Blood pump for use in pediatric patients

Abstract

Various devices, systems, and methods are disclosed. The method is (approximately 0.6 m 2 ~about 1.3m 2 The process may include determining the patient's body surface area (which may have a body surface area of ​​0.9 m²), selecting a blood pump from several different sizes based on the patient's body surface area, implanting the blood pump, and activating the blood pump to provide assistance to the patient. The selected blood pump may have a cannula connecting the inlet and outlet. The cannula may have a bend and a cannula length that measures the axial length between the inlet and outlet. The cannula length is calculated based on a body surface area of ​​0.9 m². 2 If it is less than that, it could be approximately 30mm to 46mm.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to 63 / 521,011, filed on 14 June 2023, the entire contents of which are incorporated herein by reference.

[0002] Technical field Embodiments disclosed herein relate to medical devices such as intravascular blood pumps. [Background technology]

[0003] background To pump blood from the heart into the arteries, blood pump assemblies, such as intracardiac blood pumps or intravascular blood pumps, may be introduced into the heart. Such mechanical circulatory support devices are often introduced to assist cardiac function after a cardiac episode has occurred in a patient. One type of such device is a set of devices known as the Impella® cardiac pump or blood pump. Some blood pump assemblies may be introduced percutaneously through the vascular system during cardiac procedures. Specifically, a blood pump assembly may be inserted into the ascending aorta by catheterization through, for example, the femoral artery, axillary / subclavian artery, and then inserted into the left ventricle across the valve. The inserted blood pump assembly may be configured to draw blood from the left ventricle through a cannula and release it into the aorta. A blood pump assembly may also be configured to draw blood from the inferior vena cava and release it into the pulmonary artery. Some mechanical circulatory support devices are powered by an onboard motor, while others are powered by an external motor and drive cable. [Overview of the project] [Means for solving the problem]

[0004] Brief Overview In various embodiments, methods may be provided. A method may include determining the patient's body surface area. A method may include selecting a blood pump from several different sizes based on the patient's body surface area. A blood pump may have an inlet and an outlet opposite the inlet. The outlet may be connected to the inlet by a cannula. The cannula may have a bend and a cannula length that measures the axial length between the inlet and the outlet.

[0005] Choosing a blood pump may include selecting a blood pump with a cannula length of approximately 70 mm to 78 mm if the body surface area exceeds approximately 0.8 square meters. Choosing a blood pump may include selecting a blood pump with a cannula length of 6.0 centimeters if the body surface area exceeds approximately 1.1 square meters. Choosing a blood pump may include selecting a blood pump with a cannula length of approximately 30 mm to 46 mm if the body surface area is less than 0.9 square meters. Choosing a blood pump may include selecting a blood pump with a cannula length of approximately 34 mm to 42 mm if the body surface area is less than 0.9 square meters. Choosing a blood pump may include selecting a blood pump with a cannula length of approximately 36 mm to 39 mm if the body surface area is less than 0.9 square meters.

[0006] The method may include implanting a blood pump. Implanting a blood pump may include implanting the blood pump via the midclavicular axillary line.

[0007] The method may include activating a blood pump to provide assistance to the patient.

[0008] The blood pump may have a non-traumatic distal end. The non-traumatic distal end may include a pigtail connected to the inlet. The pigtail may have a pigtail length measured from the inlet to the most distal point on the pigtail. The pigtail length may be approximately 10 to 18 millimeters if the body surface area is less than 0.9 square meters. The pigtail length may be approximately 12 to 16 millimeters if the body surface area is less than 0.9 square meters. The pigtail length may be approximately 13 to 15 millimeters if the body surface area is less than 0.9 square meters.

[0009] The curvature of the cannula can be approximately 125 to 145 degrees when the body surface area is less than 0.9 square meters. The curvature of the cannula can be approximately 130 to 140 degrees when the body surface area is less than 0.9 square meters. The curvature of the cannula can be approximately 134 to 136 degrees when the body surface area is less than 0.9 square meters.

