# US 12,102,784 B2 · Implant for local active ingredient release

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- Number: US 12,102,784 B2
- Document ID: US12102784B2
- Status: Granted
- Kind: B2
- Application number: 17/474,961
- Filed: 2021-09-14
- Published: 2022-04-07
- Granted: 2024-10-01
- Earliest claimed: 2020-10-02
- Assignees: Heraeus Medical GmbH
- Applicants: Heraeus Medical GmbH
- Inventors: Sebastian Vogt; Thomas Kluge
- Web page: https://patentgrep.com/patent/US12102784B2

## CPC

- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- A61M 5/1782: {Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003)}
- A61M 5/3286: {Needle tip design, e.g. for improved penetration}
- A61M 39/04: having pierceable self-sealing members
- A61M 5/14276: {specially adapted for implantation}
- A61M 2039/0226: {having means for protecting the interior of the access site from damage due to the insertion of a needle}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention relates to an implant for local active ingredient release having an upper wall (1), which is closed and disk-shaped and consists of a material which is pierceable with an injection cannula using a force of less than 100 N, is self-sealing and is elastically deformable, a lower wall (2) which is arranged opposite the upper wall (1), is disk-shaped, is elastically deformable and has at least one liquid-permeable feed-through (3) through the lower wall (2), a hollow space (4) which is arranged between the upper wall (1) and the lower wall (2), and an anti-piercing means (6), which is disk-shaped, between the upper wall (1) and the lower wall (2), wherein the anti-piercing means (6) consists of a material which is not pierceable with an injection cannula (100) using a force of less than 100 N. The invention also relates a method for filling such an implant with a liquid.

## Claims

### Claim 1

An implant for local active ingredient release, the implant having an upper wall, wherein the upper wall is closed and disk-shaped and consists of a material which is pierceable with a medical injection cannula using a force of less than 100 N, is self-sealing and is elastically deformable, a lower wall, wherein the lower wall is arranged opposite the upper wall, is disk-shaped, is elastically deformable and the lower wall has at least one feed-through through the lower wall, wherein the at least one feed-through is liquid-permeable, a hollow space which is arranged between the upper wall and the lower wall, an impenetrable anti-piercing means, wherein the anti-piercing means is arranged between the upper wall and the lower wall and is disk-shaped, wherein the anti-piercing means consists of a material which is not pierceable with a medical injection cannula using a force of less than 100 N, wherein the anti-piercing means is at least as large as 50% of an interior surface of the lower wall which delimits the hollow space; and wherein the anti-piercing means has surface patterning on a side facing the lower wall such that the anti-piercing means is spaced apart from the lower wall thereby allowing liquid to flow between the anti-piercing means and the lower wall.

### Claim 2 (depends on 1)

The implant according to claim 1, characterized in that
the upper wall and the lower wall are connected together via a circumferential rim or are connected together via a circumferential boundary of the anti-piercing means, wherein the upper wall and the lower wall are connected together in liquid-tight manner.

### Claim 3 (depends on 1)

The implant according to claim 1, characterized in that
the anti-piercing means consists of metal or contains at least 50% of metal and/or
the anti-piercing means is arranged in the hollow space, wherein the anti-piercing means is not firmly connected to the upper wall and the anti-piercing means is arranged on a side of the lower wall which faces the upper wall.

### Claim 4 (depends on 1)

The implant according to claim 1, characterized in that
the lower wall is pierceable with a medical injection cannula, wherein the lower wall consists of a rubber-elastic plastics material, and/or
the ratio of width to height and of depth to height of the implant is selected from the group consisting of at least 2:1 and at least 3:1.

### Claim 5 (depends on 1)

The implant according to claim 1, characterized in that
the hollow space is elastically expandable by injection of a liquid, wherein the liquid in the expanded hollow space is expellable with an elastic force from the hollow space through the at least one feed-through.

