Apparatus for preventing loss of a composition during a medical procedure

• US 6,203,526 B1
• Filed: 08/21/1998
• Issued: 03/20/2001
• Est. Priority Date: 08/22/1997
• Status: Expired due to Fees

• Current Assignee: Direct Therapeutics, Inc.
• Original Assignee: Direct Therapeutics, Inc.
• Inventors: DeCrescito, Vincent, McBeth, Dean M., Kronenthal, Richard
• Primary Examiner(s): Kennedy, Sharon
• Application Number:
  US09/138,025
• Time in Patent Office: 942 Days
• Field of Search: 604/104, 604/105, 604/106, 604/107, 604/264, 604/280, 604/246, 604/96, 604/101, 604/96.01, 604/101.04, 604/99.04, 604/103.03
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

In a method and apparatus for delivering a composition to a targeted area of tissue, exposure of a non-targeted tissue to the composition is minimized. The apparatus has at least one needle-like shaft which is inserted through a track in the non-targeted tissue to deliver the composition to the targeted tissue through an opening in the shaft. The track may be a naturally occurring lumen in a tissue, such as a vascular lumen, or may be a track created surgically by a diagnostic instrument, or by the needle-like shaft of the present apparatus. A valve-like mechanism closes the opening in the shaft to prevent premature delivery of the composition during insertion of the shaft, and to prevent loss of composition during withdrawal of the shaft. The valve-like mechanism also prevents excessive delivery of the composition to targeted tissue. An annular dam is mounted on an exterior portion of the shaft near the opening. When the opening in the shaft has been suitably positioned in the targeted tissue, the dam is radially expanded to prevent quantities of composition intended for delivery to the targeted tissue from flowing away from the targeted tissue along the track though which the shaft is inserted.

Claims

1. An apparatus for delivering a composition to a target area of a tissue, the apparatus traversing a track in the tissue, the apparatus comprising:

an elongate tubular inner member having a proximal end, a distal end and a lumen extending from the proximal end to the distal end of the inner member, said lumen adapted to receive a fluid at the proximal end of the inner member, and means for delivering said fluid from the distal end of the inner member to the target tissue by way of the lumen;

an elongate tubular central member having a proximal end, a distal end and a lumen extending from said central member proximal end to said central member distal end, said tubular inner member being coaxially positioned in said lumen of said central member;

an elongate tubular outer member having a proximal end, a distal end, lumen extending from said outer member proximal end to said outer member distal end, said tubular central member being coaxially located in said lumen of said outer member; and

means for inhibiting a migration of said composition along the track from said target area comprising a selectively, radially expandable sleeve biased toward a radially expanded position when the apparatus is stationary in said tissue, is sufficiently radially compressible to permit movement of said apparatus in said tissue, wherein said radially expandable sleeve has a proximal end and a distal end, said proximal end and distal ends being restrained from expanding, and said proximal end and distal end are separated by an expandable portion having a predetermined length and wherein the proximal end of the sleeve is engaged by the distal end of the outer member and the distal end of the sleeve is engaged by the distal end of central member and, wherein movement of said central member relative to the outer member causes a reduction in a distance between said proximal and distal ends of said sleeve so that said expandable portion of said sleeve expands radially outward.

2. The apparatus according to claim 1 wherein the means for inhibiting a migration is adapted to selectively seal the composition in the apparatus as the apparatus is inserted through the track.

3. The apparatus according to claim 1 wherein the means for inhibiting a migration is adapted to selectively seal the composition in the apparatus while the apparatus is positioned in the tissue.

4. The apparatus according to claim 1 wherein the track is formed by the insertion of the apparatus into said tissue.

5. The apparatus according to claim 1 wherein said means for inhibiting a migration is located proximal to said means for delivering fluid.

6. The apparatus of claim 1 further comprising means for providing selective interruption of composition delivery to said target area.

