Delivery catheter system for heart chamber

• US 6,322,548 B1
• Filed: 03/31/1998
• Issued: 11/27/2001
• Est. Priority Date: 05/10/1995
• Status: Expired due to Term

• Current Assignee: Cryolife Incorporated
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Rosenthal, Michael H., Kume, Stewart, Aita, Michael, Pearce, Stephen B., Payne, Sam G., Kesten, Randy J., Javier, Manuel A. Jr.
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US09/052,971
• Time in Patent Office: 1,337 Days
• Field of Search: 604/500, 604/506, 604/507, 604/508, 604/511, 604/523, 604/532, 604/28, 604/21
• US Class Current: 604/500
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• 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 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2210/125 Heart
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

A delivery catheter system for delivering a substance delivery member into a patient'"'"'s left ventricle which includes a first delivery catheter with a shaped distal extremity configured to be aligned with or parallel to a longitudinal axis or long dimension of the patient'"'"'s left ventricle and a second delivery catheter slidably and rotatably disposed within an inner lumen of the first delivery catheter which has a shaped distal shaft section and an inner lumen configured to slidably receive a substance delivery member such as an elongated cannula slidably disposed within a polymer sheath. The shaped distal section of the first delivery catheter is shaped or is shapeable within the patient'"'"'s heart chamber. The second delivery catheter is advanced out of the inner lumen of the first delivery catheter until the distal end extends out of the port in the distal end of the first delivery catheter and provides a passageway for substance delivery member to engage the endocardial surface at a perpendicular or near perpendicular orientation.

Claims

1. A catheter system for the delivery of a therapeutic or diagnostic agent, comprising:

a) a first elongated delivery catheter which has proximal and distal ends, a port in the distal end, an inner lumen extending therein to and in fluid communication with the port in the distal end, a relatively straight main shaft section and a shaped distal shaft section having at least one segment forming an angle with respect to a proximally adjacent portion of the main shaft section;

b) a second elongated delivery catheter which is slidably and rotatably disposed within the inner lumen of the first delivery catheter, which is longer than the first delivery catheter and which has proximal and distal ends, a port in the distal end, an inner lumen, an elongated main shaft section at least a portion of which is substantially alignable with a discharge axis of the first delivery catheter and a shaped distal shaft section at least a portion of which is substantially alignable with the discharge axis of the first delivery catheter and which is configured to have a discharge axis at an angle with respect to a portion of the main shaft section thereof aligned with the discharge axis of the first delivery catheter; and

c) a substance delivery member which is slidably disposed within the second delivery catheter, which has a distal extremity configured for intracorporeal delivery of a diagnostic or therapeutic substance into a patient'"'"'s tissue.

2. The catheter system of claim 1 further comprising a guiding catheter configured to rotatably and slidably receive the first delivery catheter.

3. The catheter system of claim 2 wherein the first delivery catheter has a shaped distal section configured to facilitate positioning of the distal end of the second delivery catheter to a position normal to the interior wall of a patient'"'"'s heart.

4. The catheter system of claim 1 wherein the substance delivery member comprises a polymer sheath disposed about an elongated cannula having a sharp distal end configured to penetrate tissue and deliver a therapeutic substance therein.

5. The catheter system of claim 4 further comprising an injector in fluid communication with a proximal end of the elongated cannula, whereby the injector injects a therapeutic or diagnostic substance into the proximal end of the cannula and out the sharp distal end, and further comprising a radiopaque marker on a distal end of the polymer sheath.

6. The catheter system of claim 5 wherein the injector is a syringe.

7. The catheter system of claim 4 wherein the elongated cannula further comprises at least one radiopaque marker to facilitate visualization of the cannula during delivery of a therapeutic or diagnostic agent.

8. The catheter system of claim 4 wherein the distal end of the elongated cannula comprises a bulbous portion which has a diameter greater than a proximally adjacent shaft section and a distally adjacent sharp distal end.

9. The catheter system of claim 4 wherein the substance delivery member includes at least one penetration limiter.

10. The catheter system of claim 9 wherein the penetration limiter is a radially expandable element.

11. The catheter system of claim 10 wherein the penetration limiter is comprised of a wire loop.

12. The catheter system of claim 1 wherein the shaped distal shaft section of the second delivery catheter is configured to have the disscharge axis at an angle of about 90°

to about 120°

with respect to the portion of the main shaft section thereof which is aligned with the discharge axis of the first delivery catheter.

13. The catheter system of claim 1 wherein the shaped distal section of the first delivery catheter has at least a first segment and a proximally adjacent second segment.

