Retrograde pressure regulated infusion

• US 20040181206A1
• Filed: 03/12/2003
• Published: 09/16/2004
• Est. Priority Date: 03/12/2003
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Bly, Mark J., Chan, Gregory Waimong, Chiu, Jessica G., Bai, Hongzhi, Sridharan, Srinivasan, Bei, Nianjiong J., Hatten, Tom
• Granted Patent: US 7,250,041 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A delivery catheter that includes a flexible shaft having a proximal end and a distal end, the distal end having an outer diameter less than about 13 mm; a delivery lumen having a proximal end and a distal end, the delivery lumen within the flexible shaft, the delivery lumen having at least an outlet port or at least one side hole at the distal end of the delivery lumen, the delivery lumen having a cross-sectional area at least about 5 mm²; a pressure monitoring lumen having a proximal end and a distal end, the pressure monitoring lumen within the flexible shaft; a pressure port adjacent to and connected to the distal end of the pressure monitoring lumen; a balloon inflation lumen having a proximal end and a distal end, the balloon inflation lumen within the flexible shaft; a soft tip at the distal end of the flexible shaft; a balloon at the distal end of the flexible shaft, the balloon connected to the distal end of the balloon inflation lumen, the balloon includes at least one of the following materials, polyether block amide resin, polyetheramide, polyurethane, silicone, natural latex, or synthetic latex; wherein the balloon is adapted to inflate to a diameter range of about 4 to about 15 mm.

Claims

1. A catheter comprising:

a shaft comprising a proximal end and a distal end, and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end;

a delivery port coupled to the distal end of the delivery lumen;

a pressure monitoring lumen, a portion of the pressure monitoring lumen disposed within the shaft, comprising a proximal end and a distal end;

a pressure port coupled to the distal end of the pressure monitoring lumen;

a balloon inflation lumen, a portion of the balloon inflation lumen disposed within the shaft, comprising a proximal end and a distal end;

a low-pressure high-compliance balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block co-polymer, and blends and mixtures thereof;

wherein the balloon is adapted to inflate to at least an elasticity of about 40% at a pre-determined gauge pressure of about 0.5 to about 6.0 atmospheres;

a balloon inflation port within the balloon and coupled to the distal end of the balloon inflation lumen;

wherein at least one of the delivery lumen and pressure monitoring lumen are adapted to receive a guidewire.

2. The catheter of claim 1, wherein the balloon is adapted to inflate to at least an elasticity of about 40% at a pre-determined gauge pressure of about 0.5 to about 4.0 atmospheres.

3. The catheter of claim 1, wherein the balloon is adapted to inflate to at least an elasticity of about ⁴⁰% at a pre-determined gauge pressure of about 0.5 to about 2.0 atmospheres.

4. The catheter of claim 1, wherein the delivery lumen is distal to the pressure monitoring lumen defining at least one of a tapered and a staggered tip, and the delivery lumen is adapted to receive the guidewire.

5. The catheter of claim 1, wherein the pressure monitoring lumen is distal to the delivery lumen defining at least one of a tapered and a staggered tip, and the pressure monitoring lumen is adapted to receive the guidewire.

6. The catheter of claim 1, further comprising a balloon marker adapted to locate the balloon in a vasculature system under a diagnostic system.

7. The catheter of claim 1, wherein the balloon marker comprises a radio-opaque marker.

36. A method comprising:

at least one of treating and preventing a condition selected from the group consisting of congestive heart failure, myocardial infarction, coronary artery disease, ischemia, no-reflow, reperfusion injury, stunning, arrhythmia, inflammation, angiopathy, and microembolism;

