阅读说明：本技术 主动脉移植物封堵器 (Aortic graft occluder ) 是由 C·丁格斯 J·菲尔贝克 于 2018-05-07 设计创作，主要内容包括：本发明涉及一种用于对附接到主动脉根部的管状主动脉移植物进行术中泄漏测试的主动脉移植物封堵器,该主动脉移植物封堵器包括适于密封地闭合主动脉移植物的开口的插塞,其中该插塞包括适于将主动脉移植物的内腔与供给管线连接的第一路径。(The present invention relates to an aortic graft occluder for performing an intra-operative leak test of a tubular aortic graft attached to the aortic root, comprising a plug adapted to sealingly close an opening of the aortic graft, wherein the plug comprises a first path adapted to connect the lumen of the aortic graft with a supply line.)

1. Aortic graft occluder (2) for intra-operative leak testing of a tubular aortic graft (28) attached to the aortic root, the aortic graft occluder (2) comprising a plug (4) adapted to sealingly close the opening of the aortic graft (28), wherein the plug (4) comprises a first path (16) adapted to connect the lumen (31) of the aortic graft (28) with a supply line.

2. The aortic graft occluder (2) of claim 1, wherein the first pathway (16) extends to a standardized connector (10a) adapted to sealingly connect with the supply line, the standardized connector (10a) preferably being a luer-type connector, more preferably a luer-lock connector.

3. The aortic graft occluder (2) of any preceding claim further comprising a second path (18), the second path (18) serving as an outlet.

4. The aortic graft occluder (2) of claim 3, wherein the second path (18) extends to a standardized connector (10b), the standardized connector (10b) preferably being a luer type connector, more preferably a luer lock connector.

5. The aortic graft occluder (2) of any preceding claim wherein the plug is adapted to be at least partially inserted into and connected to the lumen (31) of the graft (28) and wherein the plug (4) optionally comprises a sealing section (34), preferably comprising a sealing ring (35), more preferably an O-ring seal, for forming a seal between the plug and the graft, preferably between the outer circumference of the plug and the inner surface of the graft.

6. The aortic graft occluder (2) of claim 5, wherein the plug (4) comprises an external thread (6) adapted to be screwed into the opening of the graft (28).

7. The aortic graft occluder (2) of any preceding claim, wherein the aortic graft occluder (2) comprises an extension (8) extending from the plug (4), wherein the pathway (16, 18) extends through the extension (8), the extension (8) being configured to be at least partially retained outside of a lumen (31) of the aortic graft (28).

8. The aortic graft occluder (2) of any preceding claim further comprising a locking means (12) adapted to press a portion of the graft (28) against the plug (4).

9. The aortic graft occluder (2) of claim 8 wherein the extension (8) comprises external threads (20) and the locking device (12) comprises internal threads (22) that mate with the external threads (20) of the extension (8), the locking device (12) being configured to be driven along the external threads (20) to press at least a portion of the graft (28) against the plug (4) and the sealing section (34).

10. The aortic graft occluder (2) of claim 9, wherein the locking means (12) comprises an internal tapered section (26) for pressing at least a portion of the graft (28) against the plug (4) and the sealing section (34).

11. The aortic graft occluder (2) of claim 9 or 10, wherein the locking means (12) is fixed to the aortic graft occluder (2) to form a functional unit for use, wherein the locking means (12) is removable from the plug (4) and the extension (8).

12. The aortic graft occluder (2) of claim 8, wherein the plug (4) comprises a recess (36) adapted to receive the portion of the aortic graft (28), wherein the locking means (12) is adapted to press the portion of the aortic graft (28) into the recess (36), and wherein the locking means (12) is preferably a rope, wire and/or sling (38).

13. The aortic graft occluder (2) of any preceding claim, wherein the aortic graft occluder (2) comprises a biocompatible material, preferably an alloy comprising titanium or stainless steel, more preferably a biocompatible synthetic material, more preferably one or a combination of PPS, PS, POM, PEEK.

14. The aortic graft occluder (2) of any preceding claim, wherein the aortic graft occluder (2) is configured to provide a liquid-tight connection between the graft (28) and the supply line at an intraluminal pressure of at least 70mmHg, preferably at least 80mmHg, more preferably at least 90mmHg, more preferably at least 100mmHg, more preferably at least 150mmHg, more preferably at least 200mmHg, most preferably at least 250 mmHg.

15. The aortic graft occluder (2) of any preceding claim wherein the plug (4) comprises a third path adapted to serve as a sealable inlet for a medical device, preferably a probe and/or a catheter.

16. The aortic graft occluder (2) of any preceding claim wherein the intraoperative leak test of the tubular aortic graft (28) comprises: (i) testing the tightness of the connection of the tubular aortic graft (28) to the aortic root, or (ii) testing the tightness of the aortic valve, or (iii) testing the tightness of the connection of the tubular aortic graft (28) to the aortic root, and testing the tightness of the aortic valve.

17. Method for leak testing a tubular aortic graft (28) having a distal end attached to the aortic root and having a free proximal end, preferably by means of an aortic graft occluder (2) according to any preceding claim, comprising the steps of:

a) sealingly attaching the aortic graft occluder (2) to a free end of the graft (28);

b) fluidly connecting a lumen (31) of the aortic graft (28) with a supply line by connecting a first pathway (16) of the aortic graft occluder (2) to the supply line, preferably via a standardized connector (10a), wherein the supply line is configured to provide fluid to the first pathway (16);

c) inserting a quantity of fluid into said lumen (31) thereby generating and maintaining an intraluminal pressure above atmospheric pressure;

d) checking whether the attachment of the distal end of the aortic graft (28) to the aortic root is leak proof by checking fluid leaking from the attachment, or checking the functionality of the aortic valve by verifying the tightness of the closed aortic valve, or checking whether the attachment of the distal end of the aortic graft (28) to the aortic root is leak proof by checking fluid leaking from the attachment and checking the functionality of the aortic valve by verifying the tightness of the closed aortic valve; and

e) removing the aortic graft occluder (2) from the graft (28).

18. Method according to claim 17 with an aortic graft occluder (2) according to any of claims 3 to 16 wherein step c) further comprises the step of sealingly closing the second path (18) and/or the third path.

19. The method of claim 18, wherein step c) further comprises the steps of: removing substantially all of a gas, preferably air, from a lumen (31) of the aortic graft (28) via the second path (18) and/or the third path prior to sealingly closing the second path (18) and/or the third path.

