Dual-lumen sheath for arterial access

Abstract

This provides a sheath assembly for the insertion of a transdermal pump. [Solution] The sheath assembly 100 is sized for insertion into the blood vessel through the vascular opening. It includes a tubular sheath body 102 which has a proximal end portion 106 and a distal end portion The end portion 108, the longitudinal axis 110, the outer surface 112, and the portion substantially parallel to the longitudinal axis. A wall having an inner surface that defines a first lumen, and a space between the inner surface and the outer surface within the wall It also includes a second lumen extending from the proximal end portion to the distal end portion, and the first lumen is Dimensioned to allow passage of a portion of the transdermal pump, the second lumen is a guide Dimensioned for wire passage, the stylet effectively blocks the second lumen. It is positioned to be detachable.

Description

Technical Field

[0001] Cross-reference of related applications This application claims the benefit of U.S. Patent Application No. 14 / 827,741, filed Aug. 17, 2015, which is hereby incorporated by reference in its entirety.

Background Art

[0002] background Blood pumps, such as percutaneous intracardiac blood pump assemblies, are introduced into the heart to pump blood from the heart to the arteries. When operating within the heart, the blood pump assembly draws blood from the left ventricle and pumps it into the aorta, or draws blood from the right ventricle and pumps it into the pulmonary artery. The blood pump assembly is introduced surgically or percutaneously into the vasculature during a cardiac procedure. In one common approach, the pump assembly is inserted into the femoral artery by a catheterization procedure using a peel-away introducer sheath.

[0003] The peel-away introducer sheath is inserted into the femoral artery through an arteriotomy to form an insertion path for the pump assembly. Then, a portion of the pump assembly is advanced into the artery through the lumen of the introducer device. Once the pump assembly is inserted, the peel-away introducer sheath can be peeled away. Thereafter, a repositioning sheath can be advanced into the arteriotomy along the pump assembly. Replacing the introducer sheath with the repositioning sheath can prevent blood clot formation in the introducer sheath, prevent or reduce bleeding from the arteriotomy, and allow blood to flow through the femoral artery to the leg. However, after the introducer sheath is removed, wire access to the artery is lost. The loss of guide wire access makes it more difficult to close the blood vessel after the procedure or to replace the device within the arteriotomy.

[0004] ​To maintain guidewire access, some physicians leave peel-away introduction sheaths in the arteriotomy site for extended periods. Prolonged presence of a peel-away sheath in the arteriotomy site may reduce the return of the arteriotomy site and thus increase its final diameter. This increased diameter may increase the risk of bleeding from the arteriotomy site after the peel-away introduction sheath is finally removed. Furthermore, prolonged presence of a peel-away sheath in the artery may reduce perfusion through the femoral artery, thereby increasing the risk of ischemia.

[0005] In addition, clinicians may choose to monitor the patient's arterial pressure during the catheter insertion procedure. Measuring the patient's arterial pressure often requires the placement of additional catheters. The presence of additional catheters adds volume to the surgical site and requires insertion into the arterial system via another access point. [Overview of the Initiative]

[0006] overview A system, method, and apparatus for an improved dual-lumen repositioning sheath is presented. The dual-lumen sheath can be inserted into the arteriotomy to maintain guidewire access to the arteriotomy after the introduction sheath has been removed. The dual-lumen sheath includes a first lumen sized for the passage of a portion of the percutaneous pump and a second lumen sized for guidewire insertion. The second lumen receives the guidewire inserted into the arteriotomy along the percutaneous pump, maintaining guidewire access to the insertion path of the percutaneous pump. By using this method to maintain guidewire access, the induction sheath can be removed from the patient without losing guidewire access. This allows the physician to remove the induction sheath early during the procedure (for example, 1 hour, 30 minutes, 10 minutes, 5 minutes, or immediately after successful percutaneous pump insertion), which allows the vascular opening to retract to a smaller diameter than it would be if the induction sheath remained in the patient longer. For example, if the induction sheath is removed before the vascular opening permanently relaxes to a larger diameter than the induction sheath, a retraction of 2-3 Frenchs (0.667 mm-1 mm) can be achieved.

[0007] The dual-lumen sheath also includes a removable stylet that is inserted into the second lumen to reduce the risk of blood clot formation in the second lumen during medical procedures. Maintaining patency of the second lumen is particularly important in procedures requiring longer durations (e.g., 6 hours or more). Useful. The removable stylet can be reversibly coupled to the dual-lumen sheath during insertion of the dual-lumen sheath into the arterial incision and during medical procedures. The stylet is removed from the second lumen before the percutaneous pump is removed, allowing insertion of a guidewire through the second lumen. In some embodiments, the patency of the guidewire port is maintained using a drug-based or non-drug-based coating applied to the second lumen. In certain embodiments, the second lumen is flushed with fluid at a controlled flow rate to maintain patency.

[0008] In some embodiments, a dual-lumen sheath also includes a rotatable connection to a stabilizing structure (e.g., a suture pad). The rotatable connection allows the exit of the second lumen at the distal end of the sheath to rotate away from the arterial wall. This allows the guidewire to be inserted in a direction other than directly facing the arterial wall, thereby facilitating guidewire insertion by reducing friction associated with guidewire insertion. In addition, the rotation allows the port for the second lumen to be positioned flat relative to the patient when the second lumen is not in use.

[0009] A second lumen offers numerous other conceivable advantages. For example, it allows for arterial pressure conversion without the need for an additional catheter. Pressure conversion can allow the physician to determine when the dual-lumen sheath has been inserted to sufficient depth. When a second lumen is used for pressure conversion, rotation of the guidewire exit, enabled by a rotatable connection to a stabilizing structure, can improve the reliability of pressure measurement by keeping the second lumen exit away from the arterial wall. In addition, a second lumen can also be used to determine insertion depth without a pressure transducer. For example, insertion depth can be determined by observing the start of blood flow through the second lumen ("bleedback"), indicating penetration into the arterial incision. Whether a pressure transducer or a bleed-back indicator is used, depth marks can be placed on the outer surface of the sheath to facilitate measurement of insertion depth. Depth marks may be radiopaque. Measurements of the depth of the arterial incision in the patient's skin can facilitate the subsequent use of certain vascular occlusion devices that may require such measurements.