[0010] In various embodiments, a system may be provided. The system may include a blood pump. The blood pump may include an inlet and an outlet located opposite the inlet. The blood pump may include a cannula connecting the inlet and outlet. The cannula may have a length between the inlet and outlet. The blood pump may be configured to be inserted into a patient having a body surface area of ​​approximately 0.6 square meters to approximately 1.3 square meters. The blood pump may be implanted via the midclavicular-axillary line. The body surface area may be approximately 0.7 square meters to approximately 1.2 square meters. The body surface area may be approximately 0.86 square meters to 1.15 square meters.

[0011] The system may include a pigtail connected to the inlet. The pigtail may have a pigtail length, which is measured by the distance between the inlet and the farthest point on the pigtail.

[0012] In various embodiments, a blood pump may be provided. The blood pump may include an inlet and an outlet on the opposite side of the inlet. The blood pump may include a cannula connecting the inlet and the outlet. The cannula may include a first region and a second region. There may be a cannula angle (i.e., a bend of less than 180 degrees) between the first and second regions. The cannula may have a cannula length measured by summing the total axial lengths of the first and second regions. The blood pump may include a non-traumatic distal tip. The non-traumatic distal tip may include a pigtail connected to the inlet. The pigtail may have a pigtail length measured by the distance between the inlet and the most distal point on the pigtail. The cannula length may be about 30 mm to about 46 mm, and the pigtail length may be about 10 mm to about 18 mm.

[0013] The cannula length may be approximately 34 mm to 42 mm, and the pigtail length may be approximately 12 mm to 16 mm. The cannula length may be approximately 36 mm to 39 mm, and the pigtail length may be approximately 13 mm to 15 mm.

[0014] The cannula angle can be approximately 125 degrees to 145 degrees. The cannula angle can be approximately 130 degrees to 140 degrees. The cannula angle can be approximately 134 degrees to 136 degrees.

[0015] The blood pump may be configured for use in patients with a body surface area of ​​less than 0.9 square meters. The blood pump may be configured to be implanted via the midclavicular axillary line.

[0016] Brief explanation of the drawing The aforementioned and other purposes and advantages will become clear when considered in conjunction with the attached drawings and the following detailed description. In the drawings, similar reference numerals refer to the same parts throughout. [Brief explanation of the drawing]

[0017] [Figure 1A] An exemplary circulatory assist device that can be used according to some embodiments is shown. [Figure 1B] The circulatory assist device of FIG. 1A, positioned within a patient's heart, is shown. [Figure 1C] A ventricular assist system including the circulatory assist device of FIG. 1A is shown. [Figure 2] Valve adaptation and delivery for a patient receiving mechanical circulatory assistance are shown. [Figure 3] A method according to some embodiments is shown. <00\00089>

Mode for Carrying Out the Invention

[0018] Detailed Description As is known, pediatric patients with progressive heart failure face a high risk of death and morbidity. Similarly, as is known, there are few available mechanical circulatory assist options. For example, not all existing mechanical circulatory assist devices are suitable for the anatomical structure of pediatric patients. Specifically, some existing mechanical circulatory assist devices may be configured for larger patients (e.g., adolescent and / or adult patients) and may be too large for the vascular and / or ventricular anatomical structures of pediatric patients.

[0019] Therefore, the inventors recognize the advantages of devices sized to fit smaller patients (e.g., pediatric patients). For example, the inventors recognize the benefits of a blood pump having a geometric shape and / or scale configured to fit the small anatomical structure of a child. The inventors also recognize the advantage that, due to the cannulae being shorter, the blood flow rate through the cannulae is higher. The inventors also recognize the advantage of determining the appropriate assist device for each patient. For example, in some embodiments, the body surface area (BSA) of a patient, e.g., the BSA of a pediatric patient, can be calculated to determine whether the patient's anatomical structure is suitable for one of a plurality of different sized assist devices. In this regard, a physician can appropriately fit the patient to an adult or adolescent sized blood pump or a pediatric sized blood pump.

[0020] Referring to the drawings, Figure 1A shows a diagram of a blood pump (100) of a blood pump system according to several embodiments. The blood pump (100) may include a cannula (102), a pump housing (104), a blood inlet (106), a blood outlet (108), and a non-traumatic tip such as a pigtail (110). The cannula (102) may be connected to the blood inlet (106) at the distal portion of the cannula (102) and to the blood outlet (108) at the proximal portion. The pump housing (104) may include an impeller (112) located inside the blood outlet (108).

