Intravascular introducer devices

Abstract

To provide introducer devices that provide hemostatic sealing and allow a delivery catheter to be inserted into and retrieved from a patient's vasculature.SOLUTION: The introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through introducer seals without the use of a separate loader device that covers a medical device that is mounted on the delivery catheter. The introducers comprise a housing, a distal sheath, a distal hemostatic seal, a proximal hemostatic seal, and a tube. The tube is movable longitudinally between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed. In the distal position, the distal end of the tube extends through the distal hemostatic seal.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a device for introducing a catheter or other device into a patient's vascular system, such as for delivering a medical device into the body. [Background technology]

[0002] A conventional method for transcatheter delivery of a prosthetic heart valve into a patient's vascular system and toward the heart involves creating a venous access port through the skin using a conventional introducer device, and then using a separate delivery device to deliver a delivery catheter carrying a collapsed prosthetic heart valve through the introducer device and into the vascular system. The delivery device typically covers the collapsed heart valve with a sheath to protect it, while the delivery catheter passes through a hemostatic seal within the introducer device. Covering the collapsed prosthetic heart valve reduces the risk of the collapsed prosthetic heart valve becoming dislocated relative to the delivery catheter and of damaging the collapsed prosthetic heart valve as it passes through the seal within the introducer device. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] No prior art documents are mentioned in this specification. Summary of the Invention [Problem to be solved by the invention]

[0004] The introducer device of the present invention provides a hemostatic seal and allows a delivery catheter to be inserted into and withdrawn from a patient's vascular system, and the delivery catheter can pass through the seal of the device without the use of a separate delivery device to cover a medical device, such as a deflated prosthetic heart valve, carried on the delivery catheter. [Means for solving the problem]

[0005] Some introducer devices according to the present invention include a housing; a distal sheath extending distally from the housing, the distal sheath configured to be inserted into the patient's vasculature with the housing positioned outside the patient's vasculature; a distal hemostatic seal mounted within the housing; a proximal hemostatic seal mounted within the housing at a location proximal to the distal hemostatic seal; and a shuttle or tube disposed within the housing and longitudinally movable relative to the distal hemostatic seal between proximal and distal positions, wherein in the proximal position, the distal end of the tube is positioned proximal to the distal hemostatic seal, thereby closing the distal hemostatic seal, and in the distal position, the distal end of the tube extends through the distal hemostatic seal.

[0006] In some embodiments, when the tube is in the distal position, the proximal end of the tube is positioned distal to the proximal hemostatic seal, thereby occluding the proximal hemostatic seal, and when the tube is in the proximal position, the proximal end of the tube extends through the proximal hemostatic seal.

[0007] In other embodiments, the introducer includes a second tube, e.g., a fixed portion of the housing, and the proximal hemostatic seal is longitudinally movable relative to the proximal end of the second tube of the device between a distal position where the second tube extends through the proximal hemostatic seal and a proximal position where the proximal hemostatic seal is occluded and disposed proximal to the second tube. In such embodiments, the housing can include a main housing and a proximal portion, the main housing and proximal portions being longitudinally movable relative to one another, the proximal hemostatic seal mounted within the proximal portion, and the second tube being part of the main housing.

[0008] The tube for opening the distal seal can be part of the shuttle, which is slidable relative to the housing and distal seal. The shuttle can also have an actuator extending radially through the housing, forming a handle or grip for external manipulation by a user. In some embodiments, the shuttle actuator can slide along a slot in the housing, which can be configured to lock the shuttle in a distal or proximal position by twisting the shuttle actuator relative to the housing.

[0009] When the proximal seal is open, a delivery catheter can be inserted through a proximal port in the device into the tube and between the seals without contacting the delivery catheter against the proximal seal. The tube can then be moved to a distal position, allowing the delivery catheter to be advanced distally from the tube into the distal sheath without contacting the delivery catheter against the distal hemostatic seal. After a medical device carried on the delivery catheter is advanced through the introducer, both seals hemostatically seal around the proximal portion of the delivery catheter during a procedure.

[0010] In some embodiments, the process can be reversed to allow the delivery catheter with the medical device to be proximally withdrawn from the body through the introducer without the medical device being damaged or dislodged by the introducer seal as it moves through the introducer. As a result, both seals are protected from being damaged by the medical device mounted on the delivery catheter. With the delivery system and seal protected from being damaged by the tube during withdrawal, the same delivery system can be subsequently reintroduced into the body using the same introducer with minimal risk of malfunction.

[0011] In some embodiments, the distal hemostatic seal and / or the proximal hemostatic seal can include a narrow guidewire passage configured to hemostatically seal around a guidewire extending therethrough, and the distal hemostatic seal and / or the proximal hemostatic seal can include one or more flaps adjacent the guidewire passage configured to hemostatically seal when nothing extends therethrough.

