# US 8,092,370 B2 · Direct visualization robotic intra-operative radiation therapy applicator device

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- Number: US 8,092,370 B2
- Document ID: US8092370B2
- Status: Granted
- Kind: B2
- Application number: 12/532,123
- Filed: 2008-09-19
- Published: 2010-11-04
- Granted: 2012-01-10
- Earliest claimed: 2007-09-19
- Assignees: Sriort, LLC
- Inventors: Walter A. Roberts; Brooke Schumm, III
- Web page: https://patentgrep.com/patent/US8092370B2

## CPC

- A61N 5/1001: {using radiation sources introduced into or applied onto the body; brachytherapy}
- A61N 5/1067: {in real time, i.e. during treatment}
- A61N 2005/1052: {using positron emission tomography [PET] single photon emission computer tomography [SPECT] imaging}
- A61N 2005/1055: {using magnetic resonance imaging [MRI]}
- A61N 2005/1061: {using an x-ray imaging system having a separate imaging source}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

This invention proposes a robotic applicator device to be deployed internally to a patient having a capsule (also referred to as a cassette) and aperture with a means of alternately occluding and exposing a radioactive source through the aperture. The capsule and aperture will be integrated with a surgical robot to create a robotic IORT (intra-operative radiation therapy) applicator device as more fully described below. The capsule, radiation source, and IORT applicator arm would be integrated to enable a physician, physicist or technician to interactively internally view and select tissue for exposure to ionizing radiation in sufficient quantities to deliver therapeutic radiation doses to tissue. Via the robotic manipulation device, the physician and physicist would remotely apply radiation to not only the tissue to be exposed, but also control the length of time of the exposure. Control means would be added to identify and calculate margin and depth of tissue to be treated and the proper radiation source or radioactive isotope (which can be any particle emitter, including neutron, x-ray, alpha, beta or gamma emitter) to obtain the desired therapeutic effects. The invention enables stereotactical surgery and close confines radiation therapy adjacent to radiosensitive tissue.

## Claims

### Claim 1

A surgical robotic intra-operative radiation therapy device comprising:
a robotic device capable of surgical use having at least one robotic arm which can be manipulated remotely;
for a patient having a surgical incision, an interchangeable capsule for irradiating said at least one tissue, said capsule for irradiating said at least one tissue and said incision being sized for said capsule to be insertable through said surgical incision;
said capsule having an aperture opening to a cavity internal to said capsule, said capsule having a shutter for alternately occluding and uncovering said aperture opening to said cavity, and said capsule being mountable on said robotic arm;
said robotic arm having a first means for robotic arm electrical communication and control;
said capsule having a second means for electrical communication and control compatible for purposes of interchangeability with said means for robotic arm electrical communication and control;
a means for positive attachment between said robotic arm and said capsule, said means for positive attachment being compatible for purposes of interchangeability with said robotic arm and said first and second means for electrical communication and control;
said cavity internal to said capsule and thereby interior to said aperture being sized to contain a radioactive source for irradiating patient tissue;
said capsule having shielding selected to attenuate radiation exterior to said capsule; and
a remotely operable means for controlling said shutter;
said shutter having a fail-safe closed position;
said intraoperative surgical device having said at least one remotely manipulatable robot arm cooperating with said capsule to move said aperture of said capsule adjacent to patient tissue to be irradiated, so that by operating said electromechanical control, said shutter can be opened to expose said patient tissue to a radiation source disposed within said capsule.

### Claim 2 (depends on 1)

The surgical robotic intra-operative radiation therapy device according to claim 1, further comprising:
a general purpose computer for transmitting data to and from said capsule, said computer being programmed to provide logic, and to implement motion, timing, visualization, irradiation and position reporting functions for said device.

### Claim 3 (depends on 2)

The surgical robotic intra-operative radiation therapy device according to claim 2, further comprising:
said capsule having an adjustable aperture size.

### Claim 4 (depends on 2)

The surgical robotic intra-operative radiation therapy device according to claim 2, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 5 (depends on 4)

The surgical robotic intra-operative radiation therapy device according to claim 4, further comprising:
said capsule having an adjustable aperture size.

