Collapsible catheter

Abstract

The invention relates to a collapsible catheter. An intravascular system includes an introducer sheath (104) having a fixed diameter lumen, a first medical device (102), and a catheter (106) having a proximal end and a distal end coupled to the first medical device. When the catheter is positioned within the introducer sheath, an annular gap is formed between the outer circumference of the catheter and the inner circumference of the lumen. The catheter is configured to adopt different dimensional configurations (y, z) such that the size of the catheter and the size of the annular gap are variable. The variability in size of the catheter allows another medical device to pass through the annular gap within the lumen. The catheter may passively change configuration as the second medical device passes adjacently, or change configuration through an active mechanism under the control of a physician.

Description

[0001] This application is a divisional application of Chinese patent application 202080081260X (PCT / US2020 / 053029) entitled "Collapseable Catheter", filed on September 28, 2020.

[0002] Cross-reference to related applications This application claims priority to U.S. Provisional Application No. 62 / 908,199, filed September 30, 2019, the contents of which are incorporated herein by reference. Background Technology

[0003] If a physician plans to use mechanical circulatory support, physicians performing high-risk percutaneous coronary intervention (HRPCI) currently use two separate entry points for accessing the arterial system. The first entry point is for inserting the PCI device into the right femoral, radial, or brachial artery, and the second point is for inserting the blood pump into the left femoral artery. Using two entry points presents several disadvantages for physicians, including the additional time spent performing two insertions, a greater chance of complications during the procedure, the need for more introducers and closure devices, and a higher likelihood of not being able to treat certain patients, such as those with vascular problems. Vascular problems, such as peripheral artery disease, can be present in both femoral arteries, and in some cases, the radial or brachial artery cannot be accessed. For example, some patients may also require a third entry point if chronic total occlusion (CTO) must also be treated. The dual-entry problem also applies to venous conditions, where, for example, the blood pump is often used with pulmonary artery catheterization (PAC), and to large-port procedures, where, for example, transcatheter aortic valve replacement (TAVR) or endovascular aneurysm repair (EVAR) requires a contralateral contrast-injection catheter.

[0004] Current techniques for performing single-entry point interventions involve placing a first device through a dissecting sheath and then advancing a second device alongside the first device within the dissecting sheath. Limitations of this technique include the physician's inability to maintain the position of the first device during manipulation of the second device, poor hemostasis from the introducer valve, which is designed solely for one device insertion, and a higher likelihood of dissecting sheath hub rupture. In some cases, the introducer sheath valve is punctured with a needle adjacent to the blood pump catheter before inserting the second device; puncturing the sheath valve instead of through its center reduces the valve's hemostatic properties, leading to a higher likelihood of intraoperative complications such as significant blood loss. In one example, a 14French (Fr) dissecting sheath is inserted into the vascular system to introduce a 9Fr Impella® blood pump and catheter manufactured by Abiomed. Once the pump is up and running, the physician uses a needle to puncture a hole in the hemostatic valve of the introducer sheath, delivers a guidewire through the valve, and then delivers a long 7Fr introducer sheath with a hub for PCI. This exemplary method has limitations because the 14Fr stripping sheath has an inner diameter and a break line, so physicians must carefully consider the wall thickness and remaining available space when inserting a secondary 7Fr sheath to avoid breaking the stripping sheath.

[0005] There is a desire for a device that allows for the insertion of more than one device into a vascular system using a single-entry method. The single-entry method offers several advantages by dedicating multiple medical devices to a single-bore introducer sheath. A single-entry system minimizes access to a sterile area and thus reduces the likelihood of contamination, surgical site infection, and other procedure-related complications. A single-entry system also advantageously reduces the number of access sites to be managed and allows for a single, well-defined procedure. One approach to the solution for inserting two devices using a single standard introducer sheath of a limited diameter would involve reducing the overall size of the devices to at least match the diameter of the sheath. Summary of the Invention

[0006] The system and method described herein enable the insertion of multiple medical devices into a patient's vascular system through a single entry point via an introducer sheath by coupling a medical device to a collapsible catheter. While the collapsible catheter is positioned within a fixed-diameter introducer sheath, it allows other medical devices to pass within the introducer sheath and adjacent to the catheter.

[0007] In one exemplary aspect, an endovascular system includes an introductory sheath having a lumen of a fixed inner diameter; a first medical device; and a catheter having a proximal end, a distal end, and an outer circumference, the distal end being coupled to the first medical device, the outer circumference being configured to employ a first dimension or a second dimension when positioned within the lumen of the fixed inner diameter. The catheter can be positioned within the lumen of the sheath, leaving an annular gap between the outer circumference of the catheter and the inner circumference of the lumen of the sheath, such that the size of the annular gap can be varied by means of the outer circumference of the catheter having the first and second dimensions. In some dimensional configurations of the catheter, the annular gap is sized to allow passage of a second medical device therethrough. The first medical device may be a blood pump, and the second medical device may be a PCI device, another catheter, or another introductory sheath. The catheter may consist of a flexible layer and a rigid layer removably attached to the catheter, allowing for changes in catheter size after removal of the rigid layer. The rigid layer allows a physician or operator to insert and position the catheter within the vascular system. After the rigid layer is removed, the flexible layer can deform to accommodate a second medical device to fit adjacently within the annular gap. The catheter can alternatively be constructed of a catheter frame that can be actively triggered by a physician to collapse or expand. The catheter frame can be constructed of multiple strands and a polymer coating, the strands forming a braided mesh. At least one advantage of this exemplary aspect is that the catheter is compatible with commonly used introducer sheaths and medical devices that can be introduced alongside the catheter within the sheath. At least one other advantage of this exemplary aspect is that the physician can manipulate the catheter at their discretion during the positioning of a medical device coupled to the catheter and during the introduction of another medical device alongside the catheter.