[0012] These and other objects, features, advantages and merits of the present invention will become more apparent from the following detailed description when read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a side view of an exemplary introducer device of the present invention. [Figure 2] FIG. 2 is a perspective view of the introducer device of FIG. 1. [Figure 3] FIG. 2 is a side view of the proximal end of the introducer device of FIG. 1, showing the shuttle in a distal position and the end hub in a proximal position. [Figure 4] FIG. 4 is a cross-sectional view of FIG. [Figure 5] FIG. 2 is a cross-sectional view of the proximal end of the introducer device of FIG. 1, showing the shuttle in a proximal position and the end hub in a proximal position. [Figure 6] FIG. 2 is a cross-sectional view of the proximal end of the introducer device of FIG. 1, showing the shuttle in a proximal position and the end hub in a distal position. [Figure 7] 1 is a cross-sectional view of another exemplary introducer device of the present invention with a delivery catheter inserted therein; FIG. [Figure 8] 10 is a cross-sectional view of another exemplary introducer device of the present invention. [Figure 9] 10 is a cross-sectional view of another exemplary introducer device of the present invention. [Figure 10A] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 10B] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 10C] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 10D] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 10E] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 10F] 10A-10C illustrate an exemplary hemostatic seal in an introducer device. [Figure 11A] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11B] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11C] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11D] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11E] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11F] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 11G] 10A-10C illustrate another exemplary hemostatic seal for an introducer device. [Figure 12] FIG. 10 is a side view of another exemplary introducer device of the present invention. [Figure 13] 13 is a cross-sectional view of the introducer device of FIG. 12, with the shuttle of the introducer device shown in a neutral position and the delivery catheter shown ready for insertion. [Figure 14] 13 is a cross-sectional view of the introducer device of FIG. 12, with the shuttle of the introducer device shown in a proximal position and the delivery catheter shown partially inserted into the introducer device. [Figure 15] 13 is a cross-sectional view of the introducer device of FIG. 12, with the shuttle of the introducer device shown in a distal position and with a delivery catheter extending therethrough. [Figure 16] 10 is a cross-sectional view of another exemplary introducer device of the present invention having a longitudinally split longitudinal split member; FIG. [Figure 17] 17A and 17B show longitudinal split members in the introducer device of FIG. 16. [Figure 18] 17A and 17B show longitudinal split members in the introducer device of FIG. 16. [Figure 19] 17A and 17B show longitudinal split members in the introducer device of FIG. 16. [Figure 20] FIG. 10 is a side view of another exemplary introducer device of the present invention having a telescoping proximal body. [Figure 21] FIG. 21 is a side view of the introducer device of FIG. 20, showing the proximal body split into two sections. [Figure 22] FIG. 21 is a side view of the introducer device of FIG. 20 with the proximal body assembled and in an extended configuration. [Figure 23]FIG. 21 is a side view of the introducer device of FIG. 20 with the proximal body in a shortened configuration. [Figure 24] 1 is a side view of another exemplary introducer device of the present invention in an expanded configuration; FIG. [Figure 25] FIG. 25 is a side view of the introducer device of FIG. 24 in a shortened configuration. [Figure 26] FIG. 10 is a perspective view of another exemplary introducer device of the present invention. [Figure 27] 27 is a side view of the shuttle portion of the introducer device of FIG. 26. FIG. [Figure 28] FIG. 27 is a cross-sectional view of the introducer device of FIG. 26 with the delivery catheter ready for insertion. [Figure 29] FIG. 27 is a cross-sectional view of the introducer device of FIG. 26 with the proximal seal open and a delivery catheter inserted through the proximal seal. [Figure 30] FIG. 27 is a cross-sectional view of the introducer device of FIG. 26 with the proximal seal closed, the distal seal open, and a delivery catheter extending through the introducer device. [Figure 31] 10 is a perspective view of another exemplary introducer device of the present invention having a hinge mechanism; FIG. [Figure 32] FIG. 32 is a side view of the introducer device of FIG. 31, with the introducer device in an expanded configuration. [Figure 33] FIG. 32 is a side view of the introducer device of FIG. 31, with the introducer device in a shortened configuration. DETAILED DESCRIPTION OF THE INVENTION

[0014] 1-6 illustrate an exemplary introducer 10 of the present invention. The introducer 10 provides a hemostatic seal and allows for insertion of a delivery catheter into a patient's vascular system without the need for a separate delivery device. The introducer 10 includes a distal sheath 12, which is inserted percutaneously into a blood vessel, a tapered transition sheath 14, a housing 16, a proximal hub 18, an irrigation port 20, and a longitudinally slidable shuttle 22. The housing 16 supports a hemostatic seal 42, and the proximal hub 18 supports a hemostatic seal 56 (see FIGS. 4-6). The introducer 10 can be manipulated to selectively open and close the seals 42, 56, thereby allowing distal insertion and proximal withdrawal of a delivery catheter (not shown) through the introducer into the body without damaging a medical device mounted on the delivery catheter. For example, the delivery catheter may include a collapsed prosthetic heart valve, a collapsed stent, an inflatable balloon, and / or other medical device mounted on the delivery catheter near its distal end for introduction into the patient's vascular system. The various such devices that may be mounted on the delivery catheter are collectively referred to herein as "medical devices," and the delivery catheter is referred to as a "delivery system."

[0015] Housing 16 may comprise a main housing 32, a distal seal housing 34, and / or a distal sheath housing 36, as shown most clearly in Figure 3. As shown most clearly in Figure 4, distal seal housing 34 may be secured to the distal end of main housing 32 by a threaded connection, and distal sheath housing 36 may be secured to the distal end of distal seal housing 34 by a threaded connection. A distal seal 42 is located within distal seal housing 34, and distal sheath 12 and transition sheath 14 are secured at their proximal ends by distal sheath housing 36.

[0016] The main housing 32 houses the shuttle 22. The shuttle 22 is longitudinally slidable relative to the housing 16 between a distal position (FIGS. 1-4) and a proximal position (FIGS. 5 and 6). The shuttle 22 can have a longitudinal shuttle sheath 40. The shuttle sheath 40 has a distal end 44 and a proximal end 48. The distal end 44 of the shuttle sheath 40 is located proximal to the distal seal 42 when the shuttle is in the proximal position (FIGS. 5 and 6) and moves through the distal seal 42 when the shuttle is in the distal position (FIG. 4). The proximal end 48 of the shuttle sheath can telescopically slide within a larger diameter portion 50 of the main housing 32, sealingly engaging the larger diameter portion 50, such as with an O-ring type seal 49. The shuttle sheath 40 can also engage the main housing 32 in a more distal position near the distal seal 42, such as with another O-ring type seal 45. This can help guide the longitudinal movement of shuttle sheath 40 within main housing 32.

[0017] 4 shows the shuttle 22 in a distal position, in which the distal end of the shuttle sheath 40 protrudes through the distal seal 42. As shown, the distal seal 42 separates in response to distal movement of the shuttle sheath 40 and seals around the outer surface of the distal end 44 of the shuttle sheath.

