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

• US 6,436,068 B1
• Filed: 08/24/2000
• Issued: 08/20/2002
• Est. Priority Date: 08/24/2000
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Gust H. Bardy
• Inventors: Bardy, Gust H.
• Primary Examiner(s): Esquivel, Denise L.
• Assistant Examiner(s): NORMAN, MARC E
• Application Number:
  US09/644,666
• Time in Patent Office: 726 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 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 sensor or substantially solid material, including solid medication or drugs, in a subcutaneous location and method thereof are described. An incising shaft includes a beveled tip with a cutting edge along a distal end thereof. 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 for implanting a substantially solid material, comprising:

an incising body comprising a syringe body and an incising shaft which each define a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft comprising a beveled tip with a cutting edge on a distal end, the incising shaft bore and the syringe body bore both being sized to receive the solid material;

a delivery assembly comprising a plunger slidably fitted within the syringe body bore, the plunger conformably shaped to the syringe body bore with an end piece facilitating deployment of the substantially solid material into an implantation site; and

a clearing assembly comprising a plunger and a clearing trocar slidably fitted within the syringe body bore, the plunger conformably shaped to the syringe body bore with an end piece facilitating deployment, the clearing trocar closely fitting within the incising shaft bore and affixed to a distal end of the plunger.

2. A subcutaneous implantation instrument for implanting a substantially solid material, comprising:

an incising body comprising a syringe body and an incising shalt which each define a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft comprising a beveled tip with a cutting edge on a distal end, the incising shaft bore and the syringe body bore both being sized to receive the solid material; and

a delivery assembly comprising a plunger slidably fitted within the syringe body bore, the plunger conformably shaped to the syringe body bore with an end piece facilitating deployment of the substantially solid material into an implantation site and a pushing stylet slidably fitting within the incising shaft bore and affixed to a distal end of the plunger.

3. A subcutaneous implantation instrument for implanting a substantially solid material, comprising:

an incising body comprising a syringe body and an incising shaft which each define a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft comprising a beveled tip with a cutting edge on a distal end, the incising shaft bore and the syringe body bore both being sized to receive the solid material, the incising body further comprising a stopping flange mounted circumferentially on the syringe body; and

a delivery assembly comprising a plunger slidably fitted within the syringe body bore, the plunger conformably shaped to the syringe body bore with an end piece facilitating deployment of the substantially solid material into an implantation site.

4. A subcutaneous implantation instrument in accordance with claim 3, wherein the stopping flange is slidably mounted on the syringe body.

5. An implantation instrument for implanting a substantially solid material in a subcutaneous location, comprising:

an incising shaft comprising a beveled tip with a cutting edge along a distal end thereof;

a syringe body affixed to a proximal end of the incising shaft, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

a plunger conformably shaped to the syringe body bore and having an end piece facilitating deployment of the plunger assembly, the plunger slidably fitting within the syringe body bore and advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location; and

a clearing trocar conformably shaped to the incising shaft bore and affixed to and substantially centered on the distal end of the plunger, the clearing trocar and a pushing stylet slidably fitting within the non-circular bore of the syringe body.

6. An implantation instrument for implanting a substantially solid material in a subcutaneous location, comprising:

an incising shaft comprising a beveled tip with a cutting edge along a distal end thereof;

a syringe body affixed to a proximal end of the incising shaft, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

a plunger conformably shaped to the syringe body bore and having an end piece facilitating deployment of the plunger assembly, the plunger slidably fitting within the syringe body bore and advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location; and

a pushing stylet smaller than the incising shaft bore and affixed to the distal end of the plunger assembly, the pushing stylet slidably fitting within the syringe body bore.

