APPARATUS AND METHODS FOR COUPLING A BLOOD PUMP TO THE HEART

Abstract

An apparatus for coupling a blood pump to a patients heart is provided. The apparatus includes a sewing ring designed to be sutured to the patients heart, wherein the sewing ring has an opening sized and shaped to receive an inflow cannula of the blood pump. The apparatus further includes a locking element coupled to a housing of the blood pump and transitionable between a closed state and an open state. The locking element is structured to receive the sewing ring in the open state and engage the sewing ring in the closed state to prevent translational and rotational movement of the locking element relative to the sewing ring. In addition, the apparatus includes a biased structure designed to bias the locking element in the closed state.

Claims

1. An apparatus for coupling a blood pump to a patient's heart, the apparatus comprising: a sewing ring configured to be sutured to the patient's heart, the sewing ring comprising an opening sized and shaped to receive an inflow cannula of the blood pump; a locking element coupled to a housing of the blood pump and transitionable between a closed state and an open state, the locking element configured to receive the sewing ring in the open state and engage the sewing ring in the closed state to prevent translational and rotational movement of the locking element relative to the sewing ring; and a biased structure configured to bias the locking element in the closed state.

2. The apparatus of claim 1, wherein the locking element comprises a plurality of horizontal crenellations disposed along a circumferential opening of the locking element, the plurality of horizontal crenellations of the locking device separated by a plurality of gaps sized and shaped to receive a plurality of horizontal crenellations disposed adjacent the opening of the sewing ring when the locking element is in the open state.

3. The apparatus of claim 2, wherein in the closed state, the plurality of horizontal crenellations of the locking element are aligned with the horizontal crenellations of the sewing ring to prevent translational movement of the locking element relative to the sewing ring.

4. The apparatus of claim 2, wherein the housing of the blood pump comprises a plurality of vertical crenellations, the plurality of vertical crenellations of the housing of the blood pump configured to receive corresponding indentations of the sewing ring to prevent rotational movement of the locking element relative to the sewing ring.

5. The apparatus of claim 2, wherein the biased structure comprises a first end and a second end, the biased structure disposed circumferentially about a longitudinal axis of the blood pump between the first and second ends, the first end of the biased structure coupled to the housing of the blood pump, the second end of the biased structure coupled to the locking element via a locking pin, the locking pin moveable within a groove on the housing of the blood pump to permit movement of the second end of the biased structure.

6. The apparatus of claim 5, wherein the locking element is configured to rotate about a longitudinal axis of the housing of the blood pump to transition from the closed state to the open state, and wherein rotation of the locking element causes the second end of the biased structure to move from a first position in the closed state to a second position toward the first end in the open state, thereby compressing the biased structure in the open state.

7. The apparatus of claim 2, wherein the locking element comprises a plurality of brackets configured to engage with the housing of the blood pump, the plurality of brackets each comprising a groove sized and sized to accept one or more guide rails disposed on a surface of the housing of the blood pump such that the plurality of brackets moves along the one or more guide rails as the locking element transitions between the closed state and the open state.

8. The apparatus of claim 2, wherein the housing of the blood pump comprises a stop, the stop configured to limit rotation of the locking element relative to the housing of the blood pump, and wherein a notch of the locking element engages the stop in the open state.

9. The apparatus of claim 1, wherein the locking element comprises one or more hook portions configured to engage with the sewing ring in the closed state.

10. The apparatus of claim 9, wherein the locking element comprises two hook portions, the two hook portions positioned opposite one another along the housing of the blood pump.

11. The apparatus of claim 9, wherein the locking element is configured to move from a first position in the closed state to a second position radially inward toward the inflow cannula of the blood pump in the open state.

12. The apparatus of claim 11, wherein the biased structure is disposed circumferentially about a longitudinal axis of the blood pump, such that the biased structure is compressed when the locking element is in the second position.

13. The apparatus of claim 9, wherein the biased structure comprises first and second ends sized and shaped to slidably move radially along first and second grooves of the housing of the pump body, the first and second tabs positioned opposite one another and 45 degrees from the locking element.