[0018] The shuttle 22 further includes an actuator 30 (see FIG. 3 ). The actuator 30 projects radially from the shuttle sheath 40 through a longitudinal slot 25 in the housing 16 (see FIG. 2 ). The actuator 30 can be used to manually drive the shuttle 22 along the slot 25 in the housing 16 between a distal position and a proximal position. The actuator 30 can be locked relative to the housing 16, for example, by rotating the actuator 30 to engage a notch 28 (see FIGS. 2 and 3 ) extending circumferentially from the slot 25, thereby retaining the shuttle 22 in the proximal position. The actuator 30 can also be locked relative to the housing 16, for example, by rotating the actuator 30 to engage a notch 26 (see FIGS. 2 and 3 ) extending circumferentially from the slot 25, thereby retaining the shuttle 22 in the distal position.

[0019] A proximal hub 18 is coupled to the proximal end of the housing 16. The proximal hub 18 is longitudinally movable relative to the housing 16 between a proximal position (FIGS. 1-5) and a distal position (FIG. 6). The proximal hub 18 contains a proximal seal 56 and, optionally, a secondary proximal seal 54, as shown in FIGS. 4-6. The proximal hub 18 includes the proximal port 24 of the introducer, through which a delivery catheter carrying a medical device can be inserted and removed. The proximal hub 18 is engageable with the proximal end of the housing 16 by corresponding helical ridges 60 and grooves 62. This allows the proximal hub 18 to be selectively movable between proximal and distal positions by rotating the proximal hub 18 relative to the housing 16, as best seen in FIGS. 5 and 6. The proximal hub 18 and the housing 16 may further include interengaging features to retain or lock the proximal hub in the distal and / or proximal positions. A sealing feature, such as an O-ring, may be disposed between the proximal hub 18 and the housing 16.

[0020] The housing 16 can include a proximal tubing 52. The proximal tubing 52 extends proximally from the larger diameter portion 50 of the main housing 32. When the proximal hub 18 is in the proximal position (FIGS. 1-5), the proximal end 53 of the proximal tubing 52 is located distal to the proximal seals 54, 56, thereby maintaining the proximal seals 54, 56 in an occlusive state. When the proximal hub 18 is in the distal position (FIG. 6), the proximal end 53 of the proximal tubing 52 can be extended through the proximal seals 54, 56, allowing a delivery catheter carrying a medical device to be inserted into the proximal tubing 52 through the proximal port 24 or retracted from the proximal tubing 52 through the proximal port 24.

[0021] FIG. 6 shows the proximal hub 18 in the distal position. In this distal position, the proximal end 53 of the proximal tubing 52 protrudes through the proximal seals 54, 56. As shown, the seals 54, 56 are separated and open, allowing the proximal end 53 of the proximal tubing 52 to extend through the seals 54, 56 and seal against the outer surface of the proximal tubing. As described in more detail below, in the illustrated embodiment, the distal seal 42 and the proximal seal 56 provide a zero seal and a guidewire seal, while the proximal seal 54 provides an instrument seal, such as against a delivery catheter. Other embodiments may have other combinations and / or configurations of the zero seal, guidewire seal, and instrument seal.

[0022] In an exemplary procedure, the distal sheath 12 can first be inserted into a patient's blood vessel, for example, over a guidewire, with the shuttle 22 in the proximal position and the proximal hub 18 in the proximal position. This occludes the distal seal 42 and proximal seals 54, 56, reducing blood loss, as shown in FIG. 5. As described in more detail below, the distal seal 42 and proximal seal 56 seal around the guidewire, thereby providing hemostasis in this state. In this state, the proximal end 48 of the shuttle sheath 40 is positioned adjacent the distal end of the proximal tubing 52, thereby forming a continuous conduit having a substantially constant diameter. The proximal hub 18 can then be actuated to the distal position, as shown in FIG. 6. This opens the proximal seals 54, 56, allowing a delivery catheter to be inserted through the proximal port 24 and through the proximal tubing 52 and into the shuttle sheath 40. After the distal end of the delivery catheter carrying the medical device has been inserted past the proximal seals 54, 56 and into the proximal tubing 52, the proximal hub 18 can be moved back proximally, causing the proximal seals 54, 56 to slide past the proximal tubing 52, with the proximal seal 54 sealing around the delivery catheter. In this configuration, the delivery catheter can be slid past the proximal seals 54, 56, with the proximal seal 54 forming a tight seal around the delivery catheter, as the delivery catheter is further advanced.

[0023] With the medical device on the delivery catheter positioned within the shuttle sheath 40, the shuttle 22 can be moved distally to its distal position (FIG. 4), allowing the distal end 44 of the shuttle sheath 40 to open the distal seal 42. The delivery catheter can then be advanced distally from the shuttle sheath 40, through the distal end 46 of the housing 16, which in the illustrated embodiment has a similar diameter to the shuttle sheath 40, and through both sheaths 12 and 14, into the patient's vasculature. After the distal end of the delivery catheter, carrying the medical device, has advanced past the distal seal 42, the shuttle 22 can be moved back to its proximal position (FIG. 5), allowing the distal seal 42 to slide out of the shuttle sheath 40, allowing the delivery catheter to slide past the distal seal 42 during further advancement and / or partial retraction of the delivery catheter.

[0024] The shuttle sheath 40 and proximal tubing 52 can have sufficient rigidity to prevent them from collapsing within the seal, keeping the seal open and allowing the passage of a medical device therethrough. The shuttle sheath 40 and proximal tubing 52 thus protect the medical device from being damaged by the seal and prevent the seal from retaining the medical device and removing it from the delivery catheter. The inner surfaces of the shuttle sheath 40 and proximal tubing 52 can be smooth, minimizing friction against the medical device and preventing damage to the medical device.

