Intra-aortic balloon pump catheter and sheath seal assembly

Abstract

To provide a suitable intra-aortic balloon pump catheter and sheath seal assembly.SOLUTION: There is provided herein an intra-aortic balloon catheter including: a tube; and a sheath seal including an elastomeric housing having a proximal end, a distal end, a lumen arranged between the proximal end of the housing and the distal end of the housing, wherein the housing includes an impingement device, wherein the lumen is configured to slidably receive the tube therein and the impingement device is configured to engage the outer surface of the tube and apply a force thereto in order to prevent the tube from sliding relative to the sheath seal when the impingement device is in a first state.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application claims the priority and benefit of co-pending U.S. Provisional Patent Application No. 62 / 861,465, filed on Jun. 14, 2019, and co-pending U.S. Provisional Patent Application No. 62 / 862,544, filed on Jun. 17, 2019, the disclosures of which are hereby incorporated by reference in their entireties for all that they disclose.

[0002] Provided herein are cardiovascular assist devices and methods of using the same, and in one particular non-limiting embodiment, an assembly including an intra-aortic balloon pump (IABP) catheter, an IABP, and a sheath seal, and a method of providing cardiovascular assistance by delivering the IABP through the axillary artery or the subclavian artery.

Background Art

[0003] Intra-aortic balloon pump (IABP) catheters are typically used in patients with left ventricular failure, such as left ventricular insufficiency, to increase coronary perfusion and reduce the load on the heart, such as the left ventricle. The general arrangement and configuration of the IABP have not changed significantly over the years, and this conventional configuration has drawbacks.

[0004] The IABP is introduced into the femoral artery through an insertion sheath and is often introduced through the descending thoracic aorta until the distal end of the balloon is positioned just below (distal to) the left subclavian artery. Next, the balloon is periodically inflated and deflated to assist the heart. The drawback of inserting the IABP through the femoral artery is that the patient must remain mostly in the supine position while the IABP is in place, restricting the patient's mobility. There is a need to insert the IABP through other arteries such as the axillary artery or the subclavian artery, and then, while the IABP is in place, the patient is not restricted to a mostly supine position with restricted mobility. Therefore, in the art, different configurations of the IABP are needed that allow insertion through different blood vessels and maintain the position of the IABP within the patient's vasculature when delivered to the treatment site.

[0005] IABP assemblies have heretofore optionally included a protective sleeve with an insertion sheath. Sheath seals have also been used in such assemblies to fix the protective sleeve and / or the IABP in place during cardiac assist therapy. U.S. Patent No. 6,537,254 discloses such a sheath seal. However, there is a need in the art for a sheath seal that improves resistance to movement of the IABP during cardiac assist therapy, such as may be encountered in ambulatory cardiac assist therapy, while allowing movement or repositioning of the IABP if desired by a physician or technician. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0006] Accordingly, provided herein is a balloon catheter assembly, an intravascular balloon catheter including a proximal end, a distal end, and a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface that define at least one lumen extending between the proximal end and the distal end, and a balloon membrane disposed at the distal end; and a sheath seal including an elastomeric housing, the elastomeric housing having a proximal end, a distal end, and a lumen disposed between the proximal end of the housing and the distal end of the housing, the housing including a collision device, the lumen configured to slidably receive the tube therein, the collision device configured to engage the outer surface of the tube and apply a force to the tube to prevent the tube from sliding relative to the sheath seal when the collision device is in a first position.

[0007] Also provided herein is an intravascular balloon catheter having a proximal end, a distal end including a J tip, and a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface that define one or more lumens, and a balloon membrane disposed at the distal end.

[0008] Also provided herein is an intravascular balloon catheter having a proximal end, a distal end, and a tube including a sidewall disposed between the proximal end and the distal end, the sidewall having an outer surface and an inner surface that define a gas lumen, a sensor lumen in common lumen arrangement with the gas lumen, and a guidewire lumen in common lumen arrangement with the gas lumen and sharing a common wall with the sensor lumen, and a balloon membrane disposed at the distal end and in fluid communication with the gas lumen.

[0009] Also provided herein is a method of intravascular balloon pumping of blood, the method comprising the steps of inserting a balloon catheter assembly into a patient's axillary artery or subclavian artery, the balloon catheter assembly being an intra-aortic balloon catheter having a proximal end, a distal end, and a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface defining at least one lumen extending between the proximal end and the distal end, a balloon membrane being disposed at the distal end and in fluid communication with the at least one lumen; a sheath seal including an elastomeric housing having a proximal end, a distal end, and a lumen disposed between the proximal end of the housing and the distal end of the housing, the housing including a collision device, the lumen being configured to slidably receive a tube therein, the collision device being configured to engage an outer surface of the tube and apply a force to the outer surface of the tube; inserting the balloon catheter assembly including the sheath seal; advancing the distal end of the balloon catheter into a patient's aorta; and inflating and deflating the balloon membrane by passing fluid in and out of the balloon membrane through the at least one lumen to provide intravascular balloon pumping of blood.

[0010] Further non-limiting embodiments or aspects are described in the numbered clauses below.

[0011] Clause 1. An intra-aortic balloon catheter comprising a proximal end, a distal end, and a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface defining at least one lumen extending between the proximal end and the distal end, a balloon membrane disposed at the distal end, the intra-aortic balloon catheter, and a sheath seal including an elastomeric housing, the elastomeric housing including a proximal end, a distal end, and a lumen disposed between the proximal end of the housing and the distal end of the housing, the housing including a collision device, the lumen configured to slidably receive the tube within the lumen, and when the collision device is in a first state, the collision device engages the outer surface of the tube and is configured to apply a force to the outer surface of the tube to prevent the tube from sliding relative to the sheath seal, the balloon catheter assembly including the sheath seal.

[0012] Clause 2. When the collision device is in the first state, the collision device includes a movable pressure element disposed to exert pressure on the outer surface of the tube to prevent the tube from sliding relative to the sheath seal, the pressure element being movable to relieve pressure on the outer surface of the tube such that the tube is slidable relative to the sheath seal when the collision device is in a second state, the balloon catheter assembly according to Clause 1.

[0013] Clause 3. The housing of the sheath seal further includes a foldable section disposed between the proximal end of the housing and the distal end of the housing, and applying pressure to the foldable section of the housing causes the foldable section to be configured to move the collision device from the first state to the second state, the balloon catheter assembly according to Clause 1 or 2.

[0014] Clause 4. The balloon catheter assembly according to any one of Clauses 1 to 3, wherein the movable pressure element is selected from the group consisting of a static interference pinch lock, a bent portion disposed in the housing, an off-center section disposed to impinge on the tube in the first state, and an offset pinch that opens the lumen of the housing when pinched.

[0015] Clause 5. The balloon catheter assembly according to any one of Clauses 1 to 4, wherein the distal end of the housing of the sheath seal is tapered.

[0016] Clause 6. The balloon catheter assembly according to any one of Clauses 1 to 5, wherein the housing of the sheath seal further includes one or more suture pads configured to allow a suture thread to pass therethrough to enable fixing the sheath seal to a patient.

[0017] Clause 7. The balloon catheter assembly according to any one of Clauses 1 to 6, wherein the elastomeric housing includes a thermoplastic elastomer.

[0018] Clause 8. The balloon catheter assembly according to any one of Clauses 1 to 7, further including a Y-connection including a hub, the hub having a proximal end, a distal end, and a lumen disposed between the proximal end and the distal end of the hub.

[0019] Clause 9. The balloon catheter assembly according to any one of Clauses 1 to 8, wherein the Y-connection hub is connected to the housing of the sheath seal.

[0020] Clause 10. The balloon catheter assembly according to any one of Clauses 1 to 9, wherein an angled lumen extends between the proximal end of the Y-connection hub and the distal end of the housing of the sheath seal, for one or both of the lumen of the sheath seal and the lumen of the hub of the Y-connection.

[0021] Clause 11. The balloon catheter assembly according to any one of Clauses 1 to 10, wherein the collision device includes a channel defined by one or more side walls disposed in the lumen of the sheath seal.

[0022] Clause 12. The balloon catheter assembly according to any one of Clauses 1 to 11, wherein the longitudinal axis defined by the center of the channel is offset from the longitudinal axis defined by the center of the lumen of the sheath seal.

[0023] Clause 13. The balloon catheter assembly according to any one of Clauses 1 to 12, wherein the housing of the sheath seal includes a plurality of tabs extending therefrom, and when pressure is applied to the plurality of tabs, the pressure element moves, causing the collision device to transition to the second state.

[0024] Clause 14. The balloon catheter assembly according to any one of Clauses 1 to 13, wherein the distal end of the balloon catheter includes a pre-formed curved portion.

[0025] Clause 15. The balloon catheter assembly according to any one of Clauses 1 to 14, wherein the pre-formed curved portion includes a J-tip or a pigtail.

