Blood flow reversal valves and related systems.

(54) Title: BLOOD FLOW INVESTMENT VALVES AND RELATED SYSTEMS. (54) Title: BLOOD FLOW REVERSAL VALVES AND RELATED SYSTEMS.

(57) Summary

This disclosure relates to blood flow reversal valves and related systems and methods. The flow reversing valve includes a first member (102) having a first passage and a second passage and a second member (104) having a first passage and a second passage. The first and second members may be rotatably fixed relative to each other so that the first passage of the first member is aligned with the first passage of the second member and the second passage of the first member is aligned with the second passage of the second member. A flow direction member (120, 320) is arranged in a cavity (105) and can be moved relative to the first and second members between a first position, where the first passage of the first member and the first passage of the second member are connected in fluid communication and a second position, where the first passage of the first member and the second passage of the second member are connected in fluid communication.

(57) Abstract

This disclosure relates to blood flow reversal valves and related systems and methods. The blood flow reversal valve ineludes a first member (102) having a first passage and a second passage, and a second member (104) having a first passage and a second passage. The first and second members are rotatably fixed relative to one another such that the first passage of the first member is aligned with the first passage of the second member and the second passage of the first member is aligned with the second passage of the second member. A flow directing element (120, 320) is disposed in the cavity (105) and is moveable relative to the first and second members between a first position in which the first passage of the first member and the first passage of the second member are fluidly connected and a second position in which the first passage of the first member and the second passage of the second member are fluidly connected.

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PATENT TITLE No. 357012

Owner (s): FRESENIUS MEDICAL CARE HOLDINGS, INC .; FRESENIUS MEDICAL CARE

DEUTSCHLAND GMBH

Home:

920 Winter Street, Waltham, Massachusetts, 02451-1457, USA; 4701 130th Avenue SE, Bellevue, Washington, 98006, USA

Name: BLOOD FLOW INVESTMENT VALVES AND RELATED SYSTEMS

Classification: CIP: A61M39 / 22; A61M1 / 36; F16K11 / 074

CPC: A61M39 / 223: A61M1 / 367; F16K11 / 074

Inventor (s): CHRISTIAN SCHLAEPER; HARALD PETER; MARTIN JOSEPH CRNKOVICH

REQUEST

Number: International Presentation Date:

MX / a / 2015/003656 September 24, 2013

PRIORITY

Country:

US

Date:

September 2012

Number:

61/705,411

Validity: Twenty years Expiration Date: September 24, 2033

Issue Date: June 22, 2018

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The reference patent is granted on the basis of articles 1, 2 section V, S * fit fraction, / 59 of the Industrial Property Law.

In accordance with article 23 of the Industrial Property Law, this patent has a validity of twenty non-extendable years, counted from the date of filing of the international application and will be subject to the payment of the fee to keep current rights.

Whoever subscribes to this title bases it on the basis of the provisions of articles 6, sections III and 7Jbts 2 of the Industrial Property Law (Official Gazette of the Federation (D OF) 06/27/1991, amended on 08/02 / 1994, 10/25/1998. 12/26/1997, 05/17/1999 01/26/2004, 06/16/2005, 01/25/2006, 06/05/2009, 06/01/2010, 06/18/2010, 02/06/06 2010 01/27/2012 and 04/09/2012): articles 1, 3, fraction V, subsection a), 4, and 12, sections I and III of the Regulations of the Mexican Institute of Industrial Property (D OF 14/12 / 1999, amended on 07/01/2002, 07/15/2004, 07/28/2004 and 09/07/2007); articles 1, 3 '. 4th, 5th fraction V subsection a), 16 fractions I and til and 30 of the Organic Statute of the Mexican Institute of Industrial Property (DOF 12/27/1999, amended on 10/10/2002, 07/29/2004, 08/04/2004 and 09/13/2007); 1, 3 and 5 Clause a) of the Agreement that delegates powers to the Deputy Directors General, Coordinator, Divisional Directors. Holders of telephone offices, Divisional Deputy Directors, Departmental Coordinators and other subordinates of the Mexican Institute of Industrial Property. (DOF 12/15/1999, amended on 02/04/2000, 07/29/2004, 08/04/2004 and 09/13/2007). t

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

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NAHANNY CANAL REYES

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NAHANNY MARISOL CANAL REYES | 00001000000403252793 | Trlbutarla Administration Service | 1695 || MX / 2018/52253 | MX / a / 2015 / 003656j Patent title PCT | 1027 | RGZ | Pág (s) | wll6UQjgJY4THbeAbvNOOwLSd

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RELATED ------------------- Cross Reference with Related Requests

This Application claims the benefit of United States of America Application Serial No. 61 / 705.41 1, filed on September 25, 2012, which is incorporated herein by reference in its entirety.

Field of the Invention

The invention relates to blood flow reversing valves and related systems and methods.

Background of the Invention

Many modern medical procedures use sets of tubes of varying complexity to draw blood from the patient, or to deliver fluid to the patient, or both. An example of such a procedure is hemodialysis. In hemodialysis, the patient's blood is cleaned by removing it from the patient through a blood entry site, typically through a catheter, and passing it through an artificial kidney (often called a dialyzer ”). The artificial kidney includes a semi-permeable membrane that removes impurities and toxins by a diffusion process. The purified blood is then returned to the patient. An extracorporeal circuit that includes a hemodialysis pump and tubing is typically used to transport blood between the blood entry site and the artificial kidney.