[0025] After performing the desired procedure using the delivery system within the body, the delivery catheter is withdrawn proximally through the introducer 10. In some cases, a medical device, such as a prosthetic heart valve, is properly implanted within the heart and only the delivery catheter is withdrawn. However, in other cases, the medical device can be withdrawn while still attached to the delivery catheter. For example, if the native aortic valve is severely stenotic, the deflated prosthetic heart valve may not be able to pass through the aortic valve as required for implantation. In that case, the delivery catheter and deflated prosthetic heart valve can be withdrawn into the introducer 10 and removed from the patient's body.

[0026] In such a case, the shuttle sheath 40 can be advanced distally through the distal seal 42, and the medical device can be guided back into the distal end 44 of the shuttle sheath 40. The shuttle 22 and medical device can then be retracted through the distal seal 42 and into the housing 16 of the introducer 10. In this state, the distal seal 42 can continue to seal around the guidewire. The proximal seals 54, 56 can then be opened by moving the proximal hub 18 to a distal position. This allows the delivery catheter, with its associated medical device, to be removed from the introducer 10 through the proximal port 24. In this manner, the medical device can be removed and retrieved from the body in a reusable manner because the introducer 10 eliminates or reduces the risk of damage to the medical device by the seals.

[0027] When the delivery catheter is withdrawn, introducer 10 can remain in the patient with tip seal 42 maintaining hemostasis. For example, to treat aortic valve stenosis, balloon valvuloplasty or other procedures can then be performed using the same introducer 10. After the aortic valve has been treated, the same delivery catheter, with the previously withdrawn medical device attached, can be reintroduced using the same introducer 10.

[0028] FIG. 7 illustrates another exemplary introducer 100 of the present invention. Introducer 100 functions similarly to introducer 10. Introducer 100 can include a housing 116. Housing 116 can include a main housing 126, a distal seal housing 134, and / or a distal sheath housing 136. A shuttle 122 is slidably mounted relative to housing 116. Shuttle 122 includes a shuttle sheath 140 and an actuator 130. Actuator 130 projects radially through a slot 128 in housing 116. A distal seal 142 is housed within distal seal housing 134, and distal sheath 110 can be secured by distal sheath housing 136. A proximal hub 118 can be coupled to the proximal end of housing 116. Proximal hub 118 can retain a proximal seal 154 adjacent proximal port 124 of introducer 100.

[0029] Introducer 100 allows a delivery system to be introduced into a patient's vasculature without the need for a protective delivery device, similar to that described above with reference to introducer 10. Introducer 100 also allows for withdrawal of the delivery system from the patient's body through the introducer without damaging the delivery system, thereby allowing for retrieval of the withdrawn delivery system.

[0030] To load the delivery system 102 into the introducer 100, the shuttle 122 is moved proximally, allowing the proximal end 148 of the shuttle sheath 140 to be pushed through the proximal seal 154, as shown, thereby opening the proximal seal 154. After the medical device 106 is inserted into the shuttle sheath 140 through the proximal port 124, the shuttle 122 can be moved distally, not shown, allowing the proximal seal 154 to seal around the delivery catheter 104 and the distal end 144 of the shuttle sheath 140 to push the distal seal 142 open. The delivery system 102 can then be advanced from the shuttle sheath's distal end 144, through the distal sheath 110, and into the patient's body. The shuttle can then be moved to a neutral position, freeing both seals 142, 154 from the shuttle sheath 140. During the procedure, the proximal seal 154 then seals around the delivery catheter 104. The procedure can then be reversed and the delivery system can be withdrawn from the patient's body as described above with respect to the introducer 10. An alternative embodiment of the introducer 100 includes a distal instrument seal, which allows the shuttle 122 to be moved back to its proximal position during subsequent procedures while the proximal seal 154 remains open.

[0031] FIG. 8 illustrates another exemplary introducer 200 of the present invention. Introducer 200 functions similarly to introducer 10. Introducer 200 can include a main housing 216, a distal seal housing 234, and a distal sheath housing 236. A shuttle 222 is slidably mounted relative to main housing 216. Shuttle 222 includes a shuttle sheath 240 and an actuator 223. Actuator 223 projects radially through a slot 225 in housing 216. Distal seal 242 can be housed within distal seal housing 234, and distal sheaths 212, 214 can be secured by distal sheath housing 236. A proximal hub 218 can be coupled to the proximal end of housing 216. Proximal hub 218 can retain a proximal seal 254 adjacent proximal port 224 of introducer 200.

[0032] Introducer 200 allows a delivery system to be introduced into a patient's vasculature without the need for a protective delivery device, similar to that described above with reference to introducer 10. Introducer 200 also allows for withdrawal of the delivery system from the patient's body through the introducer without damaging the delivery system, thereby allowing for retrieval of the withdrawn delivery system.

[0033] To load the delivery system into the introducer 200, the proximal hub 218 is moved distally, for example, by rotating the proximal hub 218 relative to the main housing 216 about its respective helical threads 260, 262. This allows the proximal end of the main housing's proximal tube 252 to be pushed through the proximal seal 254, thereby opening it. The shuttle 222 is also moved proximally toward the proximal tube 252. After a medical device associated with the delivery system is inserted through the proximal port 224 and through the proximal tube 252 into the shuttle sheath 240, the proximal hub 218 is moved proximally back, thereby sliding the proximal seal 254 out of the proximal tube 252, thereby sealing around the delivery catheter of the delivery system. The shuttle 222 is then moved distally, thereby allowing the distal end 244 of the shuttle sheath 240 to push against and open the distal seal 242. The delivery system can then be advanced from the shuttle sheath distal end 244, through the distal chamber 246, and through the distal sheaths 212, 214, into the patient's body. The shuttle 222 can then be moved to a proximal position, allowing both seals 242, 254 to seal around the delivery catheter. The procedure can then be reversed to withdraw the delivery system from the patient's body through the introducer 200, as described above with respect to introducer 10.

