Apparatus and methods for sealing vascular puncture

Abstract

To provide an apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel.SOLUTION: An apparatus for sealing a vessel puncture 1504 includes a positioning assembly 1512, a sheath 1510 releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element 1514 positioned at a distal portion of the positioning assembly, and a sealant 1516 disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.SELECTED DRAWING: Figure 34F

Description

Technical Field

[0001] The present invention generally relates to devices and methods for sealing a puncture site within the body, and more specifically, to devices and methods for sealing a vascular puncture site that penetrates into a blood vessel from tissue, and to devices and methods for delivering a plug, sealant, and / or other materials from the patient's skin to a blood vessel or other body lumen (lumen) extending through a percutaneous puncture site and sealing the puncture site.

Background Art

[0002] Devices and methods for accessing a patient's vasculature percutaneously to perform, for example, a procedure within the vasculature and sealing the puncture site that occurs after the procedure is completed are known. For example, a hollow needle can be inserted from the patient's skin and the overlying tissue into a blood vessel. A guide wire can be inserted through the lumen of the needle into the blood vessel, and then the needle can be removed. Next, an introducer sheath can be advanced over the guide wire into the blood vessel, and for example, one or more dilators can be advanced simultaneously with this introducer sheath, or one or more dilators can be advanced after the introducer sheath has been inserted. A catheter or other device can be advanced along the guide wire within the introducer sheath to the site where a medical procedure is to be performed. In this way, the introducer sheath facilitates accessing and / or introducing various devices into the blood vessel, and can reduce trauma to the blood vessel wall and / or reduce blood loss. When the procedure is completed, the device and the introducer sheath are removed, but a puncture site remains that extends between the skin and the blood vessel wall.

[0003]

[0004] To seal the puncture site, the overlying tissue can be manually and / or using a sandbag ​​​​​​​​​​​External pressure can be applied until hemostasis occurs. However, this procedure can be time-consuming, taking up a lot of the medical professional's time and being costly. Furthermore, it causes discomfort to the patient, who must remain immobile in the operating room, catheter laboratory, or waiting room. Additionally, there is a risk of hematoma due to bleeding before hemostasis occurs. Moreover, it takes a lot of time and is costly, consuming a great deal of the medical professional's time. Furthermore, it causes discomfort to the patient, who must remain immobile in the operating room, catheter laboratory, or waiting room. Additionally, there is a risk of hematoma due to bleeding before hemostasis occurs. Moreover, it takes a lot of time and is costly, consuming a great deal of the medical professional's time. Furthermore, it causes discomfort to the patient, who must remain immobile in the operating room, catheter laboratory, or waiting room. Additionally, there is a risk of hematoma due to bleeding before hemostasis occurs. Moreover, it takes a lot of time and is costly, consuming a great deal of the medical professional's time. Furthermore, it causes discomfort to the patient, who must remain immobile in the operating room, catheter laboratory, or waiting room. Additionally, there is a risk of hematoma due to bleeding before hemostasis occurs.

[0005] Various devices and methods for sealing the vascular puncture site resulting from such procedures have been proposed, for example, in Patent Documents 1 to 11 (U.S. Patent Nos. 7,316,704, 7,331,979, 7,335,220, and 7,806,856, and U.S. Patent Application Publication Nos. 2007 / 0231366, 2008 / 0082122, 2009 / 0088793, 2009 / 0254110, 2010 / 0168789, 2010 / 0274280, and 2010 / 0280546), which are hereby incorporated by reference in their entirety. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3.

[0006] For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3. For example, the MATRIX (trademark) product, as described in Patent Document 1, for example, is a polymer powder of two types of synthetic polyethylene glycol (「PEG」: polyethylene glycol) mixed with a suitable buffer and injected into the femoral blood vessels at the arteriotomy site. The MYNX (registered trademark) vascular occlusion device is another system for sealing the vascular puncture site and is described in one or more of the above-mentioned patent documents, for example, Patent Document 3.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

[0008] Therefore, devices and methods for sealing a puncture site penetrating tissue are useful.

[0009] The present invention aims to provide a device and method for sealing a puncture site in the body. More specifically, the present invention aims to provide a device and method for creating temporary or permanent hemostasis in a vascular puncture site reaching a blood vessel, and / or or a device and method for delivering a sealing material and / or other materials into a percutaneous puncture site extending from a patient's skin to a blood vessel or other body lumen. [Means for Solving the Problems]

[0010] In an exemplary embodiment, the present invention provides an apparatus for sealing a puncture portion penetrating an organization, The apparatus includes an introduction sheath having a proximal end portion provided with a hub, a distal end portion, and a lumen extending between these proximal and distal end portions. Generally, the apparatus includes a positioning member having expandable positioning elements at the proximal end portion, the distal end portion, and the distal end portion, and a sealing material carried at the distal end portion of the positioning element adjacent to the positioning element, and a support member having a proximal end portion and a distal end portion, wherein the distal end portion of the support member is located at the distal end portion of the positioning member adjacent to the sealing material, the support member, and a sealing material sleeve slidably disposed on the distal end portion of the support member and covering the sealing material, The sleeve has a portion that abuts against the introduction sheath when introducing the distal end portion of the positioning member into the introduction sheath, preventing the entire sleeve from entering the lumen of the introduction sheath. Thus, when advancing the positioning member into the introduction sheath, the sealing material and the support member are exposed within the lumen of the introduction sheath, and by further advancing the positioning member, it acts on the support member and guides the sealing material in the distal direction within the lumen of the introduction sheath.

[0011] In another embodiment, the present invention provides a system for sealing a puncture portion penetrating an organization The system includes an introduction sheath having a proximal end portion provided with a hub, a distal end portion, and a lumen extending between these proximal and distal end portions, and a positioning member having expandable positioning elements at the proximal end portion, the distal end portion, and the distal end portion. The distal end portion of the positioning member is sized to be introduced into the hub and lumen of the sheath together with the positioning element in a contracted state. The positioning member described above. The sealing material is carried at the distal end portion of the positioning element adjacent to the positioning element, ​​​​​ and position a support member having a proximal end portion and a distal end portion on the positioning member, the distal end portion of the support member being positioned adjacent to the end portion of the positioning member adjacent to the sealing material. The sealing material sleeve is slidably disposed on the distal end portion of the support member and covers the sealing material. The sleeve engages the introduction sheath when the introduction sheath is introduced into the positioning member end portion, preventing the entire sleeve from entering the lumen of the introduction sheath so that when the positioning member is advanced into the introduction sheath, the sealing material and the support member are exposed within the lumen of the introduction sheath, and further advancing the positioning member acts on the support member to guide the sealing material in the distal direction within the lumen of the introduction sheath. In still another embodiment of the present invention, there is provided a method of sealing a puncture site leading to a body lumen through tissue, with an introduction sheath disposed within the puncture site. An elongated positioning member having a proximal end portion, a distal end portion, and a sleeve that at least partially surrounds the distal end portions of the sealing material and the support member is provided, the sleeve and the sealing material being disposed adjacent to the positioning element at the distal end portion of the positioning member. The distal end portion of the positioning member is advanced into the hub and lumen of the introduction sheath, this advancement being carried out until the sleeve contacts the sheath hub. The positioning member is further advanced within the sheath lumen, this advancement being carried out until the positioning element is disposed within the body lumen beyond the distal end portion of the introduction sheath, whereby the sleeve is slid on the support member

[0012] exposing the sealing material within the sheath lumen and advancing the distal end portion of the support member within the lumen of the introduction sheath to guide the sealing material from the lumen of the introduction sheath toward the distal end portion of the sheath. Next, the introduction sheath is retracted to expose the sealing material within the puncture site. and the support member, the sleeve being slidable on the support member and covering the sealing material. The sleeve has a portion that engages the introduction sheath when the introduction sheath is introduced into the positioning member end portion, preventing the entire sleeve from entering the lumen of the introduction sheath so that when the positioning member is advanced into the introduction sheath, the sealing material and the support member are exposed within the lumen of the introduction sheath, and further advancing the positioning member acts on the support member to guide the sealing material in the distal direction within the lumen of the introduction sheath. until the sleeve contacts the sheath hub. The positioning member is further advanced within the sheath lumen, this advancement being carried out until the positioning element is disposed within the body lumen beyond the distal end portion of the introduction sheath, whereby the sleeve is slid on the support member exposing the sealing material within the sheath lumen and advancing the distal end portion of the support member within the lumen of the introduction sheath to guide the sealing material from the lumen of the introduction sheath toward the distal end portion of the sheath. Next, the introduction sheath is retracted to expose the sealing material within the puncture site. and the support member, the sleeve being slidable on the support member and covering the sealing material. The sleeve has a portion that engages the introduction sheath when the introduction sheath is introduced into the positioning member end portion, preventing the entire sleeve from entering the lumen of the introduction sheath so that when the positioning member is advanced into the introduction sheath, the sealing material and the support member are exposed within the lumen of the introduction sheath, and further advancing the positioning member acts on the support member to guide the sealing material in the distal direction within the lumen of the introduction sheath.

[0013] In one embodiment, the present invention provides an apparatus for sealing a puncture site, the apparatus comprising an elongated positioning member having a proximal end portion and having an expandable positioning element at its distal end, and a cartridge movable along the positioning member from a proximal side position to a distal side position. The cartridge includes a tubular member, a sealing material disposed within the lumen of the tubular member, adjacent to the distal end of the tubular member, a support member disposed within the lumen of the tubular member adjacent to the sealing material, and a housing at the proximal end of the tubular member. An expandable positioning element is provided at the distal end of the positioning member. A deployment mechanism is provided within the housing and connected to the tubular member and the support member. The deployment mechanism includes one or more rack and pinion elements connected to the proximal end portions of the tubular member and the support member. An actuator connected to the deployment mechanism is provided in the housing. When the actuator is operated, the tubular member is guided in the proximal direction and / or the support member is guided in the distal direction in a predetermined sequence. For example, when the actuator is operated, one or more rack and pinions are sequentially: a) withdrawn the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site, and b) advanced the support member to compress the sealing material within the puncture site. The timing of the retraction and advancement can be set based on the configuration of the deployment mechanism. For example, the advancement of the support member is delayed until the sealing material is almost completely exposed from the tubular member. The cartridge includes a tubular member, a sealing material disposed within the lumen of the tubular member, adjacent to the distal end of the tubular member, a support member disposed within the lumen of the tubular member adjacent to the sealing material, and a housing at the proximal end of the tubular member. A sealing material is disposed within the lumen of the tubular member, adjacent to the distal end of the tubular member. A support member is disposed within the lumen of the tubular member adjacent to the sealing material.

[0014] A deployment mechanism is provided within the housing and connected to the tubular member and the support member. The deployment mechanism includes one or more rack and pinion elements connected to the proximal end portions of the tubular member and the support member. An actuator connected to the deployment mechanism is provided in the housing. When the actuator is operated, the tubular member is guided in the proximal direction and / or the support member is guided in the distal direction in a predetermined sequence. For example, when the actuator is operated, one or more rack and pinions are sequentially: a) withdrawn the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site, and b) advanced the support member to compress the sealing material within the puncture site. The timing of the retraction and advancement can be set based on the configuration of the deployment mechanism. For example, the advancement of the support member is delayed until the sealing material is almost completely exposed from the tubular member. The deployment mechanism includes one or more rack and pinion elements connected to the proximal end portions of the tubular member and the support member. An actuator connected to the deployment mechanism is provided in the housing. When the actuator is operated, the tubular member is guided in the proximal direction and / or the support member is guided in the distal direction in a predetermined sequence. For example, when the actuator is operated, one or more rack and pinions are sequentially: a) withdrawn the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site, and b) advanced the support member to compress the sealing material within the puncture site. The timing of the retraction and advancement can be set based on the configuration of the deployment mechanism. For example, the advancement of the support member is delayed until the sealing material is almost completely exposed from the tubular member. When the actuator is operated, the tubular member is guided in the proximal direction and / or the support member is guided in the distal direction in a predetermined sequence. For example, when the actuator is operated, one or more rack and pinions are sequentially: a) withdrawn the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site, and b) advanced the support member to compress the sealing material within the puncture site. One or more rack and pinions are sequentially: a) withdrawn the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site, and b) advanced the support member to compress the sealing material within the puncture site. Withdraw the tubular member relative to the sealing material to expose the sealing material within the lumen of the tubular member into the puncture site. Advance the support member to compress the sealing material within the puncture site. The timing of the retraction and advancement can be set based on the configuration of the deployment mechanism. For example, the advancement of the support member is delayed until the sealing material is almost completely exposed from the tubular member. The timing of the retraction and advancement can be set based on the configuration of the deployment mechanism. For example, the advancement of the support member is delayed until the sealing material is almost completely exposed from the tubular member.

[0015] In other embodiments, the present invention provides a system for sealing a puncture site in tissue, the system generally comprising an introducer sheath, a positioning member, and a cartridge. The introducer sheath includes a lumen and a proximal end portion. The positioning member is an elongated member having a proximal end portion and having an expandable positioning element at its distal end. The cartridge is movable along the positioning member from a proximal side position to a distal side position. The cartridge includes a tubular member, a sealing material disposed within the lumen of the tubular member, adjacent to the distal end of the tubular member, a support member disposed within the lumen of the tubular member adjacent to the sealing material, and a housing at the proximal end of the tubular member. ​The introducer has a proximal end portion provided with a hub, a distal end portion sized to be introduced into the puncture portion, and a lumen extending between the proximal end portion and the distal end portion. The positioning member has an elongated member having a proximal end portion and an expandable positioning element at the distal end portion of the elongated member. The cartridge can advance from a proximal position to a distal position along the positioning member, and has a tubular member containing a sealing material and a support member disposed within the lumen of the tubular member. The locking mechanism is provided on the cartridge and engages with the hub of the introducer when advancing the tubular member to the distal position and entering the introducer sheath, thereby connecting the subsequent proximal-direction movement of the tubular member and the introducer sheath to each other, for example. In still other embodiments, the present invention provides an apparatus for sealing a puncture portion that penetrates tissue. This apparatus includes an introducer sheath having a proximal end portion including a hub, a distal end portion, and a lumen extending between the proximal end portion and the distal end portion. The apparatus of the present invention can include a positioning member having a proximal end portion, a distal end portion, and an expandable positioning element at the distal end portion, and a cartridge that can advance from a proximal position adjacent to the proximal end portion of the positioning member to a distal position along the positioning member. The cartridge can have a sealing material, a support member having a distal end portion disposed adjacent to the sealing material, and a sealing material sleeve slidably disposed on the distal end portion of the support member and covering the sealing material. The sleeve has a distal end portion sized to enter the hub of the introducer sheath when advancing the cartridge toward the distal position, and a proximal end portion that abuts against the hub of the introducer sheath to prevent the entire sleeve from entering the lumen of the introducer sheath, thereby positioning the cartridge in the proximal position. The introducer has a proximal end portion provided with a hub, a distal end portion sized to be introduced into the puncture portion, and a lumen extending between the proximal end portion and the distal end. The positioning member has an elongated member having a proximal end portion and an expandable positioning element at the distal end of the elongated member. The cartridge can advance from a proximal position to a distal position along the positioning member and has a tubular member containing a sealing material and a support member disposed within the lumen of the tubular member. The locking mechanism is provided on the cartridge and engages with the hub of the introducer when advancing the tubular member to the distal position and entering the introducer sheath, thereby connecting the subsequent proximal-direction movement of the tubular member and the introducer sheath to each other, for example.

[0016] In still other embodiments, the present invention provides an apparatus for sealing a puncture portion that penetrates tissue. This apparatus includes an introducer sheath having a proximal end portion including a hub, a distal end portion, and a lumen extending between the proximal end portion and the distal end portion. The apparatus of the present invention can include a positioning member having a proximal end portion, a distal end portion, and an expandable positioning element at the distal end portion, and a cartridge that can advance from a proximal position adjacent to the proximal end portion of the positioning member to a distal position along the positioning member. The cartridge can have a sealing material, a support member having a distal end portion disposed adjacent to the sealing material, and a sealing material sleeve slidably disposed on the distal end portion of the support member and covering the sealing material. The sleeve has a distal end portion sized to enter the hub of the introducer sheath when advancing the cartridge toward the distal position, and a proximal end portion that abuts against the hub of the introducer sheath to prevent the entire sleeve from entering the lumen of the introducer sheath, thereby positioning the cartridge in the proximal position. The introducer has a proximal end portion provided with a hub, a distal end portion sized to be introduced into the puncture portion, and a lumen extending between the proximal end portion and the distal end. The positioning member has an elongated member having a proximal end portion and an expandable positioning element at the distal end of the elongated member. The cartridge can advance from a proximal position to a distal position along the positioning member and has a tubular member containing a sealing material and a support member disposed within the lumen of the tubular member.

[0017] The sleeve has a distal end portion sized to enter the hub of the introducer sheath when advancing the cartridge toward the distal position, and a proximal end portion that abuts against the hub of the introducer sheath to prevent the entire sleeve from entering the lumen of the introducer sheath, thereby positioning the cartridge in the proximal position. The sleeve has a distal end portion sized to enter the hub of the introducer sheath when advancing the cartridge toward the distal position, and a proximal end portion that abuts against the hub of the introducer sheath to prevent the entire sleeve from entering the lumen of the introducer sheath, thereby positioning the cartridge in the proximal position. The sleeve has a distal end portion sized to enter the hub of the introducer sheath when advancing the cartridge toward the distal position, and a proximal end portion that abuts against the hub of the introducer sheath to prevent the entire sleeve from entering the lumen of the introducer sheath, thereby positioning the cartridge in the proximal position. ​When advancing from the proximal position to the distal position, the distal portion of the sleeve enters the lumen of the introducer sheath and the sleeve is stopped by the hub of the introducer sheath and slides on the support member, exposing the sealing material within the lumen of the introducer sheath, and further advancing the cartridge to the distal position thereby acting on the support member to direct the sealing material distally within the lumen of the introducer sheath as follows.

[0018] Some aspects of the present invention aim at a device for sealing a puncture site in a blood vessel wall. The device of the present invention can comprise a positioning assembly having a positioning element positioned at the distal portion of the positioning assembly and a sealing material disposed at the distal portion of the positioning assembly The device of the present invention can comprise a sheath releasably engaged with the positioning assembly. The device of the present invention can comprise a support member axially advanceable within the sheath

[0019] Some aspects of the present invention aim at a device for sealing a puncture site in a blood vessel wall. The device of the present invention can comprise the positioning assembly having a sealing material disposed at the distal portion of the positioning assembly The device of the present invention can comprise a sheath within which the positioning assembly is axially advanceable. The device of the present invention can comprise a handle having an outer handle portion configured to move relative to an inner housing portion The outer handle portion can be removably coupled to the sheath and / or the inner housing portion can be removably coupled to the positioning assembly

[0020] Any of the features, methods or processes of the device of the present invention described herein can be in any implementation ​​​​​​​​It can be included in the form. For example, the positioning assembly can have a sealing material sleeve configured to accommodate the sealing material. The sheath can have a hub portion configured to accommodate the sealing material sleeve. The inner diameter of the sheath can be smaller than the outer diameter of the sealing material sleeve. The sealing material can have a first sealing material portion on the end side of the second sealing material portion. The first sealing material portion can be different from the second sealing material portion.

[0021] In some embodiments, the device of the present invention can include a positioning element movable between a non-expanded state and an expanded state. The positioning element can be positioned at the end portion of the positioning assembly and / or adjacent to the positioning element.

[0022] In some embodiments, the handle can have a first actuator configured to separate the movement between the outer handle portion and the inner housing portion. The handle can have a second actuator configured to advance the support member within the sheath. For example, the handle can have a rack and pinion. The pinion can be linked to the second actuator and configured to move the rack. In some embodiments, the handle can have a third actuator configured to retract the positioning element so as to pass through the sealing material. The third actuator can be slidable with respect to the inner housing portion.