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Many of the tube sets used in medical procedures involve extracorporeal fluid treatment, such as hemodialysis, are configured so that fluid can flow through the system in the desired direction during the medical procedure. A pumping device can be used to control the rate of fluid flow in the system. With hemodialysis, for example, a peristaltic pump is typically used to draw blood from the patient and to route blood through the tubing set during the treatment procedure. During hemodialysis, blood is initially drawn from the patient's blood port (for example, a vein or an artery, but more typically an arterio-venous graft or fistula) and flows through a series of tubing segments connected to the artificial kidney for cleaning. After passing through the artificial kidney, blood then flows through other tubing segments that return the blood to the patient. Thus, there is generally a continuous circuit of blood flowing from the patient, through the artificial kidney, and back to the patient during treatment.

During hemodialysis, blood is usually drawn upstream from the blood inlet and then returned to a downstream position from the blood inlet. However, it has been found that it is desirable, for limited periods of time, to reverse the direction in which blood is received and returned to the patient during hemodialysis. When the blood flow is reversed, blood is initially drawn from the downstream position at the blood inlet. Blood then flows through the pipe segments

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to the artificial kidney for treatment before it returns to the upstream position at the blood inlet. Typically, this procedure is performed by trained clinical personnel, for example, a hemodialysis specialist. When the blood flow is reversed, any of the different parameters, such as the rate of blood inflow, can be measured and derived from these measurements. The data can yield useful information about the patient's health status and the effectiveness of the procedure. For example, practitioners can use this information collected during periods of reverse blood flow to assess the condition of the blood inflow, to get an early warning about other health problems, such as restrictions on entry and to prescribe measures. preventive, such as checking or replacing blood, which is generally necessary after several years of continuous dialysis.

Brief Description of the Invention

In one aspect of the invention, a blood flow reversing valve includes a first member having a first passage and a second passage and a second member having a first passage and a second passage. The first and second members are rotatably fixed relative to each other, so that the first passage of the first member is aligned with the first passage of the second member and the second passage of the first member is aligned with the second passage of the second member. A flow direction element is arranged in

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INDUSTRIAL ___ a cavity formed between the first and second members. The flow direction element can be moved relative to the first and second members between a first position, where the first passage of the first member and the first passage of the second member are connected in fluid communication and the second passage of the first member and the second passage of the second member are connected in fluid communication, and a second position where the first passage of the first member and the second passage of the second member are connected in fluid communication and the second passage of the first member and the first passage of the second member are connected in fluid communication.

In another aspect of the invention, a blood treatment system includes a blood flow reversing valve that includes a first member having a first passage and a second passage and a second member having a first passage and a second passage. The first and second members are rotatably fixed relative to each other so that the first passage of the first member is aligned with the first passage of the second member and the second passage of the first member is aligned with the second passage of the second member. A flow direction element of the blood flow reversing valve is arranged in a cavity formed between the first and second members, the flow direction element can move relative to the first and second members between a first position, wherein the first passage of the first member and the first passage of the second member are connected in fluid communication and the second passage of the

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INSTITUTO MFX'Cano DE 1.Λ PRCHCÍMD industrial first member and the second passage of the second member are connected in fluid communication, and a second position where the first passage of the first member and the second passage of the second member are connected in communication of fluids and the second passage of the first member and the first passage of the second member are connected in fluid communication. The system also includes a blood treatment device that includes a valve retention element configured to ensure that the blood flow reversing valve with the blood treatment device and an actuator configured to move the flow direction element of the reversal valve for blood flow from the first position to the second position.

In a further aspect of the invention, a method for reversing blood flow uses a blood flow reversing valve that includes a first member having a first passage and a second passage, a second member rotatably fixed relative to the first member and having a first passage and a second passage, and a flow direction element arranged in a cavity formed between the first and second members. The method includes moving the flow direction element of the blood flow reversing valve from a first position, where the first passage of the first member and the first passage of the second member are connected in fluid communication and the second passage of the first member and the second passage of the second member are connected in fluid communication in a second position, where the first passage of the first member and the second

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second limb passage are connected in fluid communication

-v II I 11.111.1IJ j. | | ' : ti1 1ΓΙΙ. iíTIHI-J ιιι · ί. 'TOQnKMNmffW'irvyilVM and the second passage of the first member and the first passage of the second member are connected in fluid communication. The first and second members of the blood flow reversing valve remain fixed relative to one another as the flow direction element moves from the first position to the second position.

Implementations can include one or more of the following features:

In some implementations, the flow direction element can rotate about a longitudinal axis of the blood flow reversing valve.

In certain implementations, the first passages are aligned along an axis that is essentially parallel to the longitudinal axis, and the second passages are aligned along an axis that is essentially parallel to the longitudinal axis.

In some implementations, the flow direction element defines a first flow path and a second flow path.

In certain implementations, the first flow path connects in fluid communication the first passage of the first member with the first passage of the second member and the second flow path connects in fluid communication the second passage of the first member with the second passage of the second member, when the flow direction element is in the first position.

