US-12616825-B2 - Implantable access device for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port

Abstract

Implantable access device for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port, comprising: a port body with at least one outlet opening connected or connectable to a catheter for accessing the vascular system of the human or animal body, a needle entrance with at least one inlet opening for receiving a needle, wherein the needle entrance is connected to the port body and movable relative to the port body between a first, unactuated operating condition and a second, actuated operating condition, and locking means for locking the needle entrance in the first, unactuated operating condition and in the second, actuated operating condition, wherein the locking means are activated by inserting the needle into the needle entrance and applying a predetermined movement to needle entrance via the inserted needle and/or by applying a predetermined movement to the needle entrance via the inserted needle and removing the needle from the needle entrance.

Inventors

• Stanislas Marie Bertrand Achard de la Vente

Assignees

• pfm medical gmbh

Dates

Publication Date

20260505

Application Date

20190418

Priority Date

20180429

Claims (19)

1. 1 . An implantable access device to access a vascular system of a human or animal body, comprising: a port body with at least one outlet opening connected or connectable to a catheter to accessing the vascular system of the human or animal body; a needle entrance formed entirely by a single structure with at least one inlet opening to receive a needle, wherein the needle entrance is connected to the port body and movable relative to the port body between a first, unactuated operating condition and a second, actuated operating condition, and wherein at least a portion of the needle entrance is external to the port body; and at least one bistable locking mechanism configured to lock the needle entrance to the port body in the first, unactuated operating condition and configured to further lock the needle entrance to the port body in the second, actuated operating condition, wherein the at least one bistable locking mechanism is activated by a predetermined movement of the needle entrance relative to the port body and the predetermined movement is achieved by at least one of (1) inserting the needle into the needle entrance and moving the needle entrance via the inserted needle, and (2) moving the needle entrance via an inserted needle and removing the inserted needle from the needle entrance, and wherein the predetermined movement applied to the needle entrance comprises a pivoting movement and a translational movement.
2. 2 . The implantable access device according to claim 1 , wherein the predetermined movement applied to the needle entrance at least partially differs from a movement of the needle for inserting the needle into the needle entrance.
3. 3 . The implantable access device according to claim 1 , wherein an insertion angle of the needle entrance, in which the needle is inserted into the needle entrance, is between 15° and 40°.
4. 4 . The implantable access device according to claim 3 , wherein the insertion angle of the needle entrance is between 25° and 30°.
5. 5 . The implantable access device according to claim 1 , wherein the needle entrance comprises a funnel to guide the needle into the needle entrance.
6. 6 . The implantable access device according to claim 1 , wherein the at least one bistable locking mechanism comprises at least one of: (1) a cam on the needle entrance and a corresponding recess to guide the cam on the port body, and (2) a cam on the port body and a corresponding recess to guide the cam on the needle entrance.
7. 7 . The implantable access device according to claim 6 , wherein the cam is shaped rectangular or triangular.
8. 8 . The implantable access device according to claim 7 , wherein the cam has rounded corners.
9. 9 . The implantable access device according to claim 6 , wherein the recess has at least one pit to receive the cam in at least one of the first, unactuated operating condition and the second, actuated operating condition.
10. 10 . The implantable access device according to claim 9 , wherein the recess is heart shaped.
11. 11 . The implantable access device according to claim 6 , wherein the recess has one pit to receive the cam in the first, unactuated operating condition and another pit to receive the cam in the second, actuated operating condition.
12. 12 . The implantable access device according to claim 11 , wherein the recess is heart shaped.
13. 13 . The implantable access device according to claim 1 , wherein the at least one bistable locking mechanism comprises a push-push locking mechanism.
14. 14 . The implantable access device according to claim 1 , wherein the at least one bistable locking mechanism comprises a snap fit connection.
15. 15 . The implantable access device according to claim 14 , wherein the snap fit connection comprises a snap on the needle entrance and at least one recess or protrusion on the port body to receive or engage with the snap, to lock the needle entrance in the first, unactuated operating condition and in the second, actuated operating condition.
16. 16 . The implantable access device according to claim 1 , wherein the at least one locking bistable mechanism comprises a spring to lock the at least one bistable locking mechanism in the first, unactuated operating condition and in the second, actuated operating condition.
17. 17 . The implantable access device according to claim 16 , wherein the spring is connected to or integrally formed with a valve mechanism of the implantable access device.
18. 18 . The implantable access device according to claim 1 , wherein the at least one bistable locking mechanism creates at least one of an audio feedback and a haptic feedback when being locked in at least one of the first, unactuated operating condition and the second, actuated operating condition.
19. 19 . The implantable access device according to claim 18 , wherein the audio feedback comprises a sound and the haptic feedback comprises a vibration.

