Catheter system for performing intramyocardiac therapeutic treatment

• US 6,620,139 B1
• Filed: 05/10/2001
• Issued: 09/16/2003
• Est. Priority Date: 12/14/1998
• Status: Expired due to Fees

• Current Assignee: TRE ESSE Progettazione Biomedica S.r.l.
• Original Assignee: TRE ESSE Progettazione Biomedica S.r.l.
• Inventors: Marcelli, Emanuela, Plicchi, Gianni, Bombardini, Tonino
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): MAIORINO, ROZ
• Application Number:
  US09/831,493
• Time in Patent Office: 859 Days
• Field of Search: 606/53, 606/159, 606/170, 606/471, 606/41, 424/93.2, 604/272, 604/264, 604/22, 604/66, 604/28, 604/21, 600/564, 128/878
• US Class Current: 604/264
• 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 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/1435 Spiral
• 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 25/0084 being one or more injection needles
• CPC Class Codes: A61N 1/0575 with drug delivery

Abstract

The multilumen catheter (2) is provided at one end with a needle system (9, 9′) formed by two or more single-lumen needles which are provided with respective discharge openings (110, 111) and which, via their longitudinal lumina (10, 11), are connected to corresponding lumina (3, 4) of the catheter for separate release of a tracer fluid for external image diagnostics systems and therapeutic fluids, for example DNA plasmids. The needles may be both straight or both helical or one of these needles may be straight and the other needle may be helical.

Claims

1. Method for intramyocardiac therapeutic treatment comprising the following operational steps:

inserting into a desired chamber of a heart, with a pre-formed or steerable catheter guide, a catheter having

a) first and second longitudinal catheter lumina,

b) a terminal end,

c) a multilumen needle system provided at the terminal end, the needle system including (i) a needle section extending longitudinally from the terminal end for insertion into a myocardium of the desired chamber and including first and second longitudinal needle lumina provided with respective first and second lateral discharge openings at different longitudinal positions along the needle section, wherein the first lateral opening of the first needle lumen is located closer to the terminal end of the catheter than the second lateral opening of the second needle lumen, and (ii) a base section which respectively connects the first and second needle lumina to the first and second catheter lumina , and

d) first and second release systems which are connected respectively to the first and second lumina at external ends thereof, the first and second release systems functioning during operation to release into a desired zone inside the myocardium of the desired chamber respectively (i) a fluid for therapeutic treatment and (ii) a tracer fluid for external image diagnostics systems;

inserting the multilumen needle system into the myocardium at a desired point;

injecting the tracer fluid through the first lumen of the catheter and the first needle of the needle system and thus into the desired zone of the myocardium, wherein said injecting step includes a discharging of the tracer fluid through the first lateral opening of the multilumen needle system which is closest to the terminal end of the catheter;

checking and recording a total and correct insertion of the needle system into the desired point of the myocardium using the tracer fluid present thereat and the external image diagnostics system; and

releasing, in the desired zone of the myocardium into which the multilumen needle system has been correctly inserted, the therapeutic fluid via the second lumina of the catheter and the second needle.

2. Method according to claim 1:

wherein the first lateral opening of the first needle lumen is located closer to the terminal end of the catheter than the second lateral opening of the second needle lumen; and

wherein said injecting step includes a discharging of the tracer fluid through the first lateral opening of the multilumen needle system which is closest to the terminal end of the catheter.

3. Method according to claim 1:

wherein the needle section has a helical shape;

wherein the base section of the needle system includes an end-of-travel balloon which is activatable between an expanded and a retracted position about the base section; and

wherein said step of inserting the multilumen needle system into the myocardium at the desired point comprises activating the end-of-travel balloon to the expanded position and then rotating of the catheter and the associated needle section of the helical shape.

4. Method according to claim 1, wherein said step of releasing the therapeutic treatment fluid comprises a release of carrier systems for performing genetic transfer to cells of the heart.

5. Method according to claim 1:

wherein the needle system includes an electrical conductor; and

further including steps of (i) connecting the electrical conductor of the multilumen needle system to an external apparatus and (ii) generating electrical impulses with the external apparatus synchronized with a beat R of the heart to reinforce a transfer of the therapeutic fluid into the cells of the heart.

