(51)
Int. Cl.7:
A 61 M 39/02
A
61 M 25/18
(19) Federal
Republic of Germany
[emblem]
German
Patent and Trademark Office
(12) Patent
(10) DE 199 57 921 C1
(21) Filing number: 199 57 921.0-44
(22) Filing date: December 1,
1999
(43) Disclosure date: -
(45) Publication date
of patent grant: October 11, 2001
Opposition may be lodged within three months following
publication of grant.
|
(73) Patent holder: Hankel-Shepherd, Peter, 34260
Kaufungen, DE (74) Representative: Walther, Walther & Hinz,
34130 Kassel |
(72) Inventor: Same as the patent holder (56) Documents
taken into consideration to evaluate patentability: WO 99 34 859 |
(54) Medical port, in particular an Implanted
Port
(57) Port, in particular, an implanted port
comprising a housing upper section (30) and a housing lower section (1), where
the housing lower section (1) exhibits a chamber (10) with a tangentially
positioned outlet (20), and where an inlet (40) is arranged diagonally to the
outlet (20) in the housing lower section (1).
[see
figure]
Federal
Government Printing Office 08.01 201
410/227/7A 11
DE 199 57 921 C1
Description
[0001] The
invention relates to a port, in particular an implanted port comprising a
housing upper section and a housing lower section, where the housing lower
section exhibits a chamber with a tangentially positioned outlet.
[0002]
Vascular access systems consist of two main groups - that is, on the one hand,
so-called central venous catheters (also known as indwelling catheters) and, on
the other hand, so-called port systems. Both systems allow fast access to the
vascular system of a patient. The reasons for long term vascular access
include, inter alia, the administration of chemotherapeutic preparations or
therapeutic preparations for the relief of pain or also for the administration
of medications to combat the threats to the vital functions - for example,
asthma - or even other applications, for which it is necessary to have
continuous access to the blood stream of the patient.
[0003]
Consequently ports are nothing more than containers, which are filled with a
medicinal preparation, and which are connected by way of the veins or arteries
or the peritoneum to the blood stream of the patient. The ports may be filled
by means of catheters. In this case the housing upper section exhibits a
membrane, which is made, in particular, of silicone, and through which the
silicone needle pierces and which automatically seals upon removal of the
catheter needle. In this context reference is made to WO 99/34859 as an
example, where the top side of the port has an outlet and a membrane.
[0004] Yet
at this point it appears that only with difficulty is it possible to maintain
through a membrane made of silicone a continuous supply of the appropriate medications
to a chamber over a prolonged period of time. Rather to this end it is
necessary to provide dedicated catheters with suitable pumps, which allow a
continuous dispensing of the appropriate medication to the patient. Such pumps
are usually implanted. However, implantable pumps are relatively more expensive
than pumps, which are worn externally on the body.
[0005]
Therefore, the invention is based on the problem of providing a port of the
type that is described in the introductory part and that enables continuous
access, in order to fill with medications.
[0006] The
invention solves this problem in that an inlet in the housing lower section of
the port is arranged diagonally to the outlet. This type of inlet offers the
possibility of attaching an external pump of a catheter. This pump provides
that the port is supplied and/or filled continuously with suitable medications.
That is, there is, first of all, the possibility of passing a suitable
medication through the membrane of the port into the port in order, then, upon
detection that the patient responds to the medication, to facilitate a
semi-permanent supply through the inlet of the port through the use of a
catheter with an external pump. Furthermore, long term filling of the port
through the silicone membrane obviously cannot be allowed because the tangential
flow in the port is impeded thereby, with the result that accumulations composed
of blood and drug residues (so-called sludge) form in the port. Moreover, the
reduction in cost is very high with the inventive system, comprising a port and
an external pump, in comparison to the use of an implantable pump.
[0007] In
detail, the invention provides that the chamber floor of the chamber of the
port resembles, when viewed from the top, the cross sectional area of a cam.
The choice of such a simple shape makes it possible to achieve the goal that
the rate of flow in the chamber can be significantly increased, as compared to
a known chamber of the state of the art, where the chamber is configured, as
viewed from the top, round. A high rate of flow in the chamber of the port is desirable
insofar as it can prevent the accumulation of so-called "sludge" -
thus, blood clots and drug residues -, because such sludge clogs the port and
promotes the growth of bacteria. As a consequence, it is also provided that the
side wall of the chamber is configured so as to be convex, in order to avoid -
precisely in contrast to a rectangular chamber - such dead spaces, which may
lead to the accumulation of sludge. The arrangement of disposing the outlet and
the inlet in the area of the side wall of the chamber - thus, in areas of the
chamber that exhibit the maximum rate of flow - also serves this goal. In this
case the invention provides in detail that both the inlet and the outlet are
configured in the area of the transition from the elliptical section to the
circular section in the chamber, which has, when viewed from the top, the shape
of a cam - thus, exactly in the areas, in which the rate of flow is the
highest. The inlet and the outlet are located advantageously in a plane, in
order to suppress the formation of eddies in the chamber. In this respect the
invention provides in particular that the longitudinal axes of the inlet and
the outlet form an angle of approximately 90 deg., so that - as stated above -
both access ports to the port chamber are configured in the area of the maximum
rate of flow.
