CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Patent Application No. 62/659,400 filed April 18, 2018, the specification of which is incorporated herein in its entirety by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] The present invention relates to systems and methods for improving or assisting circulation or replacing the function of a failing heart, more particularly to an apical ring system that can temporarily assist a patient’s heart prior to implantation of a ventricular assist device (VAD).

Background Art

[0003] A ventricular assist device (VAD) is a mechanical pump that is implanted into a patient’s heart to assist the heart and further increase the amount of blood flowing through the entire body. In order to implant the VAD to the patient’s heart, a sewing ring is typically surgically attached to the patient’s heart and an opening is made inside the surgical ring, and the VAD is implanted in the opening. Typically, the VAD is implanted directly to the heart at the bottom of the left ventricle, where it draws oxygen-rich blood through the pump and pushes it into the aorta. Once blood reaches the aorta, it can flow to the rest of the body.

[0004] However, once the sewing ring is sewed onto the heart, and the incision or opening is made, the surgeon has limited time within which the VAD has to be implanted. Prior to implanting the VAD, it may be desirable to examine the patient’s heart. Thus, there is a need for an assembly that allows for inserting a cannula, for example, to assist the patient’s heart prior to implanting the VAD, which can then be removed easily in order to implant the VAD.

BRIEF SUMMARY OF THE INVENTION

[0005] The present invention discloses methods and systems for inserting and/or anchoring an instrument (e.g., a probe, a catheter, a cannula, etc.) in a patient’s heart. The methods and systems may be used prior to attaching an external device, such as a VAD, for increased assistance offered to the patient’s heart. Herein, an assembly comprising a unidirectional valve is detachably coupled to a sewing ring that is attached to the heart. In certain embodiments, by coupling the device to the sewing ring, the surgeon may have additional time to insert the instrument through the valve and examine the patient’s heart and/or assist the heart with the cannula before implanting the VAD into the heart. The present invention is not limited to use with VAD surgery.

[0006] In some embodiments, the present invention discloses a device assembly detachably coupled to a sewing ring prior to surgically opening a patient’s heart, wherein the sewing ring is surgically attached to the patient’s heart. As will be disclosed herein, the assembly may include an upper ring having a first opening, the upper ring configured to hold an instrument within the first opening and a lower ring having a second opening, the lower ring interchangeably coupled to the upper ring such that the second opening is aligned with the first opening of the upper ring. The assembly may additionally include a sealable valve positioned between the upper ring and the lower ring, wherein when the lower ring is coupled to the upper ring, the valve is pinched in between the lower ring and the upper ring forming a tight seal between the upper ring and the lower ring, wherein the valve comprises a point-of-failure at a central point of the valve.

[0007] In some embodiments, when the instrument is inserted into the first opening towards the second opening, the instrument causes the point-of-failure at the central point to fail, thereby creating an opening in the valve through which the instrument is inserted through the second opening of the lower ring into the patient’s heart, wherein the opening in the valve creates a hermetic seal around the instrument, thereby reducing blood leakage around the assembly and the sewing ring. In some embodiments, the upper ring may include an extendable armature pivotably coupled to the upper ring, wherein the extendable armature is configured to lock the instrument in the assembly while examining the patient’s heart.

[0008] In some embodiments, the valve may be unidirectional configured to allow access for the instrument to form the opening, but not allowing blood to flow out through the opening, and wherein the valve may be composed of a polymer material of varying thickness, the polymer material being thinner at the central point compared to edge of the polymer material.

[0009] In some embodiments, the lower ring may be selected based on a shape and type of the sewing ring, and wherein the lower ring comprises an O-ring that forms a tight seal with the sewing ring. In some embodiments, the instrument may comprise a cannula.