[0026] Clause 16. The balloon catheter assembly according to any one of Clauses 1 to 15, wherein the J-tip includes a first substantially straight segment connected to the distal end of the balloon catheter, a curved segment connected to the distal end of the first substantially straight segment at its first end, and a second substantially straight segment attached to the second end of the curved segment, the second substantially straight segment being disposed substantially parallel to the first substantially straight segment.

[0027] Clause 17. The balloon catheter assembly according to any one of Clauses 1 to 16, wherein the J-tip includes a thermoplastic material.

[0028] Item 18. The balloon catheter assembly according to any one of Items 1 to 17, wherein the thermoplastic material includes thermoplastic polyurethane.

[0029] Item 19. The balloon catheter assembly according to any one of Items 1 to 18, wherein the thermoplastic material includes a polyether-based thermoplastic polyurethane.

[0030] Item 20. The balloon catheter assembly according to any one of Items 1 to 19, wherein the J-tip includes metal.

[0031] Item 21. The balloon catheter assembly according to any one of Items 1 to 20, wherein the diameter of the theoretical circle formed by the J-tip and the balloon catheter exceeds 8 mm.

[0032] Item 22. The balloon catheter assembly according to any one of Items 1 to 21, wherein the distal end of the balloon catheter includes an elongated extension.

[0033] Item 23. The balloon catheter assembly according to any one of Items 1 to 22, wherein the at least one lumen of the tube includes a sensor lumen, a gas lumen, and a guide wire lumen.

[0034] Item 24. The balloon catheter assembly according to any one of Items 1 to 23, wherein the guide wire lumen is defined by a guide wire lumen side wall including a polyimide tube.

[0035] Item 25. The balloon catheter assembly according to any one of Items 1 to 24, wherein the polyimide tube is embedded in the side wall of the balloon catheter, and the polyimide tube and the gas lumen are arranged in a common lumen arrangement.

[0036] Clause 26. The balloon catheter assembly according to any one of Clauses 1 to 25, wherein the sensor lumen is defined by a sensor lumen side wall, is arranged in a common lumen arrangement with the gas lumen, and the sensor lumen side wall includes one or more openings communicating with the outside of the balloon catheter.

[0037] Clause 27. The balloon catheter assembly according to any one of Clauses 1 to 26, wherein the guide wire lumen and the sensor lumen share a common side wall.

[0038] Clause 28. The balloon catheter assembly according to any one of Clauses 1 to 27, further including a sensor disposed within the sensor lumen, and the sensor is disposed in a gap within the sensor lumen between two segments of a cured adhesive.

[0039] Clause 29. The balloon catheter assembly according to any one of Clauses 1 to 28, wherein the sensor includes a sensing portion embedded in a silicone gel.

[0040] Clause 30. The balloon catheter assembly according to any one of Clauses 1 to 29, wherein the sensor is disposed at the distal end of the balloon catheter proximal to the balloon membrane.

[0041] Clause 31. The sensor lumen, the gas lumen, and the guide wire lumen each have a cross-sectional diameter, and at least one of the cross-sectional diameters of the sensor lumen, the gas lumen, and the guide wire lumen varies along the length of the balloon catheter. The balloon catheter assembly according to any one of Clauses 1 to 30.

[0042] Clause 32. The balloon catheter assembly according to any one of Clauses 1 to 31, wherein the balloon catheter has a length of about 18 inches or less.

[0043] Clause 33. An intravascular balloon catheter comprising a proximal end, a distal end including a J tip, a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface defining one or more lumens, and a balloon membrane disposed at the distal end.

[0044] Clause 34. The balloon catheter according to clause 33, wherein the J tip includes a first substantially straight segment connected to the distal end of the balloon catheter, a curved segment connected at a first end to the distal end of the first substantially straight segment, and a second substantially straight segment attached to a second end of the curved segment, and the second substantially straight segment is disposed substantially parallel to the first substantially straight segment.

[0045] Clause 35. The balloon catheter according to clause 33 or clause 34, wherein the J tip comprises a thermoplastic material.

[0046] Clause 36. The balloon catheter according to any one of clauses 33 to 35, wherein the thermoplastic material comprises a thermoplastic polyurethane.

[0047] Clause 37. The balloon catheter according to any one of clauses 33 to 36, wherein the thermoplastic material comprises a polyether-based thermoplastic polyurethane.

[0048] Clause 38. The balloon catheter according to any one of clauses 33 to 37, wherein the J tip comprises a metal.

[0049] Clause 39. The balloon catheter according to any one of clauses 33 to 38, wherein the diameter of the theoretical circle formed by the J tip and the balloon catheter exceeds 8 mm.

[0050] Clause 40. The balloon catheter according to any one of Clauses 33 to 39, further comprising a sheath seal including an elastomer housing, wherein the elastomer housing includes a proximal end, a distal end, and a lumen disposed between the proximal end and the distal end of the housing, the housing includes one or more collision devices, the lumen is configured to slidably receive the tube within the lumen, and the one or more collision devices are configured to engage the outer surface of the tube and apply a force to the outer surface of the tube to prevent the tube from sliding relative to the sheath seal when each collision device is in a first state.

[0051] Clause 41. The balloon catheter according to any one of Clauses 33 to 40, wherein the one or more lumens include a sensor lumen, a gas lumen, and a guide wire lumen.

[0052] Clause 42. The balloon catheter according to any one of Clauses 33 to 41, wherein the guide wire lumen is defined by a guide wire lumen side wall including a polyimide tube.

[0053] Clause 43. The balloon catheter according to any one of Clauses 33 to 42, wherein the polyimide tube is embedded in the side wall of the balloon catheter, and the polyimide tube and the gas lumen are arranged in a common lumen configuration.

[0054] Clause 44. The balloon catheter according to any one of Clauses 33 to 43, wherein the sensor lumen is defined by a sensor lumen side wall, is arranged in a common lumen configuration with the gas lumen, and the sensor lumen side wall includes one or more openings communicating with the outside of the balloon catheter.

[0055] Clause 45. The balloon catheter according to any one of Clauses 33 to 44, wherein the guide wire lumen and the sensor lumen share a common side wall.

[0056] Clause 46. The balloon catheter according to any one of Clauses 33 to 45, further comprising a sensor disposed within the sensor lumen, wherein the sensor is disposed in a gap within the sensor lumen between two segments of the curable adhesive.

[0057] Clause 47. The balloon catheter according to any one of Clauses 33 to 46, wherein the sensor includes a sensing portion embedded in a silicone gel.

[0058] Clause 48. The balloon catheter according to any one of Clauses 33 to 47, wherein the sensor is disposed at the distal end of the balloon catheter proximal to the balloon membrane.

[0059] Clause 49. The balloon catheter according to any one of Clauses 33 to 48, having a length of about 18 inches or less.

[0060] Clause 50. The balloon catheter according to any one of Clauses 33 to 49, wherein the one or more impact devices include a first impact device and a second impact device that is substantially different from the first impact device.

[0061] Clause 51. The balloon catheter according to any one of Clauses 33 to 50, wherein the first impact device is a variable impact device and the second impact device is a static impact device.

[0062] Clause 52. The balloon catheter according to any one of Clauses 33 to 51, wherein the first impact device is a variable impact device that is substantially different from the second impact device, and the second impact device is also a variable impact device.

[0063] Clause 53. The balloon catheter according to any one of Clauses 33 to 52, wherein the sensor lumen has a circular cross-sectional area, the guide wire lumen has a circular cross-sectional area larger than the circular cross-sectional area of the sensor lumen, and the gas lumen has a non-circular cross-section that is at least twice the total cross-sectional area of the sensor lumen and the guide wire lumen.

[0064] Clause 54. A balloon catheter including a proximal end, a distal end, and a tube having a side wall disposed between the proximal end and the distal end, the side wall having an outer surface and an inner surface defining a gas lumen, a sensor lumen in common lumen arrangement with the gas lumen, and a guide wire lumen in common lumen arrangement with the gas lumen and sharing a common wall with the sensor lumen, and a balloon membrane disposed at the distal end and in fluid communication with the gas lumen.

[0065] Clause 55. The balloon catheter according to Clause 54, wherein the balloon catheter has a length of about 18 inches or less.

[0066] Clause 56. The balloon catheter according to Clause 54 or Clause 55, wherein the balloon catheter has a length between about 14 inches and 18 inches.

[0067] Clause 57. The balloon catheter according to any one of Clauses 54 to 56, further including a J tip attached to the distal end, the J tip including a lumen continuous with the guide wire lumen such that a guide wire can be inserted simultaneously into both the lumen of the J tip and the guide wire lumen.

