METHOD FOR CONSTRUCTING AN INSTRUMENT WITH A COVERED BORE FOR SUBCUTANEOUS IMPLANTATION

• US 20100331874A1
• Filed: 07/14/2010
• Published: 12/30/2010
• Est. Priority Date: 08/24/2000
• Status: Active Grant

• Current Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Original Assignee: Gust H. Bardy
• Inventors: Bardy, Gust H.
• Granted Patent: US 8,454,552 B2
• Time in Patent Office: Days
• US Class Current: 606/185
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A method for constructing an instrument with a covered bore for subcutaneous implantation is provided. An incising body is formed by defining a non-circular coaxial bore and sharpening a cutting edge extending from a bottom distal end beyond the opening of the coaxial bore and affixing an attachment point at a top distal end. A plunger is constructed sized to fit within the coaxial bore. The plunger is inserted in the bore of the incising body. A cover is affixed to the attachment point, wherein the cover extends down to the bottom distal end and, when closed, the cover encloses the opening proximal to the cutting edge.

Claims

1. A method for constructing an instrument with a covered bore for subcutaneous implantation, comprising:

forming an incising body by defining a non-circular coaxial bore and sharpening a cutting edge extending from a bottom distal end beyond the opening of the coaxial bore and affixing an attachment point at a top distal end;

constructing a plunger sized to fit within the coaxial bore;

inserting the plunger in the bore of the incising body; and

affixing a cover to the attachment point, wherein the cover extends down to the bottom distal end and, when closed, the cover encloses the opening proximal to the cutting edge.

2. A method according to claim 1, wherein the cover conforms to the shape of the distal end of the incising body.

3. A method according to claim 1, further comprising:

forming notches on an outer surface of the incising body.

4. A method according to claim 1, further comprising:

inserting an implant within the cavity of the incising shaft.

5. A method according to claim 1, further comprising

forming a stop extending upwards from a top surface of the distal end of the incising body and adjacent to a proximal end of the cover

6. A method for constructing an instrument with a captive plunger for subcutaneous implantation, comprising:

forming an incising body, comprising;

forming an incising shaft by defining a cavity located along a longitudinal axis and comprising a cutting edge extending from a bottom distal end beyond the opening of the cavity and an attachment point at a top distal end; and

forming a syringe body defining a bore extending along the longitudinal axis and comprising a circumference smaller than the cavity, the syringe body positioned on a proximal end of the incising shaft with the bore aligned with a portion of the cavity;

constructing a plunger assembly comprising a plunger shaft sized to fit within the syringe body and affixed on one end to a plunger comprising a captive member and that is sized to fit within the cavity;

inserting the plunger assembly through an end of the incising body; and

affixing a cover pivotally attached at the attachment point and extending down to the bottom distal end and, when closed, the cover encloses the opening of the cavity proximal to the cutting edge.

7. A method according to claim 6, further comprising:

forming a lip extending from the distal edge of the cover and angled coplanar to a top surface of the cutting edge.

8. A method according to claim 6, further comprising:

inserting an implant within the cavity of the incising shaft.

9. A method according to claim 6, further comprising

forming a stop extending upwards from a top surface of the distal end of the incising body and adjacent to a proximal end of the cover.

10. A method according to claim 6, further comprising:

forming notches on an outer surface of the incising body.

11. A method for implanting an implantable device via an instrument with a covered bore, comprising:

generating an incision into a dermis of a patient with a cutting edge extending from a bottom distal end of an incising body that defines a non-circular coaxial bore in which an implantable device is housed and a bore opening on the distal end and a cover pivotally attached to a top distal end of the incising body, when closed, the cover encloses the bore opening;

advancing the incising body into the patient along the incision to a predetermined depth;

placing the implantable device at an implantation site adjacent to the distal end of the incising body by urging the implantable device through the bore opening and placing the cover in an open position with a plunger assembly; and

withdrawing the incising body from the implantation site.

12. A method according to claim 11, further comprising:

retracting the plunger through the distal opening and returning the cover to a closed position.

13. A method according to claim 12, further comprising:

parting the tissue adjacent to the distal end of the incising body as the cover transitions from the closed position to the open position.

14. A method according to claim 11, further comprising:

inserting a trocar into the incising body through a proximal opening; and

advancing the trocar through the distal opening and tunneling into tissue adjacent to the distal end of the incising body to extend the implantation site.

15. A method according to claim 11, wherein the cover conforms to the shape of the distal end of the incising body.

16. A method according to claim 11, wherein the cover is formed integral to the incising body and extends from the top distal end of the incising body towards the cutting edge.

17. An implantation instrument assembly, comprising:

an incising body defining a non-circular coaxial bore and comprising a sharpened cutting edge extending from a bottom distal end beyond the opening of the coaxial bore and an attachment point at a top distal end;

a plunger non-fixedly contained within the coaxial bore and sliding longitudinally therein;

a cover pivotally attached at the attachment point and extending down to the bottom distal end, when closed, the cover enclosing the opening proximal to the cutting edge; and

an implant positioned within the bore.

18. An implantation assembly according to claim 17, wherein the cover conforms to the shape of the distal end of the incising body.

19. An implantation assembly according to claim 17, further comprising:

a lip extending from the distal edge of the cover and angled coplanar to a top surface of the cutting edge.

20. An implantation instrument with a covered bore package according to claim 19, further comprising:

a margin on the top surface of the cutting edge that is shaped conformably to the lip and defining a recess, wherein the top surface of the cutting edge and the lip are flush.