Collapsible catheter

Abstract

This allows for the insertion of multiple medical devices into the patient's vascular system via a single access point through an introducer sheath. [Solution] The intravascular system includes an introducer sheath 104 having a lumen of fixed diameter, 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 placed 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 take on different dimensional forms such that the size of the catheter and the annular gap are variable.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 908,199, filed on September 30, 2019, the content of which is incorporated herein by reference.

Background Art

[0002] Background Currently, when a physician planning to perform high - risk percutaneous coronary intervention (HRPCI) uses mechanical circulatory support, two separate locations are used for access to the arterial system. The first access point is for the insertion of PCI devices into the right femoral artery, radial artery, or brachial artery, and the second point is for the insertion of a blood pump into the left femoral artery. When using two access points, the physician faces several drawbacks, including spending additional time to perform the two insertions, an increased chance of complications during the procedure, an increase in the introducers and closure devices required for access, and an increased likelihood of being unable to treat certain patients, such as those with vascular problems. Vascular problems such as peripheral arterial disease can be present in both femoral arteries, and some scenarios can preclude radial or brachial access. Also, some patients may require a third access point, for example, when they have to treat, among other things, chronic total occlusion lesions (CTO). The double - access problem also applies to venous situations, such as those where a vascular pump is commonly used with pulmonary artery catheterization (PAC), and to large - bore procedures, such as transcatheter aortic valve replacement (TAVR) or endovascular aneurysm repair (EVAR), which require a contralateral contrast injection catheter.

[0003] Current techniques for performing single-access-point interventions involve inserting a first device through a peel-away sheath and then advancing a second device next to the first device within the peel-away sheath. Challenges of this technique include the inability of the physician to maintain the position of the first device during manipulation of the second device, insufficient hemostasis from the introducer valve intended for single-device insertion, and an increased risk of damage to the peel-away sheath hub. In some cases, the introducer sheath valve is punctured with a needle next to the blood pump catheter before inserting the second device. Puncturing the sheath valve outside its center can impair the valve's hemostatic properties and increase the risk of intraoperative complications such as significant blood loss. In one example, during the introduction of an Abiomed, Inc. 9-Fr Impella® blood pump and catheter, a 14-Fr peel-away sheath is inserted into the vascular system. Once the pump is started and begins to operate, the physician uses a needle to puncture a hole in the hemostatic valve of the introducer sheath, feed the wire through the valve, and then feed the long 7Fr introducer sheath with a hub for PCI. This exemplary technique is limited because the 14Fr peel-away sheath has an inner diameter and break line, and the physician must carefully consider the wall thickness and available remaining space to avoid decomposition of the peel-away sheath when inserting the second 7Fr sheath.

[0004] It is desirable to have a device that enables a single-access technique for inserting multiple devices into the vascular system. A single-access technique offers several advantages by providing multiple medical devices through a single large-diameter introducer sheath. A single-access system minimizes access to a single sterile field, thus reducing the risk of contamination, surgical site infection, and other surgery-related complications. A single-access system also conveniently reduces the number of access sites to manage, enabling a single, clearly defined procedure. To perform the insertion of two devices using a single standard introducer sheath of limited diameter, one approach to the solution would involve reducing the collective size of the devices to at least match the diameter of the sheath. [Overview of the Initiative]

[0005] overview The systems and methods described herein enable single-access-point insertion into a patient's vascular system by integrating multiple medical devices into a collapsible catheter, passing them through an introducer sheath. When the collapsible catheter is placed within a fixed-diameter introducer sheath, other medical devices are allowed to pass through the introducer sheath and be adjacent to the catheter.

[0006] In an exemplary configuration, the intravascular system includes an introducer sheath having a lumen of fixed bore diameter; a first medical device; and a catheter having a proximal end, a distal end coupled to the first medical device, and an outer circumference configured to take on a first or second dimension when placed within the lumen of fixed bore diameter. The catheter is placed within the lumen of the sheath and may leave an annular gap between the outer circumference of the catheter and the inner circumference of the lumen of the sheath, thereby the size of the annular gap being variable thanks to the catheter's outer circumference having first and second dimensions. In a particular dimensional configuration of the catheter, the annular gap is sized such that a second medical device can pass through it. The first medical device may be a blood pump, and the second medical device may be a PCI device, another catheter, or another introducer sheath. The catheter may consist of a soft layer and a hard layer detachably attached to the catheter, and the size may be changed after the hard layer is removed. The hard layer may allow a physician or operator to insert and position the catheter within the vascular system. After the rigid layer is removed, the soft layer deforms to accommodate a second medical device, which then fits adjacently within the annular gap. Alternatively, the catheter may consist of a catheter frame that can be actively moved by a physician to deflate or expand. The catheter frame may consist of multiple strands that can form a mesh-like structure and a polymer coating. 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 into the sheath along the side of the catheter. At least one other advantage of this exemplary aspect is that the catheter can be manipulated at the physician's discretion when positioning a medical device coupled to the catheter and when introducing further medical devices along the side of the catheter.

[0007] In another aspect, a method of introducing a medical device into a patient's vascular system by passing it through a single introducer sheath uses a catheter designed to accommodate multiple device sizes within the fixed size of the sheath. An introducer sheath having a lumen of fixed inner diameter is percutaneously inserted into the patient's vascular system to provide an access point for an intravascular medical device. A first medical device, coupled to the catheter, is inserted through the lumen. The first medical device may be a blood pump. When the catheter is positioned within the lumen of fixed inner diameter, the outer circumference of the catheter is configured to take on an adjustable first or second dimension. The catheter is 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. In a particular dimensional configuration of the catheter, the annular gap is sized to allow a second medical device to pass through it. The method may further include the step of introducing the 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, when the second device is inserted adjacent to it, the outer circumference of the catheter passively changes dimension. In other embodiments, the catheter must be actively moved and deformed by the physician before the second medical device is inserted adjacent to it. In further embodiments, the method includes the steps of introducing an introducer sheath into the vascular system, introducing a first medical device coupled to a catheter that can change size when moved, deforming 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 coupled to the catheter, and the outer circumference of the catheter changes size as the catheter is inserted adjacent to the second medical device. At least one advantage of this aspect is that the physician is given the ability to manipulate the catheter at their discretion before, during, or after introducing the catheter through the introducer sheath.At least one other advantage of this approach is that the use of multiple medical devices allows multiple medical issues to be addressed through a single access point. This approach also allows, for example, when another medical device is needed to address complications that arise during a patient's surgery, the physician can manipulate the catheter as needed to route another medical device through the same access point.

