Blood vessel occlusion trocar having size and shape varying insertion body

• US 6,224,619 B1
• Filed: 09/17/1996
• Issued: 05/01/2001
• Est. Priority Date: 12/17/1991
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Hill, John Donald
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/714,887
• Time in Patent Office: 1,687 Days
• Field of Search: 606/201, 606/203, 606/191-194, 604/96-99, 604/100-104
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 25/0069 Tip not integral with tube

Abstract

An occluder apparatus for obstructing the flow of blood in a blood vessel has an elongated hollow tubular body having a leading end sized for reception in the blood vessel and includes portion of the body fabricated from a material soluble in blood, and a piercing device for inserting the body through the wall of the blood vessel to extend the leading end into the interior of the blood vessel. An inflatable diaphragm is carried by the body in a collapsed, deflated condition, and the apparatus includes a passage for conducting an inflating fluid from an external source, which is into fluid communication with the interior of the diaphragm, to effect expansion the diaphragm. Elongated openings in the body enable the diaphragm to be released in an inflated state from the body into flexible occluding engagement with the interior wall of the blood vessel about the full circumference of a transverse section thereof.

Claims

1. An occluder apparatus for obstructing the flow of blood in a blood vessel comprising:

an elongated hollow tubular body having a leading end sized for reception in said blood vessel and including at least one portion of said body fabricated from a soluble material;

means for inserting said body through the wall of said blood vessel to extend said leading end into the interior of said blood vessel;

an inflatable diaphragm carried by said body in a collapsed, deflated condition;

means for conducting an inflating fluid from an external source into fluid communication with the interior of said diaphragm to effect expansion thereof; and

wherein said diaphragm in an inflated state is in flexible occluding engagement with the interior wall of said blood vessel about substantially the full circumference of a transverse section thereof.

2. The occluder apparatus according to claim 1, wherein said body includes means to enable release of said diaphragm.

3. The occluder apparatus according to claim 1, wherein said soluble material is soluble in a water-based medium.

4. The occluder apparatus according to claim 1, wherein said soluble material is soluble in blood.

5. The occluder apparatus according to claim 1, wherein said soluble material has solubility characteristics, such that a temperature solubility curve is intersected at a temperature in a range of about 1 to 41°

C. and a dissolution time in a range of about 5 seconds to 30 minutes.

6. The occluder apparatus according to claim 1, wherein said soluble material is organic.

7. The occluder apparatus according to claim 5, wherein said soluble organic material is selected from the group consisting of carbohydrates, proteins, gelatins, plastics, lipids and lipid compounds, and polyethyl glycol.

8. The occluder apparatus according to claim 1, wherein said soluble material is inorganic.

9. The occluder apparatus according to claim 7, wherein said soluble inorganic material is selected from the group consisting of sodium chloride and sodium bicarbonate.

10. The occlude apparatus according to claim 1, wherein said soluble material includes a plurality of soluble layers, each of said plurality of layers having solubility characteristics different from at least another of said plurality of layers.

11. The occluder apparatus according to claim 1, wherein said soluble material includes a honeycomb structure and a honeycomb filling material, such that said honeycomb structure and said honeycomb filling material have different solubility characteristics.

12. The occluder apparatus according to claim 1, wherein said body includes a honeycomb portion and said at least one soluble portion is a honeycomb filling portion.

13. The occluder apparatus according to claim 2, in which said diaphragm release-enabling means comprises elongated openings extending longitudinally of said body.

14. The occluder apparatus according to claim 13, in which said openings for releasing said diaphragm are substantially oppositely disposed in lateral alignment for releasing said diaphragm upon inflation substantially coincidently through both of said openings.

15. The occluder apparatus according to claim 13, including means forming a partition extending transversely of the interior of said body defining longitudinal fluid-conducting passage means therein;

and means forming at least one fluid opening in the wall of said body to place said passage means in fluid communication with the exterior of said body.

16. The occluder apparatus according to claim 1, in which said diaphragm, when inflated, defines a generally toroidally-shaped cushion portion for engaging the interior wall of said blood vessel about substantially the full circumference thereof and has a membrane portion filling the region interior of said cushion portion.

17. The occluder apparatus according to claim 1, including means on the exterior of said body for securing said body with respect to said blood vessel.

18. The occluder apparatus according to claim 17, in which said securing means comprises laterally disposed flange means extending from the exterior of said body, said flange means providing means for attaching said body to the wall of said blood vessel via sutures.

19. The occluder apparatus according to claim 1, including piercing means at the leading end of said body for incising the wall of said blood vessel to effect penetration of said blood vessel wall by said body.

20. The occluder apparatus according to claim 19, wherein said piercing means is fabricated from a soluble material.

21. The occluder apparatus according to claim 19, in which said piercing means are removably attached to said body to enable their withdrawal from said body following penetration of said vessel wall and prior to inflation of said diaphragm.

22. The occluder apparatus according to claim 19, in which said piercing means comprises a generally conical plug carried by the leading end of said body, the apex of said plug forming a point to effect penetration of the wall of said blood vessel.