[0010] In one aspect, the sheath assembly for the insertion of the transcutaneous pump passes through the vascular opening. The device includes a tubular sheath body sized for insertion into a blood vessel. The tubular sheath body includes a proximal end portion, a distal end portion, a wall having a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, and a second lumen positioned within the wall between the inner and outer surfaces and extending from the proximal end portion to the distal end portion. The first lumen is sized to allow passage of a portion of the percutaneous pump, and the second lumen is sized for the passage of a guidewire. A stylet is detachably positioned to substantially block the second lumen.

[0011] In certain embodiments, the stylet has a proximal end configured to be releasably fixed to the sheath assembly. In some embodiments, the length of the stylet is substantially equal to the length of the second lumen. In certain embodiments, the stylet is radiopaque or includes a radiopaque marker band to indicate the distance of the sheath in the vessel. In certain embodiments, the sheath assembly also includes a hub coupled to the proximal end portion of the sheath body, the hub including a first port that fluidizes to the first lumen and a second port that fluidizes to the second lumen, the second port being configured to fix the proximal end of the stylet. The sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less (e.g., 19 Fr, 18 Fr, 17 Fr, 16 Fr, 15 Fr, 14 Fr, 13 Fr, 12 Fr, 10 Fr, 9 Fr, 8 Fr, 6 Fr, or less). It is possible.

[0012] In some embodiments, the distal end portion of the sheath body is tapered and includes a tapered surface extending to the distal end face, which is substantially perpendicular to the longitudinal axis of the sheath body. In certain embodiments, the second lumen has an outlet extending through the tapered surface of the distal end portion of the sheath body. The second lumen may be coated with an antithrombotic agent. In some embodiments, the outer surface of the wall of the tubular sheath body includes a hydrophilic coating or any other suitable coating to prevent tissue adhesion. In some embodiments, the outer surface of the wall of the tubular sheath body includes a hydrophilic coating or any other suitable coating to reduce frictional forces during insertion / removal of the sheath into / from the vascular structure. In some embodiments, the outer surface of the wall of the tubular sheath body includes an antimicrobial coating or any other suitable coating to prevent or reduce the risk of infection. In addition, in some embodiments, the inner surfaces of the two lumens are coated to prevent or reduce the risk of infection. This includes an antimicrobial coating or any other suitable coating. In certain embodiments, the outer surface of the wall includes marks for determining the depth of insertion, for example, marks evenly spaced on the outer surface of the wall.

[0013] In certain embodiments, the sheath assembly of the claim also includes a stabilizing structure rotatably coupled to a tubular sheath body. The stabilizing structure may be rotatable about a longitudinal axis. In some embodiments, the stabilizing structure includes features configured for suturing to a patient. The stabilizing structure may include a pair of suture wings, each wing having a plurality of ribs for securing the suture.

[0014] In another context, a method for maintaining guidewire access includes the steps of: inserting a sheath having a first lumen and a second lumen into a blood vessel through a percutaneous insertion pathway and along a portion of a percutaneous pump; maintaining the sheath in the blood vessel for more than six hours while preventing clot formation from blocking the second lumen; and, after more than six hours, inserting a guidewire through the second lumen into the percutaneous insertion pathway.

[0015] In some embodiments, maintaining openness involves moving the stylet to the second lumen for 6 This includes inserting the device for an extended period and removing the stylet before inserting the guidewire. In certain embodiments, maintaining patency includes flushing the second lumen with purge fluid. In some embodiments, the method also includes removing the sheath while maintaining the guidewire in the percutaneous insertion path. In certain embodiments, the method also includes, after removing the sheath, inserting the percutaneous device along the guidewire into the percutaneous insertion path. In some embodiments, the method also includes coupling a sensor to the proximal entrance of the second lumen and using the sensor to convert the arterial pressure at the distal exit of the second lumen. In certain embodiments, the method also includes rotating the sheath relative to a support structure when the pressure measurement indicates that the distal exit is blocked by the arterial wall. In some embodiments, the method also includes the step of determining the insertion depth from pressure measurements. The insertion depth may be determined using depth markers placed on the outer surface of the sheath.

