Devices, systems, and methods for myocardial infarct border zone reinforcement

• US 8,105,309 B2
• Filed: 03/12/2010
• Issued: 01/31/2012
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): Ho, Jackie
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/723,015
• Publication Number:
  US 20100168651A1
• Time in Patent Office: 690 Days
• Field of Search: 604/500, 604/506, 604/511, 604/513, 604/93.01, 604/57, 604/60, 604/164.13
• US Class Current: 604/500
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2210/122 : Pericardium
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• 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 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0141 : having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like
• CPC Class Codes: A61M 60/191 : mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 : Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 : the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/508 : Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Devices, systems, and methods for myocardial infarct border zone reinforcement. In at least one embodiment of a suction/infusion catheter for facilitating myocardial infarct border zone reinforcement, the catheter comprises one or more apertures defined along a portion of the catheter at or near a distal end of the catheter, a first configuration when the suction/infusion catheter is at least partially extended from a delivery catheter, and a second configuration when the at least one suction/infusion catheter is positioned within the delivery catheter, the second configuration different from the first configuration, wherein the suction/infusion catheter, when introduced into a pericardial space surrounding a heart at or near a myocardial infarct border zone, is operable to inject a glue-like substance through a lumen of the suction/infusion catheter and out from the one or more apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone.

Claims

1. A method of myocardial infarct border zone reinforcement, the method comprising the steps of:

introducing at least one suction/infusion catheter having a lumen therethrough to a pericardial space surrounding a heart at or near a site of myocardial infarct border zone, the at least one suction/infusion catheter comprising;

one or more apertures defined along a portion of the at least one suction/infusion catheter at or near a distal end of the at least one suction/infusion catheter;

a first configuration when the at least one suction/infusion catheter is at least partially extended from a delivery catheter; and

a second configuration when the at least one suction/infusion catheter is positioned within the delivery catheter, the second configuration different from the first configuration;

injecting a glue-like substance through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone; and

injecting magnetic cells through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the magnetic cells into the pericardial space at or near the myocardial infarct border zone, wherein the magnetic cells are attracted to the glue-like substance, and wherein the magnetic cells provide structural support to the myocardial infarct border zone.

2. The method of claim 1, wherein the glue-like substance comprises a biologic glue.

3. The method of claim 2, wherein the biologic glue comprises liposomes containing magnetic particles.

4. The method of claim 3, wherein the liposomes comprise a peptide attached to an outer surface of the liposomes.

5. The method of claim 4, wherein the peptide comprises an arginine-glycine-apsartate peptide.

6. The method of claim 1, wherein the glue-like substance binds to a myocardial infarct border zone.

7. The method of claim 1, wherein the magnetic cells comprise biologic cells.

8. The method of claim 7, wherein the biologic cells comprise dermal fibroblasts.

9. The method of claim 8, wherein the dermal fibroblasts contain magnetic particles.

10. The method of claim 1, wherein the magnetic cells are attracted to a peptide attached to the glue-like substance.

11. The method of claim 1, wherein the magnetic cells, when positioned within the pericardial space at or near the myocardial infarct border zone, may reproduce to form a tissue, said tissue providing structural support at the myocardial infarct border zone.

12. The method of claim 1, wherein the first configuration comprises a coiled configuration, and wherein the second configuration comprises an uncoiled configuration.

13. The method of claim 1, wherein the step of introducing the at least one suction/infusion catheter is performed using a pericardial sac approach.

14. The method of claim 1, wherein the step of introducing the at least one suction/infusion catheter is performed by introducing the at least one suction/infusion catheter into a jugular vein, through a superior vena cava, and into the pericardial space.

15. The method of claim 1, wherein the step of introducing the at least one suction/infusion catheter is performed by introducing the at least one suction/infusion catheter into a femoral vein, through an inferior vena cava, and into the pericardial space.

16. The method of claim 1, wherein the myocardial infarct border zone is at a left ventricle of the heart, and wherein the step of introducing the at least one suction/infusion catheter comprises the introduction of the at least one suction/infusion catheter into the pericardial space at or near the left ventricle of the heart.

17. The method of claim 1, wherein the at least one suction/infusion catheter further comprises a guide wire positioned at the distal end of the at least one suction/infusion catheter, wherein the guide wire facilitates introduction of the at least one suction/infusion catheter in the step of introducing the at least one suction/infusion catheter.

18. The method of claim 1, wherein the step of introducing the at least one suction/infusion catheter further comprises extending the at least one suction/infusion catheter from the delivery catheter to allow for an increased surface area of at least one suction/infusion catheter to be positioned at or near the myocardial infarct border zone.

