# US 9,517,102 B2 · Cautery needle for separating and/or penetrating the pericardium

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

- Number: US 9,517,102 B2
- Document ID: US9517102B2
- Status: Granted
- Kind: B2
- Application number: 14/224,245
- Filed: 2014-03-25
- Published: 2015-10-01
- Granted: 2016-12-13
- Earliest claimed: 2014-03-25
- Applicants: Fawaz Alhumaid
- Inventors: Fawaz Alhumaid
- Web page: https://patentgrep.com/patent/US9517102B2

## CPC

- A61B 18/1477: {Needle-like probes}
- A61B 5/352: Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/7285: {for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00703: {correcting for movement of heart, e.g. ECG-triggered}
- A61B 2018/00595: {Cauterization}
- A61B 2018/00601: {Cutting}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/2005: {with beam delivery through an interstitially insertable device, e.g. needle}
- A61B 2018/20361: {with redirecting based on sensed condition, e.g. tissue analysis or tissue movement}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A pericardial needle that punctures a pericardial membrane with cautery to attain access into a pericardial space of a heart by positioning a cautery needle tip adjacent to or in contact with a parietal pericardium of the heart such that the puncturing does not damage the heart muscle. The pericardial needle punctures the parietal pericardium when the heart muscle moves towards the pericardial needle, away from the pericardial needle, is at rest and/or is in synchronization with the systolic contraction period of the cardiac cycle of the heart. The synchronization may be provided based on a surface electrocardiogram, an arterial pressure, or a sensing pressure at the tip of the pericardial needle when the pericardial needle is adjacent into the parietal pericardium of the heart.

## Claims

### Claim 1

A pericardial needle that punctures a pericardial membrane of a heart of a human patient, the pericardial needle comprising: an outer_cautery needle having a blunt cautery tip: an inner stylet having a sharp tip to puncture the pericardial membrane, the inner stylet being disposed inside the outer cautery needle; at least one of a first lumen having a wire passing through the first lumen and a second lumen having a contrast needle disposed inside the second lumen, wherein the at least one of the first lumen and the second lumen is affixed onto an inner surface of the outer cautery needle: and a controller that is configured to administer a cautery pulse to the blunt cautery tip through the outer cautery needle, wherein the controller is configured to track systole and diastole contraction phases of the heart for the administration of the cautery pulse through the outer cautery needle, and the pericardial needle is configured to advance toward the heart of the human patient to puncture, by cautery, the pericardial membrane of the heart in synchronization with a systole contraction phase of a mechanical activity of the heart of the human patient.

### Claim 2 (depends on 1)

The pericardial needle according to claim 1, wherein the controller is configured to receive electrocardiogram signals from the human patient and detect the systole. the diastole, the mechanical activity of heart. and motion of the heart based on the electrocardiogram signals.

### Claim 3 (depends on 2)

The pericardial needle according to claim 2, wherein the controller-is configured to monitor the electrocardiogram of the human patient and identify the phase of the mechanical activity of the heart of the human patient.

### Claim 4 (depends on 3)

The pericardial needle according to claim 3, wherein the controller is configured to acquire the electrocardiogram of the human patient, detect a QRS complex within the electrocardiogram of the human patient, wait for a predetermined time after the controller detects QRS complex, and indicate a systole phase of the heart of the human patient when the predetermined time after the detected QRS complex has elapsed.

### Claim 5 (depends on 4)

The pericardial needle according to claim 4, wherein the controller adjusts the predetermined time based on at least one of an age, a gender, a heart rate, a presence of an underlying heart disease, or a body mass index of the human patient.

### Claim 6 (depends on 5)

The pericardial needle according to claim 5, wherein the controller is configured to detect the QRS complex within the electrocardiogram of the human patient based on a slope of the electrocardiogram of the human patient, and detect if the determined slope has exceeded a predetermined slope threshold.

### Claim 7 (depends on 6)

The pericardial needle according to claim 6, wherein the controller is configured to adjust the predetermined slope threshold based on at least one of an age, a gender, a heart rate, a presence of an underlying heart disease, or a body mass index of the human patient.

