IP Library Granted Patent US 10,433,785
Granted Patent B2
US 10,433,785 · App. 14/704,690 · Granted Oct 8, 2019

Percutaneous stimulation device and method for detecting compartment syndrome

Inventors: Michael R. Hausman (New York, NY); Robert B. Strother (Willoughby, OH); Jonathan Sakai (Fairview Park, OH)
Assignee: CHECKPOINT SURGICAL, INC.
A61B5/4519A61B5/03A61B5/0488A61B5/0492A61B5/05A61B5/1104A61B5/1107A61B5/6847A61B5/6848A61B5/6852A61B5/742A61B5/7405A61B5/746A61B5/7455
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,433,785
App. No.
14/704,690
Granted
Oct 8, 2019
Kind
B2
Abstract

A diagnosis device, and more particularly, a compartment syndrome diagnostic device is described herein. The diagnostic device may include a display that renders information associated with stimulation of a motor unit suspected of suffering from compartment syndrome. The diagnostic device may generate a stimulation signal for stimulating the motor unit through an electrode. The device may determine whether the motor unit is at risk for compartment syndrome based on the response of the motor unit to the stimulation. The diagnostic device may also measure pressure of a compartment. The device may determine whether the motor unit is at risk for compartment syndrome based on the measured pressure and the response of the motor unit to the stimulation.

Claims (48)

1. A compartment syndrome diagnosis device, comprising:

a percutaneous probe comprising an electrode;

a memory to store computer executable instructions; and

a processor, communicatively coupled to the memory and the electrode, that facilitates execution of computer executable instructions to perform the following acts:

generating a stimulus signal intended to elicit a visible and/or palpable muscle contraction of a motor unit of a compartment; and

monitoring at least one stimulation parameter associated with a stimulation threshold of the motor unit of the compartment,

wherein the electrode operatively delivers, based on the stimulation parameter, a stimulation signal to the motor unit.

2. The device of claim 1 , wherein the acts further comprise:

generating a rendering of a representation of data describing a history of the at least one stimulation parameter.

3. The device of claim 2 wherein the generating the rendering of the representation further comprises generating the rendering describing at least one of a stimulus current amplitude with a fixed pulse duration, stimulus pulse duration at a fixed current amplitude, or a charge of the stimulus pulse.

4. The device of claim 1 , wherein the acts further comprise:

controlling a stimulation parameter for stimulation of the motor unit in the compartment, wherein the compartment is determined to be a location of a possible compartment syndrome.

5. The device of claim 4 ,

wherein the percutaneous probe is configured to be at least partially implanted into the tissue region, and wherein the percutaneous probe comprises at least one of a needle, a catheter, or an intramuscular lead.

6. The device of claim 4 , wherein the electrode is configured for delivering unipolar stimulation to the motor unit.

7. The device of claim 4 , further comprising a return electrode coupled to the compartment syndrome diagnosis device, the return electrode configured to provide a return path for the stimulation signal.

8. The device of claim 4 , wherein the controlling the stimulation parameter further comprises:

iterating alteration of a stimulus magnitude until a lowest stimulus magnitude is reached, the lowest stimulus magnitude producing a measurable, observable or palpable muscle twitching; and

wherein the monitoring the at least one stimulation parameter further comprises recording the lowest stimulus magnitude as the at least one stimulation parameter as the tissue stimulation recruitment threshold of a motor unit of a compartment.

9. The device of claim 8 , wherein the acts further comprise:

determining whether to adjust the stimulus magnitude based on input associated with identification of the muscle twitching.

10. The device of claim 9 , wherein the acts further comprise:

receiving the input associated with the identification from at least one of a control device configured to receive user input, a muscle twitch sensor operatively coupled to a patient receiving the stimulation, or an electromyograph electrode comprising at least one of a surface electrode or a percutaneous lead.

11. The device of claim 8 , wherein the acts further comprise:

generating a notification indicative of at least one of a prompt to a user to initiate the iterating the alteration of the stimulus magnitude, the at least one stimulation parameter exceeding a threshold, a rate of alteration of the at least one stimulation parameter exceeding a threshold rate, or a weighted combination thereof.

