DEVICE FOR SUBCUTANEOUS DELIVERY OF FLUID MEDICAMENT

• US 20190209773A1
• Filed: 03/12/2019
• Published: 07/11/2019
• Est. Priority Date: 07/07/2017
• Status: Active Grant

• Current Assignee: NeuroDerm Ltd. (Mitsubishi Chemical Group Corp.)
• Original Assignee: NeuroDerm Ltd. (Mitsubishi Chemical Group Corp.)
• Inventors: Shor, Eran, Mor, Tsabar, Ben David, Tamir, Lilach, Nir, Grossfeld, Rami, Alfandari, Shai, Nadler, Ram, Golom, Dmitry, Shaki, Daniel, Tikochinsky, Yoav, Ozsumer, Serdar
• Granted Patent: US 10,463,787 B2
• Time in Patent Office: Days
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: 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
• CPC Class Codes: A61M 5/31528 : by means of rotational movements, e.g. screw-thread mechanisms
• CPC Class Codes: A61M 5/345 : Adaptors positioned between needle hub and syringe nozzle
• CPC Class Codes: H03H 9/0509 : consisting of adhesive elements
• CPC Class Codes: H03H 9/0585 : consisting of an adhesive layer
• CPC Class Codes: H03H 9/54 : comprising resonators of piezoelectric or electrostrictive material H03H9/64 takes precedence
• CPC Class Codes: H03H 9/64 : using surface acoustic waves

Abstract

An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson'"'"'s Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.

Claims

1-74. -74. (canceled)

75. A device for delivering a fluid medicament to subcutaneous tissue of a user, the device comprising:

a pump module comprising at least one reservoir for containing the fluid medicament; and

a cannula insertion mechanism attachable to the pump module, the cannula insertion mechanism comprising;

an insertion needle, and

a cannula assembly comprising a flexible cannula connected to a rigid fluidic link and detachably coupled with the insertion needle such that, when the flexible cannula is located in the subcutaneous tissue, the cannula assembly fluidically couples the reservoir to the subcutaneous tissue via the rigid fluidic link.

217. The device of claim 75, wherein the cannula insertion mechanism further comprises a delivery mechanism comprising a spring coupled with the insertion needle, wherein release of the spring causes:

(i) delivery of the insertion needle and the flexible cannula into the subcutaneous tissue and, then, (ii) removal of the insertion needle from the subcutaneous tissue while leaving the flexible cannula within the subcutaneous tissue.

218. The device of claim 217, wherein the delivery mechanism and the insertion needle are removable after the flexible cannula is delivered into the subcutaneous tissue.

219. The device of claim 75, wherein the cannula insertion mechanism comprises:

a cannula plunger comprising a first portion attached to the insertion needle and a second portion holding the flexible cannula, said cannula initially mounted on the insertion needle;

a cam coupled to an eccentric link, the eccentric link attached to the first portion of the cannula plunger and configured to move the first portion and the second portion of the cannula plunger when the cam rotates;

a spring to rotate the cam; and

a structure for holding the spring in a compressed position and for enabling releasing the compressed spring to rotate the cam to cause;

(i) delivery of the insertion needle and the flexible cannula into the subcutaneous tissue, and

(ii) retraction of the insertion needle from the subcutaneous tissue while leaving the flexible cannula in the subcutaneous tissue.

220. The device of claim 219, wherein the structure for holding the spring in a compressed state and for releasing the compressed spring comprises:

a displaceable pin to hold the spring in the compressed state; and

a button to displace the pin to causes rotation of the cam by the spring.

221. The device of claim 220, wherein the cam, the eccentric link, the first portion, and the insertion needle are removable from the device, leaving the second portion and the flexible cannula to deliver fluid medicament from the least one reservoir to the subcutaneous tissue.