[0023] Some aspects of the present invention aim at a method for sealing a puncture site in a blood vessel wall. The method of the present invention The method may further include the step of advancing a sheath over the guidewire. The method may further include withdrawing the guidewire. The method can include advancing a positioning assembly within the sheath to enter the catheter. The positioning assembly carries a sealant disposed at a distal portion of the positioning assembly. The method of the present invention includes a step of retracting the sheath to expose the sealant to the outside of the blood vessel. In some embodiments, the step of advancing the positioning assembly may include a step of The step can include transferring the sealant from the sealant sleeve to the sheath.

[0024] Any of the inventive apparatus features, methods or processes described herein may be implemented in any manner. For example, the method may include providing a positioning element in a blood vessel. The method may further include the step of extending the positioning element in a proximal direction. The method may further include retracting the positioning element and seating the positioning element against the vessel wall. The method can include releasably engaging a positioning assembly and a sheath. The method may include releasing the positioning assembly from the sheath. The method includes the step of advancing a support member to tamp the sealant. The method may further include releasing the positioning assembly from the support member. The positioning element can be retracted through the encapsulant to hold the encapsulant in place. The method may include the step of advancing a dilator within the sheath. It may have steps.

[0025] Other aspects and features of the present invention will become apparent from the following description with reference to the accompanying drawings. will be.

[0026] The exemplary devices shown in the drawings are not drawn to scale and exaggerate various aspects and features in the illustrated embodiments.

Brief Description of the Drawings

[0027]

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Embodiments for Carrying out the Invention

[0028] Referring to the drawings, FIGS. 1A - 2B show an exemplary embodiment of an apparatus 10 having a positioning member 14 and a cartridge or shuttle 16 carried on this positioning member 1 4, for feeding the sealing material 2 in the cartridge to a piercing part (not shown). The cartridge 16 can have an elongated tubular member 20 that carries the sealing material 2 internally, a support tube or support member 30 adjacent to the sealing material 2 within the tubular member 20, and a handle or housing 23, and the handle or housing 23 can be connected and / or supported to the tubular member 20 and / or the support member 30. As shown in FIGS. 1A - 2A, the cartridge 16 is initially provided in a proximal - side position. For example, at this proximal - side position, the sealing material is spaced distally from an expandable positioning element 46 in the positioning member 14. The entire cartridge 16 can be advanced from the proximal - side position to the distal - side position, for example, as shown in FIGS. 10A - 10C, to advance the sealing material 2 into the piercing part and / or towards the positioning element 46. In some aspects, the positioning member 14 and the cartridge 16... can be carried.

[0029] As shown in FIGS. 1A - 2A, the cartridge 16 is initially provided in a proximal - side position. For example, at this proximal - side position, the sealing material is spaced distally from an expandable positioning element 46 in the positioning member 14. The entire cartridge 16 can be advanced from the proximal - side position to the distal - side position, for example, such that, as shown in FIGS. 10A - 10C, the sealing material 2 can be advanced into the piercing part and / or towards the positioning element 46. In some aspects, the positioning member 14 and the cartridge 16... can be advanced from the proximal - side position to the distal - side position to advance the sealing material 2 into the piercing part and / or towards the positioning element 46. In some aspects, the positioning member 14 and the cartridge The relative length of the ledge 16 is such that when the cartridge 16 as a whole is in a position where it does not advance from the proximal end position to the distal end position, as in the initial position, i.e., for example, the device 210 shown in FIGS. 8A - 8C and / or the device 710 shown in FIGS. 16A, 16B and as described elsewhere in this specification, the sealing material 2 is disposed adjacent to the positioning element 46.

[0030] As shown in FIG. 2B, the cartridge 16 can have a deployment mechanism 60 connected to the tubular member 20 and the support member 30 within the housing 23. As described below, the deployment mechanism 60 is configured to direct the tubular member 20 and / or the support member 30 axially with respect to the housing 23 and also with respect to the sealing material 2 and / or the positioning member 14, so as to be able to deploy and / or compress, for example, the sealing material 2.

[0031] Optionally, the device 10 (or any of the other embodiments described herein) is part of a system that also includes, for example, a sheath 80 (not shown, see FIGS. 10A - 10F) for delivery, access, treatment, introduction, or other purposes. The introduction sheath 80 can be an ordinary sheath 80 as shown in FIGS. 10A - 10F, or a custom sheath 780 as shown in FIG. 16C that includes, for example, functional features of bleedback and / or sheath lock as described below. Optionally, the device 10 and / or the system can have one or more other components, for example, one or more other components such as a needle, a guide wire, other instruments for puncturing, an inflation medium source, and / or an additional source of sealing compound (not shown), so as to form a kit for medical treatment. ​​​​​​​​​​​​​​

[0032] Generally, as shown in FIG. 2A, the tubular member 20 has a proximal end 22 that penetrates into and / or connects to the housing 23 and / or the deployment mechanism 60, a distal end 24 sized to be introduced into an introduction sheath and / or a puncture portion (not shown), and a lumen 26 extending between the proximal end 22 and the distal end 24. The tubular member 20 can be substantially rigid, semi-rigid, or flexible, and for example, it enables the tubular member 20 to be advanced from an introduction sheath or other part into a puncture portion of tissue. The distal end 24 can terminate as a tapered, rounded, or non-sharp distal tip. Optionally, similar to other embodiments described below, the distal end 24 can terminate as a collapsible, splittable, or crushable distal tip (not shown).

[0033] Further, referring to FIGS. 2A and 2B, the support member 30 can be an elongated tubular body sized to be slidably received within the lumen (lumen) 26 of the tubular member 20. The support member 30 has a proximal end 32 that penetrates into and / or connects to the housing 23 and / or the deployment mechanism 60, and a distal end 34 disposed at the proximal end side of the distal end 24 of the tubular member and / or adjacent to the sealing material 2, and for example, as described below, when the tubular member 20 is retracted during use, it contacts the sealing material 2 and / or facilitates maintaining the sealing material 2 within the puncture portion. The support member 30 also has a lumen (not shown) extending between the proximal end 32 and the distal end 34, and the positioning member 14 can be slidably received within this lumen. The support member 30 can be substantially rigid, semi-rigid, and / or substantially flexible, and for example

[0034] ​​​​​, having sufficient column strength so that the tubular member 20 can move relative to the sealing material 2 without the support member 30 buckling, and / or by pushing the proximal end portion 32 with the deployment mechanism 60 as described below, the distal end portion 34 of the support member 30 can be advanced so that the sealing material 2 can be compressed within the puncture portion. As shown by the phantom line in FIG. 2A, the sealing material 2 can be disposed within the lumen 26 of the tubular member 20 in the vicinity of the distal end portion 24, for example, immediately adjacent to and / or surrounded by the distal tip. The lumen 26 can be sized such that the tubular member 20 and the sealing material 2 can slide relative to each other, for example, as described below, the tubular member 20 can be sized to be retractable in the proximal direction relative to the sealing material 2 and / or the support member 30. In an exemplary embodiment, the sealing material 2 can have a first major section 2a on the proximal side formed from a lyophilized hydrogel and a second tip section 2b on the distal side formed from a plurality of non-lyophilized and / or non-crosslinked precursors. The second tip section 2b (not shown in FIG. 2A, see FIG. 11) can be formed as a solid mass or solid plug and fused or attached to the first section and extend distally from the first section as disclosed in U.S. Patent Application Publication No. 2014 / 0249575 (U.S. Patent Application No. 13 / 354,278 filed on January 19, 2012) (this publication is hereby incorporated by reference in its entirety). The sealing material 2 can be made of one or more materials having biocompatibility, bioabsorbability, and / or expandability, for example, a lyophilized hydrogel. The sealing material 2 can be solid or hollow.

[0035]

[0036] ​ a cylindrical shape, a rolled sheet shape, a disk shape, or other shape or an ellipse, a triangle , a square, a cone, a disk, or a polygon. For example, the sealant 2 may be a solid material having a lumen (not shown) extending between a proximal end portion and a distal end portion of the sealant material. The lumen can be formed by winding a sheet material around a mandrel by rolling, or by molding, or by perforating or removing material from a pre-formed solid material and the like. The lumen can be dimensioned such that a positioning member 14 or other instrument (not shown) can slide or pass through the sealant 2 as disclosed in U.S. Patent Application Publication No. 2014 / 0249 575 (U.S. Patent Application No. 13 / 354,278, filed on January 19, 2012) (this publication is hereby incorporated by reference in its entirety) .

[0037] In some embodiments, the sealant 2 can be formed from a biocompatible and / or bioabsorbable hydrogel , for example, polyethylene glycol (「PEG」). For example, the hydrogel can include a lyophilized PEG polymer, and this PEG polymer can include a chemically degradable group by hydrolysis, for example, when exposed to an aqueous environment, it can absorb body fluid and can include a polymer network that can expand. The size of expansion or swelling (the ratio before and after hydration) is large, for example, 2 to 10 times (2X to 10X) the lyophilized size based on volume. Additionally or alternatively, the sealant 2 can be a thrombus-promoting material, for example, one or more biological materials such as collagen, fibrin, carboxymethyl cellulose, oxidized cellulose, alginate , gelatin, or other protein-based materials . a thrombus-promoting material and / or a synthetic material such as polyglycolic acid (PGA), polylactide (PLA), polyvinyl alcohol, etc. can be included.

[0038] Optionally, the sealant 2 contains one or more therapeutic agents and / or pharmaceutical agents, for example, to promote healing and prevent infection and / or other medical interfering events, etc. Such drugs can be embedded in the sealant and / or applied as one or more coatings or layers. Additionally or alternatively, the sealant 2 can be made substantially homogeneous or contain one or more different materials at one or more locations. For example, in some embodiments, the sealant 2 has a carrier or core, and the first and second hydrogel precursors can be disposed relative to this carrier or core in a non-reactive state, and these first and second hydro gel precursors can form an adhesive coating when the sealant 2 is exposed to an aqueous environment. .

[0039] Referring to FIG. 2B, the housing 23 has an actuator 62 connected to the deployment mechanism 60, for example, to selectively guide the tubular member 20 and / or the support member 30 so that the sealant 2 can be exposed and / or compressed. In an exemplary embodiment, the deployment mechanism 60 has one or a plurality of interconnected rack & pinion elements to form a desired configuration for retracting and / or advancing the tubular member 20 and the support member 30 in a predetermined sequence.

[0040] For example, as shown in FIG. 2B, the deployment mechanism 60 includes a first rack 64 connected to the proximal end 22 of the tubular member 20, a second rack 66 connected to the proximal It has a pinion 68 connected between the 64 and the second rack 66. In an exemplary embodiment the base ends 22, 32 can be attached to the racks 64, 66, and this attachment can be, for example , by providing stems (not shown) on the racks 64, 66 and housing these stems within the base ends 22, 32 or by directly connecting, fusing, or ultrasonically welding the base ends 22, 33 to the stems or to the racks 64, 66.

[0041] The pinion 68 can be fixed so as not to translate relative to the housing 23, for example so that there is no large translation along or in a direction intersecting the longitudinal axis 11 of the device 10 and it can rotate freely about an axis fixed to the housing 23. The racks 64, 66 are mounted slidably within the housing 23, for example, along guides 70, 72 such as tracks, rails, slots, etc. so that the racks 64, 66 can slide substantially parallel to the longitudinal axis 11 within the housing. The movement of the racks 64, 66 is restricted by the movement and / or interaction of the racks and / or the actuator 62 so that, for example, the distance by which the tubular member 20 and the support member 30 move can be restricted.

[0042] Generally, the racks 64, 66 and the pinion 68 have teeth that cooperate with each other, and these teeth interact with each other such that the movement of one element causes the desired movement of the other element. For example, as shown, the pinion 68 has teeth 69 that are substantially uniformly sized and spaced apart from each other along its outer circumference, and the racks 64, 66 have similar teeth 65, 67 that extend substantially continuously along their lengths. In some embodiments, the deployment mechanism is the racks 64, 66 A plurality of pinions (not shown) connected to 66 can be provided. For example, these plurality of pinions can have different diameters or different tooth configurations. For example, the first and second racks 64, 66 can be made to have different translation rates as required.

[0043] In the embodiment shown in FIG. 2B, the actuator 62 can be a slider button directly connected to the first rack 64. The actuator 62 slides within the groove hole in the housing 23, whereby the actuator 62 can be guided from the first or end position as shown to the second or proximal position (not shown). Optionally, the groove hole or the housing 23 has a pocket or other locking functional feature (not shown) to releasably fix the actuator 62 ( and thus the deployment mechanism 60, the tubular member 20, and / or the support member 30) at one or more desired positions, for example, the end position and the proximal position. When operating the actuator 62, the deployment mechanism 60 guides the first rack 64 in the proximal direction, and thus the tubular member 20 can be retracted in the proximal direction. By the cooperating teeth 65, 67, 69, the movement of the first rack 64 rotates the pinion 68, and this rotation

[0044] advances the second rack 66 in the distal direction, and thus the support member 30 can be advanced in the distal direction. Thus, the deployment mechanism 60 shown in FIG. 2B can, as further described below, retract the tubular member 20 in the proximal direction and advance the support member 30 in the distal direction to deploy the sealing material 2 almost simultaneously. In this configuration, the relative movement between the tubular member 20 and the support member 30 is 1:1, that is, the tubular member 20 is of the support member 30, as follows. retract the tubular member 20 in the proximal direction and advance the support member 30 in the distal direction to deploy the sealing material 2. In this configuration, the relative movement between the tubular member 20 and the support member 30 is 1:1, that is, the tubular member 20 is, of the support member 30, It can move backward by a distance equal to the forward movement.

[0045] The teeth can be provided as a discontinuous and / or non-uniform configuration as required, for example, to cause a required delay in the movement between the tubular member 20 and the support member 30, and / or to have different movement rates for backward and forward movements. For example, FIG. 3 shows an alternative embodiment in which the racks 64a, 66a and / or the pinion 68a have non-continuous teeth 65a, 67a, 69a. For example, the pinion 68a can be provided with teeth 69a that only partially extend around the outer surface, or a plurality of sets of teeth 69a spaced apart from each other around the periphery of the pinion 68a (only one is shown in the figure for simplicity).

[0046] In an exemplary embodiment, when the actuators 62a initially position the racks 64a, 66a at the end side positions, they have a set of substantially continuous teeth 65a, 67a, and the teeth 65a of the first rack 64a engage the first set of corresponding teeth 69a of the pinion 68a. At this position, the teeth 67a in the second rack 66a do not engage any teeth in the pinion 68a. Therefore, when the actuator 62a is initially operated, the first rack 64a immediately moves, thereby immediately retracting the tubular member 20. When the actuator 62a and the first rack 64a move, the pinion 68a rotates, and finally, a second set of teeth 69a (not shown) in the pinion 68a can engage the teeth 67a of the second rack 66a. By further moving the actuator 62a, the second rack 66a can move, thereby advancing the support member 30 in the end direction.

[0047] By providing one or more regions without teeth 69a on the pinion 68a, the support member The forward movement of 30 can be delayed by a desired time or a desired distance after the start of the backward movement of the tubular member 20. For example, due to this delay, after the sealing material 2 is partially or entirely exposed from the end portion 24 of the tubular member 20, the support member 30 is advanced to compress the sealing material 2, thereby reducing the risk that the sealing material 2 is compressed or clogged within the tubular member 20.

[0048] As required, the sizes and / or intervals of the teeth 65a, 67a on the racks 64a, 66a are made different from each other. For example, the translational distances when the actuator 62 operates are made different. For example, a second pinion (not shown) is connected between the pinion 68a and the second rack 66a. This second pinion has a different diameter and / or a tooth configuration corresponding to the teeth 67a of the second rack 66a, so that when the actuator 62 operates, the tubular member 20 advances a distance greater than or less than the distance by which it retracts.

[0049] In some embodiments, the forward movement of the support member 30 can be delayed by indirectly connecting the proximal end portion of the support member 30 to the second rack 66. For example, as shown in FIG. 3A, a stem or other extension 79a' that partially protrudes into the proximal end portion 32 of the support member 30 is provided on the second rack 66a'. For example, the proximal end portion 32 is supported so as not to move greatly laterally. The stem 79a' is sized to slidably fit within the support member 30 and houses a positioning member (not shown) that penetrates internally. As an alternative, another support (not shown) is ​​​​​​​​Provided inside the housing 23a′, it supports the base end portion 32 of the support member 30 so that it can move in the axial direction without moving the base end portion 32 of the support member 30 laterally. In this way, in the initial position, the base end portion 32 of the support member 30 can be separated from the second rack 66a′ in the terminal direction. The racks 64a, 66a′ and the pinion 68a have substantially continuous corresponding teeth (not shown), similar to the embodiment of FIG. 2B. When the actuator 62a is operated, both racks 64a, 66a′ can move immediately due to the pinion 68a. Since the base end portion 22 of the tubular member 20 is directly connected to the first rack 64a, the first rack 64a can immediately start moving backward with the tubular member 20. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The base end portion 32 can be separated from the second rack 66a′ in the terminal direction.

[0050] The racks 64a, 66a′ and the pinion 68a have substantially continuous corresponding teeth (not shown), similar to the embodiment of FIG. 2B. When the actuator 62a is operated, both racks 64a, 66a′ can move immediately due to the pinion 68a. Since the base end portion 22 of the tubular member 20 is directly connected to the first rack 64a, the first rack 64a can immediately start moving backward with the tubular member 20. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The base end portion 22 of the tubular member 20 is directly connected to the first rack 64a, so the first rack 64a can immediately start moving backward with the tubular member 20. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The base end portion 22 of the tubular member 20 is directly connected to the first rack 64a, so the first rack 64a can immediately start moving backward with the tubular member 20. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The second rack 66a′ also immediately starts moving forward, but the support member 30 does not start moving until the second rack 66a′ contacts or engages with the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. Therefore, the movement of the support member 30 can be delayed until the tubular member 20 moves backward by, for example, the offset distance from the second rack 66a′ of the base end portion 32 of the support member 30. The movement of the support member 30 can be delayed.

[0051] Slider buttons for the actuators 62, 62a are shown in FIGS. 2B and 3, but other actuators can be provided in the housings 23, 23a′. For example, referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push Another actuator can be provided in the housings 23, 23a′. For example, referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push Referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push Referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push Referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push Referring to FIG. 4, another embodiment of the housing 23b is shown. This housing 23b has a deployment mechanism 60b having one or more pinions (only one pinion 68b is shown) and a first rack 64b and a second rack 66b connected to the tubular member 20 and the support member 30. Different from the embodiment of FIG. 3, the actuator 62b is a push A button actuator that at least partially pushes into the housing 23b to operate the deployment mechanism 60b. As shown explicitly in FIG. 4A, the actuator 62b slides along the housing 23b, for example, along a track, slot, or other guide (not shown) and has a shaft 74b.

[0052] The actuator 62b can be guided from the illustrated first or outer position to a second or inner position (not shown) further into the housing 23b. The pinion 68b has a spindle 76b, and the shaft 74b and the spindle 76b have corresponding teeth 75b, 77b. When the actuator 6 2b is operated, these corresponding teeth 75b, 77b interact to rotate the pinion 68b. The relative sizes of the outer diameters of the teeth 77b on the spindle 76b and the teeth 69b on the pinion 68b are set such that, for example, a relatively small displacement of the actuator 62b results in a larger displacement of the tubular member 20 and / or the support member 30 (or vice versa) to obtain the desired gain.

