# US 10,869,960 B2 · Local disinfection for prefilled drug delivery system

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- Number: US 10,869,960 B2
- Document ID: US10869960B2
- Status: Granted
- Kind: B2
- Application number: 15/872,552
- Filed: 2018-01-16
- Published: 2019-05-09
- Granted: 2020-12-22
- Earliest claimed: 2017-11-06
- Assignees: Sorrel Medical Ltd.
- Applicants: Sorrel Medical Ltd
- Inventors: Michael Plaskin; Shahar Zidon; Ori Ben-David
- Web page: https://patentgrep.com/patent/US10869960B2

## CPC

- A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles}
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/24: Apparatus using programmed or automatic operation
- A61M 5/14212: {Pumping with an aspiration and an expulsion action}
- A61M 5/14248: {of the skin patch type}
- 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 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- 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 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 2005/3118: {via the distal end of a syringe, i.e. syringe end for mounting a needle cannula}
- 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

A therapeutic substance delivery device is provided for delivering therapeutic substance to the subject. A 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 delivery device engages with a prefilled therapeutic substance reservoir, such that a disinfection chamber is defined between the sterile fluid path and the reservoir. The needle penetrates the disinfection chamber and subsequently the reservoir when the therapeutic substance delivery device and the reservoir are engaged with one another. A disinfection assembly is disposed within the delivery device and configured to disinfect the disinfection chamber prior to the needle penetrating the disinfection chamber. Control circuitry activates the disinfection assembly, terminates the activation of the disinfection assembly, and subsequently drives the needle to penetrate the disinfection chamber and subsequently the reservoir.

## Claims

### Claim 1

Apparatus for delivering a therapeutic substance to a subject, the apparatus comprising:
a therapeutic substance delivery device:
(a) comprising a sterile fluid path for delivering the therapeutic substance to the subject, 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
(b) configured to engage with a prefilled therapeutic substance reservoir, such that when the therapeutic substance delivery device and the reservoir are engaged with one another a disinfection chamber is defined between the sterile fluid path and the reservoir, the needle being configured to penetrate the disinfection chamber and subsequently the reservoir when the therapeutic substance delivery device and the reservoir are engaged with one another, such that fluid communication is established between the reservoir and the sterile fluid path;
a disinfection assembly disposed within the therapeutic substance delivery device and configured to disinfect the disinfection chamber prior to the needle penetrating the disinfection chamber; and
control circuitry configured to (a) activate the disinfection assembly, (b) terminate the activation of the disinfection assembly, and subsequently (c) drive the needle to penetrate the disinfection chamber and subsequently the reservoir.

### Claim 2 (depends on 1)

The apparatus according to claim 1, wherein the control circuitry is configured to terminate the activation of the disinfection assembly within 5 minutes after activating the disinfection assembly.

### Claim 3 (depends on 2)

The apparatus according to claim 2, wherein the control circuitry is configured to drive the needle to penetrate the disinfection chamber within 10 seconds after terminating the activation of the disinfection assembly.

### Claim 4 (depends on 1)

The apparatus according to claim 1, wherein a surface area of the disinfection chamber is 1-400 mm2.

### Claim 5 (depends on 1)

The apparatus according to claim 1, wherein the control circuitry is further configured to activate the therapeutic substance delivery device to deliver the therapeutic substance to the subject.

### Claim 6 (depends on 1)

The apparatus according to claim 1, further comprising the prefilled therapeutic substance reservoir, and wherein the apparatus is packaged for commercial sale with the therapeutic substance delivery device and the reservoir engaged with one another.

### Claim 7 (depends on 1)

The apparatus according to claim 1, further comprising the prefilled therapeutic substance reservoir, and wherein the apparatus is packaged for commercial sale with the therapeutic substance delivery device and the reservoir not engaged with one another.

