Medicated therapeutic brace

Apparatus for medication delivery to a patient wearing a therapeutic brace. The medication delivery system includes a medication delivery device working in conjunction with a brace. The delivery device includes a bladder formed from two opposing sheets that are joined at a peripheral edge. The sheet positioned adjacent the brace is impermeable to the medication and the opposite sheet is permeable and is in contact with the epidermis of the patient when the brace is worn. In one embodiment, the device includes a port that extends from the bladder through the brace, allowing medication to be introduced into the bladder when the delivery device is attached to the brace. In another embodiment, the port extends longitudinally from the bladder. A sealing sheet is releasably attached to the bladder to seal the medication in the bladder.

BACKGROUND

1. Field of Invention

This invention pertains to a medicated therapeutic brace. More particularly, this invention pertains to a medication delivery system incorporated into a therapeutic brace whereby a medication is delivered to a patient wearing the brace.

2. Description of the Related Art

Various types of medication delivery systems are known. A common medication delivery system is a medicated patch, such as described in European Patent Number 0190262 and related U.S. Pat. No. 5,186,938, both titled “Adhesive transdermal dosage layer.” The patents describe one type of a medicated patch for the sustained release of a pharmaceutically active drug to the skin of a human patient.

U.S. Pat. No. 11,058,803, titled “Medical devices and implements with liquid-impregnated surfaces,” describes one specific way of delivering medication with a brace. The '803 patent describes medical devices and implements with liquid-impregnated surfaces for enhanced lubricity to flesh (or biological fluid) and/or inhibited nucleation on the surface of the device/implement. The surface of the device has an impregnating liquid that is contained between multiple micro-scale and/or nano-scale solid features that are spaced close together. That is, the impregnating liquid fills the spaces between the micro or nano-scaled solid features.

U.S. Published Patent Application Number 2007/0053966, titled “Medicated orthopedic support structures for treatment of damaged musculoskeletal tissue,” very generally describes a orthopedic support device and a nitroglycerin-containing composition. The Abstract contains the statement, “The nitroglycerin-containing composition can be integrated into the orthopedic support structure or the support structure can be configured to contain removable doses of the nitroglycerin-containing composition. The system and method provides relief of pain and improved function of the musculoskeletal tissue.”

The '53966 application generically describes orthopedic support structures as including “braces, compression bandages, structurally supporting tape wraps, elastic sleeves, ceramic, plaster and fiberglass casts, etc.” Publication, para. 40. The application excludes “standard transdermal patches and non-supportive bandages.” Id. When the support structure is a brace, the brace has the medicated composition incorporated in the brace as a removable insert, such as a transdermal patch retained in a pouch on the brace. Para. 40. The “pouch can be partially open so that the nitroglycerin patch can contact the skin freely, or can include a permeable membrane or mesh that allows the drug to adequately contact the skin surface.” Id. In another embodiment, “the nitroglycerin-containing composition can be sewn into the material of the orthopedic support. In [yet] another embodiment the orthopedic support can act as a backing layer onto which the nitroglycerin-containing composition is disposed and adhered.” Para. 41. When the brace is a flexible or elastic sleeve, the “composition can be sewn into the sleeve or can be integrated directly into the sleeve, with the sleeve material acting as a backing layer for the nitroglycerin-containing composition.” Publication, para. 42.

The '53966 application describes that when the support structure is an athletic support tape, the “composition can be incorporated or integrated into the adhesive portion of the tape, or a portion of the tape. The tape can be manufactured by depositing the nitroglycerin-containing adhesive composition onto the tape substrate and allowing the nitroglycerin-containing composition to dry . . . . When tape is used as the orthopedic support structure, the tape substrate can act as a backing layer.” Publication, para. 43. The '53966 application describes a method of preparing the nitroglycerin-containing composition as part of an adhesive matrix. Paras. 45-50. In one embodiment, the resulting nitroglycerin-containing composition is laminated to or coated onto a portion of the orthopedic support structure, with the structure forming a backing layer for the composition. Publication, para. 51.

BRIEF SUMMARY

A medication delivery system that is a combination of a therapeutic brace and medication delivery device is provided. In various embodiments, the brace is rigid, flexible, or a type that includes both rigid and flexible portions. Examples of common braces include a foot boot, knee brace, back brace, and knee or elbow sleeves. The brace has a surface configured to be positioned proximate to and in contact with the epidermis or skin of the patient wearing the brace. A portion of that surface includes a medication delivery device that dispenses the medication over time as the brace is worn.

