Transdermal perfusion of fluids

• US 5,441,490 A
• Filed: 11/23/1993
• Issued: 08/15/1995
• Est. Priority Date: 01/09/1991
• Status: Expired due to Fees

• Current Assignee: Pal Svedman
• Original Assignee: Principal AB
• Inventors: Svedman, Pal
• Primary Examiner(s): KRUTER, JEROME
• Application Number:
  US08/084,267
• Time in Patent Office: 630 Days
• Field of Search: 604/115, 604/200, 604/201, 604/204, 604/289, 604/290, 604/29, 128/743
• US Class Current: 604/289
• CPC Class Codes: A61M 1/08 Cupping glasses , i.e. for enhancing blood circulation
• CPC Class Codes: A61M 1/67 Containers incorporating a piston-type member to create suction, e.g. syringes cupping glasses A61M1/08; with a flexible member creating suction A61M1/68
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

An apparatus is provided for removing a small area of epidermis from the skin to expose an intact area of dermis and subsequently deliver a liquid in contact with the exposed dermis. This method of delivery allows the rate of absorption of substances into the body to be enhanced by removal of the epidermis. A preferred embodiment removes the epidermis by forming a suction blister, the apparatus having a housing attached to the skin adhesively to define a chamber in which suction is applied. Suction is applied to the chamber without connection to an external source of suction by means of an evacuated cell separated from the chamber by a disruptable membrane. A tubular member is actuated to rupture the membrane, disrupt the blister and deliver liquid to the chamber in successive stages of operation of the apparatus.

Claims

1. Apparatus for use in transdermal perfusion of fluids through the skin of the human or animal body, the apparatus comprising a housing attachable to the body and having a contact surface which in use is held in contact with a portion of skin, the housing defining a chamber and the contact surface defining an aperture communicating with the chamber, and fluid supply means operable during a perfusion phase of operation of the apparatus to supply fluid to the chamber wherein the apparatus further comprises de-epithelializing means for removing a portion of the skin'"'"'s epidermis from the skin'"'"'s underlying dermis, the de-epithelializing means being operable during a preparatory phase of operation of the apparatus to expose an area of dermis of the skin at a treatment site which is accessible via the aperture such that subsequently during the pension phase direct contact is made between fluid in the chamber and the dermis.

2. Apparatus as claimed in claim 1 wherein the de-epithelialising means comprises suction means operable to form a partial vacuum in the chamber during a blister forming period in which an area of epithelium of the skin of the treatment site is separated from the dermis.

3. Apparatus as claimed in claim 2 wherein the housing is cooperable with the skin to form a closed compartment of which the chamber constitutes at least a part and comprises sealing means operable between the contact surface an annular area of skin peripheral to the treatment site whereby the partial vacuum is maintainable by substantially preventing the ingress of air during the blister forming period.

4. Apparatus as claimed in claim 3 wherein the suction means comprises a cell defining a space within which a partial vacuum is formed and disrupting means operable to disrupt a membrane partitioning the space from the chamber.

5. Apparatus as claimed in claim 4 wherein the cell is provided with a valve facilitating evacuation of air to create a partial vacuum within the space prior to operation of the disrupting means.

6. Apparatus as claimed in claim 3 comprising expanding means operable to expand the volume of the chamber to thereby create a partial vacuum.

7. Apparatus as claimed in any of claims 3 to 6 further comprising blister disruption means operable to open the suction blister by penetrating or removing the detached area of epithelium constituting a roof of the blister.

8. Apparatus as claimed in claim 7 comprising an actuator operable to sequentially actuate the suction means, the blister disruption means and by subsequent movement of the actuator to actuate the fluid supply means.

9. Apparatus as claimed in claim 8 wherein the actuator is operatively connected to a tubular member which is movable longitudinally in response to actuator movement so as to disrupt the membrane partitioning the space from the chamber to thereby initiate the blister forming period, the member being further longitudinally movable to a position in the chamber in which it disrupts the blister and the member further defining a longitudinal bore through which fluid is supplied to the chamber during the perfusion phase.

10. Apparatus as claimed in any of claims 3 to 6, 8 or 9 wherein the sealing means comprises an adhesive layer operable to sealingly secure the contact surface to an annular area of skin peripheral to the treatment site.

11. Apparatus as claimed in any of claims 3 to 6, 8 or 9 wherein the fluid supply means includes flow restricting means operable to restrict the flow of fluid into the chamber to a predetermined rate.

