(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