KR20230107622A - Dual lumen cannula and method of use - Google Patents

Abstract

The present invention relates to a double lumen cannula configured to be inserted into a patient's body as simply as a single lumen cannula. The double lumen cannula has at least two ends - an inner lumen proximal end and an inner lumen distal end - a hollow midrange between the two ends having one or more openings at the inner lumen distal end and at least one inner lumen at the inner lumen proximal end. at least one inner lumen with a connector unit; At least two ends - an outer lumen proximal end and an outer lumen distal end - a hollow intermediate range between the two ends having one or more openings, the middle range further comprising one or more openings at the outer lumen distal end, proximal to the outer lumen at least one outer lumen having an end thereof with at least one outer lumen connector unit; It includes at least one floating router. The outer lumen is first inserted into the body of the patient, and only then the inner lumen is inserted through the outer lumen into the body of the patient until the inner lumen connector unit makes mating contact with the outer lumen connector unit.

Description

Dual lumen cannula and method of use

This application claims priority over U.S. Provisional Patent Application Serial No. 63/111,803, filed on November 10, 2020, entitled "Dual Lumen Cannula", and U.S. Provisional Patent Application Serial No. 63/111,813, filed on November 11, 2020, entitled "Dual Lumen Cannula". claim, the contents of each of which are incorporated by reference as if fully set forth herein.

The present invention relates generally to a Dual Lumen Cannula Assembly, and more specifically, to a Dual Lumen Cannula Assembly, wherein an outer lumen and an inner lumen are connected in real time within the body and reverse flow directions through a novel flow router connector. It relates to a double lumen cannula with

Medical activities requiring extracorporeal treatment of blood, such as dialysis and extracorporeal oxygenation, require a separate tubing for removing untreated blood from the body and reinserting the treated blood back into the body. There are two commonly practiced techniques for implementing such tubing within the vascular system - two single lumen cannulas and dual lumen cannulas. Both of these technologies present significant challenges.

The use of two single-lumen cannulas is not preferred because it requires two separate incision sites. The use of multiple incisions causes patient discomfort, especially for procedures where the cannula is held in the body for hours or days, and also increases the risk of infection. Additionally, the medical staff may have to repeat the tube insertion twice, multiplying the risk and time required for this procedure step.

The use of a double lumen cannula is also challenging, for a number of reasons. One particular challenge of dual lumen cannulae relates to the manner in which the dual lumen cannula is inserted and primed. Typically, a double lumen cannula is inserted as a self-contained device with a distal end within the vascular system and a proximal end outside the body. The proximal end contains two tubes, which can branch into a Y-shape. Once the dual lumen cannula is fully inserted into the vein, each lumen of the proximal end of the dual lumen cannula is then connected to a separate tubing. This connection process requires significant force to be applied to the double lumen cannula, which increases the risk of perforation of the vessel. Also, during connection of each lumen to the tubing, care needs to be taken to ensure that no air bubbles are introduced into the vascular system. This is typically done by flushing saline into the open end of each line. Despite the extensive training that practitioners receive, it is still extremely difficult to prevent air bubbles from entering the blood flow. Entry of air bubbles can result in the formation of an embolism, which can be potentially fatal.

Some attempts have been made in the art to use double lumen cannulas. US Patent Application No. 2021023336, US Patent No. 5053004, and US Patent No. 5718678 may be considered relevant in the field of the invention.

In one major aspect, the present invention provides an outer lumen that is assembled into a double lumen cannula in vivo in real time upon insertion of the inner lumen into an outer lumen that is first inserted into a patient's body in a simple standard procedure as a single lumen cannula; and It is an object to provide a double lumen cannula consisting of a separate inner lumen thereof. Both lumens are assembled into the patient's body by a novel connector assembly that further determines the direction of flow in each lumen of the dual lumen cannula as described in detail below. The outer lumen and inner lumen are preferably reversibly connected by a novel connector assembly that allows for opposite flow directions within the outer and inner lumen of a double lumen cannula while inserting one cannula into the other.

In accordance with the present invention, an external lumen cannula is a single lumen cannula that is inserted into a patient's vascular system with minimal exertion of force upon the cannula when positioned within the patient's vascular system. Cannulation of the external cannula is preferably performed by standard intubation procedures.

When the outer lumen is placed within the patient's body, the inner lumen is first connected to a desired device or system, such as a blood therapy system, and primed to be ready for insertion into the exterior.

Thus, in one main aspect, the present invention relates to a double lumen cannula, which cannula has at least two ends, an inner lumen proximal end and an inner lumen distal end, a hollow intermediate extent between the two ends having one or more apertures. , and at least one inner lumen having at least one lumen connector unit at the inner lumen proximal end; a hollow midrange between the two ends having at least two ends, an outer lumen proximal end and an outer lumen distal end, one or more apertures, wherein the hollow midrange further comprises one or more apertures at the outer lumen distal end; and an outer lumen having one or more outer lumen connector units at the outer lumen proximal end; and at least one flow router, wherein the inner lumen is configured to be inserted into the outer lumen until the inner lumen connector unit makes mating contact with the outer lumen connector unit. The flow router is connected to the inner lumen connector unit, where the connection from the flow router to the one or more medical devices preferably need not be collinear with the inner lumen and the outer lumen. The intermediate extent of the inner lumen further includes one or more holes located between the distal and proximal ends of the outer lumen and within a region of the inner lumen that, when assembled, is within the outer lumen. The outer lumen preferably includes a narrow region at its distal end to centralize the position of the inner lumen towards the target area. The opening on the middle extent of the outer lumen is at least one drainage opening.

When the outer lumen connector unit is connected to the inner lumen connector unit, the inner lumen connector unit provides a flow path from the flow router to both the outer lumen and the inner lumen. The flow router further includes an inlet port for connecting to one or more connector tubing connected to the at least one medical device.

The outer lumen may further include at least one suturing element to enable securing the outer cannula to the patient's body once the cannula is intubated, and may further include one or more calibration marks. can include

The flow router of the dual lumen cannula provided herein may further include a first inner flow channel location connection region from the outer cannula through the outer lumen connector unit and then through the inner lumen connector unit to the medical device. In some other embodiments, the flow router further includes a second inner flow channel from the medical device through the inner lumen connector unit to the inner lumen.

