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JP-7854804-B2 - Overmolded bulkhead

JP7854804B2JP 7854804 B2JP7854804 B2JP 7854804B2JP-7854804-B2

Inventors

  • クライデマッハー，オリバー
  • レバウ，オラフ

Assignees

  • エフ． ホフマン－ラ ロシュ アーゲー

Dates

Publication Date
20260507
Application Date
20191217
Priority Date
20181219

Claims (11)

  1. A perforated partition (1) for use in drug reservoirs and infusion sets, comprising an elastic core (11) from a core material and a peripheral portion (10) from a peripheral material, wherein the elastic core (11) is entirely embedded within the peripheral portion (10), and the peripheral material has a higher Shore hardness than the core material. The surrounding portion (10) comprises two different surrounding materials, wherein the Shore hardness of the first surrounding material along the drilling path of the cannula is lower than that of the second material away from the drilling path of the cannula. Perforated partition wall (1).
  2. The perforated partition wall (1) according to claim 1, wherein the surrounding material has a Shore hardness selected such that the elongation of the core material is limited when the partition wall (1) is penetrated by a cannula.
  3. The perforated partition (1) according to claim 1 or 2, wherein the surrounding material has a Shore hardness of 0 to 100 Shore A, preferably 50 to 80 Shore A, and/or the core material has a Shore hardness of 0 to 50 Shore A, preferably 10 to 40 Shore A.
  4. The perforated partition wall (1) according to any one of claims 1 to 3, wherein the elastic core (11) is overmolded by the surrounding portion (10).
  5. A perforated partition wall (1) according to any one of claims 1 to 4, wherein the core material is an elastomer and/or the surrounding material is an elastomer or thermoplastic elastomer.
  6. The perforated partition wall (1) according to any one of claims 1 to 5, wherein the elastic core (11) is pre-stressed radially by the surrounding portion (10).
  7. The perforated partition wall (1) according to any one of claims 1 to 6, wherein the partition wall (1) comprises a sealing lip or a circumferential groove (12).
  8. An injection set comprising a perforable partition wall (1) as described in any one of claims 1 to 7.
  9. The injection set according to claim 8, wherein the partition wall (1) is subjected to pre-stress in the radial direction by radial compression.
  10. A reservoir (30) for liquid drugs, comprising a perforable partition (1) according to any one of claims 1 to 7.
  11. The reservoir (30) according to claim 10, wherein the partition wall (1) is given pre-stress in the radial direction by radial compression.

Description

This invention belongs to the art of injection or infusion. More specifically, it relates to perforated partitions used in infusion sets or reservoirs for liquid drugs, infusion sets and reservoirs equipped with partitions, and methods for manufacturing perforated partitions. Walking infusion sets are well known in the art. For example, in the treatment of diabetes, walking infusion sets are used in combination with miniaturized infusion pumps for continuous subcutaneous insulin infusion (CSII), in which small amounts of medication are metered and injected into the patient's tissues via a cannula. Such infusion sets can also be used in several other treatments, such as pain management or cancer treatment. Infusion sets are available from several suppliers, including Roche Diabetes Care GmbH in Germany, or Medtronic MiniMed Inc. in California, USA. For example, in CSII, the metered dose is in the range of microliters or nanoliters. Typical infusion sets and systems are usually operated in a continuous manner and therefore always carried by the patient, but there are some daily routines, such as showering and swimming, where the pump and tubing must be removed. In such cases, leaving the cannula unit with the patient without removing the flexible infusion cannula used to introduce medication into the patient's tissues is beneficial for both patient interest and cost reasons. Therefore, infusion systems have been developed that feature a cannula unit that can be easily disconnected from the rest of the system, particularly the tubing, by disconnecting the connector device. The connector device comprises a connector cannula that fluidly connects to the tubing and infusion pump. However, with each reconnection, the septum of the cannula unit is perforated by the connector cannula. As a result, the septum suffers multiple cuts from the commonly used sharp cannulas and thus becomes more prone to leakage. A wide variety of infusion sets for introducing liquid drugs into a patient's body rely on elastic septa that can be repeatedly punctured by a cannula or needle. A typical infusion set may comprise a cannula unit that can be fluidly connected to an infusion pump and/or drug reservoir via piping, for example, using a connector device with a connector cannula. Typically, the cannula unit further comprises a compartment for the liquid drug, at least partially formed by the surface of a septum. In particular, a septum may be used to seal this compartment, which is essentially permanently fluidly connected to the patient's tissue via the infusion cannula. In such systems, the liquid drug can be transferred to the compartment and subsequently to the patient via the connector cannula and infusion cannula. Furthermore, with respect to the infusion set, employing a flexible infusion cannula is advantageous to establish a permanent fluid connection to the patient's tissue. Such a flexible infusion cannula is inserted into the patient's tissue with the help of a puncturing needle, such as a rigid steel needle. One section of the puncturing needle is initially positioned within the lumen of the infusion cannula, while the head section is positioned above the septum, allowing the puncturing needle to penetrate the septum. After both the puncturing needle and the flexible infusion cannula are inserted into the tissue, the puncturing needle is retracted, while the flexible infusion cannula remains in the tissue. Either a single septum is used for both drug delivery and puncturing needle introduction, or two different septums may be employed instead. Typical examples are described in International Patent Publication 02/07804 A1, U.S. Patent Application Publication 2012/296290 A1, and European Patent Application 2528642 A2. To prevent leakage of liquid drugs and to avoid external contamination, these septa are generally shaped cylindrically and pre-stressed by radial compression. In these systems, the septum is incorporated into the cannula housing, which compresses the septum. A further advantageous effect of radial compression is that, after the penetration and subsequent removal of the needle or cannula, the resulting channel-shaped cut within the septum is compressed, beneficially preventing or at least mitigating leakage. As described above, one possible approach to achieving this goal is to prestress the partition wall by radial compression. However, due to structural constraints, the compressive force cannot be increased indefinitely. Importantly, while radial compression of the partition wall effectively reduces leakage of the liquid drug in cases where the partition wall is punctured only once, leakage becomes a problem when the puncture event is repeated. Furthermore, typical infusion systems employ an infusion pump, which delivers liquid medication to the patient, thus applying fluid pressure. As a result of this fluid pressure, leakage becomes a serious problem, especially if the septum has already been punctured multi