Apparatus and methods for providing selectively adjustable blood flow through a vascular graft

• US 6,053,891 A
• Filed: 05/13/1998
• Issued: 04/25/2000
• Est. Priority Date: 08/26/1996
• Status: Expired due to Fees

• Current Assignee: William M. Decampli
• Original Assignee: William M. Decampli
• Inventors: DeCampli, William M.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US09/078,318
• Time in Patent Office: 713 Days
• Field of Search: 604/66, 604/93, 604/175, 600/345, 600/347, 600/360, 600/377, 600/382, 600/459, 607/30, 607/32, 607/57, 607/60, 607/116, 607/119
• US Class Current: 604/288.01
• 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 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 for adjusting blood flow through a graft is provided comprising a balloon disposed against the exterior surface of the graft by a substantially rigid sheath, so that when the balloon is inflated with an inflation medium it causes constriction of blood flow through the graft without creating potentially thrombogenic crimps or infolds in the graft material. The balloon is adjusted by connecting an infusion device to a subcutaneously implanted balloon access port. A pair of ultrasonic elements may be optionally provided to measure blood flow through the graft and to optimize the extent of constriction of the graft. Electrical connection between the ultrasonic elements and external ultrasound processing circuitry is established via a subcutaneously implanted electrical access port that enables multiple electrical connections to be made using a single needle stick.

Claims

1. Apparatus for for monitoring or controlling an implantable device via a subcutaneous access port, the apparatus comprising:

an electrical access port adapted for subcutaneous implantation in an animal, the electrical access port comprising;

a body defining a chamber, an aperture and at least one suture hole;

a septum extending across the aperture;

a first plurality of electrical contacts disposed within the chamber; and

means for electrically coupling the first plurality of electrical contacts to the implantable device; and

a first needle comprising;

a cylindrical member;

a non-coring tip adapted to traverse tissue and pierce the septum; and

a second plurality of electrical contacts disposed on the cylindrical member and adapted to electrically couple to respective ones of the first plurality of electrical contacts; and

means for electrically coupling the second plurality of electrical contacts to external circuitry.

2. The apparatus as defined in claim 1 wherein each one of the first plurality of electrical contacts comprises a resilient member.

3. The apparatus as defined in claim 1 wherein the first plurality of electrical contacts comprises a plurality of pairs of semi-circumferential rings, adjacent ones of the plurality of pairs of semi-circumferential rings separated by an insulating circumferential ring.

4. The apparatus of claim 1 further comprising:

a fluid access port adapted for subcutaneous implantation in a living body, the fluid access port comprising;

a body defining a chamber, an aperture and at least one suture hole;

a self-sealing septum extending across the aperture; and

a lumen interposed between the fluid access port and the implantable device and providing fluid communication therebetween; and

infusion means comprising;

a second needle having a portion defining a bore, and a non-coring tip adapted to traverse tissue and pierce the septum, the non-coring tip including a portion defining an exit from the bore; and

means for infusing a fluid into the second access port via the second needle.

5. The apparatus as defined in claim 4 wherein the lumen comprises a substantially non-distensible material.

6. The apparatus as defined in claim 5 wherein the fluid actuated portion of the implantable device is a balloon.

7. The apparatus as defined in claim 3 wherein the chamber includes a longitudinal axis and the plurality of pairs of semi-circumferential rings are biased towards the longitudinal axis.

8. The apparatus as defined in claim 1 further comprising a plurality of wires that couple the first plurality of electrical contacts to the implantable device.

9. The apparatus as defined in claim 3 wherein the chamber has a cone-shaped portion disposed beneath the septum that guides the second plurality of electrical contacts into engagement with the first plurality of electrical contacts.

10. The apparatus as defined in claim 4 wherein the electrical access port and the fluid access port comprise first and second portions of a single housing.

11. Apparatus for monitoring or controlling an implantable device adapted to be coupled to an external device via a subcutaneous access port, the apparatus comprising:

a first access port adapted for subcutaneous implantation comprising;

a body defining a chamber, an aperture and at least one suture hole;

a septum extending across the aperture;

a first plurality of electrical contacts disposed within the chamber, the first plurality of electrical contacts coupled to the implantable device; and

a first needle comprising;

an elongated member having a non-coring tip adapted to traverse tissue and pierce the septum of the first access port; and

a second plurality of electrical contacts disposed on the needle and adapted to electrically couple to respective ones of the first plurality of electrical contacts, the second plurality of electrical contacts coupled to the external device.

12. The apparatus as defined in claim 11 wherein each one of the first plurality of electrical contacts comprises a resilient member.

13. The apparatus as defined in claim 11 further comprising a plurality of wires that couple the first plurality of electrical contacts to the implantable device.

14. The apparatus as defined in claim 11 wherein the chamber has a cone-shaped portion disposed beneath the septum that guides the second plurality of electrical contacts into engagement with the first plurality of electrical contacts.

15. The apparatus as defined in claim 11 wherein the first plurality of electrical contacts comprises a plurality of pairs of semi-circumferential rings, adjacent ones of the plurality of pairs of semicircumferential rings separated by an insulating circumferential ring.

16. The apparatus as defined in claim 15 wherein the chamber defines a longitudinal axis and the plurality of pairs of semi-circumferential rings are biased towards the longitudinal axis.

17. The apparatus of claim 11 further comprising:

a second access port adapted for subcutaneous implantation including;

a body defining a chamber, an aperture and at least one suture hole;

a self-sealing septum extending across the aperture; and

a lumen disposed in fluid communication between the second access port and the implantable device; and

a second needle comprising;

an elongated member having a bore and a non-coring tip adapted to traverse tissue and pierce the self-sealing septum; and

means for infusing a fluid into the second access port through the bore of the second needle.

18. The apparatus as defined in claim 17 wherein the lumen comprises a substantially nondistensible material.

19. The apparatus as defined in claim 17 wherein the implantable device comprises a balloon.

20. The apparatus as defined in claim 17 wherein the first access port and the second access port comprise first and second portions of a single housing.