METHODS AND SYSTEMS FOR INHIBITING VASCULAR INFLAMMATION

• US 20150141959A1
• Filed: 01/26/2015
• Published: 05/21/2015
• Est. Priority Date: 01/22/2002
• Status: Active Grant

• Current Assignee: Mercator MedSystems, Inc.
• Original Assignee: Mercator MedSystems, Inc.
• Inventors: Seward, Kirk Patrick
• Granted Patent: US 10,441,747 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0093 wherein at least one needle is a microneedle
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent. In one example, the catheters are used to deliver dexamethasone and other anti-inflammatory agents to the peripheral and other vasculature to treat peripheral vascular disease and other conditions.

Claims

1. A method for inhibiting inflammation in a patient'"'"'s vasculature, said method comprising:

identifying a patient at risk of or suffering from vascular inflammation;

positioning a catheter within a lumen of a blood vessel of the patient;

advancing a needle radially outwardly from the catheter through the blood vessel wall and into adventitial tissue surrounding the blood vessel;

delivering an anti-inflammatory agent into the adventitial and perivascular tissue in an amount sufficient to inhibit inflammation of the blood vessel.

2. A method as in claim 1, wherein the patient is at risk of or suffering from peripheral artery disease.

3. A method as in claim 2, wherein the blood vessel is an artery selected from the group consisting of iliac arteries, femoral arteries, and popliteal arteries.

4. A method as in claim 3, wherein the anti-inflammatory agent is selected from the group consisting of corticosteroids, mineralocorticoids, glucocorticoids, statins and non-steroidal anti-inflammatory drugs (NSAIDs).

5. A method as in claim 4, wherein the anti-inflammatory agent comprises dexamethasone.

6. A method as in claim 1, wherein the inhibition or reduction of inflammation can be detected by a lack of a significant increase or a reduction, respectively, in biomarker levels in circulating blood.

7. A method as in claim 6, wherein biomarker levels are levels of C-reactive protein.

8. A method as in claim 6, wherein biomarker levels are levels of monocyte chemotractive protein-1.