locally administering a therapeutic agent selected from the group consisting of cells such as cardiomyocytes, stem cells, progenitor cell, skeletal myocytes, smooth muscle cells, and endothelial cells, antibodies against CD18, CD11/18, P-selectin, L-selectin, ICAM, VCAM, and TNF, estrogen and estrogen receptor agonists, growth factors such as IGF-I, HGF, VEGF, NGF, FGF, TGF-beta, and their isoforms and downstream signaling mediators, heat shock proteins and their downstream signaling mediators, GIK, adenosine and adenosine receptor agonists, NO donors, Na/H exchange inhibitors, Na/K channel openers and their downstream signaling mediators, Ca channel inhibitors, beta-adrenergic receptor inhibitors, alpha-adrenergic receptor inhibitors, free radical scavengers, anti-oxidants, platelet inhibitors such as IIbIIIa receptor antagonists, complement system inhibitors, anti-apoptotic drugs like caspase inhibitors, genes that encode the peptides listed above or their ligands, or bio-engineered cells or materials that express the peptides or glycoproteins listed above or their ligands, and mixtures thereof;

wherein said agent is delivered by the catheter of claim 1.

37. The method of claim 36, wherein said agent is delivered by the catheter of claim 4.

38. The method of claim 36, wherein said agent is delivered by the catheter of claim 5.

8. A catheter comprising:

a shaft comprising a proximal end and a distal end and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end;

a delivery port coupled to the distal end of the delivery lumen;

a pressure monitoring lumen comprising a proximal end and a distal end, a portion of the pressure monitoring lumen disposed within the flexible shaft;

a pressure port coupled to the distal end of the pressure monitoring lumen;

a balloon inflation lumen comprising a proximal end and a distal end, a portion of the balloon inflation lumen within the flexible shaft;

a low-pressure high-compliance balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block co-polymer, and blends and mixtures thereof;

a balloon inflation port coupled to the distal end of the balloon inflation lumen and the balloon inflation port within the balloon;

wherein a first wall thickness of the balloon adjacent a proximal end of the balloon is smaller than a second wall thickness of the balloon adjacent a distal end of the balloon; and

wherein upon inflation, a first diameter of the balloon adjacent to a proximal end of the balloon is larger than a second diameter adjacent a distal end of the balloon.

9. The catheter of claim 8, wherein the balloon, upon inflation, has a tapered balloon shape.

10. The catheter of claim 8, wherein the balloon, upon inflation, has a conical balloon shape.

11. A catheter comprising:

a shaft comprising a proximal end and a distal end, and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end;

a delivery port coupled to the distal end of the delivery lumen;

a pressure monitoring lumen, a portion of the pressure monitoring lumen disposed within the shaft, comprising a proximal end and a distal end;

a pressure port coupled to the distal end of the pressure monitoring lumen;

a balloon inflation lumen, a portion of the balloon inflation lumen disposed within the shaft, comprising a proximal end and a distal end;

a low-pressure high-compliance balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block co-polymer, and blends and mixtures thereof;

a balloon inflation port within the balloon and coupled to the distal end of the balloon inflation lumen;

wherein the delivery lumen is distal to the pressure monitoring lumen defining at least one of a tapered and a staggered tip, and the delivery lumen is adapted to receive the guidewire.

12. A catheter kit comprising:

a catheter comprising;

a shaft comprising a proximal end and a distal end and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end;

a pressure monitoring lumen defining a lumen therethrough, comprising a proximal end and a distal end, a portion of the pressure monitoring lumen disposed within the shaft;

a pressure port coupled to the distal end of the pressure monitoring lumen;

a balloon inflation lumen defining a lumen therethrough, comprising a proximal end and a distal end, a portion of the balloon inflation lumen within the shaft;

a low-pressure high-compliance balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, polyetheramides, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block co-polymer, and blends and mixtures thereof;

wherein the balloon is adapted to inflate to at least one of a predetermined volume and to a pre-determined pressure of about 0.5 to about 5.0 atmospheres;

a guide catheter having a length and a lumen adapted to access a coronary sinus, and having a diameter sufficient to receive a portion of the delivery catheter;

a pressure increasing device adapted to connect to the proximal end of the delivery lumen;

a pressure sensing device adapted to connect to the proximal end of the pressure monitoring lumen; and

an inflation device adapted to connect to the proximal end of the balloon inflation lumen.

13. The catheter kit of claim 12, further comprising a pressure relief valve coupled to the proximal end of the balloon inflation lumen.