14. The catheter system of claim 13 wherein the first segment of the shaped distal section of the first delivery catheter is at an angle of about 95°

to about 160°

with respect to the proximally adjacent second segment and the second segment is at an angle of about 95°

to about 150°

with respect to the main shaft section proximally adjacent thereto.

15. The catheter system of claim 13 wherein the first segment of the shaped distal shaft section of the first delivery catheter is at an angle of about 100°

to about 140°

with respect to the adjacent second segment.

16. The catheter system of claim 13 wherein the shaped distal shaft section of the first delivery catheter includes a third segment proximally adjacent to the second segment, with the third segment at an angle with respect to the main shaft section proximal thereto of about 110°

to about 170°

.

17. The catheter system of claim 13 wherein the shaped distal shaft section of the first delivery catheter includes a third segment proximally adjacent to the second segment, with the third segment at an angle with respect to the main shaft section proximal thereto of about 120°

to about 150°

.

18. The catheter system of claim 13 wherein the first segment of the shaped distal shaft section of the first delivery catheter has a length of about 0.5 to about 5 cm.

19. The catheter system of claim 13 wherein the first segment of the shaped distal shaft section of the first delivery catheter has a length of about 1 to about 4 cm.

20. The catheter system of claim 13 wherein the second segment of the shaped distal shaft section of the first delivery catheter has a length of about 0.5 to about 5 cm.

21. The catheter system of claim 13 wherein the second segment of the shaped distal shaft section of the first delivery catheter has a length of about 1 to about 4 cm.

22. The catheter system of claim 17 wherein the third segment of the shaped distal shaft section of the first delivery catheter has a length of about 1 to about 5 cm.

23. The catheter system of claim 17 wherein the third segment of the shaped distal shaft section of the first delivery catheter has a length of about 2 to about 4 cm.

24. The catheter system of claim 13 wherein the length of the shaped distal shaft section of the first delivery catheter is about 2 to about 8 cm.

25. The catheter system of claim 13 wherein the length of the shaped distal shaft section of the first delivery catheter is about 4 to about 7 cm.

26. The catheter system of claim 1 wherein the shaped distal section of the first delivery catheter has a single segment.

27. The catheter system of claim 26 wherein the single segment of the shaped distal section is at an angle of about 95°

to about 160°

with respect to the proximally adjacent main shaft section.

28. The catheter system of claim 26 wherein the single segment of the shaped distal section is at an angle of about 100°

to about 140°

with respect to the proximally adjacent main shaft section.

29. The catheter system of claim 26 wherein the single segment of the shaped distal section has a length of about 3 to about 8 cm.

30. The catheter system of claim 26 wherein the single segment of the shaped distal section of the first delivery catheter has a length of about 4 to about 6 cm.

31. The catheter system of claim 26 wherein the single segment has a length of about 0.5 to about 5 cm.

32. The catheter system of claim 26 wherein the single segment of the shaped distal section of the first delivery catheter has a length of about 1 to about 4 cm.

33. The catheter system of claim 13 wherein the shaped distal section of the first delivery catheter has a third segment which is proximally adjacent to the second segment.

34. The catheter system of claim 33 wherein the third segment has a length of about 1 to about 5 cm.

35. The catheter system of claim 33 wherein the third segment has a length of about 2 to about 4 cm.

36. The catheter system of claim 33 wherein the length of the shaped distal section is about 2 to about 8 cm.

37. The catheter system of claim 33 wherein the length of the shaped distal section is about 4 to about 7 cm.

38. A method for performing a therapeutic or diagnostic procedure in a region of a wall of a patient'"'"'s heart defining a heart chamber, comprising:

a) introducing into a peripheral artery of the patient a delivery catheter system which includes;

a first delivery catheter having an elongated shaft which has proximal and distal ends, a port in the distal end and an inner lumen extending therein to and in fluid communication with the port in the distal end, a relatively straight main shaft section and a shaped distal shaft section forming an angle with respect to a proximally adjacent portion of the main shaft section so that the distal section has a discharge axis which is generally aligned with or parallel to longitudinal axis of the patient'"'"'s left ventricle; and

a second elongated delivery catheter which is slidably and rotatably disposed within the inner lumen of the first delivery catheter, which is longer than the first delivery catheter and which has proximal and distal ends, a port in the distal end, an inner lumen extending to and in fluid communication with the port in the distal end, an elongated main shaft section and a shaped distal shaft section configured to have a discharge axis at an angle of about 80°

to about 135°

with respect to a portion of the main shaft section of the second delivery catheter which is substantially aligned with the discharge axis of the first delivery catheter so as to be normal to said region of the heart wall, and

a substance delivery member having a distal extremity which is configured to extend beyond the distal end of the second delivery catheter configured to deliver a diagnostic or therapeutic substance to the wall of the patient'"'"'s heart;

b) advancing at least the first delivery catheter through the patient'"'"'s arterial system until the shaped distal shaft section of the first delivery catheter extends into the patient'"'"'s left ventricle substantially aligned with or parallel to the longitudinal axis of the left ventricle;

c) advancing the second delivery catheter within the first delivery catheter until at least a portion of the shaped distal shaft section of the second delivery catheter extends out the port in the distal end of the first delivery catheter; and

d) positioning the second delivery catheter within the left ventricle so that the shaped distal shaft section thereof is substantially normal to the region of the heart wall where the procedure is to be performed; and