[0008] The aforementioned and other objectives and advantages will become clear when the following detailed explanation is considered in conjunction with the attached drawings. Throughout the drawings, similar part numbers refer to similar parts. [Brief explanation of the drawing]

[0009] [Figure 1] Figure 1A shows a catheter in a first form, coupled to a medical device and positioned within a sheath, according to an exemplary embodiment. Figure 1B shows a catheter in a second form, coupled to a medical device and positioned within a sheath, according to an exemplary embodiment, and another medical device positioned adjacent to it within the sheath. [Figure 2] An exemplary embodiment shows a catheter having a rigid inner layer and a flexible outer layer. [Figure 3] A catheter having a soft inner layer and a rigid inner layer is shown according to an exemplary embodiment. [Figure 4] An exemplary embodiment shows a catheter frame including a coated mesh structure for the contraction and expansion of the catheter. [Figure 5] A flowchart illustrating the introduction of a collapsible catheter is shown according to an exemplary embodiment. [Figure 6] A flowchart illustrating the introduction of a blood pump coupled to a collapsible catheter and a PCI device through a single introducer sheath, according to an exemplary embodiment, is shown. [Figure 7]A flowchart illustrating the deployment of a medical device coupled to a collapsible catheter next to a previously deployed medical device is shown, according to an exemplary embodiment. [Figure 8] A flowchart illustrating the introduction of a medical device coupled to a collapsible catheter, the transformation of the catheter's shape, and the introduction of another medical device alongside the catheter is shown according to an exemplary embodiment. [Modes for carrying out the invention]

[0010] Detailed explanation To provide a comprehensive understanding of the systems, methods, and devices described herein, certain exemplary embodiments are described in detail. While the embodiments and features described herein are specifically described in relation to use in connection with endovascular catheterization, it will be understood that all components and other features outlined below may be combined with each other in any suitable manner and may be adapted and applied to other types of procedures requiring catheters.

[0011] The term "proximal" should be understood as meaning the location on the catheter that is relatively closer to the operator during catheter use, and the term "distal" should be understood as meaning the location on the catheter that is relatively farther from the operator during catheter use. The term "upstream" should be understood as meaning the location on the catheter that is relatively upstream in the blood flow within the vessel when the catheter is placed in the patient's blood vessel. The term "downstream" should be understood as meaning the location on the catheter that is relatively downstream in the blood flow within the vessel when the catheter is placed in the patient's blood vessel. The term "physician" should be understood as meaning any physician, doctor, or operator in the use of the system or method described.

[0012] Figures 1A and 1B show an intravascular system 100 configured for percutaneous insertion of two medical devices into the patient's vascular system through an introducer sheath. A size-variable catheter is coupled to the first medical device, and the second medical device is housed within the introducer sheath alongside the catheter. A cross-section of the system shows the change in catheter size with and without the second medical device introduced.

[0013] Figure 1A shows an intravascular system 100 having a first medical device 102, an introducer sheath 104, and a catheter 106. The first medical device 102 is coupled to the distal end of the catheter 106. The catheter 106 extends through the lumen 108 of the introducer sheath 104, as shown in the figure. The lumen 108 has a fixed inner diameter. The introducer sheath 104 has a cross-sectional dimension X. In this arrangement, the catheter 106 is in a first form and has a first dimension Y. Although the catheter 106 is positioned within the lumen 108 of the introducer 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 is size-variable, and therefore the annular gap is also size-variable.

[0014] The introducer sheath 104 can be configured to be inserted percutaneously into the patient's vascular system, and the first medical device 102 can be configured to be inserted proximal through the introducer sheath 104 and then positioned within the vascular system. 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 non-traumatic extension. In some embodiments, the first dimension Y is 8Fr to 11Fr. In some embodiments, the first dimension Y is 9Fr to 10Fr. In some embodiments, the first dimension Y is 9Fr. In the system of Figure 1A, the annular gap may have dimension A1, and in some embodiments, A1 = XY. For example, dimension Y may have a value greater than zero and less than or equal to the value of dimension X, and dimension A1 may have a value in the range of zero to the value of dimension X. At least one advantage of the sizable catheter 106 is that the annular gap within the lumen 108 is also sizable, and the size of the annular gap can be adjusted to a desired size, for example, by changing the shape of the catheter 106, so that the dimensions of the new shape of the catheter 106 are not equal to Y. In one example, the desired size of the annular gap can accommodate the size of a second medical device.

[0015] Figure 1B shows an intravascular system 100 comprising a first medical device 102, an introducer 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 inserted proximal through the introducer sheath 104 and then positioned within the vascular system. The catheter 106 is positioned within the lumen 108 of the introducer sheath 104. The second medical device 114 is positioned within the lumen 108 alongside the catheter 106 and is therefore located within the 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 form and has a second dimension Z.

[0016] The second medical device 114 may be, for example, a PCI device. In some embodiments, the second medical device 114 is a secondary introducer sheath or a secondary catheter. In some embodiments, the annular gap in the second form is sized such that the second medical device 114 can pass through it. In further embodiments, when the catheter 106 is in the first form, the second medical device 114 cannot fit within the annular gap, and therefore the catheter 106 enters the second form to allow the passage of the second medical device 114. In some embodiments, the annular gap in the second form is larger than the annular gap in the first form. In some embodiments, the catheter 106 enters the second form when the second medical device 114 passes through the annular gap and enters the first form when the second medical device 114 is not in the annular gap.