### Claim 6 (depends on 2)

The integrated surgical robotic intra-operative radiation therapy system according to claim 2, further comprising:
at least one means for direct visualization by remote means of tissue adjacent to said capsule to ascertain if all diseased tissue has been surgically removed and to ascertain if further irradiation is necessary.

### Claim 7 (depends on 6)

The surgical robotic intra-operative radiation therapy device according to claim 6, further comprising:
said capsule having an adjustable aperture size.

### Claim 8 (depends on 6)

The surgical robotic intra-operative radiation therapy device according to claim 6, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 9 (depends on 8)

The surgical robotic intra-operative radiation therapy device according to claim 8, further comprising:
said capsule having an adjustable aperture size.

### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 1 through 9, further comprising:
a means for utilizing ultrasonic detection to determine tissue depth, including tumor depth to determine an applicable margin to be irradiated.

### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 1 through 9, further comprising:
at least one means for direct visualization by remote display of tissue adjacent to said capsule.

### Claim 12 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 1 through 9, further comprising:
a selected radiation source in said cavity of said capsule appropriate to irradiate said tissue;
said capsule being selected to attenuate radiation based on its shielding characteristic for said selected radiation source to excess doses of radiation to said patient while said shutter is in said closed position for the time period said capsule is proposed to be inside said patient.

### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 1 through 9, further comprising:
a speech interface subject to manual override to enable voice recognition of an operator of said device to assist in direction of said capsule on pre-defined axes, said speech interface being integrated with said general purpose computer.

### Claim 14 (depends on 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 2 through 9, further comprising:
an electronic distance measuring device using optical ranging for locating the distance between said tissue being irradiated and said radioactive source.

### Claim 15 (depends on 2, 3, 4, 5, 6, 7, 8, 9)

The surgical robotic intra-operative radiation therapy device as in one of claims 2 through 9, further comprising:
stand-off remote detection for determining the distance from the radiation source to the tissue being irradiated.

### Claim 16

An integrated surgical robotic intra-operative radiation therapy system comprising:
a means for display of medical imaging of at least one tissue of a patient, said means for display being visible to an operator of said system;
at least one robotic arm which can be manipulated remotely;
for a patient having a surgical incision, an interchangeable capsule for irradiating said at least one tissue, said capsule for irradiating said at least one tissue and said incision being sized for said capsule to be insertable through said surgical incision;
said capsule having an aperture opening to a cavity internal to said capsule, said capsule having a shutter for alternately occluding and uncovering said aperture opening to said cavity, and said capsule being mountable on said robotic arm;
said at least one robotic arm having a first means for robotic arm electrical communication and control;
said capsule having a second means for electrical communication and control compatible for purposes of interchangeability with said means for robotic arm electrical communication and control;
a means for positive attachment between said at least one robotic arm and said capsule, said means for positive attachment being compatible for purposes of interchangeability with said at least one robotic arm and said first and second means for electrical communication and control;
said cavity internal to said capsule and thereby interior to said aperture being sized to contain a radioactive source for irradiating patient tissue;
said capsule having shielding selected to attenuate radiation exterior to said capsule; and
an electromechanical control for said shutter;
said shutter having a remotely operable means for controlling said shutter;
said shutter having a fail-safe closed position;
a shielded source containment table arrayed adjacent to said patient;
mobile patient shielding;
said robot arm which can be manipulated remotely being integrated through said integrated surgical robotic intra-operative radiation therapy system to remove said capsule from said shielded source containment table, and thereafter, in cooperation with capsule, to move said aperture of said capsule adjacent to at least one patient tissue to be irradiated, so that by operating said electromechanical control, said shutter can be opened to expose said patient tissue to a radiation source disposed within said capsule.

### Claim 17 (depends on 16)

The integrated surgical robotic intra-operative radiation therapy system according to claim 16, further comprising:
a means for utilizing ultrasonic detection to determine tissue depth, including tumor depth to determine an applicable margin to be irradiated.

### Claim 18 (depends on 17)

The surgical robotic intra-operative radiation therapy device according to claim 17, further comprising:
said capsule having an adjustable aperture size.

