CA2456025A1 - An implantable and sealable system for unidirectional delivery of therapeutic agents to tissues - Google Patents

An implantable and sealable system for unidirectional delivery of therapeutic agents to tissues Download PDF

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Publication number
CA2456025A1
CA2456025A1 CA002456025A CA2456025A CA2456025A1 CA 2456025 A1 CA2456025 A1 CA 2456025A1 CA 002456025 A CA002456025 A CA 002456025A CA 2456025 A CA2456025 A CA 2456025A CA 2456025 A1 CA2456025 A1 CA 2456025A1
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CA
Canada
Prior art keywords
agent
tissue
preferentially
organ
interface
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002456025A
Other languages
French (fr)
Other versions
CA2456025C (en
Inventor
Ricardo A.P. De Carvalho
Linn A. Murphree
Ed Schmitt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BIO BRIDGES GROUP Ltd
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2456025A1 publication Critical patent/CA2456025A1/en
Application granted granted Critical
Publication of CA2456025C publication Critical patent/CA2456025C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Abstract

A surgically implantable and sealable delivery device that upon contact of its contents via an interface window or port therein with an organ or tissue exposes a therapeutic agent to the organ or tissue surface, allowing a controlled, selective and unidirectional diffusion of the agent into the tissue or organ. The device protects adjacent organs or tissue structures form unnecessary high levels of the delivered agent. Novel methods to deliver chemotherapeutics or bioactive agents to mammalian organs or tissues through a surgically implanted device by the way of a selective and protected diffusion mechanism are disclosed as well as method to achieve the sealing properties of the device.

Claims (54)