[0017] In some embodiments, the second dimension Z is 7Fr to 9Fr. In some embodiments, the second dimension Z is 7Fr. In the system of Figure 1B, the annular gap may have a dimension A2 (A2 = XZ) which may have a different value from the dimension of the annular gap in the system of Figure 1A. For example, the second dimension Z may be greater than zero and less than or equal to the value of X, and the dimension A2 may be in the range of zero to the value of X.

[0018] The catheter 106 can be changed from a first form to a second form, or vice versa, by an active or passive mechanism, including, for example, a stiffening strand, tension wire, mesh, variable-stiffness sleeve, fluid material, inflatable element, or pneumatic element. In embodiments of a size-adjustable catheter having an active mechanism for dimensional change, the catheter 106 changes its shape by being moved by a physician or operator. In embodiments of a size-adjustable catheter having a passive mechanism, introducing a second medical device 114 adjacent to the catheter 106 in the lumen 108 of the introducer sheath 104 forces the catheter 106 into its second form; the second medical device can apply a normal force to the outer wall of the catheter 106, thereby deforming the shape or dimensional form of the catheter 106.

[0019] In certain embodiments, only the portion of the catheter 106 that is inside the lumen 108 changes from the first form to the second form, while the remaining portion of the catheter 106 that is not inside the lumen 108 does not change form. For example, the first medical device 102 and the catheter 106 coupled thereto are introduced through the introducer sheath 104 such that the portion of the catheter 106 defined by a longitudinal length shorter than the total longitudinal length of the catheter 106 is inside the lumen 108 of the introducer sheath 104, and the remaining length of the catheter 106 is positioned outside the introducer sheath 104; when the second medical device 114 is introduced along the side of the catheter 106, only the portion of the catheter 106 that is inside the lumen 108 undergoes a change from the first form to the second form.

[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 and second dimensions are the diameters of the circular cross-section. In some embodiments, the cross-section of the catheter is not circular, and the first and second dimensions are the widths of the cross-section in a certain direction.

[0021] In FIG. 1A, catheter 106 is disposed within lumen 108 of introducer sheath 104. An annular gap is formed between outer periphery 110 of catheter 106 and inner periphery 112 of introducer sheath 104. In this arrangement, catheter 106 is in a first configuration and has a first dimension Y, and the introducer sheath has a cross-sectional dimension X.

[0022] In some embodiments, the first dimension Y is a measurement of the size of the cross-section of 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 a certain direction. The cross-section of catheter 106 can be oval, circular, or some irregular shape. Alternatively, the first dimension Y can be any selected dimension related to the size of catheter 106.

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

[0024] The sheath cross-sectional dimension X sets the limit on the combined size of the catheter 106 and the second medical device 114 that can fit within a single introducer sheath 104. For example, the second medical device 114 may have a cross-sectional dimension S, and dimension X can constrain dimensions Z and S such that Z + S ≤ X. In a further example, the sum of the first dimension Y and the second device dimension S is greater than the sheath dimension X, representing a situation where adjustment of the catheter 106 to the second dimension Z is necessary for both the catheter 106 and the second medical device 114 to fit within a lumen 108 of a fixed inner diameter. In some embodiments, the second dimension Z is a measurement of the cross-sectional length of the catheter 106. In further embodiments, 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 a certain direction. The cross-section of the catheter 106 may be oval, circular, or some amorphous shape. 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 the catheter 106 is in its second form is sized to allow a third medical device to be housed adjacent to the catheter 106 and the second medical device 114 within the lumen 108. In further embodiments, the annular gap when the catheter 106 is in its second form is sized to allow multiple devices to be housed adjacent to the catheter 106 within the lumen 108.

[0026] At least one advantage of the system shown and described in Figures 1A and 1B is that the use of a variable-size catheter 106 allows for the placement of a second medical device 114 alongside the catheter 106 within a fixed-diameter lumen 108. By using only one introducer sheath 104 for the insertion of both medical devices 102 and 114, the system addresses the need for single-access introduction of multiple intravascular devices. This solution conveniently minimizes the number of closure devices required to manage complications and access sites associated with intravascular access.

[0027] Figure 2 shows an axial cross-section of a catheter 206, which includes a rigid inner layer 216 and a flexible outer layer 218, and the catheter 206 is an example of a variable-size catheter, such as the catheter 106 in Figures 1A and 1B. Layers 216 and 218 extend from the proximal end to the distal end of the catheter 206. The rigid inner layer 216 is detachably attached to the catheter 206 or the flexible outer layer 218. The catheter 206 may be the catheter 106 in Figures 1A and 1B. When the catheter 206 is placed in, for example, the introducer sheath 104 in Figures 1A and 1B, the rigid inner layer 216 can be removed proximal. Removal of the rigid inner layer 216 allows the catheter 206 to change from a first form to a second form, for example, from the first form to the second form described in relation to the catheter 106 in Figures 1A and 1B. The rigid inner layer 216 is configured to allow the physician to maneuver and operate the catheter 206 while introducing a medical device, such as the first medical device 102 in Figures 1A and 1B, which is coupled to the distal end of the catheter 206.