In some implementations, the first flow path connects

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IKDUSTRÍAl in fluid communication the second passage of the prtmei⁵- first passage of the second member and the second flow path connects in fluid communication the first passage of the first member with the second passage of the second member when the flow direction element is in the second position.

In certain implementations, the flow direction element is essentially cylindrical.

In some implementations, the first and second flow paths are essentially semi-helical.

In certain implementations, each of the first and second flow paths has a kidney-shaped cross-sectional area.

In some implementations, the flow direction element includes a body that defines a central lumen and a partition extended through the lumen to form the first and second flow paths.

In certain implementations, the split extends along a curved path between a first end of the body and a second end of the body.

In some implementations, the split extends along an essentially semi-helical path between the first end of the body and the second end of the body.

In certain some implementations, each of the first and second flow paths has a cross-sectional area of ​​essentially half a circle.

In some implementations, the division is flexed

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approximately 5 degrees approximately 180 degrees from the first end of the body to the second end of the body.

In certain implementations, the split flexes approximately 90 degrees from the first end of the body to the second end of the body.

In some implementations, the blood flow reversing valve also includes a projection that extends radially from the flow direction element.

In certain implementations, the projection extends through a slot that is defined by at least one of the first and second members.

In some implementations, the first and second members cooperate to define the slot.

In some implementations, the slot extends circumferentially around the first and second members.

In certain implementations, the projection extends radially a sufficient distance to engage an actuator of a blood treatment machine, when the blood flow reversing valve is connected to the blood treatment machine.

In some implementations, the valve retention element includes resilient pawls configured to releasably engage the fluid line connectors of the blood flow reversing valve.

In certain implementations, the actuator defines an opening configured to receive a radially extending projection

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from the flow direction element of the blood flow reversing valve.

In some implementations, the actuator is configured to rotate the flow direction element.

In certain Implementations, the blood treatment system also includes a controller programmed to move the actuator.

In some implementations, the controller is programmed to move the actuator at a predetermined time during blood treatment.

In certain implementations, moving the flow direction element from the first position to the second position includes rotating the flow direction element relative to the first and second members.

In certain implementations, the flow direction element is moved from the first position to the second position by the actuator of the blood treatment machine.

In some implementations, the method also includes transmitting a signal from the controller of the blood treatment machine to the actuator to move the flow direction element.

In certain implementations, the method also includes moving the flow direction element from the second position back to the first position.

In some implementations, the method also includes starting the blood pump to force the blood through the blood flow reversing valve.

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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY !.

In certain implementations, the method also includes stopping the blood pump before rotating the flow direction element from the first position to the second position.

In some implementations, the method also includes measuring one or more parameters of blood flowing through the blood flow reversing valve.

Implementations can include one or more of the following benefits.

The blood flow reversing valves described herein advantageously reverse blood flow through interconnected fluid lines without requiring the repositioning or flexing of the fluid lines relative to one another. Reduced repositioning or flexing of fluid lines can result in less flexing or tangling of fluid lines and as a result, better flow through fluid lines.

Certain blood flow reversing valves described herein can be connected to a blood treatment machine (eg, a hemodialysis machine), to automatically reverse blood flow. As a result, blood flow reversal can be more easily accomplished with automated blood flow reversal valves, described herein, than with certain manually operated blood flow reversal valves. Additionally, the system (eg, a control unit or a system processor) can be programmed to automatically reverse blood flow and take measurements at designated times through treatment. As a result, such measurements can be taken at ideal times during the

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INDUSTRIAL treatment even when the nurse is not present to manually reverse blood flow.

Details of one or more modalities are set forth in the accompanying drawings and in the following description. Other aspects, features and advantages will be apparent from the description and from the claims.

Brief Description of Drawings

Figure 1 is a perspective view of a blood flow reversing valve.

Figure 2 is an exploded perspective view of a blood flow reversing valve of Figure 1.

Figures 3 and 4 are perspective views, in section, of the blood flow reversing valve of Figure 1, with a central flow direction element of the valve in the first and second positions, respectively, to direct the flow in a normal direction and an inverted direction, respectively.

Figure 5 is a schematic illustration of a hemodialysis system including an extracorporeal blood line kit, which includes a blood flow reversing valve of Figure 1 and is connected to the hemodialysis machine.

Figure 6 is a perspective view of a valve receptacle of the hemodialysis machine of Figure 1, without the blood flow reversing valve installed.

Figure 7 is a schematic view of a reversing valve of

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blood flow of Figure 1, mounted in the valve receptacle of the hemodialysis machine of Figure 6.

Figures 8A and 8B are schematic illustrations of the blood flow through the blood flow reversing valve of Figure 1, in their normal and reversed orientations, respectively.

Figure 9 is an exploded perspective view of a blood flow reversing valve including a central flow direction element having kidney shaped flow passages, which helically curved through the direction element. flow.

Figures 10 and 11 are perspective views, in section, of the blood flow reversing valve of Figure 9 and with the blood flow directing element in the first and second positions, respectively, to direct blood flow in the normal direction and the inverted direction, respectively.

