Lateral needle-less injection apparatus and method

• US 6,613,026 B1
• Filed: 12/08/1999
• Issued: 09/02/2003
• Est. Priority Date: 12/08/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (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:
  US09/457,193
• Time in Patent Office: 1,364 Days
• Field of Search: 604/164.01, 604/164.02, 604/164.03, 604/164.04, 604/164.06, 604/164.11, 604/171, 604/173, 604/176, 604/523, 604/264, 604/272, 606/167, 606/170
• US Class Current: 604/272
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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: 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

A device and method for delivering and injecting fluid into heart tissue utilizing laterally directed injection ports to increase injectate (fluid) retention in the heart tissue. The catheter includes a shaft having an infusion lumen extending therethrough, wherein the distal end of the shaft includes a penetrating member having one or more injection ports. The penetrating member penetrates the heart tissue in a first direction, and the injection port or ports direct fluid in a second direction different from the first direction. By injecting the fluid or fluid in a direction different than the penetration direction, fluid leakage from the injection site is reduced and a greater volume of tissue is treated for a single primary injection.

Claims

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

a shaft having a proximal end, a distal end and an infusion lumen extending therein, the distal end of the shaft including a penetrating member having an injection port and a sharpened distal end, wherein the penetrating member penetrates the heart tissue at the injection site in a first direction, and wherein the injection port directs fluid in a second direction different from the first direction, said second direction is at an angle non-orthogonal and non-parallel to infusion lumen such that fluid leakage from the injection site is reduced.

2. A catheter as in claim 1, wherein a plurality of injection ports are utilized.

3. A catheter as in claim 2, wherein about 2 to about 100 injection ports are utilized.

4. A catheter as in claim 2, wherein each of the plurality of injection ports have a diameter of approximately 1 to 500 microns.

5. A catheter as in claim 1, wherein the second direction is generally lateral 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, further comprising a sheath disposed about the shaft.

8. A catheter as in claim 7, wherein the sheath has a proximal end, a distal end and a lumen disposed therein.

9. A catheter as in claim 8, wherein the distal end of the sheath includes a suction head.

10. A catheter as in claim 1, wherein the penetrating member has an outer diameter in the range of approximately 10 microns to 1.25 mm.

11. A catheter as in claim 10, wherein the penetrating member has an exposed length in the range of approximately 1 to 10 mm.

12. 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, a distal end and an infusion lumen extending therein, the proximal end of the catheter connected to the pressurized fluid source, the infusion lumen in fluid communication with the fluid contained in the pressurized fluid source, the distal end of the catheter including an axial penetrating member having a sharpened distal end and a plurality of lateral injection ports, each of the injection ports being in fluid communication with the infusion lumen such that fluid from the pressurized fluid source may be delivered to the heart tissue via the injection ports, said ports further injecting fluid at a direction non-orthogonal and non-parallel to the direction of the axial penetrating member.

13. A catheter system as in claim 12, wherein the pressurized fluid source is pressurized to a relatively low pressure of less than approximately 1 ATM to reduce tissue trauma.

14. A catheter system as in claim 12, wherein the pressurized fluid source is pressurized to a relatively high pressure of greater than approximately 100 ATM to increase tissue penetration.

15. A catheter system as in claim 12, 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.

16. 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, a distal end and an infusion lumen extending therein, the distal end of the catheter including a penetrating member, a sharpened distal end, and an injection port;

inserting the catheter into the patient;

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

actuating the penetrating member such that the sharpened distal end of the penetrating member cuts the heart tissue at the injection site in a first direction; and

injecting the fluid into the heart tissue via the injection port in a second direction said second direction non-orthogonal and non-parallel to the first direction.

17. A method of delivering a fluid as in claim 16, wherein less than approximately 100 microliters of fluid is injected into the heart tissue via the injection port.

18. A method of delivering a fluid as in claim 16, wherein the catheter includes a plurality of injection ports, and wherein fluid is injected into the heart tissue via the injection ports.

19. A method of delivering a fluid as in claim 18, wherein approximately 1 to 20 microliters of fluid is injected into the heart tissue via the injection ports.

20. A fluid delivery mechanism comprising:

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