[0028] At least one of the rigid inner layer 216 and the flexible outer layer 218 can be made of a polymer. The polymer can be selected to have a rigidity suitable for being rigid or flexible. In some embodiments, the polymer comprises at least one of ethylene vinyl acetate, polyethylene, polyolefin elastomers, maleic anhydride graft polymers, styrene butadiene styrene, polypropylene elastomers, styrene butadiene copolymers, thermoplastic polyester elastomers, thermoplastic polyurethane elastomers, thermoplastic vulcanized products, polyamides, polytetrafluoroethylene, aromatic polyesters, polyvinyl chloride, polymethyl methacrylate, acrylonitrile butadiene styrene, styrene acrylonitrile, polystyrene, polyethylene terephthalate copolymers, polycarbonates, polyphenylene oxide, polyphenylene ethers, acetates, butyrates, propionates, polysulfones, polyethersulfones, polyarylsulfones, polybutylene terephthalate, polyester terephthalate, acetals, fluorinated ethylene propylene, perfluoroalkoxy polymers, ethylene chlorotrifluoroethylene, polyvinylidene fluoride, tetrafluoroethylene perfluoromethyl vinyl ether, tetrafluoroethylene, hexafluoropropylene, liquid crystal polymers, and polyether ether ketones.

[0029] In some embodiments, the rigid inner layer 216 includes at least one peel-away slit that allows for the removal of the rigid inner layer 216 in the proximal direction. In other embodiments, the rigid inner layer 216 is removably attached to the catheter 206 by a locking mechanism, and the rigid inner layer 216 can be removed by twisting the proximal end of the rigid inner layer 216 to unlock the mechanism and sliding the rigid inner layer 216 proximal out of the catheter 206. The catheter 206 may be positioned within an introducer sheath and configured to form 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, e.g., the second medical device 114 in Figures 1A and 1B, is introduced adjacent to the catheter 206 in a fixed-size lumen, e.g., lumen 108 in the introducer sheath 104 in Figures 1A and 1B. When this second medical device applies a normal force to the flexible outer layer 218, the flexible outer layer is forced into a second form by the normal force, so that both the catheter and the medical device fit within a fixed-size lumen. When the rigid inner layer 216 is attached to the catheter 206, the catheter 206 does not change from its original form, which is optimal for the insertion, manipulation, and positioning of the catheter 206 and the medical device coupled to its distal end. At least one advantage of the catheter 206 is that, due to the difference in rigidity between layers 216 and 218, the physician can manipulate the size of the catheter 206 during surgery by removing the rigid inner layer 216 and deforming the remaining soft outer layer 218, thereby changing the size of the annular gap within the introducer sheath so that a second medical device can pass through and fit into the annular gap.

[0030] Figure 3 shows an axial cross-section of a catheter 306, which includes a flexible inner layer 320 and a rigid outer layer 322, and the catheter 306 is an example of a variable-size catheter, such as the catheter 106 in Figures 1A and 1B. Layers 320 and 322 extend from the proximal end to the distal end of the catheter 306. The rigid outer layer 322 is detachably attached to the catheter 306 or the flexible inner layer 320. The catheter 306 may be the catheter 106 in Figures 1A and 1B. When the catheter 306 is placed in, for example, the introducer sheath 104 in Figures 1A and 1B, the rigid outer layer 322 can be removed proximal. Removal of the rigid outer layer 322 allows the catheter 306 to change from a first form to a second form, for example, to the first and second forms described in relation to the catheter 106 in Figures 1A and 1B. The rigid outer layer 322 is configured to allow the physician to maneuver and operate the catheter 306 during the introduction of a medical device coupled to the distal end of the catheter 306, such as the first medical device 102 in Figures 1A and 1B.

[0031] At least one of the rigid outer layer 322 and the flexible inner layer 320 can be made of a polymer. The polymer can be selected to have a rigidity suitable for being rigid or flexible. In some embodiments, the rigid outer layer 322 includes at least one peel-away slit that allows for the removal of the rigid outer layer 322 in the proximal direction. In other embodiments, the rigid outer layer 322 is removably attached to the catheter 306 by a locking mechanism, and the rigid outer layer 322 can be removed by twisting the proximal end of the rigid outer layer 322 to unlock the mechanism and sliding the rigid outer layer 322 out of the catheter 306 in the proximal direction. The catheter 306 can be positioned within an introducer sheath and configured to form 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 the second medical device 114 in Figures 1A and 1B, is introduced adjacent to the catheter 306 in a fixed-size lumen, such as lumen 108 in the introducer sheath 104 in Figures 1A and 1B. When this medical device applies a normal force to the flexible inner layer 320, the flexible inner layer is forced into the second form by the normal force, so that both the catheter and the medical device fit within the fixed-size lumen. When the rigid outer layer 322 is attached to the catheter 306, the catheter 306 does not change from its original form, which is optimal for the insertion, manipulation, and positioning of the catheter 306 and the medical device coupled to its distal end. At least one advantage of the catheter 306 is that, due to the difference in rigidity between layers 320 and 322, the physician can manipulate the size of the catheter 306 by removing the rigid outer layer 322 during surgery and deforming the remaining soft inner layer 320, thereby changing the size of the annular gap within the introducer sheath so that a second medical device can pass through and fit into the annular gap.

[0032] Figure 4 shows a section of a catheter 406 having a contraction portion and an expansion portion, and catheter 406 is an example of a variable-size catheter such as catheter 106 in Figures 1A and 1B. Both the contraction and expansion of catheter 406 are made possible by a catheter frame 424, which includes a plurality of first strands 426 and a plurality of second strands 428 extending longitudinally from the proximal to distal end of catheter 406, and a polymer layer 430 that forms a coating around the outer surface of catheter frame 424. Catheter frame 424 is configured to deform reversibly from a first form to a second form. Deformation from the first form to the second form is contraction of catheter frame 424, and the reverse deformation from the second form to the first form is expansion of catheter frame 424. The plurality of first strands 426 may be wound helically along the length of catheter frame 424, and the plurality of second strands 428 may be wound counterclockwise along the length. The first and second strands 426 and 428 are configured with bias to contract or expand, 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 contract with the catheter frame 424 and extends around the inner surface of the catheter frame 424.

