Electrotransport system having flexible means

• US 6,725,090 B1
• Filed: 06/07/1995
• Issued: 04/20/2004
• Est. Priority Date: 12/31/1992
• Status: Active Grant

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Gyory, J. Richard, Bilitz, Mark R., Peery, John R., Lattin, Gary A., Messer, Gary A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/480,232
• Time in Patent Office: 3,240 Days
• Field of Search: 604/20-21
• US Class Current: 604/20
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

An apparatus for the electrically assisted delivery of therapeutic agent is described. An apparatus of the invention has rigid zones or regions which are physically connected by flexible means such as a web. The flexible means permits the rigid zones to move independently with respect to each other while remaining physically connected or coupled. In a preferred embodiment, the rigid zones are physically and electronically coupled by the flexible means. In another preferred embodiment, the skin side of the rigid zones has a radius of curvature which approximates that of the body site to which the device is to be attached.

A method of increasing the body or surface conformability of a rigid electrotransport device is described. The method involves the step of intentionally placing rigid subcomponents of the device in physically separate zones within the device. The rigid zones are separate and are coupled by flexible connector means. In this manner, a conformable mosaic of rigid zones which comprises the device is created.

Claims

1. An electrotransport agent delivery device for delivering an agent by electrotransport through a body surface, the device comprising:

an active electrode;

a return electrode, the electrodes being in electrical connection with,

circuitry which controls current output of the device, and

a source of electrical energy, the device having at least two rigid regions which are placed against the body surface at spaced apart locations and which are held in intimate contact with said surface, the rigid regions being physically and electronically connected to one another by a flexible means, the flexible means permitting the rigid regions to move independently with respect to each other while remaining physically and electronically connected and in place on the body surface.

2. The device of claim 1, wherein the rigid region has a flexural rigidity greater than about 1.5×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

3. The device of claim 1, wherein the flexible means has a flexural rigidity of less than about 0.75×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

4. The device of claim 1, wherein the rigid region has a flexural rigidity greater than about 5.0×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

5. The device of claim 1, wherein the flexible means has a flexural rigidity of less than about 0.45×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of defection.

6. The device of claim 1, wherein the rigid region has a flexural rigidity and the flexible means has a flexural rigidity, the difference (AEI) between the two flexural rigidity being greater than 0.3×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

7. The device of claim 1, wherein the flexible means is a flexible web.

8. The device of claim 1, wherein the flexible means is an axis of flex.

9. The device of claim 8, wherein the axis of flex is a hinge.

10. The device of claim 1, wherein the device has at least three rigid regions, at least two of the three rigid regions being connected to one another by a flexible means.

11. The device of claim 10, wherein each of the flexible means is an axis of flex.

12. The device of claim 10, wherein each of the flexible means is a hinge.

13. The device of claim 10, wherein the device has at least three rigid regions, at least two of the three rigid regions being connected to one another by a flexible means.

14. The device of claim 1, wherein at least one of the rigid regions has a curved surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature greater than 125 mm, whereby the device is adapted to be placed against a human torso.

15. The device of claim 1, wherein at least one of the rigid regions has a surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of about 50 mm, whereby the device is adapted to be placed against a human arm.

16. the device of claim 1, wherein at least one of the rigid regions has a surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of 60 to 90 mm, whereby the device is adapted to be placed against a human leg curvature of about 15 mm, whereby the device is adapted to be placed against a human finger or toe.

17. The device of claim 1, wherein each of the rigid regions includes an electronic assembly, the electronic assemblies being electronically connected to one another across the flexible means.

18. The device of claim 1, wherein at least one of the rigid regions has a surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of 60 to 90 mm, whereby the device is adapted to be placed against a human leg.

19. The device of claim 1, wherein the flexible means permits angular movement of one rigid region relative to another rigid region.

20. The device of claim 1, wherein the flexible means permits adjustable positioning of one rigid region on the body surface relative to the positioning of another rigid region on the body surface.

21. The device of claim 1, wherein at least one of the rigid regions has a curved surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of 60 to 90 mm, whereby the device is adapted to be placed against a human leg.

22. The device of claim 1, wherein at least one of the rigid regions has a curved surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of greater than 125 mm, whereby the device is adapted to be placed against a human torso.

23. The device of claim 1, wherein at least one of the rigid regions has a surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of 40 to 60 mm, whereby the device is adapted to be placed against a human arm.

24. The device of claim 1, wherein at least one of the rigid regions has a surface which is adapted to contact the body surface, the rigid body surface having a radius of cylindrical curvature of 12 to 18 mm, whereby the device is adapted to be placed against a human finger or toe.

25. An electrotransport agent delivery device for delivering an agent by electrotransport through a body surface, the device comprising:

an active electrode;

a return electrode, the electrodes being in electrical connection with,

circuitry which controls current output of the device, and

a source of electrical energy, the device comprising at least two substantially rigid regions which are placed against the body surface at spaced apart locations, each of the substantially rigid regions having substantially planar subregions including electronic subsystems, the electronic subsystems being physically and electronically connected by conductive flexible means so as to permit relative movement between said substantially rigid regions without disruption of the physical and electronic connections.

