# US 10,869,970 B2 · Dialysis needle

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- Number: US 10,869,970 B2
- Document ID: US10869970B2
- Status: Granted
- Kind: B2
- Application number: 15/743,453
- Filed: 2016-07-18
- Published: 2018-07-19
- Granted: 2020-12-22
- Earliest claimed: 2015-07-16
- Assignees: B. Braun Avitum AG
- Applicants: B. Braun Avitum AG
- Inventors: Hans Haindl; Kevin Woehr
- Web page: https://patentgrep.com/patent/US10869970B2

## CPC

- A61M 1/3661: {for haemodialysis}
- A61M 1/1654: {Dialysates therefor}
- A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 5/3221: {Constructional features thereof, e.g. to improve manipulation or functioning}
- 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)}
- A61B 17/3494: {with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors (for the peridural space A61B17/3401)}
- A61M 2005/1586: {Holding accessories for holding infusion needles on the body}
- A61M 2005/3254: {Shielding of proximal needles, e.g. for pen needles}
- A61M 2039/1005: {Detection of disconnection}
- A61M 2039/224: {of the slide-valve type}
- A61M 2205/0244: Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/18: with alarm
- 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

A safety needle is disclosed having a puncture needle with a needle lumen and a ground tip; a holding device that, during use, bears on the skin of a patient and holds the puncture needle; and a safety mechanism with a protection element that has a first, opened state and a second, closed state. When the holding device is taken away from the skin and/or when the holding device is moved with respect to the defined position, the safety mechanism automatically moves the protection element from a first position, in which the tip of the needle is exposed, to a second position, in which the tip of the needle is covered as the protection element at the same time transfers automatically from the first, opened state to the second, closed state.

## Claims

### Claim 1

A safety needle comprising:
a puncture needle having a needle lumen and a tip;
a holding device that, during use, bears on skin of a patient and holds the puncture needle; and
a safety mechanism with a protection element movably mounted to the holding device and configurable in a first, opened state and a second, closed state, wherein:
the safety mechanism is configured to move the protection element from a first position, in which the tip of the puncture needle is exposed, to a second position, in which the tip of the puncture needle is covered, when the protection element at the same time transfers from the first, opened state to the second, closed state,
the protection element comprises at least one of gaps or openings in the second state and a flow resistance of human blood through all of the at least one of gaps or openings is larger than a flow resistance of human blood through the needle lumen, and
wherein the holding device comprises or forms a housing for receiving the entire protection element therein, the holding device has an opening in a distal direction so as to allow a movement of the protection element out of the housing and toward the needle tip, the opening elastically closed by an everting collar.

### Claim 2 (depends on 1)

The safety needle according to claim 1, wherein the safety mechanism comprises a first spring configured to move the protection element from the first position to the second position.

### Claim 3 (depends on 2)

The safety needle according to claim 2, wherein the safety mechanism comprises a second spring which, when the holding device is at least one of taken away from the skin or moved with respect to a defined position, is configured to relax automatically to release the first spring.

### Claim 4 (depends on 3)

The safety needle according to claim 3, wherein the second spring at least one of (1) is a leaf spring or a conical coil spring or (2) comprises one or more latching hooks entering into engagement with the first spring in a direct or indirect manner.

### Claim 5 (depends on 1)

The safety needle according to claim 1, wherein the flow resistance of human blood through all of the at least one of gaps or openings is larger than the flow resistance through the needle lumen by such an amount that maintaining a constant blood flow of between 300 ml/min and 600 ml/min requires a pressure increase of at least 10 mmHg.

### Claim 6 (depends on 1)

The safety needle according to claim 1, wherein the flow resistance of human blood through all of the at least one of gaps or openings is larger than the flow resistance through the needle lumen by such an amount that maintaining a constant blood flow of between 300 ml/min and 600 ml/min requires a pressure increase of at least 30 mmHg.

### Claim 7 (depends on 1)

The safety needle according to claim 1, wherein the flow resistance of human blood through all of the at least one of gaps or openings is larger than the flow resistance through the needle lumen by such an amount that maintaining a constant blood flow of between 300 ml/min and 600 ml/min requires a pressure increase of at least 50 mmHg.