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

[0034] The catheter 406 may be an example of the catheter 106 in Figures 1A and 1B, such that it is coupled to a first medical device, for example, a first medical device 102, and inserted into the patient's vascular system through an introducer sheath, for example, an introducer sheath 104. In one example, the physician can manipulate the size of the catheter 406 by expanding or contracting the catheter frame 424, so that the annular gap formed between the outer circumference of the catheter 406 and the inner circumference of the introducer sheath is also variable in size. The catheter frame 424 may represent an active mechanism for deformation between first and second forms. In some embodiments, the physician may actively deform the catheter 406 by moving the catheter frame 424 proximal to contract or expand it. In some embodiments, when the catheter is in a first form with the catheter frame 424 in an expanded state, the catheter 406 and the first medical device coupled to the distal end of the catheter 406 are inserted into the patient's vascular system through the introducer sheath. In a further embodiment, the catheter 406 is moved by a physician to deform into a second form in which the catheter frame 424 deflates into a contracted state, where the annular gap expands due to the deformation. The expanded annular gap may be sized to allow insertion of a second medical device adjacent to the catheter 406 within an introducer sheath. In some embodiments, a blood pump is coupled to the distal end of the catheter 406, and the annular gap in the second form is sized to allow insertion of a PCI device within the same introducer sheath as the catheter 406. The catheter frame 424 may include a mesh formed by first and second plurality of strands 426 and 428. In some embodiments, the catheter frame 424 includes only the first plurality of strands 426. In a further embodiment, the catheter frame 424 includes a mesh formed by only the first plurality of strands 426. For example, the plurality of strands 426 and 428 may consist of polymers, metals, or other flexible materials.At least one advantage of catheter 406 is that the catheter frame 424 can be selectively moved by the physician to expand or contract, whether or not a second medical device is positioned alongside catheter 406. A further advantage arising from the design of catheter 406 is the concise construction of the device, which does not require the separation of catheter 406 into multiple parts.

[0035] Figure 5 shows a flowchart illustrating an exemplary method 500 for introducing a medical device coupled to a collapsible catheter into a patient's vascular system by passing it through an introducer sheath. Method 500 comprises steps 502 and 504. Step 502 comprises percutaneously inserting an introducer sheath, which includes a lumen having a fixed diameter and inner circumference, into the patient's vascular system. Step 504 comprises introducing a first medical device coupled to the distal end of the catheter by passing it through the introducer sheath. The catheter includes a distal end, a proximal end, and an outer circumference 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 placed within the introducer sheath. The catheter is configured to take on a first or second form when placed within a lumen of fixed diameter, and the catheter has a first dimension in the first form and a second dimension in the second form. For example, this method may be applied to the systems shown in Figures 1A and 1B, in which case the method would include percutaneously inserting an introducer sheath 104 into the vascular system and introducing a first medical device 102 coupled to a catheter 106 through the introducer sheath 104, thereby forming an annular gap between the outer circumference 110 and the inner circumference 112. The catheter in method 500 may be catheters 206, 306, or 406.

[0036] Method 500 further includes a third step of introducing a second medical device into the annular gap, the annular gap in the second form being sized to allow the second medical device to pass through it. In some embodiments, the annular gap in the second form is larger than the annular gap in the first form. In some embodiments of Method 500 using catheter 206 or 306 of Figures 2 and 3, the catheter can be in a second form when the second medical device passes through the annular gap and in a first form when the second medical device is not in the annular gap. The first medical device may be a blood pump, and the second medical device may be a PCI device. In other embodiments of Method 500, for example catheter 406 of Figure 4 being suitable for active contraction and expansion, Method 500 further includes a third step of changing the catheter from a first form to a second form, the annular gap in the second form being sized to allow the second medical device to pass through it. In embodiments of Method 500 using catheter 406 of Figure 4, the physician may move the catheter to change its form before or after inserting it into the introducer sheath. In a further embodiment, Method 500 further includes a fourth step of introducing a second medical device into an annular gap. At least one advantage of Method 500 is that a physician can operate at least two medical devices introduced into the patient's vascular system through a single introducer sheath to reduce the management and closure of the access site to a single, clearly defined procedure.

[0037] Figure 6 shows a flowchart illustrating an exemplary method 600 for introducing a blood pump and PCI device, coupled to a collapsible catheter, into a patient's vascular system through an introducer sheath. Method 600 comprises steps 602, 604, and 606. Step 602 comprises percutaneous insertion of an introducer sheath, which includes a lumen having a fixed diameter and inner circumference, into the patient's vascular system. Step 604 comprises introducing a blood pump coupled to the distal end of a catheter through the introducer sheath, the catheter having a distal end, a proximal end, and an outer circumference 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 placed within the introducer sheath. The catheter is configured to take on a first or second form when placed within the lumen of the fixed diameter, having a first dimension in the first form and a second dimension in the second form. Step 606 involves introducing a PCI device into an annular gap, the annular gap in the second embodiment being sized to allow a second medical device to pass through it. Method 600 is shown in Figures 1-4 and may be applied to the described system. For example, the catheter in Method 600 may be catheters 106, 206, 306, or 406 inserted into the introducer sheath 104. The transition from the first embodiment to the second embodiment can be achieved by a passive mechanism as shown in Figures 2-3 or an active mechanism as shown in Figure 4. In some embodiments of Method 600 using catheter 206 or 306 of Figures 2 and 3, the catheter is in the second embodiment when the second medical device passes through the annular gap and in the first embodiment when the PCI device is not in the annular gap. In other embodiments where the catheter, for example, catheter 406 in Figure 4, is suitable for active contraction and expansion, method 600 may further include a third step of changing the catheter from a first form to a second form, such that the annular gap in the second form is sized to allow a PCI device to pass through it.In an embodiment of method 600 using catheter 406 in Figure 4, the physician may move the catheter to change its shape before or after inserting it into the introducer sheath. At least one advantage of method 600 is that the physician can perform high-risk HRP PCI with a blood pump assist coupled to a variable-size catheter through a single introducer sheath that cannot accommodate the diameter of the PCI device alongside a fixed-size catheter.