Technical Field

The present invention relates to devices for use in cardiac surgery, and more particularly to devices for reconstructive surgery of aortic insufficiency and/or aortic aneurysm repair.

Background

When medical diagnosis indicates that the severity of the disease is intolerable, the affected patient needs to undergo surgical correction. A preserved aortic root replacement (valve sparing root replacement) is one of several options. In this procedure, the aortic valve may be sutured into a vascular prosthesis implanted in the patient. This technique is also referred to as a re-implant technique. Alternatively, a vascular prosthesis, also referred to as a graft, is connected to a patient's blood vessel along the (aortic) valve, which is also referred to as remodeling.

During the retained aortic valve root replacement, the patient's aorta is clamped and opened. A graft having a first end and a second end is connected at its first open end to a blood vessel and/or heart of a patient. At this point of the procedure, the first end of the graft is the distal end of the graft and the second end is the proximal end of the graft. The connection may be made at the aortic root (e.g. the natural aortic root or aortic neo-root) and/or around the aortic valve, preferably using sutures. The second end of the graft is then connected to another part of the open vessel, preferably by a suture. After the patient's circulatory system is reestablished, the normal (proper) function of the valve and graft may be verified.

Throughout this application, the terms "proximal" and "distal" are used to identify a location along a device and/or pathway from the perspective of a user performing a procedure and/or using an embodiment of the present invention for other purposes. That is, the near-side object is closer to the user than the far-side object. This may be different from other publications involving blood vessels, in which the terms "proximal" and "distal" refer to positions relative to the heart.

The retained aortic valve root replacement technique is constantly being changed and improved. However, these techniques still lack the possibility to verify the correct fit and function of the heart valve (membrane) and the tightness (leak tightness) of the suture(s) of the graft with respect to the vessel(s). With currently established techniques, the medical personnel must re-establish the circulatory system before the medical personnel can actually verify that the procedure was successful, i.e., that the valve is working properly and/or that all connections at the suture site are leak-proof. Thus, if a leak occurs and/or the aortic valve fails to function properly, another surgical correction must be performed. This typically includes clamping one or more affected vessels, modifying one or more sutures connecting the aortic graft to the one or more vessels, altering or replacing the aortic valve, re-establishing the patient's circulatory system, and/or verifying that the procedure was successful. This obviously puts stress on the patient and may cause injury to the patient and add other risks to the surgical procedure.

Disclosure of Invention

The present invention is directed to overcoming these risks and problems. The invention is defined by the features of the claims.

The invention relates to an aortic graft occluder (aortic graft occluder). The aortic graft occluder may be a simple yet effective device, for example for use in retained aortic valve root replacement. The aortic graft occluder may also be used in other surgical techniques, such as abdominal aortic surgery. The aortic graft occluder may be used for intra-operative leak testing of partially implanted tubular aortic grafts, for example during retained aortic valve root replacement. The intraoperative leak test may include verifying the functionality of the heart valve, particularly its closing (closing) efficiency, and the sealing of one or more sutures of the graft to one or more blood vessels. Thus, the terms "sealing (leak)", "leak tightness", "leak testing (leak testing)" and the like relate to (i) the tightness of the system at least at the site of connection (suturing) of the aortic graft to the patient's body, or (ii) at the aortic valve (i.e. the tightness of the closed valve), or (iii) both.

The aortic graft occluder is used with a corresponding graft having a first end (distal end) and a second end (proximal end) and a lumen connecting the first and second ends. Preferably, the first end includes an opening and the second end includes an opening. Prior to connecting the proximal end of the graft to the patient's blood vessel, the aortic graft occluder is used to sealingly close the partially implanted aortic graft at its unattached proximal end, while the distal end of the graft has been connected to the patient's blood vessel/or heart. At the same time, the aortic graft occluder provides access to the graft lumen. Through this passage (access), the lumen of the graft may be filled with fluid, i.e., gas and/or liquid (e.g., saline). By filling the lumen of the graft with fluid and preferably thereby pressurizing the interior of the graft, the tightness of the graft can be verified, particularly at its attachment site where it is typically sutured to tissue. Additionally or alternatively, the aortic graft occluder may be used to pressurize the interior of the graft and simulate the diastolic pressure on the aortic valve. Proper function (e.g., closure efficiency) of the valve can be verified during the procedure by simultaneously imaging the valve, e.g., by ultrasound, e.g., by applying transesophageal ultrasound techniques.

The aortic graft occluder may include a plug that may be configured to sealingly close an opening of a proximal end of the aortic graft. Any implant suitable for use in the above procedure is contemplated. Common aortic grafts have nominal (nominal) diameters of 26mm, 28mm, 30mm or 32 mm. The size (particularly the diameter) of the aortic graft occluder may be compatible with any of these diameters. For example, the diameter of the plug may correspond to a nominal graft diameter of 26mm, 28mm, 30mm, and/or 32 mm. However, there is no limitation on the diameter of currently common grafts. The size (particularly the diameter) of the aortic graft occluder may correspond to any desired diameter within the limits set by anatomical limitations. In particular, the aortic graft occluder may be adapted for grafts having a diameter of 8mm to 45 mm.

The plug may include a first path. The plug having the first pathway is designed such that when the plug is properly attached to the proximal opening of the aortic graft, the first pathway is in fluid communication with the lumen of the aortic graft. The first pathway may be adapted to fluidly connect to the lumen at a distal end of the pathway. Thus, when the aortic graft occluder is properly installed, the first path provides access to the graft lumen through the plug, which otherwise seals the graft lumen from the exterior of the graft. The first path may be further adapted to be connected to a supply line. The connection of the first pathway to the supply line may be at a second end (proximal end) of the first pathway.

Via the supply line, a fluid may be provided for insertion into the interior (i.e., lumen) of the graft. Preferably, blood and/or physiological saline solution is used as the fluid. The fluid may be colored and/or include additives having a color that is distinguishable from the body and/or body composition of the patient. This may help the user identify a leak because colored fluids leaking from the graft may be more easily identified than blood or colorless fluids leaking from the graft. For example, the fluid may comprise methylene blue.

Preferably, the first path extends to a first connector, preferably a standardized connector, which is adapted to sealingly connect with the supply line. The supply line may comprise a corresponding connector. The first standardized connector may be a Luer (Luer) type connector, preferably a Luer lock connector or a Luer slip type connector. Additionally or alternatively, the first connector may be any connector enabling sealed transfer of fluids in the range of just above 0 bar to 0.6 bar.