In one embodiment, the medication delivery system includes a brace and a releasably attachable medication delivery device. The medication delivery device includes a bladder that contains the medication to be dispensed. In one embodiment, the bladder has a port extending through an opening in the brace. The bladder includes two sheets joined together at their peripheral edge so as to form a sealed container. One sheet is configured to be positioned adjacent the recess in the brace. The brace-sided sheet is an impermeable material with a port. The other, outer sheet is configured to be positioned proximate to and in contact with the epidermis or skin of the patient wearing the brace. The outer sheet is permeable to the medication in the bladder.

The bladder is releasably attachable to the recess in the brace. In one such embodiment, the bladder is secured in the recess by an adhesive. For example, the brace-side sheet has a weak adhesive that holds the bladder in the recess when the brace is not being worn by the patient. In another example, the recess in the brace has a weak adhesive that engages the brace-side sheet of the bladder. With the bladder secured in the recess, the port extends from the brace-side sheet through an opening in the recess. The port is then accessible for refilling the bladder while the brace is being worn by the patient.

Another embodiment of the medication delivery system includes the bladder being incorporated in the structure of the brace. The brace has a resilient layer positioned proximate the patient. The resilient layer includes a small chamber or cavity. The surface of the chamber proximate the resilient layer is impermeable. A permeable sheet or membrane encloses an opposite side of the chamber. The membrane is proximate to and in contact with the epidermis or skin of the patient. An externally accessible port passes through the resilient layer such that the medication can be introduced into the chamber. The chamber or cavity is a reservoir for the medication, which is delivered to the patient through the permeable membrane.

Yet another embodiment of the medication delivery system includes a vesicle-type medication delivery device disposed on the surface of the brace in contact with the patient's skin. In one such embodiment, the medication delivery device includes medication infused in the portion of brace facing the patient. In another embodiment, the medication delivery device includes medication in one or more vesicles on the patient facing surface of the brace. The vesicle version delivers the medication through various mechanisms, including a vesicle with a permeable surface, a vesicle of a specific size, and/or a multitude of small vesicles with a specific life such that the vesicles rupture or dissolve over a period of time that corresponds to the treatment time. In one embodiment of the vesicle-type device is integrated with the brace and in another embodiment the vesicle-type device is configured to fit into a recess in the brace.

DETAILED DESCRIPTION

Apparatus for a medication delivery system is disclosed. The medication delivery system is generally indicated as100, with particular embodiments and variations shown in the figures and described below having an alphabetic suffix, for example,100-A,100-B,100-C. Various components are illustrated both generically and specifically in the figures and in the following description. For example, the medication delivery devices102-A,102-B,102-C are discussed individually and separately to ensure clarity when describing the configuration of each medication delivery device102-A,102-B,102-C. The medication delivery device102, when referred to collectively, is referenced without the alphanumeric suffix.

FIG.1illustrates a cross-sectional view of a first embodiment of a medication delivery system100-A that includes a brace110-A and a medication delivery device102-A.FIG.2illustrates an exploded view of the embodiment of the medication delivery system100-A that includes the brace110-A and medication delivery device102-A shown inFIG.1.FIG.3illustrates a plan view of a first embodiment of the medication delivery device102-A shown inFIG.1.

The illustrated brace110-A includes a rigid portion114-A and a resilient portion112-A. In various embodiments, the brace110is configured for a specific body part, such as a knee or a foot. In various embodiments, the brace110is configured to rigidly conform to the body part or to be articulated, such as to enable movement around a joint, for example, the knee. In such embodiments, the rigid portion114-A is configured to meet the therapeutic needs of the patient. In another embodiment, the brace110is configured to fit flexibly around the body part, for example a sleeve that fits over a body part such as a knee or elbow. In such embodiments, the brace110does not include the illustrated rigid portion114-A.

The resilient portion112-A is the patient-facing portion of the brace110-A. In one embodiment, the resilient portion112-A is flexible layer flexible layer112-A that is a cushioning material, such as foam or neoprene or other material suitable for being disposed proximate the skin or epidermis of the patient.