[0038] Figure 7 shows a flowchart illustrating method 700 for introducing a medical device coupled to a collapsible catheter through an introducer sheath that already contains a previously inserted medical device. Method 700 comprises steps 702, 704, and 706. Step 702 comprises percutaneously inserting an introducer sheath, which includes a lumen having a fixed diameter and inner circumference, into the patient's vascular system. Step 704 comprises introducing a first medical device into the introducer sheath, the first medical device having an outer circumference 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 comprises introducing a second medical device coupled to the distal end of the catheter into the annular gap, the catheter being configured to take on a first or second form, having a first dimension in the first form and a second dimension in the second form, the second form being configured to fit within a fixed-size annular gap.

[0039] The device realized by Method 700 may be the device shown in Figures 1-4, for example, using catheter 106, 206, 306, or 406 and introducer sheath 104. The catheter may be passively deformed from a first form to a second form when inserted into a fixed-size annular gap. In other embodiments, the catheter may be actively moved to deform into a second form that is sized to fit within a fixed-size annular gap. The first medical device may be a PCI device, and the second medical device may be a blood pump. At least one advantage of Method 700 is that, thanks to the variable-size catheter, the first medical device can be accompanied by the second medical device through the introducer sheath. For example, a physician may perform PCI through the introducer sheath, and if complications require blood pump assistance to the PCI, the physician can introduce a blood pump coupled to the variable-size catheter without incising another access point.

[0040] Figure 8 shows a flowchart illustrating a method 800 for introducing a medical device coupled to a collapsible catheter, changing the shape of the catheter, and introducing another medical device along the side of the catheter, according to an exemplary embodiment. The method 800 comprises steps 802, 804, 806, and 808. Step 802 comprises percutaneous insertion of an introducer sheath, which includes a lumen having a fixed diameter and inner circumference, into the vascular system. Step 804 comprises introducing a first medical device coupled to the distal end of the catheter through the introducer sheath, the catheter including a proximal end and an outer circumference having a first dimension such that an annular gap exists between the outer circumference of the catheter and the inner circumference of the sheath lumen when the catheter is positioned in the lumen of the fixed inner diameter. Step 806 comprises changing the outer circumference of the catheter from the first dimension to a second dimension to increase the annular gap, allowing a second medical device to pass through it. Step 808 comprises introducing the second medical device through the annular gap.

[0041] The device realized by Method 800 may be the device shown in Figures 1A and 1B and 4, for example, using a catheter 106 or 406 and an introducer sheath 104. The catheter can be changed by the physician to change from a state having a first dimension to a state having a second dimension, thereby changing 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 being used in the patient's vascular system, the physician can selectively change the size of the catheter and introduce the second medical device without incising a second access site to the vascular system. For example, this advantage may be useful when complications occur during surgery using the first medical device and the introduction of the second medical device is urgently required by the physician to treat those complications.

[0042] The foregoing is merely illustrative of the principles of this disclosure, and the apparatus may be implemented in embodiments other than those described herein, which are presented for illustrative purposes only and not for limitation. Although the apparatus disclosed herein is shown in relation to the use of a cardiac pump in percutaneous insertion, it will be understood that it may also be applicable to apparatus in other applications requiring hemostasis.

[0043] After considering this disclosure, those skilled in the art will likely envision variations and modifications. The disclosed features may be implemented in any combination and partial combination (including multiple dependent and partial combinations) with one or more other features described herein. The various features described above, including any of their components, may be combined with or integrated into other systems. Furthermore, certain features may be omitted or not implemented at all.

[0044] The systems and methods described herein may be implemented locally on a cardiac pump system or a control device of a cardiac pump system, such as an AIC. The cardiac pump system may include a data processing device. The systems and methods described herein may be implemented remotely on a separate data processing device. The separate data processing device may be connected directly or indirectly to the cardiac pump system via a cloud application. The cardiac pump system may communicate with its separate data processing device in real time (or near real time).

[0045] In general, the subjects and functional operating modes described herein can be implemented in digital electronic circuits, in computer software, firmware, or hardware including the structures disclosed herein and their structural equivalents, or in one or more combinations thereof.

[0046] Examples of modifications, substitutions, and alterations are verifiable to those skilled in the art and can be implemented without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference as a whole and constitute part of this application.

Claims

1. An intravascular system for inserting first and second medical devices into a patient's vascular system, An introducer sheath, configured for percutaneous insertion into the vascular system, including a lumen with a fixed inner diameter and inner circumference; The first medical device; and A catheter having a proximal end and a distal end, wherein the distal end is coupled to the first medical device and has an outer circumference configured to take a first or second dimension when the catheter is placed in the lumen of the introducer sheath, thereby allowing the catheter to be placed in the lumen of the introducer sheath to leave an annular gap between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath. A system that includes this.

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

3. The system according to claim 1 or 2, wherein the catheter is configured such that the annular gap between the outer circumference of the catheter taking a second dimension is greater than the annular gap between the outer circumference of the catheter taking a first dimension.

4. The outer circumference of the catheter When the second medical device is within the annular gap, it takes the second dimension, and When the second medical device is not in the annular gap, it takes the first dimension. The system according to claim 2 or 3, configured as follows.

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

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

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

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

9. The system according to claim 7 or 8, wherein the outer layer is soft and the inner layer is hard.

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

11. The system according to claim 7 or 8, wherein the inner layer is soft and the outer layer is hard.

12. The system according to any one of claims 7, 8, or 11, wherein the outer circumference of the catheter is configured to change from a first dimension to a second dimension after the outer layer is removed.

13. The system according to claim 10 or 12, wherein the inner or outer layer is configured to be removed in the proximal direction.

14. The system according to any one of claims 8 to 13, wherein the inner or outer layer includes at least one peel-away slit that allows the inner or outer layer to be removed.