The aortic graft occluder may include a second pathway. Thus, when the aortic graft occluder is properly installed, the second path provides access to the graft lumen through the plug, which otherwise seals the graft lumen from the exterior of the graft, in addition to the first path. The first end of the second pathway is adapted to be in fluid communication with the lumen of the aortic graft, preferably at the distal end of the second pathway, when properly attached to the aortic graft. The second pathway may extend to a second connector, preferably a standardized connector, preferably located at a second end (proximal end) of the second pathway. The standardized connector of the second path may be a luer type connector, preferably a luer lock connector or a luer slip type connector. Additionally or alternatively, the connector of the second path may also be any connector enabling a sealed transfer of fluid in the range of just above 0 bar to 0.6 bar. The second connector may be of the same type as the first connector. Alternatively, the first connector and the second connector may be different from each other. Generally, any connector type may be used with the first path and the second path. If the aortic graft occluder includes more than one connector, the connectors may include differentiating indicia (e.g., color codes, tactile codes, and/or symbol codes) that may help differentiate the connectors and thus may facilitate the connection process.

By connecting the inner lumen of the graft with the exterior of the graft, the second pathway can serve as an outlet for any fluid, i.e., gas (e.g., air) and/or liquid, within the inner lumen of the graft. Thus, when the lumen of the graft is filled by introducing (inserting) a fluid (e.g., a physiological saline solution), any fluid in the graft lumen, in particular blood, excess physiological saline solution, and/or gas (such as air) may exit the graft via the second path. Preferably, any gas (such as air) contained in the graft is removed by continuously adding fluid to the lumen of the graft through the first pass, the added fluid eventually replacing the gas in the lumen. The gas in the inner cavity may exit the inner cavity via the outlet, i.e. the second path. To assist the gas to leave the lumen, it is preferred that the aortic graft occluder and its second path are located at the highest point of the graft-aortic graft occluder combination. Substantially complete removal of gas, such as air, from the graft is advantageous for leak testing, since substantially only incompressible fluids are used to work, ensuring physical confinement during pressurization of the lumen in question. Moreover, this is also beneficial for testing the functionality of the aortic valve (e.g., sealing of the closed valve), as the testing may require imaging of the aortic valve with transesophageal ultrasound. Transesophageal ultrasound techniques can also benefit from a gas-free imaging environment.

The discharge line may preferably be connected to the second path by means of a second connector and a corresponding connector of the discharge line. This may help direct waste fluid exiting the graft to a suitable location, which is preferably in a safe position relative to the patient's body. Furthermore, the risk of accidental entry of bodily fluids into the aortic graft occluder via a second path is reduced.

The flow through the second path (flow) may be regulated in any suitable manner. Preferably, a plug or cap is provided which is adapted to sealingly close the second path, thereby inhibiting any flow through the second path. For example, the cap may include threads corresponding to threads of the second pathway and/or the second connector, thereby providing a sealed connection of the cap to the second pathway. More preferably, the discharge line with the valve is sealingly connected to the second path, preferably via a second connector. The valve may be manually and/or automatically controllable to open and/or close the discharge line to open and/or close the second path. Any suitable valve is contemplated, for example, any system that securely seals the second pathway at pressures ranging from just above 0 bar to 0.6 bar, such as a one-way (1-way) stopcock and/or a two-way (2-way) stopcock, which may include a luer-type connector and/or a clip known from central venous catheters.

The plug of the aortic graft occluder may be adapted to be at least partially inserted into the lumen of the graft. The plug may be adapted to be removably, preferably tool-lessly removably, connected to the implant. The plug may comprise a sealing section adapted to provide a leak-proof connection between the plug and the graft. The sealing section is also referred to as a sealing region. Preferably, a sealing ring with a suitable cross-section, preferably a circular cross-section, is included. The sealing ring may be an O-ring seal or any other type of sealing ring. The sealing section, and preferably the sealing ring, may comprise any material that helps to seal the plug against the aortic graft. The seal ring is preferably attached to the plug in a manner that hinders tool-less removal of the seal ring from the plug. The attachment of the sealing ring to the plug may be achieved by any suitable means, for example, clamping, gluing, stapling, screwing and/or sewing and/or any combination of these.

Many aortic grafts used in the art have a threaded wall structure. The aortic graft occluder may thus comprise corresponding threads. Preferably, the threads of the aortic graft occluder are located on the plug. Corresponding threads of the graft and the aortic graft occluder can be used to connect the aortic graft occluder to the graft. Preferably, this is a sealed, i.e. leak-proof, connection.

Different types of implants may include different diameters (as described above) and/or different types of threads. It is contemplated that the diameter and threads of the aortic graft occluder correspond to the threads of the graft used in the corresponding procedure. For example, the threads of the graft may be present on the inner surface of the wall of the graft. The respective aortic graft occluder may comprise an external thread, preferably on the plug, which is adapted to be screwed into the internal thread at the proximal end of the graft. Additionally or alternatively, the wall of the graft may include threads on its exterior surface. A corresponding aortic graft occluder may comprise an internal thread adapted to be screwed onto an external thread of the proximal end of the graft. Preferably, the internal thread of the aortic graft occluder is located at the plug. The aortic graft occluder may include different types of threads. For example, the aortic graft occluder may include a first thread (external thread) having a first diameter and a second thread (external or internal thread) having a second diameter. The external and internal threads are also referred to as external and internal threads, respectively. Such a double threaded plug may be advantageous because it may be connected to different implants by having different diameters and/or different types of threads, thereby reducing the number of devices that must be available during surgery.

The aortic graft occluder may include an extension extending from the plug. The first pathway and/or the second pathway and/or any other pathway may extend through the extension. Within the extension, the first path, the second path, and/or any other path may extend separately from one another. Additionally or alternatively, each path may extend through a different extension. Preferably, the extension comprises the first connector and/or the second connector and/or any other connector, preferably at an end opposite the plug, which is preferably a proximal end of the extension. The extension may be configured to remain at least partially outside of the lumen of the aortic graft when the aortic graft occluder is attached to the graft. Preferably, at least 10mm, more preferably at least 20mm, more preferably at least 30mm, and most preferably at least 40mm of the length of the extension remains outside the lumen of the graft. However, it is also contemplated that a larger portion of the extension remains outside the lumen of the graft. This may help to improve handling of the device during surgery. For example, such a design may facilitate connection of the supply line to the aortic graft occluder during surgery.