[0010] In some embodiments the instrument may comprise a catheter, a probe, a cannula, etc. In some embodiments, after completing an examination of the patient’s heart with the instrument, the assembly is detached from the sewing ring by detaching the lower ring from the sewing ring, thereby allowing for an external device to be coupled to the sewing ring. In some embodiments, the external device may comprise a ventricular assist device (VAD). In some embodiments, the VAD may comprise one or more of an Oxy-LVAD, hVAD, mVAD, Heartmate 3, and ProtekDuo.

[0011] According to some embodiments, a method of anchoring an instrument to a sewing ring, wherein the sewing ring is surgically attached to a patient’s heart, is provided. The method may include providing a device assembly detachably coupled to the sewing ring prior to surgically opening the patient’s heart, the assembly comprising a lower ring interchangeably coupled to an upper ring with a sealable valve therebetween, wherein the sealable valve comprises a point-of-failure at a central point of the valve and inserting the instrument first into an opening of the upper ring. The method may additionally include exerting pressure on the point-of-failure of the valve until a port in formed in the valve and inserting the instrument further through the port into an opening of the lower ring, wherein when the instrument is inserted through the port, a tight seal is formed around the instrument. The method may additionally include continuing to insert the instrument through the sewing ring into the patient’s heart to examine the patient’s heart using the instrument, wherein the examining is performed prior to attaching an external device to the patient’s heart.

[0012] In some embodiments, the assembly may be coupled to the sewing ring via the lower ring. In some embodiments, upon completing examination of the patient’s heart, the method may include removing the instrument from the patient’s heart by detaching the lower ring from the sewing ring and coupling the external device to the sewing ring, wherein the detaching comprises removing the instrument and the upper ring along with the lower ring.

[0013] In some embodiments, the assembly may be detached from the sewing ring by detaching the lower ring from the sewing ring. In some embodiments, the valve may be composed of a polymer material of varying thickness, the polymer material being thinner at the central point compared to edge of the polymer material.

[0014] In some embodiments, the method may further include the instrument in the assembly with an extendable armature of the upper ring, wherein the extendable armature is pivotably coupled to the upper ring, wherein the extendable armature is configured to lock the instrument in the assembly while examining the patient’s heart. The instrument may comprise a cannula or a catheter. The external device may comprise a ventricular assist device (VAD).

[0015] One of the unique and inventive technical features of the present invention is that the assembly may be detachably coupled to the sewing ring, thereby providing additional time in examining/assisting the patient’s heart with instruments such as cannula, before attaching the VAD. In addition, the assembly includes a unidirectional valve that allows the instrument to be inserted, while forming a blood-tight seal around the instrument, so that blood does not leak into the assembly.

[0016] Most cardiac surgeries are performed percutaneously using arteries and veins. Most surgeons would not attempt to stab a patient’s heart as it can damage the tissue of the heart, and may cause blood leaks in the heart, which may be undesirable and harmful to the patient. In some situations, surgical openings may be made on the heart, and as such, the openings may be necessary to implant a ventricular assist device (VAD) to support heart function. In such situations, a sewing ring is typically sutured to the myocardium, and the opening is made within the ring. Once the opening is made, the VAD is immediately implanted, leaving no time for any inspection or probing of the heart.

[0017] The present invention discloses an assembly that provides additional time for inspection and probing. Herein, the assembly may be removably attached to the sewing ring, prior to making the opening. The assembly includes a lower ring that is adaptively coupled to the sewing ring, and additionally includes a top portion that allows an instrument or tool to be inserted there through. The assembly additionally includes a valve that is pinched between the lower and the upper ring. Herein, the valve includes a point-of-failure at a center that allows the instrument to go through but does not allow any blood to leak out. This advantageously provides for additional time for inspection and probing of the heart without worrying about blood leaking out of the patient’s heart. Once the heart is probed and inspected using the instrument, the assembly may be removed, and the VAD may be implanted. Without wishing to limit the invention to any theory or mechanism, it is believed that the technical feature of the present invention advantageously provides for a temporary method for anchoring the instrument while a medical decision is made. None of the presently known prior references or work has the unique inventive technical feature of the present invention.