6. Method according to claim 1:

wherein the needle system also includes an ultrasound emitter; and

further including a step of activating the ultrasound emitter associated with the needle system to reinforce a transfer of the therapeutic fluid into the cells of the heart.

7. Method according to claim 1:

wherein the needle system includes an electrical conductor; and

further including a step of checking a state of penetration of the needle section of the multilumen needle system into the myocardium, said checking of the state of penetration including the steps of connecting the electrical conductor associated with the needle system to an external apparatus, and monitoring of an intramyocardiac electrocardiograph with the external apparatus.

8. Method according to claim 1:

wherein the needle system includes an electrical conductor; and

further including a step of checking of the state of penetration of the needle section into the myocardium, said checking of the state of penetration including the steps of connecting the electrical conductor associated with the multilumen needle system to an external apparatus, and measuring an bioelectric impedance with the external apparatus.

9. Method according to claim 4, wherein the released therapeutic treatment fluid is DNA plasmids.

10. (Re-presented—

formerly dependent claim #4) Method for intramyocardiac therapeutic treatment comprising the following operational steps;

inserting into a desired chamber of a heart, with a pre-formed or steerable catheter guide, a catheter having

e) first and second longitudinal catheter lumina,

f) a terminal end,

g) a multilumen needle system provided at the terminal end, the needle system including (i) a needle section extending longitudinally from the terminal end for insertion into a myocardium of the desired chamber and including first and second longitudinal needle lumina provided with respective first and second lateral discharge openings at different longitudinal positions along the needle section, and (ii) a base section which respectively connects the first and second needle lumina to the first and second catheter lumina , and

h) first and second release systems which are connected respectively to the first and second lumina at external ends thereof, the first and second release systems functioning during operation to release into a desired zone inside the myocardium of the desired chamber respectively (i) a fluid for therapeutic treatment and (ii) a tracer fluid for external image diagnostics systems;

inserting the multilumen needle system into the myocardium at a desired point;

injecting the tracer fluid through the first lumen of the catheter and the first needle of the needle system and thus into the desired zone of the myocardium;

checking and recording a total and correct insertion of the needle system into the desired point of the myocardium using the tracer fluid present thereat and the external image diagnostics system; and

releasing, in the desired zone of the myocardium into which the multilumen needle system has been correctly inserted, the therapeutic fluid via the second lumina of the catheter and the second needle, wherein said step of releasing the therapeutic treatment fluid comprises a release of carrier systems for performing genetic transfer to cells of the heart.

11. Method according to claim 10:

wherein the needle section has a helical shape;

wherein the base section of the needle system includes an end-of-travel balloon which is activatable between an expanded and a retracted position about the base section; and

wherein said step of inserting the multilumen needle system into the myocardium at the desired point comprises activating the end-of-travel balloon to the expanded position and then rotating of the catheter and the associated needle section of the helical shape.

12. Method according to claim 10:

wherein the needle system includes an electrical conductor; and

further including steps of (i) connecting the electrical conductor of the multilumen needle system to an external apparatus and (ii) generating electrical impulses with the external apparatus synchronized with a beat R of the heart to reinforce a transfer of the therapeutic fluid into the cells of the heart.

13. Method according to claim 10:

wherein the needle system also includes an ultrasound emitter; and

further including a step of activating the ultrasound emitter associated with the needle system to reinforce a transfer of the therapeutic fluid into the cells of the heart.

14. Method according to claim 10:

wherein the needle system includes an electrical conductor; and

further including a step of checking a state of penetration of the needle section of the multilumen needle system into the myocardium, said checking of the state of penetration including the steps of connecting the electrical conductor associated with the needle system to an external apparatus, and monitoring of an intramyocardiac electrocardiograph with the external apparatus.

15. Method according to claim 10:

wherein the needle system includes an electrical conductor; and

further including a step of checking of the state of penetration of the needle section into the myocardium, said checking of the state of penetration including the steps of connecting the electrical conductor associated with the multilumen needle system to an external apparatus, and measuring an bioelectric impedance with the external apparatus.