Claims for Patent: 8,128,589

Summary for Patent: 8,128,589

Title:	Apparatus and methods for enzymatic debridement of skin lesions
Abstract:	An apparatus for debridement of devitalized tissue in skin lesions, that includes a plurality of height- and angle-adjustable inlet tubes and at least one outlet tube and a member that forms an occlusive seal around a skin lesion. The plurality of inlet tubes is adapted for directing a continuous stream of enzymatic solution to the surface and into the entire volume of the wound bed of the lesion and the at least one outlet is adapted for removing the enzymatic solution, fluids draining from the lesion and tissue debris from the occluded skin lesion.
Inventor(s):	Freeman; Amihay (Ben Shemen, IL), Hirszowicz; Eran (Ramat-Gan, IL), Be\'eri-Lipperman; Michal (Moshav Beit Heruth, IL)
Assignee:	Ramot at Tel-Aviv University Ltd. (Tel-Aviv, IL) EnzySurge Ltd. (Rosh HaAyin, IL)
Application Number:	11/493,381
Patent Claims:	1. An applicator for treating a skin lesion, comprising: (a) a housing unit having at least one aperture formed therein and a first longitudinal axis; and (b) means for affixing the applicator to the skin around the circumference of skin lesion; wherein the housing unit comprises: (i) a plurality of inlet tubes each capable of penetrating into the lesion at an adjustable depth and angle for delivering a therapeutic solution, each of said plurality of inlet tubes having a first longitudinal axis and comprising a first lumen for holding fluids and a second lumen configured to hold therein a deflectable wire extending along said first longitudinal axis and operatively linked thereto and enabling to maintain an angle and shape of each of said inlet tubes, whereas each of said plurality of inlet tubes is configured to be adjustable in position and in angle with respect to said housing unit and the skin lesion along its longitudinal axis through said at least one aperture; and (ii) at least one outlet tube for draining said therapeutic solution having a second longitudinal axis and configured to be adjustable along its longitudinal axis through said at least one aperture, the applicator being configured for providing a continuous flow of said therapeutic solution into a wound bed of the skin lesion. 2. The applicator according to claim 1, wherein the housing unit comprises a plurality of apertures, and wherein each of said plurality of inlet tubes and the at least one outlet tube extend through a corresponding one of each of said plurality of apertures, and further wherein each of said plurality of inlet tubes is adjustable in position and angle with respect to the housing unit. 3. The applicator according to claim 2, further comprising one or more sealing units, each sealing unit being configured to prevent the passage of fluids between the external diameter of an inlet tube or an outlet tube and its corresponding aperture. 4. The applicator according to claim 1, wherein each of said plurality of inlet tubes has a proximal end and a distal end, the distal end configured to face said skin lesion and wherein said distal end is smoothly curved to form a non-traumatic tip, with the opening at the distal end of at least one inlet tube is at an angle with respect to the central axis of the inlet tube. 5. The applicator according to claim 4, wherein distal end of at least one of said plurality of inlet tubes comprises a plurality of openings and each of said plurality of inlet tubes is constructed from a flexible elastomer of a silicone, polyurethane, natural rubber, neoprene or ethyl vinyl acetate. 6. The applicator according to claim 1, wherein at least one all of said plurality of inlet tubes is extendable or retractable along its respective longitudinal axis. 7. The applicator according to claim 1, further comprising at least one reservoir in fluid communication with the plurality of inlet tubes, the at least one reservoir is adapted for holding said therapeutic solution which comprises an effective amount of at least one catalytically active protease, wherein the at least one catalytically active protease is selected from the group consisting of: papain, bromelain, plasminogen activator, plasmin, mast cell protease, lysosomal hydrolase, streptokinase, pepsin, vibriolysin, krill protease, chymotrypsin, trypsin, collagenase, elastase, dipase, proteinase K, Clostridium multifunctional protease and Bacillus subtilis protease. 