However, in some other embodiments of the invention, the blood flow is reversed such that the first inner flow channel provides a flow path from the medical device through the inner lumen connector unit to the outer lumen connector unit and then to the outer lumen. Alternatively, the blood flow is reversed such that the second internal flow channel provides a flow path from the internal cannula through the internal lumen connector unit to the medical device.

In some optional embodiments, the outer lumen connector unit further includes one or more barbs. Optionally, the outer lumen and outer lumen connector unit may be formed as a single piece.

In some optional embodiments, the inner lumen connector unit further includes one or more flexible connectors for connecting and sealing to one or more barbs from the outer lumen connector unit.

In some optional embodiments, the inner lumen connector unit creates a separate flow channel through the one or more lumen openings to the inner lumen and a vertical separating wall to create a separate flow channel to the outer lumen through the outer lumen connector unit. and a chamber.

The present invention also relates to a process for introducing a cannula into a patient's vascular system, which process includes at least the following steps: an introducer drawn through an external lumen to its distal end, and optionally a guide wire. inserting a first external lumen cannula into the patient's vascular system using a; withdrawing the introducer and guide wire to create a small vacuum in the outer lumen that is refilled with blood; priming the second inner lumen cannula using a priming cap connected to the priming system, after completion of priming, the priming cap is removed; and inserting a second inner lumen cannula into the first outer lumen cannula until the inner lumen connector unit engages the outer lumen connector unit.

The first outer lumen cannula may be sutured to the patient's skin by stitching a standard suture through a butterfly. Optionally, one or more flow routers are connected to the inner lumen connector unit and the medical device is connected to the flow routers.

Examples illustrating embodiments of the present disclosure are described below with reference to the drawings attached hereto. Dimensions of components and features shown in the drawings are generally selected for convenience and clarity of presentation and are not necessarily drawn to scale. Many of the drawings presented are in the form of schematic illustrations and, therefore, certain elements may be significantly simplified or to scale for illustrative clarity. These figures are not production drawings.
The drawings are as follows.
1A is an illustration of at least one embodiment of a dual lumen cannula of the present invention in ready-to-use assembled form comprising an evacuation outer lumen and an infusion inner lumen coupled therethrough by a connector assembly according to an alternative embodiment of the present invention. It is isometric.
FIG. 1B is a schematic side view of at least one embodiment of an outlet outer lumen of the dual lumen cannula of FIG. 1A according to some optional embodiments of the present invention.
1C is a schematic isometric view of at least one embodiment of an injection inner lumen of the dual lumen cannula of FIG. 1A according to some optional embodiments of the present invention.
1D is a schematic isometric sectional view of a connection region between an inner lumen and an outer lumen of the dual lumen cannula of FIG. 1A in accordance with some optional embodiments of the present invention.
FIG. 1E is a schematic partial cross-sectional view of the connection region between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 1A including a flow router connector, in accordance with some optional embodiments of the present invention.
2A is an isometric view of at least one other embodiment of a dual lumen cannula of the present invention in ready-to-use, assembled form comprising a discharge outer lumen and an injection inner lumen coupled therethrough by a connector assembly according to an alternative embodiment of the present invention; It is also
FIG. 2B is an enlarged schematic isometric view of the overlapping region at the distal end of the expanded inner infusion cannula and the outer outlet cannula of the double lumen cannula of FIG. 2A from the outer cannula.
3A-3B are schematic plan and isometric views of the outlet outer lumen of the dual lumen cannula of FIG. 2A in accordance with some optional embodiments of the present invention.
4A-4B are schematic isometric rear and isometric side views of the injection inner lumen of the dual lumen cannula of FIG. 2A according to some optional embodiments of the present invention.
5A is a schematic exploded view of the dual lumen cannula of FIG. 2A showing the main components of the dual lumen cannula of the present invention.
5B-5C are schematic posterior and anterior isometric sectional views of the junction region between the inner lumen and the outer lumen of the dual lumen cannula of FIG. 2A according to some optional embodiments of the present invention.
6A-6B are schematic top and cross-sectional views of a connection region between an inner lumen and an outer lumen of the dual lumen cannula of FIG. 2A including a flow router connector, according to some optional embodiments of the present invention.
6C-6D are schematic isometric and cross-sectional views of the flow router of the dual lumen cannula and the connector unit of the inner lumen cannula of FIG. 2A, respectively, in accordance with some optional embodiments of the present invention.
6E-6F are schematic isometric front and isometric back views of the flow router of the dual lumen cannula and the connector unit of the inner lumen cannula of FIG. 2A in accordance with some optional embodiments of the present invention.
FIG. 6G is the flow router of FIG. 2A in a position simulating the position of the unit while the dual lumen cannula of the present invention is in use with the housing of the transparent flow router showing internal components according to some optional embodiments of the present invention. It is a schematic isometric side view of

In the description that follows, various aspects of the novel single double lumen cannula and flow router connector will be described. For purposes of explanation, specific constructions and details are set forth in order to provide a thorough understanding of the invention.

Although various features of the present disclosure may be described in the context of a single embodiment, features may also be provided individually or in any suitable combination. Conversely, although this disclosure may be described herein in the context of separate embodiments for clarity, the disclosure can also be implemented in a single embodiment. It is also to be understood that this disclosure can be carried out or of being practiced in various ways, and that this disclosure can be implemented in embodiments other than the exemplary ones described herein. The description, examples and material presented in the description, as well as the claims, are not to be construed as limiting, but rather as illustrative.

In one major aspect, the present invention aims to provide a convenient and safe solution that allows the operator to insert a double lumen cannula as simple and safe as inserting a single lumen cannula. In addition to the simplicity of inserting the cannula into the target area and the benefit to the medical team, the new solution also provides for screwing a second lumen into one and the other in vivo through the first single lumen, after insertion of the first single lumen. thread, benefiting the patient and reducing possible discomfort, possible contamination and additional scarring, without the need to create additional incisions in the entry area required when standard double lumen cannulas are used. Both lumens are connected in vivo by a proprietary novel connector assembly configured to connect the two lumens and also route opposing flows in the inner and outer lumens. Thus, the outer lumen is inserted into the patient's vascular system and the inner lumen is inserted through the outer lumen to a desired location.

