Instrument for implanting sensors and solid materials in a subcutaneous location and method thereof

• US 7,780,625 B2
• Filed: 02/01/2006
• Issued: 08/24/2010
• 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): Lucchesi; Nicholas D
• Assistant Examiner(s): Price; Nathan R
• Application Number:
  US11/345,617
• Publication Number:
  US 20060253065A1
• Time in Patent Office: 1,665 Days
• Field of Search: 604 57- 64
• US Class Current: 604/57
• 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

Abstract

An implantation instrument for implanting a substantially solid material, including solid medication or drugs, in a subcutaneous location and method are described. An incising shaft includes a beveled tip with a cutting edge along a distal end. A syringe body is affixed to a proximal end of the incising shaft. The syringe body and the incising shaft each define a substantially non-circular hollow bore extending continuously along a shared longitudinal axis. The incising shaft bore does not exceed the syringe body bore in girth. Both the incising shaft bore and the syringe body bore are sized to receive the solid material. A plunger is conformably shaped to the syringe body bore and has an end piece facilitating deployment of the plunger assembly. The plunger slidably fits within the syringe body bore and advances the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location.

Claims

1. A subcutaneous implantation instrument, comprising:

a syringe body comprising a non-cylindrical shaft that axially defines a non-circular bore continuously throughout the length of the shaft, wherein the bore comprises a cross section of at least five millimeters in at least one orientation;

a non-cylindrical incising shaft comprising;

an incising shaft body that axially defines a non-circular bore sized to match the bore of the syringe body;

a beveled cutting blade comprising a beveled surface on a distal face of the incising shaft body and a straight and sharpened cutting edge cutting edge with rounded ends on each side of the cutting edge that curve inwardly, wherein the cutting edge is defined only along a bottom distal edge of the beveled tip; and

an attachment surface formed on a proximal end of the incising shaft body, wherein the incising shaft is fixedly attached to a distal end of the syringe body at the attachment surface; and

a delivery mechanism comprising a plunger longitudinally formed to slidably fit within the bores of the syringe body and the incising shaft.

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

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

constructing a syringe body comprising a non-cylindrical shaft that axially defines a non-circular bore continuously throughout the length of the shaft, wherein the bore comprises a cross section of at least five millimeters in at least one orientation;

constructing a non-cylindrical incising shaft comprising;

forming an incising shaft body that axially defines a non-circular bore sized to match the bore of the syringe body;

creating a beveled cutting blade comprising a beveled surface on a distal face of the incising shaft body and a straight and sharpened cutting edge with rounded ends on each side of the cutting edge that curve inwardly, wherein the cutting edge is defined only along a bottom distal edge of the beveled tip; and

forming an attachment surface formed on a proximal end of the incising shaft body, wherein the incising shaft is fixedly attached to a distal end of the syringe body at the attachment surface; and

introducing a delivery mechanism into the proximal end of the incising shaft and comprising a plunger longitudinally formed to slidably fit within the bores of the syringe body and the incising shaft.

4. A method in accordance with claim 3, further comprising:

forming the incising shaft into a curve arced towards the delivery mechanism.

5. A subcutaneous implantation instrument package, comprising:

a non-liquid implantable object; and

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

a syringe body comprising a non-cylindrical shaft that axially defines a non-circular bore continuously throughout the length of the shaft, wherein the bore comprises a cross section of at least five millimeters in at least one orientation;

a non-cylindrical incising shaft comprising;

an incising shaft body that axially defines a non-circular bore sized to match the bore of the syringe body;

a beveled cutting blade comprising a beveled surface on a distal face of the incising shaft body and a straight and sharpened cutting edge with rounded ends on each side of the cutting edge that curve inwardly, wherein the cutting edge is defined only along a bottom distal edge of the beveled tip; and

an attachment surface formed on a proximal end of the incising shaft body, wherein the incising shaft is fixedly attached to a distal end of the syringe body at the attachment surface; and

a delivery mechanism comprising a plunger longitudinally formed to slidably fit within the bores of the syringe body and the incising shaft.

6. A subcutaneous implantation instrument package in accordance with claim 5, wherein the incising shaft is formed into a curve arced towards the delivery mechanism.

7. A subcutaneous implantation instrument package in accordance with claim 5, wherein the implantable object is selected from the group comprising medical monitoring devices, 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 package, comprising:

selecting a non-liquid implantable object; and

packaging a subcutaneous implantation instrument, comprising;

constructing a syringe body comprising a non-cylindrical shaft that axially defines a non-circular bore continuously throughout the length of the shaft, wherein the bore comprises a cross section of at least five millimeters in at least one orientation;

constructing a non-cylindrical incising shaft comprising;

forming an incising shaft body that axially defines a non-circular bore sized to match the bore of the syringe body;

creating a beveled cutting blade comprising a beveled surface on a distal face of the incising shaft body and a straight and sharpened cutting edge with rounded ends on each side of the cutting edge that curve inwardly, wherein the cutting edge is defined only along a bottom distal edge of the beveled tip; and

forming an attachment surface formed on a proximal end of the incising shaft body, wherein the incising shaft is fixedly attached to a distal end of the syringe body at the attachment surface; and

introducing a delivery mechanism into the proximal end of the incising shaft and comprising a plunger longitudinally formed to slidably fit within the bores of the syringe body and the incising shaft.

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

forming the incising shaft into a curve arced towards the delivery mechanism.

10. A method in accordance with claim 8, wherein the implantable object is selected from the group comprising medical monitoring devices, diagnostic devices, non-medical monitoring devices, data collection monitors, medical therapeutic devices, solid objects, and semi-solid objects.