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EP-3285850-B1 - DRUG DELIVERY DEVICES WITH DRUG-PERMEABLE COMPONENT AND METHOD OF MANUFACTURING

EP3285850B1EP 3285850 B1EP3285850 B1EP 3285850B1EP-3285850-B1

Inventors

  • LEE, HEEJIN

Dates

Publication Date
20260506
Application Date
20160425

Claims (15)

  1. A drug delivery device (800, 900, 1000) comprising: an elongated, elastic housing (802, 902, 1002) having a drug reservoir lumen (804, 1004) extending between a first closed end and a second closed end; and a drug contained in the drug reservoir lumen (804, 1004), characterized in that: the housing comprises a tubular wall structure which comprises: a first annular segment (812, 912, 1012) formed entirely of a first material which is impermeable to the drug, and a second annular segment (814, 914, 1014) formed at least partially of a second material (824, 924, 1024) which is permeable to the drug in vivo by diffusion through the second material in the second annular segment, and the first annular segment (812, 912, 1012) has a first end (818, 918, 1018) which is integrally formed and connected with a first end (820, 920, 1020) of the second annular segment (814, 914, 1014), and the first material comprises a first thermoplastic polyurethane.
  2. The device of claim 1, wherein the second annular segment (814, 914, 1014) is formed of the first material and the second material.
  3. The device of claim 2, wherein in the second annular segment (814, 914, 1014), the first material forms a first arcuate portion and the second material forms a second arcuate portion, the first and second arcuate portions being integrally connected and together defining the annulus of the second annular segment.
  4. The device of claim 3, wherein the second arcuate portion has an arc angle from 15 degrees to 120 degrees, or wherein the second arcuate portion has an arc angle from 30 degrees and 60 degrees.
  5. The device of claim 1, wherein the second annular segment (814, 914, 1014) is formed primarily of the second material.
  6. The device of claim 1, wherein the tubular wall structure has a total length (L T ) between opposed ends of the housing and the second annular segment has a length (L) which is from 5% to 50% of the total length (L T ).
  7. The device of claim 1, wherein the first material comprises a polycarbonate-based thermoplastic polyurethane.
  8. The device of claim 1, wherein the second material comprises a hydrophilic thermoplastic polyurethane.
  9. A method of making a drug delivery device (800, 900, 1000) comprising an elongated, elastic housing (802, 902, 1002) having a drug reservoir lumen (804, 1004) extending between a first end and a second end, characterized in that the method comprises: forming a first annular segment (812, 912, 1012) entirely of a first material, which is impermeable to a drug to be delivered, by an extrusion process which comprises introducing the first material into an extrusion stream; and forming a second annular segment (814, 914, 1014) at least partially of a second material (824, 924, 1024), which is permeable to the drug to be delivered, by intermittently introducing the second material into the extrusion stream with the first material and at preselected positions, effective to form a tubular structure comprising one or more first annular segments integrally connected to one or more second annular segments, wherein the first material comprises thermoplastic polyurethane.
  10. The method of claim 9, further comprising: cutting the tubular structure at one or more positions to form the elongated, elastic housing; loading the drug into the drug reservoir lumen; and sealing the first and second ends of the housing.
  11. The method of claim 9, wherein the second annular segment (814, 914, 1014) is formed of the first material and the second material, or wherein the second annular segment is formed primarily of the second material.
  12. The method of claim 11, wherein, when the second annular segment (814, 914, 1014) is formed of the first material and the second material (824, 924, 1024), in the second annular segment (814, 914, 1014), the first material forms a first arcuate portion and the second material forms a second arcuate portion, the first and second arcuate portions being integrally connected and together defining the annulus of the second annular segment.
  13. The method of claim 12, wherein the second arcuate portion has an arc angle from 15 degrees to 120 degrees, or wherein the second arcuate portion has an arc angle from 30 degrees to 60 degrees.
  14. The method of claim 9, wherein the method is performed in a manner to form a tubular structure comprising two first annular segments integrally connected at opposed ends of one second annular segment.