[0018] As previously discussed, the present invention features a system for allowing insertion of an instrument into a heart of a patient having a sewing ring surgically attached therein. In some embodiments, the system comprises an upper ring having an opening for allowing passage of the instrument therethrough; a lower ring having an opening for allowing passage of the instrument therethrough, wherein the opening of the upper ring and the opening of the lower ring are aligned, the lower ring has a proximal end that detachably couples to the sewing ring in the patient’s heart; and a unidirectional valve sandwiched between the upper ring and the lower ring to form a tight seal between the upper ring and the lower ring, wherein the valve comprises a point-of- failure at a central point of the valve to allow passage of the instrument therethrough. When the instrument is inserted into the opening of the upper ring and pushes on the point-of-failure at the central point of the valve to fail, an opening in the valve is created to allow passage of the instrument therethrough and further through the opening of the lower ring and further into the patient’s heart. The valve creates a hermetic seal around the instrument, thereby reducing blood leakage around the instrument and sewing ring.

[0019] In some embodiments, the system further comprises a gripping ring for temporarily gripping the instrument, the gripping ring is positioned above the upper ring and has an opening that aligns with that of the upper ring. In some embodiments, the gripping ring is attached to the upper ring via an extendable armature. In some embodiments, the proximal end of the lower ring has a diameter that matches that of the sewing ring. In some embodiments, the lower ring has a distal end that has a diameter that matches that of the upper ring. In some embodiments, the lower ring comprises an O-ring that forms a tight seal with the sewing ring.

[0020] In some embodiments, after completing an examination of the patient’s heart with the instrument, the assembly system is detached from the sewing ring by detaching the lower ring from the sewing ring, thereby allowing for an external device to be coupled to the sewing ring. In some embodiments, the system further comprises the sewing ring. In some embodiments, the system further comprises the instrument. In some embodiments, the instrument is a probe, a cannula, a catheter, or other appropriate instrument.

[0021] The present invention also features a method of anchoring an instrument to a sewing ring surgically attached to a patient’s heart. In some embodiments, the method comprises providing a system as described herein for detachably coupling to the sewing ring; coupling the lower ring to the sewing ring; inserting the instrument through the opening of the upper ring; exerting pressure on the point-of-failure of the valve until the instrument penetrates the valve, wherein the valve creates a tight seal around the instrument; and inserting the instrument further through the opening of the lower ring and further through the sewing ring and the patient’s heart.

[0022] In some embodiments, the system further comprises a gripping ring for temporarily gripping the instrument, the gripping ring is positioned above the upper ring and has an opening that aligns with that of the upper ring. In some embodiments, the gripping ring is attached to the upper ring via an extendable armature. In some embodiments, the method further comprises detaching the system by detaching the lower ring from the sewing ring. In some embodiments, the valve is composed of a polymer material of varying thickness, the polymer material being thinner at the central point compared to edge of the polymer material. In some embodiments, the instrument comprises a cannula or a catheter. In some embodiments, the proximal end of the lower ring has a diameter that matches that of the sewing ring. In some embodiments, the lower ring has a distal end that has a diameter that matches that of the upper ring. In some embodiments, the lower ring comprises an O-ring that forms a tight seal with the sewing ring.

[0023] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0024] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:

[0025] FIG. 1 shows a schematic view of an assembly that is used for anchoring an instrument to a patient’s heart, according to an embodiment of the present invention.

[0026] FIG. 2A shows an exploded view illustrating individual components of a non- limiting example of the assembly.

[0027] FIG. 2B shows an exploded view illustrating individual components of a non- limiting example of the assembly with an armature coupled to a top portion of the assembly.

[0028] FIG. 3 shows a schematic view of a sealable valve, according to an embodiment of the present invention.

[0029] FIG. 4 shows the valve having a central point-of-failure.

