Various Catheter Devices for Myocardial Injections or Other Uses

• US 20100145306A1
• Filed: 07/24/2009
• Published: 06/10/2010
• Est. Priority Date: 07/24/2008
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Epstein, Samuel J., Edrington, John, Griffin, Mark, Kim, Grace, Mickley, Timothy J., Furnish, Greg
• Application Number:
  US12/509,105
• Publication Number:
  US 20100145306A1
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A catheter device comprising a proboscis shaft and a proboscis disposed within the proboscis shaft. In certain embodiments, the catheter device further comprises an elongate tubular member, wherein the proboscis shaft is disposed within the elongate tubular member. In certain embodiments, the catheter device comprises a tissue surface engagement structure, which has a first configuration and a second configuration. In the second configuration, the tissue surface engagement structure presents a larger transverse profile in comparison to the first configuration. The tissue surface engagement structure may have any of various designs, including an expandable assembly and a hinged assembly. In certain embodiments, a deformable cushion is positioned at the distal end of the proboscis shaft. The deformable cushion comprises a pocket that is filled with a reshapeable material. In certain embodiments, the proboscis shaft comprises a longitudinally compressible portion.

Claims

1. A catheter device comprising:

a proboscis shaft having a lumen and an exit opening at the distal end of the proboscis shaft;

a tissue surface engagement structure positioned at the distal end of the proboscis shaft, wherein the tissue surface engagement structure has a first configuration and a second configuration, and wherein the transverse profile of the tissue surface engagement structure is larger in the second configuration than in the first configuration; and

a proboscis disposed within the lumen of the proboscis shaft.

2. The catheter device of claim 1, wherein the tissue surface engagement structure switches from the first configuration to the second configuration by self-actuation.

3. The catheter device of claim 2, wherein the tissue surface engagement structure is biased towards the second configuration.

4. The catheter device of claim 1, further comprising an elongate tubular member having a lumen and an exit opening at the distal end of the elongate tubular member, and wherein the proboscis shaft is slidably disposed within the lumen of the elongate tubular member.

5. The catheter device of claim 4, wherein the tissue surface engagement structure is maintained in the first configuration when the proboscis shaft is retracted inside the elongate tubular member, and wherein the tissue surface engagement structure switches to the second configuration when the proboscis shaft is advanced out of the elongate tubular member.

6. The catheter device of claim 1, wherein the size of the transverse profile of the tissue surface engagement structure in the second configuration is at least 1.5 times the size of the transverse profile in the first configuration.

7. The catheter device of claim 1, wherein the size of the transverse profile of the tissue surface engagement structure in the second configuration is 1.5 to 10 times the size of the transverse profile in the first configuration.

8. The catheter device of claim 1, wherein the size of the transverse profile of the tissue surface engagement structure in the second configuration is 1.5 to 5 times the size of the transverse profile in the first configuration.

9. The catheter device of claim 1, wherein the size of the transverse profile of the tissue surface engagement structure in the second configuration is 1.5 to 3 times the size of the transverse profile in the first configuration.

10. The catheter device of claim 1, wherein the proboscis is slidable in relation to the proboscis shaft.

11. The catheter device of claim 1, wherein the tissue surface engagement structure is an expandable assembly, and wherein the first configuration is a collapsed configuration and the second configuration is an expanded configuration.

12. The catheter device of claim 11, wherein the expandable assembly is self-expandable.

13. The catheter device of claim 11, wherein the expandable assembly comprises a structure selected from the group consisting of:

an umbrella structure, a canopy structure, a basket structure, a wire mesh structure, a tab, a petal, a strip, a sleeve, and a wire loop.

14. The catheter device of claim 1, wherein the tissue surface engagement structure is a hinged assembly comprising one or more hinged members that are hingedly joined to the proboscis shaft at one or more hinge portions, and wherein the first configuration is a closed configuration and the second configuration is an open configuration.

15. The catheter device of claim 14, wherein the hinged assembly comprises a single hinged member, and wherein the single hinged member is a partially transected distal end of the proboscis shaft.

16. The catheter device of claim 14, wherein the hinged assembly comprises a plurality of hinged members.

17. The catheter device of claim 14, wherein the hinged assembly is self-opening.

18. The catheter device of claim 14, wherein the hinged assembly is actuated by compressing the one or more hinged members against the target tissue surface.

19. A method for delivering a therapeutic or diagnostic agent into myocardium, comprising:

positioning the distal end of a catheter device within an internal chamber of the heart, wherein the catheter device comprises;

(a) a proboscis shaft having a lumen and an exit opening at the distal end of the proboscis shaft;

(b) a tissue surface engagement structure positioned at the distal end of the proboscis shaft, wherein the tissue surface engagement structure has a first configuration and a second configuration, and wherein the transverse profile of the tissue surface engagement structure is larger in the second configuration than in the first configuration; and

(c) a proboscis disposed within the lumen of the proboscis shaft;

switching the tissue surface engagement structure from the first configuration to the second configuration;

penetrating the myocardium with the proboscis; and

injecting a therapeutic or diagnostic agent into the myocardium through the proboscis.

20. The method of claim 19, wherein the proboscis is slidable in relation to the proboscis shaft, and wherein penetrating the myocardium comprises advancing the proboscis.

21. The method of claim 19, wherein switching the tissue surface engagement structure is performed by self-actuation.

22. The method of claim 19, wherein the catheter device further comprising an elongate tubular member having a lumen and an exit opening at the distal end of the elongate tubular member, and wherein the proboscis shaft is slidably disposed within the lumen of the elongate tubular member.

23. The method of claim 22, wherein switching the tissue surface engagement structure comprises advancing the proboscis shaft such that the tissue surface engagement structure exits the exit opening on the elongate tubular member.

