# US 11,998,706 B2 · Integrated catheter assembly

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- Number: US 11,998,706 B2
- Document ID: US11998706B2
- Status: Granted
- Kind: B2
- Application number: 18/235,873
- Filed: 2023-08-20
- Published: 2023-12-14
- Granted: 2024-06-04
- Earliest claimed: 2021-08-09
- Assignees: Evolve Medicus, Inc.
- Applicants: Evolve Medicus, Inc.
- Inventors: Mark Menefee Mettauer; Steve Lepke
- Web page: https://patentgrep.com/patent/US11998706B2

## CPC

- A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters}
- 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 25/02: Holding devices, e.g. on the body
- A61M 25/0637: {Butterfly or winged devices, e.g. for facilitating handling or for attachment to the skin}
- A61M 39/10: Tube connectors or tube couplings
- A61M 1/3661: {for haemodialysis}
- A61M 25/0693: {Flashback chambers}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/0031: {characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment}
- A61M 2025/0039: {characterized by lumina being arranged coaxially}
- A61M 2025/0253: {where the catheter is attached by straps, bands or the like secured by adhesives}
- 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

An integrated catheter assembly includes a housing member, an outer lumen member extending from the housing member, and a needle member having a needle slidably or movably coupled to the housing member, wherein the needle can be extended beyond the outer lumen. Once a flash of blood is confirmed the needle member is uncoupled from the housing member and removed from within the patient's vein or artery. A non-removable inner lumen member is connected to the housing member. The distal end of the outer lumen is sealed against the distal end of the inner lumen and includes at having at least one aperture to transfer blood out of the patient to the dialysis machine. The integrated catheter assembly therefore receives and delivers blood through a single injection site.

## Claims

### Claim 1

An integrated catheter assembly, comprising:
a housing member having a first end and a second end;
an elongated outer lumen member, having a first and second end, extending from the first end of the housing member;
a non-removable elongated inner lumen member, having a first and second end, also adapted to be supported at the second end of the inner lumen member within the first end of the housing member, and positioned co-axially within the outer lumen member;
a removeable needle assembly comprising:
a holder assembly, and
a needle supported by said holder assembly and adapted to be removably inserted through the housing member and into the inner lumen member, said first end of the needle extending past the first end of the inner lumen member;
a hub assembly, having a first end and a second end, and an inner passageway, said first end of said hub assembly adapted to engage the second end of the housing member following removal of the needle assembly; and
a seal supported within the housing member,
wherein said outer lumen member includes at least one aperture proximate the first end of said outer lumen member and distal said housing member defining the commencement of a first passageway between the outer diameter of the inner lumen member and the inner diameter of the outer lumen member and wherein the first end of the outer lumen member is sealed proximate the first end of the inner lumen member distal said housing member, and
wherein the interior of the inner lumen member forms a second passageway extending from the first end of the inner lumen member distal said housing member, through said housing to said seal, and
wherein the first and second passageways permit the simultaneous flow of fluids from a body and into a body from a single target site.

### Claim 2 (depends on 1)

The catheter assembly of claim 1, further comprising:
said hub assembly includes a plunger supported co-axially with the inner lumen member within the housing assembly so that as said hub assembly engages the second end of the housing member said plunger pierces said seal establishing fluid communication between the inner passageway of said hub assembly with the second passageway defined by the inner lumen member.

### Claim 3 (depends on 1)

The integrated catheter assembly of claim 1, further comprising at least one adhesive flap contoured to approximate a curvature of an arm.

### Claim 4

An integrated catheter assembly, comprising:
a housing member having a first end, a second end, and a lateral end;
an elongated outer lumen member, having a first and second end and inner and outer diameters, said outer lumen member extending proximate the first end of the housing member;
a non-removeable elongated inner lumen member, having a first end and a second end and inner and outer diameters, said inner lumen member extending from the housing member and supported at the second end of the inner lumen member within said housing member, said inner lumen having an outer diameter smaller than the inner diameter of the outer lumen and positioned co-axially within the outer lumen member, the first end of the inner lumen member extending past the first end of the outer lumen member;
a removeable needle assembly comprising a holder assembly and a needle, having an outer diameter less than the inner diameter of the inner lumen member and supported by said holder assembly, said needle assembly adapted to be removably inserted through the housing member and into the inner lumen member, said first end of the needle extending past the first end of the inner lumen member;
a hub assembly, having a first end and a second end and an inner passageway, said first end of said hub assembly adapted to engage the second end of the housing member following removal of the needle assembly;
a seal supported within the housing member; and
said hub assembly further includes a plunger supported co-axially with the inner lumen member within said hub assembly so that as said hub assembly engages the second end of the housing member said plunger pierces said seal following removal of the needle assembly,
wherein said outer lumen member includes at least one aperture proximate the first end of said outer lumen member and distal said housing member defining the commencement of a first passageway between the outer diameter of the inner lumen member and the inner diameter of the outer lumen member and wherein the first end of the outer lumen member is sealed distal proximate the first end of inner lumen member, and
wherein the interior of the inner lumen member forms a second passageway extending from the first end of the lumen member distal said housing to said inner passageway of the hub assembly and the pierced seal, establishing an open fluid communication out the second end of the housing, and
wherein the first and second passageways permit the simultaneous flow of fluids from a body and into a body.

### Claim 5 (depends on 4)

The integrated catheter assembly of claim 4, further comprising an outflow tube coupled in fluidic communication with the first passageway.

### Claim 6 (depends on 4)

The integrated catheter assembly of claim 4, further comprising an inflow tube coupled in fluidic communication with the second end of said hub assembly.

