# US 9,517,349 B2 · System and method for treating soft tissue with force impulse and electrical stimulation

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,517,349 B2
- Document ID: US9517349B2
- Status: Granted
- Kind: B2
- Application number: 14/372,989
- Filed: 2013-01-17
- Published: 2015-01-01
- Granted: 2016-12-13
- Earliest claimed: 2012-01-17
- Assignees: Sigma Instruments Holdings, LLC
- Applicants: Sigma Instruments Holdings, LLC
- Inventors: Tamas Becse; John Crunick; Louis L. Laskey, Jr.
- Web page: https://patentgrep.com/patent/US9517349B2

## CPC

- A61H 23/0245: {with ultrasonic transducers, e.g. piezoelectric}
- A61B 5/0533: Measuring galvanic skin response
- A61B 9/00: Instruments for examination by percussion; Pleximeters
- A61B 17/22004: {using mechanical vibrations, e.g. ultrasonic shock waves (A61B17/225 takes precedence)}
- A61H 23/008: {using shock waves}
- A61N 1/00: Electrotherapy; Circuits therefor (A61N2/00 takes precedence; irradiation apparatus A61N5/00)
- A61N 1/0452: {Specially adapted for transcutaneous muscle stimulation [TMS]}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/326: {for promoting growth of cells, e.g. bone cells}
- A61N 1/36003: {of motor muscles, e.g. for walking assistance}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/37247: {User interfaces, e.g. input or presentation means}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61H 2201/0157: portable
- A61H 2201/10: with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
- A61H 2201/123: Linear drive
- A61H 2201/1664: linear
- A61H 2201/1685: interchangeable
- A61H 2201/5005: for controlling frequency distribution, modulation or interference of a driving signal
- A61H 2201/5038: freely programmable by the user
- A61H 2201/5046: Touch screens
- A61H 2201/5058: Sensors or detectors
- A61H 2201/5064: Position sensors
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

A system for treating soft tissue of a patient. The system includes a treatment head and a computer portion. The treatment head includes a probe and an electrode operably coupled to the probe. The probe and electrode are configured to respectively deliver a mechanical force impulse and an electrical stimulation to the soft tissue when placed in operable contact with the soft tissue. The computer portion includes a CPU and is configured to coordinate the delivery of the mechanical force impulse and electrical stimulation relative to each other. The system is configured to sense a shockwave in the soft tissue of the patient, the shockwave resulting from the mechanical force impulse delivered to the soft tissue via the probe. The system is also configured to analyze a characteristic of the sensed shockwave and configure the electrical stimulation to be delivered to the soft tissue via the electrode based on the characteristic analysis of the sensed shockwave. The characteristic may be at least one of frequency of the sensed shockwave, amplitude of the sensed shockwave, and/or wave shape (form) of the sensed shockwave.

## Claims

### Claim 1

A system for treating tissue associated with a desired outcome of a surgical procedure on a patient, the system comprising:
a database contained in a memory, wherein the database contains data categorized by surgical locations, the data including a plurality of anatomical images, a plurality of treatment points identified on the plurality of anatomical images, and a plurality of treatment protocols associated with the plurality of treatment points,
a treatment head comprising a probe and an electrode operably coupled to the probe, the treatment head configured to respectively deliver a mechanical force impulse and an electrical stimulation to at least one treatment point, the electrode configured to measure a galvanic response at the at least one treatment point to provide a measured galvanic response, wherein the treatment head comprises a sensor configured to sense a frequency of the mechanical force impulse associated with the at least one treatment point to provide a sensed mechanical force impulse;
wherein the system is configured such that a selection of a specific surgical location and a specific surgical procedure to occur at the specific surgical location causes an image of a specific region of the patient to be displayed on a display of the system, the image of the specific region including the specific surgical location,
wherein the at least one treatment point is caused to be displayed on the image of the specific region, the at least one treatment point being stored in the database as part of the plurality of treatment points and associated with at least one treatment protocol of the plurality of treatment protocols,
wherein the at least one treatment protocol of the plurality of treatment protocols is modified based on at least one of the measured galvanic response or the sensed mechanical force impulse associated with the at least one treatment point.

### Claim 2 (depends on 1)

The system of claim 1, wherein the system is also configured such that the selection of the specific surgical location from the database provides the ability to input information into the system regarding the specific surgical procedure to occur at the specific surgical location.

### Claim 3 (depends on 1)

The system of claim 1, wherein, when the specific surgical location is a knee, the surgical procedure comprises at least one of the following: total arthroplasty; uni-compartmental arthroplasty; ligament repair; meniscus repair, torn or ruptured tendon repair, or torn or ruptured muscle repair.