As used herein, the term "cannula" refers to a thin tube inserted into a blood vessel to extract or infuse blood through/to the blood vessel. In the disclosed embodiments, a "double lumen cannula" is a cannula comprising an inner lumen surrounded by an outer lumen, wherein blood flows in and out simultaneously, physically separate, through a single double lumen cannula inserted into a patient's vascular system. this makes it possible

The term "proximal" refers to the direction closer to the blood therapy system or any other machine to which the double lumen cannula is connected, and the term "distal" refers to the direction towards or within the patient's body/vascular system. refers to

The term “lumen” refers to the interior space within a tube for the transport of liquids or gases.

The term “drainage lumen” or “outer lumen” refers to a lumen that serves to drain or transport blood from a subject's body into the machine prior to treatment. In the following description, the terms "external lumen", "external cannula", "external vent cannula", "exhaust cannula" and "exhaust lumen" are all used interchangeably and refer to the same component.

The term “infusion lumen” or “inner lumen” refers to the lumen through which blood is injected back into the body from the machine after treatment. In the description below the terms "internal lumen", "internal cannula", "internal infusion cannula", "infusion cannula" and "infusion lumen" are all used interchangeably and are directed to the same component.

Although the description herein refers to the outer lumen as the drainage lumen and the inner lumen as the infusion lumen, in some other optional embodiments and implementations of the invention the outer lumen may be used to infuse blood into the body and the inner lumen may be It can be used to expel blood from the body.

Also, while reference is made to the evacuation and infusion of blood, it is to be understood that other bodily fluids may also be withdrawn and infused by the novel dual lumen cannula provided herein, and that the present invention is not limited in any way to blood. It should be clear.

Now refer to the drawing.

1A is a schematic isometric view of a dual lumen cannula 100 of the present invention in assembled form ready for use. In this configuration, the dual lumen cannula 100 has a drain outer lumen configured to drain blood through the drain opening 112 of the cannula 106 to an extracorporeal machine for treating the drained blood from the body of the person being treated, and an infusion inner lumen configured to infuse blood from the extracorporeal machine back into the body of the subject through the infusion opening 122 of the cannula 127, the inner and outer lumens connecting the two lumens and described in detail below. As such, they are connected to each other by connector assemblies that route the blood flow in each of them.

Cannula 106 in the outer lumen may include calibration marks 190 to provide a clinician indication of the penetration length. In a similar manner, the inner lumen cannula 127 may also include calibration marks 190 for monitoring the length of penetration of the inner lumen.

The inner lumen preferably, but does not have to, includes a connector unit 132 that is an integral part of the inner lumen. Optionally, connector unit 132 is connected to a butterfly having suture holes 116 that can be secured to the patient's skin with regular sutures to stabilize the position of the dual lumen cannula during medical treatment. It should be clear that other means for securing and securing the cannula to the patient's body may be used and the butterfly 116 is merely one non-limiting example implementation.

Connector unit 132 of the inner lumen is operatively connected at its proximal end to connector unit 136, also referred to as “floating router” 136. Flow router 136 is the connector unit between the dual lumen cannula and the extracorporeal machine, and establishes blood flow in opposite directions between the inner and outer lumens, preferably from flow in two separate parallel tubes. It is constructed and operable to establish flow in two insertable tubes into different lumens. The connector unit 132 is further connected to the connecting configuration of the cannula 106 as described with reference to FIGS. 1C-1D below. The connection between the inner lumen and the outer lumen is such that the outer lumen is first inserted into the patient as a single lumen cannula and only then screwed into the outer lumen until the inner lumen is coupled into the double lumen cannula, so that the patient's body performed in vivo. In addition, the connection of the dual lumen cannula of the present invention to a tube connected to the flow router 136 and for transporting blood from the patient's body towards the extracorporeal machine and from the extracorporeal machine towards the patient's body in the opposite direction. One of the two tube connector platforms that allow, the tube connection platform 50, is shown in the figure.

FIG. 1B is a schematic side view of the outlet outer lumen 110 of the dual lumen cannula of FIG. 1A according to some optional embodiments of the present invention. In this embodiment, the outer lumen 110 is at least a cannula 106 having a larger diameter than the diameter of the inner lumen 120, also referred to interchangeably as an “inner cannula” and an “infusion cannula,” and Allows lumen 120 to be inserted therethrough. The cannula 106 has a narrow area 111 at its distal end for centralizing the position of the inner lumen primarily towards the target area, and at least one exit opening 112. Optionally, cannula 106 includes calibration marks thereon, which may be further marked with numerals 190 to indicate the length of penetration of outer lumen 110 into the body of the patient. Cannula 106 includes a connector unit 108 at its proximal end. In the specific example illustrated herein, connector unit 108 is made of subsequent barbs that are continuous to cannula 106 . Upon connection of the inner lumen to the outer lumen connector unit 108, it is configured to be inserted into a complementary niche or socket in the inner lumen connector unit as will be described with reference to FIGS. 1C-1D. Other connection solutions such as Luer locks, snap connections, etc. may alternatively be used.