14. The apparatus of claim 9, wherein the one or more hook portions comprise a sloped surface such that contact between the sloped surface of the one or more hook portions and an inner surface of the sewing ring causes the one or more hook portions to move radially inward toward the inflow cannula of the blood pump.

15. The apparatus of claim 9, wherein the sewing ring comprises one or more slots sized and shaped to receive the one or more hook portions of the locking element in the closed state.

16. The apparatus of claim 9, further comprising a hood, the hood comprising an opening sized and shaped to receive the locking element therethrough.

17. A method for coupling a blood pump to a patient's heart, the method comprising: suturing a sewing ring to the patient's heart, the sewing ring comprising an opening sized and shaped to receive an inflow cannula of the blood pump; transitioning a locking element coupled to a housing of the blood pump from a closed state to an open state; inserting the inflow cannula of the blood pump through the opening of the sewing ring and engaging the sewing ring with the locking element in the open state; and transitioning the locking element from the open state to the closed state to prevent translational and rotational movement of the locking element relative to the sewing ring, wherein the locking element is biased toward the closed state via a biased structure adjacent the locking element.

18. The method of claim 17, wherein the locking element comprises a plurality of horizontal crenellations disposed along a circumferential opening of the locking element, the plurality of horizontal crenellations of the locking device separated by a plurality of gaps sized and shaped to receive a plurality of horizontal crenellations disposed adjacent the opening of the sewing ring, and wherein engaging the sewing ring with the locking element in the open state comprises aligning the plurality of gaps of the locking element with the plurality of horizontal crenellations of the sewing ring.

19. The method of claim 18, wherein transitioning the locking element from the open state to the closed state comprises aligning the plurality of horizontal crenellations of the locking device the plurality of horizontal crenellations of the sewing ring to prevent translational movement of the locking element relative to the sewing ring.

20. The method of claim 17, wherein the locking element comprises one or more hook portions configured to engage with the sewing ring in the closed state, wherein transitioning the locking element from the open state to the closed state comprises moving the locking element from a first position in the closed state to a second position radially inward toward the inflow cannula of the blood pump in the open state.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG. 1 illustrates an exemplary locking mechanism for coupling a heart pump to the heart constructed in accordance with the principles of the present invention.

[0018] FIGS. 2A and 2B illustrate the exemplary sewing ring of FIG. 1.

[0019] FIG. 3 illustrates the locking mechanism of FIG. 1 without the sewing ring.

[0020] FIG. 4 illustrates the internal components of the locking mechanism of FIG. 3.

[0021] FIG. 5A illustrates a side view of the locking mechanism of FIG. 1, and FIGS. 5B and 5C illustrate a cross-sectional view of the locking mechanism of FIG. 5A.

[0022] FIG. 6 illustrates another exemplary locking mechanism for coupling a heart pump to the heart constructed in accordance with the principles of the present invention.

[0023] FIGS. 7A and 7B illustrate the exemplary sewing ring of FIG. 6.

[0024] FIG. 8 illustrates the locking mechanism of FIG. 6 without the sewing ring.

[0025] FIG. 9 illustrates the internal components of the locking mechanism of FIG. 8.

[0026] FIG. 10A illustrates a side view of the locking mechanism of FIG. 6, and FIGS. 10B and 10C illustrate a cross-sectional view of the locking mechanism of FIG. 10A.

DETAILED DESCRIPTION OF THE INVENTION

[0027] Embodiments of the present invention are directed to apparatus and methods for removeably coupling the inflow cannula of the blood pump to the heart.

[0028] Referring now to FIG. 1, an exemplary locking mechanism for coupling a heart pump to the heart constructed in accordance with the principles of the present invention is provided. Locking mechanism 10 is includes sewing ring 18 designed to be sutured to a patient's heart, and locking element 20 coupled to a housing of blood pump 12, wherein locking element 20 is designed to be removeably coupled to sewing ring 18, and thus, the patient's heart. As described in further detail below, locking element 20 may be rotated from a closed state to an open state to receive sewing ring 18, and back to the closed state to lock sewing ring 18 with locking element 20 to prevent translational and rotational movement of locking element 20 relative to sewing ring 18.