### Claim 4 (depends on 3)

The system of claim 3, wherein the specific region comprises a knee region comprising a distal region of a femur and a proximal region of a tibia.

### Claim 5 (depends on 4)

The system of claim 4, wherein, when the at least one treatment point is caused to be displayed on the image of the specific region, the at least one treatment point is displayed on at least one of the following locations: a distal femur proximal to the patella; a medial or lateral epicondyle; a medial or lateral meniscus; a medial or lateral collateral ligament; a patella tendon; a lateral head of a fibula; a tibial tuberosity; a proximal tibia; or an adductor tubercle.

### Claim 6 (depends on 1)

The system of claim 1, wherein, when the specific surgical location is a hip, the surgical procedure comprises at least one of the following: femoral head total arthroplasty;
femoral head resurfacing; ligament repair; torn or ruptured tendon repair; torn or ruptured muscle repair; or femur fracture repair.

### Claim 7 (depends on 6)

The system of claim 6, wherein the specific region comprises a hip region comprising a proximal region of a femur and region of an iliac surrounding a hip joint.

### Claim 8 (depends on 7)

The system of claim 7, wherein, when the at least one treatment point is caused to be displayed on the image of the specific region, the at least one treatment point is displayed on at least one of the following locations: an anterior superior iliac crest; an inguinal ligament; a greater or lesser trochanter; a trochanteric bursa; an anterior or lateral proximal femur; a proximal hamstring tendon; or a proximal hamstring muscle.

### Claim 9 (depends on 1)

The system of claim 1, wherein, when the specific surgical location is a shoulder, the surgical procedure comprises at least one of the following: rotator cuff repair; total shoulder arthroplasty; shoulder joint resurfacing; arthroscopic acrominosplasty; ligament repair;
humerus fracture repair; clavical fracture repair; torn or ruptured tendon repair; torn or ruptured muscle repair; impingement of scapula; removal of calcified deposits in the supraspinatus or related tendons; or Mumford procedure.

### Claim 10 (depends on 9)

The system of claim 9, wherein the specific region comprises a shoulder region comprising a proximal region of a humerus and a lateral region of at least one of a clavicle or a scapula.

### Claim 11 (depends on 10)

The system of claim 10, wherein, when the at least one treatment point is caused to be displayed on the image of the specific region, the at least one treatment point is displayed on at least one of the following locations: an anterior acromioclavicular joint; an anterior acromion; an anterior corticoid process; an anterior glenohumeral joint; an anterior greater or lessor tubercle; a spine of a scapula; a supraspinatus muscle; a subacromaial bursa; a grove for a bicep tendon; or a deltoid muscle.

### Claim 12 (depends on 1)

The system of claim 1, further comprising a treatment head electrically coupled to the database and configured to deliver at least one of impulse and/or electrical therapy energy to the treatment point in accordance with the at least one treatment protocol of the plurality of treatment protocols.

### Claim 13 (depends on 1)

The system of claim 1, wherein each of the plurality of treatment protocols causes the electrical stimulation from the electrode to be delivered with the delivery of
the mechanical force impulse from the probe to the at least one treatment point.

### Claim 14

A system for delivering at least one of preoperative or postoperative therapy to tissue associated with a surgical outcome, the system comprising:
a database comprising a plurality of anatomical images respectively correlated to a plurality of surgical target sites;
an input device configured to allow a selection of a specific surgical target site from the plurality of surgical target sites;
a display device;
a treatment head comprising a probe and an electrode operably coupled to the probe, the treatment head configured to respectively deliver a mechanical force impulse and an electrical stimulation to at least one treatment point, the electrode configured to measure the galvanic response at the at least one treatment point to provide a measured galvanic response, wherein the treatment head comprises a sensor configured to sense a frequency of the mechanical force impulse associated with the at least one treatment point to provide a sensed mechanical force impulse; and
a CPU in communication with the database, input device, the display device and the treatment head,
wherein, when the specific surgical target site is selected from the plurality of surgical target sites, the CPU causes a respective specific anatomical image to be displayed on the display and the at least one treatment point to be indicated on the displayed specific anatomical image,
wherein the CPU causes the treatment head to function in accordance with a treatment protocol corresponding to the at least one treatment point,
wherein the treatment protocol is modified based on at least one of the measured galvanic response or the sensed mechanical force impulse associated with the at least one treatment point.

### Claim 15 (depends on 14)

The system of claim 14, wherein the input device comprises a touch screen or a keyboard.

### Claim 16 (depends on 14)

The system of claim 14, wherein the plurality of surgical target sites comprises surgical procedures.

### Claim 17 (depends on 14)

The system of claim 14, wherein the treatment head is configured to deliver at least one of impulse and/or electrical therapy energy in accordance with the treatment protocol.