Detailed description of the invention

Referring to Figures 1 and 2, a blood flow reversing valve 100 includes a first generally cylindrical valve body 102, a second generally cylindrical valve body 104, and a central rotary, flow direction member 120 arranged in a cavity 105 (shown in Figures 3 and 4) formed between the first and second valve bodies 102, 104. As shown in Figure 2, the first valve body 102 and the second valve body 104 are formed of generally disk-shaped end plates 142, 144 and cylindrical walls 146, 148

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extending from the end plates 142, 144. The first and second valve bodies 102, 104 are axially and rotationally fixed to each other, and the flow direction member 120 can rotate within cavity 105.

The first and second valve bodies 102, 104 are secured to each other by splice features of tabs 109 and grooves 111 that are formed around the respective adjacent edges of the first and second valve bodies 102, 104 and are spaced apart to align with each other for the Reverse Blood Flow Valve 100 assembly. The tabs 109 and slots 111 are configured to be pressed into and to engage with each other. For example, tabs 109 and slots 111 may include snap-fit ​​type retainers, resilient pawls that flex and lock in place to connect the first and second valve bodies 102, 104 or other features and interlocking elements to secure valve bodies 102, 104 together.

With reference still to Figures 1 and 2, the first valve body 102 includes bloodline connectors 156, 158 extending outwardly from the end plate 142 and the second valve body 104 Includes line connectors 160, 162 of blood extending outward from end plate 144. Fluid passages 106, 108, 110, 112 extend through bloodline connectors 156, 158, 160, 162 and end plates 142, 144 to provide fluid communication with the central cavity 105 of the valve 100. Because the first and second valve bodies 102, 104 are

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OE IA PROPERTY t '* INDUSTRIAL rotatably fixed relative to each other, 4 &amp; ^ - bloodline gutters 156 and 160 are fixed in axial alignment with each other, and bloodline connectors 158 and 1623 are fixed on axial alignment with each other. As a result, the fluid passageways 106 and 110 are axially aligned with each other, and the fluid passages 108, 112 are axially aligned with each other. However, as described below, the flow direction member 120 may be rotatably positioned to connect in fluid communication with the axially aligned pairs of fluid passages (106/110 and 108/112), of the first and second valve bodies 102, 104 or to be connected in fluid communication with the misaligned fluid passage pairs (106/112, 108/110) of the first and second valve bodies 102, 104.

As shown in Figure 2, the first valve body 102 includes a first slot portion 119A and the second valve body 104 includes a second slot portion 119B. The first and second portions 119A; Groove 119B are axially aligned with each other, when the first and second valve bodies 102 and 104 are secured to each other, as shown in Figure 1, to form a groove 119. A bolt 117 is secured with the flow directing element 120 and extends radially outward through the slot 119. The bolt 117 can be moved along the slot 119 in order to rotate the element 120 out of the way. flow direction from a first position, causing blood to flow through valve 100 in the normal direction, to a second position, where blood is caused to flow through valve 100 in an inverted direction.

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As shown in Figure 2, the first valve body 102 includes visual indicators 123, 125 that are used to indicate the orientation of the flow direction member 120 relative to the first and second valve bodies 102, 104. Specifically, visual indicators 123, 125 include the words "Normal" and "Inverted," respectively, applied (eg, printed, etched, molded, adhesive applied, or applied by any appropriate method) to portions of the wall 146 cylindrical which are adjacent opposite end regions of slot 119. As a result, the user can determine that the flow direction element 120 is in the normal flow position when the pin 117 is adjacent to the indicator 123 and can easily determine that the flow direction element 120 is in the flow position. inverted when pin 117 is adjacent to indicator 125.

The blood lines (for example, the blood line kit tubing) can be connected to the blood line connectors 156, 158, 160, 162. For example, the blood lines can be slid over the blood line connectors 156, 158, 160, 162 and secured (eg, mated with adhesive) with the blood line connectors 156, 158, 160, 162. In some implementations, the blood lines are coupled to their associated blood line connectors by applying a solvent, such as cyclohexanone, to the blood line connectors and then sliding the blood lines over the blood line connectors.

Referring to Figure 2, the flow direction element 120,

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Rotary, central is arranged and configured to rotate about the longitudinal axis 115 of the flow reversing valve 100 to direct the flow in a desired manner between the fluid passages 106, 108 of the first valve body 102 and the passages 110, 112 of fluid from the second valve body 104. The rotary flow direction member 120 is formed from an outer cylindrical wall 122, which forms an internal flow cavity and a semi-helical, internal partition 124 that divides the internal flow cavity into a first flow path 126A and into a second flow path 126B. Division 124 flexes around longitudinal axis 115 to form the semi-helical profile. As a result of this configuration, the first flow path 126A and the second flow path 126B follow curved, flexed profiles. Division 124 generally has a smooth, gradual surface that flexes along the semi-helical profile. The first flow path 126A and the second flow path 126B are essentially the same shape and size and are similarly oriented paths through the flow direction member 120 .