[0053] For example, similar to the above-described embodiment, the first rack 64b is connected to the pinion 68b, and when the actuator 62b is initially operated, the first rack 64b (and the tubular member 20) immediately recedes into the seat. The second rack 66b is not connected to the pinion 68b until a predetermined delay is reached, and the forward movement of the support member 30 can be caused after a delay of a desired time or distance after the tubular member 20 has receded. Alternatively, other delays or configurations can be provided to the deployment mechanism 60b as required, for example, delaying the retraction of the tubular member 20 by a predetermined time and / or advancing the support member 30 before the retraction of the tubular member 2 0 begins, which can be, for example, the actuation 0 Until the actuator 62b is partially pushed in, it can be achieved by providing a discontinuous region of teeth 69b on the pinion 68b that does not engage with the teeth 65b in the first rack 64b.

[0054] Referring to FIG. 5, this shows an exemplary embodiment of the housing 23c, which has a pinion 68c, a tubular member 20, and a first rack 64c and a second rack 66c connected to the proximal ends 22, 32 of the support members 30, substantially the same as in the above-described embodiment. An unfolding mechanism 60c is provided. The actuator 62c can have a lever that rotates or is guided from a first or distal position to a second or proximal position (not shown). The actuator 62c has a shaft 74c connected to the pinion 68c, and the rotation of the actuator 62c can rotate the pinion 68c. In some embodiments, one or more additional pinions can be connected between the pinion 68c and the racks 64c, 66c, for example, to produce a mechanical gain and / or an amplified translational movement of the racks 64c, 66c based on the distance when the lever 62c translates.

[0055] Similar to the above-described embodiment, the first rack 64c is connected to the pinion 68c so that the first rack 64c can immediately retract when the actuator 62c is initially operated. The second rack 66c is not connected to the pinion 68c until a predetermined delay, and the support member 30 can advance with a delay after the tubular member 20 retracts. As required, other delays or configurations can be provided for the unfolding mechanism 60c similar to other embodiments described herein.

[0056] Optionally, any of these deployment mechanisms 60 to 60c can have a functional feature portion that restricts the movement of the actuators 62 to 62c and / or the racks 64 to 64c, 66 to 66c. For example, for the embodiment of FIG. 2B (by way of example only), the first rack 64 and / or the track 70 can be provided with one or a plurality of ratchets or other one-way functional feature portions (not shown), and the first rack 64 can move freely in the proximal direction from the distal position to the proximal position and be prevented from moving in the distal direction. A similar functional feature portion can be connected to the actuator 62 and / or the pinion 68 so that the actuator 62 and / or the pinion 68 can move in only one direction. For example, the tubular member 20 can be retracted, but then cannot be advanced in the distal direction . In this way, after the tubular member 20 is retracted to at least partially expose the sealing material 2, the tubular member 20 can be prevented from advancing in the distal direction and returning onto the sealing material 2, otherwise the sealing material 2 will be clogged or damaged. Additionally or alternatively, one or a plurality of locking functional feature portions (not shown) can be provided on the positioning member 14 to restrict the movement of the tubular member 20 and / or the support member 30, for example, as described below . Optionally, any of the embodiments described herein can be provided with other desirable functional features in the housing 23. For example, as shown in FIG. 2B, a guide member 78 can be provided, and this guide member 78 can be sized to slidably receive the positioning member 14 such that the positioning member 14 passes through it . The guide member 78 can be the second rack 66 and / or the support portion . Optionally, one or a plurality of locking functional feature portions (not shown) can be provided on the positioning member 14 to, for example, restrict the movement of the tubular member 20 and / or the support member 30 as described below . .

[0057] Optionally, any of the embodiments described in this specification can be provided with other desirable functional features in the housing 23. For example, as shown in FIG. 2B, a guide member 78 can be provided, and this guide member 78 can be sized to slidably receive the positioning member 14 such that the positioning member 14 passes through it . The guide member 78 can be sized to slidably receive the positioning member 14 such that the positioning member 14 passes through it . The guide member 78 can be the second rack 66 and / or the support portion Aligned with the proximal end portion 32 of the material 30, the cartridge 10 accommodates the positioning member 14 so as to slide on the positioning member 14. Additionally or alternatively a spring mechanism 78a can be provided around the guide member 78 and / or connected between the deployment mechanism 60 and the positioning member 14. For example, a compression spring 78a is provided between a stop portion in the first rack 64 and the hub 48 in the positioning member 14 to facilitate handling of the positioning member 14 during treatment and / or enable it to be automatically retracted as described throughout this specification.

[0058] Additionally or alternatively, the housing 23 is provided with a sheath catch assembly within the shroud 23a, as in other embodiments described herein. Optionally, the housing 23 is provided with one or more return stops or other functional features (not shown) for connecting the cartridge 16 to the positioning member 14, for example, to releasably connect the housing 23 to the hub 48, as described in the incorporated reference patents and as shown in FIGS. 1A - 2A (see FIGS. 1A - 2A). Additionally or alternatively, the housing 23 has a trigger lock (not shown) that is connected to the deployment mechanism 60 and can prevent movement of the actuator 62 and / or the deployment mechanism 60 until the lock is released, as described below.

[0059] Referring to FIGS. 1A - 2A, the positioning member 14 is provided with an elongated member 40 having generally a proximal end portion 42, a distal end portion 4 4, and an occlusion or positioning element 46 at the distal end portion 44. The positioning element 46 is an expandable member, for example, a balloon, a wire mesh structure, an expandable film It can be used as a frame or the like. For example, as described in the reference patent documents incorporated herein, When in a contracted state, it can be sized to advance within the introducer. The positioning element 46 can be selectively expanded, for example, using a syringe, a tension wire and / or other actuator (not shown) that can be operated from the proximal end portion 42 of the positioning member 14. It can be made to expand.

[0060] For example, as shown in the figure, the positioning element is a balloon 46, and the positioning member 14 has a tubular body 40 that extends between a proximal end portion 42 and a distal end portion 44 and has a lumen (not shown) that communicates with the interior of the balloon 46. In some embodiments, the positioning member 14 has an inflation medium source such as a syringe 148, and this syringe 148 is communicated with the interior of the hub 48 by an inflation line 48c, or can be connected to the hub 48 at the proximal end portion 42 of the positioning member 14. Optionally, the positioning member 14 has an internal tension wire (not shown), and this internal tension wire can shorten the balloon 46 during inflation and stretch during contraction. Exemplary embodiments of the positioning member 14 having a balloon that can be used are described in U.S. Patent Application Publication Nos. 2004 / 0249342, 2004 / 026 7308, 2006 / 0253072, and 2008 / 0009794. The entire disclosures of these reference documents are incorporated herein by reference. It shall be so.

[0061] In some embodiments, the positioning element can be biased to be in an expanded state, but, for example, it is compressed by a covering sleeve or other restraint (not shown) or otherwise. can be contracted. When the restraint is removed to expose the positioning element, the expansion element can automatically expand to an expanded state. Further information regarding the expandable structure provided in the positioning member 14 is described in U.S. Patent Nos. 6,238,412, 6,635,068, and 6,890,343, and U.S. Patent Application Publication No. 2007 / 060950 (co-pending application No. 10 / 975,205 filed on October 27, 200 4). These reference documents are hereby incorporated by reference into this specification.

[0062] Additionally or alternatively, the positioning member 14 can be provided with one or more additional functional features that limit or facilitate the movement of the positioning member 14 relative to, for example, the cartridge 16 and / or other components of the device 10. For example, as shown in FIGS. 7A - 7C, the positioning member 14 is provided with a retraction lock 11 4 within the housing 23 (not shown for simplicity) to limit the movement of the positioning member 14 relative to the first rack 64. The retraction lock 11 4 is axially fixed to the tubular body 40 of the positioning member 14 and has an outer diameter larger than the opening 61 in the first rack 64. Otherwise, it would be possible to accommodate the positioning member 14 and / or the support member 30 (not shown) and axially move them relative to the first rack 64. For example, the retraction lock 114 can be an annular member attached to the outer surface of the tubular body 40, and this attachment can be performed by, for example, one or more of interference fitting, adhesive bonding, fusion, ultrasonic welding, etc.

[0063] The device 10 is provided with a retraction lock 114 arranged as shown in FIG. 7A. For example, the cartridge ​​​​​​​The edge 16 assumes the position shown in FIGS. 1A to 2A. In some embodiments, the relative lengths of the tubular body 40 of the positioning member 14 and the tubular member 20 of the cartridge 16 are such that the sealing material 2 (not shown, see FIG. 2A) is disposed immediately adjacent to the expandable member 46, i.e., throughout this specification and as described in the references incorporated herein by reference, such that the cartridge 16 need not be advanced during the procedure. In some embodiments, the relative lengths of the tubular body 40 of the positioning member 14 and the tubular member 20 of the cartridge 16 are such that the sealing material 2 (not shown, see FIG. 2A) is disposed immediately adjacent to the expandable member 46, i.e., throughout this specification and as described in the references incorporated herein by reference, such that the cartridge 16 need not be advanced during the procedure. In some embodiments, the relative lengths of the tubular body 40 of the positioning member 14 and the tubular member 20 of the cartridge 16 are such that the sealing material 2 (not shown, see FIG. 2A) is disposed immediately adjacent to the expandable member 46, i.e., throughout this specification and as described in the references incorporated herein by reference, such that the cartridge 16 need not be advanced during the procedure. In some embodiments, the relative lengths of the tubular body 40 of the positioning member 14 and the tubular member 20 of the cartridge 16 are such that the sealing material 2 (not shown, see FIG. 2A) is disposed immediately adjacent to the expandable member 46, i.e., throughout this specification and as described in the references incorporated herein by reference, such that the cartridge 16 need not be advanced during the procedure. In some embodiments, the relative lengths of the tubular body 40 of the positioning member 14 and the tubular member 20 of the cartridge 16 are such that the sealing material 2 (not shown, see FIG. 2A) is disposed immediately adjacent to the expandable member 46, i.e., throughout this specification and as described in the references incorporated herein by reference, such that the cartridge 16 need not be advanced during the procedure.

[0064] In some embodiments, the positioning member 14 cannot retreat in the proximal direction relative to the cartridge 16 when the retreat lock 4 abuts against the first rack 64 within the housing 23. Thus, the retreat lock 114 can prevent an undesired proximal movement of the positioning member 14, for example, during preparation or handling before sealing the puncture site using the device 10. In some embodiments, the positioning member 14 cannot retreat in the proximal direction relative to the cartridge 16 when the retreat lock 4 abuts against the first rack 64 within the housing 23. Thus, the retreat lock 114 can prevent an undesired proximal movement of the positioning member 14, for example, during preparation or handling before sealing the puncture site using the device 10. In some embodiments, the positioning member 14 cannot retreat in the proximal direction relative to the cartridge 16 when the retreat lock 4 abuts against the first rack 64 within the housing 23. Thus, the retreat lock 114 can prevent an undesired proximal movement of the positioning member 14, for example, during preparation or handling before sealing the puncture site using the device 10. In some embodiments, the positioning member 14 cannot retreat in the proximal direction relative to the cartridge 16 when the retreat lock 4 abuts against the first rack 64 within the housing 23. Thus, the retreat lock 114 can prevent an undesired proximal movement of the positioning member 14, for example, during preparation or handling before sealing the puncture site using the device 10. In some embodiments, the positioning member 14 cannot retreat in the proximal direction relative to the cartridge 16 when the retreat lock 4 abuts against the first rack 64 within the housing 23. Thus, the retreat lock 114 can prevent an undesired proximal movement of the positioning member 14, for example, during preparation or handling before sealing the puncture site using the device 10.

[0065] As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again. As shown in FIG. 7B, when the actuator 62 of the deployment mechanism 60 (not shown) is operated to retreat the first rack 64 (and the tubular member 20 not shown), the retreat lock 114 can be in a state of being separated from the first rack 64 by a distance 115A corresponding to the retreat. Thereafter, as described throughout this specification, when the positioning member 14 is retreated manually or automatically, for example, during the sealing procedure, the distance by which the positioning member 14 can retreat is limited to the distance 115B, i.e., as shown in FIG. 7C, the retreat lock 114 abuts against the first rack 64 again.

[0066] Additionally or alternatively, the positioning member 14 can be provided with an automatic retreat assembly 140, and the automatic retreat assembly 140 can be used to automatically retreat the positioning member 14 during use. Additionally or alternatively, the positioning member 14 can be provided with an automatic retreat assembly 140, and the automatic retreat assembly 140 can be used to automatically retreat the positioning member 14 during use. For example, Figures 6A and 6B show a positioning member 14' attached to or 1 shows an exemplary embodiment of an interlocking automatic retraction assembly 140, which includes a positioning member 14'. As generally described throughout this specification and in the references incorporated herein by reference. Alternatively, the features of the automatic retraction assembly 140 may be positioned It may be directly assembled to the hub 48' of the fixing member 14' (not shown).

[0067] Generally, the auto-retraction assembly 140 includes a housing 142 having a chamber 143 therein. A piston 144 is slidably disposed in the chamber 143. The chamber 143 is Between the piston 144 and the hub 48', for example, the piston 144 itself and / or other seals 146 may be provided. 44a, which can substantially seal the chamber and allow fluid and / or pressure to pass through the chamber substantially without leakage. The piston 144 can be inserted or extracted from the positioning member 14'. The tubular body 40' may be connected, for example, adjacent the proximal end 42' of the tubular body 40'. The connection may be, for example, one of an interference fit, adhesive bonding, fusion bonding, ultrasonic welding, etc. Or more.

[0068] Additionally, fluid / pressure line 146 communicates with chamber 143 and is similar to that shown in FIG. 1A. The expansion line 48c' can be connected to a syringe (not shown) of the same type, and the position The same syringe used to inflate and deflate the expandable member 46' of the support member 14'. The fluid / pressure line 146 has a flow control switch 146a and can be used The fluid / pressure lines 146 are selectively opened and closed during the The chamber 143 is made to communicate with the syringe only at that time.

[0069] Before use, the positioning member 14' can be provided with a piston 144 that takes the end-side position shown in FIG. 6A. As shown in the figure, at this position, the proximal end portion 42 of the tubular body 40 is substantially extended and / or in a straight state. To fix the piston 144 and the proximal end portion 42 in this state, the switch 146a is opened, and fluid is introduced into the chamber 143, and then the switch 146a is closed.

[0070] For example, after the sealing material 2 is deployed or exposed, it is desirable to retract the positioning member 14'. When this is the case, the expandable member 46 is contracted, and this contraction can be achieved, for example, by closing the switch 146a and extracting fluid through the expansion line 48c' similar to other embodiments. After the expansion member 46 has contracted, the switch 146a is opened, and for example, a syringe different from the one used to contract the same syringe or the expandable member 48 can be used to extract fluid from the chamber 143 via the fluid / pressure line 146. By this extraction, as shown in FIG. 6B, the piston 144 is slid within the housing 142 toward the hub 48' in the proximal end direction, thereby pulling the expandable member 46 in the proximal end direction and expanding it, and it can be passed through the sealing material 2 and the intermediate tubular member 20 (not shown) in the same process as shown in FIGS. 9A and 9B. When the piston 144 moves in the proximal end direction within the housing 142, the proximal end portion 42 of the tubular body 40 is also gathered and / or folded within the chamber 143 as shown in FIG. 6B. As shown in FIG. 6B, toward the hub 48' in the proximal end direction, thereby pulling the expandable member 46 in the proximal end direction and expanding it, and it can be passed through the sealing material 2 and the intermediate tubular member 20 (not shown) in the same process as shown in FIGS. 9A and 9B. When the piston 144 moves in the proximal end direction within the housing 142, the proximal end portion 42 of the tubular body 40 is also gathered and / or folded within the chamber 143 as shown in FIG. 6B. When the piston 144 moves in the proximal end direction within the housing 142, the proximal end portion 42 of the tubular body 40 is also gathered and / or folded within the chamber 143 as shown in FIG. 6B. When the piston 144 moves in the proximal end direction within the housing 142, the proximal end portion 42 of the tubular body 40 is also gathered and / or folded within the chamber 143 as shown in FIG. 6B.

[0071] In some embodiments, other automatic retraction features similar to the spring mechanism 78a shown in FIG. 2B The feature portion can be provided on the positioning member 14. For example, FIGS. 8A-8C illustrate a positioning member 214 and a cartridge 216 that are substantially similar to other embodiments described herein Another exemplary embodiment of an apparatus 210 having As shown, the positioning member 214 is a tubular body having a hub 248 at the proximal end 242 and a balloon 246 at the distal end 244 240. The cartridge 216 can have a tubular member 220 provided with a sealing material 2 and a support member 230, and a housing 233 provided with a deployment mechanism 260 similar to any of the other embodiments described herein In some embodiments, the relative lengths of the tubular body 24 0 and the tubular member 220 are such that the distal end 224 of the tubular member 220, and thus the sealing material 2, is disposed adjacent to the balloon 246, and thus the relative length is such that it eliminates the need to advance the cartridge 216 during use 0 and the tubular member 220 are such that the distal end 224 of the tubular member 220, and thus the sealing material 2, is disposed adjacent to the balloon 246, and thus the relative length is such that it eliminates the need to advance the cartridge 216 during use 0 and the tubular member 220 are such that the distal end 224 of the tubular member 220, and thus the sealing material 2, is disposed adjacent to the balloon 246, and thus the relative length is such that it eliminates the need to advance the cartridge 216 during use 0 and the tubular member 220 are such that the distal end 224 of the tubular member 220, and thus the sealing material 2, is disposed adjacent to the balloon 246, and thus the relative length is such that it eliminates the need to advance the cartridge 216 during use 0 and the tubular member 220 are such that the distal end 224 of the tubular member 220, and thus the sealing material 2, is disposed adjacent to the balloon 246, and thus the relative length is such that it eliminates the need to advance the cartridge 216 during use

[0072] The positioning member 214 can have a lock that selectively prevents the positioning member 214 from moving relative to the housing 223, and / or a biasing mechanism that automatically retracts the positioning member 214. For example, the lock can be a hydraulic lock, such as an expandable balloon or membrane 261 that surrounds the distal end located within the housing 223 of the hub 24 8. The interior of the membrane 261 can communicate with the inflation line 248c that communicates with the interior of the balloon 246, or can communicate with an individual inflation line (not shown) as desired 8. In some aspects, it can be extended and / or retracted when operated with a fluid 8. The interior of the membrane 261 can communicate with the inflation line 248c that communicates with the interior of the balloon 246, or can communicate with an individual inflation line (not shown) as desired 8. The interior of the membrane 261 can communicate with the inflation line 248c that communicates with the interior of the balloon 246, or can communicate with an individual inflation line (not shown) as desired 8. The interior of the membrane 261 can communicate with the inflation line 248c that communicates with the interior of the balloon 246, or can communicate with an individual inflation line (not shown) as desired 8. The interior of the membrane 261 can communicate with the inflation line 248c that communicates with the interior of the balloon 246, or can communicate with an individual inflation line (not shown) as desired A bellows structure (not shown) is provided to the hub 248. In some embodiments, a mechanical lock ( not shown) is provided to manually operate to lock and / or release the hub 248 from the housing 223, or the thin film 261 can be configured to engage an expandable detent or other functional feature between the hub 248 and the housing 223 as desired.

[0073] Initially, as shown in FIG. 8A, the thin film 261 can be contracted in the same manner as the balloon 246. When the balloon 246 expands, as shown in FIG. 8B, the fluid also expands the thin film 261, thus engaging the housing 223 and preventing subsequent axial movement of the positioning member 214 relative to the housing 223. When the balloon 246 is deflated as shown in FIG. 8C, the fluid is also extracted from inside the thin film 261, thus disengaging the positioning member 214 from the housing 223 and allowing subsequent retraction of the positioning member 214 relative to the housing 223, for example, passing the deflated balloon 246 into the sealant 2 and / or retracting it into the tubular member 220 as in other embodiments described herein. In some embodiments, the bellows lock can extend and / or retract to engage a detent or other functional feature between the hub 248 and the housing 223. In some embodiments, the mechanical lock can be individually engaged before or after the balloon 246 expands.