7. An implantation instrument for implanting a substantially solid material in a subcutaneous location, comprising:

an incising shaft comprising a beveled tip with a cutting edge along a distal end thereof;

a syringe body affixed to a proximal end of the incising shaft, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

a plunger conformably shaped to the syringe body bore and having an end piece facilitating deployment of the plunger assembly, the plunger slidably fitting within the syringe body bore and advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location; and

a penetration limiting mechanism comprising a stopping flange mounted circumferentially along an exterior surface of the syringe body and limiting subcutaneous penetration by the instrument.

8. An implantation instrument for implanting a substantially solid material in a subcutaneous location, comprising:

an incising shaft comprising a beveled tip with a cutting edge along a distal end thereof;

a syringe body affixed to a proximal end of the incising shaft, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

a plunger conformably shaped to the syringe body bore and having an end piece facilitating deployment of the plunger assembly, the plunger slidably fitting within the syringe body bore and advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location; and

an adjustable penetration limiting mechanism comprising;

a stopping flange limiting subcutaneous penetration by the instrument;

a frictional collar affixed to the stopping flange and slidably and circumferentially mounted along an exterior surface of the syringe body; and

an adjustable collar stay limiting movement of the frictional collar.

9. A method for implanting a substantially solid material in a subcutaneous location, comprising:

inserting a beveled tip of an incising shaft with a cutting edge along a distal end thereof into an implantation site, a proximal end of the incising shaft being affixed to a distal end of a syringe body, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location through deployment of a plunger conformably shaped to the syringe body bore, the deployment being effected via actuation of an end piece on a distal end of the plunger, the plunger slidably fitting within the syringe body bore; and

preparing the implantation site using a clearing trocar conformably shaped to the incising shaft bore and affixed to and substantially centered on the distal end of the plunger, the clearing trocar and the pushing stylet slidably fitting within the non-circular bore of the syringe body.

10. A method for implanting a substantially solid material in a subcutaneous location, comprising:

inserting a beveled tip of an incising shaft with a cutting edge along a distal end thereof into an implantation site, a proximal end of the incising shaft being affixed to a distal end of a syringe body, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location through deployment of a plunger conformably shaped to the syringe body bore, the deployment being effected via actuation of an end piece on a distal end of the plunger, the plunger slidably fitting within the syringe body bore; and

delivering the solid material into the implantation site through a pushing stylet smaller than the incising shaft bore and affixed to the distal end of the plunger assembly, the pushing stylet slidably fitting within the syringe body bore.

11. A method for implanting a substantially solid material in a subcutaneous location, comprising:

inserting a beveled tip of an incising shaft with a cutting edge along a distal end thereof into an implantation site, a proximal end of the incising shaft being affixed to a distal end of a syringe body, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location through deployment of a plunger conformably shaped to the syringe body bore, the deployment being effected via actuation of an end piece on a distal end of the plunger, the plunger slidably fitting within the syringe body bore; and

limiting the insertion of the instrument through a penetration limiting mechanism comprising a stopping flange mounted circumferentially along an exterior surface of the syringe body and limiting subcutaneous penetration by the instrument.

12. A method for implanting a substantially solid material in a subcutaneous location, comprising:

inserting a beveled tip of an incising shaft with a cutting edge along a distal end thereof into an implantation site, a proximal end of the incising shaft being affixed to a distal end of a syringe body, the syringe body and the incising shaft each defining a substantially non-circular hollow bore extending continuously along a shared longitudinal axis, the incising shaft bore not exceeding the syringe body bore in girth, both the incising shaft bore and the syringe body bore being sized to receive the solid material;

advancing the solid material through the syringe body bore and the incising shaft bore into the subcutaneous location through deployment of a plunger conformably shaped to the syringe body bore, the deployment being effected via actuation of an end piece on a distal end of the plunger, the plunger slidably fitting within the syringe body bore; and

limiting the insertion of the instrument through an adjustable penetration limiting mechanism comprising a stopping flange limiting subcutaneous penetration by the instrument, a frictional collar affixed to the stopping flange and slidably and circumferentially mounted along an exterior surface of the syringe body, and an adjustable collar stay limiting movement of the frictional collar.