Along its axial length, partition 124 rotates or flexes at an angle that allows axially aligned fluid passages 106 and 110 and axially aligned fluid passageways 108 and 112 to be connected in fluid communication when the flow direction member is in the normal flow orientation (shown in Figure 3) and allowing axially misaligned fluid passageways 106 and 112 and axially misaligned fluid passageways 108 and 110 to be connected in communication fluids when the element of

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flow direction is in the Inverted flow orientation (shown in Figure 4). In particular, when the flow direction member 120 is in the normal flow orientation, the flow path 126A connects the fluid passage 106 with the fluid passage 110 and the flow path 126B connects the fluid passage 108 with the fluid passage 112. When the flow direction member 120 is in the reverse flow orientation, path 126B connects fluid passage 106 with fluid passage 112 and flow path 126A connects fluid passage 108 with fluid passage 110. Because the first and second flow paths 126A, 126B are semi-circular and extend circumferentially nearly 180 degrees within the cylindrical outer wall 122 of the flow direction member 120, the bending angle of division 124 Generally, it only needs to be large enough to exceed the width of the fluid passages, as well as the width of the 124 division. For example, the flex angle of the split may be from about 5 degrees to about 180 degrees (eg, about 60 degrees to about 120, about 90 degrees).

The distance that the flow direction member 120 needs to be rotated in order to reverse the blood flow through the valve depends on the flexion angle of the division 124 and the arrangement of the fluid passages. As the flex angle increases, the rotational path distance required to reverse the blood flow through valve 100 will also Increase. Division 124 is generally configured so that when element 120 is rotated

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Flow direction of about 5 degrees to about 180 degrees (eg, about 60 degrees to about 120 degrees, about 90 degrees) about the longitudinal axis 115 is enough to reverse the blood flow.

Flow direction member 120 is appropriately dimensioned to create a press fit type seal within cavity 105 between first and second valve bodies 102, 104, when the first and second valve bodies 102, 104 are insured each other. For example, the flow direction member 120 may have an axial length that is greater than or equal to the axial length of cavity 105. Furthermore, the cylindrical wall 122 of the flow direction member 120 may have an external diameter that is greater than or equal to the diameter of the cavity 105.

The snap fit seal can help limit accidental flow out of the first flow path 126A and the second flow path 1236B. For example, a tight fit between the flow direction member 120 and the end plates 142, 144 of the first and second bodies 102, 104 can help limit blood flow between the first and second paths 126A and 126B of fluid and / or can help limit blood flow from the first and second flow paths 126A, 126B to the outer regions of cavity 105. Similarly, the tight fit between the cylindrical wall 122 of the flow direction member 120 and the inner surfaces of the first and second valve body walls 146, 148 102 can help prevent blood from escaping into the space

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FROM circumferential PROPERTY around flow direction element 120 in case blood escapes from one of paths 126A; 126B.

The pin 117, which extends radially outward from the outer cylindrical wall 122 of the flow direction member 120, is typically molded integrally with the cylindrical outer wall 122. Alternatively, pin 117 can be coupled to cylindrical outer wall 122 using other appropriate techniques. For example, the pin-like member 117 can be coupled to the cylindrical outer wall 122 with the use of fasteners (eg, thread fasteners), adhesive bonds, thermal bonds, or chemical bonds.

The first and second valve bodies 102, 104 and flow direction member 120 are typically made of a high impact, biocompatible thermoplastic material or a thermoset material. In some implementations, valve bodies 102, 104 are formed of an acrylic-based multi-polymer composite (for example, a high impact, biocompatible, MMA / styrene / acrylonitrile terpolymer or a thermoplastic compound that can be injection molded , Similary). However, other medical grade materials, such as polycarbonate, polysulfone, or mixtures of these types of materials, can be used alternatively or in addition. The first and second valve bodies 102, 104 and flow direction member 120 are typically formed with the use of injection molding techniques. However, alternatively or in addition, other techniques may be used, such as etching and machining.

Figures 3 and 4 are perspective views, in section, illustrating the

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flow direction member 120 in the normal flow orientation and in the reverse flow orientation, respectively. Portions of the cylindrical outer wall 122 of the flow direction member have been cut to provide a clear view of the flexed partition 124. As shown, the flow direction member 120 can be rotated within cavity 105 to connect the different passages with one another in fluid communication in the reversed fluid flow within the blood flow reversal valve 100. In particular, when the flow direction member 120 is in the normal flow orientation, as shown in Figure 3, the partition 124 is positioned relative to the stationary fluid passages, so that the passages 106, 110 of axially aligned fluid are connected in fluid communication through flow path 126A and fluid passageways 108, 112, axially aligned they are connected in fluid communication through path 126B. When the flow direction member 120 is in the reverse flow orientation, as shown in Figure 4, the partition 124 is positioned relative to the stationary fluid passages, so that the misaligned fluid passages 106, 112 axially they are connected in fluid communication through flow path 126B and axially misaligned fluid passages 108, 110 are connected in fluid communication through path 126A.

Figure 5 schematically illustrates a hemodialysis system 200 that includes a blood line set that includes a blood flow reversal valve 100 connected to a machine ίΊί j? one

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201 hemodialysis. The blood flow reversing valve 100 is fitted with a valve receptacle 250 mounted along a front face of the hemodialysis machine 201. Venous and arterial blood lines 212 and 214 are connected with blood line connectors 158 and 156, respectively, of the first valve body 102 and the outlet and inlet of blood lines 206 and 208 are secured with the connectors Blood line 162 and 160, respectively, of the second valve body 104.