[0016] After considering this disclosure, those skilled in the art will likely conceive of variations and modifications. The disclosed features may be combined with one or more other features described herein in any combination and parts. It may be implemented by a fractional combination (including multiple dependent and partial combinations). The various features described above, including any of their components, may be combined or integrated as other systems. Furthermore, certain features may be omitted or not implemented at all. [Invention 1001] A sheath assembly for the insertion of a transdermal pump, It includes a tubular sheath body sized for insertion into a blood vessel through a vascular opening, and the tubular sheath body is A wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, the first lumen being sized to permit passage of a portion of the transdermal pump; A second lumen disposed between the inner surface and the outer surface within the wall and sized for passage of a guide wire extending from the proximal end portion to the distal end portion; and A stylet having a proximal end releasably fixed to the sheath assembly and positioned to substantially occlude the second lumen comprising a sheath assembly. [Invention 1002] The sheath assembly of Invention 1001, wherein the length of the stylet is substantially equal to the length of the second lumen. [Invention 1003] The sheath assembly of Invention 1001, wherein the second lumen has a proximal region having a proximal region diameter and a distal region having a distal region diameter, the proximal region diameter being greater than the distal region diameter. [Invention 1004] The sheath assembly of Invention 1003, wherein the distal region diameter is substantially equal to the outer diameter of the stylet. [Invention 1005] The sheath assembly of Invention 1001, wherein the second lumen is coated with an anti-thrombotic agent. [Invention 1006] Further comprising a hub coupled to the proximal end portion of the sheath body, the hub having a first port in fluid communication with the first lumen, and a second port in fluid communication with the second lumen The sheath assembly of Invention 1001, wherein the second port is configured to secure the proximal end of the stylet. [Invention 1007] The sheath assembly of Invention 1001, wherein the outer surface of the wall includes at least one of a hydrophilic coating and a coating to reduce tissue adhesion. [Invention 1008] The sheath assembly of the present invention 1001, wherein the outer surface of the wall includes marks for determining the depth of insertion. [The present invention 1009] The sheath assembly of the present invention 1001, wherein the distal end portion of the sheath body is tapered and includes a tapered surface extending to the distal end face, and the distal end face is substantially orthogonal to the longitudinal axis of the sheath body. [The present invention 1010] The sheath assembly of the present invention 1009, wherein the second lumen has an outlet extending through the tapered surface of the distal end portion of the sheath body. [The present invention 1011] The sheath assembly of the present invention 1001, further including a stabilization structure rotatably coupled to the tubular sheath body. [The present invention 1012] The sheath assembly of the present invention 1011, wherein the stabilization structure is rotatable about the longitudinal axis. [The present invention 1013] The sheath assembly of the present invention 1012, wherein the stabilization structure includes features configured for suturing to a patient. [The present invention 1014] The sheath assembly of the present invention 1013, wherein the stabilization structure includes a pair of suturing wings, and each wing has a plurality of ribs for securing a suture thread. [The present invention 1015] The sheath assembly of the present invention 1001, wherein the sheath body is sized to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less. [The present invention 1016] A method for maintaining guidewire access, comprising: inserting a sheath having a first lumen and a second lumen through a percutaneous insertion path and along a portion of a percutaneous pump into a blood vessel; maintaining the sheath in the blood vessel for more than 6 hours while preventing blood clot formation from occluding the second lumen; and after more than 6 hours, inserting a guidewire through the second lumen into the percutaneous insertion path The method includes the step of inserting. including the method. [Invention 1017] Maintaining openness requires inserting the stylet for more than 6 hours in the second lumen, and A method according to the present invention 1016, comprising removing the stylet before inserting the guidewire. [Invention 1018] The method of the present invention 1016, wherein maintaining openness includes flushing a purge fluid into a second lumen. [Invention 1019] The method of the present invention 1016, further comprising the step of removing the sheath while maintaining the guidewire in the percutaneous insertion path. [Invention 1020] The method of the present invention 1019 further comprises the step of removing the sheath and then inserting the percutaneous device into the percutaneous insertion pathway along a guide wire. [Invention 1021] The process of coupling the sensor to the proximal inlet of the second lumen; and A process of converting the arterial pressure at the distal outlet of the second lumen using the sensor. The method of the present invention 1019, further comprising: [Invention 1022] The method of the present invention 1021, further comprising the step of rotating the sheath relative to a support structure when a pressure measurement indicates that the distal outlet is blocked by the arterial wall. [Invention 1023] The method of the present invention 1022, further comprising the step of determining the insertion depth from pressure measurements. [Invention 1024] The method of the present invention 1023, wherein the insertion depth is determined based on marks placed on the outer surface of the sheath.

[0017] The aforementioned and other objectives and benefits will become clear when the following detailed description is considered in conjunction with the attached drawings. Throughout the drawings, similar reference numbers refer to similar parts. [Brief explanation of the drawing]

[0018] [Figure 1]An exemplary top view of a dual-lumen sheath for arterial access is shown. [Figure 2] Figure 1 shows a lateral cross-sectional view of the dual-lumen sheath. [Figure 3] Figure 1 shows a cross-sectional view of the distal portion of the dual-lumen sheath. [Figure 4] Figure 1 shows a detailed cross-sectional view of the distal portion of the dual-lumen sheath. [Figure 5] Figure 1 shows the dual-lumen sheath inserted into the patient's blood vessel along the transcutaneous pump. [Figure 6] This illustrates an exemplary process for maintaining guidewire access. [Modes for carrying out the invention]

[0019] Detailed explanation To provide an overall understanding of the systems, methods, and apparatus described herein, certain exemplary embodiments are described. While the embodiments and features described herein are specifically described in relation to their use in connection with percutaneous blood pump systems, it will be understood that all components and other features outlined below may be combined with each other in any suitable manner and adapted and applied to other types of cardiac treatments and assisted cardiac devices, including balloon pumps and cardiac assisted devices implanted using surgical incisions.

[0020] The systems, methods, and apparatus described herein provide a dual-lumen sheath having a first lumen sized for the passage of a portion of a transcutaneous pump and a second lumen sized for the insertion of a guidewire. The second lumen is positioned to allow the guidewire to be inserted into the insertion path of the transcutaneous pump. This allows guidewire access to the insertion path to be maintained even after the transcutaneous pump and dual-lumen sheath have been withdrawn. Guidewire access is then one Alternatively, it allows multiple other instruments (e.g., vascular occlusion devices) to be inserted into the same insertion path, facilitating vascular occlusion or any other medical procedure involving guidewire access. The second lumen allows the physician to maintain guidewire access even after the introduction sheath has been removed, enabling the physician to remove the introduction sheath earlier during the medical procedure. Early removal of the introduction sheath allows the insertion path to revert to a smaller diameter, thereby reducing the risk of bleeding from the access site.

[0021] The systems, methods, and apparatus described herein also include a stylet for maintaining the patency of the second lumen. The stylet is used to block the second lumen when it is not being used for guidewire insertion or pressure measurement. For example, a removable stylet may be positioned within the second lumen during insertion of a dual-lumen sheath into an arterial incision and during operation of a percutaneous pump. The stylet is removed from the second lumen before the percutaneous pump is removed, allowing for guidewire insertion through the second lumen. Occlusion of the second lumen by the stylet prevents clot formation in the second lumen during medical procedures lasting for an extended period (e.g., more than 6 hours). This allows the second lumen to remain accessible during and after the medical procedure, for example, to provide a pathway for inserting a guidewire before removing the transdermal pump. In some embodiments, clot formation is prevented using a drug- or non-drug coating applied to the second lumen. In certain embodiments, clot formation is prevented by flushing the second lumen with a controlled flow rate of fluid.

