Note: Descriptions are shown in the official language in which they were submitted.
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This invention relates to a device for the
maintenance of a percu-taneous sinus -tract made ~or the
purposes of introductior. or removal of fluids or materials
by catheterization.
Chronic intermittent sinus tract access is
required Eor a variety oE medical procedures such as, for
example, catheteri~ation for the purposes of chronic
peritoneal dialysis.
The standard procedure for chronic peritoneal
10 dialysis is efEectuated by implantation of a silastic
catheter surgically, under general or regional anesthesia,
or with a trocar or a stylet device.
One trocar device for such purposes is more fully
descri~ed in United States Patent Nos. 3,064,653 and
3,149,196. Such device is commonly known as a "Trocath
Peritoneal Dialysis Catheter" (trocar), and is comprised of
a catheter, stylet (trocar) and device ~or attachment to
dialysis equipment.
The Trocath is comprised o~ a metal stylet with
handle (trocar) and a catheter sleeved around -the stylet.
It is also usually provided with a connecting device for
attachment to the catheter after insertion.
The trocath catheter and stylet are introduced
through an enlarged puncture site in the epidermis and then
carefully pushed through the peri-toneal cavity resulting in
the formation of a sinus tract enclosing the catheter and
stylet. The stylet is then removed and -the catheter is
~,..i ~
~L2~5~33 `
introduced further into -the peritoneal cavity to rest in
the left or right pelvic gutter. Thereafter a dialysis
apparatus is connected to khe connecting means attached to
the catheter. Dialysis treatment is then effectuated.
~ fter any catheter treatment has been completed,
it is usually desirable to remove the catheter between
procedures such as in the case of chronic peritoneal
dialysis. However, this sometimes results in the
undesireable loss of the sinus tract which has been formed
10 by surgery or a trocar sytlet thereby making it necessary
to foxm a new sinus tract with the aid of a physician
before the next treatment. Also, it is most desirable to
avoid repeti-tion of the sinus tract formation procedure for
subsequent treatments.
Previously maintaining the integrity of the sinus
tract for intermittent dialysis procedures has been
attempted by the use of a device described in UOS. Patent
No. 3,505,988 commonly known as "Deane's Peritoneal
20 Prosthesis". Deane's prosthesis is comprised of a pliable
plastic rod with a terminal disc. The Deane's prosthesis
is introduced into the empty sinus tract subsequent to
catheter removal and remains in place with the plastic rod
in the sinus tract and the terminal disc resting on the
epidermis. It is then normally secured with adhesive
tape. The Deane's prosthesis is then left in place until
just prior to subsequent catheter reintroduction.
~2~5933
However, when a solid one piece peritoneal
prosthesis, such as the Deane's prosthesis, is utilized, it
has been found that prior to the insertion of a peritoneal
catheter aEter removal of -the prosthesis, the sinus tract
to the peritoneum is lost approximately 15% of the time and
reintroduction of a new peritoneal trocar or Eurther
surgery is required to establish a new sinus tract to the
peritoneum, again requiring the attendance of a skilled
physician and carrying its associated morbidity.
10 Additionally reintroduc-tion of a catheter when only using
Deane's prosthesis to maintain sinus trac-t integrity
requires the use of a reluctantly stiEf catheter precluding
the use of more flexible catheters.
An object of this invention is to provide a
- prosthesis which will easily maintain a sinus tract between
catheterizations.
Another object of this invention is to provide a
prosthesis which, while maintaining sinus tract integrity,
20 also forms a guide for reintroduction of a catheter.
~ nother object of this invention is to provide a
prosthesis which provides an easy means of "sealing" the
sinus tract between cathe-terizations, while maintaining the
integrity of the sinus tract, to reduce the risk of
infection or the undesirable introduction or loss of
material through the sinus tract.
~ Z~S~33
Another object of this invention is to provide a
prosthesis which maintains the integrity of the sinus tract
and allows for the introduction of a catheter through the
sinus tract to the peritoneum or other location without the
necessity of the attendance of a skilled physician.
Another object of this invention is to provide a
prosthesis for sinus tract maintenance which is easy to use
and will be subject to widespread use.
Other objects, features and advantages of the
invention will become more apparent from the following
description.
