# US 11,992,644 B2 · Flush instrument with blood exposure protection and related methods

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- Number: US 11,992,644 B2
- Document ID: US11992644B2
- Status: Granted
- Kind: B2
- Application number: 17/127,588
- Filed: 2020-12-18
- Published: 2021-07-15
- Granted: 2024-05-28
- Earliest claimed: 2020-01-09
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Megan Scherich; Curtis H. Blanchard; Yiping Ma; Weston F. Harding; Jonathan Karl Burkholz
- Web page: https://patentgrep.com/patent/US11992644B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 25/09041: {Mechanisms for insertion of guide wires}
- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- A61M 2039/0202: {for taking samples}
- A61M 2039/0205: {for injecting media}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0291: {method or device for implanting it in the body}
- 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

A system for accessing a patient's vascular system may have a tube with a wall that defines an exterior surface and lumen with a proximal end and a distal end, and a guidewire that is deployable, by sliding distally, from a retracted position in which the guidewire resides in the lumen, to a deployed position in which the guidewire extends beyond the distal end. The system may further have a retraction mechanism that can be actuated to retract the guidewire from the deployed position to the retracted position, or a protective shield that can be actuated to extend distally from the distal end of the tube to cover the guidewire in the deployed position.

## Claims

### Claim 1

A system for accessing a patient's vascular system, the system comprising:
a tube comprising a wall that defines an exterior surface and a lumen with a proximal end and a distal end, wherein the proximal end is connectable to a source of pressurized fluid;
a guidewire that is deployable by sliding distally from a retracted position in which the guidewire resides in the lumen, to a deployed position in which the guidewire extends beyond the distal end, wherein the guidewire is deployable in response to pressure, proximal to the lumen, from the source of pressurized fluid; and
at least one element selected from the group consisting of:
a retraction mechanism that can be actuated to retract the guidewire from the deployed position to the retracted position; and
a protective shield that can be actuated to extend distally from the distal end of the tube to cover the guidewire in the deployed position.

### Claim 2 (depends on 1)

The system of claim 1, wherein:
the system comprises an extension set for a vascular access device (VAD); and
the distal end comprises a blunt cannula configured to mate with a needleless access connector of the VAD.

### Claim 3 (depends on 2)

The system of claim 2, further comprising a cap configured to cover the blunt cannula prior to attachment of the blunt cannula to the VAD.

### Claim 4 (depends on 1)

The system of claim 1, wherein:
the element comprises the retraction mechanism; and
the retraction mechanism is slidably coupled to the exterior surface and is coupled to the guidewire such that motion of the retraction mechanism toward the proximal end retracts the guidewire from the deployed position to the retracted position.

### Claim 5 (depends on 1)

The system of claim 1, wherein:
the element comprises the retraction mechanism;
the guidewire comprises:
a distal portion with an elongated shape; and
a proximal portion with a coupling feature with a cross-sectional shape that is enlarged relative to the distal portion; and
the retraction mechanism is coupled to the coupling feature through the wall.

### Claim 6 (depends on 5)

The system of claim 5, wherein the coupling feature comprises at least one selection from the group consisting of:
a wedge shape;
one or more rounded ridges;
one or more fins;
one or more splines;
one or more longitudinal ribs; and
one or more anti-rotation features.

### Claim 7 (depends on 5)

The system of claim 5, wherein the retraction mechanism compresses the wall into contact with the coupling feature to cause the wall to urge the coupling feature to move proximally in response to proximal motion of the retraction mechanism.

### Claim 8 (depends on 7)

The system of claim 7, wherein the retraction mechanism comprises at least one selection from the group consisting of:
one or more wheels that engage the exterior surface to compress the tube;
one or more ball bearings that engage the exterior surface to compress the tube; and
one or more manually compressible walls that can be flexed toward the tube.

