Multi-Needle Injection Apparatus and System for Delivering Pharmacological Agents to Biological Tissue

• US 20140088502A1
• Filed: 09/19/2013
• Published: 03/27/2014
• Est. Priority Date: 09/24/2012
• Status: Abandoned Application

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G., Herscher, Bret, Perry, Michael
• Application Number:
  US14/031,630
• Publication Number:
  US 20140088502A1
• Time in Patent Office: Days
• US Class Current: 604/121
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61K 31/726 Glycosaminoglycans, i.e. mucopolysaccharides chondroitin sulfate, dermatan sulfate A61K31/737
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 35/33 Fibroblasts
• CPC Class Codes: A61K 35/34 Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes vascular smooth muscle A61K35/44
• CPC Class Codes: A61K 35/35 Fat tissue; Adipocytes; Stromal cells; Connective tissues adipose-derived stem cells A61K35/28; collagen A61K38/39
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 35/38 Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
• CPC Class Codes: A61K 35/407 Liver; Hepatocytes
• CPC Class Codes: A61K 35/44 Vessels; Vascular smooth muscle cells; Endothelial cells; Endothelial progenitor cells
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61K 35/545 Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells
• CPC Class Codes: A61K 38/1741 alpha-Glycoproteins
• CPC Class Codes: A61K 38/1808 Epidermal growth factor [EGF] urogastrone
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 38/1833 Hepatocyte growth factor; Scatter factor; Tumor cytotoxic factor II
• CPC Class Codes: A61K 38/1858 Platelet-derived growth factor [PDGF]
• CPC Class Codes: A61K 38/1866 : Vascular endothelial growth factor [VEGF]
• CPC Class Codes: A61K 38/30 : Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2 insulin-like growth factor binding protein A61K38/1754
• CPC Class Codes: A61K 38/39 : Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 38/48 : acting on peptide bonds (3.4)
• CPC Class Codes: A61K 39/395 : Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2400/06 : Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/20 : for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3695 : characterised by the function or physical properties of the final product, where no specific conditions are defined to achieve this A61L27/3687, A61L27/3691 take precedence
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/14526 : the piston being actuated by fluid pressure
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2053 : Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/329 : characterised by features of the needle shaft
• CPC Class Codes: A61M 5/3298 : Needles arranged in parallel
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

An injector system for delivery of a pharmacological agent to biological tissue having a plurality of needles arranged in an array, a plurality of reservoirs configured to receive a pharmacological composition therein, the reservoirs being in fluid communication with a respective one of the plurality of needles, a pneumatic pressure source, a pneumatic drive system that is configured to induce a first discharge of the pharmacological composition out of the reservoirs and needles in a plurality of delivery modes, agent delivery volume control means for controlling volume of the pharmacological composition discharged from the needles, and a control system having actuation control means for controlling said pneumatic drive system. The control system is programmed to control the delivery modes.

Claims

1. An injector system for delivery of a pharmacological agent to biological tissue, said injector system, comprising:

a plurality of needles arranged in an array;

a plurality of reservoirs configured to receive a pharmacological composition therein, each of said reservoirs being in fluid communication with a respective one of said plurality of needles;

a pneumatic pressure source;

a pneumatic drive system in communication with said pressure source and said plurality of reservoirs, said pneumatic drive system being configured to induce a first discharge of said pharmacological composition out of said reservoirs and said plurality of needles in a plurality of delivery modes;

agent delivery volume control means for controlling volume of said pharmacological agent discharged from said plurality of needles; and

a control system, said control system including actuation control means for controlling said pneumatic drive system.

2. The injector system of claim 1, wherein said plurality of needles comprises 7 needles.

3. The injector system of claim 1, wherein each of said reservoirs is configured to receive at least 0.05 cc of said pharmacological composition.

4. The injector system of claim 1, wherein each of said reservoirs includes a reservoir piston disposed on a first end of each reservoir, each of said pistons having a first cross-sectional area.

5. The injector system of claim 1, wherein said pneumatic drive system includes a central drive piston spaced a first distance from each of said reservoir pistons, said drive piston having a second cross-sectional area.

6. The injector system of claim 5, wherein said drive piston second cross-sectional area and said first cross-sectional area of said reservoir pistons has a ratio of at least 0.5:

1.

7. The injector system of claim 1, wherein said actuation control means is programmed to maintain actuation pressure provided by said pressure source in the range of 5-1000 psi.

8. The injector system of claim 1, wherein said delivery modes comprise continuous and pulsed delivery.

9. The injector system of claim 8, wherein said pulsed delivery has a frequency in the range of 0.1 Hz-5 kHz.

10. The injector system of claim 8, wherein said actuation control means is further programmed to control said delivery modes.

11. The injector system of claim 1, wherein said pharmacological composition comprises an extracellular matrix (ECM), said ECM composition including an ECM material selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, ornamentum extracellular matrix, heart extracellular matrix and lung extracellular matrix.

12. The injector system of claim 11, wherein said ECM composition further includes at least one supplemental biologically active agent.

13. The injector system of claim 12, wherein said biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor-α

(TGF-α

), transforming growth factor-β

(TGF-β

), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platelet derived growth factor (PDGF), tumor necrosis factor-α

(TNA-α

), and placental growth factor (PLGF).

14. The composition of claim 12, wherein said biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, mesenchymal stem cell, autotransplanted expanded cardiomyocytes, adipocyte, totipotent cell, pluripotent cell, blood stem cell, myoblast, adult stem cell, bone marrow cell, mesenchymal cell, embryonic stem cell, parenchymal cell, epithelial cell, endothelial cell, mesothelial cell, fibroblast, osteoblast, chondrocyte, exogenous cell, endogenous cell, hematopoietic stem cell, bone-marrow derived progenitor cell, myocardial cell, skeletal cell, fetal cell, undifferentiated cell, multi-potent progenitor cell, unipotent progenitor cell, monocyte, cardiac myoblast, skeletal myoblast, macrophage, capillary endothelial cell, xenogenic cell, allogenic cell and post-natal stem cell.

15. The composition of claim 12, wherein said biologically active agent comprises an active agent selected from the group consisting of a collagen (types I-V), proteoglycans, glycosaminoglycans (GAGs), glycoproteins, cytokines, cell-surface associated proteins, cell adhesion molecules (CAM), endothelial ligands, matrikines, cadherins, immuoglobins, fibril collagens, non-fibrallar collagens, basement membrane collagens, multiplexins, small-leucine rich proteoglycans, decorins, biglycans, fibromodulins, keratocans, lumicans, epiphycans, heparin sulfate proteoglycans, perlecans, agrins, testicans, syndecans, glypicans, serglycins, selectins, lecticans, aggrecans, versicans, neurocans, brevicans, cytoplasmic domain-44 (CD-44), macrophage stimulating factors, amyloid precursor proteins, heparins, chondroitin sulfate B (dermatan sulfate), chondroitin sulfate A, heparin sulfates, hyaluronic acids, fibronectins, tenascins, elastins, fibrillins, laminins, nidogen/enactins, fibulin I, finulin II, integrins, transmembrane molecules, thrombospondins, ostepontins, and angiotensin converting enzymes (ACE).