# US 10,441,775 B2 · Fluid path set bolus control device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,775 B2 - Document ID: US10441775B2 - Status: Granted - Kind: B2 - Application number: 14/888,298 - Filed: 2014-04-29 - Published: 2016-03-03 - Granted: 2019-10-15 - Earliest claimed: 2013-05-01 - Assignees: Bayer HealthCare LLC - Applicants: Bayer Medical Care Inc. - Inventors: Ralph H. Schriver; James A. Dedig - Web page: https://patentgrep.com/patent/US10441775B2 ## CPC - A61M 39/24: Check- or non-return valves - A61M 5/16827: {controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407)} - A61M 5/14216: {Reciprocating piston type} - A61M 2039/1077: {Adapters, e.g. couplings adapting a connector to one or several other connectors} - A61M 2039/226: {Spindles or actuating means} - A61M 2039/242: {designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid} - A61M 2039/2466: {being fixed in its center} - 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 bolus control device for use with an injection device includes a valve body having a proximal end opposite a distal end. The valve body defines a fluid channel therethrough to allow a passage of medical fluid from the proximal end to the distal end. A connector at the proximal end and is configured for connecting to a fluid inlet line. A connector subassembly at the distal end and is configured for connecting to a fluid outlet line. A compressible check valve is disposed within the fluid channel, such that the compressible check valve is adjustable to control a cracking pressure at which the compressible check valve closes. ## Claims ### Claim 1 A bolus control device for use with an injection device, the bolus control device comprising: a valve body having a proximal end opposite a distal end, the valve body defining a fluid channel therethrough; a first connector at the proximal end configured for connecting to a fluid inlet line; a second connector at the distal end configured for connecting to a fluid outlet line; a compressible check valve disposed within the fluid channel between the proximal end of the valve body and the distal end of the valve body, the compressible check valve having a body made from a reversibly compressible material and a closed proximal end, a distal end, and a plurality of transverse openings extending through the compressible check valve body between the closed proximal end of the compressible check valve body and the distal end of the compressible check valve body, wherein the compressible check valve body is compressible longitudinally between the proximal end of the valve body and the distal end of the valve body in response to fluid pressure within the fluid channel; and an adjustment mechanism configured to adjust an axial position of the first connector relative to the distal end of the compressible check valve body, wherein adjustment of the axial position of the first connector varies a compression of the compressible check valve, and wherein the reversibly compressible material of the compressible check valve is reversibly compresses with movement of the adjustment mechanism to increase or decrease a cracking pressure at which the compressible check valve opens to allow fluid flow around the compressible check valve body and through the fluid channel during a pressurized delivery of fluid through the valve body. ### Claim 2 (depends on 1) The bolus control device of claim 1, further comprising an intermediate element disposed between the first connector and the second connector, wherein the fluid channel extends through an interior cavity of the intermediate element. ### Claim 3 (depends on 2) The bolus control device of claim 2, wherein the compressible check valve is disposed within the interior cavity of the intermediate element and wherein the fluid channel extends radially around the compressible check valve. ### Claim 4 (depends on 2) The bolus control device of claim 2, wherein the compressible check valve is disposed between a distal end of the first connector and a distal end of the intermediate element and wherein the compressible check valve is compressible under fluid pressure in a distal direction from the distal end of the first connector toward the distal end of the intermediate element. ### Claim 5 (depends on 2) The bolus control device of claim 2, wherein the adjustment mechanism comprises a sleeve extending around at least a portion of the first connector and at least a portion of the intermediate element, wherein the sleeve is rotatable relative to the first connector to adjust the axial position of the first connector relative to the intermediate element. ### Claim 6 (depends on 5) The bolus control device of claim 5, wherein the sleeve is connected to the first connector by a threaded connection. ### Claim 7 (depends on 5) The bolus control device of claim 5, wherein rotation of the sleeve relative to the first connector adjusts the compression of the compressible check valve. ### Claim 8 A fluid path set for use with an injection device, the fluid path set comprising: a fluid inlet line; a fluid outlet line; and a bolus control device disposed between the fluid inlet line and the fluid outlet line, the bolus control device comprising: a valve body having a proximal end opposite a distal end, the valve body defining a fluid channel therethrough; a first connector at the proximal end in fluid connection with the fluid inlet line; a second connector