As shown in Figure 5, the second valve body 104 is connected in fluid communication with a pump 202 through the outlet blood line 206 and is connected in fluid communication with a dialyzer 204 through the line 208 of input blood. On the opposite side of valve 100, venous and arterial blood lines 212, 214 are connected in fluid communication with the first valve body 102 and can be connected to the patient during treatment. During treatment, as will be described later, flow direction member 120 of valve 100 can be rotated toward the Inverse flow of blood within arterial and venous blood lines 212, 214 without the operation of reversing pump 202 blood or twisting lines 206, 208, 212, 214.

Blood lines 206, 208, 210, 212 and 214 can be any type of blood line. In some embodiments, the blood lines are formed from one or more compatible materials, such as polyvinyl chloride (PVC); DI (2-etl I hex 11) f ta I a to (DEHP), polyolefins, etc. However, other bloodline materials can be used.

<img file="MX357012B_D0026.tif" />

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MEXICAN INSTITUTE I heard THE PROFIEDAO INDUSTRIAt conventional, in alternative or additional form .___

Pump 202 can be any of the pumping devices that have the ability to force blood through system 200. Examples of pumping devices include peristaltic pumps, such as those available from Sarns, Inc. (Ann Arbor, Michigan) .

Dialyzer 204 can include several of different dialyzers. Examples of suitable dialyzers include the Fresenius Optiflux® series of dialyzers.

Referring to Figure 6, valve receptacle 250 includes valve retention elements (eg, resilient pawls or clamping devices) 252, which are appropriately dimensioned and configured to clamp blood flow reversal valve 100 during use. Each of the valve retaining elements 252 has ratchet-like elements 253 projecting inwardly toward the valve insertion area. The ratchet-type elements 253 are configured to hold the bloodline connectors 156, 158, 160, 162 and to help keep the blood flow reversal valve 100 generally stationary during blood treatment and flow reversal .

The pin movement device or actuator 254 is located essentially in the center of the valve retaining elements 252 and protrudes through a hole 256 formed in the face of the blood treatment machine. Actuator 254 has a pin slot 258 that is sized and configured to receive pin 117 of blood flow reversing valve 100. As shown,

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THE MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY actuator 254 is in the form of a rotatable member 260, which when rotated can move pin 117 relative to stationary blood flow reversal valve 100. Rotating member 260 is connected to a motor (eg, an electric motor) that can rotate rotating member 260. As a result, actuator 254 is able to move flow directing element 120 and reverse blood flow through valve 100.

Hemodialysis machine 201 includes a controller (eg, a microprocessor) that is electrically connected to the motor connected to the rotating member 260. Signals can be sent from the controller to the motor to operate the rotating member 260. The controller is typically also connected to a timer and / or sensors of hemodialysis machine 201 so that the controller can receive signals from those components and operate rotary member 260 based on the signals received from those components. In some implementations, the controller is programmed to transmit signals to rotate rotary member 260 and thus reverse blood flow through valve 100 at specified times during treatment. In such implementations, the controller may receive signals from the timer, which indicate the time the treatment has elapsed, and may cause the rotating member 260 to rotate when the predetermined time is reached. Alternatively or in addition, the controller may be programmed to rotate rotary member 260 upon receiving signals that readings from a sensor (eg, a pressure sensor) are out of range

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<img file="MX357012B_D0031.tif" />

predetermined.

Figure 7 illustrates a schematic side view of the blood flow reversing valve 100 mounted in the valve receptacle 250. As shown, the bloodline connectors 156, 158, 160, 162 are fastened with their associated valve retention elements 252, so that the blood flow reversal valve 100 is generally stationary relative to the hemodialysis machine 201 during use. Pin 117 of valve 100 is disposed in pin slot 258 of rotatable member 260, so that blood flow reversing valve 100 is coupled with valve receptacle 250 for use.

Figures 8A and 8B illustrate an exemplary method for using a hemodialysis system 200 to perform hemodialysis. With reference to Figure 8A; venous and arterial blood lines 212 and 214 are connected to an artery or vein, respectively, of a patient. Any of the different methods can be used to connect arterial and venous blood lines 212 and 214 to the patient. For example, blood lines 212 and 214 may be connected in fluid communication with a fistula, graft, or shunt implanted within the patient, which connects the patient's vein to the patient's artery.

To begin treatment, valve 100 is configured in the normal flow configuration, where arterial blood line 212 is connected in fluid communication with outlet blood line 206 through second element flow path 126B. 120 of

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<img file="MX357012B_D0033.tif" />

flow direction and blood line 214 ve.no ^ LSL „fi.§iá_connected in fluid communication with inlet blood line 208 through first flow path 126A of flow direction element 120. When in this position, as described above, pin 117 is aligned with indicator 123, which displays the word "normal" to inform the nurse that valve 100 is in the normal flow position. The blood is then forced through connecting line 210 to dialyzer 204, where the blood is filtered. After exiting dialyzer 204, blood advances through incoming blood line 208 and venous line 214 to the patient. Blood re-enters the patient's vein through venous line 214. Generally, blood is pumped through system 100 at a flow rate of approximately 300 ml / min. However, other flow rates are possible. Pump 202, for example, may be configured to pump blood at a rate of from about 50 ml / min to about 600 ml / min.