### Claim 8 (depends on 1)

The apparatus according to claim 1, wherein the sterile fluid path is a first sterile fluid path and the needle is a first needle, the therapeutic substance delivery device:
(a) further comprising a second sterile fluid path, the second sterile fluid path comprising a second needle at an upstream end of the second sterile fluid path and the injection assembly at a downstream end of the second fluid path,
(b) further configured to engage with a second prefilled therapeutic substance reservoir, such that when the first and second reservoirs are engaged with the therapeutic substance delivery device first and second disinfection chambers are defined respectively (i) between the first sterile fluid path and the first reservoir, and (ii) between the second sterile fluid path and the second reservoir,
(c) further comprising a first sterile fluid path valve disposed between the first needle and the injection assembly and configured to control fluid communication between the first reservoir and the injection assembly, and
(d) further comprising a second sterile fluid path valve disposed between the second needle and the injection assembly and configured to control fluid communication between the second reservoir and the injection assembly,
wherein the first and second needles are configured to penetrate the first and second disinfection chambers respectively and subsequently the first and second reservoirs respectively when the therapeutic substance delivery device is engaged with the first and second reservoirs, such that a first fluid communication is established between the first sterile fluid path and the first reservoir and a second fluid communication is established between the second sterile fluid path and the second reservoir, and
wherein the disinfection assembly is configured to (a) disinfect the first disinfection chamber prior to the first needle penetrating the first disinfection chamber, and (b) disinfect the second disinfection chamber prior to the second needle penetrating the second disinfection chamber.

### Claim 9 (depends on 1)

The apparatus according to claim 1, wherein:
(a) the needle is a first needle and the sterile fluid path further comprises a second needle at the upstream end of the sterile fluid path,
(b) when the therapeutic substance delivery device and the reservoir are engaged with one another the first and second needles are configured to penetrate the disinfection chamber and subsequently the reservoir such that fluid communication is established between the reservoir and the sterile fluid path via the first and second needles, and
(c) the control circuitry is configured to drive the first and second needles to penetrate the disinfection chamber, within 10 seconds after terminating the activation of the disinfection assembly.

### Claim 10 (depends on 1)

The apparatus according to claim 1, wherein the disinfection assembly comprises an ultraviolet radiation source.

### Claim 11 (depends on 10)

The apparatus according to claim 10, wherein the ultraviolet radiation source is configured to emit ultraviolet radiation at a power level of less than 200 mW.

### Claim 12 (depends on 10)

The apparatus according to claim 10, wherein the ultraviolet radiation source is configured to emit the ultraviolet radiation at a wavelength of 100-400 nm.

### Claim 13 (depends on 10)

The apparatus according to claim 10, wherein the ultraviolet radiation source is configured to emit the ultraviolet radiation at a plurality of wavelengths.

### Claim 14 (depends on 10)

The apparatus according to claim 10, wherein the ultraviolet radiation source comprises an ultraviolet light emitting diode.

### Claim 15 (depends on 10)

The apparatus according to claim 10, wherein at least one surface of the disinfection chamber is a reflective surface configured to reflect ultraviolet radiation.

### Claim 16 (depends on 15)

The apparatus according to claim 15, wherein the reflective surface is configured to reflect at least 10% of the ultraviolet radiation.

### Claim 17 (depends on 1)

The apparatus according to claim 1, wherein the disinfection assembly comprises a heat source and the control circuitry is configured to activate the heat source to heat the disinfection chamber.

### Claim 18 (depends on 17)

The apparatus according to claim 17, wherein the control circuitry is configured to activate the heat source to heat the disinfection chamber to a temperature of 40-300 degrees Celsius.

### Claim 19 (depends on 1)

The apparatus according to claim 1, wherein the disinfection assembly comprises a disinfectant fluid assembly comprising a disinfectant fluid reservoir containing disinfectant fluid, and the control circuitry is configured to activate the disinfectant fluid assembly to release the disinfectant fluid from the disinfectant fluid reservoir into the disinfection chamber.

### Claim 20 (depends on 1)

The apparatus according to claim 1, wherein the apparatus is packaged for commercial sale without the prefilled therapeutic substance reservoir.