U.S. patent number 3,752,162 [Application Number 05/242,505] was granted by the patent office on 1973-08-14 for artificial cutaneous stoma.
This patent grant is currently assigned to Dow Corning Corporation. Invention is credited to Mahmoud S. Newash.
United States Patent |
3,752,162 |
Newash |
August 14, 1973 |
ARTIFICIAL CUTANEOUS STOMA
Abstract
A device for providing a long term percutaneous pathway for
elongated members such as catheters, pacemaker leads, fiber optics,
and the like, comprising a flanged cup-shaped body containing coils
of the elongated member or members and having tissue fixation means
on its surface, at least one aperture in the bottom of the body
through which the elongated members pass and to which the elongated
member may be permanently affixed and a membranous cover designed
to be cut along with overlying skin for withdrawal of the coiled
portion of the elongated member after cutaneous implantation and
healing.
Inventors: |
Newash; Mahmoud S. (Saginaw,
MI) |
Assignee: |
Dow Corning Corporation
(Midland, MI)
|
Family
ID: |
22915041 |
Appl.
No.: |
05/242,505 |
Filed: |
April 10, 1972 |
Current U.S.
Class: |
604/175; 604/264;
607/113 |
Current CPC
Class: |
A61N
1/378 (20130101); A61M 39/0247 (20130101); A61B
5/076 (20130101); A61M 2039/027 (20130101); A61M
2039/0255 (20130101); A61M 2039/0273 (20130101); A61M
2039/0279 (20130101); A61M 2039/0288 (20130101) |
Current International
Class: |
A61B
5/07 (20060101); A61M 1/00 (20060101); A61N
1/378 (20060101); A61N 1/372 (20060101); A61m
025/02 () |
Field of
Search: |
;128/348,351,334C,419P,1R,2R ;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
That which is claimed is:
1. An artificial cutaneous stoma for percutaneous passage of an
elongated body insertable member, comprising:
A generally cup-shaped body of surgically implantable material
including a flange extending beyond the periphery of the cup-shaped
portion,
tissue ingrowth means affixed to the external surface of said cup
shaped body,
a flexible elongated body insertable member having an end portion
thereof extending through the bottom of said body and the remainder
thereof coiled within the cup-shaped portion thereof, and
a closure membrane closing the top of said cup-shaped body whereby
upon rupture or cutting of said membrane the coiled portion of said
elongated member can be extended and withdrawn from said cup-shaped
body while the artificial stoma is implanted.
2. An artificial cutaneous stoma as defined in claim 1 wherein said
elongated member is a catheter.
3. An artificial cutaneous stoma as defined in claim 1 wherein said
elongated member includes an electrically conductive element.
4. An artificial cutaneous stoma as defined in claim 3 wherein said
elongated member is a cardiac pacemaker lead.
5. An artificial cutaneous stoma as defined in claim 1 wherein said
elongated member is a fiber optic element.
6. An artificial cutaneous stoma as defined in claim 1 wherein said
elongated member is permanently affixed to the bottom of said
cup-shaped body.
7. An artificial cutaneous stoma as defined in claim 1 wherein said
cup-shaped member has a tubular member affixed to and extending
from the bottom thereof and has another elongated member slidably
positioned within said tubular member.
8. An artificial cutaneous stoma as defined in claim 1 wherein said
closure membrane is peripherally adhered to the top surface of said
flange.
9. An artificial cutaneous stoma as defined in claim 1 wherein the
elongated member coiled within the cup-shaped body has been
exteriorized through the closure member and the cup-shaped body has
been filled with a physiologically inert flexible material.
10. The artificial cutaneous stoma of claim 9 wherein the
physiologically inert flexible material is a room temperature
vulcanizable silicone rubber.
Description
BACKGROUND OF THE INVENTION
The present invention relates to the field of surgically
implantable skin exit devices for elongated members such as
catheters, pacemaker leads, fiber optics, and the like.