### Claim 9 (depends on 5)

The system of claim 5, wherein:
the element comprises the retraction mechanism; and
the retraction mechanism comprises at least one selection from the group consisting of:
one or more magnets that magnetically engage the coupling feature;
one or more springs coupled to the coupling feature; and
a tether secured to the coupling feature.

### Claim 10 (depends on 1)

The system of claim 1, further comprising a spring that urges the guidewire to deploy from the retracted position to the deployed position.

### Claim 11 (depends on 1)

The system of claim 1, wherein:
the element comprises the protective shield; and
the system further comprises an absorbent component positioned to remove blood from the guidewire after deployment of the guidewire.

### Claim 12 (depends on 1)

The system of claim 1, wherein the guidewire comprises at least one selection from the group consisting of:
a spring comprising a variable pitch; and
a secondary tube comprising an interior bore through which blood can be aspirated from the vascular system.

### Claim 13 (depends on 12)

The system of claim 12, wherein:
the proximal end is connectable to a source of pressurized fluid;
the guidewire is deployable in response to pressure, proximal to the lumen, from the source of pressurized fluid;
the guidewire comprises the secondary tube; and
the guidewire further comprises a valve that is closed during deployment of the guidewire and open during aspiration of blood from the vascular system.

### Claim 14 (depends on 13)

The system of claim 13, wherein at least one of the guidewire and the tube further comprises a catch mechanism that retains the guidewire in the deployed position.

### Claim 15

A method for accessing a patient's vascular system, the method comprising:
positioning a tube proximate the vascular system, the tube comprising an exterior surface and a lumen with a proximal end and a distal end;
connecting the proximal end to a source of pressurized fluid;
dispensing pressurized fluid from the source to deploy a guidewire by sliding the guidewire distally, from a retracted position in which the guidewire resides in the lumen, to a deployed position in which the guidewire extends beyond the distal end; and
performing at least one step selected from the group consisting of:
retracting the guidewire from the deployed position to the retracted position by sliding a retraction mechanism, slidably coupled to the exterior surface, proximally; and
actuating a protective shield to extend distally from the distal end of the tube to cover the guidewire in the deployed position.

### Claim 16 (depends on 15)

The method of claim 15, wherein:
the step comprises retracting the guidewire by sliding the retraction mechanism; and
the method further comprises, prior to deploying the guidewire, moving the retraction mechanism to a predetermined position such that, during deployment of the guidewire, the retraction mechanism limits a range of proximal motion of the guidewire.

### Claim 17 (depends on 15)

The method of claim 15, wherein:
the step comprises actuating the protective shield; and
the method further comprises, with an absorbent component, removing blood from the guidewire after deployment of the guidewire.

### Claim 18 (depends on 15)

The method of claim 15, wherein:
the guidewire comprises:
a secondary tube comprising an interior bore; and
a valve;
wherein deploying the guidewire comprises dispensing pressurized fluid from the source with the valve closed to prevent fluid flow through the interior bore; and
the method further comprises, after deploying the guidewire:
opening the valve to permit fluid flow through the interior bore; and
aspirating blood through the interior bore.

### Claim 19

A system for accessing a patient's vascular system, the system comprising:
a tube comprising a wall that defines an exterior surface and a lumen with a proximal end and a distal end;
a guidewire that is deployable by sliding distally from a retracted position in which the guidewire resides in the lumen, to a deployed position in which the guidewire extends beyond the distal end, the guidewire comprising:
a distal portion with an elongated shape; and
a proximal portion with a coupling feature with a cross-sectional shape that is enlarged relative to the distal portion; and
a retraction mechanism that can be actuated to retract the guidewire from the deployed position to the retracted position;
wherein:
the proximal end is connectable to a source of pressurized fluid;
the guidewire is deployable in response to pressure, proximal to the lumen, from the source of pressurized fluid;
the system comprises an extension set for a vascular access device (VAD); and
the distal end comprises a blunt cannula configured to mate with a needleless access connector of the VAD.