[0074] The housing 223 and the hub 248 cooperate with each other to automatically retract the positioning member 214 when the balloon 246 deflates or when the lock disengages. ​​It can be provided. For example, as shown in FIGS. 8A to 8C, a biasing mechanism having a spring 262 is connected between the first rack 264 (connected to the tubular member 220) of the deployment mechanism 260 and the hub 248 of the positioning member 214. It can be provided. For example, as shown in FIGS. 8A to 8C, a biasing mechanism having a spring 262 is connected between the first rack 264 (connected to the tubular member 220) of the deployment mechanism 260 and the hub 248 of the positioning member 214. It can be provided. For example, a compression spring 262 can be positioned around the end portion 242 of the tubular body 240 within the housing 223 of the cartridge 216. It can be provided. For example, a compression spring 262 can be positioned around the end portion 242 of the tubular body 240 within the housing 223 of the cartridge 216. As shown, the first end of the spring 262 can be connected to or around the proximal side extension 264a of the first rack 264, and the second end of the spring 262 can be connected to or around the end of the hub 248. As shown, the first end of the spring 262 can be connected to or around the proximal side extension 264a of the first rack 264, and the second end of the spring 262 can be connected to or around the end of the hub 248. In the initial configuration shown in FIG. 8A, the spring 262 is in a relaxed state or, optionally, a slightly compressed state, applying a bias in the distal direction to the first rack 264 within the housing 223. In the initial configuration shown in FIG. 8A, the spring 262 is in a relaxed state or, optionally, a slightly compressed state, applying a bias in the distal direction to the first rack 264 within the housing 223. In the initial configuration shown in FIG. 8A, the spring 262 is in a relaxed state or, optionally, a slightly compressed state, applying a bias in the distal direction to the first rack 264 within the housing 223.

[0075] During use, an actuator (not shown) of the deployment mechanism 260 is operated to guide the first rack 264 in the proximal direction, thereby retracting the end portion 224 of the tubular member 220 to expose the sealant 2, and further, as shown in FIG. 8B, similar to other embodiments described herein, the second rack 266 and the support member 230 are advanced. During use, an actuator (not shown) of the deployment mechanism 260 is operated to guide the first rack 264 in the proximal direction, thereby retracting the end portion 224 of the tubular member 220 to expose the sealant 2, and further, as shown in FIG. 8B, similar to other embodiments described herein, the second rack 266 and the support member 230 are advanced. During use, an actuator (not shown) of the deployment mechanism 260 is operated to guide the first rack 264 in the proximal direction, thereby retracting the end portion 224 of the tubular member 220 to expose the sealant 2, and further, as shown in FIG. 8B, similar to other embodiments described herein, the second rack 266 and the support member 230 are advanced. When the first rack 264 translates in the proximal direction within the housing 223, the first end of the spring 262 is guided in the proximal direction toward the second end. When the first rack 264 translates in the proximal direction within the housing 223, the first end of the spring 262 is guided in the proximal direction toward the second end. However, when the hydraulic lock 261 operates, the hub 248 of the positioning member 214 is restrained from moving in the proximal direction, and thus, as shown in FIG. 8B, the spring 262 can be compressed to a higher potential energy state. However, when the hydraulic lock 261 operates, the hub 248 of the positioning member 214 is restrained from moving in the proximal direction, and thus, as shown in FIG. 8B, the spring 262 can be compressed to a higher potential energy state. However, when the hydraulic lock 261 operates, the hub 248 of the positioning member 214 is restrained from moving in the proximal direction, and thus, as shown in FIG. 8B, the spring 262 can be compressed to a higher potential energy state.

[0076] Thereafter, when it is desired to contract and remove the balloon 246, fluid is introduced into the inflation line 2 Extract from 48c, thereby contracting both the balloon 246 and the thin film 261. Spring 2 Due to the potential energy stored in the spring 62, the hub 248 of the positioning member 214 is automatically guided in the proximal direction, and thus, as shown in FIG. 8C, the contracted balloon 246 is passed into the proximal sealing material 2 and retracted into the distal end portion 224 of the tubular member 220. The support member 230 remains substantially stationary during this operation, and thus can prevent the sealing material 2 from moving in the proximal direction when the balloon 246 retracts. Optionally, as shown in FIGS. 9A and 9B, the support tube 230 can have a stop or other functional feature 237 that engages the second rack 266 to prevent the support member 230 from retracting when the positioning member 214 retracts. Additionally or alternatively, the second rack 266 and / or other components of the deployment mechanism (not shown) can be provided with a brake or other functional feature that prevents the proximal movement of the second rack 266, for example, to prevent unwanted retraction of the support member 230.

[0077] Optionally, a bias mechanism can be provided with a delay function that delays the contraction of the thin film 261 for a predetermined time with respect to the contraction of the balloon 246, for example, so that the thin film 261 can contract after the balloon starts to contract or after the balloon is fully contracted. This delay allows the positioning member 214 to be released after the balloon 246 is almost contracted, and can ensure that the spring 262 automatically passes the balloon 246 into the sealing material 2 and retracts. For example, in some embodiments, a limiting function (not shown) can be provided in a hydraulic circuit that communicates from the inflation line 248c to the inside of the thin When extracting via the draw line 248c, the balloon 2 can extract fluid more rapidly than from the thin film 261. It can be extracted more rapidly from 46.

[0078] In some embodiments, the inflation fluid fed into the balloon 246 and the thin film 261 can be selected to facilitate the desired timing or delay in deflation. For example, orifices or other flow restrictors of different sizes can be provided at the flow path bifurcation from the inflation line 248c into the interior of the balloon 246 and the thin film 261 to supply a fluid having the desired viscosity and cause a delay in the fluid flow between the bifurcations. The inner diameter of the flow restrictor can be selected such that after the balloon 246 is fully deflated, the thin film 261 contracts and the positioning member 214 can pass through the sealing material 2 and retract into the support member 230.

[0079] In an exemplary embodiment, the viscosity of the fluid can be made significantly higher than that of water, for example, by mixing a radiopaque agent, which can also facilitate monitoring of the balloon 246 under fluoroscopy or other external imaging. In some embodiments, the mechanical lock can be simply disengaged at any time, and this disengagement can be caused, for example, after the balloon 246 has substantially deflated, thereby retracting the positioning member 214 and allowing the balloon 246 to be guided from within the sealing material 2 into the support member 230 as shown in FIGS. 8C and 9B.

[0080] Referring further to FIGS. 10A - 10C, using the apparatus 10 of FIGS. 1A - 2B (or any of the other embodiments described herein), within the puncture portion, for example, as described herein As described throughout, the sealant 2 is positioned and delivered immediately above or adjacent to another body lumen that communicates with the arterial incision or puncture of the blood vessel outside the blood vessel. In the embodiments shown in FIGS. 1A-2A, the cartridge 16 (along with the sealant 2 within the tubular member 20) can initially be provided at the proximal end 42 of the positioning member 14. For example, the hub 48 of the positioning member 14 and the housing 23 of the cartridge 16 can be initially connected to each other, and this connection can be made using, for example, one or more releasable detents (not shown). In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. As shown in FIGS. 10B and 10C, the cartridge 16 is slidable along the positioning member 14 in the distal direction, and this sliding can be achieved, for example, by detaching the housing 23 from the hub 48 and then advancing the cartridge 16, for example, until the distal end 24 of the tubular member 20 is adjacent to the positioning element 46. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, the hub 48 of the positioning member 14 and the housing 23 of the cartridge 16 are initially connected to each other, and this connection can be made using, for example, one or more releasable detents (not shown). In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference. In some embodiments, as shown in the embodiments of FIGS. 8A-8C (or the device 710 shown in FIGS. 16A-16D), the cartridge 216 can be provided such that the distal end 224 of the tubular member 220 is adjacent to the balloon 246, as described in, for example, U.S. Patent No. 7,335,220 and U.S. Patent Application Publication No. 2008 / 0082122, which are hereby incorporated by reference.

[0081] As shown in FIGS. 10B and 10C, the cartridge 16 is slidable along the positioning member 14 in the distal direction, and this sliding can be achieved, for example, by detaching the housing 23 from the hub 48 and then advancing the cartridge 16, for example, until the distal end 24 of the tubular member 20 is adjacent to the positioning element 46. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. For example, when the housing 23 is advanced away from the hub 48 with sufficient force, the detents in the housing 23 and the hub 48 can simply separate from each other. In some embodiments, one of the housing 23 and the hub 48 has an actuator or a lock. By operating the pusher or lock (not shown), the check valve is disengaged, or the cartridge 16 can be advanced relative to the positioning member 14.

[0082] Optionally, the cartridge 16 and / or the positioning member 14 can be provided with cooperating functional features that limit the endwise movement of the cartridge 16 relative to the positioning member 14. For example, the housing 23 of the cartridge 16 can be provided with a pocket, and the positioning member 14 can be provided with a check valve or other functional feature (both not shown) that is received

[0083] in the pocket when the cartridge 16 is advanced to the end position. Additionally or alternatively, one or more markers can be provided on the device 10, for example, to identify when a component takes one or more desired positions, or to facilitate the use of the device. For example, the positioning member 14 can be provided with one or more markers 43 at predetermined positions on the elongate member 40. According to these markers, when the cartridge 16 is

[0084] advanced to the desired end position, for example, it is possible to visually confirm when the marker 43 is exposed from the housing 23 as the cartridge 16 advances on the positioning member 14. Referring to FIGS. 10A-10G, for example, using the device of FIGS. 1A-2B (or In an embodiment, the puncture portion 90 can be a percutaneous puncture portion that communicates with a blood vessel 94 such as the femoral artery, carotid artery, etc. and the like.

[0085] In an exemplary method, the puncture portion 90 can be formed using known procedures, such as a needle, guide wire, one or more dilators, etc. (not shown). The introduction sheath 80 can be advanced from the puncture portion 90 into the blood vessel 94, for example, on a guide wire (not shown) that passes through the puncture portion 90 and is disposed in the blood vessel 94. The introduction sheath 80 allows one or more instruments (not shown) to access the blood vessel 94 and enables one or more diagnostic and / or interventional procedures, for example, performed via the blood vessel. When the procedure via the blood vessel is completed, such instruments are removed from the puncture portion 90, and the introduction sheath 80 remains extended into the blood vessel 94 through the puncture portion 90. and the like. and the like.

[0086] Referring to FIG. 10A, the positioning member 14 can be introduced into the lumen of the introduction sheath 80 and / or through this lumen, for example, by contracting an expandable positioning element 46. The cartridge 16 is provided at the proximal end portion 42 of the positioning member 40 together with the sealing material 2, for example, initially in a state where the actuator 62 is at the first end side position as shown in FIG. 2A. Therefore, the distal end portion 24 of the tubular member 20 is located outside the puncture portion 90 when advancing the positioning member 14 into the puncture portion 90. and the like. and the like. and the like.

[0087] Further referring to FIG. 10A, the distal end portion 44 of the positioning member 14 can pass through the puncture portion 90 (via the introduction sheath 80) and be inserted into the blood vessel 94. The sealing material 2 is shown in FIG. and the like. Similar to the cartridges 216 of FIGS. 8A - 8C, when constructing a cartridge to be disposed immediately adjacent to the positioning element, the distal end portion 224 of the tubular member 220 can also pass through the introduction sheath 80 and enter the blood vessel 94. Otherwise, as shown in FIGS. 10A and 10B, the distal end portion 24 of the tubular member 20 can remain outside the puncture portion 90. After the positioning element 46 is disposed within the blood vessel 94, that is, beyond the distal end portion 84 of the introduction sheath 80, the positioning element 46 can be expanded to an expanded state as shown. After the positioning element 46 is expanded, the positioning member 40 can be at least partially withdrawn, bringing the positioning element 46 into contact with the wall 96 of the blood vessel 94, for example, substantially sealing the blood vessel 94 from the puncture portion 90. In the exemplary method shown in FIGS. 10A and 10B, this involves a two - step process (although completed in a single, substantially continuous act). First, with the positioning element 46 expanded within the blood vessel 94, the positioning member 14 is withdrawn until the positioning element 46 contacts the distal end portion 84 of the introduction sheath 80. This contact provides the user with a first tactile feedback (i.e., a tactile sensation that the positioning element 46 has contacted the introduction sheath 80, based on, for example, an increased sense of weight and / or resistance to proximal movement). Next, the positioning member 14 can be withdrawn until a second tactile feedback is obtained as the positioning element 46 contacts the blood vessel wall 96, creating resistance to further withdrawal. The introduction sheath 80 is withdrawn in the proximal direction by the positioning element 46 when the positioning member 14 is withdrawn, until, for example, as shown in FIG. 10B, the distal end portion 84 of the introduction sheath 80 is withdrawn from the blood vessel 94 into the puncture portion 90.

[0088]

[0089] Apply and / or maintain a proximal tensile force on the positioning member 14 and hold the positioning element 46 against the blood vessel wall 96, for example, to seal the puncture portion 90 from the blood vessel 94 and / or prevent the positioning member 14 from disengaging further. Maintaining the proximal tensile force can be done manually or by a tension device (not shown), for example, to effect temporary hemostasis during the next step can be done. An exemplary tension device is described in U.S. Patent Application Publication No. 2004 / 02673 08.

[0090] Referring to FIG. 10C, the cartridge 16 (carrying the sealant 2) can then be advanced distally within the puncture portion 90 on the positioning member 14. As shown, the distal end 24 of the tubular member 20 enters the introduction sheath 80 and can also advance toward the positioning element 46. The cartridge 16 is advanced until a component of the cartridge 16 abuts against the stop of the positioning member 14, thereby preventing further advancement of the cartridge 16 and / or until the sealant 2 is spaced a predetermined distance from the positioning element 46 and / or can be advanced. Alternatively, the cartridge 16 is advanced within the introduction sheath 80 until the distal end 24 contacts the expanded positioning element 46 and a tactile feedback indicating that the cartridge 16 has advanced sufficiently is obtained, or until the sealant 2 is positioned within the puncture portion 90 and / or can be advanced. Optionally, when advancing the cartridge 16, the introduction sheath 80 can be coupled to the tubular member 20 in other embodiments described herein, or as described in U.S. Patent Application Publication No. 2009 / 0088793 (which is hereby incorporated by reference in its entirety). and / or can be advanced.

[0091] Optionally, when advancing the cartridge 16, the introduction sheath 80 can be coupled to the tubular member 20 in other embodiments described herein, or as described in U.S. Patent Application Publication No. 2009 / 0088793 (which is hereby incorporated by reference in its entirety). ​A sleeve or locking device (not shown) similar to the embodiment can be provided in the cartridge 16. This can be done. In some embodiments, the housing 23 of the cartridge 16 has one or more functional feature portions (not shown) that engage with the alignment functional feature portion (not shown) of the chassis hub 83. Similar to other embodiments described herein, for example, the movement of the tubular member 20 and / or other components in the cartridge 16 can be connected to the introduction sheath 80. This can be done. In some scenarios, when providing a cartridge such as the cartridge 216 of FIGS. 8A - 8C, having a sealing material 2 immediately adjacent to the distal end 224 of the tubular member 220 and the positioning element 246, the cartridge 216 is not advanced, but is simply introduced into the sheath 80 together with the positioning member 214. Therefore, before expanding the positioning element 246 and pulling out the entire device 210 to impact the positioning element 246 against the blood vessel wall 96, the distal end 224 of the tubular member 220 is merely slightly exposed within the blood vessel 94. In some aspects,

[0092] the sealing material 2 can be retracted slightly within the distal end 224. For example, if it is desirable to reduce the exposure of the sealing material 2 to body fluids, the sealing material 2 can be flush with the distal end 24, or as shown in FIG. 11 and as described throughout this specification, it can protrude slightly from the distal end 24. Optionally, in the embodiments of FIGS. 8A - 8C, the positioning member 214 and the cartridge 2 16 are advanced into the introduction sheath 80, and finally the marker (not shown) at the proximal end 222 of the tubular member 220 is aligned with the hub 83 of the introduction sheath 80. This alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element

[0093] Optionally, in the embodiments of FIGS. 8A - 8C, the positioning member 214 and the cartridge 2 16 are advanced into the introduction sheath 80, and finally the marker (not shown) at the proximal end 222 of the tubular member 220 is aligned with the hub 83 of the introduction sheath 80. This alignment causes the positioning element to be aligned with the hub 83 of the introduction sheath 80, and this alignment causes the positioning element The son 246 is disposed distally beyond the distal end 84 of the sheath 80, i.e., within the blood vessel 94. This gives a visual indication that it has been done. The positioning element 246 is expanded, and the positioning member 214 and the cartridge 216 are retracted to position the positioning element 246 against the vessel wall 96. After that, the sheath 80 is retracted by a desired distance to expose the distal end 224 of the tubular member 220 within the puncture portion 90 so that it can be optionally adjacent to the positioning element 246. Optionally, the tubular member 20 can be provided with another marker (not shown) that aligns with the hub 83 of the introduction sheath 80 when the sheath 80 is fully retracted.

[0094] Optionally, the cartridge 216 can be provided with, for example, a trigger lock (not shown) at the distal end of the housing 223, and the sheath 80 can be retracted until the hub 83 engages the trigger lock. Until the sheath 80 engages the trigger lock, the trigger lock prevents the actuator 262 of the deployment mechanism 260 from operating, and thus it is possible to prevent the unintentional deployment of the sealant 2.

[0095] In some embodiments, when the device 210 is advanced sufficiently within the sheath 80, the sheath 8 0 can be connected to the cartridge 216, for example, such that the movement of the sheath 80 can be coupled to the movement of the tubular member 2 20. The introduction sheath 80 preferably has a relative length with respect to the tubular member 220 such that the distal ends 84, 224 of the sheath 80 and the tubular member 220 are aligned with each other, for example, extending over substantially the same range as each other. In this case, when the tubular member 2 20 (and thus the sheath 80) is retracted, the sealant 2 can be exposed beyond the distal end 84 of the sheath 80. ​

[0096] Next, referring continuously to the device 10 of FIGS. 1A - 2B, FIG. 10D will be described. The actuator 62 is operated. For example, the actuator 62 is guided to a second proximal - side position, and thus the tubular member 20 (and when connected to the tubular member 20, or the introduction sheath 80 which has not yet been withdrawn) can be operated by starting its retreat relative to the positioning member 14, the sealing member 2, and the support member 30. For example, due to a delay provided in the deployment mechanism 60 (not shown, see, for example, FIG. 2B), until the sealing member 2 is largely exposed into the puncture portion 90 beyond the sheath end portion 84 as shown in FIGS. 10D and 10E, the support member 30 can prevent a large proximal - direction movement of the sealing member 2 and retreat the tubular member 20. When continuously guiding the actuator 62 towards the second position, the support member 30 starts to advance as shown in FIGS. 10E and 10 F, and thereby can press and compress the positioning element 46 with the expanded sealing member 2 and / or against the arteriotomy and the blood vessel wall 96. When the sealing member 2 is exposed into the puncture portion 90, the sealing member 2 is exposed to blood and / or other body fluids within the puncture portion 90. Due to this exposure, the sealing member 2 absorbs the body fluids and is activated to stop bleeding as described throughout this specification. When the sealing member 2 has a terminal - side section formed from an uncrosslinked precursor, the precursor cross - links and binds the sealing member 2 to the surrounding tissue, for example, to the outer surface of the blood vessel wall 96 and / or other tissues adjacent to the arteriotomy, or fills or penetrates the arteriotomy, for example, optionally penetrates into the interior of the blood vessel 94, resulting in enhancing the resulting sealing effect and / or restricting the movement of the proximal - side section of the sealing member 2, for example, the arteriotomy As shown in FIGS. 10E and 10 F, it can press and compress against the arteriotomy and the blood vessel wall 96.