[0008] In another aspect, a method for introducing a medical device into a patient's vascular system via an introducer sheath uses a catheter to accommodate multiple devices within a fixed-size sheath. An introducer sheath with a lumen of a fixed inner diameter is percutaneously inserted into the patient's vascular system to provide an entry point for an intravascular medical device. A first medical device coupled to the catheter is introduced through the lumen. The first medical device may be a blood pump. When the catheter is positioned within the fixed-diameter lumen, the outer circumference of the catheter is configured to adjustably employ a first dimension or a second dimension. The catheter may be positioned within the lumen of the sheath, leaving an annular gap between the outer circumference of the catheter and the inner circumference of the sheath's lumen. In certain dimensional configurations of the catheter, the annular gap is sized to allow a second medical device to pass through it. The method may also include introducing a second medical device through the annular gap. The second medical device may be a PCI device, another catheter, or another introducer sheath. In some embodiments, the outer circumference of the catheter passively changes dimension as the second device is inserted adjacently. In other embodiments, the catheter must be actively triggered by a physician to deform before the adjacent insertion of the second medical device. In a further embodiment, the method includes introducing an introductory sheath into a vascular system, introducing a first medical device coupled to a catheter capable of being triggered to change its dimensions, altering the catheter to increase the annular gap, and introducing a second medical device through the annular gap. In some embodiments, the second medical device is introduced into the lumen before the first medical device is coupled to the catheter, and the outer circumference of the catheter changes its dimensions as the catheter is inserted adjacent to the second medical device. At least one advantage of this aspect is that it provides the physician with the ability to manipulate the catheter at their discretion before, during, or after the catheter is introduced through the introductory sheath. At least one other advantage of this aspect is that multiple medical problems can be addressed by using multiple medical devices through a single entry point. This aspect also allows the physician to manipulate the catheter as needed to address complications that arise during surgery on a patient, for example. Attached Figure Description

[0009] The foregoing and other objects and advantages will become apparent when the following detailed description is considered in conjunction with the accompanying drawings, wherein the same reference numerals always denote the same parts, and wherein: Figure 1A A catheter in a first configuration according to an illustrative embodiment is shown, the catheter being coupled to a medical device and positioned within a sheath; Figure 1B A catheter in a second configuration according to an illustrative embodiment is shown, the catheter being coupled to a medical device and positioned within a sheath, with another medical device positioned adjacent to the sheath. Figure 2 A catheter having a rigid inner layer and a flexible outer layer according to an illustrated embodiment is shown; Figure 3 A catheter having a flexible inner layer and a rigid inner layer according to an illustrated embodiment is shown; Figure 4 A catheter frame comprising a coated braid for constricting and expanding catheters is shown according to an illustrative embodiment; Figure 5 A flowchart illustrating the introduction of a collapsible conduit according to an illustrative embodiment is shown; Figure 6 A flowchart is shown according to an illustrated embodiment for introducing a blood pump and PCI device coupled to a collapsible catheter via an introducer sheath. Figure 7 A flowchart illustrating a medical device, according to an illustrative embodiment, for introducing a medical device coupled to a collapsible catheter alongside a previously introduced medical device; and Figure 8 A flowchart is shown, according to an illustrated embodiment, for introducing a medical device coupled to a collapsible catheter, modifying the catheter's construction, and introducing another medical device alongside the catheter. Detailed Implementation

[0010] To provide a full understanding of the systems, methods, and apparatus described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically designed for use in conjunction with endovascular catheterization, it should be understood that all components and other features outlined below can be combined with each other in any suitable manner and can be adapted and applied to other types of procedures requiring catheters.

[0011] The term "proximal" should be understood as referring to a position on the catheter that is relatively closer to the operator during catheter use, while the term "distal" should be understood as referring to a position on the catheter that is relatively farther from the operator during catheter use. The term "upstream" should be understood as referring to a position on the catheter that is relatively upstream in the blood flow within the vessel when the catheter is in place in the patient's blood vessel. The term "physician" should be understood as referring to any physician, doctor, or operator using the described system or method.

[0012] Figure 1A and Figure 1B An endovascular system 100 configured for percutaneous insertion of two medical devices into a patient's vascular system via an introducer sheath is shown. A variable-sized catheter is coupled to a first medical device such that a second medical device is fitted alongside the catheter within the introducer sheath. A cross-section of the system shows the variation in catheter size with and without the second medical device introduced.