[0030] FIG. 5 shows an exploded view of the assembly and a sewing ring.

[0031] FIG. 6 shows a schematic view of the assembly detachably mounted to the sewing ring via a lower ring of the assembly.

[0032] FIG. 7 shows a schematic view of an upper ring of the assembly having an armature.

[0033] FIG. 8A shows a schematic view of the assembly aligned with the sewing ring.

[0034] FIG. 8B shows a schematic view of the assembly having the armature, wherein the assembly is aligned with the sewing ring.

[0035] FIG. 9A shows a schematic view of an instrument aligned with the assembly without the armature.

[0036] FIG. 9B shows a schematic view of the instrument aligned with the assembly and held in place by the armature coupled to the assembly.

[0037] FIG. 10 shows a schematic view of the instrument inserted into the assembly and locked using the armature of the upper ring of the assembly.

[0038] FIG. 11 shows a schematic view of the entire assembly detached from the sewing ring after completion of examination using the instrument.

DETAILED DESCRIPTION OF THE INVENTION

[0039] A ventricular assist device (VAD) is a device for assisting cardiac circulation, which may be used to partially or completely replace the function of a failing heart. Surgery for the implantation of a VAD typically involves attaching a sewing ring (60) to the heart and subsequently making an incision or opening inside a region within the sewing ring. The ventricular assist device (VAD) is implanted in that region.

[0040] The present invention features methods and systems for temporarily assisting a patient’s heart during VAD surgery, e.g., for temporarily allowing assistance after the attachment of the sewing ring (60) and prior to the surgical opening of the heart for VAD implantation. This allows the heart to be examined, e.g., with a cannula, catheter, scope, etc., prior to the attachment of the VAD.

[0041] The present invention provides an assembly system (100) that detachably couples to a sewing ring (60) and temporarily anchors a probe instrument (50) to the patient’s heart. The probe instrument (50) may be configured as shown in FIG. 1 , e.g., the probe instrument (50) may be generally cylindrical in nature with a first end and a second (opposite end).

[0042] Referring to FIG. 1 , FIG. 2A, FIG. 2B, FIG. 3, FIG. 4, FIG. 5, FIG. 6, FIG. 7, FIG. 8A, FIG. 8B, FIG. 9A, FIG. 9B, FIG. 10, and FIG. 11 , the assembly system (100) comprises an upper ring (104), a lower ring (106) coupled to and positioned below the upper ring (104), and a valve (108) sandwiched between the upper ring (104) and lower ring (106). The lower ring (106) may be threaded on the upper ring (104). In some embodiments, the lower ring (106) may be press-fitted onto the upper ring (104). The present invention is not limited to the aforementioned coupling means or attachment means for the lower ring (106).

[0043] The lower ring (106) is for temporarily coupling to a sewing ring (60). For example, the lower ring (106) may feature a proximal end (bottom end) and a distal end (top end), wherein the proximal end is coupled to the sewing ring (60) while the distal end is coupled to the upper ring (104).

[0044] Both the upper ring (104) and the lower ring comprise an opening, wherein the openings are aligned to allow passage of the probe instrument (50) therethrough. In some embodiments, the size of the opening of the upper ring (104) may be fixed, e.g., conformed to a standard size. In some embodiments, the diameter of the proximal end (bottom end) of the lower ring (106) may be different from the diameter of the distal end (top end) of the lower ring (106). The diameter of the proximal end is selected based on the inner diameter of the surgical ring that is used. Note that an inner diameter of the sewing ring (60) may be about 12-24 mm, however sewing rings are not limited to this size.