[0022] A dual-lumen sheath may also include a rotatable connection to a stabilizing structure (e.g., a suture wing). The rotatable connection allows the exit of the second lumen at the distal end of the sheath to rotate away from the arterial wall. This facilitates guidewire insertion by allowing it to be inserted in a direction not directly facing the arterial wall, thereby reducing friction during guidewire insertion. In addition, the rotation allows the port for the second lumen to be positioned substantially flat relative to the patient when the second lumen is not in use.

[0023] The second lumen can also establish fluid communication between the guidewire port and the inside of the blood vessel. This can enable arterial pressure measurement during the procedure (e.g., by a pressure transducer) without the use of a separate catheter. Arterial pressure measurement can allow the physician to detect when the dual-lumen sheath has been inserted deep enough into the blood vessel. Rotation of the guidewire outlet, enabled by a rotatable connection to a stabilizing structure, can improve the reliability of pressure measurement by keeping the outlet of the second lumen away from the arterial wall.

[0024] Figure 1 shows an exemplary dual-lumen for maintaining arterial access in a particular embodiment. The sheath assembly 100 is shown. Figure 2 is a lateral section of the sheath assembly 100 as seen from section line 2-2. The diagram shows a top view, and Figure 3 shows a cross-sectional view of the distal portion of the sheath assembly 100 as seen from section line 3-3. The sheath assembly 100 includes a tubular sheath body 102, a stylet 120, a hub 126, and a stabilizing structure 150. The tubular sheath body 102 is dimensioned for insertion into a blood vessel through a vascular opening. In some embodiments, the tubular sheath body 102 is arterial cutting It is sized to be inserted into the femoral artery through the opening. Large tubular sheath body 102 The portion may have a substantially uniform outer diameter 101 of approximately 10Fr, 11Fr, 12Fr, 13Fr, 14Fr, 15Fr, 16Fr, 17Fr, 20Fr, or any other suitable diameter. The tubular sheath body is approximately 20Fr (6.67mm) They can be dimensioned to be introduced through percutaneous access sites of the following sizes (for example, 19Fr, 18Fr, 17Fr, 16Fr, 15Fr, 14Fr, 13Fr, 12Fr, 10Fr, 9Fr, 8Fr, 6Fr, or less). The tubular sheath body may have a length of approximately 80 mm, 100 mm, 120 mm, 140 mm, 160 mm, or any other suitable length. In addition, the tubular sheath body 102 reduces the stress on the vascular opening. It may be manufactured from a flexible material such as polyether block amides or any other suitable polymer.

[0025] The tubular sheath body 102 has a wall 104, a proximal end portion 106, a distal end portion 108, a longitudinal axis 110, and an outer Surface 112, first inner surface 114, second inner surface 115, first lumen 116 and second lumen 118 The distal end portion 108 of the tubular sheath body 102 includes a tapered surface 103, a first outlet 105 which is in fluid communication with the first lumen 116, and a second outlet 107 which is in fluid communication with the second lumen 118. The tapered surface 103 has an outer diameter that gradually changes from 11Fr to 15Fr (from 3.667 mm to 5 mm). It has. The gradual change of the tapered surface 103 fills the gap between the transdermal pump and the insertion site. This allows the sheath to be inserted to a variable depth as needed.

[0026] The outer surface 112 of the tubular sheath body 102 facilitates insertion of the tubular sheath body 102 into the arterial incision site. To achieve this, it may be coated with a hydrophilic coating. The hydrophilic coating can also prevent adhesion to the blood vessel wall. Such adhesion may damage the blood vessel if the sheath is removed after being in the blood vessel for a long period of time (e.g., several days). The longer the treatment period, the greater the risk of adhesion to the blood vessel wall. In some embodiments, the outer surface 112 of the tubular sheath body 102 includes depth marks. The depth marks are on the outer surface 112. The depth mark may be pad-printed or laser-etched. In certain embodiments, the depth mark is radiopaque. The depth mark may be in centimeters, inches, millimeters, or any other suitable unit of measurement, or a combination thereof.

[0027] The first inner surface 114 of the tubular sheath body defines the first lumen 116. The first lumen 116 is sized to allow the passage of a portion of the transdermal pump. n116 extends from the proximal end portion 106 to the distal end portion 108 of the tubular sheath body 102 along the longitudinal axis 110 It extends substantially parallel to the second lumen 118. The second lumen 118 is located within the wall 104 between the inner surface 114 and the outer surface 112. The second lumen 118 is located in the proximal end portion 106 of the tubular sheath body 102. From the distal end portion 108, at a position off the longitudinal axis 110, and relative to the longitudinal axis 110. They extend substantially parallel to each other. The second lumen 118 is dimensional for the passage of the guide wire. It is attached and defined by the second inner surface 115 (as shown in Figure 3). Second inner surface 115 This involves a drug coating or non-drug coating to prevent clot formation in the second lumen 118. Coating may be included. In some embodiments, the second inner surface is coated with heparin. The second lumen 118 terminates at a second exit 102 formed on a tapered surface 103. The second exit 102 is adjacent to the first exit 105 of the first lumen 116. As a result, the guide wire If the ya is inserted through the second lumen 118, the guidewire passes through the first lumen 116 and enters the insertion path of the transdermal pump (not shown). Thus the second lumen 118 , guide wire access to the insertion path of the transdermal pump inserted through the first lumen 116 It can be used to maintain or restore access. This allows guidewire access to the insertion path to be maintained even after the introduction sheath has been removed. Guidewire access allows one or more other instruments to be inserted into the same insertion path at a later time. This facilitates vascular occlusion or any other medical procedure involving guidewire access. For example, guidewire access may allow for the subsequent insertion of a vascular occlusion device or a pressure-measuring microcatheter (e.g., MILLAR Mikro-Tip® pressure catheter). The pressure-measuring microcatheter may allow for the measurement of left ventricular pressure or any other appropriate pressure. Furthermore, the second lumen allows the physician to maintain guidewire access even after the introduction sheath has been removed, enabling the physician to remove the introduction sheath earlier. Early removal of the introduction sheath allows the vascular opening to return to a smaller diameter, thereby reducing the risk of bleeding from the access site. In addition, the second exit 107 Because it is located off-center from the longitudinal axis 110, rotation of the tubular sheath body 102 allows the position of the second outlet 107 to be adjusted. This allows the user to keep the second outlet 107 away from the vessel wall to facilitate guidewire insertion or to improve the accuracy of arterial pressure measurement.