[0097] When the sealing member 2 is exposed within the puncture portion 90, the sealing member 2 is exposed to blood and / or other body fluids in the puncture portion 90. By this exposure, the sealing member 2 absorbs the body fluids and is activated to stop bleeding as described throughout this specification. The sealing member 2 is formed from an uncrosslinked precursor having a terminal - side section. When the precursor cross - links, it binds the sealing member 2 to the surrounding tissue. For example, it binds to the outer surface of the blood vessel wall 96 and / or other tissues adjacent to the arteriotomy, or fills or penetrates the arteriotomy, for example, optionally penetrates into the interior of the blood vessel 94, resulting in enhancing the resulting sealing effect and / or restricting the movement of the proximal - side section of the sealing member 2, for example, the arteriotomy and / or the movement of the sealing member 2 in the proximal - side section, for example, the arteriotomy and fills or penetrates the arteriotomy, for example, optionally penetrates into the interior of the blood vessel 94, resulting in enhancing the resulting sealing effect and / or restricting the movement of the proximal - side section of the sealing member 2, for example, the arteriotomy It can prevent the movement away from the part and the blood vessel wall 96.

[0098] After a sufficient time has elapsed, the positioning element 46 is contracted, and the device 10 is withdrawn from the puncture part 90. Then, as shown in FIG. 10G, the sealing material 2 is left in the puncture part 90 and / or pressed against the blood vessel wall 96. Initially, the positioning member 14 can pass through the sealing material 2 and retract into the support member 30, for example, as shown in FIGS. 9A and 9B. Optionally, the positioning member 14 can be automatically retracted using an automatic retraction assembly (not shown) as described throughout this specification. In some embodiments, an actuator, such as a single button or a pair of opposing buttons (not shown), can be provided on the positioning member 14. The button is disposed on the hub 48, and this hub 48 can be attached to a table or other fixed surface on which the patient is placed during the procedure. When removing the positioning member 14 from the blood vessel 96 and the puncture part 90, it can be retracted so that the constricted balloon 46 passes through the compressed sealing material 2. Continuing the description with reference to FIGS. 9A and 9B, when the positioning member 214 retracts, the support member 30 remains substantially stationary as described throughout this specification. This prevents the sealing material 2 from being guided in the proximal direction away from the blood vessel wall 96 when the positioning member 46 passes through and is pulled within the sealing material 2. Optionally, the support member 30 can be further advanced to compress the sealing material 2 within the puncture part 90, for example. The support member 30 and other components of the device 10 that still protrude into the puncture part 90 are removed, and the sealing part

[0099] In some embodiments, an actuator, such as a single button or a pair of opposing buttons (not shown), can be provided on the positioning member 14. The button is disposed on the hub 48, and this hub 48 can be attached to a table or other fixed surface on which the patient is placed during the procedure. When removing the positioning member 14 from the blood vessel 96 and the puncture part 90, it can be retracted so that the constricted balloon 46 passes through the compressed sealing material 2.

[0100] Continuing the description of FIGS. 9A and 9B, when the positioning member 214 retracts, the support member 30 remains substantially stationary as described throughout this specification. This prevents the sealing material 2 from being guided in the proximal direction away from the blood vessel wall 96 when the positioning member 46 passes through and is pulled within the sealing material 2. Optionally, the support member 30 can be further advanced to compress the sealing material 2 within the puncture part 90, for example. The other components of the support member 30 and the device 10 that still protrude into the puncture part 90 are removed, and the sealing part 6 is prevented from moving away from the blood vessel wall. Optionally, the support member 30 can be further advanced to compress the sealing material 2 within the puncture part 90, for example. The support member 30 and other components of the device 10 that still protrude into the puncture part 90 are removed, and the sealing part 90 and other components of the device 10 that still protrude into the puncture part 90 are removed, and the sealing part The material 2 is placed within the puncture site and / or pressed against the blood vessel wall 94.

[0101] Referring now to FIG. 11, another embodiment of a device 310 for sealing a puncture in tissue is shown. Similar to the above-described embodiment, the device 310 includes a positioning member 314 and a positioning A cartridge 316 is carried on the member 314 to deliver the sealing material 2 into the puncture portion (not shown); The positioning member 314 has a tubular body 3 having a hub at a proximal end (not shown). 40 and a balloon 346 at a distal end 344. The cartridge 316 is sealed. The device has a tubular member 320 including the material 2 and a support member 330 within the tubular member 320. As in the embodiments A to 8C, the tubular body 340 of the tubular member 320 and the The relative length is the length at which the distal end 324 of the tubular member 320, and therefore the sealant 2, is attached to the balloon 346. The relative lengths can be such that they are positioned immediately adjacent to each other. It is not necessary to advance the entire cartridge 316 .

[0102] The tubular member 320 has a composite distal end 324 that is shaped differently from the adjacent distal end. The distal end segment 325 may be, for example, axially , a spiral direction, or a plurality of slots extending along at least a portion of the end segment 325. Additionally or alternatively, the end segment 325 may have a distal end or other weakened area (not shown). 322 may have a relatively thinner wall thickness than the adjacent end portion 324 and / or may expose the internal sealant 2. To be made of brittle material that can be easily split, folded, contracted, expanded or crushed to allow the can be done.

[0103] As shown in the illustration, the sealing material 2 can have a proximal side or main section 2a and a distal side or tip section 2b formed from an uncrosslinked precursor. The distal side section 2b can, for example, project at least partially from the distal segment 325 of the tubular member 320 as shown in FIG. 11. For example, the device 310 can be provided to the user with the distal side section 2b exposed, or the user can advance the support member 330 a predetermined distance using, for example, an actuator (both not shown) at the handle of the cartridge 316. When the distal side section 2b projects at least partially from the distal segment 325, the distal side section 2b can optionally be rounded or otherwise shaped, for example, to have a substantially non-invasive and / or tapered shape (not shown) that facilitates introduction into the introduction sheath and / or the puncture site. The device 310 can be introduced into the puncture site with, for example, the positioning element 346 in a contracted state from a pre-positioned introduction sheath (not shown), and the positioning element 346 and the distal segment 325 can be exposed beyond the introduction sheath within the puncture site and / or the blood vessel 94. The positioning element 346 can be expanded and guided to bear against the blood vessel wall 96 as shown in FIG. 11, and, as in other embodiments of this specification, the introduction sheath can be withdrawn if it is necessary to expose the distal segment 325. Crosslinking begins with the distal side section 2b of the sealing material 2 partially exposed, and, as in other embodiments of this specification, the sealing material 2 seals the arteriotomy, the blood vessel wall 94, and / or

[0104] The device 310 can be introduced into the puncture site with, for example, the positioning element 346 in a contracted state from a pre-positioned introduction sheath (not shown), and the positioning element 346 and the distal segment 325 can be exposed beyond the introduction sheath within the puncture site and / or the blood vessel 94. The positioning element 346 can be expanded and guided to bear against the blood vessel wall 96 as shown in FIG. 11, and, as in other embodiments of this specification, the introduction sheath can be withdrawn if it is necessary to expose the distal segment 325. Crosslinking begins with the distal side section 2b of the sealing material 2 partially exposed, and, as in other embodiments of this specification, the sealing material 2 seals the arteriotomy, the blood vessel wall 94, and / or The positioning element 346 can be expanded and guided to bear against the blood vessel wall 96 as shown in FIG. 11, and, as in other embodiments of this specification, the introduction sheath can be withdrawn if it is necessary to expose the distal segment 325. If it is necessary to expose the distal segment 325, the introduction sheath can be withdrawn.

[0105] Crosslinking begins with the distal side section 2b of the sealing material 2 partially exposed, and, as in other embodiments of this specification, the sealing material 2 seals the arteriotomy, the blood vessel wall 94, and / or and, as in other embodiments of this specification, the sealing material 2 seals the arteriotomy, the blood vessel wall 94, and / or Or it can bond with the surrounding tissue. Then, the support member 330 is advanced to seal. 3, the sealing material 2 is pressed against the vessel wall 96 and / or the positioning element 346, whereby the sealing material 2 is compressed. When the distal segment 325 of the tubular member 320 is pulled outward, the distal segment 325 is subjected to an outward expansion force. The distal segment 325 is split, folded, contracted or crushed to expose the sealant 2 within the puncture. The positioning element 346 can be contracted (e.g., by any of the methods described herein). 3, the device 310 is removed from the puncture site (using any of the devices and methods described herein). The connection of the distal section 2b to the vessel wall 96 is similar to the other embodiments of the device. This can prevent the sealing material 2 from becoming entangled and / or coming off when the sealing material 310 is removed.

[0106] Thus, the end segment 325 forms a skirt or cover over the encapsulant 2, 2. The support member 330 and the position The sealant 2 is exposed without having to be retracted against the determining element 346 and / or the vessel wall 96. The device can be opened to allow for easy access.

[0107] Referring now to FIG. 12, another exemplary embodiment of a device for sealing a puncture in tissue is shown. 4 shows a device 410. Similar to the above-described embodiment, the device 410 includes a positioning member 414 and The sealing material 2 in the positioning member is fed into the puncture portion (not shown). The cartridge 416 may have a sealant therein. Alternatively, the tubular member carrying the support member may be omitted. The ridge 416 supports the encapsulant 2 therein and is connected to the end of the support member 430 adjacent the encapsulant 2. A sealing material sleeve 450 surrounding the end portion 434 and a handle or hub 423 at the proximal end portion 432 of the support member 430 can be provided. As shown, the cartridge 416 can initially be provided adjacent to the hub 448 of the positioning member 414. As an alternative, the cartridge 416 can be provided such that initially the sealing material sleeve 450 and the sealing material 2 are disposed immediately adjacent to the positioning element 446 of the positioning member 414, which is similar to the device 710 shown in FIGS. 16A - 16D and described throughout this specification. That's all.

[0108] As clearly shown in FIG. 12A, the sleeve 450 has a relatively large diameter and abuts or contacts the hub or proximal end portion 83 of the introduction sheath 80 ( not shown, but see, for example, FIGS. 13A - 13C). The proximal end portion 452 has a relatively small diameter and is sized to enter the hub 83 and / or lumen of the introduction sheath 80. For example, the hub 83 of the introduction sheath can have one or more valves, such as hemostatic valves, provided therein, and the distal end portion 454 of the sleeve is sized to enter the hub 83 and at least partially open the valve when advancing the cartridge 416, for example, as described below, facilitating entry of the sealing material 2 and / or the support member 430 into the lumen of the introduction sheath. The sleeve 450 can have a length that is relatively short compared to the support member 430. For example, the sleeve 450 can be slidable in the proximal direction over a desired distance on the support member 430. For example, the sleeve 450 can be from about 5 millimeters to 40 millimeters (5 - 40 mm). As described below, it can facilitate the entry of the sealing material 2 and / or the support member 430 into the lumen of the introduction sheath. That's all.

[0109] The sleeve 450 can have a length that is relatively short compared to the support member 430. For example, the sleeve 450 can be slidable in the proximal direction over a desired distance on the support member 430. For example, the sleeve 450 can be from about 5 millimeters to 40 millimeters (5 - 40 mm). , having an overall length of about 10 to 24 millimeters (10 - 24 mm), and the distal end portion 454 For example, having a length of about 3 to 20 millimeters (3 - 20 mm), about 12 to 24 millimeters (12 - 24 mm), about 15 to 18 millimeters (15 - 18 mm), etc., and can be of a length sufficient to substantially cover the sealing material 2.

[0110] Optionally, the sleeve 450 has an internal lumen 456, and this internal lumen 456 is configured to create differential and / or different frictional interference with respect to the outer surface of the support member 430 and can be made to create differential and / or different frictional interference with respect to the outer surface of the support member 430. For example, the internal lumen 456 can be such that the sleeve 450 can slide freely in the proximal direction with respect to the support member 430 and create increased friction that resists movement of the sleeve 450 in the distal direction on the support member 430. Additionally or alternatively, the sleeve 450 is releasably attached to the distal end portion 434 of the support member 430. For example, this attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath. and can be made to create increased friction that resists movement of the sleeve 450 in the distal direction on the support member 430. Additionally or alternatively, the sleeve 450 is releasably attached to the distal end portion 434 of the support member 430. For example, this attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath. the sleeve 450 is releasably attached to the distal end portion 434 of the support member 430. For example, this attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath. the sleeve 450 is releasably attached to the distal end portion 434 of the support member 430. For example, this attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath. attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath. attachment can be made using an adhesive or the like with a low bonding force that can be overcome for release or coupling when advancing the cartridge 416 into the introduction sheath.

[0111] In an exemplary embodiment, the sleeve 450 can be formed from an outer annular body and a tubular section (not shown) that is at least partially received within this annular body. In some aspects, the sleeve 450 can be integrally formed as a single piece, for example, by molding, machining, casting, etc. The components of the sleeve 450 can be formed from the same or different materials, such as plastic, metal, or composite materials. Exemplary materials and methods for forming the sleeve 450 are described in U.S. Patent No. 7,993,367 (incorporated by reference) materials, such as plastic, metal, or composite materials. Exemplary materials and methods for forming the sleeve 450 are described in U.S. Patent No. 7,993,367 (incorporated by reference) materials, such as plastic, metal, or composite materials. Exemplary materials and methods for forming the sleeve 450 are described in U.S. Patent No. 7,993,367 (incorporated by reference) materials, such as plastic, metal, or composite materials. Exemplary materials and methods for forming the sleeve 450 are described in U.S. Patent No. 7,993,367 (incorporated by reference) (which is incorporated herein by reference in its entirety) is described herein.

[0112] Referring to FIGS. 13A-13C, the device 410 is used, for example, throughout this specification As described elsewhere herein, the sealant 2 can be positioned and delivered into the puncture portion 90 such that it is immediately above or adjacent to the arteriotomy in the blood vessel or other body lumen 94 from outside the blood vessel. As shown in FIG. 13A, the cartridge 416 is initially provided at the proximal end 442 of the positioning member 414, together with a sleeve 450 that is located on the distal end portion 434 of the sealant 2 and the support member 430. For example, the hub 448 on the positioning member 414 and the housing 423 on the cartridge 41 6 can be initially connected to each other using, for example, one or more releasable detents (not shown). As shown in FIG. 13B, the cartridge 41 6 can be slid distally along the positioning member 414, and this sliding is performed, for example, by disengaging the housing 423 from the hub 448 and then advancing the cartridge 416 towards the positioning element 446. Continuing to refer to FIGS. 13A-13C, the device 40 is generally used in cooperation with the introducer sheath 80 to deliver the sealant 2 into the puncture portion 90. The introducer sheath 80 can be part of a system or kit that includes the device 41

[0113] 0, or can be an independent device. Generally, the introducer sheath 80 has a proximal end 82, a distal end 84 sized to be inserted into the puncture portion 90 in the tissue, and a lumen 86 that extends between the proximal end 82 and the distal end 84. The introducer sheath 80 is formed from a generally rigid, semi-rigid, and / or flexible tubular body, and the proximal end 82 ​​​​​has a hub 83. The introducer sheath 80 extends from the patient's skin through intervening tissue to a blood vessel or other body lumen and has a sufficient length, for example, a length of about 10 centimeters to 20 centi meters (10 - 20 cm), and can also have an outer diameter of about 1.6 millimeters to 5 millime ters (1.6 - 5 mm). The distal end 84 can be provided with a substantially non-invasive distal tip that tapers and / or facilitates advancement into the puncture site.

[0114] The introducer sheath 80 can be formed, for example, of plastic, using known materials and / or methods, and the tubular body and hub 83 can be connected to each other substantially permanently, for example, by interference fit, one or more integral connectors (not shown), adhesive bonding, ultrasonic welding, etc. The hub 83 can be provided with generally one or more seals, for example, one or more hemostatic seals (not shown), which prevent blood or other body fluids from flowing out of the hub 83, but allow one or more devices such as the positioning member 414 and / or the cartridge 416 to be inserted and accommodated within the lumen 86. Optionally, as shown, the hub 83 can have a side port 89 that communicates with the lumen 86 and is for connection to a source of saline or other liquid (not shown). Initially, as shown in FIG. 13A, the positioning member 414 can be introduced into the lumen 86 of the introducer sheath 80 and / or through the lumen 86, for example, with the expandable positioning element 446 in a contracted state. The cartridge 416, together with the sealant 2 and the support member

[0115] 430, is initially, for example, as shown in FIG. 12, at the proximal end of the positioning member 440 within and / or via the lumen 86 of the introducer sheath 80, for example, with the expandable positioning element 446 in a contracted state. The cartridge 416, together with the sealant 2 and the support member 430, is initially, for example, as shown in FIG. 12, at the proximal end of the positioning member 440​​ 442 can be provided. Therefore, the distal end portion 454 of the sleeve 450 is initially spaced apart from the hub 83 outside the piercing portion 90 when advancing the positioning member 414 into the piercing portion 90. It can be arranged.

[0116] Furthermore, referring to FIG. 13A, the distal end portion 444 of the positioning member 414 can be inserted into the blood vessel 94 (via the introduction sheath 80) from the piercing portion 90. After the positioning element 446 is disposed within the blood vessel 94, that is, after being disposed beyond the distal end portion 84 of the introduction sheath 80 , the positioning element 446 is expanded to an expanded state and at least partially withdrawn until the positioning element 446 touches the blood vessel wall 96, which is the same as in other embodiments described herein .

[0117] Referring to FIGS. 13B and 13C, the cartridge 416 (carrying the sealing material 2) can be advanced distally toward the introduction sheath 80 on the positioning member 414. When the cartridge 416 advances, the sleeve 450 contacts the introduction sheath 80, thereby preventing the sleeve 450 from advancing further. For example, the distal end portion 4 54 of the sleeve 450 enters at least partially into the hub 83 of the introduction sheath 80, and the proximal side portion 452 of the sleeve 450 impacts the hub 83 as shown in FIG. 13C, thereby preventing further advancement of the sleeve 450. When the sleeve 450 is releasably attached to the support member 430 , advancing the cartridge 416 to this point can release the sleeve 450 from the distal end portion 434 of the support member 430.

[0118] ​​​​​The cartridge 416 can be further moved toward the positioning member 446 in the distal direction, and at this time, the sleeve 450 remains substantially stationary with respect to the introduction sheath 80 and can be slid proximally on the rear support member 430. Thereby, the distal end portion 434 of the support member 430 escapes from the distal side portion 454 of the sleeve 450 and enters the lumen 86 of the introduction sheath, so that, as shown in FIG. 13C, the sealing material 2 can be released from the sleeve 450 into the lumen 86 of the sheath. The distal side portion 454 of the sleeve 450 can have a sufficient length and / or have other functional features that at least partially open a valve (not shown) in the hub 83 of the introduction sheath. For example, it facilitates introducing the sealing material 2 and the distal end portion 434 of the support member 430 into the lumen 86 of the introduction sheath. In this way, the sleeve 450 protects the sealing material 2 until the sealing material 2 passes through the hub 83 and any valve within the hub and enters the lumen of the introduction sheath 80. After that, the cartridge 416 is advanced until the sealing material 2 is disposed adjacent to the positioning element 446 and / or the blood vessel 94, and the sealing material 2 is guided through the lumen 86 of the sheath. Optionally, the cartridge 416 is advanced until the components of the cartridge 416 abut against the stop portion of the positioning member 414, thereby preventing further advancement of the cartridge 416 and / or separating the sealing material 2 from the positioning element 446 by a predetermined distance, for example, approximately zero to 5 millimeters (0 - 5 mm). In some embodiments, the cartridge 416 can be advanced until the sealing material 2 contacts the positioning element 446 and / or the blood vessel 94 and resistance is detected.

