Subcutaneous implantation instrument with dissecting tool and method of construction

• US 20070249992A1
• Filed: 07/10/2006
• Published: 10/25/2007
• Est. Priority Date: 08/24/2000
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Bardy, Gust H.
• Granted Patent: US 7,736,330 B2
• Time in Patent Office: Days
• US Class Current: 604/60
• 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; and

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

2. A subcutaneous implantation instrument in accordance with claim 1, further comprising:

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

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

4. 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.

5. 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.

6. 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.

7. 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.

8. 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 1object 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; and

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

9. A method in accordance with claim 8, further comprising:

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

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

11. A method in accordance with claim 8, further comprising:

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

12. A method in accordance with claim 8, wherein the longitudinal cutting edges are formed with at least one of straight, concave, and convex surfaces.

13. A method in accordance with claim 8, 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.

14. A method in accordance with claim 8, 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.

15. A subcutaneous implantation instrument with a scissored dissecting tool assembly, 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 assembly, comprising;

a longitudinally split needle tip forming a pair of blades with cutting edges progressively defined outwardly from the needle tip;

a pair of handles that are each distally attached to one of the blades and pivotably coupled and disposed for transverse operation, wherein the dissecting tool assembly is removably affixable to the distal end of the incising shaft; and

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

16. A subcutaneous implantation instrument in accordance with claim 15, wherein the blades are formed with at least one of straight, concave, and convex surfaces.

17. A subcutaneous implantation instrument in accordance with claim 15, wherein the longitudinally split needle tip is formed into a curve arced towards the incising shaft.

18. A method for constructing a subcutaneous implantation instrument with a scissored dissecting tool assembly, comprising:

fashioning an incising shaft to longitudinally define 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;

assembly a dissecting tool assembly, comprising;

providing a longitudinally split needle tip to form a pair of blades with cutting edges progressively defined outwardly from the needle tip;

including a pair of handles that are each distally attached to one of the blades and pivotably coupled and disposed for transverse operation, wherein the dissecting tool assembly is removably affixable to the distal end of the incising shaft; and

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

19. A method in accordance with claim 18, wherein the blades are formed with at least one of straight, concave, and convex surfaces.

20. A method in accordance with claim 18, wherein the longitudinally split needle tip is formed into a curve arced towards the incising shaft.

21. 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; and

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

22. A subcutaneous implantation instrument package in accordance with claim 21, further comprising:

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.

23. A subcutaneous implantation instrument package in accordance with claim 21, 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.

24. A subcutaneous implantation instrument package in accordance with claim 21, 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.

25. 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; and

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

26. A method in accordance with claim 25, further comprising:

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.

27. A method in accordance with claim 25, 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.

28. A method in accordance with claim 25, 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.

29. A method for implanting a non-liquid object, comprising:

forming a subcutaneous implantation site by urging a subcutaneous implantation instrument that comprises an incising shaft with a beveled cutting blade formed on a distal end subdurally to a predetermined depth, wherein the incising shaft longitudinally defines a substantially non-circular bore;

deploying a non-liquid object into the subcutaneous implantation site by progressively urging a delivery mechanism distally through a syringe body proximally affixed to the incising shaft to deploy the implantable object into the incising shaft and thence to insert the implantable object into the subcutaneous implantation site; and

withdrawing the incising shaft from the subcutaneous implantation site, which is subsequently closed.

30. A method in accordance with claim 29, further comprising:

preparing the subcutaneous implantation site by inserting a dissecting tool into the subcutaneous implantation site and 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.

31. A method in accordance with claim 29, wherein at least one of the incising shaft and dissecting tool is formed into a curve arced towards the incising shaft.

32. A method in accordance with claim 29, further comprising:

withdrawing the incising shaft partway out of the subcutaneous implantation site prior to deploying the non-liquid object.

33. A method in accordance with claim 29, 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.

34. A method in accordance with claim 29, wherein the subcutaneous implantation site comprises a site that is at least one of intramuscular, submuscular, and within a body cavity, including intrathoracic.

35. A method in accordance with claim 29, wherein the non-liquid object is implanted as a functional equivalent to an injection and without an operating room or special procedures room.

36. A method for injecting a non-liquid object, comprising:

urging a subcutaneous implantation instrument that comprises an incising shaft with a beveled cutting blade formed on a distal end subdurally to a predetermined depth within a body, wherein the incising shaft longitudinally defines a substantially non-circular bore;

progressively urging a delivery mechanism distally through a syringe body proximally affixed to the incising shaft to deploy a non-liquid implantable object into the incising shaft and to insert the implantable object subcutaneously; and

withdrawing the incising shaft from within the body.

37. A method in accordance with claim 36, wherein the non-liquid 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.

38. A method in accordance with claim 36, wherein the non-liquid implantable object is inserted into a site that is at least one of intramuscular, submuscular, and within a body cavity, including intrathoracic.