumen 12 which
receives the implant 14. In the illustrated example the implant 14
is in the form of a valve for reversibly interrupting the flow of
sperm-carrying fluid. Thus, the vas 10 is formed with a suitable
incision 16 to enable the implant 14 to be introduced into the
lumen 12 at the parts thereof which extend in opposed directions
from the incision 16. The implant 14 thus is of an elongated
configuration and has the opposed ends 18 which are suitably
slotted so as to prevent plugging of the passage in the interior of
the elongated portions 20 of the implant. The elongated portions
extend from a central region 22 where a movable valve member is
located, with the valve member being moved by way of a control
member 24 situated in a hollow stem 26 which extends through the
incision 16 beyond the organ 10. The exterior surfaces of the
elongated portions 20 of the implant are surrounded by a porous
matrix 22 deposited in any known way on the exterior surfaces of
the portions 20 in order to promote the ingrowth of tissue between
the inner surface of the organ 10 and the exterior surface of the
implant, to achieve in this way not only a secure connection of the
implant in the organ but also to achieve a fluid-tight engagement
between the inner surface of the organ and the implant.
With the above conditions there may be a tendency for the organ 10
to bend, due to its flexibility, particularly at the ends 18 of the
implant 14, to such an extent that the organ 10 may form kinks at
the ends 18 of the implant, with such bending also having an
undesirable tendency to displace a part of the inner surface of the
organ 10 away from the matrix 22, thus creating a condition where
the ingrowth of tissue will not take place in the desired manner
over the entire exterior surface of the matrix 22 at each elongated
portion 20 of the implant 14.
In accordance with the present invention in order to avoid
undesirable kinking or bending of the organ with respect to the
implant, an ingrowth shroud 30 is utilized. As may be seen from
FIG. 3, the ingrowth shroud 30 consists of a sheet material means
32 which in the illustrated example is of a substantially
rectangular configuration. This sheet material means 32 is in the
form of a filamentary mesh. Thus, it is possible to form from fine
gold wires, which themselves may be in the form of fine braided
filaments, a woven mesh as illustrated in FIG. 3. While gold wire
is referred to, it is emphasized that any material compatible with
the body can be used. Thus, other metals as well as various
plastics may be utilized to form the filamentary mesh of the sheet
material means 32. The sheet material means 32 is flexible and
bendable and has a relatively small degree of resiliency. The
length of the sheet material means 32, as viewed in a horizontal
direction in FIG. 3, is chosen so as to be longer than the total
length of the implant. In addition, the opposed edges of the sheet
material means 32, shown at the top and bottom of FIG. 3, are
formed with centrally situated notches 34.
Thus, the ingrowth shroud means 30 may be placed by the surgeon
around the organ 10 after the implant 14 has been introduced. This
involves only bending the sheet material means 32 around the organ
10 so as to engage the exterior surface thereof. The opposed edges
36 of the sheet material means 32 may overlap each other with the
hollow stem 26 extending through an opening which is formed by the
overlapping notches 34, as is particularly apparent from FIG. 1. Of
course it is to be understood that the configuration of the sheet
material means 32 which is illustrated in FIG. 3 is provided only
for the specific example used to illustrate the present invention.
When the invention is applied to other implants and to other organs
the sheet material means 32 will of course have a different
configuration.
However, in accordance with the invention the sheet material means
32 is placed around the organ at the exterior thereof in such a way
that it will reliably maintain the organ in engagement with the
implant. At the same time, the sheet material means 32 extends
beyond the opposed ends 18 of the implant. As a result, the organ
10 is reinforced in such a way that while it may bend to some
extent at locations beyond the ends 18 of the implant 14, bending
to an extent sufficient to provide kinking is reliably avoided and
at the same time the shroud maintains the inner surface of the
organ 10 in engagement with the matrices 22, promoting a reliable
ingrowth of tissue at the interior of the organ.
Furthermore, because the ingrowth shroud 30 is made of a mesh, the
surface of the sheet material means 32 which engages the surface of
the organ 10 at the exterior of the latter has a sufficient
porosity to promote the ingrowth of tissue between the organ and
the shroud. Thus, before the sheet material means 32 is placed
around the organ the exterior surface of the organ 10 will be
wounded to some extent, either intentionally, or roughened as an
incident to the implanting procedure, and during healing of the
exterior surface of the organ 10 it will necessarily grow into the
openings of the mesh providing in this way ingrowth of tissue
between the organ 10 and the shroud so as to provide an exceedingly
secure connection between the organ 10 and the reinforcing shroud.
Initially, after the shroud is placed around the organ it may be
secured thereto by suitable sutures which can be extended through
meshes of the shroud.
Thus, with the method and device of the invention although the
organ 10 is still bendable to some extent, particularly at the
region where it extends beyond the ends of the implant,
nevertheless the presence of the ingrowth shroud 30 will reinforce
the organ so as to prevent excessive bending to such an extent that
undesirable kinking will take place. Furthermore, because of the
fact that the structure of the shroud is such that ingrowth of
tissue takes place between the organ and the shroud, the security
of the connection of the shroud with the organ is assured.
* * * * *