14. The catheter kit of claim 12, further comprising a pressure transferring device comprising a proximal end and a distal end, wherein the distal end is adapted to connect to the proximal end of the delivery lumen;

15. The catheter kit of claim 12, wherein the delivery lumen is distal to the pressure monitoring lumen defining at least one of a tapered and a staggered tip, and the delivery lumen is adapted to receive the guidewire.

16. The catheter kit of claim 12, wherein the guide catheter comprises a first convex curved portion;

a concave curved portion distal to the first convex curved portion; and

a second convex curved portion distal to the concave curved portion.

17. The catheter kit of claim 12, wherein the guide catheter comprises a first guide catheter portion having a first diameter, and a second guide catheter portion having a second diameter.

18. The catheter kit of claim 17, wherein the first guide catheter portion and the second guide catheter portion are coaxially and slidingly engaged.

19. The catheter kit of claim 12, further comprising a controller adapted to control at least one of the pressure increasing device, the pressure sensing device, and the inflation device.

20. The catheter kit of claim 12, wherein the balloon is adapted to inflate to a diameter range of about 4 to about 12 mm.

21. The catheter kit of claim 12, wherein the shaft comprises a polyether block amide resin having a durometer hardness of about 50 to about 70 shore D.

22. The catheter kit of claim 12, wherein the shaft is radiopaque.

23. The catheter kit of claim 12, further comprising a liquid, the liquid comprising at least one of a treatment agent and a drug.

24. The catheter kit of claim 23, wherein the liquid comprises at least one material selected from the group consisting of cells such as cardiomyocytes, stem cells, progenitor cell, skeletal myocytes, smooth muscle cells, and endothelial cells, antibodies against CD18, CD11/18, P-selectin, L-selectin, ICAM, VCAM, and TNF, estrogen and estrogen receptor agonists, growth factors such as IGF-1, HGF, VEGF, NGF, FGF, TGF-beta, and their isoforms and downstream signaling mediators, heat shock proteins and their downstream signaling mediators, GIK, adenosine and adenosine receptor agonists, NO donors, Na/H exchange inhibitors, Na/K channel openers and their downstream signaling mediators, Ca channel inhibitors, beta-adrenergic receptor inhibitors, alpha-adrenergic receptor inhibitors, free radical scavengers, anti-oxidants, platelet inhibitors such as IIbIIIa receptor antagonists, complement system inhibitors, anti-apoptotic drugs like caspase inhibitors, genes that encode the peptides listed above or their ligands, or bio-engineered cells or materials that express the peptides or glycoproteins listed above or their ligands, and mixtures thereof.

25. The catheter kit of claim 12, wherein the balloon further comprises a coating.

26. The catheter kit of claim 12, wherein the balloon, upon inflation, has at least one of a conical and a tapered shape.

27. The catheter kit of claim 12, wherein the balloon comprises a material adapted to improve control of balloon expansion diameter.

28. The catheter kit of claim 12, wherein the pressure increasing device is disposable and is selected from the group consisting of a syringe, a syringe pump, a reciprocating pump, a gear pump, and a centrifugal pump.

29. The catheter kit of claim 12, wherein the pressure increasing device comprises a centrifugal pump having a removable and disposable rotor and pump housing.

30. The catheter kit of claim 12, wherein the pressure sensing device comprises a disposable piezo-electric pressure sensor.

31. The catheter kit of claim 12, wherein the inflation device is selected from the group consisting of a syringe, a reciprocating pump, a gear pump and a centrifugal pump.

32. The catheter kit of claim 12, wherein the pressure sensing device further comprises a pressure measurement outlet, and the pressure increasing device further comprises a pressure measurement inlet, and the catheter kit further comprises a connection between the pressure measurement outlet of the pressure sensing device and the pressure measurement inlet of the pressure increasing device.

33. The catheter kit of claim 12, wherein the balloon comprises at least two materials selected from the group consisting of a polyether block amide resins, polyetheramides, and mixtures thereof.

