Method and apparatus for controlled vessel occlusion

• US 7,674,240 B2
• Filed: 12/20/2005
• Issued: 03/09/2010
• Est. Priority Date: 12/20/2005
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Webler, William E., Yambao, August R.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/313,477
• Publication Number:
  US 20070142818A1
• Time in Patent Office: 1,540 Days
• Field of Search: 604/96.01, 604/97.01, 604/97.02, 604/97.03, 604/98.01, 604/98.02, 604/99.01, 604/99.02, 604/99.03, 604/100.01, 604/100.02, 604/100.03, 606/192, 606/194
• US Class Current: 604/97.02
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

A controlled volume inflation-deflation device to inflate a balloon to occlude a blood vessel by dialing a knob that locks at rotational positions to locate a plunger at equally spaced locations within a syringe of the inflation-deflation device. The inflation-deflation device includes a releasable latch to lock the proximal and distal housings together to hold the plunger forward for occlusion, and to separate and hold the proximal and distal housings to retract the plunger for perfusion. When the inflation-deflation device is returned to the latched position, the balloon is re-inflated to its previous occlusive diameter. Also, an extension tube made of a lower modulus outer material co-extruded over and miscible with a higher modulus inner material may be used. The balloon may have tapered ends and a cylindrical center portion so that it increases by more equal increments in outer diameter to incremental equal increases in inflation volume.

Claims

1. An apparatus comprising:

a releasable latch positioning a proximal housing relative to a distal housing, the distal housing coupled to a syringe tube and the proximal housing coupled to a plunger, the plunger disposed within the syringe tube;

a screw mechanism coupling at least one of the syringe tube to the distal housing and the plunger to the proximal housing, to move the plunger along a length of the syringe tube;

wherein the latch defines a first latched position to removably lock the latch to locate the plunger at a first location along the length and a second latched position to removably lock the latch to locate the plunger at a different second location along the length proximal to the first location, the releasable latch further comprising;

a cowling attached to the distal housing, the cowling comprising;

an inner surface extending over an exterior surface of the proximal housing;

at least one cowling recess in the inner surface;

the exterior surface comprising at least two indexing locks to engage the at least one cowling recess;

wherein the at least one cowling recess comprises at least one cowling groove radially around an inner diameter of the cowling, wherein the latch is locked at the first latched position when the at least two indexing locks are removably engaged in the at least one cowling groove, and the latch is locked at the second latched position when the at least two indexing locks are one of beyond and removably engaged with an end of the cowling.

2. The apparatus of claim 1, further comprising a knob coupled to the screw mechanism and having at least one indexing lock to engage at least one recess in a surface of one of the proximal and the distal housing adjacent the knob, such that rotating the knob causes the at least one indexing lock to engage the at least one recess and to move the plunger to a plurality of locations along the length.

3. The apparatus of claim 2, wherein the plurality of locations along the length are a plurality of equidistant plunger positions.

4. The apparatus according to claim 2, wherein the indexing locks comprise one of ball spring plungers and round nose spring plungers.

5. The apparatus according to claim 2, wherein the recesses are one of through holes and blind holes having one of straight sidewalls and beveled sidewalls.

6. The apparatus of claim 1, wherein in the first latched position, a proximal end of the distal housing is adjacent to a distal end of the proximal housing, and in the second latched position the proximal end of the distal housing is separated from the distal end of proximal housing.

7. The apparatus of claim 1, wherein when the at least one indexing lock is in one of a first cowling recess and a second cowling recess when the latch is in one of the first latched position and the second latched position.

8. The apparatus of claim 1, wherein the at least one indexing lock comprises one of a ball nose spring plunger, a round nose spring plunger, a spring and an o-ring, and wherein the at least one cowling recess comprises at least one of a hole in the cowling, a blind hole in the inner surface of the cowling, and a groove extending radially around the inner surface of the cowling with respect to a longitudinal axis of the unattached one of the proximal and the distal housing.

9. The apparatus of claim 1, wherein the cowling extends over a gap between a proximal surface of the distal housing and a distal surface of the proximal housing when the latch is in the second latched position.

10. The apparatus of claim 1, wherein the at least one cowling recess includes a first groove extending radially along the inner surface of the cowling with respect to a longitudinal axis of the distal housing, the first groove to be engaged by the at least one indexing lock when the latch is in the first latched position, and a second groove extending radially along the inner surface of the cowling with respect to the longitudinal axis and to be engaged by the at least one indexing lock when the latch is in the second latched position.

11. The apparatus of claim 10, further comprising at least one mid-position groove extending radially along the inner surface of the cowling between the first groove and the second groove with respect to the longitudinal axis, the mid-beveled groove to be engaged by the at least one indexing lock when the latch is in a mid-latched position to removably lock the latch to locate the plunger at a third location along the length.