[0013] Figure 1A An endovascular system 100 is shown, comprising a first medical device 102, an introductory sheath 104, and a catheter 106. The first medical device 102 is coupled to the distal end of the catheter 106. As shown, the catheter 106 extends through the lumen 108 of the introductory sheath 104. The lumen 108 has a fixed inner diameter. The introductory sheath 104 has a cross-sectional dimension X. In this arrangement, the catheter 106 is in a first configuration and has a first dimension Y. When the catheter 106 is positioned within the lumen 108 of the introductory sheath 104, an annular gap exists between the outer circumference 110 of the catheter 106 and the inner circumference 112 of the lumen 108. The catheter 106 has variable dimensions, and therefore the annular gap also has variable dimensions.

[0014] The introducer sheath 104 can be configured for percutaneous insertion into the patient's vascular system, and the first medical device 102 can be configured to be positioned in the vascular system after proximal insertion through the introducer sheath 104. In one example, the first medical device 102 is a blood pump configured to be positioned within the patient's heart via the vascular system. The blood pump may include a motor, rotor, pump housing, cannula, distal opening, and atraumatic extension. In some embodiments, the first dimension Y is between 8 Fr and 11 Fr. In some embodiments, the first dimension Y is between 9 Fr and 10 Fr. In some embodiments, the first dimension Y is 9 Fr. Figure 1A In the system, the annular gap can have a dimension A1, where in some embodiments, A1 = XY. For example, dimension Y can have a value greater than zero and less than or equal to the value of dimension X, and dimension A1 can have a value in the range from zero to the value of dimension X. At least one advantage of the variable-size catheter 106 is that the annular gap within the lumen 108 is also variable-size, and the size of the annular gap can be adjusted to a desired size, for example, by changing the configuration of the catheter 106, such that the dimension of the catheter 106 in the new configuration is not equal to Y. In one example, the desired size of the annular gap can be adapted to the size of a second medical device.

[0015] Figure 1B An endovascular system 100 is shown, comprising a first medical device 102, an inlet sheath 104, a catheter 106, and a second medical device 114. The first medical device 102 is coupled to the distal end of the catheter 106. The first medical device 102 is positioned in the vascular system after proximal insertion through the inlet sheath 104. The catheter 106 is positioned within the lumen 108 of the inlet sheath 104. The second medical device 114 is positioned adjacent to the catheter 106 and within the lumen 108, such that it resides within an annular gap formed between the outer circumference 110 of the catheter 106 and the inner circumference 112 of the lumen 108. When the second medical device 114 is simultaneously positioned within the annular gap, the catheter 106 is in a second configuration and has a second dimension Z.

[0016] For example, the second medical device 114 may be a PCI device. In some embodiments, the second medical device 114 is a secondary insertion sheath or a secondary catheter. In some embodiments, the annular gap in the second configuration is sized to allow the second medical device 114 to pass through it. In a further embodiment, when the catheter 106 is in the first configuration, the second medical device 114 cannot fit within the annular gap, therefore the catheter 106 is in the second configuration to allow the second medical device 114 to pass through. In some embodiments, the annular gap in the second configuration is larger than the annular gap in the first configuration. In some embodiments, the catheter 106 is in the second configuration when the second medical device 114 passes within the annular gap, and in the first configuration when the second medical device 114 is not in the annular gap.

[0017] In some implementations, the second dimension Z is between 7Fr and 9Fr. In some implementations, the second dimension Z is 7Fr. Figure 1B In a system, the annular gap can have a dimension A2, where A2 = XZ, and can have the same dimensions as... Figure 1A The annular gaps in the system have different values ​​for their dimensions. For example, the second dimension Z can have values ​​greater than zero and less than or equal to X, and dimension A2 can have values ​​ranging from zero to X.

[0018] The catheter 106 can be changed from a first configuration to a second configuration, or vice versa, by an active or passive mechanism, which includes, for example, reinforcing strands, tension guidewires, braided mesh, variable stiffness sleeves, rheological materials, expandable elements, or pneumatic elements. In embodiments of a variable-size catheter with an active mechanism for dimensional change, the catheter 106 is triggered by a physician or operator to change its configuration. In embodiments of a variable-size catheter with a passive mechanism, introducing a second medical device 114 adjacent to the catheter 106 into the lumen 108 of an introducer sheath 104 forces the catheter 106 into the second configuration; the second medical device can apply a normal force to the outer wall of the catheter 106 and deform the shape or dimensional configuration of the catheter 106.

[0019] In some embodiments, only the portion of catheter 106 within lumen 108 changes from a first configuration to a second configuration, while the remaining portion of catheter 106 outside lumen 108 remains unchanged. For example, a first medical device 102 and catheter 106 coupled thereto are introduced via an introducer sheath 104 such that a portion of catheter 106, defined by a longitudinal length shorter than the total longitudinal length of catheter 106, is within lumen 108 of introducer sheath 104, and the remaining length of catheter 106 is positioned outside introducer sheath 104; as a second medical device 114 is introduced alongside catheter 106, only the portion of catheter 106 within lumen 108 undergoes a change from the first configuration to the second configuration.

