Spiral pericardial anchoring system

Abstract

A pericardial anchor for positioning a heart assist system on a patient's heart under the patient's sternum and ribs comprises a tubular shaft, a pericardial anchor, and a removable handle. A guidewire lumen extends through the tubular shaft. The pericardial anchor is disposed at the distal end of the tubular shaft and the removable handle is disposed at the proximal end of the tubular shaft. The pericardial anchor is typically a helical anchor that can be implanted to tether within the patient's pericardium by rotating the handle. The tubular shaft receives and tethers the heart assist system on the patient's heart under the patient's sternum and ribs after removal of the handle.

Description

【Technical Field】 【0001】 Cross-reference This application claims priority to U.S. Patent Application No. 63 / 350,716, filed on June 9, 2022, which is incorporated herein by reference. 【0002】 The subject matter of this patent application relates to the subject matter described in U.S. Patent Application No. 17 / 411,928, filed on August 25, 2021, International Application No. PCT / US2020 / 019974, filed on February 26, 2020, International Application No. PCT / US2022 / 0751, filed on August 17, 2022, and U.S. Provisional Patent Application No. 63 / 407,100, filed on September 15, 2022, which are incorporated herein by reference. 【0003】 Field of the Disclosure The present disclosure generally relates to devices and methods for disposing spiral, helical, or other anchors within the pericardium to secure an intrapericardial ventricular assist device after implantation of the anchor. By rotating the tip of a rigid helix disposed against the pericardium clockwise, the advancement of the coil through the pericardium can be limited to slightly more than one rotation. Limiting the advancement of the anchor can be important for avoiding damage to the lungs during and after placement of the anchor. 【Background Art】 【0004】 The balloon cannula may be inserted into the pericardial cavity and positioned in front of the left ventricle of the heart. To increase the cardiac output of patients with congestive heart failure, balloon inflation during systole and balloon deflation during diastole can be performed. The ventricular assist balloon cannula can be inserted through the pericardium on the lower surface near the apex of the heart by a subxiphoid incision or puncture. The distal end of the balloon cannula may be advanced to the left side of the heart just below the left atrial appendage, whereby the balloon is positioned in front of the left ventricle. A liquid-tight reservoir may be attached to the proximal end of the balloon cannula, and this reservoir may be implanted subcutaneously in the subxiphoid region. The balloon in the pericardium can be inflated by a battery-powered air pump outside the patient's body. A large-bore needle may puncture the patient's skin and the elastomeric seal surface of the subcutaneous reservoir, whereby the flow from the air supply line in the external unit is delivered to the pericardial balloon cannula. 【0005】 During the periodic inflation and deflation of the balloon, it may be observed that the balloon cannula can move from its position above the left ventricle and towards the right side of the heart. As a result, compression of the left ventricle may not be achieved, and the effect of left ventricular assistance may be lost. Therefore, it may be desirable to provide an anchoring system for the tip of the balloon cannula. Furthermore, it is desirable to provide an anchoring system for the ventricular assist balloon cannula that allows for the replacement of the balloon cannula while maintaining the preferred position established by the original anchoring system. The lifespan of the balloon can be finite, for example, one year. By providing an anchoring system that allows for the replacement of the balloon cannula, subsequent balloon replacement procedures can be simplified and shortened. 【0006】 An epicardial anchor catheter for stabilizing the distal end of an epicardial balloon cannula has been previously described. This catheter consists of a small-diameter, non-foldable catheter body having a short distal section consisting of a braided sheath formed from a plurality of polymeric fibers. A rounded tip may be attached to the distal end of the braided sheath, and a stainless steel wire extending the length of the braided sheath and catheter body may be attached to the tip. A single stainless steel tube may be joined to the proximal portion of the catheter body, and this stainless steel tube may extend approximately 1 centimeter proximal to the proximal end of the catheter. The steel wire within the catheter may be slidably fitted within the inner diameter of the stainless steel tube and may project several centimeters proximal to the proximal end of the stainless steel tube. By pulling on the stainless steel wire while keeping the catheter stationary, the braided sheath may be maintained in an expanded configuration by crimping the stainless steel tube onto the inner stainless steel wire. 