[0119] ​​​​​​​​​​​​​​​​​

[0120] Thereafter, the introduction sheath 80 can be at least partially retracted so that the distal end portion 84 of the introduction sheath extends beyond and the sealing material 2 can be exposed into the puncture portion 90. Optionally, one or more locking elements (not shown) for connecting the introduction sheath 80 to the sleeve 450 can be provided on the sleeve 450. Thereby, when the user pulls the sleeve 450 in the proximal direction instead of the introduction sheath 80, the introduction sheath 80 and the sleeve 450 can be pulled out together so that the distal end portion 84 of the introduction sheath 80 can be retracted. When the introduction sheath 80 is retracted, the support member 430 substantially prevents the sealing material 2 from moving in the proximal direction, and thus the sealing material 2 can be exposed into the puncture portion 90. When the sealing material 2 is exposed within the puncture portion 90, the sealing material 2 is exposed to blood and / or other body fluids within the puncture portion 90. Due to this exposure, the sealing material 2 absorbs the body fluid and / or expands within the puncture portion 90, for example, causing hemostasis. Optionally, after the sealing material 2 is exposed within the puncture portion 90, the support member 430 can be advanced to compress or tamp (pack) the sealing material 2 against, for example, the positioning element 446. Optionally, one or more markers (not shown) can be provided on the support member 430, for example, at or near the proximal end portion 432, and the support member 430 can be advanced by a desired distance within the puncture portion 90, and this desired distance can be confirmed by monitoring the marker. Additionally or alternatively, the positioning member 414 can be provided with a detent or other functional feature that allows the support member 430 to pass when advanced a predetermined distance. The detent is

[0121]

[0122] ​​​​​​​​​​​​​​Auditory confirmation of the forward movement of the holding member 430 by a predetermined distance can be provided (added to the visual confirmation by the marker or, as an alternative).

[0123] The sealing material 2 is exposed by the support member 430 for a sufficient time and / or tamped After that, the positioning element 446 is contracted, and the positioning member 414 is withdrawn from the blood vessel 94 and the puncture portion 9 0, and for example, the contracted positioning element 446 can be pulled so as to pass through the sealing material 2 and within the support member 430. The support member 430 can be maintained substantially stationary during the withdrawal of the positioning member 414, for example, preventing movement and / or peeling within the puncture portion 90 of the sealing material 2. Optionally, the cartridge 416 can be provided with an automatic retraction assembly that automatically retracts the positioning member 414, similar to the other embodiments described herein. After completely removing the positioning member 414, the support member 430 can be removed from the puncture portion 90, and the sealing material 2 can be left within the puncture portion 90.

[0124] Referring to FIGS. 16A - 16D, an apparatus 710, which is another embodiment, is described. This apparatus 7 10 generally has a positioning member 714 and a cartridge 716 that carries the internal sealing material 2 on this positioning member 714 and delivers it to a puncture portion (not shown). Similar to the apparatus 410 of FIG. 12, the cartridge 716 carries the sealing material 2 and also has a sealing material sleeve 750 that surrounds the distal end portion 734 of the support member 430 adjacent to the sealing material 2, and a handle or hub 723 at the proximal end portion 732 of the support member 730. The sealing material sleeve 750 has a relatively large diameter and surrounds the distal end portion 734 of the support member 730. For example, as shown in FIG. 16D, an introduction ​​​A proximal end portion 752 sized to abut or contact the hub or proximal end 783 of the sheath 780 and a relatively small diameter, surrounding the sealant 2, e.g., sized to enter the hub 783 and / or lumen 786 of the introduction sheath 780. The hub 783 can have a cavity for releasably receiving this small diameter portion of the sealant sleeve. Unlike the device 410, the cartridge 716 can be initially provided such that the sealant sleeve 750 and the sealant 2 are disposed immediately adjacent to the positioning element 746 of the positioning member 714.

[0125] The handle 723 can have an outer housing or shroud 772 surrounding the inner housing or frame 774 and one or more actuators 760 - 764, allowing one or more components of the device 710 to move relative to each other as described below. As shown, the outer housing 772 can have a first opening or slot 773 with the first actuator 760 and the second actuator 762 provided therein, and a second slot 775 with the third actuator 764 provided therein. The opening 773 can have one or more functional features that interact with the first and / or second actuators 760, 762 as described below.

[0126] The inner housing 774 is axially slidable relative to the outer housing 772, e.g., between an initial position, a proximal end position, and a distal end position. For example, the outer housing 772 can be attached around the inner housing 774, a two - shell - like half or ​​It has other components, and by means of rails or grooves (not shown) that cooperate therewith, the inner housing 774 can slide axially without large lateral movement. In an exemplary embodiment, one or more elongated ribs or rails (not shown) that can be slidably received between the rails or grooves (also not shown) in the inner housing 774 are formed or otherwise provided on the inner surface of the outer housing 772.

[0127] The handle 723 can be integrally formed with the outer housing 772 or have a terminal shroud 776 protruding from the outer housing 772. One or more retaining means or other functional features, such as a pair of fork-shaped teeth 778, are provided on the shroud 776 so that the hub 723 can engage a guide sheath such as the sheath 780 shown in FIG. 16D. For example, the sheath 780 has a hub 783, and this hub 783 has a pair of axially extending pockets 783a along opposite side surfaces of the hub 783. The fork-shaped teeth 778 have tabs or retaining means 778a that slide and are received within the pockets 783a, for example, when the device 710 is introduced into the sheath 780 as described below. The relative lengths of the fork-shaped teeth 778 and the pockets 783a are configured such that the retaining means 778a passes through the pockets 783a and protrudes from its end. The retaining means 778a is provided with an inclined or tapered end edge to facilitate insertion and a smooth base edge that engages the end of the pocket 783a to prevent the fork-shaped teeth 778 from slipping back out of the pockets 783a, and thus, as described below, enable the sheath 780 and the outer housing 723 of the hub 723 to be interlocked.

[0128] As shown in FIG. 16C, the apparatus 710 can have a rack and pinion configuration similar to any of the other embodiments described herein. For example, as shown, a rack 766 can be coupled to the proximal end 732 of the support member 730 and slidably received within the outer housing 772 and / or inner housing 774. The pinion 768 is rotatably mounted relative to the inner housing 774 and coupled to the rack 766, for example, in a similar manner as in other embodiments herein, by interlocking teeth 766a, 768a. A second or support actuator 762, such as a button, rotatably coupled to the inner housing 774 is coupled to the pinion 768 by interlocking teeth 762a, 768a to selectively rotate the pinion 768. For example, as described below, pushing in the second actuator 762 rotates the pinion 768 and thus advances the rack 766 in the distal direction, thereby advancing the support member 730. Optionally, as shown, a first or lock actuator 760 is provided on the hub 723 to prevent relative movement of the outer and / or inner housings 772, 774 until the support member 730 moves and / or reaches a limit of travel. For example, as shown explicitly in FIG. 16C, the lock actuator 760 can be rotatably mounted to the inner housing 774 and has a distal end 760a that abuts or engages the distal edge 773b of the opening 773 in the outer housing 772. As a result, the inner housing 774 is substantially fixed in a proximal position, and operating the lock actuator 760 moves the distal end 760a of the actuator 760 to allow relative movement between the outer and inner housings 772, 774. For example, as described below, pushing in the second actuator 762 rotates the pinion 768 and thus advances the rack 766 in the distal direction, thereby advancing the support member 730. Advancing the support member 730 in this manner can cause the support member 730 to move relative to the outer and / or inner housings 772, 774.

[0129] Optionally, as shown, a first or lock actuator 760 is provided on the hub 723 to prevent relative movement of the outer and / or inner housings 772, 774 until the support member 730 moves and / or reaches a limit of travel. For example, as shown explicitly in FIG. 16C, the lock actuator 760 can be rotatably mounted to the inner housing 774 and has a distal end 760a that abuts or engages the distal edge 773b of the opening 773 in the outer housing 772. As a result, the inner housing 774 is substantially fixed in a proximal position, and operating the lock actuator 760 moves the distal end 760a of the actuator 760 to allow relative movement between the outer and inner housings 772, 774. For example, as shown explicitly in FIG. 16C, the lock actuator 760 can be rotatably mounted to the inner housing 774 and has a distal end 760a that abuts or engages the distal edge 773b of the opening 773 in the outer housing 772. As a result, the inner housing 774 is substantially fixed in a proximal position, and operating the lock actuator 760 moves the distal end 760a of the actuator 760 7. The distal end position cannot be reached until the distal end edge 773b of the opening 773 is released. stomach.

[0130] Additionally or alternatively, the first actuator 760 may be configured to rotate the support member 730 relative to the inner housing. 774. A detent or other locking feature 760b for selectively locking against the For example, as shown in FIG. 16C, detent 760b is attached to first actuator 760. The first actuator 760 extends inwardly from the first actuator 760 and does not engage any other functional features. When the actuator 760 is operated, that is, when the actuator 760 is guided inward, the distal end 760a of the actuator 760 is guided inward to the outer hub. When disengaged from the distal edge 773b of the housing 772, the detent 760b engages the inner housing 772. As described in more detail herein, the inner and outer After the housing portions 774 and 772 on the side are allowed to move relative to each other, the handle 723 is moved in the proximal direction. 780, retracting the outer sheath 780 and exposing the sealant.

[0131] When the support actuator 762 is subsequently operated, the end portion 766b of the rack 766 passes under detent 760b, which in turn moves into a pocket (not shown). The rack 766 advances against the support member 730 to apply the sealant to the arteriotomy until it is captured. With the detent 760b captured in the pocket, The rack 766 cannot be guided in the proximal direction, and therefore the Proximal movement of support member 730 may be prevented.

[0132] The device 710 may further include a third or balloon retraction actuator 764, e.g. , similar to other embodiments in this specification, after the sealing material is deployed, the positioning element 74 6 can be passed through the sealing material 2 and retracted. For example, as shown in FIG. 16C , the third actuator 764 can be slidably attached to the inner housing 774 and selectively connected to the hub 748 of the positioning member 714. The hub 748 can be configured and / or operate in the same manner as other embodiments in this specification or reference documents incorporated herein.

[0133] Initially, the third actuator 764 is connected to the inner housing 774, but after the sealing material 2 is deployed and / or tamped, it can be separated from the inner housing 774 . For example, as clearly shown in FIG. 16C, the third actuator 764 has a third arm 764c that can be separated from the inner housing 7 74. By moving the third actuator 764 in the proximal direction with respect to the outer and / or inner housings 772, 774, the hub 748 can be similarly moved in the proximal direction, thereby guiding the positioning element 746 in the proximal direction in the same manner as other embodiments in this specification.

[0134] Further, the third actuator 764 can be provided with a second arm 764b that is slidably positioned adjacent to the proximal end portion 766c of the rack 766. When the second arm 764b is positioned in this way, the third arm 764c can remain connected to the hub 748. When the rack 766 is guided in the distal direction, for example, by operating the second actuator 762, the second arm 764b can slide away from the proximal end portion 766c of the rack 766, whereby the third arm 764c can be separated from the inner housing 7 74. 74, for example as shown, with a spring or other biasing mechanism. 764a is provided on the third actuator 764 (or optionally on the outer housing 772), The rack 766 is guided in the distal direction so that the second arm 764b is guided from the proximal end 766c of the rack 766. When the second arm 764b is released from the first arm 764, the second arm 764b is biased outward. The biasing mechanism 764a is configured to separate the third arm 764c from the inner housing. 7, which requires the actuator to be depressed to prevent accidental movement of the positioning element 746. After this, the third actuator 764 is guided in the proximal direction, and the hand The head 748 and the positioning element 746 can be retracted.

[0135] The device 710 may be used to measure the temperature of a patient's body, as well as other embodiments herein. The sealant 2 can be delivered into the puncture that communicates with the body lumen. The illustrated introducer sheath 780 is used to guide the catheter from the puncture to the body lumen, as described elsewhere herein. The device can be positioned within the structure.

[0136] Optionally, the introducer sheath 780 may include, for example, a dilator 790 and a guidewire 799 and / or Or it can be provided as part of an introduction kit that includes a system that also includes the device 710. The stretcher 790 has a proximal end 792 and is slidably received within the lumen 786 of the introducer sheath 780. The distal end 794 can have a size that is suitable for use with a guidewire, for example. 799 to introduce the dilator 790 and the introducer sheath 780 into the puncture site (not shown). terminating as a tapered, less invasive and / or other distal tip to facilitate is achievable. As shown in the figure, the dilator 790 has a proximal housing 796, and this proximal housing 796 can have fork-shaped teeth 79 8 and a detent 798a similar in configuration to the distal shroud 776 of the device 710. The dilator 790 is introduced into the hub 783 and lumen 786 of the introducer sheath 780, and finally the fork-shaped teeth 798 enter the passage 783a in the hub 783, and the detent 798a reaches the point of exiting from the passage 783a. In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire

[0137] (not shown, but as described throughout this specification, is disposed within the body lumen through the puncture portion) is loaded into the distal end portion 794 and lumen 796 of the dilator 790, and the dilator 790 and the introducer sheath 780 can be introduced into the puncture portion. After positioning the introducer sheath 780 at the desired position, the fork-shaped teeth 798 are constricted inward to disengage the detent 798a from the pocket 783a, and the dilator 790 can be withdrawn from the lumen 786 of the introducer sheath 780. Next, using the introducer sheath 780, as described throughout this specification, access to the body lumen can be obtained and one or more procedures can be performed. (not shown, but as described throughout this specification, is disposed within the body lumen through the puncture portion) is loaded into the distal end portion 794 and lumen 796 of the dilator 790, and the dilator 790 and the introducer sheath 780 can be introduced into the puncture portion. After positioning the introducer sheath 780 at the desired position, the fork-shaped teeth 798 are constricted inward to disengage the detent 798a from the pocket 783a, and the dilator 790 can be withdrawn from the lumen 786 of the introducer sheath 780. Next, using the introducer sheath 780, as described throughout this specification, access to the body lumen can be obtained and one or more procedures can be performed. In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire In this way, the dilator 790 and the introducer sheath 780 are connected to each other, and a guide wire

[0138] When it is desirable to seal the puncture portion, any instrument to be introduced into the introducer sheath 780 is removed, and for example, as shown in FIGS. 16A and 16B, the device 710 can be prepared. With the positioning element 746 in a contracted state, the distal end portion 744 of the positioning member 714 can be introduced into the hub 783 of the introducer sheath 780 and into the body lumen through the lumen 786. With the positioning element 746 in a contracted state, the distal end portion 744 of the positioning member 714 can be introduced into the hub 783 of the introducer sheath 780 and into the body lumen through the lumen 786. With the positioning element 746 in a contracted state, the distal end portion 744 of the positioning member 714 can be introduced into the hub 783 of the introducer sheath 780 and into the body lumen through the lumen 786. The sealant sleeve 750 and the sealant 2 are disposed immediately adjacent to the positioning element 746. Therefore, when introducing the distal end portion 744 into the introducer sheath 780, the sleeve 750 can contact the introducer sheath 780 and prevent further advancement of the sleeve 750. For example, the distal end portion 754 of the sleeve 750 enters at least partially into the hub 783 of the introducer sheath 780, and the proximal end portion 752 of the sleeve 750 abuts against the hub 783 to prevent further advancement of the sleeve 750. When the sleeve 750 is releasably attached to the support member 730, the advancement of the positioning member 714 can release the sleeve 750 from the distal end portion 734 of the support member 730. When the positioning member 714 is further advanced within the introducer sheath 780, the sleeve 750 remains substantially stationary relative to the introducer sheath 780 and can then slide proximally on the support member 730. In this way, the distal end portion 734 of the support member 730 exits from the distal end portion 754 of the sleeve 750 and enters the lumen 786 of the introducer sheath,

[0139] allowing the sealant 2 to be released into the lumen 786 of the introducer sheath from the sleeve 750, similar to other embodiments herein. Optionally, the distal end portion 754 of the sleeve 750 has a length and / or other functional features sufficient to at least partially open a valve (not shown) within the hub 783 of the introducer sheath, for example, facilitating the advancement of the sealant 2 and the distal end portion 734 of the support member 730 into the lumen 78 of the introducer sheath. In this way, the sleeve 750 can protect the sealant 2 until the sealant 2 passes through the hub 783 and any valves within the hub and enters the lumen 786 of the introducer sheath 780.

[0140] ​​​​​​​​​​​ Thereafter, the positioning member 714 can be advanced until the positioning element 746 extends beyond the distal end 78 4 of the introduction sheath 780, i.e., until it is disposed within the body lumen. When this occurs, the fork teeth 778 of the shroud 776 of the housing can enter into alignment with the pocket 783a in the hub 783 of the introduction sheath, and, for example, ultimately the detent 778a engages the distal end of the pocket 783a, as described above. With the detent 778a engaged with the pocket 783a, the introduction sheath 780 and the outer housing 772 are coupled to each other and can therefore move together, as in other embodiments herein. The relative lengths of the positioning member 714 and the introduction sheath 780 are such that the

[0141] sealing material 2 can be configured to remain within the lumen 786 of the introduction sheath, e.g., in the vicinity of the distal end 784 of the introduction sheath 780, with the positioning element 746 exposed from the distal end 784. The positioning element 746 can be expanded, e.g., using fluid from the syringe 148 and / or by expanding the positioning element 746 as in other embodiments herein. The entire device 710 and the introduction sheath 780 are retracted either by operating the hub 723 of the device or the hub 783 of the introduction sheath, and ultimately the expanded positioning element 746 is brought into contact with the wall of the body lumen adjacent the puncture site.

[0142] After being properly positioned, the first actuator 760 is actuated to separate the movement of the outer and inner housings 772, 774. For example, while holding the outer housing 772, the Push the actuator 760 inward and disengage the end portion 760a of the first actuator 760 from the end portion 773b of the outer housing 772. Next, retract the outer housing 772 in the proximal direction, i.e., away from the patient and the puncture site. With the inner housing 774 connected to the positioning member 714 and the support member 730, this action slides the inner housing 774 within the outer housing 772 from the proximal position (shown in FIGS. 16A - 16C) to the distal position, thereby retracting the introduction sheath 780 relative to the support member 730 and exposing the sealing member 2 adjacent to the positioning element 746 within the puncture site.

[0143] With the inner housing 774 in the distal position, operate the second actuator 762 to advance the support member 730. Similar to other embodiments herein, for example, tamp or compress the expanded positioning element 746 and / or the outer wall of the body lumen, such as over an arteriotomy, with respect to the sealing member 2. For example, with particular reference to FIG. 16C, push the second actuator 762 inward, thereby rotating the pinion 768 and advancing the rack 766, and in turn advancing the support member 730, guiding the end portion 734 toward the positioning element 746 to compress the sealing member 2 therebetween.

[0144] Optionally, the second actuator 762 can be provided with one or more functional features, such as tabs or a detent 762a, that can engage the outer housing 772 when the second actuator 762 is fully depressed. For example, as shown in FIGS. 16A and 16B, the opening 773 in the outer housing 772 is sized such that when the inner housing 774 is fully in the distal position When guided to the actuator, one or more of the actuators 762 may be aligned with tabs 762a on the second actuator 762. The pocket 773a may have a plurality of pockets or recesses 773a. 3a, the inner housing 774 is disposed at the proximal end relative to the outer housing 772. axial movement of the outer and inner housings 772, 774 relative to one another. do.

[0145] The sealing material 2 is exposed and / or tamped by the support member 730 for a sufficient period of time. Thereafter, positioning element 746 is deflated and positioning member 714 is withdrawn from the body lumen. , for example, by drawing the contracted positioning element 746 into the encapsulant 2 and the support member 730. For example, a syringe 148 can be used to collapse the positioning element 746 and Then, the third actuator 764 is operated to pass the contracted positioning element 746 through the sealing material 2. 7, the support member 730 is then pulled into the distal end 734 as in other embodiments herein. It can be inserted.

[0146] Optionally, as described above, the third actuator 764 may be actuated to move the rack 766 forward until the rack 766 is fully advanced. 3, until the third arm 764c of the third actuator is released. After this, the outer and inner parts of the third actuator 764 can be connected to the Proximal movement of the hub 748 and the positioning member 750 relative to the housings 772, 774 7. Move the entire material 714 proximally, thereby passing the positioning element 746 through the sealant 2. 7. The support member 730 is retracted into the distal end 734 of the support member 730. The length of 775 is configured to retract positioning element 746 a desired distance into distal end 734. It is possible.