[0034] FIG. 9 illustrates another exemplary introducer 300 of the present invention. Introducer 300 functions similarly to introducer 10. Introducer 300 can include a main housing 316, a distal seal housing 334, and a distal sheath housing 336. A shuttle 322 is slidably mounted relative to main housing 316. Shuttle 322 includes a shuttle sheath 340 and an actuator 330. Actuator 330 projects radially through slots 326, 328 in the housing. Distal seal 342 can be housed within distal seal housing 334, and distal sheaths 312, 314 can be secured by distal sheath housing 336. A proximal hub 318 can be coupled to the proximal end of housing 316. Proximal hub 318 can retain a proximal seal 356 adjacent proximal port 324 of introducer 300.

[0035] Introducer 300 allows a delivery system to be introduced into a patient's vasculature without the need for a protective delivery device, similar to that described above with reference to introducer 10. Introducer 300 also allows the delivery system to be withdrawn from the patient's body through the introducer without damaging the delivery system, thereby allowing the withdrawn delivery system to be retrieved.

[0036] To load the delivery system into the introducer 300, the proximal hub 318 is moved distally, for example, by rotating the proximal hub 318 relative to the main housing 316 about its respective helical threads 360, 362. This allows the proximal end of the main housing's proximal tube 352 to be pushed through the proximal seal 356, thereby opening it. The shuttle 322 is also moved proximally toward the proximal tube 352. After a medical device associated with the delivery system is inserted through the proximal port 324 and through the proximal tube 352 into the shuttle sheath 340, the proximal hub 318 is moved proximally back, thereby sliding the proximal seal 356 out of the proximal tube 352 and sealing around the delivery catheter. The shuttle 322 is then moved distally, thereby allowing the distal end 344 of the shuttle sheath 340 to push against and open the distal seal 342. The delivery system can then be advanced from the shuttle sheath's distal end 344, through the distal chamber 346, and through the distal sheaths 312, 314, into the patient's body. The shuttle 322 can then be moved to a proximal position, allowing both seals 342, 356 to seal around the delivery catheter. The procedure can then be reversed to withdraw the delivery system from the patient's body through the introducer 300, as described above with respect to introducer 10.

[0037] 10A-10F and 11A-11G illustrate exemplary seals 64, 80 that may be used in an introducer. Each of the seals 64, 80 is suitable as a distal seal and / or a proximal seal in any introducer device according to the present invention. Each of the seals 64, 80 is capable of hemostatically sealing around a guidewire (a guidewire seal) and also capable of hemostatically sealing in the absence of an object being passed through (a zero seal). To achieve this dual sealing capability, each of the seals 64, 80 includes a narrow guidewire passageway and one or more small flaps that cover the guidewire passageway. The flaps are flexible and conformable enough to occlude the guidewire passageway when no guidewire is present. When a guidewire is present, the flaps can be opened by the guidewire to form a seal around the guidewire.

[0038] The seal 64 in FIGS. 10A-10F is a duckbill-type seal and includes an annular body. The annular body has a first end 66 (e.g., a proximal end) and a second end 68 (e.g., a distal end). The seal 64 includes two semicircular sealing members or sealing lips 72, 74. The sealing lips 72, 74 project radially inward from the annular body and abut along a generally linear slit 70. A narrow guidewire passage 76 is provided in the center of the slit 70, allowing a guidewire to extend through the slit without having to separate the remainder of the slit. This allows the seal 64 to seal around the guidewire. As shown in FIG. 10F, the guidewire passage 76 can include a generally cylindrical portion 78, allowing the seal to seal around the guidewire. One or more flaps 79 at the seal's second end 68 allow the sealing lips 72, 74 to meet even when a guidewire is not present. In some embodiments, the length L2 of the slit 70 (see FIG. 10C) can be about 13 mm (about 0.5 inches), and the thickness D2 of one or more flaps 79 (see FIG. 10F) can be in the range of about 0.3 mm (about 0.012 inches) to about 0.5 mm (about 0.018 inches).

[0039] The seal 80 in FIGS. 11A-11G is a dome-type seal and includes an annular body. The annular body has a first end 82 (e.g., a proximal end) and a second end 84 (e.g., a distal end). The seal 80 includes two semicircular seal members, or seal lips 96, 98. The seal lips 96, 98 project radially inward from the annular body and abut along a generally linear joining slit 86. Reinforcing struts 88 may be positioned on the sides of the second end 84 of the seal lips 96, 98 (see FIGS. 11B and 11E). And / or ridges 90 may be positioned on the sides of the first end 82 of the seal lips 96, 98 (see FIGS. 11A and 11C). As shown in FIG. 11G, a narrow guidewire passage 92 is provided in the center of the joining slit 86. This allows a guidewire to extend through the slit 86 without having to separate the remainder of the slit. This allows seal 80 to seal around a guidewire. Guidewire passage 92 can seal around a guidewire when one is present. A narrower / occluded portion 94, such as one or more flaps, at seal second end 84 allows seal lips 96, 98 to fully coapt even when no guidewire is present in guidewire passage 92. In some embodiments, length L1 of slit 86 (see FIG. 11E) can be approximately 13 mm (approximately 0.5 inches), and thickness D1 of one or more flaps 94 (see FIG. 11G) can range from approximately 0.012 inches to approximately 0.018 inches.

[0040] 12-15 illustrate another exemplary introducer 400 of the present invention. The introducer 400 functions similarly to the introducer 10. As shown most clearly in FIG. 13, the introducer 400 can include a housing 416. The housing 416 includes a main housing 432, a distal seal housing 433, one or more distal housing sections 434, 436, a proximal seal housing 417, and / or a proximal housing 418. An irrigation port 420 can be coupled to the housing 416 at any point. A shuttle 422 is slidably mounted to the housing 416. The shuttle 422 includes a shuttle sheath 440 and an actuator 430. The actuator 430 projects radially through a slot 425 in the housing, as shown most clearly in FIG. 14. The shuttle can slide longitudinally between a proximal position in which the actuator 430 abuts against the proximal end 428 of the slot 425, and a distal position in which the actuator 430 abuts against the distal end 426 of the slot 425. More than one slot 425 and more than one actuator 430 can be provided.