【0007】 Previous epicardial anchor catheters may function well as balloon cannula stabilization devices. However, because the entire length of the braided sheath typically must extend outside the pericardium before the braided sheath expands to form an anchoring disk, the method of catheter placement can be risky for the patient. The patient's lungs are located in close proximity to the pericardium and are separated from the pericardium by several millimeters of epicardial fat and a pleura that is usually less than 0.5 millimeters thick. Because the length of the braided sheath can be more than 10 mm, there is a risk that perforation of the lung surface may occur due to the placement of the anchor. SUMMARY OF THE INVENTION 【0008】 A pericardial anchor is presented that consists of a distal unit including a flat disk having a flat distal surface with a spiral rigid coil attached around the perimeter of the disk such that one turn of the spiral coil extends distally to the flat surface of the disk. The pericardial anchor includes an elongated small-diameter stainless steel tube attached to the center of the distal unit. The distal portion of the spiral coil may be located in a plane orthogonal to the axis of the tube, and the tip of the spiral portion may include an angled undercut to form an entry point into the pericardium. A removable handle may be provided at the proximal end of the stainless steel tube. The removable handle may be a guide wire torque device consisting of a short plastic pin vice that is clamped to the stainless steel tube. 【0009】 The spiral pericardial anchor system may be inserted into the pericardial sac through an opening formed near the apical aspect of the heart. This opening may be an incision in the pericardium, which is performed by surgical pericardial windowing. Alternatively, access to the pericardial sac may be achieved percutaneously by inserting a needle through the skin in the subxiphoid region, advancing the needle through the pericardium, inserting a guidewire through the needle, removing the needle, and advancing a vascular sheath containing an inner tapered dilator over the guidewire. When removing the tapered dilator and the guidewire, the spiral pericardial anchor may be advanced into the pericardial lumen through the vascular sheath. Depending on the situation, when removing the tapered dilator, the physician may desire to leave the guidewire in place and advance the spiral pericardial anchor system over the guidewire to direct the anchor system to the desired pericardial location. Instead of a solid stainless steel wire or rod, a stainless steel tube having a lumen for disposing the guidewire may be used for the pericardial anchor system. Once the pericardial anchor system has been advanced to the desired anchor site, the guidewire may be removed from the lumen of the device and the spiral tip of the device may be pressed against the pericardium with a constant load of about 1 pound. The spiral portion may be rotated multiple times using a removable handle until there is no resistance. At this point, one rotation of the spiral anchor has exited the pericardium and the pericardium is pushed into the apex formed by the flat distal surface of the disk and the exposed spiral coil. A slight retraction of the anchor system will feel resistance, indicating that proper placement has been achieved. 【0010】 The helical coil and the elongated stainless steel tube extending proximally from the support disk may include a series of microgrooves offset radially that extend for half the distal length and the full thickness of the tube. The width of the narrow grooves is about 0.002 inches and may be formed in the stainless steel tube using a laser cutter. Such grooves can avoid the possibility of myocardial trauma when the helical anchor is implanted for a long time by providing multi-directional flexibility to the portion of the tube that contacts the heart inside the pericardium. Adjacent rows of circumferential microgrooves may be offset with respect to the previous row, thereby providing axial flexibility while maintaining the column strength and torsional rigidity of the tube necessary to apply a 1-pound perpendicular resistance force to the pericardium while rotating the helix and inserting its pointed tip into the pericardium. Adjacent grooves may be spaced evenly over most of the length of the grooved tube. However, the proximal and distal groove sections may include adjacent grooves that increase linearly in distance from the center of the grooved portion of the tube. By increasing the distance between the grooves, tension relaxation occurs when the rigid tube becomes flexible, and kinking of the tube at the junction between the solid section and the grooved section can be avoided. The proximal portion of the stainless steel tube often must be firmly attached to the reservoir of the balloon cannula by a set screw that compresses and deforms the tube during attachment, and may therefore include a solid wall. A solid proximal section of the stainless steel tube may be required at the reservoir attachment point to ensure proper anchoring of the balloon cannula and to avoid the possibility of the anchor tube breaking over the service life of the implant. 