[0008] The
chamber floor is advantageously configured so as to be outwardly convex, in
order to make possible a somewhat higher volume of the chamber. The floor of
the port is also configured so as to be outwardly convex, in order to achieve a
better seat of the port on the tissue, with the consequence that the risk of dislodgment
on the tissue is minimized. The same goal is served by the configuration of the
openings in the edge of the housing lower section, in order to ensure, for
example, against dislodgment by sewing the port on the tissue.
[0009]
Furthermore, it is well-known that catheter tubes are enveloped with a wire
mesh in order to prevent the tubes from collapsing. To date every attempt to
attach such catheter tubes to a port has failed. Yet such catheter tubes are
necessary, if a port has to be placed into the blood stream of the patient
especially within the scope of minimally invasive access. That is, the outlet
of the port receives a tube, which is enveloped with a wire or rather a wire
mesh and which cannot collapse. In order to connect such a catheter tube to the
outlet or optionally the inlet of the port, the invention provides a coupling
device for accommodating the catheter tube. In this respect the coupling device
comprises a female and a male coupling element, where the male coupling element
is accommodatable by the female coupling element by means of a screwed
connection. The coupling device, comprising a male and a female coupling
element, accommodates a tube sheath, in which the catheter tube is run. In this
case the tube sheath is made of an elastic material - for example, silicone
rubber -, which makes it possible to squeeze the tube sheath, with the goal of
sealing by means of the coupling device the access to the port against the
environment in the body.
[0010] The
invention is explained in detail below through the use of one example with
reference to the drawings.
[0011]
Figure 1 is a side view of the housing lower section, where the hatched lines
are omitted.
[0012]
Figure 2 is a view along the line II-II from Figure 1.
[0013]
Figure 3 depicts the upper section of the housing.
[0014]
Figure 4 depicts the female coupling half of the coupling device.
[0015]
Figure 5 depicts the male coupling half of the coupling device.
[0016]
Figure 6 depicts the tube sheath for accommodating the wire mesh reinforced
catheter tube.
[0017] The
first aspect of interest for the following description is the lower section of
the housing that is depicted in Figures 1 and 2. The housing lower section,
which is marked with the reference numeral 1, shows a housing chamber 10, which
exhibits, as stated above, the shape of a cam, when viewed from the top.
However, in contrast to the side faces of a cam, which are configured so as to
be straight, the side faces 11 in the figures are configured so as to be
outwardly convex - like a balloon, which bulges out on two opposing sides. This
cam-shaped chamber 10 exhibits an elliptical section 12 and a circular section
13. In the area of the transition from the elliptical section 12 to the
circular section 13 the outlet 20 is configured in the area of the convex side
wall in the chamber. Diagonally opposite the outlet, there is an inlet 40,
which is also located in the transition from the elliptical section to the circular
section of the cam-shaped chamber. That is, both the outlet 20 and the outlet
40 are positioned in such a manner that they are always located in the area of
the maximum rate of flow of the medium, which is rotating in the chamber and
which is a mixture of drugs and blood. That means that the attachment of the
outlet and/or the inlet is attached at the point of transition from the
elliptical portion of the cam-shaped chamber to the circular portion of the
cam-shaped chamber. In this case the outlet continues running at an oblique
angle in the area of the circular portion of the chamber, whereas the inlet
inserts itself running at an oblique angle into the area of the elliptical
portion of the chamber.
[0018] The
floor 15 of the chamber is configured so as to be outwardly convex, in order to
provide a somewhat enlarged volume for accommodating the drug preparation. The
floor 2 of the port is also configured so as to be outwardly convex or rather
protrudes outwardly, in order to prevent a dislodgment and/or twisting and thus
migration of the port on the tissue. In addition, the port itself exhibits a
side area 3, which shows a plurality of openings 4 for fixing the port on the
tissue. In this case the fixation may also be produced, for example, by sewing.
However, in so doing the tissue will also automatically grow through the
openings in the port. In addition, the lower section of the port has a thread 7
for accommodating the upper section 30 of the port (Figure 3). The port upper
section 30 is configured like a hat and has a thread 31, which is configured in
the upper section of the housing and matches the thread lug 7 of the lower
section of the housing. In the center the upper section of the housing exhibits
a membrane 33 made of silicone rubber.
[0019]
Figures 4 to 6 show the coupling device for connecting to the outlet 20 of the
port. In this case Figure 4 shows a so-called female coupling half 60 that
serves to accommodate the male coupling half 70, according to Figure 5. Both
coupling halves 60, 70 accommodate the tube sheath 80, which has an internal
borehole 90 for accommodating the wire-enveloped catheter tube.