The extension may include rigid and/or flexible regions. For example, it may comprise a flexible tube. The first and second paths may extend at least partially through the flexible tube. Preferably, the extension comprises a first flexible tube at least partially comprising the first pathway and a second flexible tube at least partially comprising the second pathway. One or more flexible regions (preferably one or more flexible tubes) may be located between the one or more connectors and the plug. Such a design increases the flexibility of the device, for example facilitating the process of connecting one or more paths to the supply and/or discharge lines during surgery. The extension may additionally or alternatively comprise a rigid region. The rigid region may extend from a plug, preferably located at a first end (preferably the distal end) of the rigid region, to one or more connectors, preferably located at a second end (preferably the proximal end) of the rigid region.

The aortic graft occluder may comprise a locking device. When the plug is at least partially inserted into the lumen of the graft, for example by screwing a threaded plug into a threaded wall of the graft, the locking means may press a portion of the graft which extends at least partially relative to the plug over a portion of the aortic graft occluder, preferably to sealingly connect the aortic graft occluder with the graft. Preferably, the locking means presses the portion of the implant at least partially against the sealing section, preferably against the sealing ring. Preferably, the portion of the graft that is at least partially pressed against the plug is a proximal portion of the graft. Preferably, this is reversible, i.e. the locking means may preferably be removed, thereby releasing the seal.

The extension may comprise an external thread and the locking means may comprise an internal thread matching the external thread of the extension. The locking device may be configured to be driven by its internal thread along the external thread of the extension. The gradual tightening of the locking means along the extension may cause at least part of the graft extending over a portion of the aortic graft, preferably the proximal portion, to be at least partially pressed against the sealing section, thereby providing a sealed (i.e. leak-proof) connection of the plug with the graft. A locking device with an internal tapered section may result in a gradual seal. The inner conical section gradually presses at least a part of the implant (preferably the proximal part) at least partially against the plug, preferably against the sealing section, when the conical locking means is driven along the outer thread of the extension. Due to the internal taper (taping) of the locking means, a gradual tightening of the locking means along the extension results in a gradual increase of the pressure exerted on the portion of the implant pressed against the plug, eventually resulting in a sealed (i.e. leak-proof) connection between the plug and the implant. The taper may have any suitable shape, and may be, for example, a straight taper, a stepped taper, and/or a curved taper.

In a preferred embodiment, the locking device may be fixed to the plug and/or extension of the aortic graft occluder to form a unit for use. However, the locking device may still be removable from the plug and/or extension, preferably without tools. For example, the locking means may have an annular shape with an internal thread. The opening in the annular locking means and the rest of the aortic graft occluder are designed such that the locking means can slide and/or slide out over the plug and/or extension of the aortic graft occluder only when the aortic graft occluder and the locking means are oriented in a certain relative orientation. In this way, the locking means may be intentionally slid over and/or removed from the aortic graft occluder, which largely prevents (or makes it almost impossible) to accidentally remove the locking means from the aortic graft occluder. This may improve the handling of the device and may provide additional safety by preventing accidental loss of the locking device during surgery, for example in a patient.

The locking device may further comprise a structured area providing sufficient gripping force to preferably the gloved fingers of the user to securely hold the locking device and securely use and install the locking device. The structured region may be located in any suitable position, depending on the exact shape of the aortic graft occluder and locking device. For example, the structured area may be located at a proximal edge of the locking device. The structured areas may comprise any kind of concavity (concavity) and convexity (convexity), such as embossing (rifflet), to provide increased friction.

In one embodiment, the aortic graft occluder may comprise a plug having a circumferential recess or groove. The plug is preferably substantially cylindrical. The length of the plug is not particularly limited, but is preferably 5mm or more, preferably 8mm or more, more preferably 12mm or more, and most preferably 15mm or more. Preferably, the recess extends on a side wall of the column, preferably substantially parallel to the shortest circumference of the column. The notches or grooves may have any suitable cross-sectional shape, preferably semi-circular, partially elliptical, V-shaped, U-shaped, partially straight, partially rectangular, partially trapezoidal, and/or partially polygonal.

The aortic graft occluder comprising a circumferential recess may be removably attached to the graft by means of a locking device. Preferably, the respective locking means comprise a ligature (ligature), a filament (filamentt), a wire (wire) and/or any suitable type of string (string). Preferably, the respective locking means is a sling (sling). The ligatures, filaments, wires and/or strings may be made of any suitable material, for example polyamide, polyester, polylactic acid (polyglycactin), polyglycolic acid (polyglycolic acid), polypropylene, ultra high molecular weight polyethylene (UHMPE). The aortic graft occluder may be configured to be inserted into a graft, comprising a recess or groove, wherein the recess extends substantially along the interior surface of the wall of the graft. The respective locking means is preferably configured to be wrapped around the outside of the graft and tightened such that the locking means presses a portion of the wall of the graft into the recess of the aortic graft occluder, thereby preferably sealingly connecting the aortic graft occluder with the graft. Thus, the recess may act as a sealing section. The locking means may comprise means for removably securing the sling in the tightened position, such as any type of stop. Additionally or alternatively, the locking device may be held in the tightened position by fastening it with one or more knots.

The aortic graft occluder may comprise one of a variety of biocompatible materials, preferably medical materials, or a combination of these materials. Preferably, the aortic graft occluder may comprise an alloy of titanium and/or stainless steel. Additionally or alternatively, the aortic graft occluder may comprise a biocompatible material, preferably a medical composition, such as polyphenylene sulfide (PPS), Polystyrene (PS), Polyoxymethylene (POM) and/or Polyetheretherketone (PEEK). The aortic graft occluder may be composed of one or a combination of these materials.

The aortic graft occluder can be configured to provide a fluid-tight connection to the graft under an intraluminal (intraluminal) pressure of at least 70mmHg, preferably at least 80mmHg, more preferably at least 90mmHg, more preferably at least 100mmHg, more preferably at least 150mmHg, more preferably at least 200mmHg, and most preferably at least 250 mmHg. The resistance of the installed system to such pressure not only enables testing of aortic valve functionality (e.g., valve closure) during surgery, but also the sealing of the graft suture. It can also be used in vitro (exvivo) applications, such as sealing tests, by providing pressure resistance in excess of physiologically reasonable pressures. However, the aortic graft occluder may alternatively comprise a predetermined breaking point which yields at a predetermined pressure of, for example, 250mmHg and preferably 200mmHg, providing an additional safety mechanism against the application of physiological critical pressure during, for example, intra-operative testing.