【0011】 In another embodiment of the device, a stainless - steel tube with a non - circular cross - section and a long, coaxial, sliding - fit outer polymeric sleeve of similar cross - sectional shape that is gripped to deploy the spiral anchor can be used. The cross - sectional shape of the stainless - steel tube and the corresponding cross - sectional shape of the outer sleeve to match the inner sleeve may be elliptical, square, hexagonal, or other non - circular shapes. By increasing the size of the outer sleeve shape, it can be used as a grip while placing the spiral anchor. A flexible cap may be attached to the proximal end of the stainless - steel tube to stabilize the outer polymeric sleeve while placing the spiral anchor. After placement of the spiral anchor, the proximal - end cap can be removed from the stainless - steel tube and the outer polymeric sleeve is removed. In this embodiment, there is no need to use or remove a torque - handle component. Removing the torque grip may require the physician to perform a twisting motion with both hands, which may cause the spiral anchor to shift from the pericardium. In this embodiment, since the flexible cap is axially pulled while keeping the outer sleeve stationary, torsional motion that could move the spiral anchor is avoided. 【0012】 One rotation of the spiral portion of the spiral anchor may be disposed through the pericardium. The wire diameter of the spiral portion is about 0.022 inches (0.56 mm), and the depth of one rotation of the spiral portion is about 0.056 inches (1.4 mm). The average thickness of the epicardial fat layer in healthy individuals without ischemic heart disease is 4.4 ± 1.2 mm (Meenakshi K, et al. Epicardial fat thickness: a surrogate marker of coronary artery disease: assessment by echocardiography. 2016; 68: 336 - 341). Therefore, one rotation of the spiral portion at 1.4 mm does not protrude from the epicardial fat layer and stops in front of the pleura covering the lungs. Thus, lung injury should not occur when inserting the spiral anchor into the pericardium. 【0013】 After the spiral anchor is placed, the ventricular assist balloon cannula can be advanced along the stainless steel tube component of the anchor to a predetermined position within the pericardium. An open through-lumen may extend along the entire length of the balloon, and this through-lumen may accommodate the stainless steel anchor tube. After the balloon cannula is placed in a predetermined position, an implantable reservoir is attached to the proximal end of the cannula. The proximal end of the stainless steel anchor tube can be inserted into a channel on the side of the reservoir housing, and by tightening a set screw that extends into the channel onto the stainless steel anchor tube, the balloon cannula can be fixed in a predetermined position during the duration of implantation. 【0014】 Aspects of the present disclosure provide a pericardial anchor for positioning a heart assist system over a patient's heart under the patient's sternum and ribs. An exemplary anchor may include a tubular shaft through which a guidewire lumen passes and a pericardial anchor at the distal end of the tubular shaft. The pericardial anchor may be configured to anchor within the patient's pericardium in response to manipulation of the tubular shaft. 【0015】 In some embodiments, the pericardial anchor further includes a removable handle at the proximal end of the tubular shaft. The pericardial anchor may be configured to anchor within the patient's pericardium in response to manipulation of the tubular shaft by the handle. The tubular shaft may be configured to receive and anchor the heart assist system over the patient's heart under the patient's sternum and ribs after the handle is removed. 【0016】 In some embodiments, the pericardial anchor further includes an extension shaft configured to be removably coupled to the proximal end of the tubular shaft. The extension shaft may have a guidewire lumen. The guidewire lumen of the extension shaft may be coaxial with the guidewire or the lumen of the tubular shaft. The distal end of the extension shaft may be removably fixed onto the proximal end of the tubular shaft. 【0017】 In some embodiments, the tubular shaft is a slotted metal tube having a controlled flexibility. 【0018】 In some embodiments, the pericardial anchor is a helical anchor having a flat distal surface oriented in a plane orthogonal to the axis of the tubular shaft. The helical anchor may have a sharp tip configured to penetrate the pericardium while limiting penetration into the underlying adipose tissue. 