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EP-3187210-B1 - CATHETER DEVICE

EP3187210B1EP 3187210 B1EP3187210 B1EP 3187210B1EP-3187210-B1

Inventors

  • PFEFFER, JOACHIM GEORG
  • SCHMITZ-RODE, THOMAS
  • Günther, Rolf W.

Dates

Publication Date
20260513
Application Date
20080827

Claims (15)

  1. A catheter device comprising a drive shaft (4), a rotor (3.2) configured to be compressible and self-expandable for pumping blood, which is connected to the drive shaft (4), a pump housing configured to be compressible and expandable, which surrounds the rotor, characterized in that a distal rotor bearing (17) is provided distal to the rotor (3.2), and wherein a distal shaft protector (13.1) is provided, which surrounds the drive shaft (4) to center and support it.
  2. Catheter device according to claim 1, characterized in that the distal rotor bearing (17) comprises a bearing disc (15) and a distal end spacer sleeve (16) of the rotor (3.2), both of which are arranged on the drive shaft (4).
  3. Catheter device according to one of claims 1 or 2, characterized in that a proximal rotor bearing is provided.
  4. Catheter device according to claim 3, characterized in that the proximal rotor bearing comprises a bearing disc (15) and a proximal end spacer sleeve (16) of the rotor (3.2), both of which are arranged on the drive shaft (4).
  5. Catheter device according to any one of claims 1 to 4, characterized in that the drive shaft (4) is configured to be flexible and is received by through-holes in the bearing discs (15) with virtually no play.
  6. Catheter device according to any one of claims 1 to 5, characterized in that a tubular catheter shaft (8) is provided and the drive shaft (4) is surrounded by the catheter shaft (8), wherein the catheter shaft (8) extends from a proximal end region to a distal end region of the catheter device (1), wherein the catheter shaft (8) comprises a distal and a proximal catheter shaft section (8.1, 8.2).
  7. Catheter device according to claim 6, characterized in that a distal shaft protector 13.1 and/or a proximal shaft protector 13.2 is arranged in the axial direction within the distal and proximal catheter shaft sections 8.1, 8.2.
  8. Catheter device according to claim 7, characterized in that the bearing disc 15 is arranged on the drive shaft 4 in such a way that it receives the proximal end of the distal shaft protector 13.1 and limits it in the direction of transport 5.
  9. Catheter device according to claim 7 or 8, characterized in that a clearance is formed between the distal shaft protector 13.1 and the drive shaft 4, and a clearance is formed between the drive shaft and the bearing disc, which is provided for drawing in blood or serum to lubricate the distal rotor bearing 17.
  10. Catheter device according to any one of claims 1 to 9, characterized in that the rotor (3.2) comprises a frame structure (3.2.1) formed from a helical boundary frame (3.2.2) and rotor struts (3.2.3) extending inwards from the boundary frame (3.2.2) towards the drive shaft (4), and the rotor struts (3.2.3) are secured to the drive shaft (4) at their ends remote from the boundary frame (3.2.2), and an elastic covering extends between the boundary frame (3.2.2) and the drive shaft (4), wherein the frame structure (3.2.1) is formed from an elastic material such that the rotor (3.2) unfolds autonomously following an imposed compression.
  11. Catheter device according to any one of claims 1 to 10, characterized in that the pump housing (3.1) surrounds the rotor (3.2) with a tubular pump section (3.1.3), wherein the pump housing is formed from a mesh whose openings, at least in the region of the pump section (3.1.3), are closed by means of an elastic covering, and wherein the mesh of the pump housing (3.1) is formed from a shape-memory material.
  12. Catheter device according to claim 11, characterized in that the pump housing (3.1) comprises a distal connection section (3.1.1), a conical suction section (3.1.2), the pump section (3.1.3), a conical outlet section (3.1.4) and a proximal connection section (3.1.5).
  13. Catheter device according to claim 12, characterized in that the mesh has larger mesh openings in the conical sections (3.1.1, 3.1.2) than in the remaining sections, wherein the mesh openings in the conical sections (3.1.1, 3.1.2) are open.
  14. Catheter device according to claim 11, characterized in that the pump housing comprises, at the connecting sections, the tubular shaft protector (13.1, 13.2) in which the drive shaft (4) is rotatably mounted.
  15. Catheter device according to any one of claims 1 to 14, characterized in that the catheter device is an implantable blood pump for placement in the left ventricle.