[0021] In some embodiments, the pump housing (104) may include an onboard motor (114), as shown in this figure. In other embodiments, the blood pump (100) may include an external motor.

[0022] In some embodiments, the blood pump (100) may not include a pigtail (for example, the blood pump may be without a pigtail). In some embodiments, the blood pump may not have a non-traumatic tip.

[0023] As shown in Figure 1B, the blood pump (100) can be positioned within the patient's heart (120). For example, the blood pump (100) may be inserted percutaneously into the ascending aorta (124) via the femoral artery (122), across the aortic valve (126), and into the left ventricle (128). In other implementations, the blood pump may be inserted percutaneously into the ascending aorta (124) via the axillary artery (123), across the aortic valve (126), and into the left ventricle (128). In other implementations, the blood pump may be inserted via the carotid artery (such as the common carotid artery (125) or a carotid artery connected to the common carotid artery). In other implementations, the blood pump may be inserted directly into the ascending aorta (124), across the aortic valve (126), and into the left ventricle (128).

[0024] During operation, the blood pump (100) can draw blood from the left ventricle (128) and release it into the ascending aorta (124). As a result, the blood pump (100) can perform some of the work normally done by the patient's heart (120). The hemodynamic effects of the blood pump include increased cardiac output and improved coronary blood flow, which can lead to decreased left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, myocardial work, and oxygen consumption.

[0025] As shown in Figure 1C, the blood pump (100) may form part of a ventricular assist system (129). The ventricular assist system (129) may also include a controller (130) (e.g., an AUTOMATED IMPELLA CONTROLLER® from ABIOMED, ​​Inc. (Danvers, Mass.), referred to herein as "AIC"), a display (140), a purge subsystem (150), a connector cable (160), a plug (170), and a repositioning unit (180). As shown in the figure, the controller (130) may include a display (140). The controller (130) may be configured to monitor and control the operation of the blood pump (100). During operation, the purge subsystem (150) may be configured to deliver purge fluid to the blood pump (100) through a catheter tube to prevent blood from entering the motor (not shown) in the motor housing. In some implementations, the purging fluid is a dextrose solution (e.g., 5% dextrose in water containing 25 or 50 IU / mL of heparin). A connector cable (160) may provide an electrical connection between the blood pump (100) and the controller (130).

[0026] The plug (170) may connect to a catheter tube (181), a purge subsystem (150), and a connector cable (160). In some implementations, the plug (170) may include a storage device (171) (e.g., memory) configured to store, for example, operating parameters, to facilitate transferring the patient to another controller if necessary. A relocation unit (180) may be used to relocate a blood pump (100) within the patient's heart.

[0027] As shown in the illustration, in some embodiments, the ventricular assist system may include a purge subsystem (150) having a container (151), a supply line (152), a purge cassette (153), a purge disc (154), a purge tube (155), a check valve (156), a pressure reservoir (157), an infusion filter (158), and a side arm (159). The container (151) may be, for example, a bag or a bottle. As understood, in other embodiments, the ventricular assist system may not include the purge subsystem. In some embodiments, the purge fluid may be stored in the container (151). The supply line (152) may provide a fluid connection between the container (151) and the purge cassette (153).

[0028] The purge cassette (153) can control how the purge fluid in the container (151) is delivered to the blood pump (100). For example, the purge cassette (153) may include one or more valves for controlling the pressure and / or flow rate of the purge fluid. The purge disc (154) may include one or more pressure sensors and / or flow sensors for measuring the pressure and / or flow rate of the purge fluid.

[0029] As shown in the figure, the controller (130) may include a purge cassette (153) and a purge disc (154). A purge tube (155) may provide a fluid connection between the purge disc (154) and a check valve (156). A pressure reservoir (157) may provide additional filling volume during purge fluid exchange. In some implementations, the pressure reservoir (157) may include a flexible rubber diaphragm that provides additional filling volume by an expansion chamber. An infusion filter (158) may help prevent bacterial contamination and air from entering the catheter tube (181). A side arm (159) provides a fluid connection between the infusion filter (158) and a plug (170).

[0030] Although shown as having separate purge tubes and connector cables, it will be understood that in some embodiments the ventricular assist system may include a single connector from which both fluid lines and electrical wires can be connected to the AIC.