In one aspect, the invention provides a prosthetic
device for maintaining the integrity of a sinus tract formed
during an initial catheterization for the purposes of medical
procedures to enable the tract to be repeatedly used for
subsequent catheterizations comprising, a) an outer hollow
tubular member adapted to be inserted into the initially formed
sinus tract in surrounding relation with the catheter in the
tract formed during the lnitial catheterization, with flanging
means at one terminal end of the outer hollow tubular member to
rest on the epidermis at the beginning of the sinus tract,
b) an inner solid cylindrical member adapted to be inserted
into the outer hollow tubular member for sealing the sinus tract
after the catheter has been withdrawn from the sinus tract
following the medical procedure requiring catheterization,
c) whereby subsequent removal of the inner solid cylindrical
member enables insertion of a new sterile catheter into the
ye/,~J ~ 4 -
,~
,
~2a~933
outer hollow tubular member along the same initially formed
sinus tract to permit another catheterization medical procedure
through the tract.
The present invention may be utilized in any procedure
which requires catheterization through a formed tract in any somatic
wall, membrane or tissue structure, but will be described as applied
to catheterization for the purposes of peritoneal dialysis, such
being a particularly useful application of the invention.
In accordance with the principles of this invention, the
above objects are accomplished by introducing around the in place
catheter in a surrounding relationship, an outer hollow tubular
member with flange which, when inserted into the sinus tract, with
the flange resting on the epidermis, results in the sinus tract
resting against the outer wall of said outer tubular member in
an abutting relationship thereby maintaining the integrity of the
sinus tract. After completion of the medical procedure requiring
catheterization, the catheter
- ~a -
)c
~24~933
is removed from the outer -tubular member along the sinus
tract and the second part of -the prosthesis, an i.nner solid
cylindrical member is securely inserted into the outer
tubular member to close or seal the sinus tract opening.
When a subsequent catheterization is required, the solid
inner cylindrical member is removed and a new catheter is
easily inserted within the outer tubular member along the
original sinus tract thereby utilizing the original sinus
tract. While the new catheter is in place, the above
10 procedure repeated with a new sterile inner cylindrical
member thereby maintaining the originally formed sinus
tract for yet another medical procedure requiring the use
of a sinus tract Eor a subsequent catherization.
This new peritoneal prosthesis may allow patients
that are being maintained on peritoneal dialysis in a
hospital setting, to receive peritoneal dialysis in a
non-hospital setting, including at home with the aid of
properly ~rained nursing or similar personnel or an
20 adequately trained family member. This is made possible
because without use of the present invention a physician
must be available to introduce a peritoneal trocar if the
sinus trac-t to the peritoneum is lost when the presen-t
peritoneal prosthesis are withdrawn. ~owever a properly
trained nursing or similar personnel or famil.y member may
readily be taught to reintroduce a peritoneal dialysis
catheter by means of the present invention.
,-
~ 5.
i933
Finally for the first time a peritoneal dialysis
pros-thesis can be used for the chronic maintenance of a
sinus tract within the peritoneum, with negligible risk of
losing this sinus tract.
The invention will now be described by way of
example with reference to the accompanying drawings in
whlch:
Fig. 1 is a schematic of a Trocath Peritoneal
Dialysis Cathe-ter ~trocath) about -to be introduced into the
10 epidermis in accordance with prior art procedures.
Fig. 2 shows the trocath in Fig. 1 after
in-troduction through the epidermis and the peritoneum in~o
the peritoneal cavity.
Fig. 3 shows the catheter of Fig. ~ in place
within a sinus tract after removal of the trocar stylet.
Fig. 4 shows the catheter in Fig. 3 in place and
attached to a connecting means to a dialysis device.
Fig. 5 shows the sinus tract after removal.
Fig. 6 shows the sinus tract after catheter
removal with a Deane's prosthesis about -to be in-troduced
therein in accordance with prior art procedures.
Fig. 7 shows the Deane's prosthesis shown in Fig.
6 in place within the sinus tract in accordance with prior
ar-t procedures.
Fig. 8 is a schematic showing the hollow outer
tubular member of the prosthesis in accordance with the
6.
~L2~5933
invention about to be inserted around the in place catheter
and along the sinus tract.
Fig. 9 shows the outer tubular member of the
prosthesis in place around the catheter and along the sinus
tract with -the flange resting on the epidermis.