### Claim 8 (depends on 1)

The safety needle according to claim 1, wherein a sum of a respective cross-sectional area of all of the at least one of gaps or openings is smaller than a cross-sectional area of the needle lumen.

### Claim 9 (depends on 1)

The safety needle according to claim 1, wherein the protection element comprises two resilient arms configured to close the protection element in the second state.

### Claim 10 (depends on 9)

The safety needle according to claim 9, wherein the two resilient arms are formed such that in the first state they are able to slide along an outer side of the needle with low friction.

### Claim 11 (depends on 9)

The safety needle according to claim 9, wherein at least one of the two resilient arms has its distal end provided with an arresting device that prevents the protection element from being moved from the second position to the first position.

### Claim 12 (depends on 11)

The safety needle according to claim 11, wherein the arresting device comprises at least one of a bent portion of the at least one arm or a barb.

### Claim 13 (depends on 12)

The safety needle according to claim 12, wherein the two resilient arms are configured to come into engagement with each other if the protection element is in the second position.

### Claim 14 (depends on 13)

The safety needle according to claim 13, wherein the two resilient arms are configured to at least one of interlock with each other or get entangled with each other if the protection element is in the second position.

### Claim 15 (depends on 1)

The safety needle according to claim 1, wherein a distal end of the protection element has a concave design.

### Claim 16 (depends on 1)

The safety needle according to claim 1, wherein the protection element is made of an elastomer or coated with an elastomer at least in parts.

### Claim 17 (depends on 16)

The safety needle according to claim 16, wherein the elastomer comprises one or more of the following materials: silicone, polyurethane, PTFE.

### Claim 18 (depends on 1)

The safety needle according to claim 1, wherein an inner side of the protection element is coated at least in parts with a coagulatory material.

### Claim 19 (depends on 18)

The safety needle according to claim 18 wherein the coagulatory material comprises one or more of the following materials: proteins; polypeptides;
polysaccharides; glucosamines; alginates; adsorbing substances; and/or denaturing substances.

### Claim 20 (depends on 1)

The safety needle according to claim 1, wherein the protection element has an inner side provided with one or more of the following materials: elastic foamed plastic; swelling agents; spongy and/or water-absorbing substances.

### Claim 21 (depends on 1)

The safety needle according to claim 1, wherein the needle comprises one or more protrusions preventing the protection element from detaching from the needle.

### Claim 22 (depends on 1)

The safety needle according to claim 1, further comprising a connecting element connecting the protection element to a needle attachment of the needle.

### Claim 23 (depends on 1)

The safety needle according to claim 1, wherein the holding device is provided with at least one of an adhesive strip, a detachable clip or a hand grip to prevent the safety mechanism from being activated before use of the safety needle.

### Claim 24

A safety needle comprising:
a puncture needle having a needle lumen and a tip;
a holding device that, during use, bears on skin of a patient and holds the puncture needle;
a blood stopping means comprising a clamping/pinching body which is biased against a flexible hose and at least one of a release lever or release button which is in operative engagement or can be brought into operative engagement with the clamping/pinching body, said at least one of the release lever or release button being connected to the holding device such that during/by applying the holding device on a surface the at least one release lever or release button is moved to a first flow position in which the at least one release lever or release button keeps the clamping/pinching body spaced from the hose and during lifting the holding device from the surface automatically moves to a second flow position in which the clamping/pinching body pinches off the flexible hose; and
a safety mechanism with a protection element movably mounted to the holding device and configurable in a first, opened state and a second, closed state, wherein:
the safety mechanism is configured to move the protection element from a first position, in which the tip of the puncture needle is exposed, to a second position, in which the tip of the puncture needle is covered, when the protection element at the same time transfers from the first, opened state to the second, closed state, and
the protection element comprises at least one of gaps or openings in the second state and a flow resistance of human blood through all of the at least one of gaps or openings is larger than a flow resistance of human blood through the needle lumen.