12. The device of claim 11 , wherein generating the notification further comprises:

generating the notification as at least one of an audible notification, visual notification, a tactile notification, or a communication notification sent through a communications network to a user device.

13. The device of claim 4 , wherein the stimulation parameter for stimulation of the motor unit comprises a stimulation signal comprising within a range of frequency, wherein the range is greater than about 0.5 to less than about 50 hertz.

14. The device of claim 13 , wherein the range is greater than about 0.7 to less than about 3 hertz.

15. The device of claim 1 , further comprising:

a printer configured to print information associated with the stimulation, wherein the printer comprises at least one of an integrated printer that is integrated within the device or an external printer that is at least one of wirelessly connected or hard-wired connected to the device.

16. The device of claim 1 , wherein the device is a wearable device.

17. The device of claim 1 , further comprising a pressure sensor configured to measure interstitial pressure within the compartment.

18. The device of claim 17 , wherein the percutaneous probe further comprises the pressure sensor.

19. The device of claim 17 , acts further comprising: recording the interstitial pressure;

generating a rendering of at least one of a history associated with the interstitial pressure or a history associated with the at least one stimulation parameter; and

generating a notification indicative of at least one of the at least one stimulation parameter exceeding a threshold, a rate of alteration of the at least one stimulation parameter exceeding a threshold rate, the interstitial pressure exceeding a pressure threshold, a rate of increase of the interstitial pressure exceeding a pressure threshold rate, or a weighted combination of at least two of the above.

20. The device of claim 1 , further comprising a motion sensor coupled to the processor and operatively measuring the palpable and/or visible muscle contraction.

21. A method for diagnosing compartment syndrome, comprising:

stimulating, via a device comprising a processor and a percutaneous electrode, a motor unit in a compartment suspected to be at risk of compartment syndrome, wherein stimulation is induced by a signal that induces a palpable muscle twitching;

determining a stimulation threshold associated with actuation of the motor unit; and

monitoring at least one of a history of stimulation thresholds over a period of time or a history of interstitial pressure over a period of time.

22. A compartment syndrome diagnosis device, comprising:

a stimulation component configured to generate a stimulation signal;

a percutaneous probe operatively in communication with a motor unit suspected of compartment syndrome, wherein the stimulation component is further configured to stimulate the motor unit via the percutaneous probe and based on the stimulation signal, wherein the stimulation signal comprises parameters intended to elicit a palpable and/or visible muscle contraction of the motor unit;

an intermuscular pressure sensing component configured to measure a pressure of a compartment comprising the motor unit;

a display device configured to render a display indicating stimulation parameters associated with stimulation and pressure parameters; and

a memory operatively storing a history of the stimulation parameters.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE APPLICATION NUMBER 13605862 PREVIOUSLY RECORDED AT REEL: 047237 FRAME: 0435. ASSIGNOR(S) HEREBY CONFIRMS THE RELEASE OF SECURITY INTEREST. Recorded Oct 24, 2018
From: THE DIRECTOR OF THE OHIO DEVELOPMENT SERVICES AGENCY
To: CHECKPOINT SURGICAL, INC.
Reel/Frame 047299/0952 →
RELEASE OF SECURITY INTEREST Recorded Oct 15, 2018
From: THE OHIO DEVELOPMENT SERVICES AGENCY
To: CHECKPOINT SURGICAL, INC.
Reel/Frame 047237/0435 →
SECURITY INTEREST Recorded Dec 21, 2017
From: CHECKPOINT SURGICAL, INC.
To: THE DIRECTOR OF THE OHIO DEVELOPMENT SERVICES AGENCY
Reel/Frame 044456/0496 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2017
From: HAUSMAN, MICHAEL; STROTHER, ROBERT; SAKAI, JONATHAN
To: CHECKPOINT SURGICAL, INC
Reel/Frame 042420/0060 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2016
From: CHECKPOINT SURGICAL, LLC
To: CHECKPOINT SURGICAL, INC.
Reel/Frame 039042/0917 →
Cited By (3)
US 12,318,608 US 12,611,538 US 12,616,832