[0028] The tubular sheath body 102 has its proximal end portion 106 connected to the hub 126. The hub 126 includes a first port 128, a second port 130, a second port thread 131, and a bearing 136. The second port 130 is through which the guide wire is inserted into the second lumen 118. It is connected to the second lumen 118 so that it can be brought in and out through the second outlet 107. When the guidewire is not in the second lumen 118, the stylet 120 is connected to the second port 130. It can be inserted to seal the second lumen 118 (as shown in Figures 1, 2, and 3). The stylet 120 includes a head 121, a stylet body 122, a rounded end 123, and threads 126. The stylet body 122 is sized to substantially seal the second lumen 118 when the stylet 120 is inserted into the second lumen 118. In some embodiments... In this, the stylet body 122 is made of a formable material such as metal or a ductile material. This allows the stylet to be shaped to reduce stress on the vascular opening during or before a medical procedure. In certain embodiments, the stylet 120 is radiopaque or includes a radiopaque marker band to indicate the depth of the tubular sheath body 102 in the blood vessel. The threads 124 of the stylet head 121 reversibly connect with the second port threads 131 to hold the stylet 120 within the second lumen 118. The stylet head 121 is reversibly coupled to the second port 130, and the stylet head 121 forms a liquid-tight seal across the second port 130, preventing blood leakage from the blood vessel. In certain embodiments, instead of the stylet 120, a pressure bag is used. The second port 130 is connected using thread 131. The pressure bag is connected to the second lumen 118 To maintain the openness, the fluid is used to flush the second lumen 118. This can be done. The infusion pump may be used with a pressure bag to adjust the flow rate of fluid to the patient. For example, the flow rate may be 1 mL / hour, 2 mL / hour, 5 mL / hour, 10 mL / hour, or any other appropriate rate. The flow rate may be limited. In some embodiments, a pressure measuring device is connected to a second port 130 to measure the pressure inside the blood vessel 10. Using this pressure measurement, the second port It is possible to determine when T102 has been inserted deep enough into the vascular opening. For example, When a pressure approximately equal to the pulse pressure is measured at the second port 130, the second outlet 107 may be in fluid communication with the blood vessel. The pressure measurement can also be used to monitor arterial pressure in the patient's blood vessels during medical procedures. This may allow arterial pressure measurement to be performed without the use of further catheters, which may reduce the amount of instruments required in potentially complex surgical sites.

[0029] The first port 128 of the hub 126 allows the passage of a transdermal pump (not shown). The first port 128 includes a cap 132 and a seal 134. The cap 132 snaps into the first port 128. The cap 132 and seal 134 are fitted and held against the first port 128. Together, the cap 132 and seal 134 act as a hemostatic valve, creating a liquid-tight seal between the percutaneous pump and the first port 128. The seal 134 can bend to seal around a portion of the transdermal pump. It is formed from an elastomer such as silicone.

[0030] The hub 126 is connected to the stabilizing structure 150 by bearings 136. The stabilizing structure 150 includes wings 152 and 154, suture holes 156-159, ribs 160-162, and bearings 136, etc. It includes a matching bearing surface 164. The engagement of the bearing surface 164 of the stabilizing structure 150 with the bearing 136 of the hub 126 allows the hub 126 to rotate relative to the stabilizing structure 150. This rotation allows the tubular sheath body 102 to rotate so that the second outlet 107 faces away from the blood vessel wall. In addition, this rotation allows the second port 130 to rotate when it is not in use. This allows the second port 130 to be positioned flat relative to the patient. Suture holes 156-159 allow the wings 152 and 154 to be sutured to the patient to stabilize the sheath assembly 100. Although only four suture holes 156-159 are shown, any appropriate number of suture holes can be used. It can be used. The stabilizing structure 150 can also be easily attached to the artificial blood vessel with umbilical cord tape or sutures. It is designed to allow for this. This feature is beneficial during axillary insertion or any other insertion that requires the pump to be placed through an artificial blood vessel. In addition, in some embodiments, the stabilizing structure 150 is joined to the patient using ribs 160-162. For example, sutures The thread can be wrapped around the outer surface 165 of the stabilizing structure between ribs 160-162. Once the suture is wrapped around the outer surface 165, the ribs 160-162 prevent the suture from slipping off the outer surface 165 along the longitudinal axis 110. In certain embodiments, other stabilizing devices are used. For example, surgical tape, STATLOCK® stabilization device (Bard Access Systems, Inc.) Salt Lake City, UT) or any other suitable adhesive stabilizing device around ribs 160-162 It can then be bound to the stabilizing structure 150.

