US-12622576-B2 - Device and method for applying a pharmaceutical fluid

US12622576B2US 12622576 B2US12622576 B2US 12622576B2US-12622576-B2

Abstract

A device and method for applying a pharmaceutical fluid comprising a hollow cylindrical body, which surrounds a channel that extends through the body from a proximal body end to a distal body end of the body, wherein an outer surface of the body has at least partially an external thread, and has a connecting element arranged at the proximal body end, via which a proximal channel end of the channel can be reversibly connected in terms of fluid conduction to a reservoir for the pharmaceutical fluid.

Inventors

Sebastian Vogt
Thomas Kluge

Assignees

HERAEUS MEDICAL GMBH

Dates

Publication Date: 20260512
Application Date: 20220722
Priority Date: 20210728

Claims (13)

1 . A device for applying a pharmaceutical fluid comprising: a hollow cylindrical body, which surrounds a channel that extends through the body from a proximal body end to a distal body end of the body, wherein an outer surface of the body has at least partially an external thread, and comprising a connecting element arranged at the proximal body end, via which a proximal channel end of the channel can be reversibly connected in terms of fluid conduction to a reservoir for the pharmaceutical fluid, wherein a check valve that is arranged in the channel and is fluid-impermeable in a direction of the proximal channel end, and a sealing element arranged in the channel distal to the check valve, which closes a distal channel end of the channel in terms of fluid conduction and which has a gap that can be reversibly opened in terms of fluid conduction when pressure is applied to the pharmaceutical fluid from the direction of the proximal channel end, such that the pharmaceutical fluid can be applied from the distal channel end.
2 . The device according to claim 1 , wherein the gap reversibly opens in terms of fluid conduction upon the application of pressure greater than 5 N/cm 2 .
3 . The device according to claim 1 , wherein the check valve is a ball check valve comprising a ball and a restoring element.
4 . The device according to claim 3 , wherein the restoring element and the sealing element are configured in one piece.
5 . The device according to claim 1 , wherein a filter element is arranged in the channel.
6 . The device according to claim 5 , wherein the filter element is arranged in the channel proximally to the check valve.
7 . The device according to claim 5 , wherein the filter element is a microporous filter plate.
8 . The device according to claim 7 , wherein the microporous filter plate has pores with an average pore diameter of less than 40 μm.
9 . The device according to claim 1 , wherein a hollow cylindrical sleeve is arranged in the channel distally to the sealing element, in order to prevent the discharging of the sealing element from the distal channel end during the application of the pharmaceutical fluid.
10 . The device according to claim 1 , wherein the proximal channel end is designed to be polygonal, and the connecting element is equipped with a polygonal connecting element section, in order to reversibly connect in terms of fluid conduction the connecting element to the proximal channel end by inserting the connecting element section into the proximal channel end.
11 . The device according to claim 10 , wherein the proximal channel end has a larger axial extension than the connecting element section, such that, after removal of a part of the proximal channel end, the connecting element can be reversibly connected in terms of fluid conduction to a part of the proximal channel end remaining on the device by inserting the connecting element section into the remaining proximal channel end.
12 . The device according to claim 1 , wherein the body comprises a metal and/or a polymer.
13 . A method for applying a pharmaceutical fluid by means of a device, said device comprising: a hollow cylindrical body, which surrounds a channel that extends through the body from a proximal body end to a distal body end of the body, wherein an outer surface of the body has at least partially an external thread, and comprising a connecting element arranged at the proximal body end, via which a proximal channel end of the channel can be reversibly connected in terms of fluid conduction to a reservoir for the pharmaceutical fluid, wherein a check valve that is arranged in the channel and is fluid-impermeable in a direction of the proximal channel end, and a sealing element arranged in the channel distal to the check valve, which closes a distal channel end of the channel in terms of fluid conduction and which has a gap that can be reversibly opened in terms of fluid conduction when pressure is applied to the pharmaceutical fluid from the direction of the proximal channel end, such that the pharmaceutical fluid can be applied from the distal channel end; said method for applying the pharmaceutical fluid by means of the device, comprising the following steps: a. Implanting of the device; b. Connecting in terms of fluid conduction of the device to a reservoir for the pharmaceutical fluid; c. Building up of a conveyance pressure on the pharmaceutical fluid from the direction of the proximal channel end of greater than 5 N/cm 2 ; d. Opening in terms of fluid conduction of the gap in the sealing element by the action of the conveyance pressure; e. Dispensing of the pharmaceutical fluid from the gap that is open in terms of fluid conduction; f. Closing in terms of fluid conduction of the gap by reducing the conveyance pressure to 5 N/cm 2 or less.