# US 10,869,961 B2 · Local disinfection for drug delivery system

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- Number: US 10,869,961 B2
- Document ID: US10869961B2
- Status: Granted
- Kind: B2
- Application number: 16/867,188
- Filed: 2020-05-05
- Published: 2020-08-20
- Granted: 2020-12-22
- Earliest claimed: 2017-11-06
- Assignees: Sorrel Medical Ltd.
- Applicants: Sorrel Medical Ltd.
- Inventors: Ori Ben-David; Andrei Yosef; Shahar Zidon; Michael Plaskin
- Web page: https://patentgrep.com/patent/US10869961B2

## CPC

- A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles}
- A61L 2/04: Heat (radiation A61L2/08)
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/18: Liquid substances
- A61L 2/24: Apparatus using programmed or automatic operation
- A61M 5/002: {Packages specially adapted therefor, e.g. packages for syringes or needles or kits for diabetics}
- A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves}
- A61M 5/14248: {of the skin patch type}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/11: Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
- A61L 2202/122: Chambers for sterilisation
- A61L 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Apparatus and a method are presented, including disinfecting a disinfection chamber that is defined between (i) a prefilled therapeutic substance reservoir and (ii) a sterile fluid path disposed within a therapeutic substance delivery device. The sterile fluid path includes a needle at an upstream end of the sterile fluid path and an injection assembly at a downstream end of the sterile fluid path. The disinfection occurs subsequently to the prefilled therapeutic substance reservoir being engaged with the therapeutic substance delivery device. Subsequently to disinfecting the disinfection chamber, the disinfection chamber and then the reservoir are penetrated with the needle. Other applications are also described.

## Claims

### Claim 1

A method comprising:
using a disinfection assembly disposed within a therapeutic substance delivery device, disinfecting a disinfection chamber that is defined between (i) a prefilled therapeutic substance reservoir and (ii) a sterile fluid path disposed within the therapeutic substance delivery device,
the sterile fluid path comprising a needle at an upstream end of the sterile fluid path and an injection assembly at a downstream end of the sterile fluid path; and
penetrating the disinfection chamber and then the reservoir with the needle,
the disinfecting occurring (a) subsequently to the prefilled therapeutic substance reservoir being engaged with the therapeutic substance delivery device and (b) prior to the penetrating of the disinfection chamber and then the reservoir with the needle.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the step of disinfecting the disinfection chamber is performed following a user of the therapeutic substance delivery device engaging the prefilled therapeutic substance reservoir with the therapeutic substance delivery device, wherein the disinfection chamber is defined when the prefilled therapeutic substance reservoir becomes engaged with the therapeutic substance delivery device.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the step of disinfecting the disinfection chamber is performed following a user of the therapeutic substance delivery device removing the therapeutic substance delivery device from commercial packaging, wherein the prefilled therapeutic substance reservoir and the therapeutic substance delivery device are engaged with one another inside the commercial packaging.

### Claim 4 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises activating the disinfection assembly and subsequently terminating the activation of the disinfection assembly, and wherein penetrating the disinfection chamber comprises penetrating the disinfection chamber within 10 seconds after terminating the activation of the disinfection assembly.

### Claim 5 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises activating the disinfection assembly and terminating activation of the disinfection assembly within 5 minutes after activating the disinfection assembly.

### Claim 6 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises irradiating the disinfection chamber with ultraviolet radiation.

### Claim 7 (depends on 6)

The method according to claim 6, wherein irradiating the disinfection chamber comprises irradiating the disinfection chamber with ultraviolet radiation at a power level of 1-200 mW.

### Claim 8 (depends on 6)

The method according to claim 6, wherein irradiating the disinfection chamber comprises irradiating the disinfection chamber with ultraviolet radiation at a wavelength of 100-400 nm.

### Claim 9 (depends on 6)

The method according to claim 6, wherein irradiating the disinfection chamber comprises irradiating the disinfection chamber with ultraviolet light using an ultraviolet light emitting diode.

### Claim 10 (depends on 6)

The method according to claim 6, further comprising:
subsequently to irradiating the disinfection chamber with the ultraviolet light, measuring a value indicative of intensity of the ultraviolet radiation within the disinfection chamber; and
terminating the irradiation of the disinfection chamber at a time determined based on the measured value.

### Claim 11 (depends on 10)

The method according to claim 10, wherein measuring the value indicative of intensity of the ultraviolet radiation comprises measuring the intensity of the ultraviolet radiation within the disinfection chamber using an ultraviolet sensor disposed within the disinfection chamber.

### Claim 12 (depends on 10)

The method according to claim 10, wherein (a) irradiating the disinfection chamber with ultraviolet radiation comprises activating an ultraviolet light emitting diode (UV LED) and (b) measuring the value indicative of intensity of the ultraviolet radiation comprises measuring a current input to the UV LED.

### Claim 13 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises heating the disinfection chamber.

### Claim 14 (depends on 13)

The method according to claim 13, wherein heating the disinfection chamber comprises heating the disinfection chamber to a temperature of 40-300 degrees Celsius.

### Claim 15 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises releasing a disinfectant fluid into the disinfection chamber.

### Claim 16 (depends on 1)

The method according to claim 1, wherein disinfecting the disinfection chamber comprises disinfecting the disinfection chamber within 5 minutes prior to penetrating the disinfection chamber and subsequently the reservoir with the needle.

### Claim 17 (depends on 16)

The method according to claim 16, wherein disinfecting the disinfection chamber comprises disinfecting the disinfection chamber at least 1 month following engagement of the prefilled therapeutic substance reservoir with the therapeutic substance delivery device.

### Claim 18 (depends on 17)

The method according to claim 17, wherein disinfecting the disinfection chamber comprises disinfecting the disinfection chamber at least 6 months following engagement of the prefilled therapeutic substance reservoir with the therapeutic substance delivery device.

### Claim 19 (depends on 16)

The method according to claim 16, wherein the disinfecting of the disinfection chamber is at least a second disinfecting of the disinfection chamber, a first disinfecting of the disinfection chamber occurring prior to the therapeutic substance delivery device being packaged for commercial sale.

### Claim 20 (depends on 19)

The method according to claim 19, further comprising disinfecting the disinfection chamber at least one time between the first disinfecting of the disinfection chamber and the at least a second disinfecting of the disinfection chamber.