In the illustrated embodiment, the brace110-A includes a recess or depression202-A on the patient-facing surface116-A. The rigid portion114-A has an opening118-A sized to accommodate the portion of the depression202-A that protrudes toward the outer side of the brace110-A. The depression202-A is circular so that the circular configuration of the medication delivery device102-A fits in the depression202-A. The depression202-A includes an opening122-A that receives a port106-A extending from the bladder126-A. In another embodiment, the resilient portion112-A is substantially flat with no depression or a shallow depression202-A. In such an embodiment, the medication delivery device102-A is attached to the patient-facing surface116-A and, when the brace110-A is worn by the patient, the medication delivery device102-A is squeezed between the resilient layer112-A and the patient, thereby pushing the resilient layer112-A into the opening118-A forming a depression202-A in the resilient layer112-A.

The medication delivery device102-A includes a bladder126-A and a port106-A. The bladder126-A defines a cavity124-A that receives, contains, and dispenses a medication128. The port106-A extends through the brace110-A, thereby allowing medication128to be introduced through the port106-A from the outer side136of the brace110-A.

The bladder126-A includes a proximal sheet204-A and a distal sheet104-A that are joined at a peripheral edge108-A. The proximal sheet204-A and the joined distal sheet104-A define a cavity124-A configured to receive, contain, and dispense a medication128. In one embodiment the proximal sheet204-A is a membrane that is impermeable to the medication128contained in the cavity124-A. The distal sheet104-A is a membrane that is permeable to the medication128contained in the cavity124-A. The distal sheet104-A is configured to allow the medication128to pass through the membrane at a desired rate such that the medication128is absorbed by the patient's skin, which is in contact with the distal sheet104-A. The desired rate of medication128passing through the distal sheet104-A is at a rate where the medication128has a therapeutic effect on the patient.

The medication delivery device102-A engages the depression202-A on the patient-facing surface116-A of the brace110-A. In various embodiments, an adhesive is disposed on either one or both of the surface of the depression202-A and/or the outer surface of the proximal sheet204-A. In this way, the medication delivery device102-A is secured to the brace110-A. In one such embodiment, the adhesive is weak whereby the medication delivery device102-A is releasable from the brace110-A after medication delivery device102-A is secured within the depression202-A.

When the medication delivery device102-A engages the depression202-A the port106-A engages the opening122-A in the resilient layer112-A. In one such embodiment, the opening122-A is sized to grip the sides of the port106-A, thereby helping to keep the port106-A in position when medication128is inserted into the medication delivery device102-A.

FIG.3illustrates a plan view of the first embodiment of the medication delivery device102-A.FIG.4illustrates an exploded view of the medication delivery device102-A shown inFIG.1. The medication delivery device102-A includes a bladder126-A formed of two sheets, namely a proximal sheet204-A and a distal sheet104-A. The two sheets204-A,104-A and the peripheral edge108-A joining the sheets204-A,104-A define the cavity124-A. Attached to the outside of the proximal sheet204-A is a port106-A. The two sheets204-A,104-A are joined together at a peripheral edge108-A. In one embodiment, the sheets204-A,104-A are thermoplastic sheets that are welded together at the peripheral edge108-A to form a sealed cavity124-A therebetween.

In one embodiment, the port106-A is port or inlet that allows medication128to be injected into the cavity124-A of the bladder126-A. In one such embodiment, the port106-A is self-sealing after the medication128is injected into the cavity124-A. The port106-A engages an opening404-A in the proximal sheet204-A such that the medication128flows from the port106-A into the cavity124-A. In one embodiment, the port106-A and the proximal sheet204-A are thermoplastic and welded together to form a sealed connection therebetween. In another embodiment, the port106-A and the proximal sheet204-A are joined with an adhesive.

A sealing sheet402is disposed proximate the distal sheet104-A until the medication delivery device102is deployed for use. The sealing sheet402is an impermeable membrane that covers the distal sheet104-A and prevents the medication128from being delivered to the patient. The sealing sheet402is weakly affixed to the distal sheet104-A, such as by a weak adhesive or electrostatic attraction. When delivery of the medication128is desired, such was when the brace110-A is to be worn by the patient, the sealing sheet402is peeled from the distal sheet104-A and discarded, thereby exposing the distal sheet104-A.