### Claim 8 (depends on 7)

The pericardial needle according to claim 7, wherein the controller is configured to detect[s] the QRS complex within the electrocardiogram of the human patient by determining a correlation between a time window of the electrocardiogram of the human patient and a predetermined QRS template, and determining if the determined correlation has exceeded a predetermined correlation threshold.

### Claim 9 (depends on 8)

The pericardial needle according to claim 8, wherein the controller is configured to determine the predetermined QRS template based on a previously acquired QRS complex of the human patient.

### Claim 10 (depends on 9)

The pericardial needle according to claim 9, wherein the controller is configured to detect the phase of the mechanical activity of the heart of the human patient by measuring a pressure at the tip of the needle, and determining if the measured pressure has fallen below a predetermined pressure threshold.

### Claim 11 (depends on 9)

The pericardial needle according to claim 9, wherein the controller is configured to adjust a predetermined pressure threshold based on at least one of an age, a gender, a heart rate, a presence of an underlying heart disease, or a body mass index of the human patient.

### Claim 12 (depends on 1)

The pericardial needle according to claim 1, wherein the first lumen has a first inlet outside the outer cautery needle to receive the wire and a second inlet outside the outer cautery needle to receive a second contrast syringe containing a test contrast agent: and the controller is further configured to administer the test contrast agent through the second contrast syringe and advance the wire through the pericardial membrane as soon as the pericardial membrane is punctured.

### Claim 13

A pericardial needle that punctures a pericardial membrane of a heart of a human patient, the pericardial needle comprising: an outer cautery needle having a blunt cautery tip; an inner stylet having a sharp tip to puncture the pericardial membrane, the inner stylet being disposed inside the outer cautery needle; at least one of a first lumen having a wire passing through the first lumen and a second lumen having a contrast needle disposed inside the second lumen, wherein the at least one of the first lumen and the second lumen is affixed onto an inner surface of the outer cautery needle; a controller that is connected to the outer cautery needle and administers a cautery pulse to the outer cautery needle; wherein the controller is configured to track systole and diastole contraction phases of the heart to administer a cautery pulse through the inner cautery needle and advance the cautery needle through the pericardial membrane in synchronization with a detected systole contraction phase.

### Claim 14 (depends on 13)

The pericardial needle according to claim 13, wherein the controller is configured to receive electrocardiogram signals from the human patient and detect the systole, the diastole, mechanical activity of heart, and motion of the heart based on the electrocardiogram signals.

### Claim 15 (depends on 14)

The pericardial needle according to claim 14, wherein the controller is configured to monitor the electrocardiogram of the human patient and identifies a phase of the mechanical activity of the heart of the human patient.

### Claim 16 (depends on 15)

The pericardial needle according to claim 15, wherein the controller is configured to acquire the electrocardiogram of the human patient, detect a QRS complex within the electrocardiogram of the human patient, wait for a predetermined time after the controller detects QRS complex, and indicate a systole phase of the heart of the human patient when the predetermined time after the detected QRS complex has elapsed.

### Claim 17 (depends on 16)

The pericardial needle according to claim 16, wherein the controller is configured to adjust the predetermined time based on at least one of an age, a gender, a heart rate, a presence of an underlying heart disease, or a body mass index of the human patient.

### Claim 18 (depends on 17)

The pericardial needle according to claim 17, wherein the controller is configured to detect the QRS complex within the electrocardiogram of the human patient based on a slope of the electrocardiogram of the human patient, and detect if the determined slope has exceeded a predetermined slope threshold.

### Claim 19 (depends on 18)

The pericardial needle according to claim 18, wherein the controller is configured to adjust the predetermined slope threshold based on at least one of an age, a gender, a heart rate, a presence of an underlying heart disease, or a body mass index of the human patient.

### Claim 20 (depends on 13)

The pericardial needle according to claim 13, wherein the first lumen has a first inlet outside the outer cautery needle to receive the wire and a second inlet outside the outer cautery needle to receive a second contrast syringe containing a test contrast agent, and the controller is further configured to administer the test contrast agent through the second contrast syringe and advance the wire through the pericardial membrane once as the pericardial membrane is punctured.