24. The method of claim 19, wherein the tissue surface engagement structure is an expandable assembly.

25. The method of claim 19, wherein the tissue surface engagement structure is a hinged assembly.

26. A catheter device comprising:

a proboscis shaft having a lumen and an exit opening at the distal end of the proboscis shaft;

a deformable cushion positioned at the distal end of the proboscis shaft, wherein the cushion has a pocket filled with reshapeable material, and wherein the cushion has a contact surface for engaging a target site; and

a proboscis disposed within the lumen of the proboscis shaft.

27. The catheter device of claim 26, wherein the reshapeable material is sufficiently viscous that the cushion does not substantially deform under impulse pressures.

28. The catheter device of claim 26, wherein the area of the contact surface when the cushion is deformed under compressive forces encountered during myocardial injection procedures is at least 1.5 times the area of the contact surface when the cushion is undeformed.

29. The catheter device of claim 26, wherein the area of the contact surface when the cushion is deformed under compressive forces encountered during myocardial injection procedures is at least 1.5 to 10 times the area of the contact surface when the cushion is undeformed.

30. The catheter device of claim 26, wherein the area of the contact surface when the cushion is deformed under compressive forces encountered during myocardial injection procedures is at least 1.5 to 3 times the area of the contact surface when the cushion is undeformed.

31. The catheter device of claim 26, wherein the cushion substantially returns to its original shape and dimensions when a compressive force is released.

32. The catheter device of claim 26, further comprising an elongate tubular member having a lumen and an exit opening at the distal end of the elongate tubular member, and wherein the proboscis shaft is slidably disposed within the lumen of the elongate tubular member.

33. The catheter device of claim 26, wherein the reshapeable material is selected from the group consisting of:

a fluid, a liquid, a gas, a gel, and a foam material.

34. A method of delivering a therapeutic or diagnostic agent into myocardium, comprising:

positioning the distal end of a catheter device within an internal chamber of the heart, wherein the catheter device comprises;

(a) a proboscis shaft having a lumen and an exit opening at the distal end of the proboscis shaft;

(b) a deformable cushion positioned at the distal end of the proboscis shaft, wherein the cushion has a pocket filled with a reshapeable material; and

(c) a proboscis disposed within the lumen of the proboscis shaft

engaged the cushion with the myocardial wall to create a contact surface between the cushion and the myocardial wall;

penetrating the myocardium with the proboscis;

compressing the cushion such that the area of the contact surface increases; and

injecting a therapeutic or diagnostic agent into the myocardium through the proboscis.

35. The method of claim 34, wherein the contact surface has an area of at least 0.9 mm².

36. The method of claim 34, wherein the area of the contact surface when the cushion is deformed under compression is at least 1.5 times the area of the contact surface when the cushion is undeformed.

37. The method of claim 34, wherein the area of the contact surface when the cushion is deformed under compression is from 1.5 to 10 times the area of the contact surface when the cushion is undeformed.

38. The method of claim 34, wherein the area of the contact surface when the cushion is deformed under compression is from 1.5 to 3 times the area of the contact surface when the cushion is undeformed.

39. The method of claim 34, wherein the reshapeable material is sufficiently viscous that the cushion does not substantially deform under impulse pressures.

40. The method of claim 34, wherein the proboscis is fully retracted inside the proboscis shaft, and wherein compressing the cushion exposes the proboscis.

41. A catheter device comprising:

a proboscis shaft having a longitudinally compressible portion, a lumen, and an exit opening at the distal end of the proboscis shaft; and

a proboscis disposed within the lumen of the proboscis shaft.

42. The catheter device of claim 41, wherein the compressible portion comprises a coil spring.

43. The catheter device of claim 41, wherein the compressible portion comprises accordion-type pleats.

44. The catheter device of claim 41, wherein the proboscis shaft further comprises a distal hood, and wherein the compressible portion is located on the distal hood.

45. The catheter device of claim 41, wherein the proboscis shaft includes at least one radiopaque marker.

46. The catheter device of claim 45, wherein the radiopaque marker is positioned proximal to the compressible portion and another radiopaque marker is positioned distal to the compressible portion.

47. The catheter device of claim 41, wherein the compressible portion is resiliently compressible.

48. The catheter device of claim 41, further comprising an elongate tubular member having a lumen and an exit opening at the distal end of the elongate tubular member, and wherein the proboscis shaft is slidably disposed within the lumen of the elongate tubular member.

49. A method for delivering a therapeutic or diagnostic agent into myocardium, comprising:

positioning the distal end of a catheter device within an internal chamber of the heart, wherein the catheter device comprises;

(a) a proboscis shaft having a longitudinally compressible portion, a lumen, and an exit opening at the distal end of the proboscis shaft; and

(b) a proboscis disposed within the lumen of the proboscis shaft.

engaging the proboscis shaft with the myocardial wall;

penetrating the myocardium with the proboscis; and

injecting a therapeutic or diagnostic agent into the myocardium through the proboscis.

50. The method of claim 49, wherein engaging the proboscis shaft with the myocardial wall causes compression of the compressible portion.

51. The method of claim 49, wherein the compressible portion comprises a coil spring.

52. The method of claim 49, wherein the compressible portion comprises accordion-type pleats.

53. The method of claim 49, wherein the proboscis shaft includes at least one radiopaque marker.

54. The method of claim 53, wherein the radiopaque marker is positioned proximal to the compressible portion and another radiopaque marker is positioned distal to the compressible portion.

55. The method of claim 50, wherein the proboscis is fully retracted inside the proboscis shaft, and wherein compression of the cushion exposes the proboscis.