23. The occluder apparatus according to claim 20, in which said piercing means comprises a hollow plug formed of expandable material, which, in an expanded condition, defines a generally conical exterior shape the apex of which forms a point to effect penetration of the wall of said blood vessel, and means forming a passage extending through said body to communicate the interior of said plug with an external source of inflating fluid, whereby said plug is expandable by said inflating fluid into a piercing configuration or collapsible into a condition for removal from said body.

24. The occluder apparatus according to claim 15, in which said fluid passage means includes means at an end opposite said wall openings connecting said passage means with at least one fluid source exteriorly of said body.

25. The occluder apparatus according to claim 24, in which said passage means connects at said end with a source of myocardial fluid for supply said fluid to said blood vessel on a proximate side of said diaphragm.

26. The occluder apparatus according to claim 24, in which said passage means connects at said end with a pressure monitor for monitoring the internal pressure of said blood vessel on a side of said diaphragm.

27. The occluder apparatus according to claim 24, in which said passage means connects at said end with heart-lung machine for circulating blood to said blood vessel on a side of said diaphragm.

28. The occluder apparatus according to claim 24, including means for separately connecting said one end of said fluid passage means to both a source of myocardial fluid and to a pressure monitor;

and valve means for connecting said fluid passage means with said myocardial fluid and said pressure monitor.

29. The occluder apparatus according to claim 28, including valve means in said passage means for selectively admitting blood supply from said heart-lung machine to said passage means.

30. The occluder apparatus according to claim 24, in which said partition means comprises a partition plate extending chordally across the interior of said tubular body to divide said interior into parallel longitudinally-extending fluid-conducting passages;

a first in said body for fluidly communicating one of said passages with said blood vessel on the proximal side of said diaphragm and a second opening in said body on the other side of said diaphragm release-enabling means for fluidly connecting the other of said passages with said blood vessel on the distal side of said diaphragm.

31. The occluder apparatus according to claim 30, including means at an end of said one passage for connecting said one passage to a source of myocardial fluid for circulation through said first opening with said blood vessel on the proximal side of said diaphragm.

32. The occluder apparatus according to claim 30, including means at an end of said one passage for connecting said one passage to a pressure monitor for monitoring the internal pressure of said blood vessel on the proximal side of said diaphragm.

33. The occluder apparatus according to claim 30, including means at an end of said one passage for connecting said one passage to a source of myocardial fluid and to a pressure monitor, and valve means operable with said connecting means for connecting said passage to said source of myocardial fluid and to said pressure monitor.

34. The occluder apparatus according to claim 30, including means at an end of said other passage for connecting said other passage to a heart-lung machine to circulate blood from said heart-lung machine to said blood vessel on the distal side of said diaphragm.

35. The occluder apparatus according to claim 34, including valve means in said other passage for selectively circulating blood from said heart-lung machine to said blood vessel on the distal side of said diaphragm.

36. The occluder apparatus according to claim 32, including means at an end of said other passage for connecting said other passage to a heart-lung machine;

and the valve means in said other passage for selectively circulating blood from said heart-lung machine to said blood vessel on the distal side of said diaphragm.

37. An occluder apparatus for obstructing the flow of blood in a blood vessel comprising in combination:

an elongated hollow tubular body having a leading end for reception in said blood vessel and including at least one portion of said body fabricated from a soluble material;

means for inserting said body through the wall of said blood vessel to extend said leading end into the interior of said blood vessel;

an inflatable diaphragm carried by said body in a collapsed, deflated condition for insertion into the interior of said blood vessel;

means for inflating said diaphragm to expand it about its periphery into cushioned occluding engagement with the interior wall of said blood vessel;

a belt-like pressurizing device including an inflatable cuff arranged to substantially surround the exterior of said blood vessel and to be expanded under the influence of fluid pressure into engagement with the exterior wall thereof in substantially opposing relation to the engagement of said interior wall of said blood vessel by said diaphragm; and

means for inflating said cuff.

38. The combination according to claim 37, in which said diaphragm-inflating means and said cuff-inflating means are fluidly interconnected for the admission of pressurizing fluid for the substantial simultaneous inflating of said diaphragm and said cuff.

39. The combination according to claim 38, in which said belt-like pressurizing device comprises:

a base adapted to enclose the exterior of said blood vessel;

means for attaching said cuff to the wall-facing surface of said base;

inflating-fluid inlet means formed on said base in fluid communication with the interior of said cuff for supplying pressurizing fluid thereto; and

means on said base retaining said body.

40. The combination according to claim 39, in which said retaining means comprises a substantially annular collar extending from the exterior surface of said base;

and means forming an opening extending through said collar and said cuff to receive said body.

41. The combination according to claim 40, including at least one locking projection extending from said body;

and means on said collar cooperable with said projection for fixedly retaining said body.

42. The combination according to claim 41, including means on the exterior of said body for receiving sutures to fix said body to said blood vessel;

and said locking projection on said body engaging a cooperating recess in said collar when said belt is superimposed on said body.

43. The combination according to claim 42, including a bayonet slot formed on the interior surface of said collar, said bayonet slot cooperating with said locking projection upon applying said tubular body to said collar for locking said body with respect to said collar.