12. Apparatus for use in the formation of a suction blister on the skin of the human or animal body, the apparatus comprising a housing, means for attaching the housing to the body, the housing having a contact surface which in use is held in sealing contact with the skin, the housing defining a chamber and the contact surface defining an aperture communicating with the chamber, and the apparatus further comprising suction means operable to form a partial vacuum in the chamber and thereby form a suction blister at a treatment site which is accessible via the aperture, the housing being cooperable with the skin to form a closed airtight compartment of which the chamber constitutes at least a part, the chamber shape being such as to allow a suction blister to form in the chamber by delamination of the skin at the treatment site and by comprising sealing means operable between the contact surface and an annular portion of skin peripheral to the treatment site whereby the partial vacuum is maintainable by substantially preventing the ingress of air during a blister forming period.

13. Apparatus as claimed in claim 12 wherein the suction means comprises a cell defining a space within which a partial vacuum is formed and disrupting means operable to disrupt a membrane partitioning the space from the chamber.

14. Apparatus as claimed in claim 13 wherein the cell is provided with a valve facilitating evacuation of air to create a partial vacuum within the space prior to operation of the disrupting means.

15. Apparatus as claimed in claim 12 comprising expanding means operable to expand the volume of the chamber to thereby create a partial vacuum.

16. Apparatus as claimed in any of claims 12 to 15 further comprising blister disruption means operable to open the suction blister by penetrating a detached area of epidermis constituting a roof of the blister.

17. Apparatus as claimed in claim 16 wherein the disrupting means of the suction means comprises a member extending into the closed compartment and connected to an actuator located externally of the compartment, the member being movable from a rest position into a first position in which the member actuates the suction means and a second position in which the member disrupts the blister.

18. Apparatus as claimed in claim 16 wherein the sealing means comprises an adhesive layer operable to sealingly secure the contact surface to an annular area of skin peripheral to the treatment site.

24. Apparatus as claimed in claim 12 further comprising blister disruption means operable to open the suction blister by bursting the detached area of epidermis constituting a roof of the blister.

25. Apparatus as claimed in claim 12 further comprising blister disruption means operable to open the suction blister by removing the detached areas of epidermis constituting a roof of the blister.

19. A method of transdermal perfusion of fluids through the skin of the human or animal body, comprising the steps of attaching a housing to the body such that a contact surface of the housing is held in contact with a portion of skin, the housing defining a chamber and the contact surface defining an aperture communicating with the chamber, and operating a fluid supply means during a perfusion phase of operation to supply a quantity of fluid to the chamber, further comprising the step of de-epithelialization whereby a portion of the skin'"'"'s epidermis is removed from the skins'"'"'s underlying dermis during a preparatory phase of operation of the apparatus to expose an area of dermis of the skin at a treatment site which is accessible via the aperture such that subsequently during the perfusion phase direct contact is made between fluid in the chamber and the dermis.

20. A method as claimed in claim 19 wherein the step of de-epithelialisation comprises the operation of suction means to form a partial vacuum in the chamber during a blister forming period in which an area of epithelium of the skin at the treatment site is separated from the dermis and subsequently penetrating or removing the detached area of epithelium constituting the roof of the blister.

21. A method as claimed in claim 20 wherein the housing is cooperable with the skin to form a closed compartment of which the chamber constitutes at least a part and including the step of applying sealing means between the contact surface and an annular area of the skin peripheral to the treatment site whereby the partial vacuum is maintained by substantially preventing the ingress of air during the blister forming period.

22. A method of forming a suction blister on the skin of the human or animal body, comprising the steps of attaching a housing to the body such that a contact surface of the housing is held in sealing contact with the skin, the housing defining a chamber and the contact surface defining an aperture communicating with the chamber, operating suction means to form a partial vacuum in the chamber and thereby applying suction to an area of skin at a treatment site that is accessible via the aperture, and maintaining the partial vacuum during a blister forming period of about two to three hours until a portion of the skin'"'"'s epidermis becomes separated from the skin'"'"'s underlying dermis by the formation of a suction blister, wherein the housing cooperates with the skin to form a closed compartment of which the chamber constitutes at least a part and by including the step of applying sealing means between the contact surface and an annular area of the skin peripheral to the treatment site prior to operation of the suction means whereby the partial vacuum is subsequently maintained by substantially preventing the ingress of air during said blister forming period.

23. A method as claimed in claim 22 including the further step of evacuating air from a cell defined by the housing to form a partial vacuum therein and sealing the cell prior to attaching the housing to the body, and operating the suction means to place the chamber in communication with the cell to thereby form a partial vacuum in the chamber.