# US 10,369,380 B2 · Tissue sampling, cancer detection and treatment methods

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- Number: US 10,369,380 B2
- Document ID: US10369380B2
- Status: Granted
- Kind: B2
- Application number: 15/587,336
- Filed: 2017-05-04
- Published: 2017-08-17
- Granted: 2019-08-06
- Earliest claimed: 2014-06-24
- Assignees: PROCEPT BioRobotics Corporation
- Applicants: PROCEPT BioRobotics Corporation
- Inventors: Nikolai Aljuri; Surag Mantri
- Web page: https://patentgrep.com/patent/US10369380B2

## CPC

- A61N 5/1015: {Treatment of resected cavities created by surgery, e.g. lumpectomy}
- A61B 5/0071: {by measuring fluorescence emission}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/061: {Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body (A61B1/00158 takes precedence)}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 10/02: Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)}
- A61B 10/0241: {for prostate}
- A61B 17/3203: Fluid jet cutting instruments
- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- A61B 18/1206: {Generators therefor}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/22: the beam being directed along or through a flexible conduit, e.g. an optical fibre; {Couplings or} hand-pieces therefor
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 25/10182: {Injector syringes}
- A61M 25/10185: {Valves}
- A61N 5/1007: {Arrangements or means for the introduction of sources into the body}
- A61N 5/1027: {Interstitial radiation therapy}
- G01N 33/57555: of the prostate
- A61B 5/0073: {by tomography, i.e. reconstruction of 3D images from 2D projections (A61B5/0066 takes precedence)}
- A61B 18/16: Indifferent or passive electrodes for grounding
- A61B 2010/0225: {for taking multiple samples}
- A61B 2017/32032: {using cavitation of the fluid}
- A61B 2018/0022: {Balloons}
- A61B 2018/00547: {Prostate}
- A61B 2018/00577: {Ablation}
- A61B 2018/00595: {Cauterization}
- A61B 2018/00863: {Fluid flow}
- A61B 2018/046: {in liquid form}
- A61B 2018/1253: {monopolar}
- A61B 2018/126: {bipolar}
- A61B 2090/067: {for measuring angles}
- A61B 2090/378: {using ultrasound}
- A61B 2090/508: {with releasable brake mechanisms}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61B 2218/002: Irrigation
- A61B 2218/007: Aspiration
- A61B 2505/05: Surgical care
- A61B 2562/0219: Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2210/166: Prostate
- A61N 2005/1011: {Apparatus for permanent insertion of sources}
- A61N 2005/1021: {Radioactive fluid}
- A61N 2005/1024: {Seeds}
- A61N 2005/1094: {Shielding, protecting against radiation}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A catheter treatment apparatus comprises an elongate tubular member and an expandable support. The expandable support comprises a radioactive substance to treat cancerous tissue and is configured to expand from a narrow profile for insertion to a wide profile to engage and treat tissue remaining after resection. The expandable support can be sized to fit within a volume of removed tissue to place the radioactive substance in proximity to the capsule and remaining tissue, to spare the capsule and proximate nerves and vessels to treat tissue in proximity to the capsule. The elongate tubular member may comprise a channel such as a lumen to pass a bodily fluid such as urine when the expandable support engages the tissue to treat the patient for a plurality of days. The treatment apparatus can be used to resect and diagnose tissue concurrently. Based on the diagnosis, targeted segmental treatment may be given.

## Claims

### Claim 1

A method of detecting and localizing cancer in a prostate of a patient, the method comprising:
removing, using a water jet source provided on an elongate apparatus, samples of tissue from a plurality of zones of said prostate as said elongate apparatus is moved longitudinally along said prostate;
collecting the samples of tissue that have been removed from the plurality of zones of said prostate; and
analyzing the samples removed from each of the plurality of zones to determine a presence of the cancer in said each of the plurality of zones, so as to identify a location of the cancer in the prostate of the patient;
wherein the analyzing of said samples is performed in real-time to determine the presence of the cancer in said each of the plurality of zones as said samples are being removed using the water jet source.

### Claim 2 (depends on 1)

The method of claim 1, further comprising rotating said water jet source as said elongate apparatus is moved longitudinally along said prostate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the plurality of zones comprises a plurality of transverse zones.

### Claim 4 (depends on 1)

The method of claim 1, wherein the plurality of zones comprises a plurality of sagittal zones.

### Claim 5 (depends on 1)

The method of claim 1, further comprising determining a cancer treatment dosage for said each of the plurality of zones based on the presence of the cancer in said each of the plurality of zones.

### Claim 6 (depends on 5)

The method of claim 5, further comprising applying said cancer treatment dosage to said plurality of zones.

### Claim 7 (depends on 1)

The method of claim 1, further comprising determining a severity level of the cancer in said each of the plurality of zones.

### Claim 8 (depends on 7)

The method of claim 7, further comprising determining cancer treatment dosage for said each of the plurality of zones based on the presence and the severity level of the cancer in said each of the plurality of zones.

### Claim 9 (depends on 8)

The method of claim 8, further comprising applying said cancer treatment dosage to said plurality of zones.

