Granted Patent B2

US 12,414,871 · App. 17/360,880 · Granted Sep 16, 2025

Inventors: Shawn M. Gage (Raleigh, NC); Joseph Knight (Durham, NC); Michael Lawson (Durham, NC); Craig Nichols (Durham, NC)

Assignee: InnAVasc Medical, Inc.

A61F2/966A61F2/9522A61F2002/9665

Abstract

Claims (35)

1. An implantation apparatus for subcutaneous implantation in a patient using a tunneling instrument of the type including a shaft having a proximal end and a distal end and a tip assembly positioned at the distal end of the tunneling instrument, the implantation apparatus comprising:

a vascular arteriovenous graft having a proximal end and a distal end and a length between the proximal end and the distal end; and

a coupler adapted to couple the distal end of the tunneling instrument and the proximal end of the graft, the coupler comprising

a plug configured to be coupled to the distal end of the tunneling instrument,

a clip configured to be coupled to the proximal end the graft, and

a socket for a rotatable connection of the clip to the plug such that the plug is rotatable about its longitudinal axis relative to the clip to facilitate attachment of the graft to the tunneling instrument,

wherein the coupler is configured for connecting the graft to the tunneling instrument upon removal of the tip assembly.

2. The implantation apparatus as recited in claim 1 , wherein the coupler comprises a screw thread formed on an external surface for connection of the coupler to the tunneling instrument.

3. The implantation apparatus as recited in claim 1 , wherein the coupler comprises a ferrule defining an axial passage for rotatably receiving a proximal end of the tip.

4. The implantation apparatus as recited in claim 1 , further comprising a removable sheath covering the graft.

5. The implantation apparatus as recited in claim 4 , wherein the sheath is configured to substantially cover the length of the graft.

6. The implantation apparatus as recited in claim 1 , wherein the tip comprises a body including an intermediate portion having a reduced diameter forming a circumferential groove around a periphery, and

wherein the clip is positioned in the groove, a portion of the graft being positioned between the clip and the tip within the groove, the clip being crimped about the tip to fix the graft to the tip.

7. The implantation apparatus as recited in claim 6 , wherein the clip is sized and shaped to provide a snap-fit connection within the groove.

8. The implantation apparatus as recited in claim 1 , wherein the tip is adapted to be removably attached to the distal end of the tunneling instrument.

9. The implantation apparatus as recited in claim 8 , wherein the coupler comprises a frustoconical cone having an axial opening for receiving the graft, a length of the cone including a screw thread formed on an external surface for connection of the cone to the tunneling instrument, wherein a portion of the graft is positioned between the threads of the cone and the tunneling instrument to fix the graft to the tip.

10. The implantation apparatus as recited in claim 8 , wherein the coupler comprises a hollow sleeve for rotatable connection to the tunneling instrument, and

a plug received within the proximal end of the graft, the sleeve configured for receiving the plug such that a portion of the graft is positioned between the plug and the sleeve to fix the graft in the sleeve.

11. The implantation apparatus as recited in claim 1 , wherein the graft comprises a synthetic vascular graft.

12. The implantation apparatus as recited in claim 1 , wherein the graft comprises a natural tissue vascular graft.

13. An implantable device for subcutaneous delivery in a patient using a tunneling instrument of the type including a shaft having a proximal end and a distal end, the implantable device comprising:

a vascular graft having a length, a distal end, a proximal end, an outer surface and a longitudinal axis; and

a sheath having a length and being positioned over a substantial portion of the outer surface of the vascular graft, the sheath including a tubular member, wherein the tubular member includes an inner portion and an outer portion, the outer portion being an everted portion of the tubular member, the sheath having longitudinally spaced perforations along the length of the sheath for permitting tearing of the sheath; and

a tether coupled to the sheath,

wherein the sheath is configured to evert upon application of a longitudinal force to the tether following implantation of the vascular graft to cause the sheath to move in a proximal direction during removal of the sheath from the implanted graft, and

wherein the sheath has a material strength such that the sheath everts upon application of the longitudinal force without tearing the sheath and upon eversion and continued actuation of the tether that applies a force to the sheath exceeding a tearing strength of the sheath the sheath tears progressively along the perforations that are generally oriented in a linear arrangement along the length of the sheath.

14. The implantable device as recited in claim 13 , wherein two rows of perforations are generally oriented circumferentially opposite to one another.

15. The implantable device as recited in claim 13 , wherein two rows of perforations are generally oriented adjacent and parallel to one another.

16. The implantable device as recited in claim 13 , further comprising a tether connected to the sheath for applying a pulling force in a proximal direction.

17. The implantable device as recited in claim 16 , wherein the one end of the tether is attached to the sheath at a position adjacent to the distal end of the sheath.

18. An implantable device for subcutaneous delivery in a patient using a tunneling instrument including a shaft having a proximal end and a distal end, the implantable device comprising:

a vascular graft having a length, a distal end, a proximal end, an outer surface and a longitudinal axis; and

a sheath having a length and being positioned over a substantial portion of the outer surface of the vascular graft, the sheath including an inner portion and an outer portion, the inner portion configured to evert to transition to the outer portion, the sheath having longitudinally spaced perforations along the length of the sheath for permitting tearing of the sheath,

wherein the sheath is folded back on itself to provide a double wall including an inner portion and an outer portion, and

wherein the sheath is configured to slide over itself upon application of a longitudinal force to the sheath following implantation of the vascular graft and wherein the sheath has a material strength such that the sheath everts upon application of the longitudinal force without tearing the sheath and after the sheath is everted continued actuation of the sheath is configured to cause the sheath to tear along the perforations and move in a proximal direction during removal of the sheath from the implanted graft thus reducing the force necessary to extract the sheath.

Assignments (2)

Continuity (4)

References Cited (40)