[0029] Blood pump 12 may be any heart pump designed to be affixed to a patient's heart, e.g., an LVAD designed to shunt blood from the left ventricle to the aorta of the heart such as the heart pumps disclosed in U.S. Pat. No. 9,968,720 to Botterbusch, U.S. Pat. No. 10,166,319 to Botterbusch, and U.S. Pat. No. 10,188,779 to Polverelli, assigned to the assignee of the instant application, the entire contents of each of which are incorporated herein by reference. For example, blood pump 12 includes inflow cannula 14 for receiving blood from a source of blood, e.g., the left ventricle of the heart. Inflow cannula 14 has a cylindrical shape and is positioned at the upper portion of blood pump 12.

[0030] Sewing ring 18 includes a fabric portion (not shown) that may be sutured to the heart using methods already known in the art of cardiology, and a metal portion that is designed to be removeably coupled to locking element 20. Locking element 20 includes opening 11 sized and shaped to receive inflow cannula 14 of blood pump 12. In addition, as shown in FIG. 1, locking element 20 includes three brackets 22 extending from the periphery of locking element 20, and curving downward to engage with the external side surface of the housing of blood pump 12. For example, each of brackets 22 includes grooved surface 24 sized and shaped for receiving guild rails 16 positioned about external side surface of the housing of blood pump 12, such that locking element 20 may rotate about the longitudinal axis of blood pump 12 along guide rails 16. As will be understood by a person ordinarily skilled in the art, locking element 20 may include fewer or more than three brackets, and thus, house pump 12 may include fewer or more than three guide rails, e.g., one, two, four, or more brackets and guide rails. Alternatively, the housing of blood pump 12 may have a number of guide rails less than the number of brackets, e.g., one guide rail extending partially or completely around the circumference of the housing of blood pump 12.

[0031] As illustrated in FIG. 1, locking element 26 includes notch 26 sized and shaped to engage with stop 28 coupled to the housing of blood pump 12 during rotation of locking element 20. For example, in the open state, one end of notch 26 is adjacent stop 28, and as locking element 20 is rotated about the longitudinal axis of blood pump 12, notch 26 moves along stop 28 until stop 26 engages with the opposite end of notch 26. Thus, stop 26 limits rotation of locking element 20 so that locking element 20 may easily be rotated and cease rotation in the open state.

[0032] Referring now to FIGS. 2A and 2B, sewing ring 18 is described. Sewing ring 18 has opening 31 sized and shaped to receive inflow cannula 14 of blood pump 12. Sewing ring 18 includes planar portion 32 extending circumferentially forming opening 31, and vertical portion 34 extending downward from the inner edge of planar portion 32 adjacent opening 31 of sewing ring 18. The lower edge of vertical portion 34 includes a pattern of horizontal crenellations 36 separated by gaps 38, such that the pattern of horizontal crenellations 36 extend in a radial direction outward toward the outer periphery of sewing ring 18. In addition, the lower edge of vertical portion 34 includes a pattern of vertical indentations 40 separated by the portions of horizontal crenellations 36 coupled to the lower edge of vertical portion 34.

[0033] As illustrated in FIG. 3, locking element 20 includes a pattern of horizontal crenellations 41 extending toward inner cannula 14 of blood pump 12, separated by gaps 42 along the inner edge of locking element 20 adjacent opening 11. Gaps 42 of locking element 20 are sized and shaped to receive horizontal crenellations 36 of sewing ring 18 therethrough. For example, locking element 20 may be rotated about the longitudinal axis of blood pump 12, e.g., in a clockwise direction, until notice 26 engages with stop 28 such that locking element 20 is in an open state. After horizontal crenellations 36 of sewing ring 18 are received through gaps 42 of locking element 20, locking element 20 may be rotated about the longitudinal axis of blood pump 12 in the opposite direction, e.g., in a counter-clockwise direction such that horizontal crenellations 41 are aligned with horizontal crenellations 36 of sewing ring 18, thus preventing translational movement of sewing ring 18 relative to locking element 20, e.g., along the longitudinal axis of blood pump 12. As described in further detail below, locking element 20 may be bias toward the closed state such that after locking element 20 is moved to the open state to receive sewing ring 18, locking element 20 may automatically return to the closed state upon release of locking element 20.