[0147] After pulling out the positioning element 746 from the sealing material 2, the entire device 710 is pulled out and the positioning member 730 can be removed from the puncture part, and the sealing material 2 can be left in the puncture part.

[0148] Referring to FIG. 14, a sheath catch assembly 550 which is an exemplary embodiment is shown, and this assembly can be provided in the device 510 for sealing the puncture part and / or the introduction sheath 580. Generally, the device 510 can have a positioning member ( not shown) and a cartridge 516 as in other embodiments herein. As shown in the figure, the cartridge 516 has a housing 523 that can be connected to a tubular member carrying a sealing material and / or a support member (not shown for simplicity). The introduction sheath 580 generally has a tubular body with a proximal end portion 582 and a distal end portion 584 and a hub 583 at the proximal end portion 582 as in other embodiments herein. As shown in the figure, the sheath hub 583 has a catch adapter 583a with a pocket 583b inside. The housing 523 of the cartridge 516 has, for example, a sheath catch assembly 550 within a shroud 23 as shown in FIG. 2B, and this sheath catch assembly 5 50 has a sheath catch 552 that is slidable within the housing 523, for example, between a first lateral position and a second lateral position. For example, the housing 523 has a distal passage 523a, and when the cartridge 516 is advanced into the introduction sheath 580 as in any of the embodiments described throughout herein, the catch adapter 583a can be received within the distal passage 523 a.

[0149] As shown in the figure, the sheath hub 583 has a catch adapter 583a with a pocket 583b inside. The housing 523 of the cartridge 516 has, for example, a sheath catch assembly 550 within a shroud 23 as shown in FIG. 2B, and this sheath catch assembly 5 50 has a sheath catch 552 that is slidable within the housing 523, for example, between a first lateral position and a second lateral position. For example, the housing 523 has a distal passage 523a, and when the cartridge 516 is advanced into the introduction sheath 580 as in any of the embodiments described throughout herein, the catch adapter 583a can be received within the distal passage 523 50 has a sheath catch 552 that is slidable within the housing 523, for example, between a first lateral position and a second lateral position. For example, the housing 523 has a distal passage 523a, and when the cartridge 516 is advanced into the introduction sheath 580 as in any of the embodiments described throughout herein, the catch adapter 583a can be received within the distal passage 523 a. a. When advancing the cartridge 516 into the introduction sheath 580, the catch adapter 583a can be received within the distal passage 523 a.

[0150] ​ With the sheath catch 552 in the first position, the catch adapter 583a passes through the end-side passage 523a and can enter the opening 553 in the sheath catch 552. For example, finally, the pocket 583b in the catch adapter 583a aligns with the sheath catch 552. After that, when guiding the sheath catch 552 laterally to the second position, the sheath catch 552 enters the pocket 583b, thereby preventing the subsequent axial movement of the introduction sheath 580 with respect to the housing 523.

[0151] In the embodiment shown in FIG. 14, the sheath catch 552 can be biased, for example, by a spring 556 or other biasing mechanism, toward one of the first and second positions. For example, the sheath catch 552 is biased toward the first position, thereby enabling the cartridge 516 to be separated from the introduction sheath 580 by the default position of the sheath catch 552. A hydraulic actuator having a piston 534 slidable within the chamber 558 can be provided to overcome the bias of the spring 556. As shown, the piston 534 is laterally movable within the chamber, and the piston 534 is engaged with the sheath catch 552 to, for example, overcome the bias of the spring 556 and move the sheath catch 552 from the first position to the second position.

[0152] Furthermore, as shown, the chamber 558 communicates with a fluid line 559, and fluid can be fed and / or extracted from this fluid line 559, thereby guiding the piston 534 between the engaged position and the disengaged position. In some embodiments, the fluid line 559 is positioned It can be connected to the same inflation line as the positioning element in the positioning member (not shown). For example, referring also to FIG. 1A, when the syringe 148 is pushed in to feed fluid to the inflation line 4 8c to inflate the balloon 46, the fluid is fed to the fluid line 559 almost simultaneously, thereby engaging the piston 534 with the sheath catch 552 and guiding it to the second position, thereby enabling the introduction sheath 580 to be connected to the housing 523. Thereafter, when the syringe 148 is used to extract fluid to deflate the balloon 46, the fluid is also extracted from the fluid line 559, and thus the piston 534 and the sheath catch 552 can be disengaged, allowing the cartridge 516 to be separated from the introduction sheath 580.

[0153] Therefore, the sheath catch assembly 550 also provides a safety function that can immediately separate the cartridge 516 from the introduction sheath 580 when the fluid pressure is lost in the fluid line 559, for example, when the balloon 46 ruptures or fluid leaks for other reasons. In the absence of fluid in the fluid line 559, the spring 556 automatically guides the sheath catch 5 52 to the first position, disengaging the sheath catch 552 from the sheath adapter 583a. Furthermore, during deflation of the balloon, the flow rate of fluid from the fluid line 559 for the piston 534 is slower than the fluid escaping from the balloon 46, and thus, after the balloon 4 6 deflates, the sheath catch 550 is released, which can ensure that the inflated balloon 46 is not pulled by the spring 556. Furthermore, when the balloon 46 ruptures, the sheath catch assembly 550 disengages, and thus the positioning member 14 is released. This can ensure that the inflated balloon 46 is not pulled by the spring 556. Furthermore, when the balloon 46 ruptures, the sheath catch assembly 550 disengages, and thus the positioning member 14 is released. When the balloon 46 ruptures, the sheath catch assembly 550 comes off, and thus the positioning member 14 is Even when withdrawing from the body lumen, since the introduction sheath 580 remains within the puncture portion, access to the body lumen is maintained. Access to the body lumen is maintained.

[0154] In some embodiments, other functional features for fixing the introduction sheath to the cartridge can be provided in the cartridge, for example, in the housing in any of the embodiments described herein. For example, a simple sheath catch can be provided within the shroud 23a shown in FIG. 2B, and this sheath catch automatically engages with a functional feature at the hub (not shown) of the introduction sheath. For example, within the shroud 23a, a backstop can be provided on, for example, a tubular sleeve or other support (not shown), and this backstop can be configured to freely enter into the hub of the introduction sheath but then prevent its removal, similar to the embodiments described in U.S. Patent No. 7,993,367. When such a sheath lock is provided on the tubular member of the cartridge, in a state where the sheath is engaged by the sheath lock, a deployment mechanism that retracts the tubular member can similarly automatically retract the introduction sheath. For example, after inserting a device such as the device 210 of FIGS. 8A - 8C into an introduction sheath (not shown), the sheath lock can connect the sheath hub to the housing 223 (for example, within the shroud 23a as shown in FIG. 2B). With the positioning element 246 expanded within the blood vessel, the entire device 210 and the introduction sheath can be withdrawn together until the positioning element 246 is positioned to contact the blood vessel wall, similar to the method shown in FIGS. 10A and 10B (apart from the cartridge 216 being positioned within the sheath).

[0155] ​​​​​​​​​​Thus, in some embodiments, the extended positioning element 246 is not used to retract the introducer sheath into the puncture site, thereby reducing the stress on the positioning element 246.

[0156] Optionally, the device 210 can have a release feature that allows the cartridge 216 and the introducer sheath to be retracted after positioning the positioning element 246 against the vessel wall. For example, when positioning the positioning element 246 against the vessel wall, the actuator of the release feature in the housing 223 can be actuated, thereby retracting the cartridge 216 and the sheath a predetermined distance, e.g., 1.5 cm, relative to the positioning member 214. Thus, the distal end 224 of the tubular member 220 and the sheath retract away from the positioning element 246, and this retraction can overcome the friction at the puncture site around the sheath immediately prior to deployment of the sealant 2. Otherwise, for example, tissue around a relatively small profile puncture site can add frictional resistance to retraction of the introducer sheath, causing the device to advance relative to the sheath when operating the deployment mechanism 260, and positioning the positioning element 246 and the sealant 2 more into the puncture site (and potentially into the vessel) rather than simply retracting the tubular member 220 and the sheath to deploy the sealant 2 outside the vessel.

[0157] Optionally, a sheath stabilizer (not shown) that creates a connection between the housing 223 and the introducer sheath can be provided, e.g., to prevent the cartridge 216 from moving distally relative to the sheath.

[0158] ​​​​​​​​​​​​​​​Next, referring to FIGS. 15A and 15B, an apparatus 610 in another exemplary embodiment is shown. This apparatus 610 has a bleedback assembly 650 in a housing 623 of a cartridge 616. Generally, the apparatus 610 can have a cartridge 616 that provides a tubular member carrying a sealing material and a support member (not shown) connected to the housing 623. The apparatus 610 can further have a positioning member, as in other embodiments herein, or the positioning member can be omitted.

[0159] The bleedback assembly 650 projects from the housing 623 and can have a sheath catch 652 that is received within a hub 83 or otherwise connected to an introducer sheath 80, as in other embodiments herein. The bleedback assembly 650 can further have a lumen 653 that communicates with a bleedback port 654 and also with a lumen 86 of the introducer sheath 80. For example, as shown in FIG. 15B, in use, a cartridge 616, e.g., a tubular member (not shown), is advanced into the lumen 86 of the introducer sheath, and ultimately the sheath catch 652 enters into the sheath hub 83. As shown, the sheath catch 652 can have a tip 652a that penetrates into and / or opens a valve 83a of the sheath hub 83. Further, the sheath catch 652 engages elastically or otherwise with a wall 83b of the hub 83 to prevent subsequent separation of the introducer sheath 80 from the housing 623.

[0160] In use, the apparatus 610 (not showing the end of the tubular member adjacent to the positioning member) is, as described herein, Similar to other embodiments in the specification, it can be introduced into the introduction sheath 80. Introduction The relative lengths of the introduction sheath 80 and the positioning member are such that when the sheath catch 652 engages with the sheath hub 83, the distal end 84 of the introduction sheath 80 can be determined to be offset by a predetermined distance from the positioning element. For example, the distal end 84 can be separated from the positioning element by 0.1 to 2 millimeters (0.1 - 2.0 mm) when the sheath catch 652 engages.

[0161] Due to this distance and the space around the cartridge within the sheath lumen 86, when the distal end 84 is exposed within the blood vessel, blood can flow into the sheath lumen 86. Due to the intravascular pressure, the blood flow within the sheath lumen 86 can be caused to flow into the lumen 653 of the sheath catch assembly 650 and out through the bleed - back port 654. When the device 610 is withdrawn and guided such that the expanded positioning element abuts against the vessel wall, the positioning element isolates the puncture site and thus the sheath lumen 86 from the vascular pressure, and thus, the blood flow out through the bleed - back port 654 through the sheath lumen 86 is blocked, providing a visual confirmation that the positioning element is at the position where it abuts against the vessel wall.

[0162] In some embodiments, the relative lengths of the introduction sheath 80 and the cartridge 616 are such that when the sheath catch 652 engages with the sheath hub 83, the distal end 84 of the sheath contacts or is in a slightly interfering state with the positioning element. In this configuration, while the device 610 is being introduced into the blood vessel, for example, when the positioning element expands and then later within the blood vessel Upon retraction, blood can be prevented from flowing into the through lumen 86. Subsequently, when the introduction sheath 80 is retracted (e.g., together with the tubular member), according to this configuration, the introduction sheath 8 0 can be reintroduced into the puncture site, and the bleed-back signal can be used to indicate when the introduction sheath 80 contacts the positioning element again.

[0163] In some embodiments, bleed-back can be used to position the introduction sheath at a desired position relative to the arteriotomy and / or the vessel wall. For example, as shown in FIGS. 15A and 15B the introduction sheath 80 can be provided with one or a plurality of side ports 85 (only one is shown) communicating with the through lumen 86 at the distal end 84. The side ports 85 can be offset a predetermined distance, e.g., 1.5 cm, from the distal end 84 of the sheath 80 can be.

[0164] The elongate dilator (not shown) can be provided with a distal end sized to be introduced into the through lumen 86 and a relatively small bleed-back lumen extending from one or more side ports at the distal end to the proximal end of the dilator. When the dilator is fully inserted into the through lumen 8 6, these side ports are aligned with each other, creating a flow path from outside the distal end 8 4 of the sheath 80 through the interior of the dilator to the bleed-back port at the proximal end of the dilator. can occur.

[0165] In this way, when the side ports are disposed within the blood vessel and exposed to blood pressure, blood enters the side port 85 of the sheath 80, flows into the side port of the dilator, and causes the dilator lumen to move upward. The blood flowing out from the bleed-back port is such that the distal end 84 is within the blood vessel provides a visual confirmation of being disposed at. For example, when the distal end portion 84 is drawn from the blood vessel wall into the puncture portion, the side port 85 in the sheath 80 is no longer exposed to the arterial blood pressure and after that, the bleed-back signal stops. Therefore, it provides a visual confirmation that the sheath has penetrated into the blood vessel by approximately the distance by which the side port is offset from the distal end portion 84. As an alternative, a bleed-back lumen and port are provided in the dilator. In this case, when the dilator is completely inserted into the sheath lumen 86, the port can be provided so as to be exposed beyond the sheath distal end portion 84. This port is separated from the sheath distal end portion 84 by a predetermined distance, for example, about 2 centimeters. When the bleed-back stops, the sheath 80 is advanced by a predetermined distance so that the distal end portion 84 can be positioned adjacent to the blood vessel wall. After that, for example, when introducing the device 610 to deliver the sealing material, the introduction sheath 80 can be maintained at this position. When advancing the positioning element into the sheath lumen 86, the position of the positioning element with respect to the blood vessel wall and the arteriotomy is known based on the known position of the introduction sheath 80. For example, if the side port 85 is set 2 cm off from the distal end portion 84 of the sheath 80, the user knows that the expanded positioning element needs to be retracted 2 cm to reach the blood vessel wall. This embodiment of positioning the sheath 80 minimizes the dragging of the expanded positioning element in the blood vessel and can reduce the risk of the positioning element rupturing with calcium or other substances in the blood vessel and / or misjudged tactile positioning due to blood vessel stenosis or branching.

[0166]

[0167] ​​​​​​​​​​​​Figures 17A - 17F diagrammatically illustrate a method of delivering a sealing material from device 810 to an arteriotomy site. Device 810 can be provided with any of the functional features described for device 710. For example, device 810 can be provided with a sealing material 2 disposed at the distal end portion of a positioning assembly 814. The positioning assembly 814 penetrates the puncture site and protrudes into the blood vessel such that a positioning element 846 is located within the blood vessel lumen and the sealing material 2 is located outside the blood vessel wall (Figure 17A). By expanding the positioning element 846, device 810 is fixed to the arteriotomy site (Figure 17B). By retracting the sheath 880, the sealing material 2 is exposed at the arteriotomy site (Figure 17C), and by advancing the support member 830, the sealing material 2 is tamponaded (Figure 17D). After constricting the positioning element 846 (Figure 17E), the positioning element 846 is passed through the sealing material 2 and moved in the proximal direction (Figure 17F), and the sealing material 2 can be left outside the blood vessel. The support member 830 can maintain the position of the sealing material 2 while the positioning element 846 is being withdrawn. After withdrawing the positioning element 846, the entire device 810 including the sheath 880 and the positioning assembly 814 can be withdrawn from the patient. Device 810 and the method of using device 810 are described in detail below. As shown in Figures 17A - 17F, device 810 can have a handle 823. The handle 823 can have an outer housing 872 and an inner housing 874. The outer housing 872 can move relative to the inner housing 874, for example, when moving the sheath 880 in the proximal direction relative to the positioning assembly 814. Device 810 and the method of using device 810 are described in detail below.

[0168] As shown in Figures 17A - 17F, device 810 can have a handle 823. The handle 823 can have an outer housing 872 and an inner housing 874. The outer housing 872 can move relative to the inner housing 874, for example, when moving the sheath 880 in the proximal direction relative to the positioning assembly 814. The outer housing 872 can move relative to the inner housing 874, for example, when moving the sheath 880 in the proximal direction relative to the positioning assembly 814.

[0169] The handle 823 can have one or more actuators for controlling the device 810. Each actuator can control one or more functions of the device 810. The one or more actuators can be disposed at any position along the handle 823. In FIGS. 17A - 17F, the actuators 860, 862, 864, and 848 are disposed along the handle 823 based on the steps of the procedure controlled by each actuator. The actuator configuration shown in FIGS. 17A - 17F reduces the confusion associated with operating the device 810 for the user by only requiring the user to move their hand in the proximal direction for each sequential step in the procedure. FIGS. 17A - 17F show four actuators 860, 862, 864, and 848, but the same function can be implemented using fewer or additional actuators. The device 810 can have an inflation line 48c. The inflation line 48c is in fluid communication with the positioning element 846. Connect the inflation line 48c to a syringe 148 or other device that feeds fluid to the positioning element 8 46.

[0170] The device 810 can have a first actuator 860 for controlling the fluid flow through the inflation line 48c. The first actuator 860 moves between an open position and a closed position. As shown in FIG. 17A, when the first actuator 860 is in the open position, the syringe 1 48 can feed fluid through the inflation line 48c to expand the positioning element 846. In FIG. 17B, the first actuator 860 moves to the closed position, and the inflation line 4

[0171] The device 810 can have a first actuator 860 for controlling the fluid flow through the inflation line 48c. The first actuator 860 moves between an open position and a closed position. As shown in FIG. 17A, when the first actuator 860 is in the open position, the syringe 1 48 can feed fluid through the inflation line 48c to expand the positioning element 846. In FIG. 17B, the first actuator 860 moves to the closed position, and the inflation line 4 48 can feed fluid through the inflation line 48c to expand the positioning element 846. In FIG. 17B, the first actuator 860 moves to the closed position, and the inflation line 4 48 can feed fluid through the inflation line 48c to expand the positioning element 846. In FIG. 17B, the first actuator 860 moves to the closed position, and the inflation line 4 Restrict the fluid flow through 8c and maintain the extended state of the positioning element 846. Positioning element 2 After the positioning element 46 expands, move the device 810 in the proximal direction to position the positioning element 846 at the arteriotomy adjacent to it.

[0172] The device 810 can have a second actuator 862 that controls the movement of the sheath 880 relative to the positioning assembly 814. The second actuator 862 moves between a first position and a second position. In the first position (Figs. 17A and 17B), the sheath 880 cannot move relative to the positioning assembly 814, thus preventing accidental exposure of the sealant 2. When the second actuator 862 is moved from the first position to the second position, as shown in Fig. 17 C, the sheath 880 can be moved relative to the positioning assembly 814. With the positioning assembly 814 stationary, the sheath 880 is retracted to expose the sealant 2 at the arteriotomy. By retracting the sheath 880, at least partially cover the second actuator 862 relative to a part of the outer housing 872. The device 810 can have a locking mechanism that prevents the inner housing 874 from moving relative to the outer housing 872. When the sheath 880 retracts, the outer housing 872 moves between a first position and a second position. When the outer housing 872 is in the first position (Figs. 1 7A and 17B), the inner housing 874 can move relative to the outer housing 872. When the outer housing 872 is in the second position (Fig. 17C), the inner housing

[0173] 874 cannot move in the proximal direction relative to the outer housing 872. When the sheath 880 retracts, the outer housing 872 moves between a first position and a second position. When the outer housing 872 is in the first position (Figs. 1 7A and 17B), the inner housing 874 can move relative to the outer housing 872. When the outer housing 872 is in the second position, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. When the outer housing 872 is in the second position (Fig. 17C), the inner housing 874 cannot move in the proximal direction relative to the outer housing 872.