[0045] In some embodiments, the diameter of the proximal end and the distal end of the lower ring (106) may be the same. In some other embodiments, the diameter of the proximal end and the distal end of the lower ring (106) may be different. For example, the distal end may be smaller or larger than the proximal end, without deviating from the scope of the invention. Flerein, the diameter of the distal end may be substantially equal to the diameter of the upper ring (104). In one embodiment, the upper ring (104) may be a male connector element and the distal end of the lower ring (106) may be a female connector element. By coupling the male and the female connector elements of the upper ring (104) and the distal end, the lower ring (106) may be coupled to the upper ring (104). In another embodiment, the upper ring (104) may be a female connector element and the distal end of the lower ring (106) may be a male connector element, without deviating from the scope of the invention. By coupling the female and the male connector elements of the upper ring (104) and the distal end, the lower ring (106) may be coupled to the upper ring (104). It may be appreciated that since the dimensions of the sewing ring can vary, then the proximal end, the distal end, and the upper ring (104) can also vary, as the assembly may be manufactured in a variety of sizes to accommodate different size instruments and patients. In some embodiments, both the lower ring (106) and the upper ring (104) may be interchangeable components, wherein both are adapted based on the sewing ring and the instrument used.

[0046] As a non-limiting example, for a sewing ring (60) having an inner diameter of about 20 mm, a lower ring (106) with a proximal end having an outer diameter of about 20 mm may be used, thus fitting the proximal end of the lower ring (106) into the sewing ring (60). As a non-limiting example, the upper ring (104) may feature a diameter of about 25 mm. Accordingly, a distal end of the lower ring (106) may be about 25 mm. The values mentioned herein are example values only and are not meant to be limiting. Other values of the inner and outer diameters, and lengths of the first and the second tube may be used without deviating from the scope of the invention.

[0047] In other embodiments, the outer diameter of the lower ring (106) is substantially equal to the inner diameter of the sewing ring (60). When the lower ring (106) is attached to the sewing ring, a blood-tight seal may be formed with the sewing ring (60). In some embodiment, O-rings (600) may be positioned on the outer surface of the lower ring (106) to form the blood-tight seal with the sewing ring (60) and prevent any blood leakage.

[0048] In this way, the assembly system (100) may be attached to the sewing ring. By mounting the assembly system (100) on the sewing ring (60), the surgeon may be able to insert a probe instrument (50) through the openings of the upper ring (104) and lower ring (106) and through the valve (108) to further examine the patient’s heart before attaching a VAD to the heart, as discussed below.

[0049] As described earlier, the valve (108) is sandwiched between the lower ring (106) and the upper ring (104) of the assembly system (100). Herein, when the lower ring (106) is threaded onto the upper ring (104), the valve (108) may be pinched in between the lower ring (106) and upper ring (104), thus forming a hermetic seal between the lower ring (106) and upper ring (104). In some embodiments, the valve (108) may be pinched in between the lower ring (106) and upper ring (104) when the lower ring (106) is press-fitted on to the upper ring (104).

[0050] Referring to FIG. 3, FIG. 4, FIG. 5, and FIG. 6, the valve (108) may be a unidirectional valve having a point-of-failure (310) at a central point (308) of the valve. The valve (108) may be a membrane and may comprise an upper collar (302) and a lower collar (304), wherein the upper collar (302) engages the upper ring (104) and the lower collar (304) engages the lower ring (106). In some embodiments, a diameter of the upper collar (302) may be selected so that an outer surface the upper collar (302) is in face-sharing contact with an inner surface of the upper ring (104). Likewise, a diameter of the lower collar (304) may be selected such that an outer surface of the lower collar (304) is in face-sharing contact with an inner surface of the lower ring (106). In some embodiments, the valve (108) may be composed of a polymer of varying thickness. For example, a thickness of the polymer decreases from the edge towards the central point (308), with the central point (308) being the thinnest. The present invention is not limited to this configuration.