1) A sealable drug delivery system comprised of a body or reservoir containing the therapeutic agent, delineated by an external surface impermeable to the therapeutic agent, an internal surface consisting on a biodegradable polymer layer or directly by a reservoir, and a sealing base;
2) The system claimed in 1, where the tissue is myocardium and the organ is the heart;
3) The system claimed in 1, where the tissue is the pericardium and the organ is the heart;
4) The system claimed in 1, where the tissue is the sclera and the organ is the eye;
5) The system claimed in 1, where the tissue is the liver capsule and the organ is the liver;
6) The system claimed in 1, where the tissue is the peritoneum covering the uterus body and the organ is the uterus;
7) The system claimed in 1, where the tissue is the kidney fibrous capsule and organ is the kidney;
8) The system claimed in 1, wherein carries any therapeutic or prophylactic agent in its activated or non-activated form.
9) The agent according to 1, wherein is preferentially, but not restricted to a chemotherapeutic, antibiotic, peptide, antibody, nucleotide, antibiotic, gene vector, hormone, protein, radio, photo or chemo sensitizer, cells, virus or bacterial.
10) The system claimed in 1, wherein it carries a cytotoxic agent;
11) The system according to 1, wherein the reservoir carries a vehicle for the therapeutic agent that is any form of polymer, copolymer, matrix, media, solution or tissue, chemically or physically associated to the therapeutic agents;
12) The system according to 1, wherein the reservoir carries biological or chemical therapeutic agents, associated or not to carrier vehicles or compounds to provide a sustained release of the agent;
13) The system claimed in 1, wherein the vehicle is preferentially, but not restricted to the classes of poly-orthoester, poly-glycolic acid, poly-lactic acid, poly-caprolactone, acrylate, cellulose, polyvinil-alcohol, polyvinil-pilirridone, dextran, hialuronic acid, fibrin, collagen, gelatin, or any derivatives;
14)The system claimed in 1, wherein the vehicle is in a solid, gel or liquid state;
15) The system claimed in 1, wherein the agent is in a solid, gel or liquid state;
16) The system claimed in 1, wherein the therapeutic agent is associated or not to another carrier or vehicle agent;
17) The system claimed in 1, wherein carries a therapeutic enhancer agent, preferentially, but not limited to an enzyme or a protein, such as albumin, a co-drug or a substract for the drug;
18) The system claimed in 1, wherein the reservoir carries a facilitating agent to enhance the diffusion of the therapeutic agent through the tissue's interface, preferentially but not restricted to a prostaglandin and an enzyme;
19) The system claimed in 1, wherein the facilitating agent is preferentially a collagenase or any enzyme or pro-enzyme from the matrix metalloproteinase family;
20) The system claimed in 1, wherein the reservoir is directly exposed to the target tissue;
21) The system claimed in 1, wherein the reservoir and its continent is delineated in its internal surface by a structural layer of a biodegradable and biocompatible compound;
22) The system claimed in 1, wherein the delineating layer claimed in 21 is preferentially a rapidly degradable layer of gelatin;
23) The system claimed in 1, wherein the delineating layer claimed in 21 is a monolayer of rapidly biodegradable polymer or copolymer;
24) The system claimed in 1, wherein the external surface or wall is composed by a polymer impermeable to the carried agent, preferentially composed but not limited to poly-ethylene, silicone, hydrogel, glycolic acid, lactic acid or any derivative;
25) The system claimed in 1, wherein the external surface may comprise a refilling port preferentially made of, but not restricted to a self sealing material, such as silicone rubber;
26) The system claimed in 1, wherein the refilling port is distinguished from the surface of the device by staining with biocompatible dyes;
27) The system claimed in 1, wherein the refilling port is chemically incorporated to a marker, preferentially a dye;
28) The system claimed in 1, wherein the refilling port extends beyond the surface of the implant to facilitate its access;
29) The system according to 1, where it may be foldable or flexible to allow insertion through small incisions, and fitting to irregular organs surfaces.
30) A method for selective administration to a mammal organ, tissue or system, desired levels of a therapeutic agent through a highly controlled drug permeation across the device/tissue interface through hermetical sealing its hermetical sealing to a surface;
31) The system according to 1, wherein its target interface is with the reservoir itself or a biodegradable polymer preferentially composed of, but not restricted to gelatin, ca-prolactone, hialuronic acid, cellulose, poly-glycolic acid, poly-lactic acid and any of those derivatives;
32) The system according to 1, wherein the therapeutic agent is in an encapsulated form, such as liposomes or microspheres;
33) A method of local, protected and sustained delivery of therapeutic agents directly through its tissue interface in an unidirectional way, avoiding dissipation of the agent to surrounding tissues and fluids, after surgical implantation into a mammalian organism, through a tight interposition provided by a sealable base;
34) A method according to 33, wherein the system claimed in 1 is in controlled apposition to the target tissue by way of a sealed base;
35) A system according to 1, wherein to achieve what is claimed in 33, it is held in apposition to the sclera through the placement of buckling sutures or through the use of biocompatible adhesives.
36) The system claimed in 1, wherein its architecture comprises suture stabilizers for accomplishing what is claimed in 33;
37) The system claimed in 1, wherein the suture stabilizers are placed on its outer surface to allow a buckling effect;
38) The system claimed in 1, wherein the suture tunnels are placed in the sealing base, surrounding the reservoir to allow a sealing effect;
39) The system claimed in 1, wherein the outer surface has indentation(s) for holding an encircling buckle to accomplish what is claimed in 33;
40) The system claimed in 1, wherein carries an osmotic agent associated to the therapeutic agent;
41) The method claimed in 33, wherein the system claimed in 1 is placed in contact and apposition to the target tissue preferentially through, but not limited to interposition between tissues or distinct layers of a tissue;
42) A method claimed in 33, wherein the system claimed in 1 is inserted through a surgical procedure to expose the target tissue surface;
43) A system claimed in 1, wherein to accomplish the method claimed in 33 it is inserted using an ejector or a device holder;
44) A method according to 33, wherein the system claimed in 1 is anchored preferentially through a sealing suture technique throughout the sealing base;
45) A method claimed in 33, wherein the system claimed in 1 is sealed to a tissue, preferentially using, but not limited to an acrylate, hydrogel, hyaluronate or a fibrin adhesive;
46) A system claimed in 1, wherein to accomplish the method claimed in 33 it is sealed to a tissue by using a biocompatible adhesive;
47) A method for achieving local or systemic, phisiological or pharmacological effects in a mammalian organism, by a surgically implantable device that delivers an agent directly and preferentially through its interface with the targeted tissue or organ, keeping the rest of its surface non-permeable to the carried agent by a a sealing mechanism of its base;
48) A method for achieving local or systemic, phisiological or pharmacological effects in a mammalian organism, by a surgically implantable device that delivers an agent directly and preferentially through its interface with the targeted tissue or organ, keeping the rest of its surface non-permeable to the carried agent by sealing to the target tissue through the use of buckling sutures;
49) A method for achieving local or systemic, phisiological or pharmacological effects in a mammalian organism, by a surgically implantable device that delivers an agent directly and preferentially through its interface with the targeted tissue or organ, keeping the rest of its surface non-permeable to the carried agent and sealed to the target tissue by the use of sealing surrounding sutures;
50) A method according to 33, wherein the interface is with an artificial organ
51) A method according to 33, wherein the interface is with a synthetic or biological platform for cells or biological agents
52) A method according to 33, wherein the interface is with a scaffold for tissue or cell regeneration
53) A method according to 33, wherein the interface is with a transplanted tissue or organ
54) A system according to 1, wherein the therapeutic agent is a prophylactic agent A system according to 1, wherein the effect or diffusion of the agent may be started or enhanced after the implantation procedure through the use of a secondary agent, whether its chemical, physical or biological.
CA2456025A 2001-08-29 2002-08-28 An implantable and sealable system for unidirectional delivery of therapeutic agents to tissues Expired - Lifetime CA2456025C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31595201P 2001-08-29 2001-08-29
US60/315,952 2001-08-29
PCT/US2002/027434 WO2003020172A1 (en) 2001-08-29 2002-08-28 An implantable and sealable system for unidirectional delivery of therapeutic agents to targeted tissues

Publications (2)

Publication Number Publication Date
CA2456025A1 true CA2456025A1 (en) 2003-03-13
CA2456025C CA2456025C (en) 2011-11-22

Family

ID=23226807

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2456025A Expired - Lifetime CA2456025C (en) 2001-08-29 2002-08-28 An implantable and sealable system for unidirectional delivery of therapeutic agents to tissues

Country Status (12)

Country Link
US (1) US7195774B2 (en)
EP (1) EP1420716B1 (en)
JP (2) JP2005501602A (en)
CN (1) CN1578647B (en)
AU (1) AU2002324811B2 (en)
BR (1) BR0205990A (en)
CA (1) CA2456025C (en)
ES (1) ES2393101T3 (en)
PT (1) PT1420716E (en)
RU (1) RU2311892C2 (en)
WO (1) WO2003020172A1 (en)
ZA (1) ZA200304159B (en)

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