[0020] In some embodiments, the first dimension and the second dimension are measurements of the length of the cross-section of the catheter. In some embodiments, the cross-section of the catheter is circular, and the first dimension and the second dimension are the diameters of the circular cross-section. In some embodiments, the cross-section of the catheter is not circular, and the first dimension and the second dimension are the widths of the cross-section in one direction.

[0021] exist Figure 1A In this arrangement, the conduit 106 is positioned within the lumen 108 of the introducing sheath 104. An annular gap is formed between the outer circumference 110 of the conduit 106 and the inner circumference 112 of the introducing sheath 104. In this arrangement, the conduit 106 is in a first configuration and has a first dimension Y, and the introducing sheath has a cross-sectional dimension X.

[0022] In some embodiments, the first dimension Y is a measurement of the cross-sectional dimension of the catheter 106. In further embodiments, the cross-section is circular, and the first dimension Y is the diameter of the circular cross-section; or the cross-section is not circular, and the first dimension Y is the width of the cross-section in one direction. The cross-section of the catheter 106 may be elliptical, circular, or some amorphous form. Alternatively, the first dimension Y may be any selected dimension related to the size of the catheter 106.

[0023] exist Figure 1B In this arrangement, catheter 106 is positioned within the lumen 108 of introducer sheath 104. Introducer sheath 104 has a cross-sectional dimension X. An annular gap is formed between the outer circumference 110 of catheter 106 and the inner circumference 112 of introducer sheath 104. A second medical device 114 is positioned within the annular gap and adjacent to catheter 106. In this arrangement, catheter 106 is in a second configuration and has a second dimension Z, which is at least less than X, so that the second medical device 114 is positioned within the annular gap.

[0024] The sheath cross-sectional dimension X sets a limit on the overall size of the catheter 106 and the second medical device 114 that can fit within a single intubation sheath 104. For example, the second medical device 114 may have a cross-sectional dimension S, and dimension X may constrain dimensions Z and S such that Z + S ≤ X. In another example, the sum of the first dimension Y and the second device dimension S is greater than the sheath dimension X, indicating that the catheter 106 needs to be adjusted to the second dimension Z so that both the catheter 106 and the second medical device 114 fit within a lumen 108 of a fixed inner diameter. In some embodiments, the second dimension Z is a measurement of the length of the cross-section of the catheter 106. In a further embodiment, the cross-section is circular, and the second dimension Z is the diameter of the circular cross-section; or the cross-section is not circular, and the second dimension Z is the width of the cross-section in one direction. The cross-section of the catheter 106 may be elliptical, circular, or some amorphous form. Alternatively, the second dimension Z may be any selected dimension related to the size of the catheter 106.

[0025] In some embodiments, the annular gap when catheter 106 is in the second configuration is sized to allow a third medical device to mate adjacent to catheter 106 and a second medical device 114 within lumen 108. In a further embodiment, the annular gap when catheter 106 is in the second configuration is sized to allow multiple devices to mate adjacent to catheter 106 within lumen 108.

[0026] exist Figure 1A and Figure 1B At least one advantage of the system shown and described is that the use of the variable-size catheter 106 allows a second medical device 114 to be positioned adjacent to the catheter 106 within a fixed-diameter lumen 108. By using only one introducer sheath 104 for inserting both medical devices 102 and 114, the system addresses the need for single-entry introduction of multiple endovascular devices. This solution advantageously minimizes the number of closure devices required to manage endovascular entry-related complications and access sites.

[0027] Figure 2 The diagram shows an axial cross-section of a catheter 206 comprising a rigid inner layer 216 and a flexible outer layer 218. The catheter 206 is a variable-size catheter (such as those from...). Figure 1A and Figure 1B Example of catheter 206. Layers 216 and 218 extend from the proximal end to the distal end of catheter 206. A rigid inner layer 216 is removably attached to catheter 206 or a flexible outer layer 218. Catheter 206 may be... Figure 1A and Figure 1B The catheter 106 in the middle. When the catheter 206 is positioned, for example... Figure 1A and Figure 1BWhen the catheter is inserted into the sheath 104, the rigid inner layer 216 can be removed proximally. Removal of the rigid inner layer 216 allows the catheter 206 to change from a first configuration to a second configuration, for example, regarding... Figure 1A and Figure 1B The first and second configurations of catheter 106 are described. A rigid inner layer 216 is configured to allow a physician to insert a medical device (e.g., ) at the distal end of catheter 206. Figure 1A and Figure 1B The first medical device 102 is introduced during the maneuvering and manipulation of the catheter 206.

