U.S. patent number 3,699,956 [Application Number 05/077,290] was granted by the patent office on 1972-10-24 for percutaneous lead device.
This patent grant is currently assigned to Tecna Corporation. Invention is credited to Sotiris Kitrilakis, Thomas C. Robinson.
United States Patent |
3,699,956 |
Kitrilakis , et al. |
October 24, 1972 |
PERCUTANEOUS LEAD DEVICE
Abstract
A percutaneous lead device including an element for preventing
bacterial infection caused by implanting the lead through the skin.
This element extends below and along the skin surface and includes
an antibacterial fluid reservoir coated with a
diffusion-controlling layer which maintains the desired fluid
release rate. A surface configuration on the reservoir and lead
which is highly adherent to and completely permeated by ingrowing
tissue provides a particularly effective bacterial seal.
Inventors: |
Kitrilakis; Sotiris (Berkeley,
CA), Robinson; Thomas C. (El Cerrito, CA) |
Assignee: |
Tecna Corporation (Berkeley,
CA)
|
Family
ID: |
22137207 |
Appl.
No.: |
05/077,290 |
Filed: |
October 1, 1970 |
Current U.S.
Class: |
604/175; 424/449;
604/265 |
Current CPC
Class: |
A61M
39/0247 (20130101); A61L 29/16 (20130101); A61M
2039/0285 (20130101); A61L 2300/404 (20130101) |
Current International
Class: |
A61L
29/16 (20060101); A61L 29/00 (20060101); A61M
1/00 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348,349R,35R,214.4,260 ;3/1 ;424/19 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
ersek et al - Trans. Amer. Soc. Artif. Int. Orgs. 1969, Vol. XV,
1969 (June) pp. 267-271. .
McDonald et al. - Trans. Amer. Soc. Artif. Int. Orgs. Vol. XIV 1968
- pp. 176-180..
|
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. A percutaneous device comprising an elongated lead adapted to
penetrate the skin, said lead including a portion having an
external surface compatible with skin, subcutaneous tissue and
other tissue, said surface including pockets extending into said
surface for receiving ingrowth of living cells to permanently
anchor the lead, antiseptic means including an antibacterial fluid
reservoir for providing a controlled release of said fluid adjacent
said portion of the lead, said reservoir including a walled chamber
attached to said lead, said chamber walls provided with diffusion
controlling passage means so that upon penetration of the skin by
the device the fluid is released directly from said reservoir into
the area around said reservoir portion over a prolonged period of
time to prevent bacterial penetration into the tissue along the
lead during ingrowth of said cells.
2. A lead device as in claim 1 in which said reservoir comprises an
antibacterial fluid-containing absorptive material carried within
said chamber of the lead.
3. A percutaneous lead as in claim 2 in which said release means
includes a permeable barrier covering said absorptive material.
4. A percutaneous lead device as in claim 3 in which said barrier
is a layer extending over essentially the entire surface of the
absorptive material.
5. A percutaneous lead device as in claim 4 in which said layer is
covered by a material which is compatible with living tissue having
a plurality of microcavities of predetermined size and shape.
6. A percutaneous lead device as in claim 4 in which said layer has
a thickness of from 0.001 to 0.020 inch.
7. A percutaneous lead as in claim 4 in which said layer is capable
of anchoring tissue ingrowth on its outer surface.
8. A percutaneous lead device as in claim 5 including elongated
passages through said layer of a size sufficient for
permeability.
9. A percutaneous device comprising an elongated hollow lead
adapted to penetrate the skin, said lead including a portion having
a flexible external surface compatible with skin, subcutaneous
tissue and other tissue, said surface portion including a plurality
of adjacent substantially discrete pockets having openings which
face toward the tissue, the walls of said pocket being of such
shape and size as to provide means to accommodate a number of
living cells sufficient to provide anchoring but not so large as to
prevent essentially normal transfer of nutrients to said living
cells in said pockets from said adjacent area of tissue, antiseptic
means including an antibacterial fluid reservoir for providing a
controlled release of said fluid adjacent said portion of the lead,
said reservoir including a walled chamber attached to said lead,
said chamber walls provided with diffusion controlling passage
means so that upon penetration of the skin by the device the fluid
is released directly from said reservoir into the area around said
reservoir portion over a prolonged period of time to prevent
bacterial penetration into the tissue along the lead during
ingrowth of said cells.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to method and means for preventing
bacterial infection caused by implanting a percutaneous lead device
in the skin and for achieving good fixation to minimize bacterial
penetration and to avoid accidental removal of the lead.