[0034] The housing of blood pump 12 further may include a pattern of vertical crenellations 44 disposed circumferentially about the upper surface of the housing of blood pump 12 adjacent to inflow cannula 14. Vertical crenellations 44 are sized and shaped to be received within vertical indentations 40 of sewing ring 18 such that when sewing ring 18 is received within locking element 20, rotational movement of sewing 18 relative to locking element is prevented. In addition, the housing of blood pump 12 may include ring 46 made of, e.g., rubber, disposed circumferentially about the external surface of inflow cannula 14. Accordingly, inflow cannula 14 may include a groove disposed circumferentially about the external surface of inflow cannula 14, the groove sized and shaped to receive ring 46 to form an impermeable seal against vertical portion 34 of sewing ring 18.

[0035] As illustrated in FIG. 4, locking mechanism 10 includes spring element 48. Spring element 48 includes first end 50 coupled to the upper surface of the housing of blood pump 12, and second end 52 is coupled to locking element 20 via locking pin 54. Second end 52 may include an opening for receiving locking pin 54 coupled to the locking element 20. In addition, the upper surface of the housing of blood pump 20 includes a groove sized and shaped to receive locking pin 54, such that locking pin 54 is moveable along the groove. Thus, an edge of the groove may limit further rotation of locking element 20 when locking pin 54 engages that edge of the groove. As locking element 20 is rotated from the closed state to the open state, locking pin 54 causes second end 52 of spring element 48 to move from a first position in the closed state to a second position closer to first end 50 in the open state. As first end 50 is fixed to the upper surface of the housing of blood pump 20, spring element 48 compresses as second end 52 moves from the first position to the second position. Upon release of locking element 20, spring element 48 returns to a relaxed state, and thus, second end 52 causes locking element 20 to return to the closed state via locking pin 54.

[0036] FIG. 5A illustrates a side view of locking mechanism 10 coupled to the housing of blood pump 12, and FIG. 5B illustrates a cross-sectional view of locking mechanism 10 coupled to the housing of blood pump 12 along line A-A of FIG. 5A. FIG. 5C illustrates an exploded view of circle B of FIG. 5B.

[0037] Referring now to FIG. 6, another exemplary locking mechanism for coupling a heart pump to the heart constructed in accordance with the principles of the present invention is provided. Locking mechanism 60 includes sewing ring 66 designed to be sutured to a patient's heart, and locking element 70 coupled to a housing of blood pump 62, wherein locking element 70 is designed to be removeably coupled to sewing ring 66, and thus, the patient's heart. As described in further detail below, locking element 20 may be pushed inward from a closed state to an open state to receive sewing ring 66, and back to the closed state to lock sewing ring 66 with locking element 70 to prevent translational and rotational movement of locking element 70 relative to sewing ring 66.

[0038] Blood pump 62 may be any heart pump designed to be affixed to a patient's heart, e.g., an LVAD designed to shunt blood from the left ventricle to the aorta of the heart such as the heart pumps disclosed in U.S. Pat. No. 9,968,720 to Botterbusch, U.S. Pat. No. 10,166,319 to Botterbusch, and U.S. Pat. No. 10,188,779 to Polverelli, assigned to the assignee of the instant application, the entire contents of each of which are incorporated herein by reference. For example, blood pump 62 includes inflow cannula 64 for receiving blood from a source of blood, e.g., the left ventricle of the heart. Inflow cannula 64 has a cylindrical shape and is positioned at the upper portion of blood pump 62.

[0039] Sewing ring 66 includes a fabric portion (not shown) that may be sutured to the heart using methods already known in the art of cardiology, and a metal portion that is designed to be removeably coupled to locking element 70. In addition, locking mechanism 60 may include hood 68 positioned on the upper surface of the housing of blood pump 62, and over locking mechanism 70.