[0028] At least one of the rigid inner layer 216 and the flexible outer layer 218 may be made of a polymer. The polymer is selected to have a stiffness suitable for rigidity or flexibility. In some embodiments, the polymer includes at least one of ethylene vinyl acetate, polyethylene, polyolefin elastomer, maleic anhydride graft polymer, styrene-butadiene-styrene, polypropylene-based elastomer, styrene-butadiene copolymer, thermoplastic polyester elastomer, thermoplastic polyurethane elastomer, thermoplastic vulcanized rubber, polyamide, polytetrafluoroethylene, aromatic polyester, polyvinyl chloride, polymethyl methacrylate, acrylonitrile-butadiene-styrene, styrene-acrylonitrile, polystyrene, polyethylene terephthalate copolymer, polycarbonate, polyphenylene ether, polyphenylene ether acetate, butyrate, propionate, polysulfone, polyethersulfone, polyarylsulfone, polybutylene terephthalate, polyester terephthalate, acetal, fluorinated ethylene propylene, perfluoroalkoxy polymer, ethylene chloride trifluoroethylene, polyvinylidene fluoride, tetrafluoroethylene perfluoromethyl vinyl ether, tetrafluoroethylene, hexafluoropropylene, liquid crystal polymer, and polyetheretherketone.

[0029] In some embodiments, the rigid inner layer 216 includes at least one dissection slit allowing removal of the rigid inner layer 216 in a proximal direction. In other embodiments, the rigid inner layer 216 is removably attached to the catheter 206 by a locking mechanism and can be removed by twisting the proximal end of the rigid inner layer 216 to unlock the mechanism and slide the rigid inner layer 216 proximally out of the catheter 206. The catheter 206 may be configured to be positioned within an introducer sheath, forming an annular gap between the catheter 206 and the introducer sheath. In some embodiments, the rigid inner layer 216 is removed from the catheter 206, and a second medical device (such as...) is inserted... Figure 1A and Figure 1B The second medical device 114) is adjacent to the catheter 206, which introduces a lumen of a fixed size (such as...). Figure 1A and Figure 1BThe catheter 206 is placed within the lumen 108 of the introducer sheath 104, and the second medical device applies a normal force to the flexible outer layer 218, which is constrained to the second configuration by the normal force, such that both the catheter and the medical device fit within a fixed-size lumen. Although the rigid inner layer 216 is attached to the catheter 206, the catheter 206 does not change from its original configuration, which is optimal for the insertion, adjustment, and positioning of the catheter 206 and the distally coupled medical device. At least one advantage of the catheter 206 is that the stiffness difference between layers 216 and 218 allows the physician to manipulate the size of the catheter 206 by removing the rigid inner layer 216 during the procedure, allowing the remaining flexible outer layer 218 to deform and change the size of the annular gap within the introducer sheath to fit the second medical device through the annular gap.

[0030] Figure 3 An axial cross-section of a catheter 306, including a flexible inner layer 320 and a rigid outer layer 322, is shown. Catheter 306 is an example of a variable-size catheter, such as those from... Figure 1A and Figure 1B The catheter 306. Layers 320 and 322 extend from the proximal end to the distal end of the catheter 306. The rigid outer layer 322 is removably attached to the catheter 306 or the flexible inner layer 320. The catheter 306 may be... Figure 1A and Figure 1B catheter 106 in. When catheter 306 is positioned, for example... Figure 1A and Figure 1B When the catheter is inserted into the sheath 104, the rigid outer layer 322 can be removed proximally. Removal of the rigid outer layer 322 allows the catheter 306 to change from a first configuration to a second configuration, for example, regarding... Figure 1A and Figure 1B The first and second configurations of catheter 106 are described. The rigid outer layer 322 is configured to allow a physician to insert a medical device (e.g., ) at the distal end of catheter 306. Figure 1A and Figure 1B The catheter 306 is mobilized and manipulated during the introduction of the first medical device 102.

[0031] At least one of the rigid outer layer 322 and the flexible inner layer 320 may be made of a polymer. The polymer may be selected to have a stiffness suitable for rigidity or flexibility. In some embodiments, the rigid outer layer 322 includes at least one dissection slit that allows removal of the rigid outer layer 322 in a proximal direction. In other embodiments, the rigid outer layer 322 is removably attached to the catheter 306 by a locking mechanism and can be removed by twisting the proximal end of the rigid outer layer 322 to unlock the mechanism and slide the rigid outer layer 322 proximally out of the catheter 306. The catheter 306 may be configured to be positioned within an introducer sheath, forming an annular gap between the catheter 306 and the introducer sheath. In some embodiments, the rigid outer layer 322 is removed from the catheter 306, and a medical device (such as...) is... Figure 1A and Figure 1B The second medical device 114) is adjacent to the catheter 306, which introduces a lumen of a fixed size (such as...). Figure 1A and Figure 1B Within the lumen 108 of the introducer sheath 104, the medical device applies a normal force to the flexible inner layer 320, which is constrained to the second configuration by the normal force, such that both the catheter and the medical device fit within a fixed-size lumen. Although the rigid outer layer 322 is attached to the catheter 306, the catheter 306 does not change from its original configuration, which is optimal for the insertion, adjustment, and positioning of the catheter 306 and the distally coupled medical device. At least one advantage of the catheter 306 is that the stiffness difference between layers 320 and 322 allows the physician to manipulate the size of the catheter 306 by removing the rigid outer layer 322 during the procedure, allowing the remaining flexible inner layer 320 to deform and change the size of the annular gap within the introducer sheath to fit the second medical device through the annular gap.