15. The system according to any one of claims 2 to 14, wherein when a second medical device is introduced into the introducer sheath, the second medical device applies a normal force to the outer surface of the catheter, and the normal force forces the outer circumference of the catheter to a second dimension.

16. The system according to any one of claims 2 to 15, wherein the catheter comprises a polymer.

17. The system according to claim 16, wherein the polymer comprises at least one of ethylene vinyl acetate, polyethylene, polyolefin elastomer, maleic anhydride graft polymer, styrene butadiene styrene, polypropylene elastomer, styrene butadiene copolymer, thermoplastic polyester elastomer, thermoplastic polyurethane elastomer, thermoplastic vulcanized product, polyamide, polytetrafluoroethylene, aromatic polyester, polyvinyl chloride, polymethyl methacrylate, acrylonitrile butadiene styrene, styrene acrylonitrile, polystyrene, polyethylene terephthalate copolymer, polycarbonate, polyphenylene oxide, polyphenylene ether, acetate, butyrate, propionate, polysulfone, polyethersulfone, polyarylsulfone, polybutylene terephthalate, polyester terephthalate, acetal, fluorinated ethylene propylene, perfluoroalkoxy polymer, ethylene chlorotrifluoroethylene, polyvinylidene fluoride, tetrafluoroethylene perfluoromethyl vinyl ether, tetrafluoroethylene, hexafluoropropylene, liquid crystal polymer, and polyetheretherketone.

18. The system according to any one of claims 1 to 5, wherein the catheter includes a catheter frame configured to reversibly deform the outer circumference of the catheter from a first dimension to a second dimension.

19. A polymer layer that covers the outer circumference of the catheter frame and forms a coating around the outer surface of the catheter frame. The system according to claim 18, further comprising:

20. The catheter frame is configured to contract and expand. The contraction of the catheter frame includes a change from a first dimension to a second dimension, and The expansion of the catheter frame includes a change from the second dimension to the first dimension; The polymer layer is configured to expand and contract together with the catheter frame. The system according to claim 18 or 19.

21. The catheter Multiple strands, configured with bias for contraction or expansion, and extending longitudinally between the proximal and distal ends. A system according to any one of claims 18 to 20, including the system described in any one of claims 18 to 20.

22. The system according to claim 21, wherein the catheter is configured to allow the strands to slide relative to one another as the catheter frame contracts and expands.

23. The system according to any one of claims 19 to 21, wherein the coating extends around the inner surface of the catheter frame.

24. The system according to any one of claims 18 to 23, wherein the catheter frame includes a mesh-like structure formed of a plurality of first strands, the plurality of first strands being wound helically along the length of the catheter frame.

25. The system according to claim 24, wherein the catheter frame includes a second plurality of strands, the second plurality of strands being wound in a counterclockwise direction along their length.

26. The system according to any one of claims 1 to 25, wherein the first dimension is approximately 9 Fr to approximately 10 Fr, and the second dimension is greater than approximately 7 Fr and less than approximately 9 Fr.

27. The system according to any one of claims 1 to 26, wherein a first portion of the catheter is located within the lumen of the introducer sheath, and a second portion of the catheter is not located within the lumen of the introducer sheath.

28. The system according to claim 27, wherein the first portion of the catheter changes from the first to the second size while the second portion of the catheter remains at the first size.

29. The system according to any one of claims 2 to 28, wherein the second dimension allows the catheter and the second medical device to be housed adjacent to each other within the lumen of the introducer sheath.

30. The system according to any one of claims 1 to 29, wherein the first dimension and the second dimension are measured values ​​of the length of the cross-section of the catheter.

31. The system according to claim 30, wherein the cross-section of the catheter is circular, and the first and second dimensions are the diameter of the circular cross-section.

32. The system according to claim 30, wherein the cross-section of the catheter is not circular, and the first and second dimensions are the width of the cross-section in a certain direction.

33. A method for inserting two medical devices into a patient's vascular system, A process of percutaneously inserting an introducer sheath, which includes a lumen having a fixed inner diameter and inner circumference, into the vascular system, and A step of introducing a first medical device, which is coupled to the distal end of a catheter, through the introducer sheath, wherein the catheter The proximal end and The outer circumference is configured to be adjustable to a first or second dimension when the catheter is placed within the lumen of the introducer sheath, thereby allowing the catheter to be placed 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. process Methods that include...

34. The process further includes introducing a second medical device into the annular gap, While the outer circumference of the catheter takes on a second dimension, the annular gap is sized to allow the second medical device to pass through it. The method according to claim 33.

35. The method according to claim 33 or 34, wherein the annular gap when the outer circumference of the catheter takes a second dimension is greater than the annular gap when the outer circumference of the catheter takes a first dimension.

36. The outer circumference of the catheter When the second medical device is inside the annular gap, take the second dimension. When the second medical device is not in the annular gap, it takes the first dimension. The method according to claim 34 or 35, configured as follows.

37. The method according to any one of claims 33 to 36, wherein the first medical device further comprises a blood pump.

38. The method according to any one of claims 34 to 37, wherein the second medical device includes a percutaneous coronary intervention device.

39. The process further includes removing the second medical device from the introducer sheath, As the second medical device retracts proximal to the introducer sheath, the outer circumference of the catheter changes from the second dimension to the first dimension. The method according to any one of claims 34 to 38.

40. The method according to any one of claims 33 to 39, wherein the catheter includes an inner layer and an outer layer.

41. The method according to claim 40, wherein at least one of the inner or outer layer is detachably attached to the catheter.

42. The method according to claim 40 or 41, wherein the outer layer is soft and the inner layer is hard.

43. The method according to any one of claims 40 to 42, wherein the outer circumference of the catheter is configured to change from a first dimension to a second dimension after the inner layer is removed.