1C is a schematic isometric view of the injection inner lumen 120 of the dual lumen cannula of FIG. 1A according to some optional embodiments of the present invention. The inner lumen cannula 120 includes an inner lumen connector unit 132 attached to the cannula 127, in the example illustrated herein, the flow router 136 and connected as one piece to the proximal end of the cannula 127. ). Cannula 127 has a smaller diameter than cannula 106 that functionally permits insertion through cannula 106 and a greater length permitting extension beyond cannula 106 to the target area. The cannula 127 includes at least one injection opening 122 at its distal end for returning treated blood from the extracorporeal machine to the patient's blood vessel. Cannula 127 may further include a pressure regulation hole 128 formed along the circumference of the inner lumen. The pressure regulating hole 128 is positioned at a location along the cannula 127 such that the pressure regulating hole 128 is covered by the outer lumen 110 when the inner lumen 120 is inserted into the outer lumen 110 . The pressure regulation hole 128 serves to alleviate high pressure conditions within the injection lumen that can lead to cavitation. Cavitation is a phenomenon in which rapid changes in pressure in a liquid lead to the formation of small vapor-filled cavities at relatively low pressures. Cavitation within blood vessels can lead to the formation of liquid jets, potentially leading to vessel rupture. The dimensions of the hole 128 are such that when the pressure within the inner lumen 120 increases above a predetermined level, blood passes through the pressure regulating hole 128 from the inner lumen to the outer lumen, bypassing the patient vascular system. It is decided. In such a situation, blood flows into the hole 128 based on the principles of fluid dynamics where liquid always follows the path of least resistance. Blood continues to flow through the hole 128 until the pressure within the infusion lumen 120 decreases, to the point where the infusion lumen 120 again becomes the path of least resistance. The connector unit 132 may include a butterfly with a suture hole 116 to allow stitching of the dual lumen cannula of the present invention to a patient's skin during medical procedures.

Also, as shown in these Figures, the tube connection platforms 50 and 50' connect the outer tube to the inner lumen and to the outer lumen to flow expelled blood into the machine and from the machine to the patient's blood vessels. Allow to flow back into the system. Inner lumen 120 may further include a priming cap (not shown) at its distal end. The priming cap is removable and can be connected to a priming system for priming the inner lumen 120 . For example, the priming cap can be connected to a source of saline and removed after priming is complete.

Proximate to the priming cap, inner lumen 120 includes an injection opening 122 for fluid connection to the patient's vascular system. These openings form gateways for processed blood to flow back into the cardiovascular system. Also shown in these figures are calibration marks 190 and tubes 50, 50' that transport blood to and from the medical machine.

1D is a schematic isometric partial view of the connection region between the inner lumen 120 and the outer lumen 110 of the dual lumen cannula 100 of FIG. 1A in accordance with some optional embodiments of the present invention. In this figure, cannula 127 is connected at its proximal end to inner lumen connector unit 132 and is inserted through its distal end through outer connector unit 108 into the proximal end of cannula 106. The connector unit 108 is then pushed into the interior space of the inner lumen connector unit 132 so that its barbs are hooked and covered by the connector unit 132 .

1E is a schematic partial cross-sectional view of the connection region between the inner lumen 120 and the outer lumen 110 of the dual lumen cannula 100 of FIG. 1A including a flow router connector, according to some optional embodiments of the present invention. am.

In the cross-sectional view, the opposite flow directions of the expelled and infused blood in the infusion inner cannula 127 and the outlet outer cannula 106 are shown. For simplicity of explanation, connector unit 108 of the outer lumen cannula and connector unit 132 of the inner lumen cannula are separated to clearly show the parts involved in connection. Blood flow begins only when the two cannulae are engaged and when the barb 108 hooking them therein is pushed at the connector unit 132 distal end. During engagement of the two lumens, cannula 106 receives cannula 127 inserted therein. Blood flow in connector units 131 and 132 as well as in both lumens is conducted in opposite directions as indicated by the arrows in parallel lumens and along the two cannulas. The flow router 136 collects all the drained blood that flows together within the chamber 1326 into a single tube that is connected to the tube connector platform 50 to transport the blood into an extracorporeal machine for treatment. In the same way but in the opposite direction, the processed blood from the extracorporeal machine is connected to the tube connector platform 50' to transport the processed blood through the flow router 136 into the cannula 127 towards the patient's body. It is injected back into the treated patient's vascular system via a tube.

2A is a schematic isometric view of a dual lumen cannula 200 of the present invention in assembled form ready for use. In this configuration, the dual lumen cannula 200 has a draining outer lumen comprising a cannula 106 configured to drain blood through the drain opening 112 into a machine for treating the drained blood from the body of a subject; and an infusion inner lumen comprising a cannula (127) configured to infuse blood from the machine back into the body of the subject through the infusion opening (122), the inner and outer lumens being connected to a connector assembly connecting the two lumens. connected to each other and routes the flow of blood in each of them as described in detail below.

Optionally, cannulae 106 and 127 include calibration marks 190 to provide a clinician indication of the length of penetration. The outer lumen preferably, but need not be, an integral part of the connector assembly 130 includes a proximal end external connector unit 131 configured to allow physical connection of the outer lumen and the inner lumen. The outer lumen may optionally include a butterfly having a suture hole 116 that can be secured to the patient's skin with standard sutures to secure the outer cannula to the patient's body and position prior to insertion through the inner cannula. can stabilize. In this particular example, connector unit 131 is connected to butterfly 116 . It should be clear that other means for stabilizing and securing the external cannula to the patient's body are also within the scope of the present invention, and the example provided herein is merely one illustrative alternative implementation.

Also shown in this figure is an inner lumen connector unit 132 which is preferably, but not necessarily, an integral part of the inner lumen. When screwing the inner lumen into the outer lumen, the outer lumen connector unit 131 and the inner lumen connector unit 132 are coupled as described in detail with reference to FIGS. 5A-5B . A floating router 136 is also shown in the figure. Flow router 136 is a connector unit between the dual lumen cannula and the extracorporeal machine, and is configured and operable to establish blood flow in opposite directions between the inner and outer lumens. Connector units 131 , 132 and 136 together constitute connector assembly 130 . Also shown in the figure is a tube connector platform 50 having the same role as described with reference to FIG. 1A above.