[0031] As shown in Figure 1A, the cannula (102) may have a first cannula region (116) and a second cannula region (118). In some embodiments, the cannula (102) may further include a bending angle (117). The bending angle (117) may be the angle between the longitudinal axis of the first cannula region (116) and the longitudinal axis of the second cannula region (118). The cannula (102) may have a cannula length equal to the sum of the axial lengths of the first cannula region (116) and the second cannula region (118). As can be understood, two regions are used here, but any number of suitable regions may be used. In such embodiments, the cannula length may be equal to the sum of the axial lengths of each region of the cannula, regardless of the number of regions.

[0032] Furthermore, the pigtail (110) may have a pigtail length (111). The pigtail length (111) may be equal to the distance from the distal end of the blood inlet (106) to the most distal point of the pigtail (110).

[0033] In some embodiments, the cannula length and pigtail length (111) may be varied to provide different sized blood pumps for different pediatric patients. A blood pump with appropriate dimensions may be selected based on BSA.

[0034] The patient's heart (200) is shown in Figure 2. The patient's BSA may correlate with the patient's left ventricular length (202), ascending aortic length (204), brachiocephalic diameter (206), and left subclavian inlet diameter (208). For example, in some embodiments, a cannula length of 74.3 ± 0.2 mm and a pigtail length of approximately 40 mm may be suitable for the anatomical structure of a patient with a BSA greater than 0.86 mm square meter. As understood, any suitable intravascular blood pump having a cannula length of 74.3 ± 0.2 mm, e.g., Impella CP, may be used. In such embodiments, a patient with a BSA greater than 0.86 mm square meter may have a left ventricular length (202) that can be adapted to the cannula length and pigtail length. In other embodiments, a blood pump without a pigtail and with a cannula length of 86 mm may be suitable for the anatomical structure of a patient with a BSA of 1.15 mm square meter. As understood, any suitable intravascular blood pump with a cannula length of 86 millimeters, such as the Impella 5.5, may be used. In such embodiments, a patient with a BSA of 1.15 square meters may have a left ventricular length (202) that may not accommodate a larger cannula and pigtail, so a blood pump with a shorter cannula and no pigtail may be used. In some embodiments, the patient's BSA may be less than 0.9 square meters, so a pump with different dimensions and / or geometric shape than commercially available intravascular blood pumps may be required.

[0035] In patients with a BSA of less than 0.9 square meters, the blood pump may have different cannula lengths, pigtail lengths (111) and / or flexion angles (117). In one embodiment, the cannula length may be about 30 mm to about 46 mm. A shorter cannula length results in a higher blood flow rate through the cannula. In some embodiments, the pigtail length may be about 10 mm to about 18 mm. In some embodiments, the flexion angle may be about 125 degrees to about 145 degrees. As understood, the cannula length, pigtail length and / or flexion angle may be any appropriate values. As similarly understood, other dimensions and / or geometric shapes may be modified in addition to and / or instead of the dimensions described above.

[0036] In some embodiments, the blood pump may be introduced or implanted by a femoral access or any other suitable method. In some embodiments, the blood pump may be introduced or implanted via the axillary artery. In some embodiments, the blood pump may be introduced or implanted via the carotid artery. In some embodiments, the blood pump may be introduced or implanted directly (e.g., directly into or through the ascending aorta). In other embodiments, the blood pump may be surgically implanted via a graft sutured to the aortic valve. In some embodiments, the patient's BSA may be less than 1.15 square meters, and the patient's brachiocephalic diameter (206) and / or left subclavian inlet diameter (208) may be too small to accommodate some blood pumps. In such embodiments, the blood pump may be implanted via a midclavicular access. In other embodiments, the blood pump may be implanted via a carotid access.

[0037] As will be appreciated in view of the above, in some embodiments, the first length, the second length, and the bending angle can be configured to assist various patient populations. In that regard, the shape and size of the blood pump or multiple parts of the blood pump can vary according to the size of the patient. Accordingly, in some embodiments, a method for determining a patient's eligibility and suitability for intravascular blood pump assistance is described.

[0038] An exemplary method is shown in FIG. 3, which can include a method (300) of using a blood pump for patients requiring hemodynamic assistance, such as pediatric patients. In some embodiments, the method (300) can include determining the body surface area of the patient (302).