Percutaneous lead devices such as tubes, shunts, cannulae,
insulated wire, and various rods or tubular devices have been
implanted through the skin for a wide variety of reasons. For
example, such devices are used temporarily or over long periods of
time to provide access to the circulated blood for blood pressure
monitoring, blood sampling, the infusion of various substances, and
the like. These lead devices are also used to connect external
equipment to implanted devices, such as blood-flow probes, blood
pumps, and pace makers. Two particularly widespread uses are as
blood vessel connections in hemodialysis and as abdominal cavity
access tubes for peritoneal dialysis. Both dialysis techniques are
important tools in the treatment of kidney failure.
Although there is a substantial need for chronic, or long-term, use
of percutaneous lead devices of the aforementioned type, the
presently-available lead devices tend to cause infection by
bacteria being transmitted across the skin and along the boundary
between such devices and the surrounding skin tissue. Use of
topical antibiotics at the skin puncture or the use of systemic
antibiotics have been only marginally successful in the control of
such infections since surface or systemic bacterial control does
not prevent the eventual infection of the internal tissue. The only
effective treatment of infections along present leads has been the
removal of the lead and infected tissue, necessitating the
implantation of a lead in a new site. Such untreated local
infections will eventually result in systemic infections.
SUMMARY OF THE INVENTION AND OBJECTS
In accordance with the present invention, method and means are
provided at a peripheral portion of a percutaneous lead device for
releasing antibacterial fluid into the surrounding tissue at a
controlled rate upon implanting the lead device into the skin. The
release means includes a fluid reservoir, such as an absorptive
material to which the antibacterial fluid is applied carried by a
peripheral lead portion. In on embodiment, the coating material
contains a plurality of microcavities which are compatible with
blood and living tissue and form a tenacious base for anchoring
tissue ingrowth which minimizes bacterial penetration along the
lead surface.
It is a general object of the present invention to provide a method
and means for preventing infection in a percutaneous lead device
when implanted in the skin caused by bacteria being transmitted
along the surface.
It is another object of the invention to provide a method and means
for the controlled release of antibacterial fluid from the surface
of a percutaneous lead device.
It is another object of the invention to provide a method and means
for obtaining tissue fixation which avoids movement of the lead
relative to adjacent tissue or accidental detachment or
removal.
The foregoing and other objects will become apparent from the
following description when taken in conjunction with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is an enlarged view of a portion of skin and subcutaneous
tissue together with a percutaneous lead device according to the
invention; and
FIG. 2 is an enlarged view of the portion of FIG. 1 showing the
release device of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the drawing, percutaneous lead line 10 in the form of
a hollow tube is illustrated in an implanted position after
penetration through skin 11 and subcutaneous tissue 12. Line 10 may
also be a solid rod such as an insulated wire for monitoring
purposes. Various uses for either type of percutaneous lead line
are described hereinbefore. In one embodiment, line 10 includes an
outer wall containing a plurality of microcavities 13, such as
formed in accordance with the method set forth in the copending
application Ser. No. 77,289, filed Oct. 1, 1970. These
microcavities allow the skin and subcutaneous tissue to grow around
the outside walls and become permanently fixed or anchored to the
wall by tissue ingrowth.
As further disclosed in the aforementioned application, the lead
wall material may be rigid or flexible, depending upon the
particular use of the lead line. A flexible lead line has the
desirable property of reducing surface shear forces as caused by
body movement or external forces applied to the line.
An additional technique to increase surface area and reduce shear
stresses as illustrated in FIG. 1 is the disposition of a
subcutaneous portion of the lead line generally parallel to the
skin surface. This additional length provides increased fixation as
well as other advantages discussed below.
Tissue growth in the microcavities forms a generally sealing
interface which effectively blocks the ingress of infection causing
bacteria across the skin for prolonged periods of time. However,
this tissue seal is not completed until growth of the surrounding
tissue into all interstices of the microcavity surface structure
takes place. Even though this seal is formed in a relatively short
period of time (e.g., several days), it is necessary to prevent
bacterial penetration into the tissue along the lead surface during
seal formation. This protection is provided by the means described
herein.