[0040] Referring now to FIGS. 7A and 7B, sewing ring 66 is described. Sewing ring 66 has opening 71 sized and shaped to receive inflow cannula 64 of blood pump 62. Sewing ring 66 includes upper planar portion 72 extending circumferentially forming opening 71, inner vertical portion 73 extending downward from the inner edge of planar portion 72 adjacent opening 71 of sewing ring 66, outer vertical portion 74 extending downward from the outer edge of planar portion 72 of sewing ring 66, and lower planar portion 76 extending from the lower edge of vertical portion 74 radially inward toward the longitudinal axis of sewing ring 66. Lower planar portion 76 may include a plurality of protrusions 78 circumferentially along an inner edge of planar portion 76, opposite from the edge of planar portion 76 coupled to vertical portion 74 of sewing ring 66. Plurality of protrusions 78 are separated by gaps 80, gaps 80 sized and shaped to receive the hook portion of locking element 70 as described in further detail below.

[0041] As illustrated in FIG. 8, the housing of blood pump 62 may include ring 85 made of, e.g., rubber, disposed circumferentially about the external surface of inflow cannula 64. Accordingly, inflow cannula 64 may include a groove disposed circumferentially about the external surface of inflow cannula 64, the groove sized and shaped to receive ring 85 to form an impermeable seal against vertical portion 73 of sewing ring 66.

[0042] In addition, hood 68 includes opening 84 for receiving hook portion 86 of locking element 70. As illustrated in FIG. 8, locking mechanism 60 includes two locking elements 70, each having hook portion 86. Hook portion 86 of locking element 70 has a width selected to permit hook portion 76 to be received through gaps 80 of sewing ring 66. The upper surface of hook portion 86 may have sloped surface 87 such that as hook portion 86 is brought into contact with the lower surface of sewing ring 66, hook portion 76 moves radially inward toward the longitudinal axis of blood pump 62. Locking element 70 may include a button portion designed to be pushed radially inward toward the longitudinal axis of blood pump 62, thereby causing hook portion 76 to move from a closed state radially inward toward the longitudinal axis of blood pump 62 to an open state. In the open state, hook portion 76 may be received through gaps 80 of sewing ring 66. Upon release of the button portion of locking element 70, hook portion 76 returns to its initial position and is sandwiched between upper planar portion 72 and lower planar portion 76 of sewing ring 66, thus preventing translational and rotational movement of sewing ring 66 relative to locking element 70. As described in further detail below, locking element 70 may be bias toward the closed state such that after locking element 70 is moved to the open state to receive sewing ring 66, locking element 70 may automatically return to the closed state upon release of locking element 70.

[0043] As illustrated in FIG. 9, locking mechanism 60 includes spring element 88 disposed on the upper surface of blood pump 62. Spring element 88 has first end 90 and second end 92, both sized and shaped to fit moveably within grooves 94 and 96, respectively. Grooves 94 and 96 are each positioned 45 degrees from locking element 70 along the upper surface of blood pump 62. In addition, spring element 88 has a circular shape and abuts hook portion 86 of locking 70 such that as locking element 70 moves from the closed state to the open state, spring element 88 compressed into a more oval shape. As spring element 88 compresses, first and second ends 90 and 92 move radially outward from the longitudinal axis of blood pump 62 within grooves 94 and 96, respectively. Upon release of locking element 70, spring element 88 returns to a relaxed state, and thus, pushes against locking element 70 in a radially outward direction to return locking element 70 the closed state.

[0044] FIG. 10A illustrates a side view of locking mechanism 60 coupled to the housing of blood pump 62, and FIG. 10B illustrates a cross-sectional view of locking mechanism 60 coupled to the housing of blood pump 62 along line A-A of FIG. 10A. FIG. 10C illustrates an exploded view of circle B of FIG. 10B.

[0045] While various illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made herein without departing from the invention. It will further be appreciated that the devices described herein may be implanted in other positions in the heart. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.