12. The apparatus of claim 1, further comprising a longitudinal adjustable attachment between the cowling and the attached one of the proximal and the distal housing over an outer surface of the attached one of the proximal and the distal housing along a length of the longitudinal axis of the attached one of the proximal and the distal housing to adjust a location of the plunger along the length when a cowling recess is engaged by the at least one indexing lock.

13. The apparatus of claim 12, wherein the adjustable attachment comprises threads on an outer surface of the attached one of the proximal and the distal housing and corresponding threads on an inner surface of the cowling.

14. The apparatus of claim 1, further comprising a stop adjacent to the at least one cowling recess to stop the at least one indexing lock from extending along the inner surface of the cowling distal to the at least one cowling recess.

15. The apparatus of claim 1, further comprising at least one retaining pin constrained by two members, the members comprising the cowling, the distal housing and the proximal housing, each retaining pin extending through a portion of at least one of the members and including a stop surface to engage at least one surface of a one of the proximal and the distal housing to limit a distance the two constrained members can move apart and to prevent rotation of the two constrained members relative to each other.

16. The apparatus of claim 15, wherein at least one retaining pin includes at least one radial groove, each groove at a location along a length of the retaining pin, and wherein a housing that the pin extends through includes at least one indexing lock to engage the at least one groove to removably lock the pin to locate the plunger at least one location along the length.

17. The apparatus of claim 1, further comprising at least one interference between a portion of the cowling and a portion of the unattached one of the proximal and the distal housing to limit a distance the proximal and distal housings can move apart and to prevent rotation of the proximal housing the distal housing relative to the proximal housing.

18. The apparatus of claim 1, further comprising:

a rotational indexing device in the attached one of the proximal and the distal housing to engage an inner surface of the cowling over the rotational indexing device to removably lock the rotation of the cowling with respect to the unattached one of the proximal and the distal housing at a plurality of rotational positions around a longitudinal axis of the unattached one of the proximal and the distal housing.

19. The apparatus of claim 18, further comprising:

a plurality of mid-position recesses along the inner surface of the cowling at a plurality of positions corresponding to the plurality of rotational positions of the cowling relative to the attached one of the proximal and the distal housing and along a longitudinal axis of the cowling, the plurality of mid-position recesses to be aligned in turn with the at least one indexing lock of the unattached one of the proximal and the distal housing to define a plurality of mid-latched positions to removably lock the latch to locate the plunger at a plurality of locations along the length; and

at least one interference between the distal housing and the proximal housing, the interference comprising a mutually constrained member to prevent rotation of the distal housing relative to the proximal housing.

20. The apparatus of claim 19, wherein the rotational indexing device comprises at least one a ball nose spring plunger and a round nose spring plunger in the distal housing to engage a plurality of rotationally aligned recesses in the inner surface of the cowling at the plurality of rotational positions, such that rotating the cowling with respect to the attached one of the proximal and the distal housing along the longitudinal axis of the attached one of the proximal and the distal housing causes the ball nose or round nose spring plunger to select and removably lock into position one of the plurality of rotational positions and causes the at least one indexing lock of the unattached one of the proximal and the distal housing to select at least one of the plurality of mid-position recesses to select one of the plurality of mid-latched positions.

21. The apparatus of claim 19, wherein the plurality of mid-latched positions correspond to a plurality of plunger positions along the length correspond to a plurality of selected volumes of fluid to be pushed by the plunger by the transition of the releasable latch from a mid-position to the first position into a plurality of different occlusion devices after insertion of the occlusion devices into a blood vessel.

22. The apparatus of claim 1, further comprising:

an aspiration syringe attached to a detachable connector of a two way stopcock;

the two way stopcock coupled to the syringe tube and to a catheter having a dimension suitable for percutaneous advancement through a blood vessel, the two way stopcock having a plurality of adjustable positions to prohibit flow into or out of one of the aspiration syringe, the catheter and the syringe tube;

the catheter comprising;

a proximal end;

a distal end;

a balloon axially coupled to an exterior surface of the catheter at or adjacent to the distal end of the catheter, the balloon comprising a property such that the balloon will inflate to an inflated outer diameter that will occlude a blood vessel at a region of interest;

wherein the aspiration syringe, partially filled with a fluid or a fluid solution, has a plunger forming an aspirator seal with a sidewall, and a volume sufficient to aspirate the catheter and the balloon while the stopcock is adjusted to a first position precluding flow into and out of the syringe tube; and

wherein the detachable connector has a connector seal to allow the aspiration syringe to be removed from the stopcock after the stopcock is adjusted to a second position to preclude flow into or out of the aspiration syringe.

23. The apparatus of claim 1, wherein the screw mechanism comprises a first set of threads coupled to the syringe tube, and a second set of threads having threads that match the first set of threads coupled to the plunger.

24. The apparatus of claim 1, wherein the at least two indexing locks extend outward from the exterior surface of the proximal housing and move along the inner surface of the distal housing to removably engage the at least one cowling groove.