### Claim 6 (depends on 1)

The implant according to claim 1, characterized in that,
the lower wall has, on a side opposite the upper wall, protruding patterning which is suitable for distributing a liquid on this external surface, wherein the protruding patterning comprises ribs and/or bumps and/or the at least one feed-through opens into at least one channel on this outer surface of the lower wall and the at least one channel is shaped by the protruding patterning, and/or
a liquid is present in the hollow space, wherein the liquid comprises cyclosporin A, or an active ingredient solution or an ingredient in the solid or semisolid state.

### Claim 7 (depends on 1)

The implant according to claim 1, characterized in that
the anti-piercing means is at least as large as 75% of the interior surface of the lower wall which delimits the hollow space, and/or
the anti-piercing means does not rest flush at a circumferential boundary of the anti-piercing means against the internal side of the hollow space.

### Claim 8 (depends on 1)

The implant according to claim 1, characterized in that
the implant is disk-shaped and the upper wall forms an upper side of the implant and the lower wall forms a lower side of the implant, wherein the entire external surface of the implant or the entire external surface of the implant apart from a circumferential rim is formed by the upper and the lower wall, and/or
the hollow space has an interior which is delimited by the upper wall and by the anti-piercing means, wherein the interior spaces the upper wall from the anti-piercing means by at least 0.5 mm or by at least 1 mm.

### Claim 9 (depends on 1)

The implant according to claim 1, characterized in that
a pressure relief valve is arranged in each of the at least one feed-throughs, which pressure relief valve opens to the outside from a minimum pressure and-opens to the outside from a minimum pressure of at least 20 kPa, and/or
the upper wall and/or the lower wall consists or consist of a rubber-elastic plastics material or, apart from a rim, consists or consist of a rubber-elastic plastics material, wherein, after piercing by and withdrawal of a medical injection cannula, the rubber-elastic plastics material of the upper wall contracts again and closes liquid-impermeably.

### Claim 10 (depends on 1)

The implant according to claim 1, characterized in that
the anti-piercing means has at least one liquid-permeable opening, wherein the at least one opening has a free cross-section of a maximum of 0.5 mm, and/or
the anti-piercing means has surface patterning on the side facing the upper wall.

### Claim 11 (depends on 1)

The implant according to claim 1, characterized in that
the anti-piercing means is firmly connected to the lower wall and/or,
on an upper side which faces the upper wall, the anti-piercing means has a concave shape and/or has a protruding boundary, and/or
the implant has one or more lugs by which the implant can be sutured to soft tissue.

### Claim 12 (depends on 1)

A method for filling an implant according to claim 1, characterized by the steps:
A) providing the implant and a syringe filled with a liquid, wherein the syringe has a medical injection cannula,
B) piercing the upper wall with the medical injection cannula of the syringe,
C) injecting liquid from the syringe through the medical injection cannula and into the hollow space of the implant,
D) spreading the liquid in the hollow space, wherein the liquid flows up to the at least one feed-through, and,
E) optionally, elastic expansion of the hollow space by injection of the liquid.

### Claim 13 (depends on 12)

The method according to claim 12, characterized in that
the method does not involve any medical treatment of a human or animal body and/or the liquid is not delivered to a human or animal body in the context of the method.

### Claim 14 (depends on 12)

The method according to claim 12, characterized in that,
in step B), the tip of the medical injection cannula is inserted through the upper wall to such an extent that it comes into contact with the anti-piercing means, wherein an orifice at the tip of the medical injection cannula is then located in an interior of the hollow space, wherein the interior of the hollow space is arranged between the anti-piercing means and the upper wall.

### Claim 15 (depends on 12)

The method according to claim 12, characterized in that
the following steps F) and G) and optionally H) proceed after step E):
F) withdrawal of the medical injection cannula from the hollow space and from the upper wall and
G) liquid-tight closure of the upper wall by rubber-elastic recovery of the upper wall, and optionally
H) compression of the hollow space due to the elastic restoring force of the elastically expanded hollow space and expulsion of the liquid from the hollow space through the at least one feed-through.