[0032] Figure 4 A segment of catheter 406 with a constricting portion and an expanding portion is shown. Catheter 406 is an example of a variable-size catheter, such as those from... Figure 1A and Figure 1BThe catheter 106. The contraction and expansion of the catheter 406 are achieved by a catheter frame 424 and a polymer layer 430. The catheter frame 424 includes a first plurality of strands 426 and a second plurality of strands 428, both extending longitudinally from the proximal end to the distal end of the catheter 406. The polymer layer 430 forms a coating around the outer surface of the catheter frame 424. The catheter frame 424 is configured to reversibly deform from a first configuration to a second configuration. Deformation from the first configuration to the second configuration is the contraction of the catheter frame 424, and the reverse deformation from the second configuration to the first configuration is the expansion of the catheter frame 424. The first plurality of strands 426 may be wound in a helical direction along the length of the catheter frame 424, and the second plurality of strands 428 may be wound in a counterclockwise direction along the length. The first plurality of strands 426 and the second plurality of strands 428 are configured to be biased for contraction or expansion, and the strands may be configured to slide relative to each other as the catheter frame 424 contracts and expands. The polymer coating 430 is configured to expand and collapse with the conduit frame 424 and extend around the inner surface of the conduit frame 424.

[0033] In some embodiments, the polymer coating 430 includes at least one of ethylene vinyl acetate, polyethylene, polyolefin elastomer, maleic anhydride graft polymer, styrene-butadiene styrene, polypropylene-based elastomer, styrene-butadiene copolymer, thermoplastic polyester elastomer, thermoplastic polyurethane elastomer, thermoplastic vulcanized rubber, polyamide, polytetrafluoroethylene, aromatic polyester, polyvinyl chloride, polymethyl methacrylate, acrylonitrile-butadiene styrene, styrene-acrylonitrile, polystyrene, polyethylene terephthalate copolymer, polycarbonate, polyphenylene ether, polyphenylene ether acetate, butyrate, propionate, polysulfone, polyethersulfone, polyarylsulfone, polybutylene terephthalate, polyester terephthalate, acetal, fluorinated ethylene propylene, perfluoroalkoxy polymer, ethylene chloride trifluoroethylene, polyvinylidene fluoride, tetrafluoroethylene perfluoromethyl vinyl ether, tetrafluoroethylene, hexafluoropropylene, liquid crystal polymer, and polyetheretherketone.

[0034] Catheter 406 can be Figure 1A and Figure 1BAn example of catheter 106 is provided, such that it is coupled to a first medical device 102 and inserted into a patient's vascular system via an introductory sheath 104. In one example, a physician can manipulate the size of catheter 406 by expanding or contracting catheter frame 424, such that the size of the annular gap formed between the outer circumference of catheter 406 and the inner circumference of introductory sheath is also variable. Catheter frame 424 may represent an active mechanism for deformation between a first configuration and a second configuration. In some embodiments, a physician can actively deform catheter 406 by proximally triggering the contraction or expansion of catheter frame 424. In some embodiments, when the catheter is in the first configuration with catheter frame 424 in an expanded state, catheter 406 and the first medical device coupled to the distal end of catheter 406 are inserted into the patient's vascular system via the introductory sheath. In a further embodiment, catheter 406 is triggered by a physician to deform into a second configuration where catheter frame 424 collapses to a contracted state, wherein the annular gap is widened by deformation. The enlarged annular gap can be sized to allow insertion of a second medical device into the introductor sheath and adjacent to catheter 406. In some embodiments, a blood pump is coupled to the distal end of catheter 406, and the annular gap in the second configuration is sized to allow insertion of a PCI device into the same introductor sheath as catheter 406. Catheter frame 424 may include a braided mesh formed of a first plurality of strands 426 and a second plurality of strands 428. In some embodiments, catheter frame 424 includes only the first plurality of strands 426. In further embodiments, catheter frame 424 includes a braided mesh formed only of the first plurality of strands 426. For example, the plurality of strands 426 and 428 may be made of polymers, metals, or other materials with flexible properties. At least one advantage of catheter 406 is that catheter frame 424 can be selectively triggered by a physician to expand or contract, with or without the second medical device positioned adjacent to catheter 406. Another advantage resulting from the design of catheter 406 is the simple structure of the device, which does not require dividing catheter 406 into multiple parts.

[0035] Figure 5A flowchart illustrating an exemplary method 500 for introducing a medical device coupled to a collapsible catheter into a patient's vascular system via an introducer sheath is shown. Method 500 includes steps 502 and 504. Step 502 includes percutaneously inserting an introducer sheath into the patient's vascular system, the introducer sheath including a lumen having a fixed diameter and an inner circumference. Step 504 includes introducing a first medical device coupled to the distal end of a catheter via the introducer sheath. The catheter includes a distal end, a proximal end, and an outer circumference, the outer circumference being sized such that an annular gap is formed between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath when the catheter is positioned within the introducer sheath. The catheter is configured to employ a first configuration or a second configuration when positioned within a lumen of a fixed diameter, the catheter having a first dimension in the first configuration and a second dimension in the second configuration. For example, this method can be applied to… Figure 1A and Figure 1B The system shown, wherein the method would include percutaneously inserting an introducer sheath 104 into a vascular system and introducing a first medical device 102 coupled to a catheter 106 through the introducer sheath 104, forming an annular gap between the outer circumference 110 and the inner circumference 112. The catheter in method 500 may also be catheter 206, 306, or 406.