[0068] Clause 58. A method of intravascular balloon pumping of blood, comprising the step of inserting a balloon catheter assembly into the axillary artery or subclavian artery of a patient, said balloon catheter assembly comprising a proximal end, a distal end, and a tube disposed between said proximal end and said distal end, said tube having an outer surface and an inner surface defining at least one lumen extending between said proximal end and said distal end, and said balloon catheter comprising a balloon membrane disposed at said distal end and in fluid communication with said at least one lumen, and a sheath seal comprising an elastomeric housing, said elastomeric housing comprising a proximal end, a distal end, and a lumen disposed between said proximal end of said housing and said distal end of said housing, said housing comprising a collision device, said lumen being configured to slidably receive said tube within said lumen, said collision device being configured to engage said outer surface of said tube and apply a force to said outer surface of said tube, said method comprising the step of inserting said balloon catheter assembly, the step of advancing said distal end of said balloon catheter into the aorta of said patient, and the step of providing intravascular balloon pumping of blood by passing fluid in and out of said balloon membrane through said at least one lumen to inflate and deflate said balloon membrane.

[0069] Clause 59. The method according to Clause 58, wherein the housing of the sheath seal further comprises one or more suture pads configured to allow a suture to pass therethrough to fix the sheath seal to the patient, and the method further comprises the step of fixing the sheath seal to the patient. This specification also provides, for example, the following items. (Item 1) An intra-aortic balloon catheter comprising a proximal end, a distal end, and a tube disposed between said proximal end and said distal end, said tube having an outer surface and an inner surface defining at least one lumen extending between said proximal end and said distal end, and a balloon membrane disposed at said distal end. A sheath seal including an elastomeric housing, said elastomeric housing including a proximal end, a distal end, and a lumen disposed between said proximal end of said housing and said distal end of said housing, said housing including a collision device, said lumen configured to slidably receive said tube within said lumen, said collision device configured to engage said outer surface of said tube and apply a force to said outer surface of said tube to prevent said tube from sliding relative to said sheath seal when said collision device is in a first state, said sheath seal A balloon catheter assembly comprising. (Item 2) When said collision device is in said first state, said collision device includes a movable pressure element disposed to exert pressure on said outer surface of said tube to prevent said tube from sliding relative to said sheath seal. The balloon catheter assembly according to item 1, wherein said pressure element is movable to reduce the pressure exerted on said outer surface of said tube such that said tube is slidable relative to said sheath seal when said collision device is in a second state. (Item 3) The housing of said sheath seal further includes a foldable section disposed between said proximal end of said housing and said distal end of said housing. The balloon catheter assembly according to item 2, wherein said foldable section is configured to move said collision device from said first state to said second state by applying pressure to said foldable section of said housing. (Item 4) The balloon catheter assembly according to item 2, wherein said movable pressure element is selected from the group consisting of a static interference pinch lock, a bend disposed in said housing, an off-axis central section disposed to impact said tube in said first state, and an offset pinch that opens said lumen of said housing when pinched. (Item 5) The balloon catheter assembly according to item 1, wherein the distal end of the housing of the sheath seal is tapered. (Item 6) The balloon catheter assembly according to item 1, wherein the housing of the sheath seal further includes one or more suture pads configured to allow a suture to pass therethrough so as to be able to fix the sheath seal to a patient. (Item 7) The balloon catheter assembly according to item 1, wherein the elastomeric housing includes a thermoplastic elastomer. (Item 8) Further including a Y-connection including a hub, the hub having a proximal end, a distal end, and a lumen disposed between the proximal end and the distal end of the hub. The balloon catheter assembly according to item 1. (Item 9) The balloon catheter assembly according to item 8, wherein the Y-connection hub is connected to the housing of the sheath seal. (Item 10) The balloon catheter assembly according to item 9, wherein a lumen angled with respect to one or both of the lumen of the sheath seal and the lumen of the hub of the Y-connection extends between the proximal end of the Y-connection hub and the distal end of the housing of the sheath seal. (Item 11) The balloon catheter assembly according to item 1, wherein the impact device includes a channel defined by one or more side walls disposed in the lumen of the sheath seal. (Item 12) The balloon catheter assembly according to item 11, wherein the longitudinal axis defined by the center of the channel is offset from the longitudinal axis defined by the center of the lumen of the sheath seal. (Item 13) The balloon catheter assembly according to item 1, wherein the housing of the sheath seal includes a plurality of tabs extending from the housing, and when pressure is applied to the plurality of tabs, the pressure element moves and the impact device transitions to the second state. (Item 14) The balloon catheter assembly according to item 1, wherein the distal end of the balloon catheter includes a pre-formed curved portion. (Item 15) The balloon catheter assembly according to item 14, wherein the pre-formed curved portion includes a J-tip or a pigtail. (Item 16) The balloon catheter assembly according to item 15, wherein the J-tip includes a first substantially straight segment connected to the distal end of the balloon catheter, a curved segment connected to the distal end of the first substantially straight segment at its first end, and a second substantially straight segment attached to the second end of the curved segment, the second substantially straight segment being arranged substantially parallel to the first substantially straight segment. (Item 17) The balloon catheter assembly according to item 15, wherein the J-tip includes a thermoplastic material. (Item 18) The balloon catheter assembly according to item 17, wherein the thermoplastic material includes a thermoplastic polyurethane. (Item 19) The balloon catheter assembly according to item 17, wherein the thermoplastic material includes a polyether-based thermoplastic polyurethane. (Item 20) The balloon catheter assembly according to item 15, wherein the J-tip includes a metal. (Item 21) The balloon catheter assembly according to item 15, wherein the diameter of the theoretical circle formed by the J-tip and the balloon catheter exceeds 8 mm. (Item 22) The balloon catheter assembly according to item 1, wherein the distal end of the balloon catheter includes an elongated extension. (Item 23) The balloon catheter assembly according to item 1, wherein at least one lumen of the tube includes a sensor lumen, a gas lumen, and a guide wire lumen. (Item 24) The balloon catheter assembly according to item 23, wherein the guide wire lumen is defined by a guide wire lumen side wall including a polyimide tube. (Item 25) The balloon catheter assembly according to item 24, wherein the polyimide tube is embedded in the side wall of the balloon catheter, and the polyimide tube and the gas lumen are arranged in a common lumen arrangement. (Item 26) The sensor lumen is defined by a sensor lumen side wall and is arranged in a common lumen arrangement with the gas lumen. The balloon catheter assembly according to item 23, wherein the sensor lumen side wall includes one or more openings communicating with the outside of the balloon catheter. (Item 27) The balloon catheter assembly according to item 26, wherein the guide wire lumen and the sensor lumen share a common side wall. (Item 28) Further comprising a sensor disposed within the sensor lumen. The balloon catheter assembly according to item 23, wherein the sensor is disposed in a gap within the sensor lumen between two segments of a cured adhesive. (Item 29) The balloon catheter assembly according to item 28, wherein the sensor includes a sensing portion embedded in a silicone gel. (Item 30) The balloon catheter assembly according to item 28, wherein the sensor is disposed at the distal end of the balloon catheter proximal to the balloon membrane. (Item 31) The sensor lumen, the gas lumen, and the guide wire lumen each have a cross-sectional diameter. The balloon catheter assembly according to item 23, wherein at least one of the cross-sectional diameters of the sensor lumen, the gas lumen, and the guide wire lumen varies along the length of the balloon catheter. (Item 32) The balloon catheter assembly according to item 1, wherein the balloon catheter has a length of about 18 inches or less. (Item 33) A proximal end, A distal end including a J tip, A tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface defining one or more lumens, A balloon membrane disposed at the distal end and including an intra-aortic balloon catheter. (Item 34) The J tip includes a first substantially straight segment connected to the distal end of the balloon catheter, a curved segment connected to the distal end of the first substantially straight segment at its first end, and a second substantially straight segment attached to the second end of the curved segment, and the second substantially straight segment is disposed substantially parallel to the first substantially straight segment. The balloon catheter according to item 33. (Item 35) The J tip of the balloon catheter according to item 33 contains a thermoplastic material. (Item 36) The thermoplastic material of the balloon catheter according to item 35 contains thermoplastic polyurethane. (Item 37) The thermoplastic material of the balloon catheter according to item 35 contains polyether-based thermoplastic polyurethane. (Item 38) The J tip of the balloon catheter according to item 33 contains metal. (Item 39) The diameter of the theoretically formed circle by the J tip and the balloon catheter exceeds 8 mm. The balloon catheter according to item 33. (Item 40) Further comprising a sheath seal including an elastomeric housing, The elastomeric housing includes a proximal end, a distal end, and a lumen disposed between the proximal end of the housing and the distal end of the housing, The housing includes one or more collision devices, The lumen is configured to slidably receive the tube within the lumen, and the one or more collision devices are configured to engage the outer surface of the tube and apply a force to the outer surface of the tube to prevent the tube from sliding relative to the sheath seal when each collision device is in a first state. The balloon catheter according to item 33. (Item 41) The balloon catheter according to item 33, wherein the one or more lumens include a sensor lumen, a gas lumen, and a guide wire lumen. (Item 42) The balloon catheter according to item 41, wherein the guide wire lumen is defined by a guide wire lumen side wall including a polyimide tube. (Item 43) The balloon catheter according to item 42, wherein the polyimide tube is embedded in the side wall of the balloon catheter, and the polyimide tube and the gas lumen are arranged in a common lumen configuration. (Item 44) The sensor lumen is defined by a sensor lumen side wall and is arranged in a common lumen arrangement with the gas lumen, The balloon catheter according to item 41, wherein the sensor lumen side wall includes one or more openings communicating with the outside of the balloon catheter. (Item 45) The balloon catheter according to item 41, wherein the guide wire lumen and the sensor lumen share a common side wall. (Item 46) Further comprising a sensor disposed within the sensor lumen, The balloon catheter according to item 41, wherein the sensor is disposed in a gap within the sensor lumen between two segments of a cured adhesive. (Item 47) The balloon catheter according to item 46, wherein the sensor includes a sensing portion embedded in a silicone gel. (Item 48) The balloon catheter according to item 46, wherein the sensor is disposed at the distal end of the balloon catheter proximal to the balloon membrane. (Item 49) The balloon catheter according to item 33, wherein the balloon catheter has a length of about 18 inches or less. (Item 50) The balloon catheter according to item 40, wherein the one or more impact devices include a first impact device and a second impact device that is substantially different from the first impact device. (Item 51) The balloon catheter according to item 50, wherein the first impact device is a variable impact device and the second impact device is a static impact device. (Item 52) The balloon catheter according to item 50, wherein the first impact device is a variable impact device that is substantially different from the second impact device, and the second impact device is also a variable impact device. (Item 53) The balloon catheter according to item 41, wherein the sensor lumen has a circular cross-sectional area, the guide wire lumen has a circular cross-sectional area larger than the circular cross-sectional area of the sensor lumen, and the gas lumen has a non-circular cross-section that is at least twice the total cross-sectional area of the sensor lumen and the guide wire lumen. (Item 54) A proximal end, a distal end, a tube including a side wall disposed between the proximal end and the distal end, the side wall having an outer surface and an inner surface that define a gas lumen, a sensor lumen in a common lumen arrangement with the gas lumen, and a guide wire lumen in a common lumen arrangement with the gas lumen and sharing a common wall with the sensor lumen, the tube, a balloon membrane disposed at the distal end and in fluid communication with the gas lumen and including an intra-aortic balloon catheter. (Item 55) The balloon catheter according to item 54, wherein the balloon catheter has a length of about 18 inches or less. (Item 56) The balloon catheter according to item 54, wherein the balloon catheter has a length between about 14 inches and 18 inches. (Item 57) Further comprising a J-tip attached to the distal end, The balloon catheter according to item 56, wherein the J-tip includes a lumen continuous with the guide wire lumen such that a guide wire can be inserted simultaneously into both the lumen of the J-tip and the guide wire lumen. (Item 58) A method of intravascular balloon pumping of blood, comprising: Inserting a balloon catheter assembly into the axillary artery or subclavian artery of a patient, wherein the balloon catheter assembly comprises: An intra-aortic balloon catheter including a proximal end, a distal end, and a tube disposed between the proximal end and the distal end, the tube having an outer surface and an inner surface defining at least one lumen extending between the proximal end and the distal end, a balloon membrane disposed at the distal end and in fluid communication with the at least one lumen; and a sheath seal including an elastomeric housing, the elastomeric housing including a proximal end, a distal end, and a lumen disposed between the proximal end of the housing and the distal end of the housing, the housing including a collision device, the lumen being configured to slidably receive the tube therein, the collision device being configured to engage the outer surface of the tube and apply a force to the outer surface of the tube. Inserting the balloon catheter assembly; Advancing the distal end of the balloon catheter into the aorta of the patient; By passing fluid in and out of the balloon membrane through the at least one lumen, expanding and contracting the balloon membrane to provide intravascular balloon pumping of blood The method, comprising. (Item 59) The housing of the sheath seal further includes one or more suture pads configured to allow a suture to pass therethrough to enable fixation of the sheath seal to a patient The method of claim 58, further comprising fixing the sheath seal to the patient BRIEF DESCRIPTION OF THE DRAWINGS