[0031] Figure 4 shows a detailed cross-sectional view of the distal end portion 108 of the dual lumen sheath assembly 100 shown in Figures 1, 2, and 3. The distal end portion 108 includes the tapered surface 103, the first outlet 105, the second outlet 107, and the distal portions of the stylet body 122, the first lumen 116, and the second lumen 118. The first lumen 116 includes a proximal section 116a with an inner diameter 117, a distal section 116b with an inner diameter 217 smaller than the inner diameter 117, and a throttling section 216 between them. The inner diameter 117 is approximately 13 Fr (4.333 mm), and the inner diameter 217 is approximately 9 Fr (3 mm). The throttling section 216 allows the distal section 116b of the first lumen 116 to form a tighter fit with the transcutaneous pump, preventing or reducing blood leakage without generating unacceptably high friction in the proximal section 116a. Similar to the first lumen 116, the second lumen 118 includes a proximal section 118a with a diameter 119, a distal section 118b with a diameter 219 smaller than the diameter 119, and a throttling section 218 between them. The diameter 119 is approximately 1.1 mm, and the diameter 219 is approximately 1 mm. The aperture portion 218 is a style in the distal region 118a This allows for a tighter fit between the stylet body 122 and the second lumen 118, reducing friction and blood intrusion while allowing play in the proximal region 118b. Friction between the second lumen 118 and the stylet body 122 is further reduced by the rounding of the end 123 of the stylet body 122. When the stylet 120 is fully inserted into the second lumen 118, the rounded end 123 is adjacent to the second exit 107, thereby reducing blood intrusion into the second lumen 118. To prevent or reduce liquid ingress.

[0032] Figure 5 shows the dual-lumen sheath assembly 100 of Figure 1 inserted into the patient's blood vessel 10 along the transcutaneous pump 60. The transcutaneous pump 60 includes a pump head 66 and a catheter body 62. The transcutaneous pump 60 may be an intravascular blood pump, a blood pump driven by a flexible drive shaft, a blood pump including an implantable motor, a blood pump having an expandable pump rotor, or any other suitable pump. The dual lumen sheath assembly 100 allows the catheter of the transcutaneous pump 60 to pass through the vascular opening 12 in the direction indicated by arrow 70. The body 62 is advanced into the blood vessel 10. When the transcutaneous pump 60 is first inserted into the blood vessel 10, the first lumen 116 of the dual lumen sheath assembly 100 may be screwed into the catheter body 62. The blood vessel 10 may be the femoral artery, and the blood vessel opening 12 may be an arterial incision. The blood vessel opening 12 may have an opening slightly larger than the diameter 64 of the catheter body 62. Thus, the tubular body 102 of the dual lumen sheath assembly 100 may effectively fill the gap between the blood vessel opening 12 and the catheter 64 when the sheath assembly 100 is advanced into the blood vessel 10 along the catheter body 62. The outer diameter 101 of the tubular sheath body The diameter of the tubular sheath body 102 may change gradually as described above, increasing from its distal end portion 108 to its proximal end portion 106. This allows the tubular sheath body 102 to be inserted deeper into the blood vessel 100 to fill a larger gap between the vascular opening 12 and the catheter body 62. The gap-filling effect of the tubular sheath body 102 reduces bleeding from the vascular opening 12. Or it can be prevented. The tubular sheath body 102 is flexible so that it can form a bend 80 that allows the tubular sheath body 102 to follow the shape of the blood vessel 10. This flexibility reduces the force required to deform the tubular sheath body 102, thereby preventing blood This can reduce the stress on the pipe opening 12.

[0033] Once the tubular sheath body 102 opens into the blood vessel along the catheter body 62 of the transcutaneous pump 60 Once advanced to a depth sufficient to fill the gap between part 12 and the catheter body 62, the dual-lumen sheath assembly 100 may be fixed to the catheter body 62. Fixation can be achieved by fixing the stabilizing structure 150 to the patient's tissue 14. In one embodiment, this is achieved by suturing the wings (not shown) of the stabilization structure 150 to the patient's tissue 14. In certain embodiments, the stabilization structure 150 is attached to the artificial blood vessel with umbilical tape or sutures. This may be performed during axillary insertion or any other insertion requiring the pump to be positioned through the artificial blood vessel. In some embodiments, securing the position of the dual-lumen sheath assembly 100 may be achieved by tightening the seal 134 around the catheter body 62 or by a separate fixing ring. The second port 130 may be rotated relative to the stabilization structure 150 so that it is positioned flat against the patient's tissue 14. The dual-lumen sheath assembly 100 is secured in the appropriate position. Subsequently, the physician may initiate the operation of the percutaneous pump 60. The percutaneous pump 60 is used during percutaneous coronary intervention (PCI), cardiac incision surgery, heart valve replacement surgery, or treatment of acute myocardial infarction (AMI), cardiogenic shock or ST-elevation myocardial infarction (STEMI), and any other It may be operated during appropriate medical procedures. In certain embodiments, the transdermal pump 60 is operated for extended periods, such as more than 6 hours, more than 12 hours, more than 24 hours, more than 48 hours, more than 72 hours, more than one week, or any other appropriate period. In such cases, there is a risk of blocking the second lumen 118. To prevent blood from entering the second lumen 118, which could lead to coagulation or bleeding from the second port 130, a stylet such as the stylet 120 shown in Figures 1-4 (not shown in Figure 5) is positioned within the second lumen 118 during insertion of the dual lumen sheath assembly 100. That's good too.

[0034] In certain embodiments, the second port 130 of the dual-lumen sheath assembly 100 is used to deliver a contrast agent (e.g., an iodine or barium compound) into the blood vessel for visualization of blood flow.

[0035] In certain embodiments, in order to maintain the openness of the second lumen 118, a pressure battery The 'g' is connected to the second port 130 instead of the stylet. The injection pump and the pressure bag They may be used together to adjust the flow rate of fluid to the patient. For example, the flow rate may be limited to 1 mL / hour, 2 mL / hour, 5 mL / hour, 10 mL / hour, or any other appropriate flow rate. Several implementations In this state, a pressure measuring device is connected to the second port 130 in order to measure the pressure inside the blood vessel 10. The process continues. Using this pressure measurement, the second port 102 is inserted deeply enough into the vascular opening 12. The timing of insertion can be determined. For example, when a pressure approximately equal to the arterial pressure is measured at the second port 130, the second outlet 107 may be in fluid communication with the blood vessel 10. After penetration into the blood vessel opening 12 is detected, the depth of the blood vessel opening 12 relative to the patient's skin can be measured using depth marks placed on the outer surface of the sheath. This depth measurement can facilitate the subsequent use of certain vascular occlusion devices that may require such measurements. Pressure measurements can also be used to monitor arterial pressure in the blood vessel 10 during medical procedures. This may allow arterial pressure measurement to be performed without the use of further catheters, which may reduce the amount of instruments required in potentially complex surgical sites. In addition, the second lumen 118 can enable the determination of the insertion depth without a pressure transducer by allowing observation of the initiation of blood flow through the second lumen 118 ("bleedback"), indicating penetration into the blood vessel opening 12.