;

e) extending the distal extremity of the substance delivery member until the distal end thereof is in a position to deliver a diagnostic or therapeutic substance into the patient'"'"'s heart wall.

39. The method of claim 38 wherein the delivery catheter system further comprises an intermediate delivery catheter having a proximal and distal end and which is slidably and rotatably received by the first delivery catheter and which slidably and rotatably receives the second delivery catheter, and further comprising the step of advancing the intermediate delivery catheter through the first delivery catheter after it has been positioned within the patient'"'"'s left ventricle, and then advancing the second delivery catheter within the intermediate delivery catheter until a portion of the shaped distal shaft section of the second delivery catheter extends out of the distal end of the intermediate delivery catheter.

40. The method of claim 38 wherein the substance delivery member is an elongated cannula with a distal extremity and wherein the distal extremity is extended out of the port in the distal end of the second delivery catheter until the distal extremity penetrates the desired region of the patient'"'"'s heart wall.

41. The method of claim 40 wherein the substance delivery member further comprises a polymer sheath slidably disposed about the elongated cannula and slidably disposed within the second delivery catheter.

42. The method of claim 40 including the step of activating the substance delivery member so as to perform the procedure at said region.

43. A method for developing neovasculogenesis within a region of a patient'"'"'s heart wall defining a heart chamber, comprising:

a) advancing a first delivery catheter through the patient'"'"'s vasculature until a distal section of the first delivery catheter extends into the patient'"'"'s heart chamber and is substantially aligned with or parallel to a longitudinal axis of the heart chamber;

b) advancing a second delivery catheter through an inner lumen of the first delivery catheter until a shaped distal section of the second delivery catheter extends out of the distal end of the first delivery catheter;

c) adjusting the position of the second delivery catheter until a discharge axis of the second delivery catheter is substantially normal to the region of the heart wall in which the neovasculogenesis is to be developed;

d) advancing a substance delivery member from the distal end of the second delivery catheter until the distal end of the substance delivery member penetrates into the desired region of the patient'"'"'s heart wall; and

e) delivering an neovasculogenesis agent through the distal extremity of the substance delivery member within the heart wall to develop angiogenesis therein.

44. The method of claim 43 wherein the substance delivery member is an elongated cannula.

45. A delivery catheter system for delivering a therapeutic substance in a desired region of a wall of a patient'"'"'s heart, comprising:

a) a first delivery catheter which has proximal and distal ends, a port in the distal end, an inner lumen extending to and in communication with the port in the distal end, an elongated proximal section with a longitudinal axis and a distal section which is shorter than the proximal section, with the distal shaft section shaped so as to be directed toward the desired region of the heart wall and which includes a proximal portion having a longitudinal axis and extending at an angle of about 50°

to about 130°

from the longitudinal axis of the proximal section and a distal portion which is at an angle of about 50°

to about 130°

from the longitudinal axis of the proximal portion; and

b) a substance delivery member slidably disposed within the inner lumen of the first delivery catheter and configured to have a distal end which extends out of the port in the distal end of the first delivery catheter.

46. A delivery catheter system for percutaneously delivering diagnostic or therapeutic substances into a patient'"'"'s heart comprising:

a) a first delivery catheter which has proximal and distal ends, a port in the distal end, an inner lumen extending therein to and in communication with the port in the distal end, a main shaft portion and a distal shaft portion which is configured to extend at least into the patient'"'"'s ascending aorta and having a discharge axis; and

b) a second delivery catheter which is slidably disposed within the inner lumen of the first delivery catheter, which is longer than the first delivery catheter, and which has proximal and distal ends, a port in the distal end, an inner lumen extending therein to and in fluid communication with the port in the distal end of the second delivery catheter and a distal extremity having discharge axis at an angle of at least 30°

from the discharge axis of the first catheter; and

c) a substance delivery member which is slidably disposed within the inner lumen of the second delivery catheter and which is configured to extend out the port in the distal end of the second delivery catheter to engage a portion of a patient'"'"'s heart.