Fig. 10 shows the outer tubular member of the
prosthesis in place along the sinus tract as in Fig. 9
after catheter removal.
Fig. 11 shows the outer tubular member oE the
10 prosthesis in place as in Fig. 10 and with the inner
cylindrical member of the prosthesis about to be introduced
into the outer tubular member.
Fig. 12 shows the outer tubular member oE the
prosthesis in place along the sinus tract and the inner
cylindrical member in place within the outer tubular member
of the prosthesis.
Fig. 13 shows the outer tubular member of the
prosthesis in place and the inner cylindrical member in
20 place within the outer tubular member with a ridge and
groove securing means.
Figs. 1 through 7 illustrate the prior art methods
of sinus tract formation and maintenance oE sinus -tract
integrity.
Figs. 8 through 12 illustrate -the prosthesis is
accordance with the principles of the invention showing i-ts
application in catheterization for peritoneal dialysis.
However, the principles of the invention are not limited to
~Z~933
use o~ the invention for peritoneal dialysis as the
invention may be used in connection with any medical
procedure requiring tract formation and maintenance for
catheterization purposes in any somatic wall, membrane or
tissue s-tructure.
ReEerring to the drawings, particularly Figs. 1
through 7, a trocar stylet 2 within a catheter 4 is
introduced into the epidermis 6 at an enlarged puncture
site therein. The sharpened point of the stylet 2 is used
10 to part the tissue to form the sinus tract 10 which is
further enlarged by the introduction of the catheter 4.
The stylet 2 wihtin the catheter 4 is then gently pushed
through the epidermis 6 into the subdermal tissue 7
resulting in the formation o~ a sinus tract 10 around the
catheter 4 in an abutting relationship to the catheter 4,
containing the stylet 2. The stylet ~ and catheter 4 are
then ~urther gently pushed through the subdermal tissue 7
until the peritoneum or peritoneal wall 9 is reached. The
20 stylet 2 with catheter 4 surrounding it are then gently
pushed through the peritoneum or peritoneal cavity 8 along
a formed sinus tract 10 as shown in Fig. 2. ~he s-tylet 2
is then removed and the catheter 4 is then gently pushed
further into the peritoneal caviky 8 along the Eormed sinus
tract 10 until the catheter rests in either the left or
right pelvic gutter ~not shown) as shown in Fig. 3.
Thereafter, a connecting means 12 is attached to the
catheter 4, said connecting means 12 being attached to the
8.
~5933
dialysis apparatus (not shown) as shown in Fig. 4~ ~fter
dialysis is completed, the connecti~g tube 12 is
disattached from the catheter 4 as shown in Fig. 4. In
accordance with the prior art, the catheter 4 is removed as
shwon in Fig. 5 and a Deane's prosthesis 14 is introduced
into the sinus tract 10 as shown in Figs. 6 and 7. The
sinus tract 10 rests against the flexible pin portion of
the Deane's prosthesis 14, in an abutting relationship,
with the flanging means of the Deane's prosthesis 14
10 resting on the epidermis 6 as shown in Fig. 7.
However, prior to the introduction of the Deane's
prosthesis 14 into the formed sinus tract 10, or subsequent
to the removal of the Deane's prosthesis 14 J the sinus
tract 10 can be lost making the introduction of a new
catheter 4 into the sinus tract 10 impossible without the
subsequent use of a trocar stylet 2 with catheter 4. The
reformation of a sinus tract 10 allowing the introduction
of a new catheter 4 for subsequent dialysis procedures
20 always requires the attendance of a skilled physician and
can be associa-ted with morbidity such as bowel bladder, or
vascular perforation and/or a peritonitis associated with
this blind procedure.
Referring to Figs. 8 through 12 to describe the
present invention, Fig. 8 is identical to Fig. 3 with the
addition of -the hollow outer tubular member 16 of the
present invention about to be "sleeved'l over the catheter 4
such that said outer tubular member 16 encloses or
~5~33
surrounds the catheter 4. As shown in Fig. 9, the outer
tubular member is then gently introduced as surroundlng the
catheter 4 and through the opening in the epidermis 6 along
the sinus tract 10 and may extend just into the peritoneal
cavity 8 such that the sinus tract 10 rests against the
outer wall of the outer tubular member 16 in an abutting
relationship with the catheter 4 resting against the inner
wall of the outer tubular member in an abutting
relationship.