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority pursuant to 35 U.S.C. 119(a) to European Patent Application No. 21188130.5, filed Jul. 28, 2021, which application is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION The invention relates to a device for applying a pharmaceutical fluid comprising a hollow cylindrical body, which surrounds a channel that extends through the body from a proximal body end to a distal body end of the body, wherein an outer surface of the body has at least partially an external thread, and comprising a connecting element arranged at the proximal body end, via which a proximal channel end of the channel can be reversibly connected in terms of fluid conduction to a reservoir for the pharmaceutical fluid. The invention further relates to a method for applying a pharmaceutical fluid by means of such a device. The subject matter of the invention is in particular a medical device for the temporary, the local application of pharmaceutical fluids or other medical fluids over a period of hours up to several months. The device according to the invention is particularly intended for the treatment of inflammatory diseases of joints, such as activated osteoarthritis and rheumatoid arthritis. Inflammatory diseases of the joints, such as activated osteoarthritis and rheumatoid arthritis, are widespread. Such diseases are frequently associated with joint pain and can cause increasing joint destruction due to a progressive inflammation process, which can lead to an impairment of joint function or even to a complete loss of joint function. In addition to a systemic pharmacological therapy option, which can be associated with side effects for the patient and which is less effective due to a comparatively low active ingredient concentration at the inflammation site, there is the possibility of influencing the inflammation process by intra-articular injection of pharmaceutical fluids, in particular anti-inflammatory active ingredients. For example, dexamethasone phosphate, cyclosporine, sulfasalazine and methotrexate can be considered as active ingredients in this case. It is critical in intra-articular injection that there is a not insignificant risk of infection for the intra-articular space. Furthermore, the joint capsules of humans are equipped with nociceptors, whereby the joint capsules are very sensitive to pain. Bone screws with a central channel in the screw body and outlet openings connected thereto are known under the name of cannulated and fenestrated screws. Up to now, such bone screws have been used substantially in the spine region as so-called cannulated and fenestrated pedicle screws. In this case, bone cement paste is injected through the channel of the screws into the mostly osteoporotic vertebral bodies, as a result of which a cement casing coaxial with the longitudinal axis of the pedicle screw is predominantly formed. The bone cement then hardens and forms an abutment for the pedicle screws. A large number of cannulated and fenestrated bone screws have been proposed. By way of example, the patent specifications and published patent applications DE 35 08 759 A1, DE 1994 9285 C2, DE 10 2011 112 890 B4, EP 1 210 019 B1, EP 2 887 899 B1 are cited. In addition, cannulated and fenestrated bone screws can also be used for the local application of pharmaceutical fluids, as was described by way of example in the patent specifications and published patent applications U.S. Pat. No. 9,616,205 B2, U.S. Pat. No. 10,357,298 B2 and US 2018/0014867 A1. A disadvantage of the previously described cannulated and fenestrated bone screws is an ingrowth of tissue, in particular of connective tissue, into the discharging openings of the bone screws, which impedes or even completely prevents further application of pharmaceutical fluids by means of the bone screw closed in this way in terms of fluid conduction. Therefore, what is desirable is a device that is protected against the ingrowth of tissue, in particular of connective tissue, such that an application of a pharmaceutical fluid over a longer period of time, for example over several weeks or even months, is possible. The device should also allow a local application of any desired active pharmaceutical ingredients in the form of pharmaceutical fluids, wherein it is possible at any time to exchange the composition and/or the concentration of active ingredients in the pharmaceutical fluid. Moreover, it is desirable that the active ingredient concentration in the pharmaceutical fluid that is achieved immediately at the implantation site of the device be adjustable directly from the outside. It is an object of the present invention to at least partially overcome one or more of the disadvantages resulting from the prior art. In particular, a device for the local application of pharmaceutical fluids, such as, for example, antiphlogistic, cytostatic and glucocorticoid solutions, is to be provided, with