[0039] As will be appreciated, the body surface area of the patient can be determined using any suitable method. For example, in Du Bois, D., et al., “A formula to estimate the approximate surface area if height and weight be known” (Published 1 June 1916), Medicine, JAMA Internal Medicine, a formula for body surface area based on a person's weight and height was estimated based on the following formula: BSA (m 2 ) = 0.007184 × weight 0.425 × height 0.725 (where weight is in kg and height is in cm). Other similar methods (e.g., estimating BSA using a person's height and weight) include, for example, Mosteller's formula: BSA = square root of ((height × weight) / 3600), Haycock's formula: BSA = 0.024265 × weight 0.5378 × height 0.3964 , Gehan and George's formula: BSA = 0.0235 × weight 0.51456 × height 0.42246 or Fujimoto's formula: BSA = 0.008883 × weight 0.444 × height 0.663This includes other methods. For example, in some embodiments, the BSA estimate is based on body weight alone. See, for example, El Edelbi, RA, et al., “Estimation of body surface area in neonates, infants, and children using body weight alone”, Int J Pediatr Adolesc Med. 2021 Dec; 8 (4): 221-228. Three options are described there, including a cubic polynomial (BSA = B0 + B1 * body weight + B2 * body weight). 2 +B3*weight 3 ), Meeh type equation (BSA=A×body weight B ) and Boyd's self-regulating equation (BSA = A × body weight) BClog(体重) It includes.

[0040] The blood pump is configured to be inserted into a patient having a body surface area of ​​approximately 0.6 square meters to approximately 1.3 square meters. In some embodiments, the body surface area may be approximately 0.7 square meters to approximately 1.2 square meters. In some embodiments, the body surface area may be approximately 0.86 square meters to 1.15 square meters.

[0041] In some embodiments, the method may also include selecting a blood pump of an appropriate size based on the patient's body surface area (304). In such embodiments, the blood pump may be similar to those described herein and may have an inlet and an outlet which may be located opposite the inlet. The outlet may be connected to the inlet by a cannula having a bend and a length measured by the distance between the bend and the inlet. In some embodiments, the method may also include implanting the blood pump (306). In such embodiments, the blood pump may be implanted via the midclavicular axillary line. However, as understood, the blood pump may be implanted by any suitable means. In some embodiments, the method may include activating the blood pump to provide assistance to the patient (308).

[0042] In some embodiments, selecting a blood pump (304) may include selecting a blood pump having a predetermined length that is selected based on the patient's body surface area.

[0043] In some embodiments, the length of the blood pump may be one of two lengths (i.e., a relatively short length when the body surface area is below a predetermined first threshold and a relatively long length when the body surface area is above a predetermined second threshold). In some embodiments, the total cannula length of the blood pump may be one of three lengths. For example, in one embodiment, the blood pump may have a cannula length of 6.0 centimeters when the body surface area is greater than 1.1 square meters. In another embodiment, the blood pump may have a cannula length of about 4.6 centimeters to 6.0 centimeters when the body surface area is between 0.9 square meters and 1.1 square meters. In yet another embodiment, the blood pump may have a cannula length of about 3.0 centimeters to about 4.6 centimeters when the body surface area is less than 0.9 square meters. In such embodiments, the blood pump may have a cannula length of 3.8 centimeters when the body surface area is less than 0.9 square meters.

[0044] In some embodiments, the blood pump may include a pigtail that can be connected to an inlet. In such embodiments, the pigtail may have a pigtail length equal to the distance between the inlet and the distal end of the pigtail. In some embodiments, the pigtail length may be about 1.0 cm to about 1.8 cm when the body surface area is less than 0.9 square meters. In such embodiments, the pigtail length may be 1.4 cm when the body surface area is less than 0.9 square meters.

[0045] In some embodiments, the blood pump may have a cannula length of about 70 mm to about 78 mm when the body surface area exceeds about 0.8 square meters.

[0046] In some embodiments, the blood pump may have a cannula length of about 30 mm to about 46 mm when the body surface area is less than 0.9 square meters. In some embodiments, the blood pump may have a cannula length of about 34 mm to about 42 mm when the body surface area is less than 0.9 square meters. In some embodiments, the blood pump may have a cannula length of about 36 mm to 39 mm when the body surface area is less than 0.9 square meters.