【0019】 In some embodiments, the pericardial anchor further comprises a polymer sleeve configured to cover the tubular shaft. 【0020】 In some embodiments, the manipulation of the tubular shaft includes rotating the tubular shaft. 【0021】 Also, other aspects of the present disclosure provide a method for positioning a heart assist system on a patient's heart under the patient's sternum and ribs. An exemplary method includes percutaneously advancing a guidewire to a position under the patient's ribs and on the patient's heart, advancing a pericardial anchor at the distal end of the tubular shaft on the guidewire to position the pericardial anchor adjacent to a preselected position on the patient's pericardium, implanting the pericardial anchor into the pericardium to stabilize the tubular shaft on the patient's heart, and advancing the heart assist system on the tubular shaft to place the heart assist system on the patient's heart under the patient's sternum and ribs. 【0022】 In some embodiments, implanting the pericardial anchor into the pericardium includes rotating the shaft to implant a helical anchor into the pericardium. The helical anchor may have a flat distal surface oriented in a plane orthogonal to the axis of the tubular shaft. The helical anchor may have a sharp tip configured to penetrate the pericardium while limiting penetration into the underlying adipose tissue. 【0023】 In some embodiments, the heart assist system comprises: (i) a pneumatic effector configured to be implanted under the patient's pericardium and on the surface of the myocardium covering the patient's left ventricle; (ii) an implantable port configured to receive a percutaneously introduced cannula, the implantable port being connected to supply the driving gas received from the cannula to the pneumatic effector; (iii) an external drive unit including (a) a pump assembly and (b) a control circuit configured to operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm; and (iv) a connecting tube having a pump end attachable to the pump assembly and a cannula end attached to the cannula. 【0024】 In some embodiments, after advancing the heart assist system on a tubular shaft and positioning the heart assist system on the patient's heart under the patient's sternum and ribs, the heart assist system is fixed in place relative to the tubular shaft to prevent one or more of axial or lateral movement of the heart assist system relative to the heart. BRIEF DESCRIPTION OF THE DRAWINGS 【0025】 【Figure 1a】 A diagram illustrating components of a spiral pericardial anchoring system and its assembled configuration. 【Figure 1b】 A diagram illustrating components of a spiral pericardial anchoring system and its assembled configuration. 【Figure 2a】 A diagram depicting the geometric configuration of the distal end of a spiral pericardial anchor. 【Figure 2b】 A diagram depicting the geometric configuration of the distal end of a spiral pericardial anchor. 【Figure 2c】 A diagram depicting the geometric configuration of the distal end of a spiral pericardial anchor. 【Figure 3a】 A diagram depicting the configuration of a stainless steel anchor tube partially provided with grooves. 【Figure 3b】 A diagram depicting the configuration of a stainless steel anchor tube partially provided with grooves. 【Figure 4a】 FIG. depicts another embodiment of a spiral pericardial anchor system. 【Figure 4b】 FIG. depicts another embodiment of a spiral pericardial anchor system. 【Figure 4c】 FIG. depicts another embodiment of a spiral pericardial anchor system. 【Figure 5】 FIG. illustrates the anatomical layers of the pericardium, epicardial fat, and pleura in relation to the position of the heart and left lung, and the placement of the spiral pericardial anchor. 【Figure 6a】 FIG. is an enlarged view depicting the insertion process of a spiral anchor through the pericardium. 【Figure 6b】 FIG. is an enlarged view depicting the insertion process of a spiral anchor through the pericardium. 【Figure 7】 FIG. illustrates the process of placing a vascular sheath in a fixed position inside the pericardium on a previously placed guide wire. 【Figure 8】 FIG. shows where the spiral pericardial anchor system is being advanced through a vascular sheath to guide its placement within the pericardium. 【Figure 9】 FIG. shows where a ventricular assist balloon cannula is being advanced over a spiral pericardial anchor implanted within the pericardium. 