### Claim 19 (depends on 17)

The surgical robotic intra-operative radiation therapy device according to claim 17, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 20 (depends on 19)

The surgical robotic intra-operative radiation therapy device according to claim 19, further comprising:
said capsule having an adjustable aperture size.

### Claim 21 (depends on 16)

The integrated surgical robotic intra-operative radiation therapy system according to claim 16, further comprising:
a general purpose computer for transmitting data to and from said capsule, said computer being programmed to provide logic, and to implement motion, timing, visualization, irradiation and position reporting functions for said device.

### Claim 22 (depends on 21)

The surgical robotic intra-operative radiation therapy device according to claim 21, further comprising:
said capsule having an adjustable aperture size.

### Claim 23 (depends on 21)

The surgical robotic intra-operative radiation therapy device according to claim 21, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 24 (depends on 23)

The surgical robotic intra-operative radiation therapy device according to claim 23, further comprising:
said capsule having an adjustable aperture size.

### Claim 25 (depends on 21)

The integrated surgical robotic intra-operative radiation therapy system according to claim 21, further comprising:
a means for utilizing ultrasonic detection to determine tissue depth, including tumor depth to determine an applicable margin to be irradiated.

### Claim 26 (depends on 25)

The surgical robotic intra-operative radiation therapy device according to claim 25, further comprising:
said capsule having an adjustable aperture size.

### Claim 27 (depends on 25)

The surgical robotic intra-operative radiation therapy device according to claim 25, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 28 (depends on 27)

The surgical robotic intra-operative radiation therapy device according to claim 27, further comprising:
said capsule having an adjustable aperture size.

### Claim 29 (depends on 21)

The integrated surgical robotic intra-operative radiation therapy system according to claim 21, further comprising:
means for locating and recording a waypoint for re-visitation at the close of initial traditional resection surgery to enable rapid re-visitation and medical examination of particular tissue to determine if irradiation is appropriate.

### Claim 30 (depends on 29)

The surgical robotic intra-operative radiation therapy device according to claim 29, further comprising:
said capsule having an adjustable aperture size.

### Claim 31 (depends on 29)

The surgical robotic intra-operative radiation therapy device according to claim 29, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 32 (depends on 31)

The surgical robotic intra-operative radiation therapy device according to claim 31, further comprising:
said capsule having an adjustable aperture size.

### Claim 33 (depends on 21)

The integrated surgical robotic intra-operative radiation therapy system according to claim 21, further comprising:
a means for locating the three-dimensional coordinates of medical imaging on said patient relative to said robot arm;
a means for identifying and tracking the three-dimensional coordinates in real time of said capsule within the body and displaying the location of said capsule within the body relative to said at least one tissue to be irradiated in said patient.

### Claim 34 (depends on 33)

The surgical robotic intra-operative radiation therapy device according to claim 33, further comprising:
said capsule having an adjustable aperture size.

### Claim 35 (depends on 33)

The surgical robotic intra-operative radiation therapy device according to claim 33, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 36 (depends on 35)

The surgical robotic intra-operative radiation therapy device according to claim 35, further comprising:
said capsule having an adjustable aperture size.

### Claim 37 (depends on 33)

The integrated surgical robotic intra-operative radiation therapy system according to claim 33, further comprising:
said general purpose computer being enabled to accept input of data on the radioactive characteristics of said selected radioactive source, to accept input of type of tissue being irradiated, to accept input of data on the distance of said source from said tissue being irradiated, to accept input of data on the length of time said shutter is in the open position, to accept input of ambient radiation information, and to output display real time radiation field distribution on said display means; and
said general purpose computer determining a desired margin relative to said tissue to be irradiated, automatically positioning said capsule, and based on said margin, output of said means for locating and said means for means for identifying and tracking the three-dimensional coordinates of said capsule, opening said shutter, and setting stop-limits for said opening of said shutter in order to irradiate said tissue.

### Claim 38 (depends on 37)

The surgical robotic intra-operative radiation therapy device according to claim 37, further comprising:
said capsule having an adjustable aperture size.

### Claim 39 (depends on 37)

The surgical robotic intra-operative radiation therapy device according to claim 37, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 40 (depends on 39)

The surgical robotic intra-operative radiation therapy device according to claim 39, further comprising:
said capsule having an adjustable aperture size.

