Lateral needle injection apparatus and method

• US 6,969,371 B2
• Filed: 10/22/2001
• Issued: 11/29/2005
• Est. Priority Date: 05/07/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Palasis, Maria, Rosenthal, Arthur
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US09/982,934
• Publication Number:
  US 20020026150A1
• Time in Patent Office: 1,499 Days
• Field of Search: 604/158, 604/162, 604/164.01, 604/164.02, 604/164.06, 604/164.08, 604/164.09, 604/164.11, 604/165.01, 604/165.02, 604/170.02, 604/170.03, 604/171, 604/173, 604/264, 604/372, 604/523, 606/167, 606/184, 606/185
• 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 comprising:

a shaft having a proximal end and a distal end and a wall defining at least one aperture, the distal end of the shaft including a primary penetrating member having a sharpened end and at least one secondary penetrating member having a sharpened end, wherein the primary penetrating member is adapted to penetrate tissue 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 tissue in a second direction different from the first direction when extended from the primary penetrating member, the shaft further comprising an insert having a lumen extending in a longitudinal direction of the shaft and transitioning to a generally lateral direction adjacent the at least one aperture to direct the at least one secondary member through the at least one aperture.

2. The catheter of claim 1, wherein the tissue is selected from the group consisting of tumors, heart, lung, brain, liver, kidney, bladder, urethra, ureters, eye, intestines, stomach, pancreas, ovary, prostate, skeletal muscle, smooth muscle, breast, cartilage and bone.

3. The catheter of claim 1, wherein the at least one secondary penetrating member comprises microneedles.

4. The catheter of claim 1, wherein the second direction is generally perpendicular to the first direction.

5. The catheter of 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 system comprising:

a pressurized fluid source including fluid therein, and

a catheter having a proximal end and a distal end and a wall defining at least one aperture, wherein the proximal end of the catheter is connected to the pressurized fluid source, wherein the distal end of the catheter includes a primary penetrating member having a sharpened end and at least one secondary penetrating members having a sharpened end, wherein the primary penetrating member is adapted to penetrate tissue in a first direction, and wherein each of the at least one secondary penetrating members is retractable to a first position within the primary penetrating member and a second position extended from the primary penetrating member, with each of the least one secondary penetrating members having a lumen in fluid communication with the pressurized fluid source such that fluid may be delivered to the tissue via the secondary penetrating members, the shaft further comprising an insert having a lumen extending in a longitudinal direction of the shaft and transitioning to a generally lateral direction adjacent the at least one aperture to direct the at least one secondary member through the at least one aperture.

7. The catheter system of claim 6, wherein the secondary penetrating members penetrate the tissue in a second direction different from the first direction when extended from the primary penetrating member.

8. The catheter system of claim 6, wherein the second direction is generally perpendicular to the first direction.

9. The catheter system of claim 6, wherein the second direction is at an angle of about 5 to about 90 degrees relative to the first direction.

10. The catheter system of claim 6, wherein the tissue is selected from the group consisting of tumors, heart, lung, brain, liver, kidney, bladder, urethra, ureters, eye, intestines, stomach, pancreas, ovary, prostate, skeletal muscle, smooth muscle, breast, cartilage and bone.

11. The catheter system of claim 6, wherein the fluid comprises at least one therapeutic agent.

12. The catheter system of claim 6, wherein the at least one secondary penetrating member comprises microneedles.