FIG.5illustrates a plan view of another embodiment of the medication delivery device100-A′. In the illustrated embodiment, the port106-A attached to the proximal sheet204-A as shown inFIGS.1-6is omitted. In its place is a side port or inlet106-A′ that extends longitudinally from the bladder126-A. The side port106-A′ extends longitudinally from the peripheral edge108-A of the bladder126-A. The side port106-A′ includes a neck504connecting the side port106-A′ to the bladder126-A. The side port106-A′ includes a distal end506opposite the neck504. The distal end506includes opening502-A, which is one end of a passageway through the port106-A′ into the bladder126-A.

The side port106-A′ allows the medication delivery device102-A′ to be a single-use device that is filled with medication128before being deployed. The medication128enters through an opening502-A in the distal end506of the port106-A′. For example, the distal end506of the port106-A′ receives a tube through which the medication128flows through the port106-A′ and into the cavity124-A. After the cavity124-A is filled with medication128, the port106-A′ is sealed or welded at the neck504where the port106-A′ joins the cavity124-A.

In one embodiment, the two sheets204-A′,104-A have an extended portion that, when joined together, form a passageway into the cavity124-A defined between the two sheets204-A′,104-A. The sealed peripheral edge108-A extends around the sheets204-A′,104-A and along the sides of the side port106-A′.

FIG.6illustrates a cross-sectional view of a second embodiment of a medication delivery system100-B that includes a brace110-B and an integral medication delivery device102-B.FIG.7illustrates an exploded view of the embodiment of the medication delivery system100-B shown inFIG.6. In the illustrated embodiment, the medication delivery device102-B is integrated into the brace110-B.

The medication delivery device102-B includes a port106-B, a proximal sheet204-B, and a distal sheet104-B. The proximal sheet204-B, and the distal sheet104-B are joined at a peripheral edge108-B. A cavity124-B is defined by the space between the proximal sheet204-B, and the distal sheet104-B.

The port106-B engages an opening122-B in the flexible layer112-B of the brace110-B. In one embodiment, the port106-B is secured to the flexible layer112-B, such as with an adhesive or by plastic welding. In the illustrated embodiment, the flexible layer112-B has a depression202-B that extends through an opening118-B in the rigid portion114-B of the brace110-B. The port106-B is disposed in the depression202-B. In another embodiment, the resilient portion112-B is substantially flat with no or a shallow depression202-B. In such an embodiment, when the brace110-B is worn by the patient, the medication delivery device102-B is squeezed between the resilient layer112-B and the patient, thereby allowing a portion of the resilient layer112-B to be pushed into the opening118-B, thereby forming a depression202-B in the resilient layer112-B.

The proximal sheet204-B is a membrane that is impermeable to the medication128contained in the cavity124-B. The proximal sheet204-B includes an opening404-B that is aligned with the port106-B such that the medication128flows from the port106-B into the cavity124-B. In one embodiment, the port106-B and the proximal sheet204-B are thermoplastic and welded together to form a sealed connection therebetween. In another embodiment, the port106-B and the proximal sheet204-B are joined with an adhesive.

The proximal sheet204-B is attached to the patient-sided surface116-B of the brace110-B. In the illustrated embodiment, the proximal sheet204-B is slightly larger than the distal sheet104-B. In another embodiment, the entire patient-sided surface116-B of the brace110-B is covered by a proximal sheet204-B. In another embodiment, the entire patient-sided surface116-B of the brace110-B is coated with an impermeable material or is otherwise impermeable to the medication128.

The distal sheet104-B is a membrane that is permeable to the medication128contained in the cavity124-B. The distal sheet104-A is configured to allow the medication128to pass through the membrane at a desired rate such that the medication128is absorbed by the patient's skin, which is in contact with the distal sheet104-A. The desired rate of medication128passing through the distal sheet104-A is at a rate where the medication128has a therapeutic effect on the patient.

The peripheral edge108-B of the distal sheet104-B is attached to the proximal sheet204-B such that the distal sheet104-B and the proximal sheet204-B define a cavity124-B therebetween.

A sealing sheet402is disposed proximate the distal sheet104-B. The sealing sheet402is an impermeable membrane that covers the distal sheet104-B and prevents the medication128from being delivered to the patient. The sealing sheet402is weakly affixed to the distal sheet104-B, such as by a weak adhesive or electrostatic attraction. When delivery of the medication128is desired, such was when the brace110-B is to be worn by the patient, the sealing sheet402is peeled from the distal sheet104-B and discarded, thereby exposing the distal sheet104-B.

