# US 10,864,356 B2 · Percutaneous access pathway system and method

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- Number: US 10,864,356 B2
- Document ID: US10864356B2
- Status: Granted
- Kind: B2
- Application number: 16/015,586
- Filed: 2018-06-22
- Published: 2018-10-18
- Granted: 2020-12-15
- Earliest claimed: 2013-12-26
- Assignees: Critical Innovations, LLC
- Applicants: Critical Innovations, LLC
- Inventors: Ross I. Donaldson
- Web page: https://patentgrep.com/patent/US10864356B2

## CPC

- A61M 27/00: Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202})
- A61B 17/34: Trocars; Puncturing needles
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 17/3496: {Protecting sleeves or inner probes; Retractable tips (for protecting body piercing guide needles A61M25/0612)}
- A61M 1/04: {Artificial} pneumothorax apparatus
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61B 90/40: Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
- A61B 2017/00809: {Lung operations}
- A61B 2017/3409: {including needle or instrument drives}
- A61M 2025/0024: {Expandable catheters or sheaths}
- A61M 2210/101: Pleural cavity
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An improved method and device are provided for forming and/or maintaining a percutaneous access pathway. The device generally comprises at least one of three type of components: access pathway, insertion device, and attachment device. In one embodiment, the device is used to form and/or maintain a percutaneous access pathway into the pleural cavity (i.e. tube thoracostomy). The provided assembly substantially reduces the possibility of iatrogenic infection while accessing and/or re-accessing a body space.

## Claims

### Claim 1

A device for forming and/or maintaining a percutaneous access pathway into a body of a patient, comprising:
an access pathway catheter configured to connect an internal portion of a body of a patient to an external environment, the access pathway catheter including a distal opening configured to extend at least partially into the internal portion of the body;
an access pathway port configured to maintain a barrier between the internal portion of the body and the external environment when in a closed position, the access pathway port including at least one distal opening connecting to the access pathway catheter;
an attachment device connectable to the access pathway port and configured to selectively allow the access pathway port to open by opening one or more doors in the access pathway; and
a collapsible attachment device sheath at least partially surrounding the attachment device and configured to enable insertion of at least part of the attachment device into the internal portion of the body through the one or more doors in the access pathway when the attachment device is connected to the access pathway port.

### Claim 2 (depends on 1)

The percutaneous access pathway of claim 1, wherein the one or more doors in the access pathway includes a door in the access pathway port that is configured to be reversibly opened and closed.

### Claim 3 (depends on 2)

The percutaneous access pathway of claim 2, wherein the access pathway is configured to enable opening of the door in the access pathway port only when the attachment device is connected to the access pathway port.

### Claim 4 (depends on 2)

The percutaneous access pathway of claim 2, wherein the access pathway is configured to inhibit removal of the attachment device from the access pathway port while the door in the access pathway port is open.

### Claim 5 (depends on 1)

The percutaneous access pathway of claim 1, wherein the attachment device is configured to be reversibly connected to and disconnected from the access pathway port.

### Claim 6 (depends on 1)

The percutaneous access pathway of claim 1, wherein the attachment device is configured to be manipulated from the external environment through the attachment device sheath while maintaining a barrier from the external environment to within the body with the access pathway port and the attachment device sheath.

### Claim 7 (depends on 1)

The percutaneous access pathway of claim 1, further comprising an insertion device configured to cause the access pathway catheter to be inserted into the internal body of the patient and configured to selectively cause the access pathway catheter to expand.

### Claim 8 (depends on 1)

The percutaneous access pathway of claim 1, wherein the access pathway catheter and access pathway port are unitarily formed in a single component.

### Claim 9 (depends on 1)

The percutaneous access pathway of claim 1, wherein the attachment device is configured to connect to suction in the external environment.

### Claim 10 (depends on 1)

The percutaneous access pathway of claim 1, wherein the attachment device sheath is internally sterile and air-impermeable.

### Claim 11 (depends on 1)

The percutaneous access pathway of claim 1, wherein the access pathway port contains an adhesive configured to secure the access pathway to the body of a patient.

### Claim 12 (depends on 1)

The percutaneous access pathway of claim 1, wherein the access pathway catheter contains an adhesive configured to secure the access pathway to the body of a patient.

### Claim 13

A device for forming and/or maintaining a percutaneous access pathway into a body of a patient, comprising:
an access pathway catheter configured to connect an internal portion of a body of a patient to an external environment, the access pathway catheter including a distal opening configured to extend at least partially into the internal portion of the body;
an access pathway port configured to maintain a barrier between the internal portion of the body and the external environment when in a closed position, the access pathway port including at least one distal opening connecting to the access pathway catheter;
an access pathway door;
an attachment device connectable to the access pathway port and configured to selectively allow the access pathway port to open by opening the access pathway door; and
a collapsible attachment device sheath at least partially surrounding the attachment device and configured to enable insertion of at least part of the attachment device into the internal portion of the body through the door in the access pathway when the attachment device is connected to the access pathway port,
wherein the access pathway door is configured to open only when the attachment device is attached to the access pathway port and to prohibit disconnection of the attachment device from the access pathway port when the access pathway door is open.

### Claim 14 (depends on 13)

The device of claim 13, wherein the attachment device is configured to be reversibly connected to and disconnected from the access pathway port.

### Claim 15 (depends on 13)

The device of claim 13, wherein the attachment device is internally sterile and configured to be manipulated from the external environment through the attachment device sheath while maintaining a barrier from the external environment to within the body when connected to the access pathway port and the access pathway catheter.

### Claim 16 (depends on 13)

The device of claim 13, further comprising an insertion device configured to cause the access pathway catheter to be inserted into the internal body of the patient and to selectively cause the access pathway catheter to expand.

### Claim 17 (depends on 13)

The device of claim 13, wherein the attachment device is configured to connect to suction in the external environment.

### Claim 18 (depends on 13)

The device of claim 13, wherein the access pathway port and/or the access pathway catheter includes an adhesive configured to secure the access pathway to the body of a patient.

### Claim 19 (depends on 13)

The device of claim 13, wherein the access pathway catheter and the access pathway port are unitarily formed in a single component.