According to the invention, microcavity-containing lead lines
achieve long-term use by antiseptically preventing early bacterial
infections below the skin. For this purpose, (e.g., antibacterial
fluid reservoir 14 is mounted onto peripheral lead portion 10a. To
provide a slow release of the fluid so that it is available for a
prolonged period of time, a diffusion-controlling layer in the form
of coating 16 is mounted or applied to lead portion 10a over
essentially the entire area of reservoir 14 so that the reservoir
is sealed at its proximal and distal ends. In one embodiment,
reservoir 14 is an antibacterial fluid containing a wick-like
absorbant material such as porous cloth (e.g., knitted or woven
Dacron) or a fibrous mat e.g., Teflon felt). The antibacterial
agent is applied to the material and released at a controlled rate
through the diffusion-controlling layer 16 into the skin.
In one embodiment of a diffusion-controlling layer 16 shown in the
drawings, a plurality of elongated passages 17 are provided
throughout the layer to promote the desired diffusion rate.
Passages 17 may be formed in a similar manner to microcavities 13
or by physically puncturing or perforating the layer. Passages 17
may be supplemented by microcavities 18 of the same type as
microcavities 13 throughout the coating in such a manner that they
are linked with passages 17 to form paths through the coating of
sufficient size and density to accomplish the desired diffusion
properties. Microcavities 18 also serve to permit tissue ingrowth
and adhesion to prevent bacterial penetration along the surface of
the layer. In an example of one such coating, an average of about
100 penetrations per cm.sup.2 of 0.1 mm length and 0.05 mm width
are positioned throughout the layer. A typical thickness for such a
layer is 0.001 to 0.020 inch.
In another embodiment of a diffusion-controlling element (not
shown), microcavity surface material may inherently possess the
desired diffusion rate without the need for passages 17, as
exemplified by Dacron cloth or a silicone rubber membrane
layer.
The antibacterial fluid in reservoir 14 is of a type which is
capable of allowing tissue growth on the outer surface of the
percutaneous lead device while preventing bacterial infection.
Suitable fluids include the following: maphenide acetate, silver
nitrate, and silver sulfadiazine, and the like.
Antibiotic treatment is primarily beneficial from the time of
implantation until tissue ingrowth occurs creating an effective
bacterial seal at the tissue-microcavity surface. Thus, the
antibiotic is supplied in amounts to be consumed at approximately
that time.
The antibiotic treatment is maintained until complete tissue
ingrowth and fixation occur, and may be discontinued at this time
because an effective bacterial seal is created at the
tissue-microcavity surface. If antibiotic treatment is
discontinued, then means for preventing bacterial invasion of
reservoir 14 are provided. These means include an impervious
coating external to the skin (coating 18) which is either applied
prior to implantation or at the time antibacterial treatment is
stopped. If the reservoir is wholly beneath the surface of the
skin, then no surface coating need be applied. In either case, the
reservoir can be filled with an inert substance (curable silicon
rubber, silicone grease) to prevent bacterial growth within the
reservoir.
In general, it is noted that reservoir 14 may extend to any desired
degree above the surface of the skin or therebelow. The reservoir
may extend above the skin or may terminate just below the skin in
the subcutaneous tissue as shown in FIG. 1.
After depletion of antibiotic, a pathway may be formed for bacteria
through the porous coating 16 and empty reservoir 14 into the skin.
To prevent this, it is preferred to terminate the reservoir and
coating just below the skin in the subcutaneous tissue so that
permeable layer 16 is not exposed. If it is desired to extend the
reservoir above the skin, then the externally projecting portion of
layer 16 should be rendered impermeable as by application of an
impermeable coating prior to implantation or after termination of
treatment.
Depletion of antibiotic fluid may also provide a site for bacteria
growth in body fluids which diffuse through layer 16. This may be
avoided by filling the depleted reservoir with an inert substance
(e.g., curable silicone rubber or silicone grease) after antibiotic
fluid depletion.
To form the antiseptic means for preventing infection according to
the invention, the bacterial fluid is first supplied to reservoir
14 either before mounting layer 16 or thereafter as through a
hypodermic needle penetrating the coating.
* * * * *