The above described introduction of the outer
tubular member 16 can take place at any time, either before
or subsequent to -the dialysis procedure. However, it is
usually introduced after the catheter 4 is in place within
the sinus tract 10 as shown in Figs. 8 and 9~ Prior to its
introduction, the outer tubular member 16 can be trimmed in
length and shaped to account for variations in sinus tract
10 angle and length which can vary from patient to patient.
After the medical procedure requiring
catheterization is completed, such as in for example, the
above described peritoneal dialysis procedure, the catheter
4 may be removed from within the outer tubular member 16
while said outer tubular member 16 is kept in place along
the sinus tract 10 with the flange 11 resting on the
epidermis 6, as shown in Fig. 10, resulting in a continual
maintenance of the integrity of the sinus tract 10 as shown
in Fig. 10, such never having been available in the prior
art.
10 .
933
Thereafter, the sinus tract 10 can be "sealed"
with use of the inner cylindrical member 20 shown in Fig.
11. Fig. 11 is identical to Fig. 10 with the addition of a
view of the inner cylindrical member 20 about to be
introduced into the outer tubular member 16 to efEecutate
such "sealing" of the sinus tract 10. As shwon in Fig. 12,
while the outer tubular member 16 is in place along the
sinus tract 10, the inner sylindrical member 20 is
introduced in the outer -tubular member 16 such that said
10 inner tubular member 20 rests along the inner wall of the
outer tubular member 16. The inner cylindrical member 20
remains securely in place along the inner wall of the outer
tubular member 16, resulting in the integrity of the sinus
tract 10 being maintained and "sealed" to prevent the
undesireable introduction of foreign material or bacteria
or the undesirable exudation of body fluids.
Referring to Figs. 10, 11, 12 ~ 13 when a
subsequen-t catheteri~ation procedure is desired, the inner
20 cylindrical member 20 is removed from the outer tubular
member 16, while said outer -tubular member is kept in place
in the sinus tract 10 resulting in -the view shown in Fig.
10. Thereafter, as shown in Fig. 9, a new catheter 4 is
introducecl into the outer -tubular member 16 and said
catheter 4 can therefore be easily in-troduced along the
original sinus tract 10 and within -the outer tubular member
16, resulting in the catheter ~ being aligned along the
sinus tract 10. The in-troduction of such new catheter 4
~L2~5~33
into said outer tubular member 16 along said sinus tract 10
may be performed without the attendance of a skilled
physician. Since it is no longer a blind procedure with
risk of morbidity. Thereafter, a subsequent dialysis can
be ef~ectuated and the above procedure repeated to
facilitate yet subsequent catheterization procedures.
However, it is recommended that periodically (after no more
than one week or 5 or 6 catheterization procedures) that
the outer tubular member 16 be replaced with a new sterile
outer -tubular member 16 in the following manner:
The cathe-ter ~ is held carefully in place and the
outer tubular member 16 is removed and discarded. A new
sterile outer tubular member 16 is sleeved over the in
place catheter 4 in the same manner as shown in Figs. 8 and
9. when the new catheter 4 is removed the sinus tract 10
is again maintained by the new outer tubular member 16 and
is sealed by introduction of a new sterile inner
cylindrical member 21 in the same manner as shown in Figs.
10, 11 and 12.
Fig. 13 is identical to Fig. 12 with the addition
of a securing means provided by at least one ridge 22 on
the surface of the inner cylindrical member 20 and a
complementary groove 24 provided on the inner wall of the
outer -tubular member 16 such -that the inner cylindrical
member 20 Eits snugly in place within the outer tubular
member 16 to prevent inadvertent removal oE the inner
cylindrical member 20 from the outer tubular member 16.
12.
593~
The above described invention may be comprised of
any suitable makerial, such as plastic or silicone rubber
or combination of same, or any other suitable material such
that the resultant device is suitably -flexible and
sterilized or sterilizable Eor the above described use.
Although the procedure described above relates to
use of -the invention in connection with the catheterization
procedure for the purposes of chronic peritone~l dialysis,
the principles of the invention are suitable for the
maintenance o~ the integrity of any epidermal sinus tract
formed for the purposes of other medical procedures
requiring chronic catheter introduction, such as chronic
intermittent laproscopy or chronic catheterization
procedures.