[0036] When it is time to remove the transdermal pump 60, the guide wire 50 is inserted through the second port 130. It is inserted into the second lumen 118 and then into the blood vessel 10 from the second outlet 107. Thus, the guidewire 50 enters the same insertion path as the percutaneous pump 60, thereby maintaining access to the insertion path. A stylet is used during the insertion of the dual-lumen sheath assembly 100. If so, the stylet is removed before inserting the guidewire 50. The guidewire 50 has an outer diameter that approximately matches the inner diameter of the second outlet 107 in order to prevent blood from flowing out of the blood vessel 10 through the second port 130. For example, the guidewire may have an outer diameter of approximately 1 mm. In addition In some embodiments, a seal is included on the second port 130 to further ensure that blood does not leak out of the second port 130 while the guidewire 50 is in place.

[0037] After the guidewire 50 is positioned in the blood vessel 10, the percutaneous pump 60 and dual-lumen assembly 100 are removed through the blood vessel opening 12 while the guidewire 50 remains in place. The tubular sheath body 102 is designed to prevent adhesion to the hydrophilic coating or blood vessel 10. It may be coated with another suitable coating, thereby facilitating the removal of the tubular sheath body 102 without damaging the blood vessel 10. Removing the dual-lumen sheath assembly 100 and the transcutaneous pump 60 allows guidewire access to the insertion path 11 to be maintained. The diameter 68 of the pump head 66 is Because it cannot pass through the first lumen 116, the withdrawal of the transdermal pump 60 is dua The lumen sheath assembly 100 must be removed simultaneously. The reason is that the first lumen The inner diameter of part 116 fits snugly around the diameter 64 of the catheter body 62. This is because it cannot accommodate the larger diameter 68 of the pump head 66. As a result, the first lumen 116 maintains guidewire access to the insertion path 11. It cannot be used for this purpose. Therefore, the second lumen 118 is used as a guide to the insertion path 11. It is necessary to maintain wire access.

[0038] After the transdermal pump 60 and dual lumen sheath assembly 100 are removed, The guidewire 50 remains in the blood vessel 10 and insertion path 11. Therefore, another device can be inserted into the insertion path 11 along the guidewire 50. In some embodiments, a vascular occlusion device is inserted into the insertion path 11 using the guidewire 50. The vascular occlusion device may be a VASOSEAL vascular occlusion device, an ANGIO-SEAL bioabsorbable active occlusion system, a PERCLOSE vascular occlusion device, or any other suitable vascular occlusion device or combination thereof. After the vascular occlusion device or other device has been successfully inserted into the insertion path 11 through the vascular opening 12, the guidewire 50 can be withdrawn from the vascular opening 12.

[0039] Figure 6 shows an exemplary process 600 for maintaining guidewire access. The exemplary process 600 can be performed using a dual-lumen sheath assembly 100 or any other suitable sheath tool. In step 602, the sheath is inserted through the percutaneous insertion route and The transcutaneous pump is inserted into the blood vessel along a portion of it. The sheath has a first lumen and a second lumen. The blood vessel may be an artery such as the femoral artery. The insertion route passes through the opening of the blood vessel (e.g., an arterial incision). Prior to step 602, the transcutaneous pump was inserted using an introduction device. It is inserted into the pathway. Thus, the percutaneous pump guides the sheath into the existing insertion pathway. The percutaneous pump may be an intravascular blood pump, a blood pump driven by a flexible drive shaft, a blood pump including an implantable motor, a blood pump having an expandable pump rotor, or any other suitable pump. To prevent leakage of blood from the patient's blood vessels, the first lumen of the sheath may be sealed to the percutaneous pump by a hemostatic valve.

[0040] In some embodiments, the sheath is inserted into the blood vessel only to the depth necessary to close the gap between the percutaneous pump and the vascular opening to prevent bleeding. To reliably detect whether the sheath has been inserted deep enough into the blood vessel, a second lumen can be used to detect intravascular pressure. For example, a detected pressure approximately equal to the arterial pressure may indicate that the outlet of the second lumen has been inserted into the blood vessel. Alternatively, the second lumen can allow for determination of the insertion depth without a pressure transducer by enabling observation of the initiation of blood flow through the second lumen ("bleedback"), indicating penetration into the vascular opening. After penetration into the vascular opening has been detected, the depth of the vascular opening relative to the patient's skin can be measured using depth marks placed on the outer surface of the sheath. In some embodiments, the depth marks are radiopaque and can be imaged using tomography (e.g., CT, MRI, X-ray). This depth measurement can facilitate the subsequent use of certain vascular occlusion devices that may require such measurements. In addition, once inserted to the appropriate depth, the arterial pressure during the procedure can be measured using the second lumen.

[0041] In step 604, the sheath is inserted into the blood vessel while preventing the formation of a blood clot from blocking the second lumen. The sheath is maintained for approximately 6 hours or more. The sheath can be maintained in the blood vessel for 6 hours, 12 hours, 24 hours, 48 ​​hours, 72 hours, 1 week, 2 weeks, or any other appropriate period. During this period, a stylet can be used to temporarily block the second lumen to prevent clot formation in the second lumen. For example, the stylet 120 in Figures 1-3 can be used to temporarily block the second lumen. Obtained. In certain embodiments, clot formation in the second lumen is prevented or reduced by using a drug-based or non-drug-based coating in the second lumen. The coating may contain heparin or any other suitable substance. In some embodiments, clot formation in the second lumen is prevented or reduced by flushing the second lumen with a liquid (e.g., saline solution, glucose solution, or any other suitable solution). Preventing blockage of the second lumen by clots allows the patency of the second lumen to be ensured for guidewire insertion.