FIG.8illustrates a cross-sectional view of a third embodiment of a medication delivery system100-C.FIG.9illustrates a plan view of the patient-facing side of the medication delivery system100-C shown inFIG.8. The medication delivery system100-C is a vesicle-type medication delivery system that includes a brace110-C and a medication delivery device102-C disposed on the patient-facing116-C surface of the brace110-C. In one embodiment, the brace110-C is a flexible brace, such as a knee or elbow sleeve and the medication delivery device102-C is integrated with the brace110-C.

The illustrated medication delivery device102-C includes a multitude of cavities126-C1,126-C2that are vesicles that each contain an amount of medication128. In the illustrated embodiment, the vesicles or cavities126-C1,126-C2have different shapes and are randomly disposed across the area of the medication delivery device102-C. In other embodiments, the vesicles or cavities126-C1,126-C2have a uniform shape and/or are disposed in a regular pattern across the area of the medication delivery device102-C.

A distal sheet104-C is configured to be disposed in contact with the skin or epidermis of the patient. The vesicles or cavities126-C1,126-C2are positioned between the distal sheet104-C and the flexible layer112-C. The distal sheet104-C is permeable to the medication128in the vesicles or cavities126-C1,126-C2. In one embodiment, the permeability of the distal sheet104-C various such that the vesicles or cavities126-C1,126-C2dispense medication128at different rates and at different times so that the medication128is dispensed according to a desired treatment time. In one embodiment, a sealing sheet402is disposed proximate the distal sheet104-C until the medication delivery device102-C is deployed for use.

In one embodiment, the brace110-C of the medication delivery system100-C is a sleeve of an elastic material. In such an embodiment, the medication delivery device102-C is disposed on an inside or patient-facing surface of the sleeve110-C.

In another embodiment, the medication delivery device102-C is sized and configured to fit with the recess202such as illustrated inFIGS.1&2. In such an embodiment, the flexible layer112-C is independent of the brace110-C, that is, the layer112-C is sized such that the medication delivery device102-C fits in the recess202with the distal sheet104-C configured to contact the skin of the person wearing the brace110-C. In one such embodiment, the medication delivery device102-C is weakly adhered in the recess202such that the medication delivery device102-C is replaceable.

The medication delivery system100includes various functions. The function of dispensing medication128to the skin of a patient that is covered by a brace110is implemented, in various embodiments, by a medication delivery system100that includes a brace110and a medication delivery device102where the medication delivery device102is disposed on the brace110proximate the area to be treated by the medication128.

The function of holding a medication delivery device102in position against the skin of a patient that is covered by a brace110is implemented, in various embodiments, by a resilient portion or flexible layer112of brace. In one embodiment, the medication delivery device102-A is releasably attachable to the flexible layer112-A such that the port106-A extending from the bladder126-A of the medication delivery device102-A extends through the flexible layer112-A. In a second embodiment, the medication delivery device102-B is integrated with the flexible layer112-B with the port106-B extending from the cavity124-B of the medication delivery device102-B extends through the flexible layer112-B. In a third embodiment, the medication delivery device102-C incorporates a multitude of vesicles or cavities126-C1,126-C2dispense medication128as illustrated inFIGS.8&9.

The function of filling a medication delivery device102with medication128is implemented, in various embodiments, by a port106-A,106-B through which the medication128can be injected into the cavity124-A,124-B of the medication delivery device102-A,102-B. In another embodiment, the function of filling the delivery device102-A′ with medication128is implemented by a side port106-A′ formed from the proximal and distal sheets204-A′,104-A. The side port106-A′ is sealed after the medication128is introduced into the cavity124-A.

The function of sealing the medication delivery device102to prevent the delivery of medication128until desired is implemented by the sealing sheet402that is weakly attached to the distal sheet104. When delivery of medication128is desired, the sealing sheet402is peeled away from the distal sheet104.

From the foregoing description, it will be recognized by those skilled in the art that a medication delivery system100that includes a brace110and a medication delivery device102has been provided. In various embodiments, the medication delivery device102includes a bladder126that engages a recess202on an inside surface of a brace110. In other embodiments, the medication delivery device102includes a vesicle-type medication delivery device102-C that is either incorporated in a brace110-C or is sized and configured to engage a recess202in the brace110.