# US 10,478,109 B2 · Methods and apparatus for selectively occluding the lumen of a needle

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- Number: US 10,478,109 B2
- Document ID: US10478109B2
- Status: Granted
- Kind: B2
- Application number: 15/705,695
- Filed: 2017-09-15
- Published: 2018-05-10
- Granted: 2019-11-19
- Earliest claimed: 2013-03-12
- Assignees: Magnolia Medical Technologies, Inc.
- Applicants: Magnolia Medical Technologies, Inc.
- Inventors: Gregory J. Bullington; Jay M. Miazga; Shan E. Gaw; Richard G. Patton
- Web page: https://patentgrep.com/patent/US10478109B2

## CPC

- A61B 5/150633: {Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/16804: {Active flow controllers}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- A61M 5/3291: {Shafts with additional lateral openings}
- A61M 2005/1585: {Needle inserters}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M 2205/0205: Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
- A61M 2205/0238: the material being a coating or protective layer
- A61M 2205/0266: Shape memory materials
- 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

A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

## Claims

### Claim 1

A device for parenterally transferring fluid between a patient and a fluid container, the device comprising:
a housing defining a fluid flow path configured to transfer a flow of fluid;
a needle having a distal end portion and a proximal end portion, and defining a lumen therebetween, the distal end portion having a closed distal end surface and being configured for insertion into the patient, the distal end portion defining an opening proximal to the closed distal end surface and in fluid communication with the lumen, the proximal end portion configured to be fluidically coupleable to the housing to place the lumen of the needle in fluid communication with the fluid flow path; and
an occlusion member configured to selectively obstruct the opening of the needle to control fluid flow to or from the fluid flow path, the occlusion member having a first state in which a distal end surface of the occlusion member is substantially coplanar with the closed distal end surface of the needle to obstruct the opening of the needle during insertion into the patient, and a second state in which the distal end surface of the occlusion member is nonparallel to the distal end surface of the needle such that the opening of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer between the patient and the fluid flow path.

### Claim 2 (depends on 1)

The device of claim 1, wherein the occlusion member is movably disposed on the needle and configured to be in a first position relative to the needle when in the first state and a second position relative to the needle when in the second state, the second position being different from the first position.

### Claim 3 (depends on 1)

The device of claim 1, wherein the occlusion member is rotatably disposed on the needle and configured to be in a first rotational position relative to the needle when in the first state and a second rotational position relative to the needle when in the second state, the second rotational position being different from the first rotational position.

### Claim 4 (depends on 1)

The device of claim 1, wherein the closed distal end surface of the needle is a beveled distal end surface and the distal end surface of the occlusion member is a beveled distal end surface, the beveled distal end surfaces of the needle and the occlusion member being substantially coplanar when the occlusion member is in the first state.

### Claim 5 (depends on 4)

The device of claim 4, wherein the beveled distal end surfaces of the needle and the occlusion member are offset when the occlusion member is in the second state.

### Claim 6 (depends on 1)

The device of claim 1, further comprising:
an actuator coupled to the occlusion member, the actuator configured to switch the occlusion member from the first state to the second state in response to a force exerted on the actuator.

### Claim 7 (depends on 1)

The device of claim 1, wherein the distal end surface of at least one of the occlusion member or the needle includes a coating configured to reduce contamination of the distal end surface of at least one of the occlusion member or the needle, respectively.

### Claim 8

A device for parenterally transferring bodily fluid from a patient, the device comprising: a housing that defines a fluid flow path; a needle having a distal end portion and a proximal end portion, and enclosing a lumen between the distal end portion and the proximal end portion, the distal end portion having a closed distal end surface and being configured for insertion into the patient, the distal end portion defining at least one opening proximal to the closed distal end surface and in fluid communication with the lumen, the proximal end portion being fluidically coupled to the housing to place the lumen of the needle in fluid communication with the fluid flow path; and an occlusion mechanism configured to selectively control fluid flow between the patient and the fluid flow path, the occlusion mechanism having an occlusion member coupled to and disposed about the needle, the occlusion mechanism configured to be in a first state during insertion of the needle into the patient and configured to be transitioned to a second state after the needle is inserted into the patient, the opening of the needle being obstructed by the occlusion member when the occlusion mechanism is in the first state and being unobstructed by the occlusion member when the occlusion mechanism is in the second state thereby allowing a volume of bodily fluid to flow from the patient through the fluid flow path; wherein the occlusion member is rotatably coupled to the needle and configured to be in a first rotational position relative to the needle when in the occlusion mechanism is in the first state and a second rotational position relative to the needle when in the occlusion mechanism is in the second state.

