Subcutaneous implantation instrument with dissecting tool and method of construction

• US 7,736,330 B2
• Filed: 07/10/2006
• Issued: 06/15/2010
• Est. Priority Date: 08/24/2000
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): Norman; Marc E
• Application Number:
  US11/484,084
• Publication Number:
  US 20070249992A1
• Time in Patent Office: 1,436 Days
• Field of Search: 604/57, 604/58, 604/59, 604/60, 604/61, 604/62, 604/63, 604/65
• US Class Current: 604/57
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• 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 subcutaneous implantation instrument with dissecting tool and method of construction are described. An incising shaft longitudinally defines a substantially non-circular bore continuously formed to communicatively receive an implantable object and further includes a beveled cutting blade formed on a distal end. A dissecting tool includes a needle tip forming a pair of longitudinal cutting edges progressively defined outwardly from the needle tip planar to the beveled cutting blade and removably affixable to the distal end of the incising shaft through a proximal coupling. A delivery mechanism longitudinally defines a substantially non-circular bore formed to deploy the implantable object into the incising shaft. One goal is to reduce the subcutaneous sensor insertion of implantable objects and devices, such as sensors, having non-conforming shapes to be the functional equivalent of an injection.

Claims

1. A subcutaneous implantation instrument with dissecting tool, comprising:

an incising shaft longitudinally defining a substantially non-circular bore continuously formed to communicatively receive an implantable object and further comprising a beveled cutting blade formed on a distal end;

a dissecting tool comprising a needle tip forming a pair of longitudinal cutting edges progressively defined outwardly from the needle tip planar to the beveled cutting blade and removably affixable to the distal end of the incising shaft through a proximal coupling;

a delivery mechanism longitudinally defining a substantially non-circular bore formed to deploy the implantable object into the incising shaft; and

a lumen defined longitudinally through needle tip of the dissecting tool and proximally interfaced to the delivery mechanism.

2. A subcutaneous implantation instrument in accordance with claim 1, wherein the dissecting tool is formed into a curve arced towards the incising shaft.

3. A subcutaneous implantation instrument in accordance with claim 1, further wherein the proximal coupling is formed as at least one of an over sheath and a snap-off assembly.

4. A subcutaneous implantation instrument in accordance with claim 1, wherein the longitudinal cutting edges are formed with at least one of straight, concave, and convex surfaces.

5. A subcutaneous implantation instrument in accordance with claim 1, wherein the dissecting tool comprises longitudinally divided halves, further comprising:

a pair of pivotably coupled handles that are each distally attached to one of the longitudinally divided halves of the dissecting tool and disposed for operation transversely to the dissecting tool.

6. A subcutaneous implantation instrument in accordance with claim 1, wherein the implantable object is selected from the group comprising medical monitoring and diagnostic devices, non-medical monitoring devices, data collection monitors, medical therapeutic devices, solid objects, and semi-solid objects.

7. A method for constructing a subcutaneous implantation instrument with dissecting tool, comprising:

fashioning an incising shaft to longitudinally define a substantially non-circular bore continuously formed to communicatively receive an implantable object and to further comprise a beveled cutting blade formed on a distal end;

providing a dissecting tool to comprise a needle tip that forms a pair of longitudinal cutting edges progressively defined outwardly from the needle tip and be removably affixable to the distal end of the incising shaft through a proximal coupling;

attaching a delivery mechanism to longitudinally define a substantially non-circular bore continuously formed to deploy the implantable object into the incising shaft; and

defining a lumen longitudinally through needle tip of the dissecting tool and proximally interfaced to the delivery mechanism.

8. A method in accordance with claim 7, wherein the dissecting tool is formed into a curve arced towards the incising shaft.

9. A method in accordance with claim 7, further comprising:

forming the proximal coupling as at least one of an over sheath and a snap-off assembly.

10. A method in accordance with claim 7, wherein the longitudinal cutting edges are formed with at least one of straight, concave, and convex surfaces.

11. A method in accordance with claim 7, wherein the dissecting tool comprises longitudinally divided halves, further comprising:

providing a pair of pivotably coupled handles that are each distally attached to one of the longitudinally divided halves of the dissecting tool and disposed for operation transversely to the dissecting tool.

12. A method in accordance with claim 7, wherein the implantable object is selected from the group comprising medical monitoring and diagnostic devices, non-medical monitoring devices, data collection monitors, medical therapeutic devices, solid objects, and semi-solid objects.

13. A subcutaneous implantation instrument package, comprising:

a non-liquid implantable object; and

a subcutaneous implantation instrument packaged with the non-liquid implantable object, comprising;

an incising shaft longitudinally defining a substantially non-circular bore continuously formed to communicatively receive the implantable object and further comprising a beveled cutting blade formed on a distal end;

a dissecting tool comprising a needle tip forming a pair of longitudinal cutting edges progressively defined outwardly from the needle tip planar to the beveled cutting blade and removably affixable to the distal end of the incising shaft through a proximal coupling;

a delivery mechanism longitudinally defining a substantially non-circular bore formed to deploy the implantable object into the incising shaft; and

a lumen defined longitudinally through needle tip of the dissecting tool and proximally interfaced to the delivery mechanism.

14. A subcutaneous implantation instrument package in accordance with claim 13, wherein the beveled cutting blade is shaped into at least one of a point, semi-point, rounded edge, curved edge, upward curve, and angled curve.

15. A subcutaneous implantation instrument package in accordance with claim 13, wherein the implantable object is selected from the group comprising medical monitoring and diagnostic devices, non-medical monitoring devices, data collection monitors, medical therapeutic devices, solid objects, and semi-solid objects.

16. A method for constructing a subcutaneous implantation instrument package, comprising:

selecting a non-liquid implantable object; and

packaging a subcutaneous implantation instrument, comprising;

fashioning an incising shaft longitudinally to define a substantially non-circular bore continuously formed to communicatively receive the implantable object and further comprising a beveled cutting blade formed on a distal end;

including a dissecting tool comprising a needle tip forming a pair of longitudinal cutting edges progressively defined outwardly from the needle tip planar to the beveled cutting blade and removably affixable to the distal end of the incising shaft through a proximal coupling;

providing a delivery mechanism to longitudinally define a substantially non-circular bore formed to deploy the implantable object into the incising shaft; and

defining a lumen longitudinally through needle tip of the dissecting tool and proximally interfaced to the delivery mechanism.

17. A method in accordance with claim 16, further comprising:

shaping the beveled cutting blade into at least one of a point, semi-point, rounded edge, curved edge, upward curve, and angled curve.

18. A method in accordance with claim 16, wherein the implantable object is selected from the group comprising medical monitoring and diagnostic devices, non-medical monitoring devices, data collection monitors, medical therapeutic devices, solid objects, and semi-solid objects.