Description

The invention relates to a catheter device that is a miniaturized pump. Implantable blood pumps are increasingly being used to treat patients with severe heart disease. These pumps are currently primarily intended for long-term use. However, blood pumps are also being developed that are designed for short-term cardiac support and can be implanted minimally invasively. The medical goals are to relieve the strain on the heart and promote its recovery, or to bridge the gap until a possible heart transplant. The range of applications for such pumps depends on the ease of implantation, the achievable technical specifications, and, in particular, the reliably achievable operating time of the available pump systems. Ideally, such a blood pump should be implantable percutaneously-intravascularly for short-term treatment without any surgical intervention. In cardiogenic shock, the ejection fraction of the left ventricle is significantly reduced. This diminished coronary blood supply can lead to irreversible heart failure. The use of a temporary left ventricular assist device (LVAD) aims to partially or largely take over the pumping function of the left ventricle and improve coronary blood supply. During cardiac surgery, such a system can be used in both the left and right ventricle and can replace a heart-lung machine. One percutaneously implantable system that has gained clinical significance is the intra-aortic balloon pump (IABP). The intra-aortic balloon pump, or intra-aortic counterpulsation, is a mechanical system also used to support the heart's pumping function in patients with cardiogenic shock. It involves the insertion of a catheter with a cylindrical A shaped plastic balloon is advanced through the groin into the thoracic aorta, so that it lies below the origin of the left subclavian artery. There, an external pump rhythmically inflates the balloon with 30-40 cm³ of helium with each heartbeat during diastole and deflates it during systole. In this way, the balloon pump improves blood flow to the heart muscle and all other organs. However, the achievable hemodynamic improvement is very limited because, due to the design principle of the IABP, there is no active blood pumping. A counterpulsation, performed in rhythm with the heartbeat, merely closes off the aorta below the left ventricle, thus pushing back and redistributing the blood ejected by the heart, including into the coronary arteries. There is no increase in blood flow. A well-known transfemoral implantable micro-axial pump, "Hemopump ™ " from Medtronic Inc., USA, has proven to be a promising concept, based on experimental and preliminary clinical trials, capable of providing sufficient left ventricular decompression. The pump's intake port is placed retrogradely across the aortic valve in the left ventricle. The pump rotor is located at the end of a cannula in the upper descending aorta and is driven by an external motor. A disadvantage of the system is that, due to the rotor's large diameter, transfemoral implantation is only possible surgically via a femoral arteryectomy and, if necessary, with graft coupling. From the WO 99/44651 This results in an axial pump that can be inserted through a patient's vascular system. The axial pump features a flexible, compressible tube that forms the pump housing. A radially compressible rotor is located within the tube. The rotor's drive shaft runs through a catheter. The catheter, along with the tube and rotor, can be drawn into a cover sheath. The radial compressibility of the components allows for a puncture diameter that is acceptable for percutaneous implantation using the Seldinger technique. Due to the expansion within the cardiovascular system, a relatively large pump diameter of 10 to 14 mm can be used. This reduces the rotor speed and thus the mechanical stress on the components. In the US 4,753,221 A catheter with an integrated blood pump featuring hinged vanes is described. The blood pump is an axial pump located within a catheter tube. A balloon is provided at the end of the catheter tube. This balloon can be inflated to unfold the pump casing, thereby closing the flow path past the pump and securing the pump within the blood vessel. In a further embodiment, a cup-shaped end of the catheter is provided within a tubular guide catheter. to order, to withdraw it and in this way unfold the cup-like end. From the DE 10 059 714 C1 An intravascular pump is created. The pump consists of a drive unit and a pump unit, both with such a small diameter that they can be inserted through a blood vessel. A flexible cannula is attached to the pump unit. To reduce flow resistance, the cannula can be expanded to a diameter larger than that of the drive unit or the pump unit. To insert the pump into the body using the Seldinger technique by puncturing the blood vessel, the cannula is constricted, resulting in a small diameter. Once inside the blood vessel, it expands, thus offering less flow resistance to the bloo