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

• US 9,095,648 B2
• Filed: 01/30/2012
• Issued: 08/04/2015
• 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): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US13/361,622
• Publication Number:
  US 20120130320A1
• Time in Patent Office: 1,282 Days
• Field of Search: 604/164.13, 604/500, 604/506, 604/511, 604/513, 604/93.01, 604/57, 604/60, 604/43, 604/530
• US Class Current: 1/1
• 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 includes 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 system for facilitating myocardial infarct border zone reinforcement comprising:

a suction/infusion catheter, comprising;

a plurality of apertures defined along and perforating a portion of the suction/infusion catheter at or near a distal end of the suction/infusion catheter;

a first configuration whereby the suction/infusion catheter automatically takes on a spiral configuration when the suction/infusion catheter is at least partially extended from a delivery catheter, wherein the plurality of apertures at or near the distal end of the suction/infusion catheter are defined along a portion of the suction/infusion catheter having the spiral configuration; and

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

a glue-like substance capable of binding to a heart at or near a myocardial infarct border zone;

wherein the suction/infusion catheter, when introduced into a pericardial space surrounding the heart at or near the myocardial infarct border zone and presented in the first configuration within the pericardial space, is configured and operable to inject the glue-like substance through a lumen of the suction/infusion catheter and out of the plurality of apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone so that the delivered glue-like substance can bind to the heart at or near the myocardial infarct border zone.

2. The system of claim 1, wherein the suction/infusion catheter is further operable to inject magnetic cells through the lumen of the suction/infusion catheter and out from one or more of the 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.

3. The system of claim 1, wherein the first configuration comprises a substantially planar spiral configuration, and wherein the second configuration comprises a substantially uncoiled configuration.

4. The system of claim 1, further comprising:

a guide wire positioned at the distal end of the suction/infusion catheter, wherein the guide wire facilitates introduction of the suction/infusion catheter into the pericardial space.

5. The system of claim 1, further comprising:

an occluder positioned within the lumen of the suction/infusion catheter, wherein the occluder may partially or completely block one or more apertures of the suction/infusion catheter.

6. The system of claim 1, further comprising:

a support wire positioned along at least part of a length of the suction/infusion catheter.

7. The system of claim 6, wherein the support wire facilitates introduction of the suction/catheter into the pericardial space.

8. The system of claim 6, wherein the support wire is used to define the spiral configuration of the first configuration.

9. The system of claim 8, wherein the first configuration comprises a substantially planar spiral configuration.

10. The system of claim 6, wherein the support wire provides rigidity to the suction/infusion catheter.

11. A system for facilitating myocardial infarct border zone reinforcement comprising:

an engagement catheter having a proximal end, a distal end, and a lumen positioned therethrough;

a delivery catheter having a proximal end, a distal end, and a lumen positioned therethrough, the delivery catheter positioned at least partially within the lumen of the engagement catheter;

a first suction/infusion catheter positioned at least partially within the lumen of the delivery catheter, the first suction/infusion catheter comprising;

a plurality of apertures defined along and perforating a portion of the first suction/infusion catheter at or near a distal end of the first suction/infusion catheter;

a first configuration whereby the first suction/infusion catheter automatically takes on a spiral configuration when the first suction/infusion catheter is at least partially extended from the delivery catheter, wherein the plurality of apertures at or near the distal end of the suction/infusion catheter are defined along a portion of the suction/infusion catheter having the spiral configuration; and

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

a glue-like substance capable of binding to a heart at or near a myocardial infarct border zone;

wherein the suction/infusion catheter, when introduced into a pericardial space surrounding the heart at or near the myocardial infarct border zone and presented in the first configuration within the pericardial space, is configured and operable to inject the glue-like substance through a lumen of the suction/infusion catheter and out of the plurality of apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone so that the delivered glue-like substance can bind to the heart at or near the myocardial infarct border zone.

12. The system of claim 11, wherein the first suction/infusion catheter is further operable to inject magnetic cells through the lumen of the first suction/infusion catheter and out from one or more of the 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.

13. The system of claim 11, wherein the first configuration comprises a substantially planar spiral configuration, and wherein the second configuration comprises a substantially uncoiled configuration.

14. The system of claim 11, further comprising a guide wire positioned at the distal end of the first suction/infusion catheter, wherein the guide wire facilitates introduction of the first suction/infusion catheter into the pericardial space.

15. The system of claim 11, further comprising an occluder positioned within the lumen of the first suction/infusion catheter, wherein the occluder may partially or completely block one or more apertures of the first suction/infusion catheter.

16. The system of claim 11, further comprising a support wire positioned along at least part of a length of the first suction/infusion catheter.

17. The system of claim 16, wherein the support wire facilitates introduction of the first suction/catheter into the pericardial space.

18. The system of claim 16, wherein the support wire is used to define the spiral configuration of the first configuration.

19. The system of claim 18, wherein the first configuration comprises a substantially planar spiral configuration.

20. The system of claim 16, wherein the support wire provides rigidity to the first suction/infusion catheter.

21. The system of claim 11, further comprising:

a second suction/infusion catheter positioned at least partially within the lumen of the delivery catheter, the second suction/infusion catheter comprising;

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

a first configuration whereby the second suction/infusion catheter automatically takes on a curvilinear configuration when the second suction/infusion catheter is at least partially extended from a delivery catheter; and

a second configuration when the second suction/infusion catheter is positioned within the delivery catheter, the second configuration different from the first configuration.

22. A suction/infusion catheter, comprising:

a plurality of apertures defined along and perforating a portion of the suction/infusion catheter at or near a distal end of the suction/infusion catheter;

a first configuration whereby the suction/infusion catheter automatically takes on a substantially planar spiral configuration when the suction/infusion catheter is at least partially extended from a delivery catheter, wherein the plurality of apertures at or near the distal end of the suction/infusion catheter are defined along a portion of the suction/infusion catheter having the spiral configuration; and

a second configuration when the suction/infusion catheter is positioned within the delivery catheter, the second configuration comprising a substantially uncoiled configuration;

wherein the suction/infusion catheter, when introduced into a pericardial space surrounding the heart at or near the myocardial infarct border zone and presented in the first configuration within the pericardial space, is configured and operable to inject a glue-like substance capable of binding to a heart at or near a myocardial infarct border zone through a lumen of the suction/infusion catheter and out of the plurality of apertures to deliver the glue-like substance into the pericardial space at or near the myocardial infarct border zone so that the delivered glue-like substance can bind to the heart at or near the myocardial infarct border zone.