7. The apparatus for delivering a composition to a target area of a tissue according to claim 1, wherein the means for delivering is stationary relative to the means for inhibiting migration of the composition along the track.

8. The apparatus according to claim 1 wherein the means for delivering is movable relative to the means for inhibiting a migration of said composition along the track from said target area.

9. The apparatus according to claim 1 wherein the distal end of the inner member is steerable.

10. The apparatus according to claim 1, where in the delivery means may be selectively positioned within the target area.

11. The apparatus according to claim 1, wherein the apparatus is introduced into the target tissue by surgical means.

12. The apparatus according to claim 1 further comprising imaging means for locating the target tissue.

13. The apparatus according to claim 1 wherein the radially expandable sleeve is a balloon.

14. The apparatus according to claim 13 wherein the balloon is expanded by mechanical means.

15. The apparatus according to claim 1, wherein said movement of said central member relative to said outer member is along a longitudinal axis of said apparatus.

16. The apparatus according to claim 1, wherein said distal end of said central member has a radially outwardly directed annular shoulder, said shoulder forming a proximally facing annular bearing surface, and wherein said distal end of said sleeve engages said bearing surface of said shoulder.

17. The apparatus according to claim 1, wherein the proximal end of the sleeve is secured to the distal end of the outer member, the distal end of the sleeve is engaged by the distal end of the central member, and wherein a longitudinal movement of the central member relative to the outer member in a direction to cause a reduction in the distance between the proximal and distal ends of the sleeve causes said expandable portion of sleeve to expand radially outwardly.

18. The apparatus according to claim 1, wherein the proximal end of the sleeve is secured to the distal end of the outer member, the distal end of the sleeve is engaged by the distal end of the central member, and wherein a longitudinal movement of the central member relative to the outer member to cause a reduction in the distance between the proximal and distal ends of the sleeve causes said expandable portion of sleeve to expand radially outwardly.

19. The apparatus according to claim 1, wherein said radially expandable sleeve is comprised of an elastic material.

30. The apparatus of claim 1, wherein the means for delivering said fluid is axially movable relative to the means for inhibiting migration.

20. An apparatus for delivering a composition to a target area of a tissue, the apparatus traversing a track in the tissue, the apparatus comprising:

an elongate tubular inner member having a proximal end, a distal end and a lumen extending from the proximal end to the distal end of the inner member, said lumen adapted to receive a fluid at the proximal end of the inner member, and means for delivering said fluid from the distal end of the inner member to the target tissue by way of the lumen;

an elongate tubular central member having a proximal end, a distal end and a lumen extending from said central member proximal end to said central member distal end, said tubular inner member being coaxially positioned in said lumen of said central member;

an elongate tubular outer member having a proximal end, a distal end, lumen extending from said outer member proximal end to said outer member distal end, said tubular central member being coaxially located in said lumen of said outer member; and

means for inhibiting a migration of said composition along the track from said target area, wherein said means for inhibiting migration of said composition is a vacuum provided along a portion of the apparatus in the tissue such that an adjacent portion of tissue collapses onto the apparatus.

21. The apparatus of claim 20, wherein the track in said tissue from said target area is created by insertion of said apparatus.

22. The apparatus according to claim 20 wherein said means for inhibiting a migration is located proximal to said means for delivering fluid.

23. The apparatus of claim 20 further comprising means for providing selective interruption of composition delivery to said target area.

24. The apparatus according to claim 20, wherein the means for delivering is stationary relative to the means for inhibiting migration of the composition along the track.

25. The apparatus according to claim 20 wherein the means for delivering is movable relative to the means for inhibiting a migration of said composition along the track from said target area.

26. The apparatus according to claim 20 wherein the distal end of the inner member is steerable.

27. The apparatus according to claim 20, where in the delivery means may be selectively positioned within the target area.

28. The apparatus according to claim 20, wherein the apparatus is introduced into the target tissue by surgical means.

29. The apparatus according to claim 20 further comprising imaging means for locating the target tissue.