### Claim 10 (depends on 8)

The method of claim 8, wherein said cancer treatment dosage is different depending on the severity level of the cancer in said each of the plurality of zones.

### Claim 11 (depends on 1)

The method of claim 1, wherein the presence of the cancer in said each of the plurality of zones is detected using an optical method.

### Claim 12 (depends on 11)

The method of claim 11, wherein the optical method comprises optical absorption and scattering, fluorescence spectroscopy or microscopy, or optical coherence domain reflectometry.

### Claim 13 (depends on 1)

The method of claim 1, wherein said elongate apparatus comprises a plurality of aspiration ports distributed longitudinally along said elongate apparatus.

### Claim 14 (depends on 13)

The method of claim 13, wherein said collecting of the samples comprises suctioning said samples from the plurality of zones through the plurality of aspiration ports as said samples are being removed by the water jet source.

### Claim 15 (depends on 1)

The method of claim 1, comprising:
inserting an elongate tubular member of the elongate apparatus from an external opening of a urethra to the prostate, the elongate tubular member comprising a lumen sized to pass urine, the elongate tubular member comprising a longitudinal length sized to extend at least from the external opening of the urethra to the prostate;
causing a support on the elongate tubular member to expand outwardly away from the elongate tubular member such that the support engages tissue adjacent a capsule of the prostate, wherein the support comprises a balloon configured to inflate to a wide profile configuration with injection of a fluid into a second lumen in order to engage tissue and to retract to a narrow profile configuration for removal with removal of the fluid; and
inhibiting, with aid of an access port with a barrier structure, to inhibit passage of the fluid when placed in the balloon, and wherein each of the balloon, the elongate tubular member, the barrier structure and the second lumen is configured to retain the balloon in the expanded configuration for a plurality of days.

### Claim 16

A method of detecting and localizing cancer in a prostate of a patient, the method comprising:
removing, using a water jet source provided on an elongate apparatus, samples of tissue from a plurality of zones of said prostate as said elongate apparatus is moved longitudinally along said prostate;
collecting the samples of tissue that have been removed from the plurality of zones of said prostate;
analyzing the samples removed from each of the plurality of zones to determine a presence of the cancer in said each of the plurality of zones, so as to identify a location of the cancer in the prostate of the patient; and
determining a cancer treatment dosage for said each of the plurality of zones based on the presence of the cancer in said each of the plurality of zones.

### Claim 17 (depends on 16)

The method of claim 16, further comprising rotating said water jet source as said elongate apparatus is moved longitudinally along said prostate.

### Claim 18 (depends on 16)

The method of claim 16, wherein the plurality of zones comprises a plurality of transverse zones.

### Claim 19 (depends on 16)

The method of claim 16, wherein the plurality of zones comprises a plurality of sagittal zones.

### Claim 20 (depends on 16)

The method of claim 16, further comprising applying said cancer treatment dosage to said plurality of zones.

### Claim 21 (depends on 16)

The method of claim 16, further comprising determining a severity level of the cancer in said each of the plurality of zones.

### Claim 22 (depends on 21)

The method of claim 21, further comprising determining cancer treatment dosage for said each of the plurality of zones based on the presence and the severity level of the cancer in said each of the plurality of zones.

### Claim 23 (depends on 22)

The method of claim 22, further comprising applying said cancer treatment dosage to said plurality of zones.

### Claim 24 (depends on 22)

The method of claim 22, wherein said cancer treatment dosage is different depending on the severity level of the cancer in said each of the plurality of zones.

### Claim 25 (depends on 16)

The method of claim 16, wherein the presence of the cancer in said each of the plurality of zones is detected using an optical method.

### Claim 26 (depends on 25)

The method of claim 25, wherein the optical method comprises optical absorption and scattering, fluorescence spectroscopy or microscopy, or optical coherence domain reflectometry.

### Claim 27 (depends on 16)

The method of claim 16, wherein said elongate apparatus comprises a plurality of aspiration ports distributed longitudinally along said elongate apparatus.

### Claim 28 (depends on 27)

The method of claim 27, wherein said collecting of the samples comprises suctioning said samples from the plurality of zones through the plurality of aspiration ports as said samples are being removed by the water jet source.

### Claim 29 (depends on 16)

The method of claim 16, comprising:
inserting an elongate tubular member of the elongate apparatus from an external opening of a urethra to the prostate, the elongate tubular member comprising a lumen sized to pass urine, the elongate tubular member comprising a longitudinal length sized to extend at least from the external opening of the urethra to the prostate;
causing a support on the elongate tubular member to expand outwardly away from the elongate tubular member such that the support engages tissue adjacent a capsule of the prostate, wherein the support comprises a balloon configured to inflate to a wide profile configuration with injection of a fluid into a second lumen in order to engage tissue and to retract to a narrow profile configuration for removal with removal of the fluid; and
inhibiting, with aid of an access port with a barrier structure, to inhibit passage of the fluid when placed in the balloon, and wherein each of the balloon, the elongate tubular member, the barrier structure and the second lumen is configured to retain the balloon in the expanded configuration for a plurality of days.