[0070]

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Mode for Carrying Out the Invention

[0071] The following description is merely exemplary in nature and is in no way intended to limit or define the invention, its applications, or its use. The description is devised to enable those skilled in the art to make and use the disclosed subject matter, and specific examples are provided for that purpose, but they should in no way be considered limiting. It will be apparent to those skilled in the art that various modifications to what follows are included within the appended claims. The present disclosure should not be considered limited to the presently disclosed aspects, whether provided as examples or elsewhere in this specification.

[0072] For the following description, terms such as "upper", "lower", "right", "left", "vertical", "horizontal", "above", "bottom", "lateral", "longitudinal", and derivatives thereof shall be related to the orientation shown in the drawings. However, it should be understood that the systems and methods disclosed herein may assume various alternative variations and step sequences, unless explicitly specified to the contrary. It should also be understood that the specific devices and methods shown in the accompanying drawings and described in the following specification are merely exemplary embodiments. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0073] The use of numerical values in the various ranges specified in this application document is presented as approximate values, as if the word "about" preceded both the minimum and maximum values within the specified ranges, unless explicitly stated otherwise. Thus, minor variations above and below the stated ranges (e.g., ±10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or 0.5%) can be used to achieve substantially the same results as the values within the range. Also, unless stated otherwise, the disclosure of a range is intended to be a continuous range that includes all values between the minimum and maximum values. As used herein, "a" and "an" refer to one or more.

[0074] As used herein, the terms "patient" or "subject" refer to members of the animal kingdom including, but not limited to, humans, and "mammal" refers to all mammals including, but not limited to, humans.

[0075] As used herein, the terms "comprising", "comprise" or "comprised", and variations thereof, are open-ended and do not exclude the presence of other elements not specified. In contrast, the term "consisting of" and variations thereof are intended to be closed and exclude additional elements except in trace amounts.

[0076] Provided herein is, for example, but not limited to, a balloon catheter assembly for use in cardiac assist therapy. The cardiac assist therapy may be left ventricular assist therapy. Referring to FIG. 1, in a non-limiting embodiment or aspect, the assembly 1000 includes an intra-aortic balloon catheter (hereinafter interchangeably referred to as an intra-aortic balloon catheter and an intra-aortic balloon pump (IABP)) 100, and the IABP 100 has a proximal end 120, a distal end 140, and a tube 160 disposed therebetween. The tube 160 has an outer surface and an inner surface defining at least one lumen therethrough. The IABP 100 further includes a balloon membrane 180 disposed at its distal end 140.

[0077] The IABP 100 including the tube 160 and / or the balloon membrane 180 may be of any useful diameter and length for providing cardiac assist therapy. In non-limiting embodiments or aspects, the tube 160 has a diameter of 8 French, 7.5 French, or 7 French. In non-limiting embodiments or aspects, the IABP 100 is about 18 inches in length. In non-limiting embodiments or aspects, the IABP 100 is about 18 inches or less in length when measured from the distal end of the suture pad 432 of the y-connection 408 to the base (nearest proximal end) of the balloon membrane 180, including, for example, but not limited to, 17 inches, 16 inches, 15 inches, 14 inches, 13 inches, 12 inches, 11 inches, 10 inches, 9 inches, 8 inches, or 7 inches, and all sub-ranges therebetween. In non-limiting embodiments or aspects, the IABP 100 is between 14 inches and 18 inches in length, including all sub-ranges therebetween. Those skilled in the art will appreciate that the patient's size and insertion location (e.g., right or left axillary artery insertion) at least partially determine the appropriate length of the IABP 100 and various lengths can be selected at least partially based thereon. As described below, in non-limiting embodiments or aspects, the catheter assembly is delivered to the treatment site within the patient through a route other than the conventional femoral artery route, such as through the axillary artery or the subclavian artery. In non-limiting embodiments or aspects, the IABP 100 is configured for insertion through the axillary artery or the subclavian artery and is not suitable for insertion through the femoral artery. Thus, an advantage of the IABP described herein is that the device, e.g., the tube 160, may be of a length shorter than that of a typical IABP.

[0078] The IABP 100 including the tube 160 and the balloon membrane 180 can be formed of any suitable material known to those skilled in the art. For example, but not limited to, the balloon membrane 180 can be formed of biocompatible metals and / or polymers. As used herein, the term "biocompatible" means that the material and any of its degradation products are substantially non-toxic to cells or organisms. As used herein, "non-toxic" means that the material is at least non-carcinogenic, non-thrombogenic, and / or non-immunogenic when maintained in the patient's body during the treatment period. In non-limiting embodiments or aspects, the material (e.g., metal and / or polymer) is biostable. As used herein, "biostable" means that the material is substantially non-biodegradable when placed in a patient during the typical usage period of the IABP.