FIG. 2B shows the overlapping region at the distal end of the inner infusion cannula 127 and the outer outlet cannula 106 extending from the tip of the distal portion of the outer cannula 106 of the double lumen cannula of FIG. 2A. It is a schematic isometric enlarged view of As shown in this figure, the distal tip of the outer cannula 106 is narrow in another area about the diameter of the outer lumen dimension. This narrow area 111 at the distal end of the outer cannula 106 forces centralization of the inner cannula 127 as the inner cannula passes it towards a target area within the patient's body. The inner cannula 127 is preferably longer than the outer cannula 106 in such a way as to allow the infusion of treated blood through the infusion opening 122 away from the blood expelled through the drain opening 112 . The distance that the inner cannula 127 extends beyond the outer cannula 106 is preferably a fixed length. Also shown in this figure are calibration marks 190 on both the outer cannula 106 and the inner cannula 127. Calibration marks are only optional features, and other methods for estimating penetration length may be used. Also shown in the figure is a pressure regulation hole 128 located on the inner lumen 120 .

3A-3B are schematic plan and isometric views of the outlet outer lumen 110 of the dual lumen cannula 200 of FIG. 2A in accordance with some optional embodiments of the present invention. The outer lumen 110 includes at least one cannula 106 having a fixed diameter greater than the diameter of the inner lumen 120 thereby permitting insertion of the inner lumen 120 therethrough. The cannula 106 has a narrow area 111 at its distal end for centralizing the position of the inner lumen primarily towards the target area, and at least one exit opening 112. Optionally, the cannula 106 includes calibration marks thereon, which may be further marked with numbers to indicate the length of penetration of the outer lumen 110 into the body of the patient. Cannula 106 has at its proximal end at least two protruding elements 1312 configured to be inserted into complementary niches or sockets in inner lumen connector unit 132 of inner lumen 120 in the particular example illustrated herein. It is attached to the external connector unit 131 including Other connection solutions such as luer locks, barbs, snap connections or others may alternatively be used. In some optional embodiments, the outer lumen 110 secures the outer cannula 110 to the patient's body once the cannula is intubated, ensuring minimal movement and unwanted pulling of the cannula from the patient's body. It further includes a sealing element. The fixation of the external drain cannula to the body ensures stable drainage and infusion from and back to the patient's body prior to insertion of the internal cannula therethrough.

4A-4B are schematic isometric rear and isometric side views of the injection inner lumen 120 of the dual lumen cannula 200 of FIG. 2A in accordance with an alternative embodiment of the present invention. In these figures, inner lumen connector unit 132 and flow router 136 are attached to each other and connected as one piece to the proximal end of cannula 127 . Cannula 127 has a smaller diameter than cannula 106 that functionally permits insertion through cannula 106 and a greater length permitting extension beyond cannula 106 to the target area. The cannula 127 includes at least one injection opening 122 at its distal end to allow the return of treated blood from the extracorporeal machine to the patient's vascular system. Cannula 127 further includes a pressure regulation hole 128 formed along the circumference of the inner lumen. The pressure regulating hole 128 is positioned at a location along the cannula 127 such that the pressure regulating hole 128 is covered by the outer lumen 110 when the inner lumen 120 is inserted into the outer lumen 110 . The pressure regulation hole 128 serves to alleviate high pressure conditions within the injection lumen that can lead to cavitation. Cavitation is a phenomenon in which rapid changes in pressure in a liquid lead to the formation of small vapor-filled cavities at relatively low pressures. Cavitation within blood vessels can lead to the formation of liquid jets, potentially leading to vessel rupture. The dimensions of the hole 128 are determined such that when the pressure within the inner lumen 120 increases above a predetermined level, blood passes through the pressure regulating hole 128 from the inner lumen to the outer lumen, bypassing the patient vascular system. do. In such a situation, blood flows into the hole 128 based on the principles of fluid dynamics where liquid always follows the path of least resistance. Blood continues to flow through the hole 128 until the pressure within the infusion lumen 120 decreases, to the point where the infusion lumen 120 again becomes the path of least resistance.

Also shown are tube connector platforms 50 and 50' that allow connecting inner lumens and outer lumen extensions to tubes for transporting expelled blood to the machine and from the machine back to the patient's blood vessels. is shown in Inner lumen 120 may further include a priming cap (not shown) at its distal end. The priming cap is removable and can be connected to a priming system for priming the inner lumen 120 . For example, the priming cap can be connected to a source of saline and removed after priming is complete.

Proximate to the priming cap, inner lumen 120 includes an injection opening 122 for fluid connection to the patient's vascular system. These openings form gateways for processed blood to flow back into the cardiovascular system. Also shown in these figures are calibration marks 190 and tube connector platforms 50 and 50' for transporting blood to and from the medical machine.

5A is a schematic exploded view of the dual lumen cannula 200 of FIG. 2 showing the major components of the device.

As shown in this figure, the dual lumen cannula 200 comprises three main functional components: an outer lumen 110, an inner lumen 120 and its proximal end tube connection platforms 50 and 50'. Consisting of a flow router 136, enabling the transport of blood to and from the medical machine.

In some preferred embodiments of the present invention, flow router 136 is an integral part of inner lumen connector unit 132, both connected as one unit to the outer end of the lumen to create inner lumen 120. . As shown in this figure, the inner lumen is through the outer lumen 110 pre-intubated into the body of the patient as a single lumen cannula, with the inner lumen connector unit 132 and optionally with the connector unit 136. Designed to be screwed in. Also shown in this figure is a connector unit with a connecting element between the three connector units. These components are described in detail below. However, the connection element described herein should be construed as one non-limiting implementation of the present invention as it is an alternative embodiment in which other connection means may also be implemented to connect between the connector assembly units of the present invention. The following elements are also shown in this figure.

For external lumen cannula 110: external connector unit 131, protruding element 1312, cannula 106, calibration mark 190, discharge opening 112, narrow area of external cannula 111 , and a butterfly with a sealing hole (116).

For inner lumen cannula 120: inner lumen connector unit 132, cannula 127, calibration mark 190, injection aperture 122, pressure regulation hole 128, vertical separation wall 1324, and chamber 1326.

For flow router 136: chamber 110', cannula 127. Also shown are the tubes 50 and 50' connected to the openings of the flow router 136, but not part thereof.

Detailed descriptions of all components and their functional roles are described below.