In various surgical procedures it has become a common practice to
permanently implant an elongated member such as a catheter, a
pacemaker lead, a fiber optic element, and similar devices in a
manner such that one end of the elongated member remains in
position within the body on a long-term or permanent basis and the
other end must be passed through the skin to some type of external
device. For example, in the case of a chronic renal malfunction
permanently indwelling cannulae are provided for extracorporeal
hemodialysis. Similarly, electrical conductors such as heart pacer
leads are permanently implanted for purpose of interconnecting an
internal organ with an external power source or monitoring
device.
The primary problems associated with long-term indwelling of
percutaneous leads and catheters have been infection introduced at
the point of exit from the skin of the device and displacement of
the device. The infection is caused by migration of microorganisms
from the point of exteriorization of the device. The displacement
can mean loss of proper position of the implanted end of the device
as well as increased infection as the device slides back and forth
through the skin exit. It is toward these problems of the prior art
that the present invention is directed.
SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide a means
for permanent access to the inner body through the skin which
reduces or eliminates the problems heretofore prevalent in many
such devices. In accordance with this and other objects there is
provided by the present invention a device for providing a
long-term percutaneous pathway for elongated members such as
catheters, pacemaker leads, fiber optics, and similar devices and
is useful generally in any application that requires repeated
transfer of substances between intracorporeal and extracorporeal
environments or which requires transfer of energies such as
electricity, heat, light, etc. between these environments. In its
simplest form the invention comprises a flanged cup-shaped body
which contains coils of the elongated member and has tissue
fixation means on its external surface. However, this device is not
limited to a cup-shaped device. Any form can be employed so long as
it provides a sealed housing to accommodate the coiled portion of
the elongated member of this device. An aperture in the bottom of
the cup-shaped body allows the elongated member to pass
intracorporeally. The elongated member may be permanently affixed
to the bottom of the cup. A membranous cover is designed to be cut
along with the overlying skin for withdrawal of the coiled portion
of the elongated member subsequent to the cutaneous implantation
and healing of the incision made for implantation. The device is
designed to be initially implanted totally beneath the skin and
after substantial healing has taken place an incision is made
through the overlying skin and through the cover of the device to
expose the coiled length of catheter or other elongated member
contained therein. The small incision required and the viability of
the tissue surrounding the incision will minimize migration of
microorganisms during the most critical period. Even if immediate
exteriorization of the indwelling elongated member is required at
the time of implantation the design of the device of the present
invention together with proper surgical techniques as discussed
below guard in marked manner against infection and sharply reduces
incidents of trauma and displacement. The cup-shaped body may be
filled with a room temperature vulcanizable silicone rubber or
suitable material after the elongated member coiled therein has
been exteriorized, thus further blocking passage of infectious
organisms.
Other objects and advantages of the present invention will become
clear to those skilled in the art from a reading of the following
detailed description when read in connection with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view in perspective of an artificial cutaneous stoma
made in accordance with the present invention.
FIG. 2 is a vertical cross-section of the device shown in FIG.
1.
FIG. 3 is a vertical cross-section of the device shown in FIGS. 1
and 2 after exteriorization of the device has been
accomplished.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now to the drawings wherein like reference numerals
designate like parts throughout the figures thereof, there is shown
in FIG. 1 a device for providing a long-term percutaneous pathway
which comprises a flanged cup-shaped body 11 with the flange 12
positioned around the top thereof. The body 11 including the flange
12 are preferably made of a physiologically inert flexible
substance such as silicone rubber. A membranous cover 13 is
provided over the open end of the body 11. The flange 12 and the
membranous cover 13 may be a unitary element or separate parts. The
cover may also be made of silicone rubber which is adhesively
secured in its peripheral areas to the top surface of the flange
12. An artificial stroma (tissue ingrowth means) 14 which may, for
example, be a Dacron.RTM. mesh, a felt, or a tissue-permeable open
cell foam, are provided on the surface of the body 11, preferably
on both the cup-shaped portion and the flange portions thereof. The
artificial stroma (tissue ingrowth means) 14 serves to securely
anchor the device in position and also to allow growth of tissue
intimately with the device to deter the ingress of infection.
The elongated member 16 which is designed to be passed
percutaneously has one end thereof coiled within the cup-shaped
portion 11 and the other end thereof passing through and preferably
permanently attached to the bottom of the cup-shaped portion at 17.