[0051] As an example, the thickness of the valve (108) may be t1 at the edge and may decrease to a thickness of t2 at the center of the valve (108). By having the central point as the thinnest part of the valve, the point-of-failure is intentionally created at the central point (308). Thus, when the instrument is inserted through the upper ring (104), even a slight force applied on the point-of-failure (310) will cause the central point (308) to fail, thereby creating a port or opening in the valve (108) at the central point. Once the opening is formed in the valve, the probe instrument (50) may then be inserted through the opening to the lower ring (106). As such, when the probe instrument (50) is inserted through the valve (108), the polymer material surrounding the probe instrument (50) forms a hermetic seal around the probe instrument (50), thereby preventing blood from inside the patient’s heart leaking though the valve to the outside of the patient’s heart. As an example, the probe instrument (50) may be a cannula configured to assist the patient’s heart during the cardiac procedure. Mounting the assembly to the sewing ring offers a temporary method of assisting the patient’s heart with the cannula before attaching the VAD.

[0052] Referring to FIG. 1 , FIG. 2B, FIG. 5, FIG. 6, FIG. 7, FIG. 8B, FIG. 9B, FIG. 10, and FIG. 11 , in some embodiments, the upper ring (104) has a wing (110) that extends outwardly from a side portion. The wing (110) may be used to support a gripping ring (112), which is for supporting the probe instrument (50). As shown in FIG. 1 , the gripping ring (112) has an opening that aligns with that of the upper ring and lower ring, as it is for allowing passage of probe instrument (50) therethrough. The gripping ring (112) is positioned above the upper ring. The gripping ring (112) is connected to the wing (112) of the upper ring (104) via an extendable armature. The gripping ring (112) can engage the probe instrument (50) via its opening and can lock or support the instrument (50) in place once the probe instrument (50) is fully inserted through the assembly system (100), e.g., as shown in FIG. 2B, FIG. 8B, and FIG. 9B.

[0053] Flerein, in some embodiments, the extendable armature comprises an arm (501 ) with a ball joint (500) that rotatably engages the wing (110) of the upper ring (104), about which the extendable armature rotates. The extendable armature (e.g., the arm (501 )) pivotally connects to the gripping ring (112), e.g., via a pivot joint. For example, the pivot joint may be disposed on the end of the arm (501 ) and connect to a wing (113) of the gripping ring (112) via a screw (504), e.g., as shown in FIG. 11. The present invention is not limited to this configuration.

[0054] As an example, when the instrument (50) is inserted into the assembly system (100) and further into the patient’s heart, the opening of the gripping ring (112) may be positioned around the probe instrument (50) and the tightening screw (504) may be used to secure the gripping ring (112) in place and lock the probe instrument (50) in place. In this way, the probe instrument (50) may be locked in position once it is inserted into the patient’s heart, thereby reducing any unwanted movement of the probe instrument (50) inside the patient’s heart.

[0055] Once the probe instrument (50) has provided additional assistance to the patient’s heart, the probe instrument (50) may be removed from the sewing ring (60) and the assembly, the system (100) may be removed from the sewing ring (60), and the VAD may be attached to the sewing ring (60). In order to remove the assembly system (100) from the sewing ring (60), the lower ring (106) of the assembly may be detached from the sewing ring (60). By detaching the lower ring (106), the valve (108) and the upper ring (104) are also detached from the sewing ring (60). In this way, the entire assembly (100) may be removed as a single piece, thereby reducing any tissue damage or scarring in the patient’s heart. In some embodiments, the assembly (100) and probe instrument (50) are detached from the sewing ring (60) at the same time.

[0056] In some other embodiments, the valve (108) may reseal when the probe instrument (50) is pulled out of the assembly (100. In such embodiments, the probe instrument (50) may be inserted through the valve (108) and can be pulled out without blood leaking out of the heart, and another probe instrument (50) may be inserted for additional examination purposes.

[0057] The system of the present invention creates a port into the heart that forms a tight seal around the probe instrument (50) and may be intended as a temporary method of holding the probe instrument (50) in place while a medical decision is made.

[0058] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as“consisting essentially of” or“consisting of”, and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase“consisting essentially of” or“consisting of” is met.

[0059] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.