THERAPEUTIC DELIVERY DEVICES, SYSTEMS, AND METHODS

• US 20130289528A1
• Filed: 04/09/2013
• Published: 10/31/2013
• Est. Priority Date: 03/04/2010
• Status: Active Grant

• Current Assignee: Grifols SA
• Original Assignee: Grifols SA
• Inventors: Novokhatny, Valery, Fineberg, David, Chamberlain, Dean
• Granted Patent: US 9,028,465 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• 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 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• 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 25/104 used for angioplasty

Abstract

Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

Claims

1-17. -17. (canceled)

18. A method for treating thrombosis in a vessel or graft comprising:

(a) occluding the vessel or graft distal to a thrombus thereby creating an infusion zone;

(b) administering plasmin into the infusion zone; and

(c) incubating plasmin in the infusion zone, thereby dissolving the thrombus.

19. The method of claim 18, wherein the infusion zone corresponds to a subject'"'"'s treatment zone comprising the thrombus mass length within the vessel or graft.

20. The method of claim 18, wherein the infusion zone is maximized.

21. The method of claim 18, wherein the thrombus is a peripheral arterial occlusion.

22. A method for treating thrombosis in a vessel or graft comprising:

(a) inserting a coaxial occlusion/infusion catheter system into a subject'"'"'s vessel or graft and advancing the catheter to a position where a distal tip of the catheter lies distal to a thrombus;

wherein the coaxial occlusion/infusion catheter system comprises;

(i) an occlusion catheter component; and

(ii) an infusion catheter component, wherein at least a portion of the occlusion catheter component is coaxially positioned within the infusion catheter component,

wherein the occlusion catheter component provides for occlusion of the vessel or graft distal to an thrombus; and

wherein a composition comprising plasmin can be infused into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter thereby providing the composition comprising plasmin to a treatment zone;

(c) activating the occlusion catheter component thereby occluding the vessel or graft distal to the thrombus and creating an infusion zone;

(d) administering the composition comprising plasmin into the infusion zone; and

(e) incubating the composition comprising plasmin in the infusion zone, thereby dissolving the thrombus.

23. The method of claim 22, further comprising:

(f) inactivating the occlusion catheter component, thereby permitting normal blood flow through the vessel or graft; and

(g) removing the catheter system from the subject'"'"'s vessel or graft.

24. The method of claim 22, wherein the occlusion catheter distal tip extends beyond the infusion catheter'"'"'s distal tip such that the occlusion lies distal to the infusion catheter'"'"'s distal tip and thereby is capable of occluding a vessel or graft distal to the infusion zone wherein the distal tip of the catheter lies.

25. The method of claim 22, wherein the infusion zone corresponds to a subject'"'"'s treatment zone comprising the thrombus mass length within the vessel or graft.

26. The method of claim 22, wherein the infusion zone is maximized.

27. The method of claim 22, wherein the thrombus is a peripheral arterial occlusion.