5B-5C are schematic posterior and anterior isometric partial views of the junction region between the inner lumen 120 and the outer lumen 110 of the dual lumen cannula 200 of FIG. 2A according to some optional embodiments of the present invention. am. In this figure, cannula 127 is connected to inner lumen connector unit 132 at its proximal end, and protruding element 1312 of outer connector unit 131 receives cannula 127 and at its distal end The external connector unit through its distal end in such a way as to functionally create a mechanical support for centralizing the positioning of the cannula 127 within the external cannula 106 at its proximal end in addition to the narrow structure of the cannula 106. is inserted into the proximal end of (131). The protruding element 1312 is then inserted into the interior space of the inner lumen connector unit 132 . In some optional embodiments of the invention, cannula 127 extends into inner lumen connector unit 132 until reaching the proximal end. In this scenario, cannula 127 is connected to the outer periphery of inner lumen connector unit 132 by at least one vertical separating wall (septum) 1324 . In the particular example shown in this figure, the inner lumen connector unit 132 includes four separating walls 1324, and the expelled blood from the patient's vascular system passes through the outer lumen 110 to and from the separating walls 1324. It flows into the chamber 1326 created between the cannula 127, while the infused blood flows back to the body through the lumen (opening) 1270 of the cannula 127. In addition, for safe use of the double lumen cannula 200 of the present invention, a suture hole 116 (also referred to as a "suture element") used to secure the external cannula 110 to the patient's skin with standard sutures is provided. Butterflies with are also shown in these figures. As noted above, other fastening means such as rubber bands, external securing devices, etc. may additionally or alternatively be used. In some other alternative embodiments of the present invention, inner cannula 127 is such that the distal end of inner lumen connector unit 132 and a central hollow tube-like structure within connector unit 132 are extensions of inner cannula 127. It functions as a part and extends only until it replaces it.

6A-6B are schematic plan views and cross-sectional partial views of the connection regions of the inner lumen cannula 120 and the outer lumen cannula 110 of the double lumen cannula 200 of FIG. 2A. The external connector unit 131 is attached to the cannula 106 at its distal end and to the suture element 116 at its bottom side. The outer connector unit 131 is ready to be inserted into a complementary space within the inner lumen connector unit 132 and has a protruding element 1312 on its proximal side that receives the cannula 127 of the inner lumen cannula 120. have A floating router connector 136 is also shown in these figures while attached to the inner lumen connector unit 132 . As mentioned above, the flow router 136 should be considered as the third connector unit of the connector assembly of the present invention, and may be a separate unit of the inner lumen connector unit 132 or an integral unit. In scenarios where the flow router 136 is a separate, independent unit, it may be assembled with the inner lumen connector unit 132 by any suitable connecting means known in the art. For example, an operator can snap them together, lock them by a luer lock, or fasten one to the other using, for example, a fastening ring or the like. Infused blood and expelled blood are transported from the machine to the patient's body and back by tubes (not shown) connected to tube connector platforms 50, 50' extending from the flow router 136 towards the extracorporeal machine. do.

In the cross-sectional view, the opposite flow directions of expelled blood and infused blood in the inner infusion cannula 120 and the outer outlet cannula 110 are shown. For simplicity of explanation, connector unit 131 of the outer lumen cannula and connector unit 132 of the inner lumen cannula are separated to clearly show the parts involved in connection. Blood flow starts only when the two cannulas are joined. Cannula 106 receiving cannula 127 is shown in this section. Blood flow in both lumens as well as in the connector units 131 and 132 is in the opposite direction to the parallel lumens as indicated by the arrows along the cannula. The flow router 136 collects all the drained blood that flows together within the chamber 1326 into a single tube that is connected to the tube connector platform 50 to transport the blood into an extracorporeal machine for treatment. In the same way but in the opposite direction, the processed blood from the extracorporeal machine is connected to the tube connector platform 50' to transport the processed blood through the flow router 136 into the cannula 127 towards the patient's body. It is injected back into the treated patient's vascular system via a tube.

6C-6D are schematic isometric and cross-sectional views of the inner lumen connector unit 132 and flow router 136 of the dual lumen cannula 200 of FIG. 2A in accordance with some optional embodiments of the present invention. The flow router 136 collects the blood drained from the outer tube 110 through the different chambers 1326 of the inner lumen connector unit 132 into a single tube connected to the tube connector platform 50 that transports it to the extracorporeal machine. In addition, the flow router 136 transfers blood flowing from the extracorporeal machine to the tube connector platform 50' in such a way that blood flowing in two separate adjacent tubes is converted to flow in two lumens inserted into different tubes. Route through connected tubes.

In an isometric view ( FIG. 6C ), inner lumen connector unit 132 and flow router 136 are coupled together, and tube connector platforms 50 and 50 ′ are shown partially at the proximal end of flow router 136 . The isometric view shows the cannula 127 and lumen 1270 shown at the distal end of the inner lumen connector unit 132, the outer connector unit having the separating wall 1324, the chamber 1326, and the protruding element 1312 ( 131) further shows the region 131' connected thereto. The cross-sectional view ( FIG. 6C ) shows the treated blood flow within the cannula 127 from the tube connected to the tube connector platform 50' to the patient's vascular system. In the opposite direction, the expelled blood flowing out of the body through the outer lumen 110 flows through the outer lumen 110 to transport the expelled blood from the body to the extracorporeal machine via a tube configured to be connected to the tube connector platform 50. It enters the chamber 1326 of the inner lumen connector unit 132, which functions functionally as an extension. Blood from chamber 1326 is preferably collected within flow router 136 into a single chamber 110' connected to a tube connector platform 50 that transports the blood drained at its proximal end to a tube connected to an extracorporeal machine. .

Extracorporeal machines that may be implemented with the dual lumen cannulas 100 and 200 of the present invention are preferably extracorporeal oxygenation systems and dialysis systems.