34. The catheter kit of claim 33, wherein at least two materials have a Shore D Hardness less than about 70D.

35. The catheter kit of claim 33, wherein at least two materials have a Shore D Hardness less than about 63D.

39. A method comprising:

at least one of treating and preventing a condition selected from the group consisting of congestive heart failure, myocardial infarction, coronary artery disease, ischemia, no-reflow, reperfusion injury, stunning, arrhythmia, inflammation, angiopathy, and microembolism;

locally administering a therapeutic agent selected from the group consisting of cells such as cardiomyocytes, stem cells, progenitor cell, skeletal myocytes, smooth muscle cells, and endothelial cells, antibodies against CD18, CD11/18, P-selectin, L-selectin, ICAM, VCAM, and TNF, estrogen and estrogen receptor agonists, growth factors such as IGF-I, HGF, VEGF, NGF, FGF, TGF-beta, and their isoforms and downstream signaling mediators, heat shock proteins and their downstream signaling mediators, GIK, adenosine and adenosine receptor agonists, NO donors, Na/H exchange inhibitors, Na/K channel openers and their downstream signaling mediators, Ca channel inhibitors, beta-adrenergic receptor inhibitors, alpha-adrenergic receptor inhibitors, free radical scavengers, anti-oxidants, platelet inhibitors such as IIbIIIa receptor antagonists, complement system inhibitors, anti-apoptotic drugs like caspase inhibitors, genes that encode the peptides listed above or their ligands, or bio-engineered cells or materials that express the peptides or glycoproteins listed above or their ligands, and mixtures thereof;

wherein said agent is delivered by the catheter kit of claim 12.

40. The method of claim 39, wherein said agent is delivered by the catheter kit of claim 15.

41. A method comprising:

accessing a vein selected from the group consisting of external femoral, interior femoral, carotid, jugular, brachial, subclavian, and cephalic with a guide catheter;

accessing a coronary sinus with the guide catheter;

feeding a guidewire and a retroinfusion balloon catheter to the coronary sinus through the guide catheter;

performing a venogram;

deploying the guidewire and the balloon catheter to a targeted vein;

measuring a baseline parameter in the vein adjacent to a distal end of the balloon catheter;

inflating a balloon at the distal end of the balloon catheter to a pressure sufficient to make a pressure waveform in the vein become ventricularized;

after inflating the balloon, delivering a liquid comprising at least one of a drug and a treatment agent through the balloon catheter to an outlet port on the balloon catheter distal to the balloon;

stopping the delivering of the liquid;

deflating the balloon; and

removing the catheter from the vessel.

42. The method of claim 41, further comprising performing an infusate-uptake-enhancing procedure selected from the group consisting of electroporation, ultrasonic excitation, and photodynamic therapy.

43. The method of claim 41, wherein the target vein is selected from the group consisting of coronary sinus, great cardiac vein, anterior interventricular vein, oblique vein of left atrium, posterior vein of left ventricle, middle cardiac vein, small cardiac vein, lateral vein, and anterior cardiac vein of right ventricle.

44. The method of claim 41, wherein the liquid comprises a material selected from the group consisting of cells such as cardiomyocytes, stem cells, progenitor cell, skeletal myocytes, smooth muscle cells, and endothelial cells, antibodies against CD18, CD11/18, P-selectin, L-selectin, ICAM, VCAM, and TNF, estrogen and estrogen receptor agonists, growth factors such as IGF-I, HGF, VEGF, NGF, FGF, TGF-beta, and their isoforms and downstream signaling mediators, heat shock proteins and their downstream signaling mediators, GIK, adenosine and adenosine receptor agonists, NO donors, Na/H exchange inhibitors, Na/K channel openers and their downstream signaling mediators, Ca channel inhibitors, beta-adrenergic receptor inhibitors, alpha-adrenergic receptor inhibitors, free radical scavengers, anti-oxidants, platelet inhibitors such as IIbIIIa receptor antagonists, complement system inhibitors, anti-apoptotic drugs like caspase inhibitors, genes that encode the peptides listed above or their ligands, or bio-engineered cells or materials that express the peptides or glycoproteins listed above or their ligands, and mixtures thereof.

45. The method of claim 41, wherein accessing the coronary sinus with the guide catheter further comprises:

feeding the guide catheter into the femoral vein;

feeding the guide catheter into a inferior vena cava;

feeding the guide catheter into a right atrium; and

feeding the guide catheter into a coronary sinus.