The aortic graft occluder may also include a third pathway. The third path may extend through the aortic graft occluder and be configured to provide access to the lumen when the aortic graft occluder is mounted on the graft. The third path may be adapted for use as an inlet for introducing a medical device (e.g., a probe, a catheter, a cannula (such as a cannula used with cardiopulmonary devices), and/or any other desired device) through an installed aortic graft occluder into an otherwise sealed graft lumen. The inlet (i.e., the third pathway) may be adapted for devices intended to be inserted through the third pathway. The third path may include a sealing mechanism relative to the exterior configured to sealingly close the third path when a device, such as a probe and/or catheter, is inserted and properly connected. For example, the third pathway and the device may include corresponding threads configured to sealingly connect the device with the third pathway. The aortic graft occluder may include a cap or cap portion that may be attached to the third pathway when no attachment device is inserted into the third pathway. A lid or cap portion is adapted to sealingly close the third path. The lid or cap portion may comprise a sealing section, for example a sealing ring, preferably an O-ring seal. Additionally or alternatively, the cap or cap portion may include threads that mate with the threads of the third path for sealingly screwing the cap or cap portion into and/or onto the third path.

In one embodiment, an echo probe for 3D imaging of the aortic root under pressure may be inserted via the third path.

Additionally or alternatively, the aortic graft occluder may have a second path that includes features described in connection with the third path.

In one embodiment of the invention, the aortic graft occluder and the graft are designed as one unit. In such embodiments, the first end of the graft is open and configured for connection to a blood vessel, and thus, the first end is the distal end of the graft. In this embodiment, for example, as described above, the proximal end of the graft is closed by the plug of the aortic graft occluder. Alternatively, the plug may be secured to the graft in any suitable manner, such as by stitching, adhesive, welding, crimping (crimp), melting, and the like. Since the aortic graft occluder is integrally formed with the graft, the graft may also have a closed end. For example, the plug may be integrally formed with the graft. After the graft is attached to the vessel, a leak test may be performed. If a leak occurs, the graft to vessel connection can be adjusted (corrected) and tested again. In the case of tightness, the proximal end of the graft including the aortic graft occluder may be cut, clamped, torn off or otherwise severed, and the resulting free end of the graft may be positioned and sutured to the appropriate site within the patient.

In embodiments of the aortic graft occluder, one or any combination of the plug, the one or more extensions and the one or more connectors may be integrally formed.

To verify the functionality of the aortic graft occluder, a test may be required in which the aortic graft occluder is attached to the graft and the seal of the attachment is tested. According to the test method, an aortic graft occluder according to the present invention is attached to one end of a graft to be used. The other end of the graft is closed with any suitable occluding device. The first path of the aortic graft occluder is connected to a fluid reservoir (fluid reservoir). The aortic graft occluder may be connected to a fluid reservoir via a supply line. However, the supply line itself may be the fluid reservoir or at least a part of the fluid reservoir. If the aortic graft occluder comprises a standardized connector, the aortic graft occluder is preferably connected to the supply line via a connector. All connections are configured to withstand the expected applied pressure. For example, luer type connectors may be used for a wide range of pressures, as is well known in the art. However, the type of connection to the fluid reservoir is not limiting. Fluid from the reservoir may then be inserted into the graft via the first path, preferably via the supply line. This may be achieved in any suitable way, for example by a manually operated pump such as a syringe (syring), an elastic tubular body and/or by an automatic pump such as a peristaltic pump or a vibrating diaphragm pump. The applied pressure resulting from the insertion of fluid into the graft is measured by a suitably mounted and suitable pressure sensor. The measurement position is not restrictive and may be chosen according to the sensors used, preferably taking into account the size and shape of the setup (setup). Preferably, pressures up to at least 70mmHg, preferably at least 80mmHg, more preferably at least 90mmHg, more preferably at least 100mmHg, more preferably at least 150mmHg, more preferably at least 200mmHg, most preferably at least 250mmHg are applied.

Although pressure may be applied and measured with gas (e.g., air) entrapped in the graft, it is preferred that any entrapped air (or any other gas) be removed from the graft prior to measuring the pressure. This may facilitate accurate pressure measurements. If there is a second pathway that serves as an exit port, the exit port is set to an open state when the graft is filled with fluid to allow entrapped gas (e.g., air) to escape through the exit port when the space in the lumen is filled with fluid. To support this gas removal process, it may be suggested to orient the setup in such a way that the second path is the aortic graft occluder and the highest point of the graft. With this orientation, the graft is substantially free of entrapped air or other gases as fluid begins to escape from the exit port. The second path (i.e., the outlet) is then sealingly closed, preferably by closing a suitable valve attached to the second path, by adding a cap or cap to the second path of the aortic graft occluder, and/or by any other means. Pressure may then be applied, for example, as described above. If the aortic graft occluder includes a third pathway, the third pathway preferably remains sealed closed throughout the procedure. The same applies to any other path that the aortic graft occluder may include.

It has been found that for embodiments of the present invention, the intraluminal pressure is equal to twice the biologically relevant pressure, e.g., at least 250mmHg, over a test period of up to 20 minutes to maintain hermeticity.

Furthermore, a method of leak testing a tubular aortic graft having a distal end attached to the aortic root and having a free end (proximal end) by means of the aortic graft occluder according to the present invention will now be described. The method may be applied between two successive steps of surgery (e.g., a retained aortic valve root replacement). The method comprises the step of sealingly attaching an aortic graft occluder to the free (proximal) end of the graft. After establishing a leak-proof connection of the aortic graft occluder with the graft, the lumen of the graft is separated from the outside of the graft, except for the path or paths provided by the aortic graft occluder (which may leak if present). The method further comprises the following steps: a step of connecting the lumen of the aortic graft with the supply line by connecting the first path of the aortic graft occluder to the supply line, preferably via a standardized connector of the aortic graft occluder and a corresponding connector of the supply line, wherein the supply line is configured to provide fluid to the first path. Preferably, the supply line is in turn connected to a fluid reservoir having a sufficient volume, e.g. an infusion bag such as a physiological saline solution. The fluid may be inserted into the lumen of the graft via a first pathway, preferably via a supply line. This may be achieved in any suitable way, for example by a manually operated pump such as a syringe, an elastic tubular body and/or by an automatic pump such as a peristaltic pump or a vibrating diaphragm pump. The intraluminal pressure thus applied to the graft is measured with a suitable pressure sensor. The measuring position is not restrictive and may be chosen according to the sensors used, preferably taking into account the size and shape of the arrangement. By continuously measuring and checking the pressure in the implant, physiologically critical pressures can be avoided. The pressure in the implant is preferably set above atmospheric pressure, preferably at least 70mmHg, preferably at least 80mmHg, more preferably at least 90mmHg, more preferably at least 100mmHg, more preferably at least 150mmHg, more preferably at least 200mmHg, most preferably at least 250mmHg, but always within the limits set by the biological system concerned.