6E-6F are schematic diagrams of the flow router 136 of the dual lumen cannula 200 and the inner lumen connector unit 132 of the inner lumen cannula 120 of FIG. 2A according to some alternative embodiments of the present invention. An isometric front view and an isometric rear view. In the isometric front view ( FIG. 6E ), the four chambers 1326 created at the interface of the separating wall 1324 and the cannula 127 are clearly visible. Blood expelled from the patient's body is transported through these chambers to the extracorporeal machine, while return blood that is about to be infused back into the patient's vascular system reaches the infusion opening 122 and cannula 127 until it is infused back into the body. ) flows within the lumen 1270. An isometric rear view ( FIG. 6F ) shows a tube connector platform (which transports blood expelled from the body through the outlet opening 112 of the outer lumen and through the cannula 106 to the chamber 1326 of the inner lumen connector unit 132). 50, 50'), which are all collected into a single chamber 110' of the flow router 136 and connected to a tube (not shown) connected to a tube connector platform 50. transported into the machine outside the body. Also shown in the rear view is the entry point for processed blood from the extracorporeal machine through a tube (not shown) connected to the tube connector platform 50' from the proximal end of the flow router 136 through the inner lumen connector unit 132. With the cannula 127 extending, and also into the cannula 106 through the external connector unit 131 until it extends from the distal end to the target area. In practice, the cannula 127 in this alternative implementation of the invention passes through the entire unit of the connector assembly 130 until the target area is reached and blood is injected through the infusion aperture 122, the cannula ( 106) pass. However, in some alternative embodiments, the inner cannula 127 may extend to the distal end of the connector unit 132 and from that point to the tubes connected to the tube connector platform 50', and the processed blood may flow through them. It flows through dedicated chambers in flow router 136 and connector unit 132 until it reaches internal cannula 127 .

6G is a schematic isometric view of the flow router 136 of FIG. 2A in a position simulating the position of the unit while the dual lumen cannula is in use and connected to the patient's body, the housing of the flow router 136 of the present invention. Transparently depicts internal components according to some optional embodiments of. In this view, the tube connector platforms 50 and 50' are positioned upwards. As described above, in one alternative embodiment, the tube connector platform 50' is connected at one end to the cannula 127 and a tube (not shown) carrying blood from the extracorporeal machine into the patient's body; The tube connector platform 50 is connected to the chamber 110' at one end and to a tube (not shown) at the other end that transports blood drawn from the body to the extracorporeal machine. Also shown are the flow router 136 and internal components of the flow router 136, including these location connection areas 1328 of the inner lumen connector unit 132 and the cannula 127 and chamber 110'. .

In typical implementations of the dual lumen cannulas 100 and 200 provided herein, the inner lumen is an infusion lumen for delivering treated blood back into the patient's vascular system and the outer lumen is for removing untreated blood from the vascular system. is the discharge lumen for However, in some other alternative implementations of the invention, the outer lumen may be used to return blood into the body while the inner lumen is used to expel blood from the body. Also, the inner lumen 120 has a longer extension than the outer lumen 110 . The advantage that the inner lumen is longer than the outer lumen and the inner lumen is the infusion lumen is that the processed blood is deposited into the vascular system downstream of the outlet lumen. This orientation reduces the likelihood of cyclic flow of the treated blood from the infusion lumen 120 to the outlet lumen 110 and back into the blood treatment system.

In an illustrative, non-limiting example, internal lumen 120 is sized to a length and diameter sufficient for insertion into a femoral vein and/or through a major vein superior to the heart and into the superior vena cava. Major veins include, but are not limited to, the left and right internal jugular veins, the left and right external jugular veins, and the left and right brachiocephalic veins. The dimensions of the inner and outer lumen may be governed by considerations such as the size of the patient and the desired volume and flow rate of blood through the lumen. In an exemplary embodiment, the inner lumen 120 has a length of 10 to 40 mm and a diameter of 5 to 16 Fr, and the outer lumen 110 has a length of 10 to 40 mm and a diameter of 10 to 24 Fr.

The connection between the inner lumen and the outer lumen may be reversible and they may be disconnected. Upon insertion of the inner lumen into the outer lumen, the position of one lumen relative to the other lumen is fixed and predetermined by a connector unit connected to each cannula.

The connector assembly 130 is shown schematically, wherein the connector assembly and each of its units and the connections between them are converted from inner and outer tubes to side by side tubing so long as their functionality remains the same. It is clear to those skilled in the art that it may take any other form suitable for the following.

Drainage lumen 110 includes an opening 112 for drawing blood from the patient's vascular system. The opening 112 is a suction hole, and blood is sucked through it by the force of a pump that is part of an extracorporeal blood treatment machine. Aperture 112 is preferably located at the distal end of drainage lumen 110 . In some embodiments, aperture 112 is located and sized to the side of the distal end of drainage lumen 110 to prevent blocking of blood drainage during aspiration. Blockage may occur by coagulation or venous attachment to the drainage lumen by suction forces.

Introduction of the dual lumen cannula 100, 200 of the present invention into a patient's vascular system proceeds as follows. First, the outer lumen 110 is inserted into the patient's vascular system. The outer lumen may be sutured to the subject's skin by stitching standard sutures through the butterfly 116. Typically, the outer lumen is inserted through the use of an introducer, and optionally a guide wire, and drawn through the outer lumen 110 to its distal end according to conventional practice (Seidinger technique). As a result, there is no need to prepare the external lumen cannula prior to insertion since the presence of the introducer prevents the formation of air bubbles. When the introducer and guide wire are withdrawn, the withdrawal causes a small vacuum to form within the outer lumen 110, which in turn fills with blood.

Next, the inner injection lumen 120 is preferably pre-primed through the use of a priming cap (not shown) that can be connected to a priming system. The priming system may be a stand-alone system or may be integrated with a blood extracorporeal machine. After priming is complete, the priming cap is removed.

The inner lumen 120 is then inserted into the outer lumen 110 through the outer lumen connector unit 108 or 131 . The inner lumen 120 is advanced to protrude through the outer lumen 110 until the connector of each lumen is engaged. The inner lumen 120 is secured to the outer lumen 110 when the connector assembly unit is connected. Once the two lumens are connected, they function as a single double lumen cannula (100, 200).

Insertion of the inner lumen is performed with minimal strain on the patient. Additionally, since the inner lumen 120 is already fully primed prior to connection, there is no need to prime the open connection port during the connection process as with other dual lumen cannulas known in the art. Thus, the cannula injection process for the dual lumen cannula of the present invention is significantly easier and safer than the cannula of other dual lumen cannulas available on the market.

