Lateral needle injection apparatus and method

• US 6,319,230 B1
• Filed: 12/08/1999
• Issued: 11/20/2001
• Est. Priority Date: 05/07/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Palasis, Maria, Rosenthal, Arthur
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/457,254
• Time in Patent Office: 713 Days
• Field of Search: 604/22, 604/271, 604/115-117, 604/272, 604/164-1-1, 604/165.01, 604/158, 604/159, 604/264, 606/167, 606/168, 606/169, 606/170-174, 606/192-194
• US Class Current: 604/164.01
• 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 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• 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

Abstract

A device and method for delivering and injecting fluid into heart tissue utilizing a laterally directed needle to increase injectate (fluid) retention in the heart tissue. The device may comprise a catheter having a shaft wherein the distal end of the shaft includes a primary penetrating member and a secondary penetrating member. The secondary penetrating member includes an injection lumen in fluid communication with a pressurized fluid source. The primary penetrating member penetrates the heart tissue at the injection site in a first direction, and the secondary penetrating member penetrates the heart tissue in a second direction different from the first direction such that fluid leakage from the injection site is reduced and the volume of treated tissue is increased.

Claims

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

a shaft having a proximal end and a distal end, the distal end of the shaft including a primary penetrating member and at least one secondary penetrating member having an injection lumen, wherein the primary penetrating member is adapted to penetrate the heart tissue at the injection site in a first direction, and wherein the at least one secondary penetrating member is retractable to a position within the primary penetrating member and penetrates the heart tissue in a second direction different from the first direction when extended from the primary penetrating member.

2. A catheter as in claim 1, wherein 1 to 20 secondary penetrating members are utilized.

3. A catheter as in claim 1, wherein the plurality of secondary penetrating members comprise microneedles.

4. A catheter as in claim 1, wherein the second direction is generally perpendicular to the first direction.

5. A catheter as in claim 1, wherein the second direction is at an angle of about 5 to about 90 degrees relative to the first direction.

6. A catheter as in claim 5, wherein the first direction is generally orthogonal to the heart tissue at the injection site.

7. A catheter as in claim 1, wherein the primary penetrating member includes at least one opening, and the at least one secondary penetrating member retracts and extends through said at least one opening.

8. A catheter as in claim 7, wherein the primary penetrating member includes a means for directing the at least one secondary penetrating member through the opening in the primary penetrating member.

9. A catheter as in claim 8, wherein said means for directing the at least one secondary penetrating member through the opening in the primary penetrating member comprises at least one lumen within the primary penetrating member extending generally in the longitudinal direction and transitioning to a generally lateral direction at the at least one opening.

10. A catheter as in claim 1, further comprising a sheath disposed about the shaft.

11. A catheter as in claim 10, wherein the sheath has a proximal end, a distal end and a lumen disposed therein.

12. A catheter as in claim 11, wherein the distal end of the sheath includes a suction head.

13. A catheter as in claim 1, wherein the primary penetrating member has a diameter in the range of approximately 20 to 36 Gauge.

14. A catheter as in claim 13, wherein the secondary penetrating member has a diameter in the range of approximately 27 to 40 Gauge.

15. A catheter system for delivering a fluid to heart tissue, comprising:

a pressurized fluid source containing a fluid therein; and

a catheter having a proximal end and a distal end, the proximal end of the catheter connected to the pressurized fluid source, the distal end of the catheter including an axial penetrating member adapted to penetrate heart tissue having a plurality of lateral penetrating members connected thereto wherein each of the lateral penetrating members is moveable from a first position retracted within the axial penetrating member to a second position extended from the axial penetrating member with each of the lateral penetrating members having a lumen in fluid communication with the pressurized fluid source such that fluid may be delivered to the heart tissue via the lateral penetrating members.

16. A catheter system as in claim 15, wherein the pressurized fluid source is pressurized to a relatively low pressure of less than approximately 1 ATM.

17. A catheter system as in claim 15, wherein the pressurized fluid source is pressurized to a relatively high pressure of greater than approximately 30 ATM.

18. A catheter system as in claim 15, further comprising:

a vacuum source; and

a sheath disposed about the catheter, the sheath having a proximal end, a distal end and a suction lumen disposed therein, the proximal end of the sheath connected to the vacuum source with the suction lumen of the sheath in fluid communication with the vacuum source, wherein the distal end of the sheath is disposed adjacent the heart tissue such that the distal end of the sheath is stabilized against the heart tissue when a vacuum is applied to the suction lumen using the vacuum source.

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

providing a catheter comprising a shaft having a proximal end and a distal end, the distal end of the catheter including a primary penetrating member and at least one secondary penetrating member, wherein the at least one secondary penetrating member is retractable to a position within the primary penetrating member and penetrates the heart tissue in a second direction different from the first direction when extended from the primary penetrating member;

inserting the catheter into the patient;

navigating the catheter until the distal end of the catheter is positioned adjacent the injection site;

actuating the primary penetrating member with the at least one secondary penetrating member retracted within the primary penetrating member such that the primary penetrating member penetrates the heart tissue at the injection site in a first direction;

actuating the at least one secondary penetrating member by extending the at least one secondary penetrating member from the primary penetrating member such that the at least one secondary penetrating member penetrates the heart tissue in a second direction different from the first direction; and

injecting the fluid into the heart tissue via the at least one secondary penetrating member.

20. A method of delivering a fluid as in claim 19, wherein less than approximately 100 microliters of fluid is injected into the heart tissue via the at least one secondary penetrating member.

21. A method of delivering a fluid as in claim 19, wherein the catheter includes a plurality of secondary penetrating members, and wherein fluid is injected into the heart tissue via the plurality of secondary penetrating members.

22. A method of delivering a fluid as in claim 19, wherein the at least one secondary penetrating member comprises a microneedle, and wherein fluid is injected into the heart tissue via the microneedle.

23. A method of delivering a fluid as in claim 22, wherein approximately 1 to 20 microliters of fluid is injected into the heart tissue via each microneedle.

24. A method of delivering a fluid as in claim 19, wherein the secondary member is 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.

25. A method of delivering a fluid as in claim 24, wherein the period of time ranges from about 5 seconds to about 120 seconds.

26. A method of delivering a fluid as in claim 24, wherein the period of time ranges from about 5 seconds to about 30 seconds.