Although pressure may be applied and measured with gas (e.g., air) entrapped in the graft, it is preferred that any entrapped gas be removed from the graft prior to measuring the pressure. This may facilitate accurate pressure measurements. If there is a second pathway that serves as an outlet, the outlet is set to an open state when the graft is filled with fluid to allow entrapped gas to escape through the outlet when the space in the lumen is filled with fluid. To support this gas removal process, it may be advantageous to orient the placement in such a way that the second path is the aortic graft occluder and the highest point of the graft. With this orientation, the graft is substantially free of entrapped gas (e.g., air) as fluid begins to escape from the exit port. The second path (i.e. the outlet) is then preferably sealingly closed, e.g. by adding a cap or cap to the second path of the aortic graft occluder and/or by any other means, e.g. by closing a suitable valve attached to the second path. Pressure may then be applied, for example, as described above. If the aortic graft occluder includes a third pathway, the third pathway preferably remains sealed closed throughout the procedure. For example, by allowing air to exit the lumen, the third path may also remain open during the gas removal process and be used to support the gas removal process. The same may apply to any other path that the aortic graft occluder may include. The method may further comprise: a step of checking the tightness of the attachment of the distal end of the aortic graft to the aortic root by checking the fluid leaking from the attachment (attachment). The leak may be identified by a fluid leak from the connection of the graft to the aortic root, preferably in a colour readily distinguishable from the human body. Additionally or alternatively, the leak testing of the aortic graft occluder may include pressurizing the interior of the graft and simulating the diastolic pressure on the aortic valve. By simultaneously imaging the valve (e.g., by ultrasound), the proper functionality of the valve (e.g., closure efficiency (tightness)) can be verified during the procedure.

Experiments with the aortic graft occluder of the present invention have shown that the use of the occluder allows effective and clinically meaningful verification of the functionality of the aortic valve. The experiment was carried out as follows:

introduction:

if the aortic valve is not fully closed, the amount of regurgitation (blood) can be easily detected by Color Doppler echocardiography. It appears as a colored jet (jet) with specific characteristics, such as size, volume, direction, origin and shape. Based on these facts, the surgeon can draw conclusions about the underlying pathology of the valve, and thus the appropriate surgical intervention.

The method comprises the following steps:

the inventors' hypothesis is that the morphology of the dynamic jet and the static jet is comparable for the same simulated pathology of the respective flap. In vitro (in vitro) experiments were performed on 15 porcine hearts using a beating heart simulator. After the anastomosis of the hypercrossed Dacron graft, the aortic valve was studied at two pressure levels (45ramHg and 60mmHg) using the aortic graft occluder of the present invention under dynamic (pulsatile) and static conditions, respectively. Different jets have been generated by modifying the natural valve. The jet is characterized using clinically relevant ultrasound imaging techniques (characterization).

As a result:

in 15 pig hearts, a total of 108 paired studies (dynamic versus static) were performed. At a root pressure of 45mmHg, the same results regarding the presence, direction and orientation of the jet were observed in 50 of 54 cases (92.6%). At a pressure of 60mmHg, 52 (96.3%) of the 54 matching pairs matched even more closely (accordance).

And (4) conclusion:

these results show that under static conditions using the aortic graft occluder of the present invention, the ultrasound image appearance of a particular valve regurgitant jet (sonographic appearance) is highly comparable to that of a beating heart.

After the leak test, the aortic graft occluder may be removed from the graft. The procedure may then continue.

Drawings

The invention will be further explained by referring to the drawings. It should be noted that the drawings are intended to illustrate certain features that may be optional to the present invention. In other embodiments, the drawings should not be construed in a limiting sense, and any features discussed with reference to the drawings may occur alone or in combination with one or more other features.

Figure 1A shows a perspective view of an embodiment of an aortic graft occluder in accordance with the present invention;

figure 1B shows another perspective view of an embodiment of the aortic graft occluder according to the present invention;

figure 2A shows a perspective view of a portion of an embodiment of an aortic graft occluder in accordance with the present invention;

figure 2B shows a side view of the portion of the aortic graft occluder of figure 2A;

figure 2C shows a top view of the portion of the aortic graft occluder of figure 2A;

figure 2D illustrates a bottom view of the portion of the aortic graft occluder of figure 2A;

figure 2E shows a cross-section of the portion of the aortic graft occluder of figures 2A-2D, as shown by line E-E in figures 2C and 2D;

figure 3A shows a perspective view of an embodiment of another part of the aortic graft occluder according to the present invention;

figure 3B shows a side view of the portion of the aortic graft occluder of figure 3A;

figure 3C shows a top view of the portion of the aortic graft occluder of figure 3A;

figure 3D illustrates a bottom view of the portion of the aortic graft occluder of figure 3A;

figure 3E shows a cross-section of the portion of the aortic graft occluder of figures 3A-3D, as shown by line E-E in figures 3C and 3D;

fig. 4A shows a perspective view of an embodiment of an implant;

figure 4B shows a perspective view of the embodiment of the aortic graft occluder of figures 1A and 1B attached to the graft of figure 4A;

FIG. 4C shows a longitudinal cross-sectional view through the device of FIG. 4B;

figure 5 shows a cross-section of a detail of another embodiment of the aortic graft occluder according to the present invention;

figure 6A shows a perspective view of another embodiment of the aortic graft occluder according to the present invention;

figure 6B shows a perspective view of another embodiment of the aortic graft occluder according to the present invention;

figure 7A shows a perspective view of another embodiment of the aortic graft occluder according to the present invention;

FIG. 7B shows a perspective view of the embodiment of FIG. 7A attached to an implant;

figure 7C shows a cross-section of a detail of the embodiment of figure 7A attached to the implant shown in figure 7B.