[0036] Method 500 may further include a third step, which includes introducing a second medical device into the annular gap, wherein the annular gap in the second configuration is sized to allow the second medical device to pass through it. In some embodiments, the annular gap in the second configuration is larger than the annular gap in the first configuration. Figure 2 and Figure 3 In some embodiments of method 500, the catheter 206 or 306 may be in a second configuration when the second medical device passes within the annular gap, and in a first configuration when the second medical device is not within the annular gap. The first medical device may be a blood pump, and the second medical device may be a PCI device. In this method 500, the catheter (such as...) Figure 4 In other embodiments where the catheter 406 is suitable for active contraction and dilation, method 500 may further include a third step comprising changing the catheter from a first configuration to a second configuration, wherein the annular gap in the second configuration is sized to allow passage of a second medical device. When using from... Figure 4In an embodiment of method 500 with catheter 406, the physician may trigger a change in the catheter's configuration before or after insertion into the introducer sheath. In a further embodiment, method 500 includes a fourth step comprising introducing a second medical device into the annular gap. At least one advantage of method 500 is that the physician can operate at least two medical devices introduced into a patient's vascular system through a single introducer sheath, thereby reducing the management of the entry site and closure to a well-defined procedure.

[0037] Figure 6 A flowchart illustrating an exemplary method 600 for introducing a blood pump and a PCI device coupled to a collapsible catheter into a patient's vascular system via an introducer sheath is shown. Method 600 includes steps 602, 604, and 606. Step 602 includes percutaneously inserting an introducer sheath into the patient's vascular system, the introducer sheath including a lumen having a fixed diameter and an inner circumference. Step 604 includes introducing a blood pump coupled to the distal end of a catheter via the introducer sheath, the catheter having a proximal and distal end and an outer circumference sized such that an annular gap is formed between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath when the catheter is positioned within the introducer sheath. The catheter is configured to employ a first configuration or a second configuration when positioned within the fixed-diameter lumen, the catheter having a first dimension in the first configuration and a second dimension in the second configuration. Step 606 includes introducing a PCI device within the annular gap, the annular gap in the second configuration being sized to allow a second medical device to pass through it. Method 600 can be applied to the system shown and described in Figures 1-4. For example, the catheter in method 600 can be catheter 106, 206, 306, or 406 inserted into the introducer sheath 104. The change from the first configuration to the second configuration can be achieved through, for example... Figure 2-3 The passive mechanism described in the text or through, for example Figure 4 This is achieved using the active mechanism described in [the document]. [In use]... Figure 2 and Figure 3 In some embodiments of method 600 involving catheter 206 or 306, the catheter is in a second configuration when the second medical device passes within the annular gap, and in a first configuration when the PCI device is not within the annular gap. In this configuration, the catheter (such as...) Figure 4 In other embodiments where the catheter 406 is suitable for active contraction and dilation, method 600 may further include a third step comprising changing the catheter from a first configuration to a second configuration, wherein the annular gap in the second configuration is sized to allow the PCI device to pass through it. When using from... Figure 4In an embodiment of method 600 with catheter 406, the physician can trigger a change in the catheter's configuration before or after insertion into the introducer sheath. At least one advantage of method 600 is that the physician can perform high-risk HRPCI through a single introducer sheath that cannot be adapted to the diameter of the PCI device next to a fixed-size catheter, even when the blood pump support is coupled to a variable-size catheter.

[0038] Figure 7 A flowchart illustrating a method 700 for introducing a medical device coupled to a collapsible catheter via an introducer sheath that already contains a previously inserted medical device is shown. Method 700 includes steps 702, 704, and 706. Step 702 includes percutaneously inserting an introducer sheath into a patient's vascular system, the introducer sheath including a lumen having a fixed diameter and inner circumference. Step 704 includes introducing a first medical device into the introducer sheath, the first medical device having an outer circumference sized such that a fixed-size annular gap is formed between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath when the first medical device is positioned within the introducer sheath. Step 706 includes introducing a second medical device coupled to the distal end of the catheter into the annular gap, wherein the catheter is configured with a first configuration having a first dimension in the first configuration and a second dimension in the second configuration, the second configuration being configured to fit within the fixed-size annular gap.

[0039] The device implemented in method 700 can be the device described in Figures 1-4, for example, using catheters 106, 206, 306, or 406 and an inlet sheath 104. As the catheter is inserted into a fixed-size annular gap, the catheter can passively deform from a first configuration to a second configuration. In other embodiments, the catheter can be actively triggered to deform into a second configuration sized to fit within a fixed-size annular gap. The first medical device can be a PCI device, and the second medical device can be a blood pump. At least one advantage of method 700 is that the first medical device can be accompanied by the second medical device via an inlet sheath using a variable-size catheter. For example, a physician may be performing PCI through an inlet sheath, and then complications may require blood pump support for the PCI, so the physician can introduce a blood pump coupled to the variable-size catheter without opening another access point.

