# US 9,872,978 B1 · Disinfecting methods and apparatus

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- Number: US 9,872,978 B1
- Document ID: US9872978B1
- Status: Granted
- Kind: B1
- Application number: 15/631,664
- Filed: 2017-06-23
- Granted: 2018-01-23
- Earliest claimed: 2017-06-21
- Assignees: Inikoa Medical, Inc.
- Applicants: Inikoa Medical, Inc.
- Inventors: Brett M. Zaborsky; Michael R. Lopez; Jay Vahlensieck
- Web page: https://patentgrep.com/patent/US9872978B1

## CPC

- A61L 2/04: Heat (radiation A61L2/08)
- A61B 1/012: characterised by internal passages or accessories therefor
- A61B 1/015: Control of fluid supply or evacuation
- A61B 1/018: for receiving instruments
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61L 2/08: Radiation
- A61L 2/084: Visible light
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/26: Accessories
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/28: Clamping means for squeezing flexible tubes, e.g. roller clamps {(tube strippers A61M1/83)}
- G01M 11/31: {with a light emitter and a light receiver being disposed at the same side of a fibre or waveguide end-face, e.g. reflectometers}
- G02B 6/001: {the light being emitted along at least a portion of the lateral surface of the fibre}
- G02B 6/02: Optical fibres with cladding {with or without a coating}
- G02B 6/102: {for infrared and ultraviolet radiation}
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2202/11: Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
- A61L 2202/14: Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
- A61L 2202/16: Mobile applications, e.g. portable devices, trailers, devices mounted on vehicles
- A61M 39/284: {Lever clamps}
- A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement}
- A61M 2025/004: {characterized by lumina being arranged circumferentially}
- A61M 2209/10: Equipment for cleaning
- A61N 5/0624: {for eliminating microbes, germs, bacteria on or in the body}
- G02B 1/045: {Light guides}
- G02B 6/0229: {characterised by nanostructures, i.e. structures of size less than 100 nm, e.g. quantum dots}
- G02B 6/036: core or cladding comprising multiple layers {(multicore optical fibres G02B6/02042; microstructured properties G02B6/02295; omniguide fibres G02B6/023)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)}
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

According to one implementation an assembly is provided that includes a polymeric body having a working lumen and an external profile. The polymeric body is secured to a clamp that is transitional between an open position and a closed position. In the closed position the clamp applies a force on the polymeric body to cause a full or partial closure of the working lumen. The clamp includes a wall having a through opening that has an internal profile that is substantially similar to the external profile of the polymeric body. At least a portion of the polymeric body resides in the through opening so that the polymeric body is prevented from rotating in the clamp.

## Claims

### Claim 1

An assembly comprising:
a polymeric body having walls that define a working lumen and a fiber lumen, the polymeric body having a first part in which the working lumen resides and a second part in which the fiber lumen resides, the first part having a first external shape and the second part having a second external shape that is different from the first shape, the polymeric body having an external profile defined by a perimeter of the first and second parts: and
a clamp transitional between an open position and a closed position, in the closed position the clamp applies a force on the second part of the polymeric body to cause a deformation of the first part to cause a full or partial closure of the working lumen, the clamp having a proximal wall and a distal wall, at least one of the proximal and distal walls having a through opening that has an internal profile that is substantially similar to the external profile of the polymeric body, at least a portion of the polymeric body residing in the through opening so that the polymeric body is prevented from rotating in the clamp.

### Claim 2 (depends on 1)

The assembly according to claim 1, further comprising an optical fiber residing in the fiber lumen.

### Claim 3 (depends on 1)

The assembly according to claim 1, wherein the working lumen is defined by a top wall having a first thickness, a bottom wall having a second thickness and first and second side walls that each have a third thickness, the first and second side walls being located between the top and bottom walls, the third thickness being less than both the first and second thicknesses, the dimensional characteristics of the top wall, bottom wall and first and second side walls result in a bending of the first and second side walls when a downward force is applied to the top wall by the clamp, the bending allowing an inner surface of the top wall to contact an inner surface of the bottom wall to effectuate the full or partial closure of the working lumen.

### Claim 4 (depends on 1)

The assembly according to claim 1, wherein a wall segment that defines at least in part the fiber lumen protrudes into the working lumen.

### Claim 5 (depends on 3)

The assembly according to claim 3, wherein a wall segment that defines at least in part the fiber lumen protrudes into the working lumen.

### Claim 6 (depends on 5)

The assembly according to claim 5, wherein the inner surface of the top wall includes a recess that is configured to mate with the protruding wall segment.

### Claim 7 (depends on 2)

The assembly according to claim 2, wherein the optical fiber is a radially emitting fiber.

### Claim 8 (depends on 2)

The assembly according to claim 2, wherein the optical fiber is an end emitting fiber.

### Claim 9 (depends on 1)

The assembly according to claim 1, wherein the clamp includes an upper pad and a lower pad, the lower pad including a groove in which at least a portion of the first part of the polymeric body resides.

### Claim 10 (depends on 9)

The assembly according to claim 9, wherein the first part and the groove are configured to inhibit a rotating of the polymeric body in the clamp.

### Claim 11 (depends on 9)

The assembly according to claim 9, wherein when clamp is in the open position the upper pad does not press against the polymeric body and when the clamp is in the closed position the upper pad presses downward on the polymeric body, the clamp being continuously urged in the open direction.

### Claim 12 (depends on 11)

The assembly according to claim 11, wherein the clamp includes a latch assembly to hold the clamp in the closed position.

### Claim 13 (depends on 9)

The assembly according to claim 9, wherein the clamp includes a base onto which the lower pad is attached and an arm onto which the upper pad is attached, the arm being joined to the base by the proximal wall.

### Claim 14 (depends on 13)

The assembly according to claim 13, wherein the proximal wall includes a hinge.

### Claim 15 (depends on 1)

The assembly according to claim 1, wherein the polymeric body is an infusion shaft of a central venous catheter.

### Claim 16 (depends on 1)

The assembly according to claim 1, wherein each of the proximal and distal walls have a through opening that has an internal profile that is substantially similar to the external profile of the polymeric body, at least a portion of the polymeric body residing in each of the through openings so that the polymeric body is prevented from rotating in the clamp.

### Claim 17 (depends on 11)

The assembly according to claim 11, wherein the clamp further comprises a stop to limit the amount by which the upper pad can be pressed against the polymeric body.

### Claim 18 (depends on 13)

The assembly according to claim 13, wherein a bottom of the base includes one or more slip resistant grips.

### Claim 19 (depends on 13)

The assembly according to claim 13, wherein a top of the arm includes one or more slip resistant grips.

### Claim 20 (depends on 15)

The assembly according to claim 15 wherein the infusion shaft includes a proximal connector, the clamp being directly attached to the proximal connector.