Portable medical fluid delivery device with drive screw articulated with reservoir plunger

• US 9,999,722 B2
• Filed: 12/30/2009
• Issued: 06/19/2018
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Ben-David, Shai
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US13/142,912
• Publication Number:
  US 20120022453A1
• Time in Patent Office: 3,093 Days
• Field of Search: 604 67, 604131, 604155
• 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 2005/14533 cam actuated
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• 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 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod

Abstract

A device for delivering fluid into the body is provided. The device may comprise a reservoir including at least one wall for retaining fluid and a plunger (400), wherein the plunger is articulated with a drive screw (300) having a distal end (304) that rotates within the plunger and displaces the plunger in a linear direction. The device may further comprise a reusable part having a motor, one or more gears and a receiving portion, and also a disposable part having a reservoir, a plunger and a drive screw having a proximal end capable of engaging with the receiving portion upon connecting the reusable part and the disposable part

Claims

1. A portable pump device for delivering fluid into the body of a user, the device comprising:

a first part comprising a motor, one or more gears and a receiving portion driven by at least one of the motor and the one or more gears; and

a second part configured to connect removably with the first part, the second part comprising a reservoir, a plunger having an unthreaded socket, and a drive screw having a proximal end and a distal end, the distal end of the drive screw being received at least partially in the socket of the plunger so as to be articulated with the plunger and axially retained by the socket of the plunger so as to move the plunger synchronized therewith in both axial directions, and the proximal end of the drive screw being configured to directly contact and removably engage the receiving portion of the first part upon connection of the first part and the second part,

wherein rotation of the drive screw by the receiving portion displaces the plunger in a linear direction within the reservoir without rotating the plunger, and

wherein the second part further comprises an engagement member having a threaded portion and a non-threaded portion, the engagement member being configured to be movable between at least a first position in which the non-threaded portion of the engagement member allows the drive screw to move linearly substantially unrestricted and a second position in which the drive screw is coupled to the threaded portion of the engagement such that the rotation of the drive screw by the receiving portion displaces the plunger in the linear direction within the reservoir,

wherein the plunger has;

a first groove which has a uniform depth and is configured such that an entire outer circumference of a gasket supported by the first groove maintains constant contact with an inner wall of the reservoir, and either;

a second groove which has a non-uniform depth and includes one or more projections such that a second gasket supported by the second groove contacts the inner wall of the reservoir via those portions of the second gasket positioned over the one or more projections, or

two or more guide flaps that support the plunger within the reservoir, each guide flap having at least a portion that maintains contact with the inner wall of the reservoir as the plunger is advanced within the reservoir, wherein each of the two or more guide flaps extends from the plunger at a single point of contact and are separate from each other in a plane transverse to the axial directions so that positioning and orientation of each guide flap relative to the inner wall of the reservoir is adjustable individually with elasticity.

2. The device according to claim 1, wherein the distal end of the drive screw is spherical in shape.

3. The device according to claim 1, wherein the distal end of the drive screw is truncated.

4. The device according to claim 1, wherein the socket includes a longitudinal cross-section selected from the group consisting of polygonal, circular and a combination thereof and/or includes a transverse cross-section selected from the group consisting of polygonal, circular and a combination thereof.

5. The device according to claim 1, wherein the articulation of the distal end of the drive screw with the socket of the plunger permits an angular movement of the drive screw relative to the plunger.

6. The device according to claim 1, wherein the socket includes one or more protrusions to hold the distal end of the drive screw at least partially in the socket upon engagement of the distal end of the drive screw with the socket.

7. The device according to claim 1, wherein the engagement of the distal end of the drive screw with the socket comprises a snap-fit engagement.

8. The device according to claim 1, wherein articulation of the distal end of the drive screw with the socket is configured to enable pushing of the plunger using the drive screw, pulling of the plunger using the drive screw and substantially unrestricted rotation of the distal end within the socket.

9. The device according to claim 1, wherein the reservoir includes a non-circular cross-section and wherein the cross-section of at least a portion of the plunger corresponds to the non-circular cross-section of the reservoir.

10. The device according to claim 9, wherein the plunger comprises oval shape.

11. The device according to claim 1, wherein at least a portion of a wall of the second part comprises at least a portion of at least one wall of the reservoir.

