# US 2023/0056293 A1 · Needle safety systems

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- Number: US 2023/0056293 A1
- Document ID: US20230056293A1
- Status: Published application
- Kind: A1
- Application number: 17/820,154
- Filed: 2022-08-16
- Published: 2023-02-23
- Earliest claimed: 2016-12-21
- Assignees: Hemotek Medical Incorporated
- Applicants: Hemotek Medical Incorporated
- Inventors: Patrick ROUSCHE; Peter TEK; Charles VENTURA; Richard A. SCRIBNER; Andrew BLACK; Andrew LEOPOLD; Mark CARLSON; Todd MACY; Daniel LANE; Adam HENSEL; Edward BROWKA
- Web page: https://patentgrep.com/patent/US20230056293A1

## CPC

- A61B 90/03: {Automatic limiting or abutting means, e.g. for safety}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61B 5/1422: {provided with indicating means, e.g. for vein entry}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/16813: {by controlling the degree of opening of the flow line}
- A61M 39/26: Valves closing automatically on disconnecting the line and opening on reconnection thereof {(check valves A61M39/24)}
- A61B 2090/036: {abutting on tissue or skin}
- A61M 5/16881: {Regulating valves}
- A61M 39/281: {Automatic tube cut-off devices, e.g. squeezing tube on detection of air}
- A61M 39/284: {Lever clamps}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M 2005/1588: {having means for monitoring, controlling or visual inspection, e.g. for patency check or for avoiding extravasation}
- 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)}

## Abstract

Tissue access devices and methods of using the same are disclosed. The devices can have a sensor configured to occlude a flow path by deflecting a membrane into the flow path when the devices become dislodged from tissue. The sensor can be configured to partially or fully occlude the flow path. The sensor can have a spring. The spring can be biased to move the sensor from a sensor first configuration to a sensor second configuration when a force applied by the sensor first surface against a non-sensor surface changes from a first force to a second force less than the first force. The membrane can be deflected into the flow path when the sensor is in the sensor second configuration.

## Claims

### Claim 1

A tissue access device comprising:
a needle;
a first-shot mold and a second-shot mold, wherein the first-shot mold and the second-shot mold define a flow channel; and
an occluder, wherein the occluder is movable toward and away from the flow channel,
wherein the tissue access device has a first configuration and a second configuration, and
wherein the flow channel has a cross-sectional area that is larger when the tissue access device is in the first configuration than when the tissue access device is in the second configuration.

### Claim 2 (depends on 1)

The tissue access device of claim 1, wherein the occluder is movable toward and away from the needle.

### Claim 3 (depends on 1)

The tissue access device of claim 1, wherein the occluder is closer to the needle when the tissue access device is in the second configuration than when the tissue access device is in the first configuration.

### Claim 4 (depends on 1)

The tissue access device of claim 1, wherein the second-shot mold has a deformable membrane, and wherein the deformable membrane is deformable by the occluder.

### Claim 5 (depends on 4)

The tissue access device of claim 4, wherein the deformable membrane is more deformed by the occluder when the tissue access device is in the second configuration than when the tissue access device is in the first configuration.

### Claim 6 (depends on 1)

The tissue access device of claim 1, further comprising a spring, wherein the spring is biased to move the tissue access device from the first configuration to the second configuration.

### Claim 7 (depends on 6)

The tissue access device of claim 6, wherein the spring is between the needle and the occluder when the tissue access device is in the first configuration and when the tissue access device is in the second configuration.

### Claim 8 (depends on 6)

The tissue access device of claim 6, wherein the spring comprises a torsion spring having a first arm and a second arm, wherein the first arm and the second arm are between the needle and the occluder when the tissue access device is in the first configuration and when the tissue access device is in the second configuration.

### Claim 9 (depends on 1)

The tissue access device of claim 1, wherein the cross-sectional area is 1% to 100% smaller when the tissue access device is in the second configuration than when the tissue access device is in the first configuration.

### Claim 10 (depends on 1)

The tissue access device of claim 1, wherein the first configuration is a non-occluded configuration, and wherein the second configuration is an occluded configuration.

### Claim 11 (depends on 1)

The tissue access device of claim 1, wherein the first configuration is a partially occluded configuration, and wherein the second configuration is a fully occluded configuration.

### Claim 12

A tissue access device comprising:
a needle;
a first-shot mold and a second-shot mold, wherein the first-shot mold and the second-shot mold define a flow channel; and
an occluder, wherein the occluder is movable toward and away from the flow channel,
wherein the tissue access device has a first configuration and a second configuration, and
wherein the occluder is farther from a center of the flow channel when the tissue access device is in the first configuration than when the tissue access device is in the second configuration.

### Claim 13 (depends on 12)

The tissue access device of claim 12, wherein the occluder is movable toward and away from the needle.

### Claim 14 (depends on 12)

The tissue access device of claim 12, wherein the occluder is closer to the needle when the tissue access device is in the second configuration than when the tissue access device is in the first configuration, wherein the second-shot mold has a deformable membrane, and wherein the deformable membrane is deformable by the occluder.

### Claim 15 (depends on 12)

The tissue access device of claim 12, further comprising a first spring and a second spring, wherein the first spring and the second spring are biased to move the tissue access device from the first configuration to the second configuration.

### Claim 16 (depends on 15)

The tissue access device of claim 15, wherein the first spring is a torsion spring, and wherein the second spring is a torsion spring.

### Claim 17 (depends on 15)

The tissue access device of claim 15, wherein the first spring and the second spring are between the needle and the occluder when the tissue access device is in the first configuration and when the tissue access device is in the second configuration.

### Claim 18 (depends on 17)

The tissue access device of claim 17, wherein the occluder is between the first spring and the second spring when the tissue access device is in the first configuration and when the tissue access device is in the second configuration.

### Claim 19

A tissue access device comprising:
a needle;
a first-shot mold and a second-shot mold, wherein the first-shot mold and the second-shot mold define a flow channel;
a spring; and
an occluder, wherein the occluder is movable toward and away from the flow channel, the first-shot mold, and the second-shot mold,
wherein the tissue access device has a first configuration and a second configuration,
wherein the spring is biased to move the tissue access device from the first configuration to the second configuration,
wherein the flow channel is more occluded by the occluder when the tissue access device is in the second configuration than when the tissue access device is in the first configuration, and
wherein the occluder is between a first end of the spring and a second end of the spring when the tissue access device is in the first configuration and when the tissue access device is in the second configuration.

### Claim 20 (depends on 19)

The tissue access device of claim 19, wherein the first configuration is a non-occluded configuration, wherein the second-shot mold has a deformable membrane, and wherein the deformable membrane is deformable by the occluder.