[0041] One or more distal seals 442 may be housed within the distal seal housing 433, and an additional distal shuttle seal 450 may be provided within the housing 416 around the shuttle sheath 440. Similarly, one or more proximal seals 454 may be housed within the proximal seal housing 417, and an additional proximal shuttle seal 452 may be provided within the housing 416 around the shuttle sheath 440. The plurality of distal seals 442 may be secured between the distal seal housing 433 and the distal housing section 434 along with an annular gasket 460. Similarly, the plurality of proximal seals 454 may be secured between the proximal seal housing 417 and the proximal housing section 418 along with an annular gasket 462. The distal sheaths 412, 414 may be secured relative to the introducer housing 434 by the distal sheath housing 436.

[0042] Introducer 400 allows a delivery system to be introduced into a patient's vasculature without the need for a protective delivery device, similar to that described above with reference to introducer 10. Introducer 400 also allows the delivery system to be withdrawn from the patient's body through the introducer without damaging the delivery system, thereby allowing the withdrawn delivery system to be retrieved.

[0043] To load the delivery system 402 into the introducer 400, the shuttle 422 is moved proximally, allowing the proximal end 448 of the shuttle sheath to be pushed through the proximal seal 454, thereby opening the proximal seal 454 (see FIG. 14). After a medical device associated with the delivery catheter of the delivery system is inserted into the shuttle sheath 440 through the proximal port 424, the shuttle 422 is moved distally, allowing the proximal seal 454 to seal around the delivery catheter. The distal end 444 of the shuttle sheath 440 is then able to push and open the distal seal 442 (see FIG. 15). The delivery system 402 can then be advanced from the shuttle sheath's distal end 444, through the tapered transition section 446, and through the distal sheaths 412, 414 into the patient. The shuttle 422 can then be moved to its neutral position. This allows both seals 442, 454 to be freed from the shuttle sheath 440 and seal around the delivery catheter (see FIG. 13). Alternatively, the shuttle 422 can be moved back to its proximal position while maintaining the proximal seal 454 open during the remainder of the procedure. The procedure can then be reversed to withdraw the delivery system from the patient's body as described above with respect to introducer 10.

[0044] FIG. 16 illustrates another exemplary introducer 500 of the present invention. The introducer 500 includes housing components that are separable along a longitudinal seam. The introducer 500 can include a main housing 532 that is separated into components 532A and 532B (shown in FIG. 17), a distal housing 533 that is separated into components 533A and 533B (shown in FIG. 18), and a shuttle actuator 522 that is separated into components 522A, 522B, 522C, and 522D (shown in FIG. 19). The ability to separate the components allows them to be removed from around a delivery catheter that extends through the introducer into the patient's body without having to slide the components proximally relative to the end of the catheter system. Other components of the introducer 500, such as the shuttle and proximal housing, can also be separated into smaller components or configured to be removable from around a delivery catheter. This can increase the working length of the catheter system by reducing the remaining length of the introducer that protrudes from the patient's body.

[0045] Introducer 500 may further include one or more additional distal housing portions, such as 534 and 536, a distal sheath 512, and / or a proximal housing 518. A shuttle actuator 522 is slidably mounted within housing slots 525A and 525B (see FIG. 17 ). Shuttle actuator 522 may include a shuttle sheath housed within the housing. The shuttle sheath is driven by shuttle actuator 522 to slide longitudinally between a proximal position where one or more proximal seals are open and a distal position where one or more distal seals are open, similar to that described above with respect to other introducer embodiments in accordance with the present invention.

[0046] With the delivery catheter inserted into the patient through the introducer, the splittable members 522, 532, 533 and / or other members of the introducer 500 can be separated and laterally removed from the delivery catheter, leaving only the seal and leading edge members (e.g., 512, 534, 536) of the introducer engaged with the delivery catheter and the patient for hemostatic sealing purposes. With the reduced length of the delivery catheter disposed within the introducer 500, the delivery catheter can then be inserted further distally into the patient, if desired. After the procedure using the delivery catheter is complete, the various members removed to increase the working length of the delivery catheter can be reassembled around the delivery catheter, thereby partially or completely restoring introducer functionality. Alternatively, the delivery catheter can be withdrawn from the patient through the remaining distal portion of the introducer 500 without the need to reassemble the removed members.

[0047] 20-23 illustrate another exemplary introducer 600 of the present invention. The introducer 600 includes telescoping housing members, allowing the housing of the introducer 600 to shorten or lengthen its length for delivery of a delivery catheter through the distal seal of the introducer 600. The introducer 600 includes an outer housing 604, an intermediate housing 602, an inner distal housing 606, a proximal housing 608, a proximal section 610, a distal sheath 612, a distal sheath housing 616, an inner sheath 618 (FIG. 21), lateral ports 620, 622 (FIG. 20), and / or a proximal port 624. A distal seal is housed within the inner distal housing 606, and a proximal seal is housed within the proximal housing 608.

[0048] The proximal end of introducer 600, including outer housing 604 and proximal housing 608 (see the right side of FIG. 20), can be telescopically moved distally onto the distal end of introducer 600, including mid-housing 602 and inner tip housing 606 (see the left side of FIG. 20). Additionally or alternatively, mid-housing 602 can be telescopically moved onto inner tip housing 606 and / or onto sheath housing 616 (shown in FIG. 23) to shorten the length of introducer 600. As the proximal end of the introducer moves over the distal end of the introducer, inner sheath 618 compresses and opens the tip seal, allowing the delivery catheter to be inserted into or withdrawn from the patient without damaging the tip seal.