[0079] In some non-limiting embodiments or aspects, the IABP 100 includes a metal or other rigid frame and the balloon membrane 180 thereon, and the balloon membrane 180 is an elastomeric material. In non-limiting embodiments or aspects, the frame is not included and the IABP 100 includes the elastomeric balloon membrane 180. In non-limiting embodiments or aspects, the balloon membrane 180 is formed of a polyurethane (PU) polymer or a PU-based copolymer. As is known in the art, PU can be formed from isocyanates and polyols. In non-limiting embodiments or aspects, PU is formed by reacting or capping a macrodiol (e.g., polyether, polyester, polycarbonate, and / or polysiloxane) with a diisocyanate to form a prepolymer. Next, the prepolymer can be reacted / bonded with a diol or diamine. Those skilled in the art will understand that the above are merely examples and that various other PUs and methods of making them are known. As long as a polymeric material such as PU is elastomeric and biocompatible, those skilled in the art will understand that it can be used in the devices described herein.

[0080] In addition to the polymeric material, the balloon membrane 180 can include one or more optional coatings, such as one or more coatings to improve the hydrophilicity of the membrane material and / or to reduce thrombus formation and / or immunogenicity.

[0081] The tube 160 can also be formed of any suitable material. In non-limiting embodiments or aspects, the tube 160 can be formed of a biocompatible polymer, optionally, in non-limiting embodiments or aspects, a bio-stable polymer. In non-limiting embodiments or aspects, the tube 160 is formed of a polyimide or polyimide-based material. As will be described in more detail below, the tube 160 can include a plurality of lumens. In non-limiting embodiments or aspects, one or more of the lumens are formed of a polyimide or polyimide-based material, and the tube 160 can include forming a superposition of a more flexible polymeric material on at least a portion of the polyimide material, or otherwise covering it (e.g., forming one or more additional lumens). For example, but not limited to, the tube 160 can include a guide wire lumen formed of a polyimide or polyimide-based material, and can be incorporated into or otherwise received in a more flexible polymer such as a thermoplastic elastomer, thermoplastic urethane, polyethylene terephthalate, silicone, etc., known in the field of catheters, particularly in the field of cardiovascular catheters (described herein or known in the art). Such materials can optionally include a radiopaque material, as is known in the art (and as described herein).

[0082] Continuing to refer to FIG. 1, the balloon catheter assembly 1000 includes a sheath seal 200. Referring to FIGS. 2, 3A, and 3B, the sheath seal 200 includes a housing 220 having a proximal end 240, a distal end 260, and a lumen 280 disposed between the proximal end 240 and the distal end 260. In non-limiting embodiments or aspects, the distal end 260 of the sheath seal housing 220 is tapered, and its outer surface tapers in the distal direction. In non-limiting embodiments or aspects, the housing 220 is formed of an elastomeric material. In non-limiting embodiments or aspects, the housing 220 is formed of a thermoplastic elastomer. One of ordinary skill in the art will understand that various elastomeric materials, including thermoplastic materials, are suitable for the sheath seal 200. In non-limiting embodiments or aspects, the sheath seal housing 220 is formed from one or more of copolymers formed from plastics and rubbers, including, but not limited to, styrene block copolymers, thermoplastic polyolefin elastomers, thermoplastic vulcanizates, thermoplastic polyurethanes, thermoplastic polyesters, thermoplastic polyamides. Suitable thermoplastic elastomers are commercially available, for example, from PolyOne Corporation (e.g., the Versaflex™ series of thermoplastic elastomers, including G2705N).

[0083] In non-limiting embodiments or aspects, the sheath seal housing 220 includes one or more elements for enabling attachment of the sheath seal 200 to a patient. In the non-limiting embodiment or aspect shown in FIGS. 2, 3A, and 3B, the sheath seal housing 220 includes a suture pad 224 for enabling attachment of the sheath seal 200 to a patient's clothing or skin.

[0084] Continuing to refer to FIGS. 2, 3A, and 3B, the sheath seal 200 includes one or more impact devices 300, 302. In non-limiting embodiments or aspects, the sheath seal 200 includes two impact devices 300, 302. FIGS. 3A and 3B show the impact devices 300, 302 in a particular location, and it should be noted that the devices described herein may include one or both of the impact devices 300, 302. Using multiple impact devices 300, 302 allows a large amount of resultant force to be applied to the outer surface 162 of the catheter tube 160, while minimizing the resultant force in any one section of the tube 160 and reducing occlusion of the lumen 166 (including the gas lumen, as described below). The impact device(s) 300, 302 impact (e.g., via friction and / or pressure, e.g., contact and engagement) the catheter tube 160 received within the lumen 280 of the housing 220. When the impact device(s) 300, 302 are used alone or in combination, they engage the catheter tube 160 with a force sufficient to resist movement or sliding of the catheter tube 160, for example, during ambulatory cardiac assist therapy.

[0085] The collision device 300 is a variable collision device and can assume a plurality of states in which it exerts collision forces of various degrees. In a non-limiting embodiment or aspect, in a first state, the collision device 300 engages the catheter tube 160 and exerts a specific collision force. In a non-limiting embodiment or aspect, in a second state, the collision device 300 is disengaged from the catheter tube 160, or otherwise does not contact the catheter tube 160, or at least does not substantially contact the catheter tube 160, thereby enabling the catheter tube 160 to slide freely or easily within the sheath seal lumen 280. In a non-limiting embodiment or aspect, the collision device 300 may assume one or more additional states, for example, but not limited to, a third state. In the third state, the collision device 300 remains engaged or in contact with the catheter tube 160 to a lesser extent (e.g., with a smaller collision force) than in the first state, such that the catheter tube 160 can slide within the sheath seal lumen 280, but such movement requires a greater pulling or pushing force to slide the catheter tube 160 than when the collision device 300 is in the second state. According to non-limiting embodiments or aspects of the present disclosure, the first state, the third state, and the second state may constitute a continuum characterized by the magnitude of the force exerted by the collision device(s) 300 on the outer surface of the catheter tube 160.

[0086] On the other hand, the collision device 302 is a static collision device because the collision force it exerts is not essentially variable. In other words, since the collision device 302 has only one state, the collision force it exerts is essentially static. In the non-limiting example of FIG. 3A, the collision device 302 causes constriction of the lumen 280.

[0087] Continuing to refer to FIGS. 2, 3A, and 3B, in non-limiting embodiments or aspects, the sheath seal 200 includes one or more features that enable a user to change the state of one or more impact devices (s). In non-limiting embodiments or aspects, the sheath seal housing 220 includes a foldable section 222 disposed between its proximal end 240 and distal end 260, to which an external pressure can be applied. In the embodiments shown in FIGS. 2, 3A, and 3B, the pressure applied to the foldable portion 222 perpendicular to the longitudinal axis of the sheath seal housing 220 moves the variable impact device (s) 300 from the (above-mentioned) first state to the (also above-mentioned) second and / or third states. In non-limiting embodiments or aspects, the sheath seal housing 220 includes one or more tabs extending therefrom, and applying pressure to the one or more tabs causes the impact device to move from the first state to the second and / or third states.

[0088] In non-limiting embodiments or aspects, referring to FIGS. 8A, 8B, and 9-11, the variable impact device (s) 300 can include one or more movable pressure elements configured to apply pressure to the outer surface 162 of the catheter tube 160. In non-limiting embodiments or aspects, the movable pressure element can be one or more of an interference pinch lock 314 (FIGS. 8A and 8B), a bend 310 in the lumen 280 (FIG. 9), an off-axis central section and channel 320 (FIG. 10), and / or an offset pinch (via tab 330, FIG. 11). For example, an interference pinch lock as shown in FIGS. 8A and 8B combines internal interference fits (e.g., friction fits or interference fits) that provide different resistances when pinched and when not pinched. By using different materials, designs can be enabled that provide higher interference forces, or greater changes in interference forces, when pinched.

[0089] For example, as shown in FIG. 9, the bend 310 of the lumen 280 utilizes a section of the locally thin sheath seal housing 220 to ensure that the lumen 280 deflects at a location that provides interference between the catheter tube 160 and the sheath seal 200. By bringing the tabs 312 closer to each other across the tabs 312 (e.g., pinching along the longitudinal axis of the housing 220 as is apparent from the arrow (F) in FIG. 9), the lumen 280 becomes straight and allows the catheter tube 160 to move freely within the sheath seal lumen 280. In this embodiment or aspect of the sheath seal 200, it is the bend 310 that promotes an increase in friction between the housing 220 and the outer surface 162 of the catheter tube 160, which helps to brake the movement of the catheter tube 160 within the housing lumen 280 as a result of a collision.