### Claim 9 (depends on 8)

The device of claim 8, wherein the housing is configured to be coupled to a sample reservoir after the needle is inserted into the patient, the occlusion member configured to obstruct the opening of the lumen during insertion of the needle into the patient such that a volume of bodily fluid substantially free of contaminants is transferred from the patient to the sample reservoir via the lumen of the needle and the fluid flow path when the occlusion mechanism is transitioned to the second state.

### Claim 10 (depends on 8)

The device of claim 8, wherein a distal end surface of the occlusion member is aligned with a distal end surface of the needle when the occlusion mechanism is in the first state such that the opening of the needle is obstructed during insertion into the patient, and the distal end surface of the occlusion member is misaligned relative to the distal end surface of the needle when the occlusion mechanism is in the second state such that the opening of the needle is unobstructed after the needle has been inserted into the patient.

### Claim 11 (depends on 10)

The device of claim 10, wherein the distal end surface of the needle is a beveled distal end surface, the distal end surface of the occlusion member is a beveled distal end surface and is substantially coplanar with the beveled distal end surface of the needle when the occlusion member is in the first state.

### Claim 12 (depends on 11)

The device of claim 11, wherein the beveled distal end surfaces of the needle and the occlusion member are non-coplanar when the occlusion member is in the second state.

### Claim 13 (depends on 8)

The device of claim 8, wherein the occlusion mechanism includes an actuator portion, the actuator portion configured to transition the occlusion mechanism from the first state to the second state in response to a force exerted on the actuator portion.

### Claim 14 (depends on 13)

The device of claim 13, wherein the actuator portion of the occlusion mechanism configured to rotate in response to the force to transition the occlusion member between the first rotational position relative to the needle and the second rotational position relative to the needle.

### Claim 15

A method for transferring fluid to or from a patient using a parenteral transfer device, the device including a housing defining a fluid flow path, a needle having a lumen in fluid communication with the fluid flow path, and an occlusion member operable to selectively control fluid flow to or from the patient through the lumen of the needle and the fluid flow path, the needle having a closed distal end surface and defining an opening proximal to the closed distal surface and in fluid communication with the lumen of the needle, the method comprising:
disposing the occlusion member in a first state relative to the needle such that the opening of the needle is obstructed to prevent at least one of tissue, bodily fluid, and contaminants from entering the lumen, the closed distal end surface of the needle and a distal end surface of the occlusion member being substantially coplanar when the occlusion member is in the first state;
inserting the needle into the patient, the occlusion member being in the first state as the needle is inserted into the patient; and
after the needle has been inserted into the patient, transitioning the occlusion member from the first state to a second state such that the distal end surface of the occlusion member is nonparallel to the closed distal end surface of the needle, the opening of the needle being unobstructed when the device is in the second state to allow a volume of fluid substantially free of tissue and contaminants to be transferred between the patient and the fluid flow path.

### Claim 16 (depends on 15)

The method of claim 15, wherein transitioning the device from the first state to the second state includes moving the occlusion member from a first position to a second position.

### Claim 17 (depends on 16)

The method of claim 16, wherein the occlusion member is moved manually from the first position to the second position.

### Claim 18 (depends on 15)

The method of claim 15, wherein transitioning the occlusion member from the first state to the second state includes rotating the occlusion member from a first rotational position to a second rotational position.

### Claim 19 (depends on 18)

The method of claim 18, wherein the distal end surface of the occlusion member is coplanar with the distal end surface of the needle when the occlusion member is in the first rotational position and is non-coplanar to the distal end surface of the needle when the occlusion member is in the second rotational position.

### Claim 20 (depends on 18)

The method of claim 18, wherein the device further includes an actuator coupled to the occlusion member, the actuator configured to transition the occlusion member from the first rotational position to the second rotational position in response to a force exerted on the actuator.