222. The device of claim 75, wherein the cannula insertion mechanism further comprises:

a cannula plunger comprising a first portion fixedly attached to the insertion needle and a second portion holding the flexible cannula, such that the flexible cannula is mounted on the insertion needle;

a hub comprising a first gear;

a second gear rotatable by and in the first gear, said second gear attached to the first portion of the cannula plunger and configured to move the first portion and the second portion of the cannula plunger when the hub rotates;

a spring to rotate the hub; and

a structure for holding the spring in a compressed position and for releasing the compressed spring, wherein releasing the compressed spring causes;

(i) the insertion needle and the flexible cannula to be delivered into the subcutaneous tissue, and

(ii) the insertion needle to be removed from the subcutaneous tissue while leaving the flexible cannula within the subcutaneous tissue.

223. The device of claim 222, wherein the second gear includes a pin, said pin configured to fit into a slot in the first portion.

224. The device of claim 222, wherein the spring, the hub, the first gear, the second gear, the first portion and the insertion needle are removable from the device after delivery of the flexible cannula to the subcutaneous tissue.

225. The device of claim 75, wherein the cannula insertion mechanism is configured to deliver more than one flexible cannula into the subcutaneous tissue, such that the at least one flexible cannula couples each reservoir to the subcutaneous tissue.

226. The device of claim 75, wherein the cannula insertion mechanism comprises more than one cannula insertion mechanism, wherein each reservoir has a corresponding cannula insertion mechanism operable to deliver at least one flexible cannula into the subcutaneous tissue, such that at least one flexible cannula couples each reservoir to the subcutaneous tissue.

227. The device of claim 75, wherein the pump module is configured to operate the reservoirs such that each reservoir delivers the fluid medicament to a different injection site or to a same injection site of the user.

228. The device of claim 75, wherein the pump module is configured to operate the reservoirs to deliver fluid medicament simultaneously.

229. The device of claim 228, wherein at least two of the reservoirs contain different fluid medicaments.

230. The device of claim 75, wherein the pump module is configured to operate the reservoirs such that at least two reservoirs deliver the fluid medicament at a different time.

231. The device of claim 230, wherein at least two of the reservoirs contain a different fluid medicament.

232. The device of claim 75, further comprising a temperature control unit to control a temperature of the fluid medicament.

233. The device of claim 232, wherein the temperature control unit comprises a heating element, a cooling element, or combinations thereof.

234. The device of claim 232, wherein the temperature control unit comprises an apparatus for thermally isolating the fluid medicament from the body of the user, from ambient temperature, or from combinations thereof.

235. The device of claim 232, wherein the temperature control unit comprises a temperature sensor for sensing the temperature of the fluid medicament.

236. The device of claim 75, further comprising a skin property control unit operable to apply ultrasonic vibration to an injection site.

237. The device of claim 75, wherein the flexible cannula comprises a surface coating to reduce a trauma caused by insertion of the flexible cannula.

238. The device of claim 75, further comprising a penetration depth control unit to control an insertion depth of the flexible cannula into the subcutaneous tissue.

239. The device of claim 238, wherein the penetration depth control unit is configured to control the insertion depth of the flexible cannula based on subcutaneous inspection.

240. The device of claim 238, wherein the penetration depth control unit is configured to deactivate insertion of the flexible cannula if the penetration depth control unit identifies an undesirable tissue structure which is located at an insertion depth of the flexible cannula or the needle.

241. The device of claim 75, wherein the fluid medicament comprises levodopa, carbidopa, or combinations thereof.

76-108. -108. (canceled)

109. A method of delivering a fluid medicament to subcutaneous tissue of a user, the method comprising the steps of:

providing a pump module comprising at least one reservoir for containing the fluid medicament;

attaching a cannula insertion mechanism to the pump module, the cannula insertion mechanism comprising;

an insertion needle, and

a cannula assembly comprising a flexible cannula connected to a rigid fluidic link and detachably coupled to the insertion needle; and

fluidically coupling the pump module to the subcutaneous tissue of the user such that the cannula assembly fluidically couples the at least one reservoir to the subcutaneous tissue via the rigid fluidic link.

110-216. -216. (canceled)