[0090] Referring to FIG. 10, in a non-limiting embodiment or aspect, the variable collision device(s) 300 includes a channel 320 defined by one or more side walls 322 disposed within the lumen 280 of the sheath seal 200. Note that FIG. 10 shows the sheath seal 200 with the catheter tube 160 not in a predetermined position. However, those skilled in the art will understand that the catheter tube 160 can be inserted through the channel 320. In a non-limiting embodiment or aspect, the channel 320 has a longitudinal axis A offset from the longitudinal axis B defined by the center of the sheath seal lumen 280. By pinching the central portion of the sheath seal housing 220, the longitudinal axes A and B are aligned, thereby enabling the insertion of the catheter tube 160 through the channel 320. When the pinching force is removed from the central portion of the sheath seal housing 220, the channel 320 moves towards its offset position, as a result, the longitudinal axes A and B are no longer aligned, and as a result, the collision device(s) 300 exerts a collision force against the outer surface of the catheter tube 160. Subsequently, when the central section of the sheath seal housing 220 is pinched again, the longitudinal axes A and B realign, thereby removing the collision force from the outer surface of the catheter tube 160 and freeing the catheter tube 160 for movement.

[0091] As is apparent from FIG. 10, when the central section of the sheath seal housing 220 is sandwiched so that the longitudinal axes A and B are aligned, there is no collision of the catheter tube 160 by the side wall 322 of the channel 320. However, when the central section of the sheath seal housing 220 is not sandwiched, the longitudinal axis B of the channel 320 tends to deviate from alignment with the longitudinal axis A of the lumen 280, and the catheter tube 160 is collided by the side wall 322 of the channel 320.

[0092] Referring to FIGS. 11A and 11B, a variable collision device 300 employing an offset pinch arrangement (via tabs 330) is shown. The sheath seal lumen 280 is configured to maintain a collision interference around at least 270° of the catheter tube 160 since the inner surface of the lumen 280 exerts a collision force on the outer surface of the catheter tube 160, and the diameter of the lumen 280 or at least a portion of the lumen 280 is slightly smaller than the diameter of the catheter tube 160. By pushing the tabs 330 against each other (perpendicular to the longitudinal axis of the sheath seal 200, as is apparent by the arrows (F) pointing at each other), the collision interference is at least partially reduced by the notch 335 continuous with the lumen 280, thereby allowing an increase in the diameter of the lumen 280 when the tabs 330 are sandwiched so as to approach each other and the catheter tube 160 is released for movement.

[0093] Referring to FIGS. 1 and 3A, the assembly 1000 includes one or more valves 302 within the sheath seal 200 in a non-limiting embodiment or aspect. Such valves, which may constitute a fixed collision device, enable the use and fixation of multiple devices during treatment such as heart assist therapy.

[0094] Referring to FIGS. 4A and 4B, the Y-connection assembly 400 includes a hub 406 and a Y-connection 408 having a proximal end 420, a distal end 430, and a lumen 440 disposed therebetween. The lumen 440 is configured to carry gas for operating the balloon membrane 180 and includes a constriction or taper therein. In non-limiting embodiments or aspects, the Y-connection 408 includes one or more elements for enabling attachment to a patient. In the non-limiting embodiment or aspect shown in FIGS. 4A and 4B, the Y-connection 408 includes a suture pad 432 for enabling attachment of the Y-connection 408 to the patient's clothing or skin. In non-limiting embodiments or aspects, the hub 406 is removably or fixedly connected to the sheath seal housing 220.

[0095] In non-limiting embodiments or aspects, the Y-connection 408 includes a main section 412 that extends at an angle or is curved and an elongate section 414. The proximal end(s) of the main section 412 and / or the elongate section 414 may include connections known in the art, such as, but not limited to, a luer connection (male or female). In non-limiting embodiments or aspects, a gas lumen 440 is formed by a continuous arrangement of the sheath seal lumen 280 that is angled with respect to one or both of the sheath seal lumen 280 and the Y-connection 408, extending between the proximal end 420 of the Y-connection 408 and the distal end 260 of the sheath seal 200, and the lumen 440 and the sheath seal lumen 280 are continuous with each other. In non-limiting embodiments or aspects, the lumen 440 is disposed in the main section 412 and is thus angled with respect to the lumen 280 of the sheath seal 200. A guidewire lumen 470 is disposed within the elongate section 414 and is configured to allow a guidewire to pass therethrough. Thus, the guidewire lumen 470 is configured to connect directly or indirectly to the guidewire lumen 172 of the catheter tube 160, such that a guidewire can enter the guidewire lumen 172 through the guidewire lumen 470 and then enter the lumen 143 of the curved portion 142.

[0096] In non-limiting embodiments or aspects, the Y-connection 408 includes a sensor cable lumen 475 through which a sensor cable (not shown) extends and connects to the sensor 190 via the sensor lumen 168 of the catheter tube 160. FIG. 4B shows only a portion of the sensor cable lumen 475 that winds through the Y-connection 408 and follows the sensor lumen 168 of the catheter tube 160.

[0097] Continuing to refer to FIG. 1, as described above, the assembly 1000 includes the IABP 100. Referring to FIGS. 5A and 5B, in non-limiting embodiments or aspects, the IABP 100 includes a curved portion 142 that can be configured as a J-tip or pigtail at the distal end of the membrane 180.

[0098] When used in the methods described herein (e.g., for introduction into a patient for cardiac assist therapy), the curved portion 142 of the IABP 100 can prevent the distal end of the balloon membrane 180 from entering a blood vessel, such as the superior mesenteric artery (SMA), in an undesirable manner during ambulatory cardiac assist therapy or during other event(s) that may cause movement of the IABP 100. In non-limiting embodiments or aspects, the curved portion 142 is a pre-formed curve, such that the curved portion 142 substantially or fully exhibits its final shape prior to insertion of the IABP 100 into the patient. In non-limiting embodiments or aspects, the curved portion is a pre-formed J-tip. The J-tip is so named from its appearance.

[0099] In a non-limiting embodiment or aspect, referring to FIG. 5B, the curved portion 142, or J-chip, includes a first substantially straight section 144, a curved section 146 connected at its first end to the distal end of the first straight section 144, and a second substantially straight section 148 connected at its proximal end to the distal end of the curved section 146. In a non-limiting embodiment or aspect, the second substantially straight section 148 is substantially or completely parallel to the first substantially straight section 144. In a non-limiting embodiment or aspect, one or more additional curved and / or straight sections may extend from the distal end of the second substantially straight section 148. In a non-limiting embodiment or aspect, the curved portion 142 forms a theoretical circle completed by the hatching shown in FIG. 5B, which may be characterized as a pigtail. In a non-limiting embodiment or aspect, the diameter of such a theoretical circle is greater than 8 mm, for example, 9 mm, 10 mm, or 11 mm. Since the diameter of a typical branch from the aorta is 5-7 mm (renal artery) or 6-8 mm (SMA and celiac artery), a diameter larger than such a radius helps prevent the balloon membrane 180 and the IABP 100 from entering the branches of the aorta in an undesirable manner during placement and / or treatment.

[0100] In non-limiting embodiments or aspects, the curved portion 142 is formed of a thermoplastic material such as a thermoplastic elastomer as described above. In non-limiting embodiments or aspects, the curved portion 142 is formed of or at least partially includes thermoplastic polyurethane. In non-limiting embodiments or aspects, the curved portion 142 is formed of a polyether-based thermoplastic polyurethane. Such materials are commercially available, for example, from Lubrizol Corporation (e.g., the Estane® series of thermoplastic polyurethanes including Estane® 58887). In non-limiting embodiments or aspects, the curved portion 142 is formed of or at least partially includes a metal such as a shape memory alloy. In non-limiting embodiments or aspects, the curved portion 142 includes one or more radiopaque materials such as, but not limited to, barium, e.g., barium sulfate. Other suitable radiopaque materials are known to those of ordinary skill in the art.

[0101] In non-limiting embodiments or aspects, the J-chip is configured to include a non-curved portion that is radiopaque because it is made of a blend of Pelethane® 5855 (an aromatic polyether-based thermoplastic polyurethane) and tungsten particles. In non-limiting embodiments or aspects, the J-chip configuration may include a curved, flexible "white" portion made from Estane® 58887 blended with BaSO4 and a "black" straight portion made from Pelethane® 5855 blended with tungsten particles (where the membranes are joined by plastic welding), both of these portions being molded at the ends of the polyimide lumen of the J-chip.

[0102] In non-limiting embodiments or aspects (not shown), rather than the curved portion 142, the distal end of the IABP 100 can include an elongate section. The elongate section can have a length from 120 mm to 210 mm, optionally from 130 mm to 200 mm, including all sub-ranges therebetween. Without wishing to be bound by any particular theory, such an elongate extension is believed to be present in the common iliac artery, thereby preventing the IABP 100 from entering the aortic branches during placement and / or treatment.

