Injection array apparatus

• US 20040138622A1
• Filed: 12/19/2003
• Published: 07/15/2004
• Est. Priority Date: 05/07/1999
• Status: Abandoned Application

• Current Assignee: Maria Palasis
• Original Assignee: Maria Palasis
• Inventors: Palasis, Maria
• Application Number:
  US10/739,024
• Publication Number:
  US 20040138622A1
• Time in Patent Office: Days
• US Class Current: 604/173
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0093 wherein at least one needle is a microneedle
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A fluid delivery system for delivering and injecting fluid into heart tissue, or other organ tissues. The fluid delivery system includes an injection catheter disposed in an elongate sheath. A nozzle, including an injection array, is disposed adjacent the distal end of the injection catheter. In a first (microneedle) embodiment, the injection array comprises a plurality of microneedles each defining an injection lumen in fluid communication with the lumen of the catheter. In a second (needle-less) embodiment, the injection array comprises a plurality of injection lumens in fluid communication with the lumen of the catheter. Fluid is transferred to the injection lumen array from a fluid source through the lumen in the catheter. The injection lumen array distributes the fluid at the injection site over a greater area than would otherwise be achieved with a single needle injection. Thus, the injection lumen array improves fluid retention in the tissue at the injection site.

Claims

1. A catheter for delivering a fluid to an injection site in heart tissue, comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen extending therethrough;

a nozzle member disposed proximate the distal end of the tubular member; and

a plurality of microneedles connected to the nozzle member, the microneedles defining a plurality of injection lumens in fluid communication with the lumen of the tubular member.

2. A catheter as in claim 1, further comprising an anchor disposed proximate the distal end of the tubular member.

3. A catheter as in claim 1, further comprising an outer sheath having a proximal end, a distal end, and a lumen extending therethrough, the tubular member slidingly disposed in the lumen of the sheath.

4. A catheter as in claim 3, further comprising an anchor disposed proximate the distal end of the sheath.

5. A catheter as in claim 1, wherein each of the microneedles have a diameter in the range of approximately 0.005 to 0.05 inches.

6. A system for delivering a fluid to an injection site in heart tissue, comprising:

a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;

a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member;

a nozzle member disposed proximate the distal end of the second tubular member;

the nozzle member including a plurality of microneedles, each microneedle defining an injection lumen in fluid communication with the lumen of the second tubular member, the lumen of each microneedle terminating with an injection orifice; and

a fluid source in fluid communication with the lumen of the second tubular member.

7. A system as in claim 6, wherein an anchor is disposed proximate the distal end of the second tubular member.

8. A system as in claim 6, wherein an anchor is disposed proximate the distal end of the first tubular member.

9. A system as in claim 8, wherein the anchor comprises a vacuum orifice.

10. A system as in claim 9, wherein the vacuum orifice is in fluid communication with a vacuum source via the lumen of the second tubular member.

11. A system as in claim 6, wherein each of the microneedles have a diameter in the range of approximately 0.005 to 0.05 inches.

12. A method of delivering a fluid to an injection site in a patient'"'"'s heart tissue, comprising the steps of:

providing a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;

providing a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member, the second tubular member including a nozzle member disposed proximate the distal end thereof, the nozzle member including a plurality of microneedles, each microneedle defining an injection lumen in fluid communication with the lumen of the second tubular member, the lumen of each microneedle terminating with an injection orifice;

inserting the first tubular member into the patient;

advancing the first tubular member until the distal end thereof is proximate the injection site in the patient'"'"'s heart tissue;

advancing the second tubular member through the first tubular member until the plurality of injection orifices are proximate the injection site;

urging the fluid from the fluid source to the lumen of second tubular member; and

injecting the fluid into the heart tissue at the injection site via the microneedles.

13. A method of delivering a fluid as in claim 12, further including the step of stabilizing the distal end of the first tubular member relative to the target site.

14. A method of delivering a fluid as in claim 12, wherein the microneedles are advanced into the tissue and retained in the tissue for a period of time after the fluid has been injected into the tissue in order to allow the fluid to be absorbed by the tissue.

15. A method of delivering a fluid as in claim 14, wherein the period of time ranges from about 5 seconds to about 120 seconds.

16. A method of delivering a fluid as in claim 14, wherein the period of time ranges from about 5 seconds to about 30 seconds.

17. A catheter for delivering a fluid to an injection site in heart tissue, comprising:

an elongate tubular member having a proximal end, a distal end, and a lumen extending therethrough;

a nozzle member disposed proximate the distal end of the tubular member; and

a plurality of injection lumens defined by the nozzle member, the injection lumens terminating with an injection orifice in fluid communication with the lumen of the tubular member.

18. A catheter as in claim 17, further comprising an outer sheath having a proximal end, a distal end, and a lumen extending therethrough, the tubular member slidingly disposed in the lumen of the sheath.

19. A catheter as in claim 18, further including an anchor disposed proximate the distal end of the sheath.

20. A catheter as in claim 19, wherein the anchor comprises a vacuum orifice defined by the lumen of the sheath adjacent the distal end thereof.

21. A catheter as in claim 17, wherein each of the injection lumens have a diameter in the range of approximately 0.00005 to 0.005 inches.

22. A system for delivering a fluid to an injection site in heart tissue, comprising:

a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;

a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member;

a nozzle member disposed proximate the distal end of the second tubular member;

the nozzle member including a plurality of injection lumens in fluid communication with the lumen of the second tubular member, the injection lumens terminating with an injection orifice; and

a fluid source in fluid communication with the lumen of the second tubular member.

23. A system as in claim 22, wherein an anchor is disposed proximate the distal end of the first tubular member.

24. A system as in claim 23, wherein an anchor is disposed proximate the distal end of the second tubular member.

25. A system as in claim 24, wherein the anchor comprises a vacuum orifice.

26. A system as in claim 25, wherein the vacuum orifice is in fluid communication with a vacuum source via the lumen of the second tubular member.

27. A system as in claim 22, wherein each of the injection lumens have a diameter in the range of approximately 0.00005 to 0.005 inches.

29. A method as in claim 25, further including the step of stabilizing the distal end of the first tubular member relative to the target site.

28. A method of delivering a fluid to an injection site in a patient'"'"'s heart tissue, comprising the steps of:

providing a first tubular member having a proximal end, a distal end, and a lumen extending therethrough;

providing a second tubular member having a proximal end, a distal end, and a lumen extending therethrough, the second tubular member slidingly disposed within the lumen of the first tubular member, the second tubular member including a nozzle member disposed proximate the distal end thereof, the nozzle member including a plurality of injection lumens in fluid communication with the lumen of the second tubular member, each injection lumen terminating with an injection orifice;

inserting the first tubular member into the patient;

advancing the first tubular member until the distal end thereof is proximate the injection site in the patient'"'"'s heart tissue;

advancing the second tubular member through the first tubular member until the plurality of injection orifices are proximate the injection site;

urging the fluid from the fluid source to the lumen of second tubular member; and

injecting the fluid into the heart tissue at the injection site via the injection lumens.