Source: https://patents.google.com/patent/US9918665B2/en
Timestamp: 2019-08-18 21:38:27
Document Index: 255106582

Matched Legal Cases: ['§ 120', '§ 119', 'Application No. 60', 'Application No. 60', 'application No. 2016', 'application No. 2016', 'application No. 2925191', 'application No. 16207154']

US9918665B2 - Transdermal porator and patch system and method for using same - Google Patents
US9918665B2
US9918665B2 US14/147,263 US201414147263A US9918665B2 US 9918665 B2 US9918665 B2 US 9918665B2 US 201414147263 A US201414147263 A US 201414147263A US 9918665 B2 US9918665 B2 US 9918665B2
US14/147,263
US20150190074A1 (en
2014-01-03 Application filed by Nitto Denko Corp filed Critical Nitto Denko Corp
2014-01-03 Priority to US14/147,263 priority patent/US9918665B2/en
2015-07-09 Publication of US20150190074A1 publication Critical patent/US20150190074A1/en
2018-03-20 Publication of US9918665B2 publication Critical patent/US9918665B2/en
A transdermal permeant delivery of at least one permeant composition into a tissue membrane of a subject including a disposable substrate having at least a portion of a bottom surface of a first release liner connected to an upper surface of the substrate and a patch having a backing layer and a reservoir that is selectively removable from the top surface of the first release liner. In a connected position, a first portion of the backing layer of the patch is releaseably mounted to a top surface of the first release liner in spaced registration with a poration area of the substrate.
This patent application is a divisional application of U.S. patent application Ser. No. 13/272,592, titled Transdermal Porator and Patch System and Method for Using Same, filed Oct. 13, 2011, which claims priority under 35 U.S.C. § 120 to U.S. patent application Ser. No. 12/017,996, titled Transdermal Porator and Patch System and Method for Using Same, filed Jan. 22, 2008, and granted on Feb. 14, 2012, as U.S. Pat. No. 8,116,860, which claims priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 60/886,039, filed on Jan. 22, 2007. U.S. patent application Ser. No. 13/272,592 is also a continuation-in-part of U.S. patent application Ser. No. 10/384,763, filed on Mar. 11, 2003, which also claims priority to U.S. Provisional Application No. 60/363,022, filed on Mar. 11, 2002. These applications are herein incorporated by reference in their entireties.
Optionally, the means for forming at least one micropore can comprise, for example and not meant to be limiting, a filament capable of conductively delivering thermal energy via direct contact to the tissue biological membrane to cause the ablation of some portion of that membrane deep enough to form the micropore, a probe element capable of delivering electrical energy via direct contact to a tissue membrane to cause ablation of some portion of said membrane deep enough to form the micropore, an electro-mechanical applicator, a microlancet, an array of micro-needles or lancets, a sonic energy ablator, a laser ablation system, and a high-pressure fluid jet puncturer as described in U.S. Pat. No. 5,885,211 to Eppstein, et al., U.S. Pat. No. 6,527,716 to Eppstein, et al., and pending U.S. Published application Ser. No. 11/081,448, all of which are incorporated herein by reference in their entirety.
In one exemplary aspect, the filament array 70 is mounted to a portion of the upper substrate surface 42. Optionally, an adhesive layer 73 can be mounted to a portion of the upper substrate surface and is configured to allow for the mounting of the electrically isolated portions of the filament array, i.e., the adhesive layer 73 is interposed between the upper substrate surface and portions of the electrically isolated portions of the filament array. In this aspect, it is contemplated that the adhesive layer 73 defines a pair of openings that are configured to allow the passage of the anode 31 and cathode 32 when the substrate is connected to the applicator. In operation, the adhesive layer 73, is connected to a portion of the bottom surface of the respective electrically isolated portions of the filament array and the portion of the upper substrate surface. This connection is configured to minimize possible vacuum loss through the ports 45 in the substrate that extend from the lower substrate surface (which are described in more detail below) when vacuum is supplied to the substrate.