19. The method of claim 1, further comprising the step of introducing an occluder within the lumen of the at least one suction/infusion catheter, wherein the occluder may partially or completely block one or more apertures of the at least one suction/infusion catheter.

20. The method of claim 1, wherein the at least one suction/infusion catheter further comprises a support wire positioned along at least part of a length of the at least one suction/infusion catheter.

21. The method of claim 20, wherein the support wire facilitates the step of introducing at least one suction/catheter into the pericardial space.

22. The method of claim 20, further comprising the step of introducing an occluder within the lumen of the at least one suction/infusion catheter, wherein the step of introducing an occluder is facilitated by the support wire.

23. A method of myocardial infarct border zone reinforcement, the method comprising the steps of:

introducing at least one suction/infusion catheter having a lumen therethrough to a pericardial space surrounding a heart at or near a site of myocardial infarct border zone, the at least one suction/infusion catheter comprising;

one or more apertures defined along a portion of the at least one suction/infusion catheter at or near a distal end of the at least one suction/infusion catheter;

a first configuration when the at least one suction/infusion catheter is at least partially extended from a delivery catheter; and

a second configuration when the at least one suction/infusion catheter is positioned within the delivery catheter, the second configuration different from the first configuration;

injecting a glue-like substance comprising a biologic glue through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone; and

injecting magnetic cells through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the magnetic cells into the pericardial space at or near the myocardial infarct border zone, wherein the magnetic cells are attracted to the glue-like substance, and wherein the magnetic cells provide structural support to the myocardial infarct border zone.

24. The method of claim 23, wherein the biologic glue comprises liposomes containing magnetic particles.

25. The method of claim 24, wherein the liposomes comprise a peptide attached to an outer surface of the liposomes.

26. The method of claim 23, wherein the magnetic cells comprise biologic cells.

27. The method of claim 26, wherein the biologic cells comprise dermal fibroblasts.

28. The method of claim 23, wherein the myocardial infarct border zone is at a left ventricle of the heart, and wherein the step of introducing the at least one suction/infusion catheter comprises the introduction of the at least one suction/infusion catheter into the pericardial space at or near the left ventricle of the heart.

29. The method of claim 23, wherein the step of introducing the at least one suction/infusion catheter further comprises extending the at least one suction/infusion catheter from the delivery catheter to allow for an increased surface area of at least one suction/infusion catheter to be positioned at or near the myocardial infarct border zone.

30. A method of myocardial infarct border zone reinforcement, the method comprising the steps of:

introducing at least one suction/infusion catheter having a lumen therethrough to a pericardial space surrounding a heart at or near a site of myocardial infarct border zone, the at least one suction/infusion catheter comprising;

one or more apertures defined along a portion of the at least one suction/infusion catheter at or near a distal end of the at least one suction/infusion catheter;

a coiled configuration when the at least one suction/infusion catheter is at least partially extended from a delivery catheter; and

an uncoiled configuration when the at least one suction/infusion catheter is positioned within the delivery catheter, the uncoiled configuration different from the coiled configuration;

injecting a glue-like substance through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone; and

injecting magnetic cells through the lumen of the at least one suction/infusion catheter and out from the one or more apertures to deliver the magnetic cells into the pericardial space at or near the myocardial infarct border zone, wherein the magnetic cells are attracted to the glue-like substance, and wherein the magnetic cells provide structural support to the myocardial infarct border zone.

31. The method of claim 30, wherein the biologic glue comprises liposomes containing magnetic particles.

32. The method of claim 31, wherein the liposomes comprise a peptide attached to an outer surface of the liposomes.

33. The method of claim 30, wherein the magnetic cells comprise biologic cells.

34. The method of claim 33, wherein the biologic cells comprise dermal fibroblasts.

35. The method of claim 30, wherein the myocardial infarct border zone is at a left ventricle of the heart, and wherein the step of introducing the at least one suction/infusion catheter comprises the introduction of the at least one suction/infusion catheter into the pericardial space at or near the left ventricle of the heart.

36. The method of claim 30, wherein the step of introducing the at least one suction/infusion catheter further comprises extending the at least one suction/infusion catheter from the delivery catheter to allow for an increased surface area of at least one suction/infusion catheter to be positioned at or near the myocardial infarct border zone.

37. The method of claim 30, wherein the step of introducing the at least one suction/infusion catheter is performed by introducing the at least one suction/infusion catheter into a jugular vein, through a superior vena cava, and into the pericardial space.