  15. The method of any one of claims 9 to 14, further comprising thermally shape setting the tubular structure to have a coiled retention shape which is elastically deformable into an uncoiled shape.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62/151,982, filed April 23, 2015 and to U.S. Provisional Patent Application No. 62/293,232, filed February 9, 2016. BACKGROUND The present disclosure is generally in the field of medical devices, and more particularly relates to drug delivery devices for insertion into the body of patient for controlled release of drug, including but not limited to devices deployable in the urinary bladder for administration of drug into the bladder. Intravesical drug delivery devices are known. Examples of such devices are described in U.S. Patent No. 8,679,094 to Cima et al., U.S. Patent No. 9,017,312 to Lee et al., U.S. Patent No. 9,107,816 to Lee et al., and U.S. Patent Application Publication No. 2012/0089121 A1 to Lee et al. In some embodiments, the intravesical devices include a water permeable housing defining a drug reservoir lumen which contains a solid or semi-solid drug formulation, and release of the drug in vivo occurs by water from the bladder diffusing into drug reservoir lumen to solubilize the drug, and then an osmotic pressure build-up in the drug reservoir lumen drives the solubilized drug out of the device through a release aperture. In some cases, e.g., with certain drugs and therapeutic applications, it would be desirable to extend the period over which a therapeutic amount of the drug is released and/or to keep the drug from coming out too quickly. One way of accomplishing this is by retarding the rate at which the water can enter the drug reservoir. U.S. Patent Application Publication No. 2009/0149822 A1 to Cima et al. discloses adding a conformal coating or sheath over at least a portion of an outer surface of the housing to reduce the water-permeability of the housing. However, this approach complicates manufacturing. Furthermore, because the device housing of these intravesical devices typically are designed to be elastically deformable, maintaining an effective coating may be challenging, since the coating may delaminate and/or crack during device deformation, which could undesirably alter the drug release kinetics and negatively impact reproducibility of results. U.S. Patent Application Publication No. 2014/0276636 A1 to Lee et al. discloses devices in which drug is released from a housing made of a first wall structure and a hydrophilic second wall structure, wherein the first wall structure is impermeable to the drug and the second wall structure is permeable to the drug. It would be desirable to provide improvements and/or alternative embodiments to these devices, to provide devices capable of delivering drugs at effective release rates for a range of different drugs, and to provide methods for making these devices with greater flexibility of and control over the relative sizes and locations of the two wall structures. US2014276636A1 describes implantable drug delivery devices including a housing having a closed drug reservoir lumen bounded by a first wall structure and a hydrophilic second wall structure, and a drug contained in the drug reservoir lumen, wherein the first wall structure is impermeable to the drug and the second wall structure is permeable to the drug. Methods of providing controlled release of drug to a patient include deploying a drug delivery device in the patient releasing a drug from the drug reservoir lumen via diffusion through the second wall structure. WO2015026813A1 describes implantable drug delivery devices including a housing defining a reservoir, a first unit within the reservoir, and a second unit within the reservoir. The first unit contains a drug and the second unit contains a functional agent that facilitates release of the drug. Intravesical drug delivery devices include a housing portion containing a drug formulation and a housing portion containing an excipient, and are configured to release the drug according to a first release profile and the excipient according to a second release profile. Methods include inserting any of these devices into a patient and releasing drug from the device. SUMMARY The invention is defined by the independent claims. BRIEF DESCRIPTION OF THE DRAWINGS The detailed description is set forth with reference to the accompanying drawings. The use of the same reference numerals may indicate similar or identical items. Various embodiments may utilize elements and/or components other than those illustrated in the drawings, and some elements and/or components may not be present in various embodiments. Elements and/or components in the figures are not necessarily drawn to scale. FIG. 1A is a longitudinal cross-sectional view of one embodiment of a drug delivery device in a coiled retention shape, in accordance with the present disclosure.FIG. 1B is a traverse cross-sectional view of the drug delivery device of FIG. 1A, in accordance with the present disclosure.FIG. 2 is a traverse cross-sectional view of one embodiment o