The member 16 may be a catheter, an electrically conductive
element, or a fiber optic element, for example, and in general may
be any kind of elongated member useful for transfer of substances
between intracorporeal and extracorporeal environments or which is
useful for transfer of energy such as electricity, heat, light,
etc. between such environments. The elongated member 16 may be a
single tube or element or it may be two or more such elements as in
the case of electrical leads in a heart pace control device. It
should be understood, of course, that the surface of such elongated
element must also be of a material which is compatible with body
tissue. Again a silicone rubber material is preferred for the
surface of the elongated body.
For operation of the device the extended portion of the elongated
member 16 is surgically positioned as required within the body and
the cup-shaped body 11 is surgically implanted, for example, using
a blunt subcutaneous disection. Preferably a U-shaped skin incision
is utilized so that a skin flap may be placed over the device and
sutured such that the suture line is distant from and not on the
device. Preferably, several days postoperatively a second skin
incision is made directly over the cup-shaped body 11 of the
device. The incision is made as small as possible but must extend
through the overlying skin flap and the closure membrane 13
directly over the cup-shaped body 11 in order that the coiled end
of the elongated member 16 can be exteriorized through the
incision. The exteriorized portion of the elongated member can then
be connected to the necessary extracorporeal equipment to be
associated with the device. It is to be understood that if
necessary because of medical urgency the coiled portion of the lead
contained within the cup-shaped portion of the device can be
exteriorized at the time of the initial surgical procedure where
the extended portion of the member 16 is implanted
intracorporeally; however, by waiting until substantial healing has
taken place the danger of infection is minimized and the danger of
displacement of the intracorporeal portion of the device is also
minimized. After the exteriorization of the portion of the
elongated member or members 16 coiled within the cup-shaped body
11, the cup-shaped body 11 may be filled with an inert
non-permeating permanently flexible material such as room
temperature vulcanizable silicone rubber or other suitable material
to eliminate the creation of a subcutaneous pocket or void.
Various modifications of the device as described hereinabove are
within the skill of those versed in the art. For example, instead
of the device having a tubular member 17 extending from the bottom
thereof through which the elongated member 16 is telescopingly
positioned, the elongated member 16 may be simply adhesively
secured to the bottom of the cup-shaped portion of the body 11.
Further, the closure membrane may have artificial stroma 14 on
either or both sides and the flange 12 can be positioned along the
cup-shaped body 11 rather than at the top thereof. Further,
multiple flanges can be employed if desired. It is understood
further that the intracorporeal portion of the elongated member 16
can include special structures for fixation, valves or other flow
controlling mechanisms, branches or other arrangements for
directing the flow, inner-cannulae or other irrigation mechanisms.
It is to be further understood that the extracorporeal portion, for
example, can be modified to incorporate structures such as skin
plates, inner-cannulae, valves, and preparations which would
facilitate connection or attachment to other extracorporeal
devices. The entire device or any portion thereof may be prepared
from radiopaque material to facilitate radiographic visualization
of such a portion.
Particular examples of applications of the device described
hereinabove include hemodialysis; peritoneal dialysis; percutaneous
stoma communicating with the kidney, bladder, uretera, stomach,
ileum, colon, or any other internal region or organ; percutaneous
stoma for power lines needed to operate an internal artificial
organ powered by an external source; electric wires and gas lines
for an artificial source; and electric wires for artificial
pacemakers and transducers. The device may be used also as a
percutaneous stoma through which a metabolic product or byproduct
can be repeatedly withdrawn. This applies to situations where
repeated biopsies from an internal organ or system are indicated.
It is useful as a percutaneous stoma through which an applicable
medication or treatment can be administered. By use of fiber optics
it is useful as a percutaneous window through which an organ or a
system or their activities can be observed.
Other applications as well as modifications and variations of the
embodiments described with particularity hereinabove will become
obvious to those skilled in the art from a reading of the
foregoing. It is therefore to be understood that within the scope
of the appended claims the invention may be practiced otherwise
than as specifically described.
* * * * *