In one exemplary aspect, the means for forming at least one micropore further comprises a control unit 90 that is attachable to the plurality of electrodes, which is preferably fixed to a suitable area of a subject's skin. The means for forming at least one micropore can administer an active substance through the normally substantially-impermeable stratum corneum layer of the skin by passing a controlled electric current between the plurality of electrodes, which ablates the stratum comeum and generates micro-channels through which the substance can pass.
In one aspect, when means for forming at least one micropore drives current through the stratum corneum, the affected tissue is heated resistively, so that the tissue is ablated by the total energy dissipated therein when a sufficient quantity of energy has passed therethrough in a short time period. The ablation creates the desired micropores in the form of micro-channels in the tissue. In an additional aspect, the application of a current to a small area of the skin leads to formation of micro-channels that can be sized to allow for even large molecules to pass relatively freely, without the necessity of ionizing or polarizing the molecules, and without causing pain or substantial trauma to the dermis and epidermal tissue underlying the stratum comeum.
Preferably, the spacing between electrodes in each electrode pair is smaller than about 0.1 mm, although, for example and not meant to be limiting, it may range from between about 0.1 min to about 0.3 mm. Generally, the distance between the respective electrodes of an electrode pair is set such that a desired electric field penetration depth is achieved. In one example, the desired electric field penetration depth is substantially of the same magnitude as the thickness of the stratum corneum, so that the current mostly does not enter epidermal tissue underlying the stratum comeum. In this exemplary aspect, maintaining the electrode spacing between about 0.01 mm and about 0.1 mm, including additional spacing of 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, and 0.09 mm, generates micro-channels therein the stratum corneum while substantially reducing damage, sensation and/or pain in the innervated dermis and in the epidermal tissue below the stratum comeum.
Further, as used herein, an anti-healing agent can include, for example, anticoagulants, anti-inflammatory agents, agents that inhibit cellular migration, re-epithelization inhibiting agents, and osmotic agents. Suitable anticoagulants can comprise, for example, heparin having a molecular weight from 3,000 to 12,000 daltons, pentosan polysulfate, citric acid, citrate salts, EDTA, and dextrans having a molecular weight from 2,000 to 10,000 daltons. Suitable anti-inflammatory agents can comprise, for example, hydrocortisone sodium phosphate, betamethasone sodium phosphate, and triamcinolone sodium phosphate. Suitable agents that inhibit cellular migration can comprise, for example, laminin and/or its related peptides.
Identified system interfaces can comprise, without limitation: functional test, programming interface and user interface. In one aspect, the functional test executes if the serial interface is attached and enabled and initiated. The test starts after startup diagnostics when the test user requests initiation. In one example, the functional test can utilize the beeper to indicate the result of the functional test where tone frequency indicates a 1 (high frequency tone) or 0 (low frequency tone) and position dependence in binary format identifies specific module test pass/fail results. Result codes are also displayed through the serial interface. Specific test module details and place value dependence are described later. For any functional test module result that indicates a failure, the unit will generate a FT fail tone while flashing test codes. If all functional test modules pass, the processor-controlled LEDs will flash times while the unit generates a FT pass tone sequence (4 high frequency tones). Functional test modules can include: [0143] 1. Timer Test—checks timer function by verifying timer is incrementing. [0144] 2. Memory Test—verify memory function by writing and reading from selected locations in memory. [0145] 3. Charge Test—verify charge function by charging system to 100V within 1 second. [0146] 4. Vacuum System Test—verify that vacuum threshold can be reached to start activation. [0147] 5. ADC Test—verify function of ADC circuit and 3.3V supply by reading AVREF. Result should be within 5% of 2.5 Volts [0148] 6. PWM Test—verify function of PWM by checking for completion of programmed tone. [0149] 7. Battery Test—verify battery check circuit by confirming that AVREF voltage is between 2.25 and 3.35 volts and battery voltage is within 5.8-7.0 volts. [0150] 8. Watchdog Test—verify watchdog timer by setting error code to functional test mode and allowing timeout. [0151] 9. Parameter Test—verify that parameter values match secondary location. [0152] 10. Checksum Test—verify program integrity by comparing generated 16 bit checksum to stored value. [0153] 11. CLK test generates a 1 millisecond pulse on CLK1 followed by a 1 millisecond pulse on CLK2. Test verification will be performed prior to final assembly. [0154] 12. Control and Status Signals Loopback test—Verify function of main to secondary control and status signals if in Loopback Test mode.