[0049] Additionally, proximal section 610 can be moved distally relative to proximal housing 608, causing the inner tube to compress the proximal seal and the inner tube to open the proximal seal. This allows a delivery catheter to be inserted or removed from inner sheath 618 through proximal port 624 and through the proximal seal without damaging the proximal seal. The interface between proximal housing 608 and proximal section 610 can include a push-lock or twist-lock type mechanism to selectively lock the proximal seal open or selectively lock the proximal seal closed.

[0050] 24 and 25 illustrate another exemplary introducer 700 of the present invention. Introducer 700 includes telescoping housing members, allowing the housing of introducer 700 to shorten or lengthen its length for delivery of a delivery catheter through the distal seal of introducer 700. Introducer 700 includes an outer housing 702, an inner housing 704, a distal seal housing 706, a proximal seal housing 708, a proximal section 710, a distal sheath 712, lateral ports 720, 722, and / or a proximal port 724. The distal seal is housed within distal seal housing 706, and the proximal seal is housed within proximal seal housing 708.

[0051] The proximal end of the introducer 700, including the outer housing 702, can be telescopically moved distally onto the distal end of the introducer 700, including the inner housing 704, thereby shortening the length of the introducer 700. As the outer housing 702 moves over the inner housing 704, an inner sheath attached to the outer housing 702 pushes the distal seal open, allowing the delivery catheter and medical device to be inserted into or withdrawn from the patient without the medical device being damaged by the distal seal. The introducer 700 can further include a spring 730 or other biasing mechanism within the housing. The spring 730 or other biasing mechanism biases the outer housing 702 and inner sheath rearward, or proximally, away from the inner housing 704 and distal seal. A user can move the outer housing 702 from the position shown in FIG. 24 to the position shown in FIG. 25, thereby opening the distal seal and allowing the delivery catheter to be moved through the distal seal. The housings can then simply be released, allowing the biasing force of spring 730 to move the inner and outer housings 704, 702 apart to the position shown in FIG. 24, thereby re-closing the tip seal. The inner and outer housings 704, 702 can further include a twist lock mechanism, whereby twisting the outer housing 702 relative to the inner housing 704 can lock the introducer in the shortened configuration shown in FIG. 25, keeping the tip seal open. Some embodiments of twist lock mechanisms include mating threads on the inner and outer housings 704, bayonet mechanisms, etc.

[0052] Additionally, proximal section 710 can be moved distally relative to proximal seal housing 708, causing the inner tube to compress the proximal seal and the inner tube to open the proximal seal. This allows a delivery system to be inserted or removed from the inner sheath through proximal port 724 and through the proximal seal without the delivery system being damaged by the proximal seal. The interface between proximal seal housing 708 and proximal section 710 can include a push-lock or twist-lock type mechanism to selectively lock the proximal seal open or selectively lock the proximal seal closed.

[0053] 26-30 illustrate an exemplary introducer 800 of the present invention. Introducer 800 includes a shuttle 802, a main housing 804, a distal seal housing 806, a proximal section 810, a distal sheath 812, lateral ports 820, 822, and / or a proximal port 824. One or more distal seals 842 are housed within distal seal housing 806, and one or more proximal seals 854 are housed within proximal section 810 (see FIG. 27).

[0054] The shuttle 802 includes an outer cylindrical portion that slides over the main housing 804 (FIG. 26) and a shuttle sheath 834 (FIG. 27) within the main housing. The distal end 836 of the shuttle sheath can compress a distal seal 842 to open it when the shuttle 802 is moved to a distal position (FIG. 30). The proximal end 838 of the shuttle sheath can compress a proximal seal 854 to open it when the shuttle 802 is moved to a proximal position (FIG. 29). The shuttle sheath 834 can also have an intermediate or neutral position (FIGS. 26-28). In the intermediate or neutral position, both the distal seal 842 and the proximal seal 854 are occluded. Distal and proximal seals, such as O-rings 850 and 852, can be positioned around the shuttle sheath 834 to seal against the interior of the main housing 804.

[0055] The introducer 800 can further include springs 830, 832 (FIG. 27) or other biasing mechanism within the main housing 804. The springs 830, 832 or other biasing mechanism bias the shuttle 802 toward a neutral position. One end of each spring 830, 832 can abut against a respective O-ring. The other end of each spring abuts against the shuttle 802. A user can move the shuttle 802 proximally from the neutral position shown in FIGS. 26-28, thereby opening the proximal seal 854 (FIG. 29). This allows delivery catheter 860, carrying a medical device 862, to be inserted into the shuttle sheath 834. The user can then release the shuttle 802 and / or utilize the springs 830, 832 to move the shuttle 802 distally toward the neutral position. This causes the proximal seal 854 to seal around the delivery catheter 860 behind the medical device 862. The user can then move the shuttle 802 to the distal position (FIG. 30), opening the distal seal 842 and allowing the delivery catheter 860 to pass through it. After moving the medical device 862 mounted on the delivery catheter distally past the distal seal 842, the user can release the shuttle 802 or use the springs 830, 832 to move the shuttle 802 proximally, thereby moving the shuttle 802 back to its neutral position. This allows the distal seal to seal around the delivery catheter 860 as it is advanced into the patient.

[0056] The main housing 804 can include longitudinal slots 814, 818 ( FIG. 26 ). The longitudinal slots 814, 818 allow the shuttle 802 to move longitudinally between a proximal position and a distal position. In some embodiments, the main housing 804 can further include a distal slot 815 extending circumferentially from the longitudinal slot 814. This allows the shuttle 802, when in the distal position, to be rotated relative to the main housing to lock the shuttle in the distal position and maintain the distal seal 842 in an open state. Similarly, the main housing 804 can further include a proximal slot 819 extending circumferentially from the longitudinal slot 818. This allows the shuttle 802, when in the proximal position, to be rotated relative to the main housing to lock the shuttle in the proximal position and maintain the proximal seal 854 in an open state. The main housing 804 can further include one or more additional slots. This allows the shuttle 802 to be rotated to a locked position relative to the main housing and locked in a neutral position.