[0103] Referring further to FIG. 5B, the curved portion 142 can include a lumen 143 therein, and the lumen 143 of the curved portion 142 is continuous with the lumen 166 of the catheter tube 160, or more particularly, the guidewire lumen 172 of the lumen 166, such that the lumen 143 allows a guidewire, such as the guidewire used during placement of the IABP 100, to enter therein. The lumen 166 is continuous with the sheath seal lumen 280 and the lumen 470 of the Y-connection 408. Entry of the guidewire into the lumen 143 can temporarily straighten the curved portion 142, and the curved portion 142 can return to its pre-formed curvature when the guidewire is withdrawn from the lumen 143.

[0104] As briefly described above, the catheter tube 160 can include a plurality of lumens therethrough. Referring to FIGS. 6A and 6B, the IABP 100 (FIG. 6A) and a cross-section therethrough (FIG. 6B) are shown. In the non-limiting embodiment or aspect shown in FIG. 6B, the catheter tube 160 includes a lumen 166, and the lumen 166 is divided into a sensor lumen 168, a gas lumen 170, and a guidewire lumen 172. In non-limiting embodiments or aspects, for example, in an aspect where the IABP 100 is not delivered via a guidewire, the lumen 172 can be used as a second sensor lumen. In non-limiting embodiments or aspects, one or more of the sensor lumen 168, the gas lumen 170, and the guidewire lumen 172 can have a cross-sectional diameter that varies along the length of the IABP 100.

[0105] In a non-limiting embodiment or aspect, the guidewire lumen 172 communicates with the lumen 143 of the curved portion 142, such that a guidewire passing through the guidewire lumen 172 can enter the lumen 143 of the curved portion 142. As also described above, the guidewire lumen 172 can be formed of a material different from the catheter tube 160, such as, but not limited to, polyimide, so as to form its own separate tube. Accordingly, the guidewire lumen 172 can include a sidewall 173 formed of polyimide and embedded in another material constituting the circular wall of the catheter tube 160, and a sensor lumen 168 and / or a gas lumen 170 are formed within the catheter tube 160. In a non-limiting embodiment or aspect, the guidewire lumen 172 and the gas lumen 170 are formed as inner partitions of the lumen 166 within the outer wall 161 of the catheter tube 160, and thus are arranged in a common lumen (e.g., one lumen is disposed within another lumen) arrangement. In a non-limiting embodiment or aspect, the guidewire lumen 172 and the sensor lumen 168 share a common sidewall 176. In a non-limiting embodiment or aspect, the sensor lumen 168 includes a sensor lumen sidewall 169. In a non-limiting embodiment or aspect, the sensor lumen 168 and the gas lumen 170 are formed as inner partitions of the lumen 166 within the outer wall 161 of the catheter tube 160, and thus are arranged in a common lumen (e.g., one lumen is disposed within another lumen) arrangement. In a non-limiting embodiment or aspect, the sensor lumen 168 includes one or more openings 174 in its sidewall 161. In a non-limiting embodiment or aspect, the sensor lumen 168 includes four openings 174a, 174b, 174c, 174d in its sidewall 161, such that the sensor 190 within the sensor lumen 168 can measure the pressure of the vascular system in which the catheter tube 160 is disposed, taking into account one or more of the openings 174 that open to the space outside the catheter tube 160.

[0106] Continuing to refer to FIGS. 6A and 6B, the gas lumen 170 is in fluid communication with the interior of the balloon membrane 180, allowing the passage of inflation gas to and from the balloon membrane 180, thereby enabling periodic inflation and deflation of the balloon membrane 180 of the IABP 100 to deliver cardiac assist therapy. By arranging and configuring the gas lumen 170 as described herein, the rate and efficiency of filling and emptying the balloon membrane 180 can be improved, improving the therapeutic efficiency of the IABP 100. In non-limiting embodiments or aspects, the maximum diameter of the gas lumen 170 is greater than the maximum diameter of the guide wire lumen 172, and the maximum diameter of the guide wire lumen 172 is greater than the maximum diameter of the sensor lumen 168. In non-limiting embodiments or aspects, the cross-sectional area of the gas lumen 170 is greater than the cross-sectional area of the guide wire lumen 172, and the cross-sectional area of the guide wire lumen 172 is greater than the cross-sectional area of the sensor lumen 168. In non-limiting embodiments or aspects, the sensor lumen 168 has a circular cross-sectional area, the guide wire lumen 172 has a circular cross-sectional area greater than the circular cross-sectional area of the sensor lumen 168, and the gas lumen 170 has a non-circular cross-section that is at least twice the area of the combined cross-sectional areas of the sensor lumen 168 and the guide wire lumen 172.

[0107] Referring to FIGS. 7A and 7B, in non-limiting embodiments or aspects, an assembly 1000 including an IABP 100 includes a sensor 190. The sensor 190 can be, for example, but not limited to, a pressure sensor for sensing blood pressure within the blood vessel(s) in which the IABP 100 is disposed. In non-limiting embodiments or aspects, the sensor 190 is an optical fiber pressure sensor such as that used in Maquet / Getinge's CS300™ IABP. In embodiments or aspects that use a catheter tube 160 having a plurality of lumens, the sensor 190 can be disposed in a sensor lumen 168. In non-limiting embodiments or aspects, the sensor 190 is disposed in the catheter tube 160, for example, in the sensor lumen 168 at the distal end 140 of the catheter tube 160 proximal to the balloon membrane 180, and in some non-limiting embodiments or aspects, near the base (the most proximal end) of the balloon membrane 180. Without intending to be bound by a particular theory, disposing the sensor 190 in this manner is thought to enable the sensor 190 to be positioned (relative to the patient's aortic valve) in a manner similar to current IABPs that are considerably longer than the IABP 100 when combined with the shorter length IABP 100 as described herein.

[0108] In non-limiting embodiments or aspects, sensor 190 can sense blood pressure based at least in part on the presence of opening(s) 174 disposed in the wall of catheter tube 160, and in particular embodiments or aspects, on the sidewall 161 of sensor lumen 168. In non-limiting embodiments or aspects, sensor 190 is disposed within sensor lumen 168 and located within a pocket between two segments of curable adhesive 192. Adhesive 192 can be any biocompatible adhesive that is bio-stable or not bio-stable, as long as it can hold sensor 190 in place within sensor lumen 168. In non-limiting embodiments or aspects, adhesive 192 is one or more of an acrylic adhesive, an epoxy adhesive, a silicone adhesive, and / or a styrene block copolymer adhesive. As noted above, sensor lumen 168 can include a plurality of openings 174, e.g., but not limited to, four openings 174 as shown in FIG. 7A. Sensor 190 can be disposed within sensor lumen 168 such that adhesive 192 is introduced into the most proximal opening 174a and the most distal opening 174d to hold sensor 190 in a predetermined position. Next, the most medial openings 174b and 174c can be used by sensor 190 to detect the pressure within the blood vessel in which IABP 100 is disposed. This is because these openings allow for fluid communication of pressure between the pocket in which sensor 190 is located within sensor lumen 168 and the blood flowing outside the outer surface 162 of catheter tube 160 when the catheter tube is disposed within a patient's vasculature. To calibrate sensor 190 according to known techniques described in U.S. Patent No. 7,771,362, which is incorporated herein by reference in its entirety, another pressure sensor can be used to confirm the arterial pressure of the artery in which balloon membrane 180 is disposed using the pressure measured in gas lumen 170. According to aspects of the present disclosure, gel 194 can be introduced into sensor lumen 168 using the most medial openings 174b and 174c.

[0109] Continuing to refer to FIG. 7B, in a non-limiting embodiment or aspect, the sensor 190 is surrounded by a gel 194, such as, but not limited to, a viscous gel, such as, but not limited to, a silicone gel. In a non-limiting embodiment or aspect, the gel 194 is introduced into a pocket between the adhesives 192 in which the sensor 190 is disposed. The gel 194 can be introduced into the pocket through the innermost openings 174b and / or 174c as seen in FIG. 7A. The gel 194 is suitable for transmitting pressure from the space outside the catheter tube 160 to the sensor 190 within the pocket of the sensor lumen 168.