【Figure 10】 FIG. shows where the proximal end of the spiral pericardial anchor is being attached to the housing of a subcutaneous reservoir attached to a ventricular assist balloon cannula. DETAILED DESCRIPTION OF THE DRAWINGS 【0026】 Figure 1a depicts an exploded assembly view of the components forming a spiral pericardial anchor system (10) shown in an assembled state in Figure 1b. A stainless steel spiral shape (11) with a pointed distal tip can be welded to a stainless steel bushing (12), and a long stainless steel tube (13) can be attached to the center of the bushing (12). The spiral structure (11) can be formed of 316 stainless steel with a wire diameter of about 0.022 inches and an outer diameter value of about 0.180 inches. The stainless steel tube (13) can have an outer diameter of 0.050 inches and a wall thickness of 0.005 inches such that its inner lumen can accommodate a 0.038-inch guide wire. A guide wire torque device (14) is fixed on the proximal end of the stainless steel tube (13) and can function as a handle to facilitate rotation of the spiral pericardial anchor (10) during its placement within the pericardium. The guide wire torque device (14) is shown as a (visible) block in Figures 1a and 1b. Alternatively, or in combination, the proximal end of the stainless steel tube (13) may be fixed on the distal end of another stainless steel tube so as to extend or elongate the stainless steel tube (13). In some cases, an additional stainless steel tube may be used as the guide wire torque device (14). In some cases, a separate guide wire torque device (14) may be fixed on the proximal end of the additional stainless steel tube. The additional stainless steel tube may likewise have a guide wire lumen configured to be coaxial with the inner lumen of the stainless steel tube (13). 【0027】 Figure 2a illustrates the configuration when the spiral portion (11) is attached to the bushing (12). One revolution of the spiral portion (11) can extend distally beyond the distal flat surface of the bushing (12). Figure 2b shows the configuration of the pointed distal tip of the spiral portion (11) formed by angling and grinding the inner side surface of the wire tip. As illustrated in Figure 2c, an angled undercut of the wire can be used to form the distal tip such that the distal portion of the spiral portion (11) is located within a plane perpendicular to the axis of the spiral anchor system (10). 【0028】 Figure 3 depicts the configuration of a stainless - steel tube (13) with minute grooved holes (15) formed in opposing side surfaces of the wall. The grooved holes (15) may not be visible to the naked eye, have a width of 0.002 inches, and extend for a length of 70% of the 0.050 - inch diameter of the stainless - steel tube (13), i.e., 0.035 inches. Adjacent axial grooved holes (15) can be separated by a distance of 0.015 inches. Adjacent grooved holes (15) are radially offset from the previous set of grooved holes (15) by a distance equal to 20% of the length of the grooved holes (15), i.e., 0.035 inches. The grooved holes (15) may extend for half of the distal length of the stainless - steel tube (13). This can impart flexibility to the portion of the stainless - steel tube (13) within the pericardium that contacts the heart. This flexibility can be essential for avoiding trauma to the heart during the insertion of the spiral pericardial anchor and during long - term implantation. Excessive rigidity of the stainless - steel tube 13 can cause lacerations or perforations of the heart during the insertion of the spiral anchor and can also cause myocardial lacerations during long - term implantation. A series of radially offset grooved holes (15) can provide flexibility in all directions of the distal stainless - steel tube (13) without sacrificing the column strength or torsional strength required when the pericardial anchor applies a force of approximately 1 pound against the pericardium and is then rotated to achieve penetration and proper fixation into the pericardium. 【0029】 Figure 4a depicts the internal components of another embodiment of a spiral pericardial anchor system (10) consisting of a spiral portion (11), a bushing (12), and a stainless steel tube (13). In this embodiment, the stainless steel tube (13) includes a non-circular cross-sectional shape such as a square. Figure 4b is a diagram showing where a flexible slip-fit polymer sleeve (16) is fitted over the non-circular stainless steel tube (13). The polymer sleeve (16) may include a lumen that conforms to the outer shape of the non-circular stainless steel tube (13) and may have a length slightly shorter than that of the stainless steel tube (13). Figure 4c shows that a flexible end cap (17) can be attached to the exposed proximal end of the stainless steel tube (13) to stabilize the polymer sleeve (16) when gripping and rotating the polymer sleeve (16) for inserting the anchor system (10) into the pericardium. The proximal portion of the polymer sleeve (16) can function as a handle for inserting the spiral anchor (11). After inserting the anchor (11), when removing the end cap (17) from the stainless steel tube (13), the polymer sleeve (16) can be held in a stationary state. An advantage of this embodiment may be that, unlike the embodiment shown in Figure 1b, it does not require a twisting operation to remove the attached torque device (14). The twisting of both hands required to remove the torque device (14) may cause the spiral portion (11) to shift from the pericardium. The removal of the end cap (17) may involve an axial movement in which the fixed spiral portion (11) is less likely to shift. 