ADJUSTABLE TISSUE OR NERVE CUFF AND METHOD OF USE

• US 20090210042A1
• Filed: 02/12/2009
• Published: 08/20/2009
• Est. Priority Date: 02/15/2008
• Status: Active Grant

• Current Assignee: Angeltear Solutions, Inc.
• Original Assignee: Angeltear Solutions, Inc.
• Inventors: Kowalczewski, Jan
• Granted Patent: US 8,116,882 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable adjustable body tissue cuff, apparatus and method. The cuff is an elastomeric strap of biocompatible non-conductive material. The strap'"'"'s tail and head provide adjustable length fastening by a) the tail being formed with longitudinally spaced, laterally paired locking projections and the head being formed with one or more locking apertures; or b) the tail being formed with longitudinally spaced locking apertures and the head being formed with one or more laterally paired locking projections. The locking projection shape allows for passage through the locking aperture, while restricting movement in a reverse direction. The cuff accommodates devices such as tissue stimulators or recorders, with conductive elements attached, imbedded, or printed on the strap body. The cuff is intra-operatively adjusted to optimize placement and contact between conductive elements and body tissue, without tissue damage. This cuff accommodates varying tissue diameters and simplifies manufacture and surgical placement.

Claims

1. An implantable, circumferentially adjustable tissue cuff to enable circumferential attachment to an internal body tissue, the cuff comprising:

a flat, thin, elastomeric strap formed of a biocompatible non-conductive material, the strap being elongated along a longitudinal axis, the strap having a body portion connected between a tail end portion and a head end portion, and a length in excess of a circumference of the body tissue;

the tail end portion and the head end portion being configured for adjustable length fastening one to the other when wrapped around the body tissue with a configuration of either;

a) the tail end portion being formed with a plurality of longitudinally spaced, laterally paired locking projections and the head end portion being formed with one or more locking apertures;

or

b) the tail end portion being formed with a plurality of longitudinally spaced locking apertures and the head end portion being formed with one or more laterally paired locking projections; and

each of the laterally paired locking projections being shaped to allow for passage through the locking apertures by flexing of the locking projections in an insertion direction through the locking aperture, and to restrict movement in a reversing direction through the locking aperture.

2. The tissue cuff of claim 1, wherein:

the tail end portion and the head end portion are configured as in (a);

the one or more locking apertures is a slot having a transverse width dimension; and

each pair of locking projections has a transverse width dimension at a widest point which is greater than the transverse width dimension of the slot.

3. The tissue cuff of claim 2, wherein the plurality of laterally paired locking projections are longitudinally spaced by narrower neck portions, and the neck portions have a transverse width dimension which is no greater than the transverse width dimension of the slot.

4. The tissue cuff of claim 3, wherein each pair of the locking projections is generally arrow shaped to resist movement in the reversing direction.

5. The tissue cuff of claim 3, wherein each pair of the locking projections is generally tear drop shaped to resist movement in the reversing direction.

6. The tissue cuff of claim 3, wherein each pair of locking projections is rounded to resist movement through the slot in both the insertion and reversing directions.

7. The tissue cuff of claim 3, further comprising a suture connected to the tail end portion of the strap, and a needle connected to the suture.

8. The tissue cuff of claim 3, wherein the tail end portion is formed with an elongated lead tab at its free end, the lead tab having a transverse width at a lead end which is less than the transverse width of the slot to facilitate insertion of the tail end portion through the slot.

9. The tissue cuff of claim 3, wherein the head end portion is formed with a loop that forms the locking aperture.

10. A tissue cuff apparatus to enable circumferential attachment of a tissue interacting device to an internal body tissue, said tissue cuff apparatus comprising a tissue cuff as defined in claim 1 and one or more implantable tissue interacting devices attached to, imbedded in, or printed on the body portion of the strap, wherein the tissue interacting device includes one or more conductive elements adapted to be in conducting proximity to the body tissue when the strap is wrapped around the body tissue.

11. The tissue cuff apparatus of claim 10, wherein the tissue interacting device is adapted to stimulate or record the body tissue, and wherein the one or more conductive elements is adapted to respond to one or more of electrical, thermal, auditory, vibrational, light or fluid stimulation.

12. The tissue cuff apparatus of claim 11, wherein the one or more conductive elements comprise one or more electrical contacts on an inner face of the body portion of the strap.

13. The tissue cuff apparatus of claim 12, further comprising insulated leads connecting the one or more electrical contacts to a remote stimulating or recording device.

14. The tissue cuff apparatus of claim 11, wherein the tissue interacting device is an electrode lead or a conductor adapted to be held in contact with the body tissue by the strap.

15. The tissue cuff apparatus of claim 11, wherein the tissue interacting device is a wireless stimulator adapted to be attached to the strap or to be held in contact with the body tissue.

16. A method for circumferentially attaching a tissue cuff to an internal body tissue, the method comprising the steps of:

i. providing the tissue cuff as defined in claim 1;

ii. wrapping the strap around the body tissue; and

iii. fastening the tail end portion and the head end portion together with an appropriate one of the laterally paired locking projections and locking apertures, whereby the plurality of locking apertures or the plurality of laterally paired projections allow for a circumference of the tissue cuff to be adjusted intra-operatively to a particular circumference of the body tissue.

17. The method of claim 16, wherein an excess of the strap remaining in the tail end portion or the head end portion after fastening is removed by cutting.

18. The method of claim 16, wherein an excess of the strap remaining in the tail end portion or the head end portion after fastening is sutured to the strap or to surrounding tissue to anchor the tissue cuff.

19. The method of claim 16, wherein an excess of the strap remaining in the tail end portion or the head end portion after fastening is fastened to the strap with a biocompatible adhesive.

20. The method of claim 16, further comprising providing one or more implantable tissue interacting devices attached to, imbedded in or printed on the body portion of the strap, the tissue interacting device including one or more conductive elements adapted to held in conducting proximity to the body tissue when the strap is wrapped around the body tissue.