12. The device according to claim 1, wherein the fluid being delivered comprises insulin.

13. The device according to claim 1, further comprising a cradle unit securable to the skin of the user, wherein one or more of housings of the first part and the second part are removably connectable to the cradle unit.

14. The device according to claim 1, wherein the first part comprises a reusable part including a reusable part housing and wherein the second part comprises a disposable part including a disposable part housing.

15. The device according to claim 1, wherein the engagement member comprises a drive nut.

16. The device according to claim 1, wherein at least a portion of the one or more flaps is resilient.

19. The device according to claim 1, wherein the receiving portion is a rotating sleeve and the proximal end of the drive screw is configured to directly contact and removably engage within the rotating sleeve upon connection of the first part and the second part, and rotate when the rotating sleeve is rotated.

20. The device according to claim 19, wherein the drive screw is received at least partially in the socket of the plunger so as to be articulated with the plunger such that unintentional lateral movement of the drive screw due to eccentricity or misalignment of the proximal end within the rotating sleeve is absorbed by articulations between the distal end and the socket and not transferred to the plunger.

21. The device according to claim 1, wherein the proximal end of the drive screw is star-shaped.

17. A portable pump device for delivering fluid into the body of a user, the device comprising:

a first part comprising a motor, one or more gears and a receiving portion driven by at least one of the motor and the one or more gears; and

a second part configured to connect removably with the first part, the second part comprises;

a reservoir for retaining the fluid;

a plunger having a socket; and

a drive screw having a proximate end and a distal end, the proximal end of the drive screw being configured to directly contact and removably engage the receiving portion of the first part upon connection of the first part and the second part, and the distal end being received at least partially in the socket of the plunger so as to be articulated with the plunger and be axially retained by the socket of the plunger so as to move the plunger synchronized therewith in both axial directions, the distal end of the drive screw and the socket of the plunger being configured and arranged such that rotation of the drive screw displaces the plunger in a linear direction within the reservoir without substantially rotating the plunger;

wherein the distal end of the drive screw has a spherical shape and the socket has a polygonal shape,

wherein the socket is non-threaded,

wherein the distal end of the drive screw and the socket engage by a snap-fit engagement, and

wherein the plunger has two or more guide flaps that support the plunger within the reservoir, each guide flap having at least a portion that maintains contact with the inner wall of the reservoir as the plunger is advanced within the reservoir, wherein each of the two or more guide flaps extends from the plunger at a single point of contact and are separate from each other in a plane transverse to the axial directions so that positioning and orientation of each guide flap relative to the inner wall of the reservoir is adjustable individually with elasticity.

18. A portable pump device for delivering fluid into the body of a user, the device comprising:

a first part comprising a motor, one or more gears and a receiving portion driven by at least one of the motor and the one or more gears; and

a second part configured to connect removably with the first part, the second part comprises;

a reservoir for retaining the fluid;

a plunger; and

a drive screw having a proximate end and a distal end, the proximal end of the drive screw being configured to directly contact and removably engage the receiving portion of the first part upon connection of the first part and the second part, and the distal end being articulated with the plunger,

wherein rotation of the drive screw displaces the plunger in a linear direction within the reservoir without substantially rotating the plunger,

wherein the plunger includes a socket for engagement of the distal end of the drive screw to provide articulation therebetween, such that the articulation of the distal end of the drive screw with the socket of the plunger permits an angular movement of the drive screw relative to the plunger, and axially retain the distal end of the drive screw by the socket so as to move the plunger synchronized therewith in both axial directions,

wherein the socket is non-threaded,

wherein the distal end of the drive screw and the socket engage by a snap-fit engagement, and

wherein the plunger has;

a first groove which has a uniform depth and is configured such that an entire outer circumference of a gasket supported by the first groove maintains constant contact with an inner wall of the reservoir, and either;

a second groove which has a non-uniform depth and includes one or more projections such that a second gasket supported by the second groove contacts the inner wall of the reservoir via those portions of the second gasket positioned over the one or more projections, or

two or more guide flaps that support the plunger within the reservoir, each guide flap having at least a portion that maintains contact with the inner wall of the reservoir as the plunger is advanced within the reservoir, wherein each of the two or more guide flaps extends from the plunger at a single point of contact and are separate from each other in a plane transverse to the axial directions so that positioning and orientation of each guide flap relative to the inner wall of the reservoir is adjustable individually with elasticity.