In a further aspect, the applicator functions can be exemplarily implemented through control software that can be broken into tasks to facilitate a modular approach. For example, the tasks can be broken down to the following: Main—software entry point and top level task sequence. Initialization—device initialization and startup diagnostics. Monitoring-Prepare device for activation. Activation—checks for valid activation conditions and controls delivery of energy to porator. Shutdown—updates error status and powers down device.
The Applicator software can contain additional modular units to interface to hardware and internal functions such as, for example and without limitation: User Interface (UI); Functional Test; Error Handler; Analog to Digital Conversion (ADC); Timers; Port I/O; and/or Programmable Counter (PCA).
1. A method of transdermal monitoring, comprising steps of:
forming at least one micropore in a tissue membrane by a microporation device, while delivering a vacuum to draw the tissue membrane; and
monitoring a subcutaneous fluid via the at least one micropore by a monitoring device;
the microporation device comprising:
a vacuum source to generate the vacuum;
a disposable substrate
defining a poration area and
having an upper substrate surface, a lower substrate surface, a conduit that extends between the upper substrate surface and the lower substrate surface;
at least one channel disposed on the upper substrate surface and in fluid communication with the conduit so that the vacuum, is delivered to the poration area via the conduit and the at least one channel;
a means for forming at least one micropore in the tissue membrane, wherein said means is mounted on the substrate, and wherein at least a portion of the means is positioned within the poration area; and
wherein the vacuum acts to draw the tissue membrane into contact with the means for forming at least one micropore, when the microporation device acts to form the at least one micropore in the tissue membrane.
2. The method of transdermal monitoring according to claim 1, wherein the monitoring device comprises a sensor for measuring a characteristic of the subcutaneous fluid.
3. The method of transdermal monitoring according to claim 2, wherein the sensor is for determining a concentration of an analyte in the subcutaneous fluid.
4. The method of transdermal monitoring according to claim 3, wherein the sensor is a glucose sensor.
5. A transdermal monitoring system, comprising:
a microporation device adapted to form at least one micropore in a tissue membrane, while delivering a vacuum to draw the tissue membrane; and
a monitoring device adapted to monitor a subcutaneous fluid via the at least one micropore;
at least one channel disposed on the upper substrate surface and in fluid communication with the conduit so that the vacuum is delivered to the poration area via the conduit and the at least one channel;
6. The transdermal monitoring system according to claim 1, wherein the monitoring device comprises a sensor for measuring a characteristic of the subcutaneous fluid.
7. The transdermal monitoring system according to claim 6, wherein the sensor is for determining a concentration of an analyte in the subcutaneous fluid.
8. The transdermal monitoring system according to claim 7, wherein the sensor is a glucose sensor.
US14/147,263 2000-06-08 2014-01-03 Transdermal porator and patch system and method for using same Active US9918665B2 (en)
US14/147,263 US9918665B2 (en) 2002-03-11 2014-01-03 Transdermal porator and patch system and method for using same
US20150190074A1 US20150190074A1 (en) 2015-07-09
US9918665B2 true US9918665B2 (en) 2018-03-20
ID=53494335
US14/147,263 Active US9918665B2 (en) 2000-06-08 2014-01-03 Transdermal porator and patch system and method for using same
US (1) US9918665B2 (en)
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