In particular, the described method relates to an alternative dual lumen cannula system in which two lumens are inserted as their separate single units and advanced to a desired location within the body while connected to each other, before the inner lumen is further advanced relative to the outer lumen. particularly advantageous compared to Simultaneous movement of the inner and outer lumens may result in higher forces being applied to the vessel and correspondingly require greater technical skill to do so without harming the patient. In contrast, when the outer lumen 110 is sealed in place prior to insertion of the inner lumen 120, it is only necessary to advance the inner lumen 120 relative to the outer lumen 110. Additionally, inserting the inner lumen separate from the outer lumen allows for pre-priming of the inner lumen prior to connection. After placement of the inner lumen cannula within the outer lumen cannula, fluid tight connections may be made.

In some alternative embodiments, the inner diameter of outer cannula 106 at the distal end is sized to be only slightly wider than the outer diameter of inner cannula 127 . This sizing allows free sliding of the inner cannula 127 through the narrow area 111, while also resulting from the flow of blood through the area 111 instead of continuing through the outer cannula 127. Minimize inefficiencies.

In the described embodiment, the proximal point of connection between the inner lumen 120 and the outer lumen 110 is fixed. Thus, the inner lumen 120 always extends a specified distance beyond the outer lumen 110 .

Preferably, the double lumen cannula is designed so that after processed blood enters the body through the infusion lumen, it circulates through the entire blood flow before the blood is removed through the outlet lumen.

It should be clear that the description of the embodiments described herein and the accompanying drawings do not limit their scope and serve only for a better understanding of the present invention. Further, it should be apparent that a person skilled in the art, after reading this specification, may adjust or modify the accompanying drawings and the foregoing embodiments which would still be covered by the present invention.

Claims (20)

A dual lumen cannula, the cannula comprising:
at least two ends, an inner lumen proximal end and an inner lumen distal end, a hollow midrange between the two ends having one or more openings at the inner lumen distal end, and at least one inner lumen connector unit at the inner lumen proximal end. at least one inner lumen having;
a hollow intermediate range between the two ends having at least two ends, an outer lumen proximal end and an outer lumen distal end, one or more openings, the middle range further comprising one or more openings at the outer lumen distal end; and at least one outer lumen having at least one outer lumen connector unit at the outer lumen proximal end; and
at least one floating router;
the inner lumen is configured to be inserted into the outer lumen until the inner lumen connector unit makes mating contact with the outer lumen connector unit;
the flow router is connected to the inner lumen connector unit; the connection from the flow router to one or more medical devices is collinear with the inner lumen and the outer lumen;
cannula. According to claim 1,
The cannula of claim 1 , wherein the intermediate extent of the inner lumen further comprises one or more holes located between the distal end and the proximal end of the outer lumen and in a region of the inner lumen that when assembled is within the outer lumen. According to any one of claims 1 or 2,
The cannula of claim 1 , wherein the outer lumen further comprises a narrow area at its distal end for centralizing the position of the inner lumen towards a target area. 4. A cannula according to any one of claims 1 to 3, wherein the one or more apertures on the intermediate extent of the outer lumen are at least one discharge aperture. According to any one of claims 1 to 4,
wherein when the outer lumen connector unit is connected to the inner lumen connector unit, the inner lumen connector unit provides a flow path from the flow router to both the outer lumen and the inner lumen. According to any one of claims 1 to 5,
wherein said at least one flow router further comprises an inlet port (50) for connection to one or more connector tubing connected to at least one medical device. According to any one of claims 1 to 6,
The cannula of claim 1 , wherein the outer lumen further comprises at least one suture element enabling securing the outer cannula to the body of the patient once intubated. According to any one of claims 1 to 7,
wherein the inner lumen or the outer lumen further comprises one or more calibration marks (190). According to any one of claims 1 to 8,
wherein the flow router further comprises a first inner flow channel location connection region from the outer cannula through the outer lumen connector unit and then through the inner lumen connector unit to the medical device. According to any one of claims 1 to 9,
wherein the flow router further comprises a second inner flow channel from the medical device through the inner lumen connector unit to the inner lumen. The method of claim 9 or 10,
wherein the flow is reversed such that the first inner flow channel provides a flow path from the medical device through the inner lumen connector unit to the outer lumen connector unit and then to the outer lumen. According to claims 9 to 11,
wherein the flow is reversed such that the second inner flow channel provides a flow path from the inner cannula through the inner lumen connector unit to the medical device. According to any one of claims 1 to 12,
The cannula of claim 1 , wherein the outer lumen connector unit further comprises one or more barbs. According to claim 13,
wherein the outer lumen and the outer lumen connector unit are formed as a single piece. According to any one of claims 1 to 14,
The cannula of claim 1 , wherein the inner lumen connector unit further comprises one or more flexible connectors for connecting to and sealing one or more barbs from the outer lumen connector unit. According to any one of claims 1 to 14,
The inner lumen connector unit further includes vertical separating walls and chambers for creating a separate flow channel through the one or more lumen openings to the inner lumen and a separate flow channel to the outer lumen through the outer lumen connector unit. Do, Cannula. A process for introducing a cannula into a patient's vascular system, the process comprising:
inserting a first external lumen cannula into the patient's vascular system through use of an introducer drawn through the external lumen to its distal end, and optionally a guide wire;
withdrawing the introducer and guide wire, allowing a small vacuum to be created in the outer lumen filled with visible blood;
priming the second inner lumen cannula through use of a priming cap connected to a priming system, after completion of the priming, the priming cap is removed; and
inserting the second inner lumen cannula into the first outer lumen cannula until the inner lumen connector unit engages the outer lumen connector unit.
process. According to claim 17,
wherein the first external lumen cannula is sutured to the skin of the patient by stitching standard sutures through a butterfly. According to any one of claims 17 or 18,
wherein one or more flow routers are connected to the inner lumen connector unit. According to claim 19,
The process of connecting the one or more medical devices to the floating router.

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