[0020] The
male coupling half 70 has a head 71 with a cylindrical attachment 72. Both the
head 71 and the cylindrical attachment 72 are provided with an external thread
71a or 72a. In the cylindrical attachment 72 is located a borehole 73, which
continues as far as into the head 71, but at 74 continues with a tapered cross
section.
[0021] The
male coupling half 70 is accommodated by the female coupling half 60. To this
end, the female coupling half 60 exhibits a borehole 61, which is provided with
an internal thread 61a. In this case this thread 61a corresponds with the
corresponding thread 72a. The borehole 62 does not exhibit an internal thread.
That means that the cylindrical attachment 72 is accommodated by the borehole
61 with the thread 61a. In addition, following the boreholes 61 and 62, the
female coupling half 60 exhibits an additional borehole 65, which is arranged
in an external attachment 66 with an external thread 66a. In this case the
cylindrical attachment 66 is screwed into the corresponding borehole of the
outlet 20 of the port.
[0022] The
tube sheath 80 consists, as illustrated in Figure 6, of two sections 81, 82,
the inside diameter 90 of which is, however, identical. As stated above, the internal
borehole 90 accommodates the catheter tube, which is encased with wire mesh.
The section 82 of the tube sheath 80 is located in the cylindrical borehole 74
of the male coupling half 70. In contrast, the tube sheath section 81 is
located in the internal borehole 73 of the cylindrical attachment 72 of the
male coupling half 70. In the screwed together state the tube sheath 80 with
its one end 82 projects at this point beyond the internal borehole 74, whereas
the section 81 of the tube sheath 80 projects beyond the borehole 73 of the
male coupling half 70, so that this projecting tube section is pinched in the
area of the borehole 62. The internal borehole 65 has neither the silicone tube
nor the catheter, but rather the borehole is free and unimpeded. Such a method
of connecting together the three parts makes it possible, owing to the design
of the tube sheath 80 made of silicone rubber in conjunction with the pinching
operation, to achieve that the access to the port is sealed against the
environment when the catheter tube is placed in the tube sheath.
Patent Claims
1. Port,
in particular, an implanted port comprising a housing upper section (30) and a
housing lower section (1), where the housing lower section (1) exhibits a
chamber (10) with a tangentially positioned outlet (20), characterized in that
an inlet (40) is arranged diagonally to the outlet (20) in the housing lower
section (1).
2. Port,
as claimed in claim 1, characterized in that the chamber floor (15) resembles,
when viewed from the top, the cross sectional area of a cam.
3. Port,
as claimed in claim 1, characterized in that the side wall (11) of the chamber
(10) is configured so as to be convex.
4. Port,
as claimed in claim 3, characterized in that the outlet (20) is arranged in the
area of the side wall (11) of the chamber (10).
5. Port,
as claimed in claim 2, characterized in that both the outlet (20) and the inlet
(40) are configured in the transition from the elliptical section (12) to the
circular section (13) of the chamber (10), which has, when viewed from the top,
the shape of a cam.
6. Port,
as claimed in claim 2, characterized in that the inlet (40) and the outlet (20)
lie in a plane.
7. Port,
as claimed in claim 2, characterized in that the longitudinal axes of the inlet
(40) and the outlet (20) form an angle of approximately 90 deg.
8. Port,
as claimed in claim 1, characterized in that the chamber floor (15) is
configured so as to be outwardly convex.
9. Port,
as claimed in claim 1, characterized in that the floor (2) of the port exhibits
an outwardly directed convexity.
10. Port,
as claimed in claim 1, characterized in that the housing upper section (30)
exhibits a membrane (33).
11. Port,
as claimed in claim 10, characterized in that the membrane (33) is made of
silicone rubber.
12. Port,
as claimed in claim 1, characterized in that the port is made of titanium.
13. Port,
as claimed in claim 1, characterized in that the housing lower section (1) in
the area of the edge (3) exhibits openings (4) for fixation also to the tissue.
14. Port,
as claimed in claim 1, characterized in that for the attachment to the inlet
(40) or the outlet (20) of the port there is a coupling device (60, 70), which
serves to accommodate a catheter tube.
15. Port,
as claimed in claim 14, characterized in that the coupling device (60, 70)
comprises a female (60) and a male (70) coupling half.
16. Port,
as claimed in claim 14, characterized in that the coupling device (60, 70)
exhibits a tube sheath (80) for accommodating the catheter tube.
17. Port,
as claimed in claim 16, characterized in that the tube sheath (80) can be made
of an elastic material - for example, silicone rubber.
18. Port,
as claimed in any one of the preceding claims 14 to 17, characterized in that
the catheter tube is wire encased.
19. Port,
as claimed in claim 14, characterized in that the two coupling halves (60, 70)
are made of titanium.
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4
sheet(s) of drawings
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key to the
figures
DRAWINGS
SHEET
Number:
DE 199 57 921 C1
Int.
Cl.7: A 61 M 39/02
Publication
date: October 11, 2001