44. The method according to claim 40 or 41, wherein the inner layer is soft and the outer layer is hard.

45. The method according to any one of claims 40, 41, or 44, wherein the outer circumference of the catheter is configured to change from a first dimension to a second dimension after the outer layer is removed.

46. The method according to claim 43 or 45, wherein the inner or outer layer is configured to be removed in the proximal direction.

47. The method according to any one of claims 41 to 46, wherein the inner or outer layer includes at least one peel-away slit that allows the inner or outer layer to be removed.

48. The method according to any one of claims 34 to 47, wherein the second dimension allows the catheter and the second medical device to be housed adjacent to each other within the lumen of the introducer sheath.

49. The method according to any one of claims 35 to 48, wherein when a second medical device is introduced into an introducer sheath, the second medical device applies a normal force to the outer surface of the catheter, and the normal force forces the outer circumference of the catheter to a second dimension.

50. The process further includes changing the outer circumference of the catheter from a first dimension to a second dimension, While the outer circumference of the catheter takes the second dimension, the annular gap is sized to allow a second medical device to pass through it. The method according to any one of claims 33 or 35 to 38.

51. The method according to claim 50, further comprising the step of introducing a second medical device into an annular gap.

52. The method according to claim 50 or 51, wherein the catheter includes a catheter frame configured to reversibly deform the outer circumference of the catheter from a first dimension to a second dimension.

53. A polymer layer that covers the outer circumference of the catheter frame and forms a coating around the outer surface of the catheter frame. The method according to claim 52, further comprising:

54. The catheter frame is configured to contract and expand. The contraction of the catheter frame includes a change from a first dimension to a second dimension, and The expansion of the catheter frame includes a change from the second dimension to the first dimension; The polymer layer is configured to expand and contract together with the catheter frame. The method according to claim 52 or 53.

55. The catheter Multiple strands, configured with bias for contraction or expansion, and extending longitudinally between the proximal and distal ends. The method according to any one of claims 52 to 54, including the method described in any one of claims 52 to 54.

56. The method according to claim 55, wherein the catheter is configured such that the strands slide relative to one another when the catheter frame contracts and expands.

57. The method according to any one of claims 53 to 56, wherein the coating extends around the inner surface of the catheter frame.

58. The method according to any one of claims 52 to 57, wherein the catheter frame includes a mesh-like structure formed of a plurality of first strands, the plurality of first strands being wound helically along the length of the catheter frame.

59. The method according to claim 58, wherein the catheter frame includes a second plurality of strands, the second plurality of strands being wound in a counterclockwise direction along their length.

60. The method according to any one of claims 34 to 59, wherein the first dimension and the second dimension are measured values ​​of the length of the cross-section of the catheter.

61. The method according to claim 60, wherein the cross-section of the catheter is circular, and the first and second dimensions are the diameter of the circular cross-section.

62. The method according to claim 61, wherein the cross-section of the catheter is not circular, and the first and second dimensions are the width of the cross-section in a certain direction.

63. The method according to any one of claims 34 to 62, wherein the first dimension is 9Fr to 10Fr, and the second dimension is greater than 7Fr and less than 9Fr.

64. An intravascular system for inserting a blood pump and a percutaneous coronary intervention device into a patient's vascular system, An introducer sheath, configured for percutaneous insertion into the vascular system, including a lumen with a fixed inner diameter and inner circumference; Blood pump; and A catheter having a proximal end and a distal end, wherein the distal end is connected to a blood pump, and the catheter has an outer circumference configured to take a first or second dimension adjustable when placed in the lumen of the introducer sheath, thereby allowing the catheter to be placed in the lumen of the introducer sheath to leave an annular gap between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath. A system that includes this.

65. The system according to claim 64, wherein the catheter is configured such that the annular gap between the outer circumference of the catheter and the second dimension is sized to allow a percutaneous coronary intervention device to pass through it.

66. A method for inserting a blood pump and a percutaneous coronary intervention device into a patient's vascular system, The process of percutaneously inserting an introducer sheath, which includes a lumen having a fixed inner diameter and inner circumference, into the vascular system; and A step of introducing a blood pump, which is coupled to the distal end of a catheter, through the introducer sheath, wherein the catheter Proximal end and; The outer circumference is configured to be adjustable to a first or second dimension when the catheter is placed within the lumen of the introducer sheath, thereby allowing the catheter to be placed 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. process Methods that include...

67. The process further includes the step of introducing a percutaneous coronary intervention device into the annular gap, While the outer circumference of the catheter takes on a second dimension, the annular gap is sized to allow the percutaneous coronary intervention device to pass through it. The method according to claim 66.

68. A method for inserting two medical devices into a patient's vascular system, A process of percutaneously inserting an introducer sheath, which includes a lumen having a fixed inner diameter and inner circumference, into the vascular system; A step of introducing a first medical device into an introducer sheath, wherein the first medical device has an outer circumference such that, when the first medical device is placed in the introducer sheath, a fixed-size annular gap is formed between the outer circumference of the first medical device and the inner circumference of the lumen of the introducer sheath; and The process of introducing a second medical device, which is attached to the distal end of a catheter, into the annular gap. Includes, A method wherein the catheter is configured to take on a first or second dimension.

69. A method for inserting two medical devices into a patient's vascular system, A process of percutaneously inserting an introducer sheath, which includes a lumen having a fixed inner diameter and inner circumference, into the vascular system; A step of introducing a first medical device, which is coupled to the distal end of a catheter, through the introducer sheath, wherein the catheter The proximal end and When the catheter is placed in the lumen of the introducer sheath, the outer circumference has a first dimension such that an annular gap exists between the outer circumference of the catheter and the inner circumference of the lumen of the introducer sheath. Processes including; A step of changing the outer circumference of the catheter from the first dimension to the second dimension so as to increase the annular gap and allow a second medical device to pass through it; and The process of introducing a second medical device through the annular gap. Methods that include...

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