Detailed Description

Figure 1A shows an embodiment of an aortic graft occluder 2 according to the present invention. A perspective view of the aortic graft occluder 2 is shown from above at an angle. FIG. 1B shows a perspective view of the same embodiment from below at an angle.

As shown in fig. 1A and 1B, the aortic graft occluder 2 may include a plug 4 with external threads 6. The plug 4 may comprise an extension 8 having two standardized connectors 10a, 10b, preferably luer type connectors, more preferably luer locks. The aortic graft occluder 2 may also include a locking device 12. In the shown embodiment the locking means 12 has an annular shape and is adapted to form a functional unit with the plug 4 and its extension 8. The shown locking means 12 comprises an opening 14 adapted to the shape of the plug 4, the extension 8 and the connectors 10a, 10b, such that the locking means 12 can be slid into the shown position, e.g. by guiding (product) the locking means 12 in one specific way and/or in one or more specific orientations with respect to the plug 4, the extension 8 and/or the connectors 10a, 10 b. This ensures that the likelihood of the locking means 12 falling off the plug 4, which could lead to accidental loss of the locking means 12, is greatly reduced. As mentioned above, this may improve handling by avoiding, for example, accidental loss of the locking device 12 within the patient during a surgical procedure, which improves patient safety.

Fig. 2A, 2B, 2C and 2D show perspective, side, top and bottom views, respectively, of the plug 4 and its extension 8 and connectors 10a, 10B of fig. 1A and 1B, respectively, at an angle from above. A cross-section of the plug 4, extension 8, connectors 10a, 10b as shown by line E-E in fig. 2C and 2D is shown in fig. 2E. Figures 2A to 2E show that the aortic graft occluder 2 may have a first path 16 and a second path 18. A first path 16 extends from the first standardized connector 10a through the plug 4 and its extension 8. A second path 18 extends from the second standardized connector 10b through the plug 4 and its extension 8. In the illustrated embodiment of the aortic graft occluder 2, the first path 16 and the second path 18 are fluidly separated from each other.

Fig. 3A, 3B, 3C and 3D show perspective, side, top and bottom views, respectively, of the locking device 12 of fig. 1A and 1B, angled from above. Fig. 3E shows a cross-section of the locking device 12, as indicated by line E-E in fig. 3C and 3D. Fig. 3A to 3E show that the locking device 12 may have an annular shape. As shown, internal threads 22 may be provided in the opening 14 of the locking device 12. It may also be described that the internal thread 22 on the inner wall of the locking means 12 may correspond to the external thread 20 of the extension 8. For example, threads 20 can be seen in FIG. 2E. The locking device 12 may also include a structured area 24 that provides additional friction to the user's fingers, preferably gloved fingers. In the embodiment shown in fig. 3E, the structured area 24 is located at the proximal edge of the locking device 12 and may comprise any kind of concavity and convexity, e.g. embossing.

Fig. 3D and 3E further illustrate the tapered section 26. As can be seen in fig. 3D and 3E, the tapered section 26 may be located at the distal end of the locking device 12.

Fig. 4A shows a schematic of an exemplary graft 28 for use in a retained aortic valve root replacement. The graft 28 may include a threaded formation 30 along its entire length, for example in the form of a helical support element. Alternatively, the graft 28 may include threads 30 at the proximal end of the graft, wherein the threads 30 extend over only a portion of the graft 28.

The threaded configuration of implant 28 may be implemented on both the inner and outer surfaces of implant 28, as shown in FIG. 4A.

Figure 4B shows the embodiment of the aortic graft occluder 2 of figures 1A-3E attached to the graft 28 of figure 4A in accordance with the present invention. In figure 4B, the aortic graft occluder 2 is attached to the proximal end of the graft 28. In the case of figure 4B, the aortic graft occluder 2 has been partially driven into the graft 28. More specifically, as shown in the corresponding cross-section in fig. 4C, the plug 4 and the distal portion of the extension 8 have been driven into the lumen 31 of the graft 28. For example, a proximal portion 28p of graft 28 (also referred to as proximal graft portion 28p) encompasses at least a portion of plug 4 and optionally a distal portion of extension 8. In the situation shown in fig. 4B and 4C, the locking device 12 has been slid over the extension and driven distally along the implant 28 using the thread 22 of the locking device 12 and the thread 20 of the extension 8. Distal movement of the locking device 12 along the implant 28 causes the proximal implant portion 28p to be at least partially urged toward the longitudinal central axis 32 of the implant 28 by the tapered inner surface 26 of the locking device 12. As can be seen in fig. 2E, 3E and 4C, the plug 4 may include a sealing region 34. In the embodiment shown, the sealing area 34 may comprise a sealing ring 35, more specifically an O-ring having a circular cross-section. The sealing ring 35 may be attached to the plug 4 in a manner that hinders tool-less removal of the sealing ring 35 from the plug 4. Attachment of sealing ring 35 to plug 4 may be accomplished by any suitable means, such as clamping, bonding, stapling, screwing and/or suturing and/or any combination thereof. Fig. 4C shows that when screwed in the distal direction along the thread 20 of the extension 8, the tapered inner surface 26 of the locking means 12 presses at least a part of the proximal portion 28p of the implant 28 enclosing the plug 4 against the sealing area 34, i.e. against the sealing ring 35. Here, the pressure provided by the tapered region 26 of the locking device and the sealing region 34 of the plug 4 acting on at least a portion of the proximal graft section 28p increases as the locking device is further driven in the distal direction. It should be understood that the straight shape of the illustrated tapered region 26 is not limiting, and that any other suitable shape is contemplated, such as curved and/or stepped rather than straight tapers.

Figure 5 shows a schematic view of a detail of an embodiment of the aortic graft occluder 2. The embodiment of fig. 5 comprises a first extension 8a between the plug 4 and the first connector 10 a. This embodiment also includes a second extension 8b between the plug 4 and the second connector 10 b. Fig. 5 shows a plug 4 having portions of a first path 16 and a second path 18 extending through the plug 4 and from the plug 4 to the standardized connectors 10a, 10b through the first and second extension portions 8a, 8b, respectively. At least one, preferably both, of the first and second extensions 8a, 8b may be made of flexible tubing. The plug 4 of fig. 5 may include any of the features or any combination of features described herein for the plug. The embodiment of fig. 5 is adapted to have at least a portion of the plug 4 and optionally a portion of the first and second extensions 8a, 8b inserted into the lumen of the graft when mounted on the graft. The implant may be any other implant described herein, for example, implant 28 of any of the other figures. Preferably, when installed according to the invention, the connectors 10a, 10b and at least a portion of each extension 8a, 8b, preferably at least a 100mm long proximal portion, remain outside the implant. Thereby, the aortic graft occluder 2 according to figure 5 may provide additional flexibility, which may facilitate the connection of a supply line (not shown) and optionally a discharge line (not shown), for example to the connectors 10a, 10b, respectively.

