Methods and apparatus for delivering substances into extravascular tissue

• US 6,217,554 B1
• Filed: 02/12/1999
• Issued: 04/17/2001
• Est. Priority Date: 02/12/1999
• Status: Expired due to Fees

• Current Assignee: Pharmaspec Corporation
• Original Assignee: Pharmaspec Corporation
• Inventors: Green, Bert
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/249,751
• Time in Patent Office: 795 Days
• Field of Search: 604/264, 604/48, 604/500, 604/506, 604/507-509, 604/93, 604/96, 604/158, 604/523, 604/529, 604/530
• US Class Current: 604/164.01
• 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 2018/00392 Transmyocardial revascularisation
• 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 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Apparatus and methods for delivering a therapeutic or diagnostic agent into extravascular tissue surrounding a body passageway is provided comprising a catheter having a sheath, a tubular member, and a plurality of hollow needles on a distal end of the tubular member. The tubular member is selectively movable between delivery position, wherein the plurality of hollow needles are retracted within the sheath, and an extended position, wherein the plurality of hollow needles extend beyond a distal endface of the sheath to pierce and penetrate extravascular tissue. The catheter also includes a balloon for applying pressure to seal puncture wounds created by the hollow needles.

Claims

1. A catheter for directly delivering a therapeutic or diagnostic agent into extravascular tissue, the catheter comprising:

(a) a sheath;

(b) a tubular member slidably disposed within the sheath, the tubular member having a proximal end, a distal end, and a first lumen extending therebetween; and

(c) means for both penetrating extravascular tissue, and for delivering a therapeutic or diagnostic agent into said extravascular tissue, without piercing a vessel wall, said means comprising a plurality of hollow needles arrayed around a portion of a circumference of said tubular member, each hollow needle having a sharpened tip capable of penetrating the extravascular tissue, said plurality of hollow needles being disposed on the distal end in fluid communication with the first lumen, the plurality of hollow needles having a delivery position wherein the plurality of hollow needles are disposed within the sheath, and an extended position wherein the plurality of hollow needles extend beyond a distal endface of the sheath, the plurality of hollow needles being biased to curve outwardly from the tubular member in the extended position to penetrate into the extravascular tissue, said plurality of hollow needles being configured such that when in said extended position only extravascular tissue is penetrated, while said vessel wall is not penetrated.

2. The catheter as defined in claim 1, further comprising an endcap affixed to the distal end of the tubular member, the plurality of hollow needles being affixed to a distal face of the endcap.

3. The catheter as defined in claim 2, wherein the hollow needles are arranged in a pattern on the distal face of the endcap.

4. The catheter as defined in claim 3 wherein the hollow needles are arranged in a semicircular pattern.

5. The catheter as defined in claim 1 wherein the hollow needles comprise a nickel-titanium alloy.

6. The catheter as defined in claim 1 further comprising an inner member coaxially disposed within the tubular member.

7. The catheter as defined in claim 1 further comprising a handle coupled to the sheath and tubular member to selectively extend the plurality of hollow needles to the extended position by a predetermined amount.

8. The catheter as defined in claim 1, wherein each one of the plurality of hollow needles further comprises a non-coring tip.

9. The catheter as defined in claim 1 further comprising a radio-opaque marker ring disposed on the tubular member.

10. The catheter as defined in claim 1 further comprising a balloon mounted on a distal end of the sheath.

11. A catheter for directly delivering a therapeutic or diagnostic agent into extravascular tissue, the catheter comprising:

(a) a sheath;

(b) a tubular member slidably disposed within the sheath, the tubular member having a proximal end, a distal end, and a first lumen extending therebetween;

(c) means for penetrating extravascular tissue and delivering a therapeutic or diagnostic agent into said extravascular tissue, without piercing a vessel wall, said means comprising a plurality of hollow needles arrayed around a portion of a circumference of said tubular member, each hollow needle having a sharpened tip capable of penetrating the extravascular tissue, said plurality of hollow needles being disposed on the distal end in fluid communication with the first lumen, the plurality of hollow needles being biased to curve outwardly from the tubular member in an extended position;

said plurality of hollow needles being configured such that when in said extended position only extravascular tissue is penetrated, while said vessel wall is not penetrated; and

(d) a handle coupled to the sheath and tubular member to selectively move the plurality of hollow needles from a delivery position, wherein the plurality of hollow needles are disposed within the sheath, to the extended position, so that in the extended position, the plurality of hollow needles extend beyond a distal endface of the sheath and penetrate the extravascular tissue.

12. The catheter as defined in claim 11, further comprising an endcap affixed to the distal end of the tubular member, the plurality of hollow needles being affixed to a distal face the endcap.

13. The catheter as defined in claim 12, wherein the hollow needles are arranged in a semi-circular pattern.

14. The catheter as defined in claim 11 wherein the hollow needles comprise a nickel-titanium alloy.

15. The catheter as defined in claim 11 further comprising an inner member coaxially disposed within the tubular member, the inner member including a lumen defining a guide wire lumen.

16. The catheter as defined in claim 11, wherein each one of the plurality of hollow needles further comprises a non-coring tip.

17. The catheter as defined in claim 11 further comprising a balloon mounted on a distal end of the sheath.

18. A method for directly delivering a therapeutic or diagnostic agent into extravascular tissue surrounding a body passageway, comprising the steps of:

(a) providing a catheter that includes a sheath, a tubular member having a lumen slidably disposed within the sheath, a handle coupled to the tubular member, and a plurality of hollow needles, each hollow needle having a sharpened tip capable of penetrating extravascular tissue, said plurality of hollow needles being disposed on a distal end of the tubular member in fluid communication with the lumen, the plurality of hollow needles being biased to curve outwardly to penetrate extravascular tissue in an extended position;

(b) operating the handle to retract the plurality of hollow needles within the Sheath;

(c) percutaneously and transluminally inserting the catheter to position a distal end of the sheath at a desired location in the body passageway;

(d) orienting the catheter so that the hollow needles are positioned to pierce the body passageway and penetrate the extravascular tissue;

(e) operating the handle so as to extend the plurality of hollow needles to pierce the body passageway and penetrate the extravascular tissue to a first depth; and

(f) injecting a therapeutic or diagnostic agent through the hollow needles and into the extravascular tissue at the first depth.

19. The method of claim 18, further comprising the steps of:

(a) after injecting a therapeutic or diagnostic agent at the first depth, operating the handle to extend the plurality of hollow needles to a second depth greater than the first depth; and

(b) injecting a therapeutic or diagnostic agent through the hollow needles and into the extravascular tissue at the second depth.

20. The method of claim 18, wherein the catheter further comprises a balloon;

and wherein the step of operating the handle to extend the plurality of hollow needles to the first depth forms a plurality of puncture wounds, the method further comprising the steps of;

(a) after injecting a therapeutic or diagnostic agent at the first depth, operating the handle to retract the plurality of hollow needles within the sheath;

(b) repositioning the catheter within the body passageway so that the balls is aligned with the plurality of puncture wounds; and

(c) inflating the balloon to apply pressure to seal the puncture wounds.