8. The applicator according to claim 7, further comprising (a) a connector being in fluid communication with at least one inlet tube of said plurality of inlet tubes and with the at least one reservoir, thereby to open and close the fluid communication between said at least one inlet tube and said at least one reservoir; (b) a separator being in fluid communication with at least one inlet tube of said plurality of inlet tubes and with the at least one reservoir, thereby to reversibly disconnect and reconnect said at least one inlet tube from said at least one reservoir; (c) control means in the form of a peristaltic pump or a drip counter and being in fluid communication with at least one inlet tube of said plurality of inlet tubes and with the at least one reservoir, or (d) a combination of (a), (b), and/or (c) to thereby control the flow rate of fluids flowing from the at least one reservoir through the at least one inlet tube. 9. The applicator according to claim 7, further comprising one of more of: a thermo-regulating means in communication with the at least one reservoir thereby to affect the temperature of fluids held in said at least one reservoir; at least one filter within at least one inlet tube of said plurality of inlet tubes, for filtering fluids flowing through said at least one inlet tube; a collecting reservoir being in fluid communication with the at least one outlet tube and configured to collect fluids draining from said at least one outlet tube; and a vacuum source being in fluid communication with the at least one outlet tube, adapted for generating a negative pressure at the occluded skin lesion. 10. The applicator according to claim 1, further comprising a plurality of reservoirs wherein a first reservoir of said plurality of reservoirs being adapted for holding a first solution comprising at least one catalytically non-active protease and wherein a second reservoir of said plurality of reservoirs being adapted for holding a second solution comprising an agent capable of activating the at least one catalytically non-active protease, the first reservoir and the second reservoir being in fluid communication with one another and at least one of said first and second reservoirs further being in fluid communication with at least one inlet tube of said plurality of inlet tubes. 11. The applicator according to claim 9, further comprising a mixing chamber that includes mixing means and being in fluid communication with said first and second reservoirs and with said at least one inlet tube, thereby to hold a catalytically active proteolytic mixture comprising said first and second solutions. 12. The applicator according to claim 1, wherein the means for affixing the applicator to the skin comprises a first plane attached to the housing and a second plane configured to surround and adhere to the lesion, wherein the second plane includes adhesive means that is biocompatible and is optionally covered with a protective detachable film. 13. The applicator according to claim 1, wherein said deflectable wire comprises a rigid material that is flexible and elastic and does not extend beyond said distal end of said at least one inlet. 14. An apparatus for treating a skin lesion, said apparatus comprising: (a) a spacer for occluding an area comprising the skin lesion, the spacer having a lower plane facing the skin, an upper plane facing the housing, wherein the lower plane comprises adhesive means for affixing the spacer to the skin at the circumference of said skin lesion; and (b) an applicator according to claim 1. 15. The apparatus according to claim 14, wherein the spacer comprises a resilient liquid-impermeable material of an elastomer or foam material selected from the group consisting of silicone, silicone foam, polyurethane, natural rubber, neoprene and ethyl vinyl acetate. 16. The apparatus according to claim 14, wherein the adhesive means comprises a material selected from the group consisting of: thermoplastic resin, pressure sensitive adhesive, hydrocolloid adhesive and rubber. 17. The apparatus according to claim 14, further comprising an adhesive plaster being in communication with said housing and extending outwards the first longitudinal axis of said housing, the plaster having an upper plane facing the applicator and a lower plane facing the lesion, wherein the lower plane comprises biocompatible adhesive means and is optionally covered with a protective detachable film. 18. A method for treating a skin lesion, the method comprising: (a) providing an applicator according to claim 1; (b) placing against the skin at the circumference of said skin lesion said affixing means, thereby affixing the apparatus to the skin at the circumference of said skin lesion to obtain an occluded lesion; (c) connecting the plurality of inlet tubes to at least one reservoir by a fluid communication, wherein the at least one reservoir encompassing a debriding solution comprising at least one catalytically active protease; (d) initiating a flow of the debriding solution from the at least one reservoir through at least one inlet tube of the plurality of inlet tubes to the occluded lesion; and (e) draining said