[0040] Figure 8A flowchart illustrating a method 800 for introducing a medical device coupled to a collapsible catheter, modifying the catheter's configuration, and introducing another medical device alongside the catheter, according to an illustrated embodiment, is shown. Method 800 includes steps 802, 804, 806, and 808. Step 802 includes percutaneously inserting an introducer sheath into a vascular system, the introducer sheath including a lumen having a fixed inner diameter and an inner circumference. Step 804 includes introducing a first medical device coupled to the distal end of a catheter through the introducer sheath, the catheter including a proximal end and an outer circumference having a first dimension, such that when the catheter is positioned within the lumen of the fixed inner diameter, an annular gap exists between the outer circumference of the catheter and the inner circumference of the sheath lumen. Step 806 includes changing the outer circumference of the catheter from the first dimension to a second dimension, such that the annular gap increases to allow the second medical device to pass through it. Step 808 includes introducing the second medical device through the annular gap.

[0041] The apparatus implemented in method 800 may be Figure 1A , Figure 1B and Figure 4 The device described herein, for example, uses catheter 106 or 406 and an introducer sheath 104. The catheter can be actively altered or triggered by the physician to change from having a first dimension to having a second dimension, thereby altering the annular gap formed between the catheter and the lumen. In some embodiments, the first medical device is a blood pump. In some embodiments, the second medical device is a PCI device, a second introducer sheath, or a second catheter. At least one advantage of method 800 is that, when the coupled first medical device is used within the patient's vascular system, the physician can selectively change the size of the catheter so that the second medical device can be introduced into the vascular system without opening the second access site. This advantage can be useful, for example, if complications occur during surgery using the first medical device and the physician urgently needs to introduce the second medical device to manage the complications.

[0042] The foregoing description merely illustrates the principles of this disclosure, and the instrument can be practiced in other ways besides the described embodiments, which are presented for illustrative purposes and not for limitation. It should be understood that while the instrument disclosed herein is shown for percutaneous insertion into a heart pump, it can be applied to other applications requiring hemostasis.

[0043] Variations and modifications will occur to those skilled in the art upon review of this disclosure. The disclosed features may be implemented in any combination and sub-combination (including multiple dependent combinations and sub-combinations) with one or more other features described herein. The various features described or illustrated above (including any components thereof) may be combined or integrated into other systems. Furthermore, certain features may be omitted or not implemented.

[0044] The systems and methods described herein can be implemented locally on a heart pump system or its controller (such as an AIC). The heart pump system may include data processing instruments. The systems and methods described herein can also be implemented remotely on a separate data processing instrument. The separate data processing instrument can be connected to the heart pump system directly or indirectly via a cloud application. The heart pump system can communicate with the separate data processing instrument in real-time (or near real-time).

[0045] Typically, embodiments of the subject matter and functional operation described in this specification can be implemented in digital electronic circuits, or in computer software, firmware, or hardware (including the structures disclosed in this specification and their equivalents), or in a combination of one or more of them.

[0046] Examples of changes, substitutions, and alterations can be determined by those skilled in the art and can be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated in their entirety and form part of this application.

Claims

1. An intravascular system for inserting a first medical device and a second medical device into a patient's vascular system, the system comprising: An introducer sheath configured for percutaneous insertion into a vascular system, the introducer sheath comprising a lumen having a fixed inner diameter and inner circumference; First medical device; as well as A catheter having a proximal end and a distal end, the distal end being coupled to the first medical device, the catheter having an outer circumference configured to adjustably employ a first dimension or a second dimension when positioned within the lumen of the introducer sheath, such that the catheter can be positioned within the lumen of the introducer sheath, and leaving an annular gap between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath.

2. The system of claim 1, wherein the catheter is configured such that the annular gap when the outer circumference of the catheter adopts the second dimension is sized to allow the second medical device to pass through it.

3. The system according to any one of claims 1 or 2, wherein the conduit is configured such that the annular gap when the outer circumference of the conduit adopts the second dimension is greater than the annular gap when the outer circumference of the conduit adopts the first dimension.

4. The system according to any one of claims 2 or 3, wherein the outer circumference of the conduit is configured as follows: When the second medical device is within the annular gap, the second dimension is employed; and When the second medical device is not in the annular gap, the first dimension is used.

5. The system according to any one of claims 1-4, wherein the first medical device further comprises a blood pump.

6. The system according to any one of claims 2-5, wherein the second medical device comprises a percutaneous coronary intervention device.

7. The system according to any one of claims 1-6, wherein the conduit comprises an inner layer and an outer layer.

8. The system of claim 7, wherein at least one of the inner layer or the outer layer is removably attached to the conduit.

9. The system according to any one of claims 7 or 8, wherein: The outer layer is flexible; and The inner layer is rigid.

10. The system according to any one of claims 7-9, wherein the outer circumference of the conduit is configured to change from the first dimension to the second dimension after the inner layer is removed.

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