at the distal end in fluid connection with the fluid outlet line; a compressible check valve disposed within the fluid channel between the proximal end and the distal end of the valve body, the compressible check valve having a body made from a reversibly compressible material and a closed proximal end, a distal end, and a plurality of transverse openings extending through the compressible check valve body between the closed proximal end of the compressible check valve body and the distal end of the compressible check valve body; and an adjustment mechanism configured to adjust an axial position of the first connector relative to the distal end of the compressible check valve body, wherein adjustment of the axial position of the first connector varies a compression of the compressible check valve, wherein the reversibly compressible material of the compressible check valve is reversibly compresses longitudinally between the proximal end of the valve body and the distal end of the valve body in response to fluid pressure within the fluid channel, and wherein movement of the adjustment mechanism increases or decreases a compression of the reversibly compressible material to increase or decrease a cracking pressure at which the compressible check valve opens to allow fluid flow around the compressible check valve body and through the fluid channel during a pressurized delivery of fluid through the valve body. ### Claim 9 (depends on 8) The fluid path set of claim 8, further comprising an intermediate element disposed between the first connector and the second connector, wherein the fluid channel extends through an interior cavity of the intermediate element. ### Claim 10 (depends on 8) The fluid path set of claim 8, wherein the first connector is connected to the fluid inlet line by a threaded connection. ### Claim 11 (depends on 8) The fluid path set of claim 8, wherein the second connector is connected to the fluid outlet line by a threaded connection. ### Claim 12 (depends on 8) The fluid path set of claim 8, wherein the fluid inlet line is configured for connecting to the injection device. ### Claim 13 (depends on 8) The fluid path set of claim 8, wherein the fluid outlet line is configured for connecting to a catheter for delivering fluid to a patient. ### Claim 14 A bolus control device for use with an injection device, the bolus control device comprising: a valve body having a proximal end opposite a distal end, the valve body defining a fluid channel therethrough; a first connector at the proximal end configured for connecting to a fluid inlet line; a second connector at the distal end configured for connecting to a fluid outlet line; a compressible check valve disposed within the fluid channel between the proximal end of the valve body and the distal end of the valve body, the compressible check valve having a body made from a reversibly compressible material and a closed proximal end, a distal end, and a plurality of transverse openings extending through the compressible check valve body between the closed proximal end of the compressible check valve body and the distal end of the compressible check valve body; and an adjustment mechanism for varying a compression of the compressible check valve against the first connector, wherein the adjustment mechanism comprises an eccentric cam element and a rotatable valve stem associated with the distal end of the compressible check valve body, wherein the reversibly compressible material of the compressible check valve is reversibly compresses longitudinally between the proximal end of the valve body and the distal end of the valve body in response to fluid pressure within the fluid channel, and wherein movement of the adjustment mechanism increases or decreases a compression of the reversibly compressible material to increase or decrease a cracking pressure at which the compressible check valve opens to allow fluid flow around the compressible check valve body and through the fluid channel during a pressurized delivery of fluid through the valve body. ### Claim 15 (depends on 14) The bolus control device of claim 14, wherein the adjustment mechanism includes a housing with a cavity configured to receive the rotatable valve stem and the eccentric cam element. ### Claim 16 (depends on 15) The bolus control device of claim 15, wherein the compressible check valve is disposed between a distal end of the first connector and the eccentric cam element and wherein the compressible check valve is compressible under fluid pressure in a distal direction from the distal end of the first connector toward the eccentric cam element. ### Claim 17 (depends on 15) The bolus control device of claim 15, wherein the eccentric cam element and the rotatable valve stem are rotatable within the housing of the adjustment mechanism. ### Claim 18 (depends on 17) The bolus control device of claim 17, wherein rotation of the eccentric cam element and the rotatable valve stem adjusts the compression of the compressible check valve against the first connector to control the cracking pressure at which the compressible check valve opens to allow fluid flow through the fluid channel. ### Claim 19 (depends on 14) The bolus control device of claim 14, further comprising an intermediate element disposed between the second connector and the housing of the adjustment mechanism, wherein the fluid channel extends through an interior cavity of the intermediate element.