[0057] 31-33 illustrate an exemplary introducer 900 of the present invention. The introducer 900 utilizes a hinge mechanism that allows the distal and proximal ends of the introducer to be moved toward or away from one another, thereby enabling delivery of a delivery catheter and a medical device mounted thereon. The introducer 900 can include a distal housing 902, a proximal housing 904, a distal seal housing 906, a proximal seal housing 908, a proximal section 910, a distal sheath 912, a distal sheath housing 916, lateral ports 920, 922, a proximal port 924, an inner introducer sheath 930, a distal hinge arm 932, and / or a proximal hinge arm 934. Hinge arms 932, 934 connect the distal housing 902 to the proximal housing 904 and allow the proximal end of the introducer 900 to move between a proximal extended position, as shown in Figure 32, and a distal retracted position, as shown in Figure 33. Any number of hinge arms 932, 934 can be provided. For example, as shown, there can be four pairs of hinge arms spaced at 90° intervals around the housing.

[0058] The proximal portion 910 can be engaged against the proximal seal housing 908, thereby allowing the inner tube (e.g., the proximal end of the introducer sheath 930) to open the proximal seal by pushing the proximal portion 910 toward the proximal seal housing 908, and allowing the delivery catheter and medical device to be inserted through the proximal port 924 and through the proximal seal into the introducer sheath 930. After the medical device mounted on the catheter has been advanced past the proximal seal, the proximal portion 910 can be moved proximally rearward, thereby allowing the proximal seal to seal against the portion of the delivery catheter behind the attached medical device.

[0059] With the delivery catheter loaded into the introducer sheath 930, the proximal housing 904 can be moved distally relative to the distal housing 902, causing the hinge arms 932, 934 to bend radially outward and protrude, as shown in FIG. 33 . Alternatively, the introducer sheath 930 can be moved distally through the distal seal housing 906, opening the distal seal. With the introducer sheath 930 positioned through the distal seal, the delivery catheter can be advanced through the distal sheath 912 and into the patient's body. The delivery catheter and medical device can also be withdrawn from the patient's body without damage to the seal by reversing this process.

[0060] Although various embodiments of the introducer have been described above, any feature, characteristic, or associated use described with respect to one or more embodiments may be equally applicable or used in any other embodiment, to the extent practicable.

[0061] As used herein, the terms "distal" and "distal side" refer to a portion of an elongate member that is located away from or toward the end of the elongate member that protrudes from the patient's body when the elongate member is implanted or inserted into the patient's vasculature (e.g., percutaneous insertion into a blood vessel), and also refer to a portion of the elongate member that is located near or toward the end of the elongate member that is located inside the patient's body when the elongate member is implanted or inserted into the patient's vasculature (e.g., percutaneous insertion into a blood vessel). The terms "proximal" and "proximal side" refer to a portion of an elongate member that is located near or toward the end of the elongate member that protrudes from the patient's body when the elongate member is implanted or inserted into the patient's vasculature (e.g., percutaneous insertion into a blood vessel), and also refer to a portion of the elongate member that is located away from or toward the end of the elongate member that is located inside the patient's body. The term "longitudinal" refers to the direction of an axis extending distally or proximally, or the direction of the longitudinal axis of a cylindrical body or lumen.

[0062] For purposes of disclosure, certain aspects, advantages, and novel features of various embodiments of the present invention have been described herein. The methods, apparatus, and systems described above are not intended to limit the present invention. Rather, the present invention encompasses all novel features and aspects of the various embodiments, whether alone or in various combinations. The methods, apparatus, and systems according to the present invention are not limited to any particular aspect or feature, nor are they limited to the embodiments described above with particular advantages or specific problems to be solved.

[0063] Although operations in some methods according to the present invention are described in a particular order for convenience, it will be understood that rearrangement of the order is encompassed unless a particular order is desired. For example, operations described as having an order may, in some cases, be performed in a rearranged order or simultaneously. Moreover, for simplicity, the accompanying drawings may not illustrate various ways in which the disclosed methods may be used in other ways.

[0064] As used herein, the terms "a" and "at least one" are inclusive of one or more of the specified elements. That is, where two specified elements are present, one of those elements is present, and thus, "one" element is said to be present. The term "plurality" refers to two or more specified elements. As used herein, the term "and / or" used between at least two listed elements refers to any one of the listed elements or more than one of the listed elements. For example, "A, B, and / or C" means "A" or "B" or "C" or "A and B" or "A and C" or "B and C" or "A and B and C." As used herein, the term "coupled" generally means physically coupled and does not exclude the presence of intervening elements between the coupled elements, unless specifically stated otherwise.

[0065] In view of the numerous possible embodiments to which the principles of the present invention may be applied, it will be understood that the illustrated embodiments are merely preferred examples of the invention and are not intended to limit the scope of the invention in any way. Rather, the scope of the invention is defined by the claims that follow. Accordingly, the scope of the invention is to be defined by the scope and spirit of the claims. [Explanation of symbols]

[0066] 10 Introducer 22 Shuttle 30 Actuator 40 Longitudinal Shuttle Sheath 42 Tip hemostatic seal 56 Proximal hemostatic seal 100 introducer 122 Shuttle 130 Actuator 140 Shuttle Sheath 142 Tip hemostatic seal 154 Proximal Hemostatic Seal 200 introducer 222 Shuttle 223 Actuator 240 Shuttle Sheath 242 Tip Hemostatic Seal 254 Proximal Hemostatic Seal 300 introducer 322 Shuttle 330 Actuator 340 Shuttle Sheath 400 introducer 422 Shuttle 430 Actuator 440 Shuttle Sheath 442 Tip Hemostatic Seal 454 Proximal Hemostatic Seal 500 introducer 522 Shuttle Actuator 600 introducer 700 introducer 800 introducer 802 Shuttle 842 Tip hemostatic seal 854 Proximal hemostatic seal 900 introducer

Claims

[Claim 1] 10. A device for introducing a catheter into the vascular system of a patient, as herein described and illustrated.

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