【0030】 Figure 5 depicts the heart (18) and the left lung (22) within the thoracic cavity. The heart (18) is enclosed by the pericardium (19). A pericardial fat pad (20) is located outside the pericardium (19), and a fibrous pleura (21) encloses the lung (22). The pleura (21) is in contact with the pericardial fat pad (20). 【0031】 Figure 6a shows the positioning of the helical portion (11) for insertion into the pericardium (19). The epicardial adipose body (20), pleura (21), and lung (22) are located outside the pericardium (19). As seen in Figure 6b, the helical portion (11) can be advanced to contact the pericardium (19) with a light force, i.e., a force of about 1 pound, and using the torque handle (14), it can be rotated 2 - 3 rotations until a resistance is felt, indicating that one rotation of the helical portion (11) has penetrated the pericardium (19) and the pericardium (19) is abutted against the distal surface of the bushing (12). The human pericardium has an average thickness of 1.02 mm (Lee JM. Mechanical properties of human pericardium. Circ Res 1985;55:475), and the epicardial adipose body has a thickness of about 4.4 mm. Therefore, the tip of the helical portion (11) during placement does not penetrate the pleura (21) or the lung (22), thereby avoiding the possibility of perforation or laceration of the lung (22). 【0032】 Figure 7 depicts the positioning of the vascular sheath (24) inside the pericardium (19) on the left outer surface of the heart (18) for placement of the helical anchor catheter. The vascular sheath (24) may be advanced over a previously placed guide wire (23) inserted by needle puncture into the pericardium (19) on the lower surface of the heart (18). The positioning of the guide wire (23) and the vascular sheath (24) may be performed under fluoroscopic guidance. 【0033】 Figure 8 shows the helical anchor catheter (10) advancing through the vascular sheath (24) positioned at the left outer edge of the pericardium (19). The vascular sheath (24) can be held stationary when the helical anchor catheter (10) is rotated to achieve placement through the pericardium (19). 【0034】 Figure 9 shows the ventricular assist balloon cannula (25) advancing along the shaft of the helical anchor catheter (10) after the helical portion (11) has been secured to the pericardium (19). The ventricular assist balloon may be a component of a ventricular assist device as described in U.S. Patent Application No. 17 / 411,928, filed August 25, 2021, International Application No. PCT / US2020 / 019974, filed February 26, 2020, International Application No. PCT / US2022 / 0751, filed August 17, 2022, and U.S. Provisional Patent Application No. 63 / 407,100, filed September 15, 2022, which applications are incorporated herein by reference. 【0035】 Figure 10 shows that after the ventricular assist balloon cannula (25) has advanced over the helical anchor catheter (10), a subcutaneous reservoir (26) may be attached to the proximal end of the ventricular assist balloon cannula (25), and the proximal end of the helical anchor catheter (10) may be inserted into a channel within the housing of the subcutaneous reservoir (26), where it is fixed in place using a set screw (27). Fixing the helical portion (11) embedded in the pericardium (19) and the proximal helical anchor catheter (10) to the reservoir (26) by the set screw (27) may prevent axial and lateral movement of the ventricular assist balloon cannula (25) relative to the heart (18). 【0036】 Preferred embodiments of the present disclosure have been shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided by way of example only. The present disclosure is not intended to be limited by the specific examples provided within this specification. Although the present disclosure has been described with reference to the foregoing specification, the description and illustration of the embodiments herein are not intended to be construed in a limiting sense. Those skilled in the art will envision numerous variations, modifications, and substitutions without departing from the present disclosure. Furthermore, it should be understood that all aspects of the present disclosure are not limited to the specific depictions, configurations, or relative ratios described herein, which depend on various conditions and variables. It should be understood that various alternative forms of the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. Accordingly, it is intended that the present invention encompass any such alternatives, modifications, variations, or equivalents. The following claims define the scope of the present disclosure, and it is intended that methods and structures within the scope of these claims and their equivalents be covered by the following claims.