### Claim 41 (depends on 37)

The integrated surgical robotic intra-operative radiation therapy system according to claim 37, further comprising:
at least one means for direct visualization by remote display of tissue adjacent to said capsule.

### Claim 42 (depends on 41)

The surgical robotic intra-operative radiation therapy device according to claim 41, further comprising:
said capsule having an adjustable aperture size.

### Claim 43 (depends on 41)

The surgical robotic intra-operative radiation therapy device according to claim 41, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 44 (depends on 43)

The surgical robotic intra-operative radiation therapy device according to claim 43, further comprising:
said capsule having an adjustable aperture size.

### Claim 45 (depends on 37)

The integrated surgical robotic intra-operative radiation therapy system according to claim 37, further comprising:
a means for utilizing ultrasonic detection to determine tissue depth, including tumor depth to determine an applicable margin to be irradiated.

### Claim 46 (depends on 45)

The surgical robotic intra-operative radiation therapy device according to claim 45, further comprising:
said capsule having an adjustable aperture size.

### Claim 47 (depends on 45)

The surgical robotic intra-operative radiation therapy device according to claim 45, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 48 (depends on 47)

The surgical robotic intra-operative radiation therapy device according to claim 47, further comprising:
said capsule having an adjustable aperture size.

### Claim 49 (depends on 37)

The integrated surgical robotic intra-operative radiation therapy system according to claim 37, further comprising:
an electronic distance measuring device using optical ranging for locating the distance between said tissue being irradiated and said radioactive source.

### Claim 50 (depends on 49)

The surgical robotic intra-operative radiation therapy device according to claim 49, further comprising:
said capsule having an adjustable aperture size.

### Claim 51 (depends on 49)

The surgical robotic intra-operative radiation therapy device according to claim 49, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 52 (depends on 51)

The surgical robotic intra-operative radiation therapy device according to claim 51, further comprising:
said capsule having an adjustable aperture size.

### Claim 53 (depends on 37)

The integrated surgical robotic intra-operative radiation therapy system according to claim 37, further comprising:
stand-off remote detection for determining the distance from the radiation source to the tissue being irradiated.

### Claim 54 (depends on 53)

The surgical robotic intra-operative radiation therapy device according to claim 53, further comprising:
said capsule having an adjustable aperture size.

### Claim 55 (depends on 53)

The surgical robotic intra-operative radiation therapy device according to claim 53, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 56 (depends on 55)

The surgical robotic intra-operative radiation therapy device according to claim 55, further comprising:
said capsule having an adjustable aperture size.

### Claim 57 (depends on 37)

The integrated surgical robotic intra-operative radiation therapy system according to claim 37, further comprising:
means for locating and recording a waypoint for re-visitation at the close of initial traditional resection surgery to enable rapid re-visitation and medical examination of particular tissue to determine if irradiation is appropriate.

### Claim 58 (depends on 57)

The surgical robotic intra-operative radiation therapy device according to claim 57, further comprising:
said capsule having an adjustable aperture size.

### Claim 59 (depends on 57)

The surgical robotic intra-operative radiation therapy device according to claim 57, further comprising:
a shroud to narrow a beam of radiation emanating from said capsule through said shutter.

### Claim 60 (depends on 59)

The surgical robotic intra-operative radiation therapy device according to claim 59, further comprising:
said capsule having an adjustable aperture size.

### Claim 61 (depends on 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)

The integrated surgical robotic intra-operative radiation therapy system as in one of claims 16 through 60, further comprising:
in a patient having tissue to be irradiated, a selected radiation source in said cavity of said capsule appropriate to irradiate said tissue;
said capsule being selected to attenuate radiation based on its shielding characteristic for said selected radiation source to excess doses of radiation to said patient while said shutter is in said closed position for the time period said capsule is proposed to be inside said patient.

### Claim 62 (depends on 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60)

The surgical robotic intra-operative radiation therapy device as in one of claims 21 through 60, further comprising:
a speech interface subject to manual override to enable voice recognition of an operator of said device to assist in direction of said capsule on pre-defined axes, said speech interface being integrated with said general purpose computer.