Description

FILED The invention relates to an implantable access port for accessing the vascular system of a human or animal body, particularly subcutaneously implantable access port. BACKGROUND During a medical treatment it is sometimes necessary to repeatedly access the vascular system of a human or animal body, for example for infusing therapeutic agents, drugs or such the like, removing body fluids, treating body fluids, injecting contrast agents and/or insertion of medical devices such as cameras, ultra-sound probes, brushes, catheters, catching devices or similar devices. In case of fluid exchange therapies, like for example hemodialysis, hemofiltration, hemodiafiltration, plasmapheresis, ultrafiltration, aquafiltration, n lipid pheresis, hemoperfusion, peritoneal dialysis or the like, devices for accessing the vascular system of a human or animal body which allow a high-volume fluid flow are preferred. From the prior art a variety of strategies are known for accessing the vascular system of a human or animal body, like for example direct vessel cannulation, short and long term catherization and implantation of subcutaneous port systems. A temporary access to the vascular system of the human or animal body can be simply provided by a direct percutaneous introduction of a needle through the skin of the human or animal body into a vessel of the vascular system of the human or animal body. Such an approach is the least expensive and simplest form of accessing the vascular system of the human or animal body and is particularly suitable for short term applications like for example intravenous drug delivery, removal of blood or the like. However, repeated introduction of a needle through the skin of the human or animal body into a vessel of the vascular system of the human or animal body can result in vessel thrombosis, stenosis and formation of pseudo-aneurisms, as well as infections. Transcutaneous devices, like short and long-term catheters, are used to address the problems of repeated direct percutaneous introduction of a needle through the skin of the human or animal body into a vessel of the vascular system of the human or animal body. Such transcutaneous devices can be flexible cannulae, which are inserted percutaneously into the region of interest such as a blood vessel or cavity in the human or animal body. However, although transcutaneous devices deal with the problems of a direct percutaneous introduction of a needle through the skin of the human or animal body into a vessel of the vascular system of the human or animal body they often cause complications due to infections. The infection usually infects the point where the device passes through the skin of the human or animal body or even the vascular system of the human or animal body itself. Thus, such transcutaneous devices can cause local or even systemic infections. Therefore a direct percutaneous introduction of a needle through the skin of the human or animal body into a vessel of the vascular system of the human or animal body or use of a transcutaneous catheter are not well suited for long term applications or for extracorporeal procedures that must be repeated periodically, like for example hemodialysis, hemofiltration, hemodiafiltration, plasmapheresis, ultrafiltration, aquafiltration, n lipid pheresis, hemoperfusion, peritoneal dialysis or the like. To deal with the above problems varieties of subcutaneously implanted ports have been proposed over the years for long term and/or periodically repeated accesses to the vascular system of the human or animal body. A typical subcutaneously implanted port has an access region for receiving a needle or access catheter, a fluid flow path through the port and a subcutaneously catheter attached to a vessel of the vascular system of the human or animal body. Thus, a fluid flow path is provided from the access catheter through the subcutaneously implanted port and the subcutaneously catheter to the vascular system of the human or animal body. The most common type of subcutaneously implanted ports, like for example disclosed in U.S. Pat. No. 6,056,717, comprises a housing with a port chamber for receiving an introduced needle. The surface of the port chamber next to the skin of the human or animal body is enclosed by a high-density self-sealing septum, typically made of silicone rubber. A subcutaneously implanted catheter, which communicates with a vein or other site within the human or animal body, is connected and in fluid connection to the port chamber. Implantation of such devices generally proceeds by making a small subcutaneous pocket in an appropriate area of the human or animal body under local anaesthesia. The subcutaneously implanted catheter is tunnelled to the desired infusion site. Since the septum faces towards the skin of the human or animal body and the subcutaneously implanted catheter runs substantially parallel to the skin of the human or animal body, there exists a 90° bend in the flow path