solution from said occluded lesion through the at least one outlet tube. 19. The method according to claim 18, further comprising: (a) providing an apparatus comprising an applicator, said applicator comprising a housing unit having at least one aperture formed therein, and means for affixing the applicator, wherein said housing unit comprising : (i) a plurality of inlet tubes, each of said plurality of inlet tubes having a first longitudinal axis and configured to be adjustable along its longitudinal axis through said at least one aperture; and (ii) at least one outlet tube having a second longitudinal axis; (b) providing a spacer for occluding the skin lesion, the spacer having a lower plane facing the skin, an upper plane facing the housing of said applicator, wherein the lower plane comprises adhesive means for affixing the spacer to the skin at the circumference of said skin lesion; (c) affixing the lower plane of the spacer to the skin at the circumference of said skin lesion; (d) affixing the applicator to the upper plane of the spacer, thereby obtaining an occluded lesion; (e) connecting the plurality of inlet tubes to at least one reservoir by a fluid communication, wherein the at least one reservoir encompassing a debriding solution comprising at least one catalytically active protease; (f) initiating a flow of the debriding solution from the at least one reservoir through at least one inlet tube of the plurality of inlet tubes to the occluded lesion; and (g) draining said solution from said occluded lesion through the at least one outlet tube. 20. The method according to claim 18, wherein step (c) further comprises dispersing a sealing medium at the edge of the spacer that contacts the circumference of the occluded lesion. 21. The method according to claim 18, further comprising adjusting the position and angle of each of said plurality of inlets with respect to said housing unit. 22. The method according to claim 18, wherein connecting the plurality of inlet tubes to at least one reservoir by a fluid communication, provides a liquid-impermeable, vacuum-proof seal around the occluded lesion. 23. The method according to claim 18, further comprising providing control means being in fluid communication with at least one inlet tube of said plurality of inlet tubes and with the at least one reservoir, thereby initiating a controlled flow of fluids from the at least one reservoir through the at least one inlet tube, wherein the flow has a rate within the range of 1 ml/hour to 10 ml/hour. 24. The method according to claim 18, further comprising positioning the at least one reservoir on a higher level than the lesion, thereby initiating flow of debriding solution from the at least one reservoir through the plurality of inlet tubes to the lesion by gravitation. 25. The method according to claim 18, further comprising providing a plurality of control means, each control means being in fluid communication with a corresponding inlet tube of the plurality of inlet tubes and with the at least one reservoir, thereby controlling the flow rate within each inlet tube independently by a separate control means, wherein the flow rate within each inlet tube is within the range of 1 ml/hour to 10 ml/hour. 26. The method according to claim 18, further comprising providing at least one element being in fluid communication with the at least one reservoir and at least one inlet tube of the plurality of inlet tubes, the element is selected from the group consisting of: a control means adapted for controlling the rate of flow from the at least one reservoir to the at least one inlet tube; a connector adapted for opening and closing the fluid communication between the at least one reservoir and the at least one inlet tube; a filter for filtering a solution flowing within the at least one inlet tube; a mixing means for mixing the solution within the at least one reservoir; a thermo-regulating means for affecting the temperature of the solution within the at least one reservoir; a thermo-regulating means for affecting the temperature of the solution flowing within the at least one inlet tube; a separator being in fluid communication with at least one inlet tube of said plurality of inlet tubes and with the at least one reservoir, thereby to reversibly disconnect and reconnect said at least one inlet tube from said at least one reservoir; a vacuum source being in fluid communication with the at least one outlet tube, adapted for generating a negative pressure at the occluded skin lesion; and a collecting reservoir being in fluid communication with the at least one outlet tube configured to collect the fluids drained from the proximal end of said at least one outlet tube.

Details for Patent 8,128,589

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2024-01-27