[0047] In some embodiments, the pigtail length (measured from the entrance to the distal point on the pigtail) may be about 10 to 18 millimeters when the body surface area is less than 0.9 square meters. In some embodiments, the pigtail length may be about 12 to 16 millimeters when the body surface area is less than 0.9 square meters. In some embodiments, the pigtail length may be about 13 to 15 millimeters when the body surface area is less than 0.9 square meters.

[0048] In some embodiments, the cannula may have a bend. In such embodiments, the bend may be about 125 degrees to about 145 degrees when the body surface area is less than 0.8 square meters. In such embodiments, the bend of the cannula may be 135 degrees. In some embodiments, the bend of the cannula may be about 125 degrees to about 145 degrees when the body surface area is less than 0.9 square meters. In some embodiments, the bend of the cannula may be about 130 degrees to about 140 degrees when the body surface area is less than 0.9 square meters. In some embodiments, the bend of the cannula may be about 134 degrees to about 136 degrees when the body surface area is less than 0.9 square meters.

[0049] All definitions defined and used herein should be understood to take precedence over dictionary definitions, definitions in literature incorporated by reference, and / or the ordinary meanings of the terms defined.

[0050] As used herein and in the claims, the indefinite articles “a” and “an” should be understood to mean “at least one” unless explicitly stated otherwise.

[0051] As used herein and in the claims, the phrase "and / or" should be understood to mean "either or both" of the elements thus joined, i.e., elements that exist in some cases conjunctively and in other cases disjunctively. Multiple elements enumerated by "and / or" should also be interpreted in the same manner, i.e., "one or more" of the elements thus joined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally exist, whether related to or unrelated to those specifically identified elements. For this reason, as a non-restrictive example, when used in combination with open-ended language such as "includes," a reference to "A and / or B" may, in one embodiment, refer only to A (optionally including elements other than B), in another embodiment to B (optionally including elements other than A), and in yet another embodiment to refer to both A and B (optionally including other elements), and so on.

[0052] As used herein and in the claims, the phrase “at least one” means, in relation to a list of one or more elements, at least one element selected from any one or more elements in the list of elements, but not necessarily including at least one of every element specifically enumerated in the list of elements, nor excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase “at least one” refers, whether related to or unrelated to those specifically identified elements. Therefore, as a non-limiting example, "at least one of A and B" (or equally "at least one of A or B" or equally "at least one of A and / or B") may mean, in one embodiment, at least one without B, optionally for example, two or more A's (and optionally including elements other than B); in another embodiment, at least one without A, optionally for example, two or more B's (and optionally including elements other than A); and in yet another embodiment, at least one, optionally for example, two or more A's and at least one, optionally for example, two or more B's (and optionally including other elements), and so on.

[0053] The usage and terminology used herein are for illustrative purposes only and should not be considered limiting. The use of “include,” “contain,” “have,” “contain,” “accompany,” and their variations herein is intended to include the items listed therein and their equivalents, as well as any additional items.

[0054] In the claims and the above-mentioned specification, transitional phrases such as “include,” “encompass,” “carry,” “have,” “contain,” “accompany,” “hold,” and “compose” are all understood to be open-ended, meaning they include but are not limited to. Only the transitional phrases “consist of” and “essentially become from” are restrictive or semi-restrictive transitional phrases, respectively.

[0055] The use of ordinal terms such as “first,” “second,” and “third” in the claims to modify the claimed elements does not in itself imply any priority, order, or sequence or temporal order in which any action of method is performed of one claimed element over another, but is simply used as a label to distinguish the claimed elements, to distinguish one claimed element having a particular name from another element having the same name (but using ordinal terms).

Claims

1. Determining the patient's body surface area, The selection of a blood pump from a plurality of different sizes based on the patient's body surface area, wherein the blood pump has an inlet and an outlet opposite the inlet, the outlet is connected to the inlet by a cannula, and the cannula has a bend and a cannula length that measures the axial length between the inlet and the outlet. The aforementioned blood pump is implanted, To operate the blood pump in order to provide assistance to the patient A method that includes this.

2. The method according to claim 1, wherein the implantation of the blood pump further comprises implanting the blood pump via the midclavicular axillary line.