As described above, it may be desirable at any time during hemodialysis to reverse the blood flow. For example, certain parameters can be measured in the standard flow and reverse flow configurations and compared with each other in order to determine the rate of entry of blood flow. Examples of methods for determining blood flow entry rates are described, for example, in United States Patent No. 5,830,365 and United States Patent No. 6,648,845, the contents of which are incorporated herein by reference in its entirety.

<img file="MX357012B_D0034.tif" />

When the dialysis system 200 determines that it is appropriate to reverse the blood flow through the blood flow reversal valve 100, the pump 202 typically stops briefly. Once blood flow has stopped, the controller of the dialysis system 200 sends a signal to a rotatable member 260 of the valve receptacle 250. The rotatable member 260 is then rotated to move the pin slot 258 (i.e., move the pin slot 258 down in the orientation shown in Figure 7) to move the pin 117. As pin 117 moves from the normal flow position to the reverse flow position, partition 124 rotates within blood flow reversal valve 100 to a position where fluid passages are connected in fluid communication at a way to induce a reserve flow.

After being placed in the reverse flow position, illustrated in FIG. 8B, arterial blood line 212 is placed in fluid communication with inlet blood line 208 through second flow path 126B of the steering element 120 flow and venous blood line 214 is connected in fluid communication with the outgoing blood line 206 through the first flow path 126A of the flow direction member 120. Pump 202 is then restarted, causing blood to be drawn from the patient's vein and routed through venous blood line 214 and outgoing blood line 206 to pump 202. Blood then passes to through dialyzer 204 and flows through inlet blood line 208. Blood then passes through valve 100

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<img file="MX357012B_D0035.tif" />

up to arterial blood line 212. Blood re-enters the patient's artery in the same way (that is, in the same direction) in which it is operated during normal flow. Pump 202 typically pumps blood at a rate of approximately 300 ml / min during the reverse flow operation. However, other flow rates are possible. Pump 202 for example, may be configured to pump at a rate of from about 50 ml / min to about 600 ml / min during periods of reverse blood flow.

After the reverse flow of blood is complete, pump 202 stops again and flow direction member 120 is rotated back to the normal flow position. Pump 202 then restarts, and blood treatment is resumed.

Although various modalities have been described, other modalities are possible.

Although the flow direction element 120 has been described as being press fit within the cavity 105 formed between the first and second valve bodies 102, 104, in order to create liquid tight seals between the ends of the flow element 120 flow direction and the end plates 142, 144 of the first and second valve bodies 102, 104, other sealing techniques may be used, alternatively or in addition. In some embodiments, for example, gaskets are coupled with each axial end of the flow direction member 120. The gaskets may be shaped to correspond to the shapes of the end surfaces of the flow direction member 120. By

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INDUSTRIAL.&gt; * Example, each of the packings may include an outer ring-shaped member and a central partition that is drawn through the central ring-shaped member opening to form two semi-passages. flow circulars. The gaskets can be coupled (eg, adhesive-coupled, heat-coupled, chemical-coupled, or over-molded) to the ends of the flow direction element 120, so that the fluid passages in the gaskets align with paths 126A and Flow 126B of flow direction element 120. The gaskets are compressed between the ends of the flow direction element 120 and the end plates 142, 144 of the first and second valve bodies 102, 104 to form a watertight seal between the ends of the flow direction element 120 and the end plates 142, 144 of the first and second valve bodies 102, 104. Packages can include one or more biocompatible materials having a durometer from about 30 Shore D to about 40 Shore D (eg, about 30 Shore D). Examples of materials from which gaskets can be formed include polysoprene latex, silicone, Krayton, and mixtures of these types of materials.

In some implementations, the flow direction element (eg, cylindrical outer wall 122 and / or partition 124) and / or the first valve body 102 and the second valve body 104 may include a fluid sealing element (eg, an O-ring type sealing washer or other sealing elements) arranged along its edges to limit fluid from accidentally flowing from the first and second flow paths.

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MEXICAN INSTITUTE CE LA f INDUSTRIAL RCEIEDAD

In some implementations, one of the bodies includes a recessed groove portion that essentially defines the full groove, and the opposite valve body does not include the groove portion. Alternatively or additionally, the flow direction element may include other types of projections that allow the flow direction element to move within the blood flow reversal valve. For example, in some implementations, the flow direction element includes a region that has exposed teeth within the slot that engage teeth of an external gear to the blood flow reversal valve.

Although the blood flow reversing valve status indicators 123, 125 have been described in the form of words applied with the first valve body, other types of indicators can be used to indicate the state of the reversal direction of the blood flow. For example, in some implementations, colored Figures or suggestive symbols may be applied to indicate the status of the blood flow reversal valve. The indicators can be applied, alternatively or in addition, with other components of the blood flow reversing valve. For example, gauges can be applied to the second valve body or gauges can be applied to portions of the flow direction element that are visible within the slot when the flow direction element is rotated to the position associated with the particular indicator.