### Claim 18 (depends on 14)

The system of claim 14, wherein the database further comprises a plurality of treatment protocols correlated to a plurality of treatment points correlated with the plurality of surgical sites.

### Claim 19

A method for delivering at least one of preoperative or postoperative therapy to tissue associated with a surgical outcome, the method comprising:
imputing at least one of a surgical procedure or surgical target site into an apparatus comprising a treatment head, the apparatus displaying on a display an anatomical image comprising the surgical target site, the apparatus also displaying treatment points on anatomical landmarks shown in the anatomical image, the apparatus correlating the treatment points with the at least one of the surgical procedure or surgical target site, the apparatus correlating a treatment protocol with the treatment points;
using the treatment head comprising a probe and an electrode operably coupled to the probe to respectively deliver a mechanical force impulse and an electrical stimulation to at least one of the treatment points and to measure a galvanic response at the at least one of the treatment points to provide a measured galvanic response
using the treatment head comprising a sensor to sense a frequency of the mechanical force impulse associated with the at least one of the treatment points to provide a sensed mechanical force impulse;
using the treatment head to apply therapy to locations on a patient that correspond to the treatment points, the therapy being configured according to the therapy protocol controlling the treatment head,
wherein the treatment protocol is modified based on at least one of the measured galvanic response or the sensed mechanical force impulse associated with the at least one of the treatment points.

### Claim 20 (depends on 19)

The method of claim 19, wherein, when the surgical procedure concerns a knee or the surgical target site comprises a knee, the surgical procedure comprises at least one of the following: total arthroplasty; uni-compartmental arthroplasty; ligament repair; meniscus repair, torn or ruptured tendon repair, or torn or ruptured muscle repair.

### Claim 21 (depends on 20)

The method of claim 20, wherein the anatomical image comprises a knee region comprising a distal region of a femur and a proximal region of a tibia.

### Claim 22 (depends on 21)

The method of claim 21, wherein, when the treatment points are displayed on the anatomical landmarks shown in the anatomical image, the treatment points are displayed at least some of the following locations: a distal femur proximal to the patella; a medial or lateral epicondyle; a medial or lateral meniscus; a medial or lateral collateral ligament; a patella tendon; a lateral head of a fibula; a tibial tuberosity; a proximal tibia; or an adductor tubercle.

### Claim 23 (depends on 19)

The method of claim 19, wherein, when the surgical procedure concerns a hip or the surgical target site comprises a hip, the surgical procedure comprises at least one of the following: femoral head total arthroplasty; femoral head resurfacing; ligament repair; torn or ruptured tendon repair; torn or ruptured muscle repair; or femur fracture repair.

### Claim 24 (depends on 23)

The method of claim 23, wherein the anatomical image comprises a hip region comprising a proximal region of a femur and region of an iliac surrounding a hip joint.

### Claim 25 (depends on 24)

The method of claim 24, wherein, when the treatment points are displayed on the anatomical landmarks shown in the anatomical image, the treatment points are displayed at least some of the following locations: an anterior superior iliac crest; an inguinal ligament; a greater or lesser trochanter; a trochanteric bursa; an anterior or lateral proximal femur; a proximal hamstring tendon; or a proximal hamstring muscle.

### Claim 26 (depends on 19)

The method of claim 19, wherein, when the surgical procedure concerns a shoulder or the surgical target site comprises a shoulder, the surgical procedure comprises at least one of the following: rotator cuff repair; total shoulder arthroplasty; shoulder joint resurfacing; arthroscopic acrominosplasty; ligament repair; humerus fracture repair; clavical fracture repair; torn or ruptured tendon repair; torn or ruptured muscle repair; impingement of scapula; removal of calcified deposits in the supraspinatus or related tendons; or Mumford procedure.

### Claim 27 (depends on 26)

The method of claim 26, wherein the anatomical image comprises a shoulder region comprising a proximal region of a humerus and a lateral region of at least one of a clavicle or a scapula.

### Claim 28 (depends on 27)

The method of claim 27 wherein, when the treatment points are displayed on the anatomical landmarks shown in the anatomical image, the treatment points are displayed at least some of the following locations: an anterior acromioclavicular joint; an anterior acromion; an anterior corticoid process; an anterior glenohumeral joint; an anterior greater or lessor tubercle; a spine of a scapula; a supraspinatus muscle; a subacromaial bursa; a grove for a bicep tendon; or a deltoid muscle.

### Claim 29 (depends on 19)

The method of claim 19, wherein the treatment head is configured to deliver at least one of impulse and/or electrical therapy energy to the treatment points in accordance with the therapy protocol.