3. The method according to claim 1, wherein the selection of a blood pump includes selecting a blood pump having a cannula length of about 70 mm to about 78 mm if the body surface area is greater than about 0.8 square meters.

4. The method according to claim 1, wherein the selection of a blood pump includes selecting a blood pump having a cannula length of 6.0 centimeters if the body surface area is greater than approximately 1.1 square meters.

5. The method according to claim 1, wherein the selection of a blood pump includes, if the body surface area is less than 0.9 square meters, selecting a blood pump having a cannula length of about 30 millimeters to about 46 millimeters.

6. The method according to claim 5, wherein the selection of a blood pump includes, if the body surface area is less than 0.9 square meters, selecting a blood pump having a cannula length of about 34 millimeters to about 42 millimeters.

7. The method according to claim 6, wherein the selection of a blood pump includes, if the body surface area is less than 0.9 square meters, selecting a blood pump having a cannula length of about 36 to 39 millimeters.

8. The method according to claim 1, wherein the blood pump has a pigtail coupled to the inlet, and the pigtail has a pigtail length measured from the inlet to the most distal point on the pigtail.

9. The method according to claim 8, wherein the pigtail length is about 10 millimeters to about 18 millimeters when the body surface area is less than 0.9 square meters.

10. The method according to claim 9, wherein the pigtail length is about 12 millimeters to about 16 millimeters when the body surface area is less than 0.9 square meters.

11. The method according to claim 10, wherein the pigtail length is about 13 millimeters to 15 millimeters when the body surface area is less than 0.9 square meters.

12. The method according to claim 1, wherein the curved portion of the cannula is approximately 125 degrees to approximately 145 degrees when the body surface area is less than 0.9 square meters.

13. The method according to claim 12, wherein the bent portion of the cannula is approximately 130 degrees to approximately 140 degrees when the body surface area is less than 0.9 square meters.

14. The method according to claim 13, wherein the curved portion of the cannula is approximately 134 degrees to approximately 136 degrees when the body surface area is less than 0.9 square meters.

15. It is a blood pump, An entrance and an exit located on the opposite side of the entrance, A cannula connecting the inlet and the outlet, the cannula having a length between the inlet and the outlet. blood pumps A system comprising a blood pump configured to be inserted into a patient having a body surface area of ​​approximately 0.6 square meters to approximately 1.3 square meters.

16. The system according to claim 15, wherein the blood pump is implanted via the midclavicular axillary line.

17. The system according to claim 15, wherein the body surface area is approximately 0.7 square meters to approximately 1.2 square meters.

18. The system according to claim 17, wherein the body surface area is approximately 0.86 square meters to 1.15 square meters.

19. The system according to claim 15, further comprising a pigtail coupled to the inlet, the pigtail having a pigtail length measured by the distance between the inlet and the farthest point on the pigtail.

20. It is a blood pump, The entrance and the exit on the opposite side of the said entrance, A cannula connecting the inlet and the outlet, further comprising a first region, a second region, and a cannula angle between the first region and the second region, and having a cannula length measured by the total axial length of the first region and the second region, A pigtail connected to the inlet, the pigtail having a pigtail length measured by the distance between the inlet and the farthest point of the pigtail. A blood pump comprising a cannula with a length of approximately 30 mm to 46 mm and a pigtail with a length of approximately 10 mm to 18 mm.

21. The blood pump according to claim 20, wherein the cannula length is about 34 mm to about 42 mm, and the pigtail length is about 12 mm to about 16 mm.

22. The blood pump according to claim 21, wherein the cannula length is approximately 36 mm to approximately 39 mm, and the pigtail length is approximately 13 mm to approximately 15 mm.

23. The blood pump according to claim 20, wherein the cannula angle is approximately 125 degrees to approximately 145 degrees.

24. The blood pump according to claim 23, wherein the cannula angle is approximately 130 degrees to approximately 140 degrees.

25. The blood pump according to claim 24, wherein the cannula angle is approximately 134 degrees to approximately 136 degrees.

26. The blood pump according to claim 20, configured for use in patients having a body surface area of ​​less than 0.9 square meters.

27. The blood pump according to claim 20, which is implanted via the midclavicular axillary line.

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