[0110] In view of the foregoing, this specification also provides an intra-aortic balloon catheter, such as catheter 100 shown in FIGS. 1, 5A, 6A, and 6B. Catheter 100 includes a proximal end 120, a distal end having a curved portion 142 or a J tip, a tube 160 having an outer surface 162 and an inner surface 164 disposed between the proximal end 120 and the distal end and defining one or more lumens 166, and a balloon membrane 180 disposed at the distal end proximal to the curved portion 142 or the J tip. As described above, catheter 100 can have any suitable length, but in certain non-limiting embodiments or aspects, the length is less than 18 inches, and in certain non-limiting embodiments or aspects, the length is 14-18 inches. As described above and as shown in the non-limiting embodiment or aspect of FIG. 6B, catheter tube 160 can include a sensor lumen 168, a gas lumen 170, and a guidewire lumen 172. In a non-limiting embodiment or aspect, as described above, the guidewire lumen can be formed of a more rigid polyimide material and embedded or otherwise received within a more flexible polymer that makes up the remainder of catheter tube 160. Guidewire lumen 172 (e.g., a polyimide tube) can be in a common lumen arrangement with gas lumen 170. Sensor lumen 168 can include one or more openings 174, as described above and as shown in FIG. 7A. Sensor lumen 168 can also be in a common lumen arrangement with gas lumen 170. Guidewire lumen 172 and sensor lumen 168 can share a common sidewall 176. Thus, gas lumen 170 can be defined by a portion of the inner surface 164 of catheter tube 160, as well as by sidewall 169 of sensor lumen and sidewall 179 that surrounds guidewire tube 173. Inner surface 164, sidewall 169 of sensor lumen, and sidewall 179 are made of the same material. Guidewire lumen 172 is formed by tube 173, which is preferably made of a material different from the material of sidewall 161 that forms the inner surface 164 and outer surface 162 of catheter tube 160. Sensor lumen 168 is defined by sidewall 169 of sensor lumen, common sidewall 176, and a portion of sidewall 161, all of which are made of the same material.

[0111] Regarding FIG. 5B, as previously explained, the curved portion 142 or J-chip includes a first substantially straight segment 144, a curved segment 146 connected to the distal end of the first straight segment 144 at a first end, and a second substantially straight segment 148 connected to the distal end of the curved segment 146 at a proximal end. In non-limiting embodiments or aspects, the second substantially straight segment 148 is substantially or completely parallel to the first substantially straight segment 144. In non-limiting embodiments or aspects, one or more additional curved and / or straight segments may extend from the distal end of the second substantially straight segment 148. In non-limiting embodiments or aspects, the J-chip forms a theoretical circle completed by the hatching shown in FIG. 5B. In non-limiting embodiments or aspects, the diameter of such a theoretical circle is greater than 8 mm, for example, 9 mm, 10 mm, or 11 mm. Also as described above, the curved portion 142 or J-chip can include one or more radiopaque materials therein. In non-limiting embodiments or aspects, the curved portion 142 or J-chip is formed of a thermoplastic material such as the thermoplastic elastomer described above. In non-limiting embodiments or aspects, the curved portion 142 or J-chip is formed of a metal such as a shape memory alloy or at least partially includes a metal such as a shape memory alloy.

[0112] As shown in FIGS. 1, 2, 3A, and 3B, the aortic balloon catheter may further include a sheath seal 200. Referring to FIGS. 2, 3A, and 3B, the sheath seal 200 can include a housing 220 having a proximal end 240, a distal end 260, and a lumen 280 disposed between the proximal end 240 and the distal end 260. In non-limiting embodiments or aspects, the distal end 260 of the sheath seal housing 220 is tapered and narrowed externally in the distal direction. In non-limiting embodiments or aspects, the housing 220 is formed of an elastomeric material. In the above non-limiting embodiments or aspects, the housing 220 is formed of a thermoplastic elastomer. The sheath seal 200 can also include one or more variable impact devices 300 and / or one or more static impact devices 302. In non-limiting embodiments or aspects, the sheath seal 200 includes two impact devices 300, 302. As described above, the impact device(s) 300, 302 impact (e.g., via friction and / or pressure, e.g., contact and engagement) the catheter tube 160 received within the lumen 280. The impact device(s) 300, 302 engage the catheter tube 160 with a force sufficient to resist movement or sliding of the catheter tube 160, for example, during ambulatory cardiac assist therapy. According to the present disclosure, when multiple impact devices are used, multiple of the same impact device may be used and / or different impact devices may be used simultaneously to achieve a force sufficient to resist movement or sliding of the catheter tube 160.

[0113] As described above, the catheter 160 can include a sensor 190 disposed in the sensor lumen 168 and positioned / disposed in a gap or pocket between two segments of the cured adhesive 192. The sensor 190 can be surrounded by a gel 194, such as a viscous silicone gel. The sensor 190 can be disposed at the most distal end of the catheter tube 160 proximal to (and in some non-limiting embodiments or aspects, directly adjacent to the proximal end of) the balloon membrane 180.

[0114] Also provided herein, referring to FIGS. 1 and 6B, is an intra-aortic balloon catheter 100 having a proximal end 120, a distal end 140, a tube 160 having a sidewall 161 with an outer surface 162 and an inner surface 164 defining a gas lumen 170, a sensor lumen 168 in a common lumen arrangement with the gas lumen 170, and a guidewire lumen 172 in a common lumen arrangement with the gas lumen 170 and sharing a common sidewall 176 with the sensor lumen 168. In non-limiting embodiments or aspects, the proximal end 120 is bifurcated (e.g., two proximal ends) or trifurcated (e.g., three proximal ends). In non-limiting embodiments or aspects, the number of proximal ends matches the number of lumens within the tube 160 of the intra-aortic balloon catheter 100. For example, without limitation, one proximal end including a gas lumen 440 may be connected to a gas source to inflate and deflate a balloon membrane via the gas lumen 170, and one end has an opening for a guidewire lumen 470 that is continuous with the guidewire lumen 172 so that a guidewire can be inserted. There may be a third end, or at least a channel 475, associated with the sensor 190 and the sensor lumen 168. The intra-aortic balloon catheter 100 includes a balloon membrane 180 disposed at the distal end 140 of the tube 160 and in fluid communication with the gas lumen 170. As described above, the catheter 100 may have any suitable length, but in certain non-limiting embodiments or aspects, the length is less than 18 inches, and in certain non-limiting embodiments or aspects, the length is 14 - 18 inches. As described above, the distal end of the catheter 100 distal to the balloon membrane 180 can include a curved portion 142, or a J-tip. Also, as described above, the curved portion 142 or J-tip can include a lumen 143 to allow a guidewire, e.g., a guidewire passing through the guidewire lumen 172, to be received therein.

[0115] As described above, the assemblies / devices / catheters described herein are useful in methods of providing cardiac assist therapy, such as right heart assist therapy and / or left heart assist therapy. The catheters and assemblies described herein may be used, for example, but not limited to, with known systems such as Maquet / Getinge's CS300™ and CARDIOSAVE (e.g., computer-controlled cardiac assist therapy systems) to provide cardiac assist therapy. In non-limiting embodiments or aspects, based on one or more of a curved portion / J-tip, a hardened adhesive within the sensor lumen, a sheath seal, and / or a suture pad for a y-connection, and a shorter catheter length that enables access to the vasculature proximate the heart through the axillary artery or subclavian artery, the assemblies / devices / catheters provided herein are useful for ambulatory cardiac assist therapy. By ambulatory is meant that, unlike previous cardiac assist therapy protocols where the patient is restricted to a supine position, a patient receiving cardiac assist therapy can sit, stand, and / or move (i.e., walk around) in an upright position.

[0116] A method of providing cardiac assistance by intravascular balloon pumping of blood, as described above, includes the step of inserting an intra-aortic balloon catheter or IABP into a patient's vasculature. In non-limiting embodiments or aspects, the IABP is inserted into the patient's axillary artery or subclavian artery. The IABP includes a tube having a proximal end, a distal end, and an outer and inner surface disposed between the proximal and distal ends and defining one or more lumens, and a balloon membrane disposed at the distal end and in fluid communication with at least one of the one or more lumens. The IABP may also include a sheath seal as described above, the sheath seal having an elastomeric housing having a lumen disposed between the proximal end, the distal end, and the proximal and distal ends. The housing includes one or more abutment devices that engage the outer surface of a catheter tube received in the lumen of the sheath seal, the one or more abutment devices applying a force to the outer surface of the catheter tube. The method further includes the step of advancing the distal end of the IABP to the patient's aorta (for left heart assistance), and the step of periodically inflating and deflating the balloon membrane by passing a fluid (such as helium gas) through at least one of the one or more lumens. In non-limiting embodiments or aspects, as described above, the sheath seal may include one or more suture pads to enable fixing the sheath seal to the patient. In non-limiting embodiments or aspects of the method, a further step includes fixing the sheath seal to the patient.

[0117] The devices, assemblies, and methods have been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments, but such details are for illustrative purposes only and are not to be considered limiting, but rather are intended to cover modifications and equivalent configurations within the spirit and scope of the appended claims. For example, it is to be understood that the present systems and methods contemplate combining one or more features of any one embodiment with one or more features of any other embodiment, to the extent possible.

Claims

【Claim 1】 The invention described in this specification.

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