Although the flow direction element 120 has been described with a cylindrical cavity divided into two flow paths of form

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<img file="MX357012B_D0040.tif" />

INSTITUTO MEXICANO DE LA F &amp; CP.F.CAO INDUSTRIAL helical, essentially semi-circle by division 124 generally helical, other configurations are possible. For example, Figure 9 is an exploded perspective view of a blood flow reversal valve 300 having a flow direction element 320 including two helical flow paths 322, 324. Each of the flow paths 322, 324 has an essentially curved cross-sectional shape (eg, a kidney-like cross-sectional area) that follows the essentially helical path through the flow direction member 320. Flow direction member 320 is arranged in cavity 105 between first and second valve bodies 102, 104 and can rotate between the normal flow position and the reverse flow position, to connect in fluid communication with the different fluid end plate passages 106, 108, 110, 112. Flow direction element 320 can be sealed within cavity 105 with the use of any of the different techniques described above with respect to flow direction element 120.

Curved flow paths 322, 324 can improve fluid flow through the blood flow reversal valve 300, as well as reduce blood clotting. The geometry and configuration of the curved flow paths 322, 324 can also affect the angular distance that the flow direction element 320 needs to rotate in order to reverse the flow through the blood flow reversing valve. The angle of rotation at which flow direction member 320 must be rotated in order to reverse flow through valve 300 depends on several factors, including axial length and angle of

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<img file="MX357012B_D0042.tif" />

Bending of flow paths 322, 324 ^ -— Θ —- enng-H + e · -de-rotawó-n typically required, can be determined by subtracting the bending angle of the flow path from 180 degrees. therefore, as the flex angle increases (and the extension and size of the flow path 322 increases), the angle of rotation necessary to reverse the flow decreases. Flow paths 322, 324 are typically designed such that as the flow direction member 320 rotates by about 5 degrees to about 180 degrees (eg, from about 60 degrees to 120 degrees, about 90 degrees) about the longitudinal axis of valve 300 is sufficient to reverse flow through valve 300.

Figures 10 and 11 are perspective views in section illustrating the different positions of the flow direction member 320 relative to the first and second valve bodies 102, 104. Referring to Figure 10, when the flow direction member 320 is disposed in the first position (eg, the normal flow position) relative to the first and second valve bodies 102, 104, the first flow path 322 Flow connects the axially aligned fluid passages 106 and 110 in fluid communication and the second flow path 324 connects the axially aligned flow passages 108 and 112 in fluid communication. Referring to Figure 11, when the flow direction member 320 is disposed in a second position (eg, the reverse flow position) relative to the first and second valve bodies 102, 104, the first flow path 322 flow connects in communication of fluids the passages 108 and 110 of

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<img file="MX357012B_D0043.tif" />

axially misaligned fluid and the second flow path 324 connects fluidly misaligned axially fluid passageways 106 and 112 to reverse blood flow through valve 300.

Valve 300 can be incorporated into a bloodline set and connected to hemodialysis machine 201 in the manner described above with respect to valve 100. In this way, actuator 254 can be used to automatically reverse blood flow. through valve 100 during treatment.

Although the blood flow reversal valves 100, 330 include splice tabs and groove which are used to secure the valve bodies 102, 104 to each other, other devices or techniques can be used. For example, alternatively or in addition to the interlocking tabs and grooves, fasteners (eg, threaded fasteners (eg, bolts or screws), rivets, and other fasteners) may be used. In some implementations, one of the valve bodies includes a circumferentially formed recess or lip with appropriate dimensions to receive and engage with a circumferentially formed, resilient, conical ring disposed around the attached rim or with the other valve body . With the use of a circumferentially formed recess and ring, the two valve bodies can be pressed together and the ring can be press fit within the recess to secure the valve bodies together. In some implementations, the first and second valve bodies 102, 104 include thread portions that allow to be screwed together. In some

<img file="MX357012B_D0044.tif" />

MEXICAN INSTITUTE OF PROPERTY

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<img file="MX357012B_D0045.tif" />

Implementations, devices can be used only clamps to press the first valve body 102 onto the second valve body 104.

Although the actuator 254 of the hemodialysis machine 201 has been described as rotating, the actuator may alternatively include a vertically movable member, having a hole for receiving the pin of the blood flow reversing valve. Alternatively or additionally, the valve retaining element may include a movable gear configured to engage a splice gear mounted on the blood flow reversing valve to move the flow direction element.

Although blood lines have been described as being attached to blood line connectors with the use of an adhesive, other techniques can be used. For example, blood lines can be joined with heat and / or chemicals with blood line connectors. As another example, blood lines and blood line connectors can include splicing Luer-type locking mechanisms that can be used to secure blood lines with blood line connectors.

Although the blood flow reversal valve has been described as being used in combination with a dialysis machine that has the ability to automatically reverse blood flow through the valve when convenient, other configurations are possible. For example, in some implementations, the user (for example, the nurse, the patient, or someone else administering the blood treatment process) manually moves the steering element

IMPI

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<img file="MX357012B_D0046.tif" />

flow (for example, by holding the radially extended projection from the flow direction member) from the normal flow position to the Inverted flow position.

Although the blood flow reversing valve has been described as a component for a hemodialysis system, the blood flow reversing valve may, alternatively or in addition, be used with other types of blood treatment systems, where the reversal of flow is convenient. Examples of other types of blood treatment systems include, plasmapheresis, autotransfusion devices, and blood-absorbing devices.

Various embodiments have been described, however, it should be understood that various modifications can be made without departing from the scope and spirit of the invention. Accordingly, other embodiments are within the scope of the following claims.

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INSTITUTO MEXICa NO Dt LA PROPIEDAD INDUSTRIAL

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