IP Verse

Biopsy Tract Ablation System For Tumor Seeding Prevention And Cauterization

Patent No. US10959776 (titled "Biopsy Tract Ablation System For Tumor Seeding Prevention And Cauterization") was filed by Traceless Biopsy Llc on Nov 30, 2017.

What is this patent about?

’776 is related to the field of medical devices, specifically addressing the problem of bleeding and tumor seeding following core needle biopsies. Current biopsy procedures carry risks of both bleeding from injured blood vessels and the potential spread of cancerous cells along the needle tract, which can lead to metastasis. The patent aims to provide a solution that minimizes these risks, potentially improving patient outcomes and reducing treatment costs.

The underlying idea behind ’776 is to use a small, electrically heated probe to cauterize the tissue surrounding the biopsy tract immediately after a tissue sample is taken. This cauterization serves two purposes: it stops bleeding by sealing blood vessels, and it kills or inactivates any cancer cells that may have been dislodged during the biopsy, preventing them from spreading and forming new tumors. The probe is designed to be compatible with existing biopsy needles and cannulas, making it easy to integrate into standard procedures.

The claims of ’776 focus on a hand-held ablation probe with an onboard battery and a power switch. The probe features an elongate shaft with an electrically resistive heating element at its tip. This heating element is made of a resistive material patterned onto a non-conductive rod. The pattern is created by plating the resistive material and then using a laser to ablate away unwanted portions. The shaft is thermally insulated so that only the tip heats up to a temperature sufficient to prevent tumor seeding.

In practice, after a biopsy is performed using standard techniques, the ablation probe is inserted through the existing cannula to the biopsy site. Once in place, the user activates the probe, causing the tip to heat up and cauterize the surrounding tissue. The probe is then withdrawn, potentially along with the cannula, leaving behind a treated biopsy tract. The hand-held, battery-powered design allows for easy and immediate use without the need for external power sources or complex equipment.

The invention differentiates itself from prior approaches by providing a compact, self-contained device specifically designed for post-biopsy ablation. Unlike surgical cauterization methods, this probe is small enough to fit through standard biopsy needles. The use of a patterned resistive heating element on a non-conductive rod allows for precise control of the heated area, minimizing damage to surrounding tissues. The thermal insulation of the probe shaft is also a key feature, ensuring that only the tip is heated to the ablation temperature.

How does this patent fit in bigger picture?

Technical landscape at the time

In the late 2010s when ’776 was filed, core needle biopsies were typically implemented using standard trocar needles and biopsy needles. At a time when systems commonly relied on cauterization techniques to stop bleeding during surgeries, adapting these techniques to the small scale of biopsy needles presented non-trivial hardware or software constraints. The prevention of tumor seeding after biopsy was an area where existing methods were considered inadequate.

Novelty and Inventive Step

The applicant's amendments and associated arguments were initially persuasive, leading to the withdrawal of previous rejections. However, a new ground of rejection was subsequently issued. Claims 1, 6, 7, 13-17, 26 and 29-37 were rejected under 35 U.S.C. 103. The Office action was made final.

Claims

This patent contains 22 claims, with independent claims 1, 11, and 14. The independent claims are directed to ablation probes and systems for reducing tumor seeding, generally involving a hand-held housing with a battery, and an ablation probe tip that heats to a tumor-seeding prevention temperature. The dependent claims generally elaborate on specific features, materials, configurations, and functionalities of the ablation probe and system described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Electrically non-conductive rod portion
(Claim 1, Claim 11)		“In example forms, the electrically-conductive material is supported by a non-conductive ceramic or other non-conductive material.”A part of the ablation probe tip onto which the electrically-resistive material is applied.
Electrically-resistive graphite probe tip
(Claim 14)		“In example forms, cauterization is carried out by an electrically resistive material at the tip of an ablation probe such as, for example, a graphite tip or tube or a resistive metal tip.”A probe tip made of graphite that heats up when electricity is applied.
Electrically-resistive heating element
(Claim 1, Claim 11)		“In example forms, a metal probe is heated in order to effect cauterization. In example forms, cauterization is carried out by an electrically resistive material at the tip of an ablation probe such as, for example, a graphite tip or tube or a resistive metal tip. In other example forms, heat at the tip of an ablation probe is generated through the transmission of electricity through an electrically conductive material.”A component of the ablation probe tip that generates heat when electricity from the onboard battery power source is applied to it.
Thermally non-conductive material
(Claim 1)		“In example embodiments, only the tip of the ablation probe heats to cauterization and cancer cell elimination temperatures. In example embodiments, insulation can be provided around the trocar needle remote from the probe tip to protect the patient from tissue trauma caused by exposure to excessive heat.”A material that prevents heat transfer from the ablation probe tip to other parts of the elongate body.
Tumor-seeding prevention temperature
(Claim 1, Claim 11, Claim 14)		“In example modes of use, tumor cells cannot be spread from tissue that has been cauterized, or any cell spreading is very locally minimized and preferably eliminated. In another aspect, cauterization kills tumor cells so that even if they spread through tissue upon trocar removal, they cannot seed new tumors.”A temperature high enough to prevent cell migration and potential tumor seeding in a biopsy tract.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-02365Mar 5, 2025Endo Usa, Inc. V. Baxter Healthcare Corporation

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US10959776

TRACELESS BIOPSY LLC
Application Number
US15827464
Filing Date
Nov 30, 2017
Status
Granted
Expiry Date
Nov 30, 2037
External Links
Slate, USPTO, Google Patents