Fig. 6A and 6B show schematic diagrams of another embodiment of the present invention. Figure 6A shows an embodiment of an aortic graft occluder 2 which is integrally formed with a graft 28 (e.g. any graft disclosed herein, such as the graft 28 of any of the other figures). More precisely, the plug 4 is formed integrally with the implant 28. That is, the aortic graft occluder 2 will not disconnect from the graft 28 without destroying at least one of the aortic graft occluder 2 and the graft 28. Preferably, the plug 4 is made of the same material as the graft 28. Alternatively, the plug 4 may comprise only some of those materials used in the graft 28. Alternatively, the plug 4 may include additional material not used to construct the graft 28. As shown in fig. 6A, the aortic graft occluder 2 may include a first extension 8a extending from the plug 4. The aortic graft occluder 2 may include a first connector 10 a. As shown in fig. 6A, the aortic graft occluder 2 may have a first extension 8a extending from the plug 4 to the first connector 10 a. The aortic graft occluder 2 may also include a second extension 8b and/or a second connector 10 b. The second extension 8b may extend between the plug 4 and the second connector 10 b. The first connector 10a and the second connector 10b may be standardized connectors, preferably luer type connectors, more preferably luer locks. The first extension portion 8a and the second extension portion 8b may be respectively made of flexible tubes. As explained previously, this may increase the flexibility of the aortic graft occluder 2, which may help facilitate the process of connecting a supply line (not shown) and/or a drain line (not shown) to the aortic graft occluder 2 via the first connector 10a and/or the second connector 10b, respectively. For the embodiment of fig. 6, the use of the aortic graft occluder 2 is slightly different from the use of the other embodiments. The embodiment of fig. 6 is preferably designed as a single use embodiment, although other embodiments may be removed from the implant after use and thus reused, for example, in other procedures. Since the graft 28 of figure 6A and the aortic graft occluder 2 are integrally formed, the graft 28 with the aortic graft occluder 2 is configured to be connected to a patient's blood vessel at the distal end of the graft 28. A leak tightness test and/or an aortic valve functionality test as described above may then be performed. After these tests, the aortic graft occluder 2 must be removed from the graft 28 in order to proceed with the subsequent steps of the procedure, that is to say in order to be able to connect the still free unbroken other end of the graft 28 to the body of the patient. To do so, the aortic graft occluder 2 must be cut, clamped and/or torn off or otherwise separated from the graft 28, for example, by using scissors, a wire cutter and/or any other suitable tool. This means that for a person selecting an aortic graft occluder 2 integrally formed with a graft 28 for surgery, the future foreshortening resulting from removing the aortic graft occluder 2 from the graft 28 must be taken into account when selecting the appropriate graft of the appropriate length for the patient.

Fig. 6B shows another embodiment according to the present invention. The schematic diagram of figure 6B shows an embodiment similar to the embodiment of figure 6A, wherein the aortic graft occluder 2 is integrally formed with a graft 28. More precisely, the plug 4 is formed integrally with the implant 28. However, in this embodiment, the first and second connectors 10a, 10b leading to the first and second paths are located directly on the plug 4, without one or more extensions between the plug 4 and the first and second connectors 10a, 10 b. Such an embodiment may be easier to manufacture. Since the graft must be cut during surgery anyway (similar to the embodiment of fig. 6B), the length of the flexible graft 28 can be selected to provide the required flexibility to easily connect, for example, supply and/or discharge lines (neither of which are shown in fig. 6B).

Figure 7A shows a schematic view of another embodiment of the aortic graft occluder 2 according to the present invention. Figure 7A shows an aortic graft occluder 2 having a plug 4 in the shape of a short cylinder. The cylindrical plug 4 comprises a circumferential recess 36 in the side wall of the short cylinder forming the plug 4. In the embodiment of fig. 7A, the recess 36 has a semi-circular cross-sectional shape. However, any other suitable shape, such as V-shaped, U-shaped, and/or partially polygonal, is contemplated. As shown in fig. 7A, the aortic graft occluder 2 may include a first extension 8a and a second extension 8 b. The first extension 8a and/or the second extension 8b may be made of flexible tubing. The first and second extensions 8a and 8b may extend to the first and second connectors 10a and 10b, respectively. Alternatively, the first connector 10a and the second connector 10b may be located directly on the plug 4 without the first extension 8a and the second extension 8 b.

Independent of the position of the first connector 10a and the second connector 10b, the use of the embodiment shown in figure 7A comprises positioning the plug 4 of the aortic graft occluder 2 within the lumen of the graft, with the recess 36 extending substantially along the inner surface of the graft. To attach the aortic graft occluder 2 to the graft, a sling may be used. Figure 7B shows the aortic graft occluder 2 of figure 7A attached to a graft 28 with a sling 38 as a locking device. The sling 38 may be made of wire, rope, filament, ligature and/or any other filamentous device, or any combination thereof.

In figure 7B, the plug 4 of the aortic graft occluder 2 has been inserted into the graft 28 and the sling 38 has been wrapped around the outer surface of the graft 28. The sling 38 has been positioned along the circumferential recess 36 of the plug 4. Thus, the notch 36 and sling 38 extend parallel along the wall of the graft 28 but on opposite sides of the wall. In order to correctly mount the aortic graft occluder 2 to the graft 28, that is, attach the aortic graft occluder 2 to the graft 28, the sling 38 has been tightened so that the sling 38 presses the graft 28 into the recess 36 (see cross-section in figure 7C). Although depicted with a slight gap between the graft 28 and the surface of the recess 36, it is contemplated that the sling 38 may press the graft against the surface of the recess so that the graft is in contact with the surface of the recess. In fig. 7B, an optional securing device 40 is used to hold the sling in a tightened position, although other mechanisms (e.g., forming a knot) are contemplated.

Any embodiment may include any of the foregoing features, alone or in any combination thereof, within the scope of the present invention unless explicitly stated otherwise.