Therapeutic delivery devices, systems, and methods

• US 9,028,465 B2
• Filed: 04/09/2013
• Issued: 05/12/2015
• Est. Priority Date: 03/04/2010
• Status: Active Grant

• Current Assignee: Grifols SA
• Original Assignee: Grifols SA
• Inventors: Chamberlain, Dean, Novokhatny, Valery, Fineberg, David
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US13/859,395
• Publication Number:
  US 20130289528A1
• Time in Patent Office: 763 Days
• Field of Search: 604/103.05, 604/101.04, 604/96.01, 606/200
• 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. 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 system lies distal to a thrombus, the thrombus length corresponding to the infusion zone;

wherein the coaxial occlusion/infusion catheter system comprises;

(i) an occlusion catheter component having an occlusion chamber, wherein the occlusion catheter component provides for occlusion of the vessel or graft distal to the infusion zone;

(ii) an infusion catheter component comprising 1 to 40 pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within the thrombus, wherein at least a portion of the occlusion catheter component is coaxially positioned within the infusion catheter component; and

(iii) an outer sheath component having an occlusion chamber, wherein at least a portion of the infusion catheter is coaxially positioned within the outer sheath component, wherein the sheath component provides for the occlusion of the vessel or graft proximal to the infusion zone;

wherein a composition comprising plasmin can be administered by infusion into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter, wherein said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus;

(b) activating the occlusion chamber of the occlusion catheter prior to the administering step, thereby occluding the vessel or graft distal to the infusion zone, wherein the occlusion chamber of the occlusion catheter is activated by inflation through an inflation lumen that is in contact with the occlusion chamber of the occlusion catheter with a suitable volume of material comprising air, gas, or fluid;

(c) activating the occlusion chamber of the sheath prior to the administering step thereby occluding the vessel or graft proximal to the infusion zone, wherein the occlusion chamber of the sheath is activated by inflation through an inflation lumen that is in contact with the occlusion chamber of the sheath with a suitable volume of material comprising air, gas, or fluid;

(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.

2. The method of claim 1, further comprising:

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

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

3. The method of claim 1, wherein the occlusion catheter distal tip extends beyond the infusion catheter'"'"'s distal tip such that the occlusion chamber 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 infusion catheter lies.

4. The method of claim 1, wherein the infusion zone is maximized.

5. The method of claim 1, wherein the thrombus is a peripheral arterial occlusion.

6. 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 system lies distal to a thrombus, the thrombus length corresponding to the infusion zone;

wherein the coaxial occlusion/infusion catheter system comprises;

(i) an occlusion catheter component having an occlusion chamber, wherein the occlusion catheter component provides for occlusion of the vessel or graft distal to the infusion zone;

(ii) an infusion catheter component, comprising 1 to 40 pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within the thrombus, wherein at least a portion of the occlusion catheter component is coaxially positioned within the infusion catheter component; and

(iii) an outer sheath component wherein at least a portion of the infusion catheter is coaxially positioned within the outer sheath component;

wherein a composition comprising plasmin can be administered by infusion into an annular fluid passageway between an outer wall of the occlusion catheter and an inner wall of the infusion catheter, wherein said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin zone within the thrombus;

(b) activating the occlusion chamber of the occlusion catheter prior to the administering step, thereby occluding the vessel or graft distal to the infusion zone, wherein the occlusion chamber of the occlusion catheter is activated by inflation through an inflation lumen that is in contact with the occlusion chamber of the occlusion catheter with a suitable volume of material comprising air, gas, or fluid;

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

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

7. The method of claim 6, further comprising:

(e) inactivating the occlusion chamber of the occlusion catheter component thereby permitting normal blood flow through the vessel or graft; and

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

8. The method of claim 6, 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.

9. The method of claim 6, wherein the infusion zone is maximized.

10. The method of claim 6, wherein the thrombus is a peripheral arterial occlusion.

11. 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 system lies distal to a thrombus, the thrombus length corresponding to the infusion zone;

wherein the infusion catheter system comprises;

(i) an occlusion wire component; and

(ii) an infusion catheter component comprising 1 to 40 pressure responsive slits or side holes and one or more detectable markers for positioning all of said pressure responsive slits or side holes within the thrombus and having an occlusion chamber, wherein at least a portion of the occlusion wire component is coaxially positioned within the infusion catheter component,

wherein the infusion catheter component provides for occlusion of the vessel or graft distal to the infusion zone; and

wherein a composition comprising plasmin can be administered by infusion into the infusion catheter, wherein said composition comprising plasmin exits said pressure responsive slits or side holes thereby providing the composition comprising plasmin within the thrombus;

(b) activating the occlusion chamber of the inclusion catheter prior to the administering step, thereby occluding the vessel or graft distal to the infusion zone;

wherein the occlusion chamber of the infusion catheter is activated by inflation through an inflation lumen that is in contact with occlusion chamber of the infusion catheter with a suitable volume of material comprising air, gas, or fluid;

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

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

12. The method of claim 11, further comprising:

(e) inactivating the occlusion chamber of the inclusion catheter component and, thereby permitting normal blood flow through the vessel or graft; and

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

13. The method of claim 11, wherein the infusion zone corresponds to a subject'"'"'s treatment zone comprising the thrombus mass length within the vessel or graft.

14. The method of claim 11, wherein the infusion zone is maximized.

15. The method of claim 11, wherein the thrombus is a peripheral arterial occlusion.