### Claim 7 (depends on 4)

The integrated catheter assembly of claim 4, further comprising at least one adhesive flap contoured to approximate a curvature of an arm.

### Claim 8

An integrated catheter assembly, comprising:
a housing member having a generally Y-configuration and a first end, a second end, and a third end opposite the first end, defining a first passageway from the first end of the Y-configuration through the second end of the Y-configuration, and a second passageway from the first end of the Y-configuration through the third end of the Y-configuration;
an elongated outer lumen member, having a first and second end and inner and outer diameters, said outer lumen member extending from at least the first end of the housing member;
an elongated inner lumen member, having a first end and a second end and inner and outer diameters, said inner lumen member extending from at least the first end of the housing member and supported at the second end of the inner lumen member proximate the first end of the housing member, said inner lumen having an outer diameter smaller than the inner diameter of the outer lumen and positioned co-axially within the outer lumen member, the first end of the inner lumen member extending past the first end of the outer lumen member;
a removeable needle assembly comprising:
a holder, having a first end and a second end and adapted to engage the third end of the housing member, and
a hollow needle, having a first end and a second end, said outer diameter of said needle being less than the inner diameter of the inner lumen member and supported by said holder and adapted to be removably inserted through the housing member and into the inner lumen member, said first end of the needle extending past the first end of the inner lumen member;
a seal supported within the second passageway within the housing member;
a hub assembly, having a first end and a second end and an inner passageway, said hub assembly adapted to engage the third end of the housing member following removal of the needle assembly so that said inner passageway and said second passageway are in fluid communication,
wherein said outer lumen member includes at least one aperture proximate the first end of said outer lumen member and distal said housing and wherein the first end of the outer lumen member is sealed proximate the first end of said outer lumen member defining the commencement of the first passageway from said at least one aperture distal said housing between the inner diameter of the outer lumen member and the outer diameter of the inner lumen member to the first end of the Y-configuration and through the second end of the Y-configuration, and
wherein the interior of the inner lumen member defines the second passageway extending from the first end of the inner lumen member distal said housing to the first end of the Y configuration and through to the third end of the Y-configuration permitting the simultaneous flow of fluids through the first and second passageways from a single target site.

### Claim 9 (depends on 8)

The integrated catheter assembly of claim 8 wherein said hub assembly includes a plunger supported co-axially with the inner lumen member so that as said hub assembly engages the third end of the Y-configuration housing member said plunger pierces said seal establishing fluid communication between the inner passageway of said hub assembly with the passageway defined by the inner diameter of the inner lumen member further defining the second passageway.

### Claim 10 (depends on 8)

The integrated catheter assembly of claim 8, further comprising an outflow tube coupled in fluidic communication with the first passageway.

### Claim 11 (depends on 8)

The integrated catheter assembly of claim 8, further comprising an inflow tube coupled in fluidic communication with the second passageway.

### Claim 12 (depends on 8)

The integrated catheter assembly of claim 8, further comprising at least one adhesive flap contoured to approximate a curvature of an arm.

### Claim 13

An integrated catheter assembly, comprising:
a housing member having a first end, a second end, and a lateral end, defining a first passageway from the first end through the second end of the housing member and a second passageway from the first end through the lateral end of the housing member;
an elongated outer lumen member, having a first and second end and inner and outer diameters, said outer lumen member extending from the first end of the housing member and supported within the housing member wherein said outer lumen member includes at least one aperture proximate the first end of said outer lumen member defining the commencement of said second passageway;
a non-removable elongated inner lumen member, having a first end and a second end and inner and outer diameters, said inner lumen member extending from the first end of the housing member and supported at the second end of the inner lumen member within the housing member co-axially within the outer lumen, said inner lumen having an outer diameter smaller than the inner diameter of the outer lumen, the first end of the inner lumen member extending past the first end of the outer lumen member;
a removeable needle assembly comprising a holder, having a first end and a second end and adapted to engage the second end of the housing member, and a needle, having a first end and a second end, the outer diameter of the needle being less than the inner diameter of the inner lumen member and adapted to be removably inserted through the housing member and into the inner lumen member, said first end of the needle extending past the first end of the inner lumen member;
a seal supported within the first passageway within the housing member; and
a hub assembly having an inner passageway and adapted to engage the second end of the housing member following removal of the needle assembly so that said inner passageway and said first passageway are in fluid communication, said hub assembly includes a plunger to pierce said seal establishing fluid communication between the inner passageway of said hub assembly with the passageway defined by the inner diameter of the inner lumen member,
wherein the first end of the outer lumen member is sealed proximate to the first end of said outer lumen member distal said at least one aperture to the first end of the inner lumen member defining the commencement of the second passageway from said at least one aperture distal said housing between the inner diameter of the outer lumen member and the outer diameter of the inner lumen member to the first end of the housing member and through the lateral end of the housing member, and
wherein the interior of the inner lumen member defines the first passageway extending from the first end of the inner lumen member distal said housing to the first end of the housing member, through the inner passageway of the housing member and the pierced seal and out the second end of the housing, and
wherein the first and second passageways permit the simultaneous flow of fluids out of a body and back into a body.

### Claim 14 (depends on 13)

The integrated catheter assembly of claim 13, further comprising an outflow tube coupled in fluidic communication with the second passageway.

### Claim 15 (depends on 13)

The integrated catheter assembly of claim 13, further comprising an inflow tube coupled in fluidic communication with the first passageway.

### Claim 16 (depends on 13)

The integrated catheter assembly of claim 13, further comprising at least one adhesive flap contoured to approximate a curvature of an arm.