Claims

[Claim 1] A pericardial anchor for positioning a cardiac support system on the patient's heart below the patient's sternum and ribs, A tubular shaft through which the guidewire lumen passes, Pericardial anchor at the distal end of the tubular shaft and A pericardial anchor comprising a tubular shaft, configured to be anchored within the patient's pericardium in response to the operation of the tubular shaft. [Claim 2] The pericardial anchor according to claim 1, further comprising a removable handle at the proximal end of the tubular shaft. [Claim 3] The pericardial anchor according to claim 2, configured to be anchored within the patient's pericardium in response to the operation of the tubular shaft by the handle. [Claim 4] The pericardial anchor according to claim 2, wherein the tubular shaft is configured to receive and anchor the cardiac support system on the patient's heart below the patient's sternum and ribs after the handle has been removed. [Claim 5] The pericardial anchor according to any one of claims 2 to 4, further comprising an extension shaft configured to be removably connected to the proximal end of the tubular shaft. [Claim 6] The pericardial anchor according to claim 5, wherein the extension shaft has a guide wire lumen. [Claim 7] The pericardial anchor according to claim 1 or 2, wherein the tubular shaft is a grooved metal tube having controlled flexibility. [Claim 8] The pericardial anchor according to claim 1 or 2, wherein the pericardial anchor is a spiral anchor having a flat distal surface oriented in a plane perpendicular to the axis of the tubular shaft, and the spiral anchor has a sharp tip configured to penetrate the pericardium while restricting penetration into the underlying fat layer. [Claim 9] The pericardial anchor according to claim 1 or 2, further comprising a polymer sleeve configured to cover the tubular shaft. [Claim 10] The pericardial anchor according to claim 1 or 2, wherein the operation of the tubular shaft includes rotating the tubular shaft. [Claim 11] The pericardial anchor according to claim 10, wherein the rotation of the tubular shaft is clockwise, causing the pericardial anchor to advance and become anchored within the patient's pericardium. [Claim 12] The pericardial anchor according to claim 1 or 2, wherein the pericardial anchor comprises a spiral portion having at least one rotation. [Claim 13] The pericardial anchor according to claim 12, wherein the wire diameter of the spiral portion is approximately 0.56 mm. [Claim 14] The pericardial anchor according to claim 12, wherein one rotation of the spiral portion has a penetration depth of approximately 1.4 mm. [Claim 15] The pericardial anchor according to claim 12, wherein the tip of the spiral portion has an angled undercut. [Claim 16] The pericardial anchor according to claim 12, wherein the pericardial anchor includes a flat distal surface, and at least one rotation of the spiral portion extends distally from the flat distal surface. [Claim 17] The pericardial anchor according to claim 1 or 2, wherein the pericardial anchor is made of at least a portion of metal. [Claim 18] The pericardial anchor according to claim 17, wherein the metal is stainless steel.

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