26. The device of claim 25, wherein the regions of subsyantial rigidity have a flexural rigidity of greater than about 1.5×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

27. The device of claim 25, wherein the flexible means has a flexural rigidity of less than about 0.75×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

28. The device of claim 25, wherein the subsyantially rigid regions have a flexural rigidity greater than about 5.0×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

29. The device of claim 25, wherein the flexible means has a flexural rigidity of less than about 0.45×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

30. The device of claim 25, wherein the subatantially rigid regions have a flexural rigidity and the flexible means has a flexural rigidity, the difference (Δ

EI) between the two flexural rigidities being greater than 0.3×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

31. The device of claim 25, wherein the flexible means is a flexible web.

32. The device of claim 25, wherein the flexible means is an axis of flex.

33. The device of claim 32, wherein the axis of flex is a hinge.

34. In an electrotransport agent delivery device for delivering an agent by electrotransport through a body surface, the device comprising:

an active electrode;

a return electrode, the electrodes being in electrical connection with,

circuitry which controls current output of the device, and

a source of electrical energy, the device comprising a replaceable component and a non-replaceable component, the non-replaceable component having at least two substantially rigid regions which are placed against the body surface at spaced apart locations, both of said components including electronic subassemblies, the improvement which comprises;

conductive flexible means, the flexible means extending between the regions and physically and electronically connecting the subassemblies while permitting relative movement therebetween without disruption of the physical and electronic connections.

35. The device of claim 34, wherein the rigid regions have a flexural rigidity of greater than about 1.5×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

where;

E=Young'"'"'s modulus (or $\text{\hspace{1em}<br><br>}<br><br>\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

36. The device of claim 34, wherein the flexible means has a flexural rigidity of less than about 0.75×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

37. The device of claim 34, wherein the rigid region has a flexural rigidity greater than about 5.0×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

38. The device of claim 34, wherein the flexible means has a flexural rigidity of less than about 0.45×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

39. The device of claim 34, wherein the rigid region has a flexural rigidity and the flexible means has a flexural rigidity, the difference (Δ

EI) between the two flexural rigidity being greater than 0.3×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid region as $\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection.

40. The device of claim 34, wherein the flexible means is a flexible web.

41. The device of claim 34, wherein the flexible means is an axis of flex.

42. The device of claim 41, wherein the axis of flex is a hinge.

43. The device of claim 34, wherein the conductive flexible means comprises a polymeric hinge overlying a flexible electronic circuit.

44. The device of claim 34, wherein the conductive flexible means comprises a flexible membrane.

45. The device of claim 34, wherein the flexible means permits angular movement of one rigid region relative to another rigid region.

46. The device of claim 45, wherein the flexible means permits the rigid regions to deviate from substantial planarity by at least about 15 degrees.

47. The device of claim 34, wherein the flexible means permits adjustable positioning of one rigid region on the body surface relative to the positioning of another rigid region on the body surface.

48. A method of increasing the conformability of a skin mountable electrotransport device comprising:

an active electrode;

a return electrode, the electrodes being in electrical connection with,

circuitry which controls current output of the device, and a source of electrical energy, the device having at least one rigid component comprising physically separable, rigid, individual subcomponents, the method comprising the step of;

separating the subcomponents;

providing a flexible connector means; and

intentionally connecting said subcomponents with said flexible connector means in physically separate, rigid zones within said device, said zones being coupled and separated by a flexible connector means, said connecting step being accomplished so that a conformable mosaic of rigid zones comprising the component is created.

49. The method of claim 48 wherein the physically separate rigid zones have length and width dimensions in the range of about 10 to 35 mm.

50. The method of claim 48 wherein the physically separate rigid zones have body proximal side radii of curvature which correspond to approximately that of the body surface to which the device is to be affixed.

51. A body surface mountable electrotransport device comprising:

an active electrode;

a return electrode, the electrodes being in electrical connection with,

circuitry which controls current output of the device, and

a source of electrical energy, the device having

a rigid component having a flexural rigidity greater than about 1.5×

10<sup>−

3</sup> kg-m²/rad wherein flexural rigidity is defined as the product of Young'"'"'s modulus (E) and the moment of inertia (I) for the rigid component as follows;

$\mathrm{EI}=\frac{{\mathrm{WL}}^2}{2<br><br>\text{\hspace{1em}<br><br>}<br><br>\mathrm{\theta <br><br>}}$

where;

E=Young'"'"'s modulus (or modulus of elasticity);

I=moment of inertia;

W=the applied load;

L=the moment arm; and

θ

=the angle of deflection, the rigid component having a body proximal side and a body distal side, said body proximal side having a shape which substantially corresponds to the shape of the body surface to which the device is to be mounted.

52. A device according to claim 51 in which the substanially rigid component are physically and electronically coupled.

53. The device of claim 51, wherein said body proximal side has a radius of curvature which substantially corresponds to the radius of curvature of the body surface upon which the device is to be applied.

54. The device of claim 51 in which the rigid components are coupled by a flexible coupling means.

55. The device of claim 51 in which the electrotransport device is a flexible mosaic of substantially rigid components.