[0042] In step 606, after approximately 6 hours or more, the guidewire is inserted percutaneously through the second lumen. Insert into the insertion route. If a stylet is used to temporarily block the second lumen, remove the stylet before inserting the guidewire. A percutaneous pump inserted through the first lumen may be removed after the guidewire has been inserted. After the guidewire has been inserted, the sheath may be removed from the percutaneous insertion route while the guidewire remains in place. This may allow another device (e.g., an access closure device) to be inserted into the insertion route. This frees the physician from relying on the introduction device to maintain guidewire access. Therefore, the physician may remove the introduction device earlier during the procedure. This may allow for greater retraction of the vascular opening, thereby reducing the risk of bleeding. For example, removing the introduction device within one hour of insertion may allow for approximately 2-3 Fr (0.667 mm-1 mm) of retraction.

[0043] The foregoing is merely illustrative of the principles of this disclosure, and the systems, methods, and apparatus may be implemented in ways other than those described herein, which are presented for illustrative purposes only and not for limitation. Although the systems, methods, and apparatus disclosed herein are shown in relation to use in percutaneous intravascular blood pump systems, it will be understood that they may also be applicable to systems, methods, and apparatus for other implantable blood pumps or implantable cardiac assist devices.

[0044] After considering this disclosure, those skilled in the art will likely conceive of variations and modifications. For example, in some embodiments, the sheath assembly is used for short periods of time (e.g., less than 6 hours). It may be used to provide guidewire access for placement. Furthermore, the stylet may be omitted in some embodiments where the openness of the second lumen is adequately maintained by other means. For example, in some embodiments, the second lumen is intermittently or continuously flushed with liquid. The disclosed features may be used in any combination and partial combination (multiple) of one or more other features described herein. These may be implemented through dependent and partial combinations. The various features described above, including any of their components, may be combined or integrated as other systems. Furthermore, certain features may be omitted or not implemented at all.

[0045] Examples of modifications, substitutions, and alterations are verifiable by 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 herein by reference as a whole and constitute part of this application.

Claims

1. An assembly for inserting a percutaneous intravascular blood pump and guidewire, The assembly is A guidewire having a proximal end and a distal end, A stylet having a proximal end and a distal end, and having a stylet head at the proximal end, A tubular sheath body, sized for insertion into a blood vessel through a vascular opening and for receiving and delivering intravascular blood pumps, wherein the tubular sheath body is A wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow the passage of at least a portion of the intravascular blood pump; and A second lumen is located within the wall between the inner and outer surfaces and extends from the proximal end to the distal end. The tubular sheath body includes, A hub having a port coupled to the tubular sheath body and in fluid communication with the second lumen Includes, The second lumen is sized to accommodate (1) the distal end of the guidewire and (2) the distal end of the stylet, When the stylet is positioned within the second lumen, the distal end of the stylet blocks the second lumen, and the stylet head of the stylet forms a liquid-tight seal across the port. assembly.

2. The assembly according to claim 1, wherein the stylet and the second lumen each have a length, and the length of the stylet is equal to the length of the second lumen.

3. The assembly according to claim 1, wherein the second lumen has a proximal region having a proximal region diameter and a distal region having a distal region diameter, the proximal region diameter being greater than the distal region diameter.

4. The assembly according to claim 3, wherein the distal region diameter is equal to the outer diameter of the stylet.

5. The assembly according to claim 1, wherein the second lumen is coated with an antithrombotic agent.

6. The hub is coupled to the proximal end portion of the sheath body, and the port is a second port in the hub, The first lumen and the first port which is in fluid communication The assembly according to claim 1, further comprising the second port being configured to secure the proximal end of the stylet.

7. The assembly according to claim 6, wherein the outer diameter of the distal end of the stylet is equal to the inner diameter of the second port Yellowtail.

8. The assembly according to claim 1, wherein the outer surface of the wall includes at least one of a hydrophilic coating and a coating for reducing tissue adhesion.

9. The assembly according to claim 1, wherein the outer surface of the wall includes marks for determining the depth of insertion.

10. The distal end portion of the sheath body is tapered and includes a tapered surface that extends to the distal end face. The assembly according to claim 1, wherein the distal end face is perpendicular to the longitudinal axis of the sheath body.

11. The assembly according to claim 10, wherein the second lumen has an outlet extending through the tapered surface of the distal end portion of the sheath body.

12. Claim 1 further includes a stabilizing structure rotatably coupled to a tubular sheath body. assembly.

13. The assembly according to claim 12, wherein the stabilizing structure is rotatable about a longitudinal axis.

14. The assembly according to claim 13, wherein the stabilizing structure includes features configured for suturing to a patient.

15. The assembly according to claim 14, wherein the stabilizing structure includes a pair of suture wings, each wing having a plurality of ribs for securing sutures.

16. The assembly according to claim 1, wherein the sheath body is dimensioned to be introduced through a percutaneous access site of 6.67 mm or less.

17. The assembly according to claim 1, further comprising an intravascular blood pump.

18. The assembly according to claim 1, wherein the stylet is dimensioned to reduce the risk of blood clot formation in the second lumen.

19. The assembly according to claim 1, wherein the intravascular blood pump is a percutaneous intracardiac blood pump.

20. The assembly according to claim 1, wherein the first lumen includes a first cross-sectional area that is larger than the second cross-sectional area of ​​the second lumen.

21. The assembly according to claim 1, wherein the first lumen has a proximal region having a first diameter and a distal region having a second diameter smaller than the first diameter.

22. The stylet includes a stylet body sized to block the second lumen when the stylet is positioned within the second lumen, as described in claim 1. The assembly.

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