[0174] As shown in FIGS. 17C and 17D, the device 810 has a third actuator 864 which is capable of. The third actuator 864 moves between a first position and a second position. When the third a ctuator 864 is moved from the first position to the second position, the support member 830 is advanced, and the sealing material 2 is tamped. Tamping of the sealing material 2 substantially prevents movement of the sealing material 2 and promotes hemostasis.

[0175] By moving the third actuator 864 from the first position to the second position, the retraction lock 8 16 is released. The retraction lock 816 prevents the positioning assembly 814 from accidentally retracting before the sealing material 2 is tamped. By releasing the retraction lock 816, at least a part of the positioning assembly 814 can be moved in the proximal direction with respect to the support member 830 is possible.

[0176] The device can be provided with a fourth actuator 848 that can move between a first position and a second position. By unlocking the retraction lock 816, the fourth actuator 848 can be moved. By moving the fourth actuator 848 from the first position to the second position, the positioning assembly 814 is at least partially retracted with respect to the support member 830. retracted with respect to the support member 830. retracted.

[0177] In FIG. 17E, the first actuator 860 is moved to the open position to allow fluid flow through the inflation line 48c When the first actuator 860 is in the open position, the positioning element 846 can be squeezed by the syringe 148. In FIG. 17F, the positioning member 814 is retracted to allow it to pass through the sealing material 2, thereby passing the entire device 810 through the affected member 814 is retracted to allow it to pass through the sealing material 2, thereby passing the entire device 810 through the affected can be removed from the person.

[0178] As described above, the device 810 can have an operating mechanism that controls the fluid flow to the positioning element 846. This operating mechanism can be provided with any one or a combination of the functional features described with reference to FIGS. 18A to 20B.

[0179] FIGS. 18A and 18B show a first actuator 860a that moves between an open position and a closed position. FIGS. 18A-1 and 18B-1 show a cross-sectional view of the inflation line 48a. The outer housing 872a of the handle has an opening through which a part of the first actuator 860a protrudes. In FIGS. 18A and 18B, the first actuator 860a is a valve, but the first actuator 860a and the valve can also be separate components. The valve can have a pinch mechanism that restricts the fluid flow through the inflation line 48a.

[0180] The first actuator 860a can move between an open position (FIG. 18A) and a closed position (FIG. 18B). In the open position, the fluid can flow through the inflation line 48a. FIGS. 18A and 18B show the first actuator 860a as a rocking rocker, but the first actuator 860a can have other shapes.

[0181] FIGS. 19A and 19B show a device having a first actuator 860b and a contraction actuator 866b. FIGS. 19A-1 and 19B-1 show a cross-sectional view of the inflation line 48b. The link mechanism portion 867b connects the first actuator 860b to the contraction actuator 866b. The link mechanism portion 867b shown in FIGS. 19A and 19B has a plurality of link members. However, the link mechanism portion 867b can have only one link member (see FIGS. 19E through 19F). The outer housing 872b has two openings through which the first actuator 860b and the shrink actuator 866b project.

[0182] Similar to FIGS. 18A and 18B, the first actuator 860b moves from the first position to the second position to restrict the fluid flow through the expansion line 48b. When the first actuator 860b moves from the first position to the second position, the shrink actuator 866b is moved from the first position to the second position. Moving the shrink actuator 866b from the second position to the first position moves the first actuator 860b from the second position to the open position, allowing the fluid flow through the expansion line 48b.

[0183] Similar to FIGS. 19A and 19B, the devices of FIGS. 19C and 19D can have a first actuator 860c and a shrink actuator 866c connected by a link mechanism portion 867c. The link mechanism portion 867c can have one or more link members. Unlike FIGS. 19A and 19B, the first actuator 860c and the shrink actuator 866c are different from the valve 884c. For example, the valve 884c can be disposed on the end side with respect to the first actuator 860c and the shrink actuator 866c.

[0184] The first actuator 860c moves from the first position to the second position to close the valve 884c and can restrict the fluid flow through the expansion line. Moving the first actuator 860c from the first position to the second position moves the shrink actuator 866c from the first position Move it to the second position. By moving the contraction actuator from the second position to the first position, the first actuator 860c is moved from the second position to the first position, and the valve 884c can be opened.

[0185] Similar to FIGS. 19A - D, the devices of FIGS. 19E and 19F can have a first actuator 860d and a contraction actuator 866d connected by a link mechanism portion 867d. Unlike FIGS. 19A and 19B, the link mechanism portion 867d has only one link member. Further, similar to FIGS. 19A and 19D, the first actuator 860d and the contraction actuator 866d are different from the valve 884d. For example, the valve 884d can be disposed on the end side with respect to the first actuator 860d and the contraction actuator 866d. The first actuator 860d moves from the first position to the second position to close the valve 884d and can restrict the fluid flow through the expansion line. By moving the first actuator 860d from the first position to the second position, the contraction actuator 866d is moved from the first position to the second position. By moving the contraction actuator from the second position to the first position, the first actuator 860d is moved from the second position to the first position, and the valve 884d can be opened. The device having the first actuator and the contraction actuator is useful for reducing the confusion related to operating the device. For example, when providing an additional actuator in the device and controlling the steps of expanding and contracting the positioning element, this additional 4d d can be arranged.

[0186] The first actuator 860d moves from the first position to the second position to close the valve 884d and can restrict the fluid flow through the expansion line. By moving the first actuator 860d from the first position to the second position, the contraction actuator 866d is moved from the first position to the second position. By moving the contraction actuator from the second position to the first position, the first actuator 860d is moved from the second position to the first position, and the valve 884d can be opened. The first actuator 860d moves from the first position to the second position to close the valve 884d and can restrict the fluid flow through the expansion line. By moving the first actuator 860d from the first position to the second position, the contraction actuator 866d is moved from the first position to the second position. By moving the contraction actuator from the second position to the first position, the first actuator 860d is moved from the second position to the first position, and the valve 884d can be opened. 1 position to the second position, the contraction actuator 866d is moved from the first position to the second position. By moving the contraction actuator from the second position to the first position, the first actuator 860d is moved from the second position to the first position, and the valve 884d can be opened.

[0187] The device having the first actuator and the contraction actuator is useful for reducing the confusion related to operating the device. For example, when providing an additional actuator in the device and controlling the steps of expanding and contracting the positioning element, this additional connected actuator, the steps of expanding and contracting the positioning element, when controlling, this additional The actuator can be arranged between the first actuator and the contraction actuator along the handle. The actuator is arranged based on the treatment steps for controlling each actuator, so that the user can move their hand in the proximal direction for each sequential step of the treatment. Since the contraction of the positioning element is the final step before withdrawing the device, the contraction actuator can be arranged on the proximal side of the additional actuator. As described above, the first actuator and the valve can be separate components. As shown in FIGS. 20A - B, the first actuator 960 moves between a first position and a second position to control the position of the valve 961. By moving the first actuator 960 from the first position (FIG. 20A) to the second position (FIG. 20B), the valve 961 is moved from the open position to the closed position. In the closed position, the valve 961 restricts the fluid flow through the inflation line 948. FIGS. 20A - 1 and 20B - 1 show cross - sectional views of the inflation line 948 moving from the open configuration to the closed configuration. By moving the first actuator 960 from the second position to the first position, the valve 961 is moved from the closed position to the open position, thereby allowing the fluid flow through the inflation line 948.

[0188] As described above, the first actuator and the valve can be separate components. As shown in FIGS. 20A - B, the first actuator 960 moves between a first position and a second position to control the position of the valve 961. By moving the first actuator 960 from the first position (FIG. 20A) to the second position (FIG. 20B), the valve 961 is moved from the open position to the closed position. In the closed position, the valve 961 restricts the fluid flow through the inflation line 948. FIGS. 20A - 1 and 20B - 1 show cross - sectional views of the inflation line 948 moving from the open configuration to the closed configuration. By moving the first actuator 960 from the second position to the first position, the valve 961 is moved from the closed position to the open position, thereby allowing the fluid flow through the inflation line 948. By moving the first actuator 960 from the first position (FIG. 20A) to the second position (FIG. 20B), the valve 961 is moved from the open position to the closed position. In the closed position, the valve 961 restricts the fluid flow through the inflation line 948. FIGS. 20A - 1 and 20B - 1 show cross - sectional views of the inflation line 948 moving from the open configuration to the closed configuration. By moving the first actuator 960 from the second position to the first position, the valve 961 is moved from the closed position to the open position, thereby allowing the fluid flow through the inflation line 948.

[0189] The first actuator 960 can be a lever. The first actuator 960 is connected to the valve 961 by a pin. The valve 961 is a sliding valve having a pin mechanism and restricts the fluid flow through the inflation line 948. By moving the first actuator 960 between the first position and the second position, the valve 961 is linearly moved between the open position and the closed position. By moving the first actuator 960 between the first position and the second position, the valve 961 is linearly moved between the open position and the closed position. Slide it. FIGS. 20A - B show the first actuator 960 as a lever, but the device can have any other mechanism capable of moving the valve 961, such as a rack - and - pinion configuration, a cam mechanism, or any other actuator.

[0190] The device 810 can have a second actuator 862 that controls the movement of the sheath 880 relative to the positioning assembly 814. The outer housing 872 can have an opening through which at least a portion of the second actuator 862 protrudes. As shown in FIGS. 21A and 21B, the second actuator 862 can be a spring - loaded button. The second actuator 862a moves between a first position (FIG. 21A) and a second position (FIG. 21B). When the second actuator 862a is in the first position, it prevents proximal movement of the sheath relative to the positioning assembly. When the second actuator 862a is in the second position, the sheath can move proximally relative to the positioning assembly. When the sheath moves proximally, the outer housing 872a prevents the second actuator 862a from moving to the first position. The second actuator 862a shown in FIGS. 21A and 21B has a spring mechanism 868a, but any other locking mechanism described herein can be used to control the movement of the sheath relative to the positioning assembly. As shown in FIGS. 22A and 22B, the second actuator 862b can have a detent 869b. When the second actuator 862b is in the first position (FIG. 22A),

[0191]

[0192] The sheath cannot move relative to the positioning assembly. When the second actuator 86 2b is in the second position (FIG. 22B), the detent 869b locks the second actuator 862 b in the depressed position, thereby allowing the sheath to move in the proximal direction relative to the positioning assembly. When the sheath moves in the proximal direction, the outer housing 872b moves on the second actuator 862b and maintains the second actuator 862b in the depressed state. When the sheath moves in the proximal direction, the outer housing 872b moves on the second actuator 862b and maintains the second actuator 862b in the depressed state. When the sheath moves in the proximal direction, the outer housing 872b moves on the second actuator 862b and maintains the second actuator 862b in the depressed state.

[0193] The device 810 can further include a mechanism for limiting the distance that the sheath 880 can move relative to the positioning assembly 814. For example, as shown in FIGS. 21B and 22B, the distal end of the inner housing 874 can move only until it abuts the distal end of the outer housing 872 or a different functional feature on the handle 823. As described above, the handle 823 can include a locking mechanism for locking the inner housing 874 relative to the outer housing 872. As shown in FIGS. 17A-17F, the locking mechanism can include one or more protrusions 863 positioned along the inner wall of the outer housing 872 and one or more elastic members 875 positioned on the inner housing 874. When the sheath 880 is moved in the proximal direction, one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863. After one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. The distal end of the inner housing 874 can move only until it abuts the distal end of the outer housing 872 or a different functional feature on the handle 823.

[0194] As described above, the handle 823 can include a locking mechanism for locking the inner housing 874 relative to the outer housing 872. As shown in FIGS. 17A-17F, the locking mechanism can include one or more protrusions 863 positioned along the inner wall of the outer housing 872 and one or more elastic members 875 positioned on the inner housing 874. When the sheath 880 is moved in the proximal direction, one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863. After one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. The locking mechanism can include one or more protrusions 863 positioned along the inner wall of the outer housing 872 and one or more elastic members 875 positioned on the inner housing 874. When the sheath 880 is moved in the proximal direction, one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863. After one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. When the sheath 880 is moved in the proximal direction, one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863. After one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. After one or more of the elastic members 875 flex inwardly and pass one or more of the protrusions 863, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872.

[0195] ​​​In FIGS. 23A and 23B, the locking mechanism includes at least two protrusions 863 along the inner wall of the outer housing 872, and at least two elastic members 875 disposed at the proximal end of the inner housing 874. The elastic members 875 deflect inward and can move in the distal direction through one or more protrusions 863. When pulling out the sheath 880, the elastic members 875 deflect inward and pass through the protrusions 863. After the elastic members

[0196] 875 pass through the protrusions, the inner housing 874 cannot move in the proximal direction relative to the outer housing 872. As an alternative, the locking mechanism can include one or more protrusions 8 63 disposed on the inner housing 874 and one or more elastic members disposed

[0197] along the inner wall of the outer housing 872. Other locking mechanisms described herein can also be used to lock the inner housing 874 relative to the outer housing 872.

[0198] FIGS. 24A-24C show a mechanism for preventing the support member 830 from advancing before the outer sheath 880 retracts. As shown in FIG. 24A, the locking mechanism can be a tab 873 that prevents the movement of the third actuator 864. However, after the sheath 880 moves in the proximal direction can be moved from the first position (FIG. 24B) to the second position (FIG. 24C). As described herein using other locking mechanisms described, it is also possible to prevent the support member 830 from advancing .

[0199] FIGS. 25A and 25B show one mechanism for advancing the support member 830. By moving the third actuator 864 from the first position to the second position, the link element 865 is extended to advance the support member 830. The support member 830 extends until a part of the support member 830 abuts against a functional feature of the handle, for example, the end of the inner housing 874 or the outer housing 872 . The distance that the support member 830 advances is limited by the distance that the link element 865 extends .

[0200] FIGS. 26A and 26B show an apparatus 810 having a spring member 870. By moving the third actuator 864 from the first position to the second position, the spring member 870 is extended, and also the support member 830 is advanced in the distal direction. The support member 830 can extend until a part of the support member 830 abuts against a functional feature of the handle, for example, the end of the inner housing 874 or the outer housing 872 . The distance that the support member 830 advances is limited by the distance that the spring member 870 extends. Other mechanisms can be used to advance the support member 830, for example, the rack-and-pinion configuration described for the apparatus 710 or any other actuator can be used.

[0201] As described above, the apparatus 810 can have a retraction lock 816 that locks the position relative to the inner housing 874 of the positioning assembly 814. The third actuator 8 The retraction lock 816 can be released by moving 64 from the first position to the second position, and this release is performed by moving the lever 817 from the first position to the second position. When the lever 817 is in the second position, the positioning assembly 814 can move relative to the outer housing 872. By retracting the fourth actuator 848 of the positioning assembly 814, the positioning assembly 814 can be retracted to pass through the sealing material 2. While the positioning assembly 814 is retracting, the support member 830 holds the position of the sealing material 2. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. Figures 28A - 28F diagrammatically show a sealing material delivery method similar to the method shown in Figures 17A - 17F. However, as described above, it is not necessary to provide four actuators 860, 862, 864, and 848 on the handle 823. For example, as shown in Figures 28A - 28F, the handle does not have the first actuator 860. Instead, the inflation line 48c has a valve 882. The valve 882 moves between a first position and a second position. When the valve 882 is in the first position, as shown in Figure 28C, fluid can flow from the syringe to the positioning member 846. When the valve 882 moves from the first position to the second position, as shown in Figure 28D, fluid can no longer flow from the syringe to the positioning member 846. Figures 29A - B show a device 1010 for delivering a sealing material to an arteriotomy site. When the lever 817 is in the second position, the positioning assembly 814 can move relative to the outer housing 872. By retracting the fourth actuator 848 of the positioning assembly 814, the positioning assembly 814 can be retracted to pass through the sealing material 2. While the positioning assembly 814 is retracting, the support member 830 holds the position of the sealing material 2. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. By retracting the fourth actuator 848 of the positioning assembly 814, the positioning assembly 814 can be retracted to pass through the sealing material 2. While the positioning assembly 814 is retracting, the support member 830 holds the position of the sealing material 2. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. By retracting the fourth actuator 848 of the positioning assembly 814, the positioning assembly 814 can be retracted to pass through the sealing material 2. While the positioning assembly 814 is retracting, the support member 830 holds the position of the sealing material 2. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. While the positioning assembly 814 is retracting, the support member 830 holds the position of the sealing material 2. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein. After the positioning assembly 814 has retracted, the entire device 810 is removed from the patient. It is also possible to lock the inner housing 874 of the positioning assembly 814 using other locking mechanisms described herein.

[0202] Figures 28A - 28F diagrammatically show a sealing material delivery method similar to the method shown in Figures 17A - 17F. However, as described above, it is not necessary to provide four actuators 860, 862, 864, and 848 on the handle 823. For example, as shown in Figures 28A - 28F, the handle does not have the first actuator 860. Instead, the inflation line 48c has a valve 882. The valve 882 moves between a first position and a second position. When the valve 882 is in the first position, as shown in Figure 28C, fluid can flow from the syringe to the positioning member 846. When the valve 882 is in the first position, as shown in Figure 28C, fluid can flow from the syringe to the positioning member 846. When the valve 882 is in the first position, as shown in Figure 28C, fluid can flow from the syringe to the positioning member 846. When the valve 882 moves from the first position to the second position, as shown in Figure 28D, fluid can no longer flow from the syringe to the positioning member 846. When the valve 882 moves from the first position to the second position, as shown in Figure 28D, fluid can no longer flow from the syringe to the positioning member 846.

[0203] Figures 29A - B show a device 1010 for delivering a sealing material to an arteriotomy site. can have any of the functional features of the sealant delivery device detailed herein. For example, device 1010 can have a positioning assembly 1014 provided with a handle 1023 and a positioning element 1046. At least one part of the positioning assembly 1014 can penetrate into the sheath 1080. The inflation line 48c can extend from the positioning element 104 6 to the syringe 148, or any other mechanism that expands and contracts the positioning element 1046 up to. The inflation line 48c can have a first actuator 1082 that controls the fluid flow to the positioning element 1046. The handle 1023 can have a second actuator 1062 that can retract the sheath 1080 relative to the positioning member 1014, a third actuator 1064 that advances a support member (not shown), and / or a fourth actuator 1048 that retracts at least a part of the positioning assembly 1014 relative to the sheath 1080.

[0204] The sheath 1080 can have a mechanism indicating when the distal portion of the sheath enters the blood vessel. For example, the sheath 1080 can have one or more inflow openings 1089 at the distal portion of the sheath 1080. When the sheath 1080 enters the blood vessel, blood flows into the inflow opening and out through an outflow opening outside the user.

[0205] As shown in FIG. 29A, the sheath 1080 can have a hub 1083 that engages the handle 1023. By pushing in the sheath hub 1083, the sheath 1080 can be released from the positioning assembly 1014. The sheath hub can have a sealant sleeve A catch can be provided that engages with (not shown). When the positioning assembly 1014 enters the sheath 1080, the sheath catch engages with the sealant sleeve and transfers the sealant from the sealant sleeve to the sheath 1080.

[0206] The device 1010 can further include an inflation indicator 1002. The inflation indicator 1002 indicates when the positioning element 1046 has inflated to a predetermined pressure and also signals the user to seal the inflation line 48c. As shown in FIG. 29B, the inflation line is connected to the plunger system 1004. When the positioning element 1046 inflates, the shaft member 1005 moves from the first position to the second position. When the shaft member 1005 moves to the second position, the indicator 1002 moves from the first position to the second position. When the indicator 1002 is in the second position, the positioning element 1046 is fully inflated. When the positioning element 1046 deflates, the shaft member 1005 moves from the second position to the first position, and the indicator 1002 moves from the second position to the first position. When the indicator 1002 is in the first position, the positioning element 1046 is not fully inflated.

[0207] The indicator 1002 can include a first indicator 1003a and a second indicator 1003 b. When the positioning element 1046 is not fully inflated, the first indicator 1003a can be seen through the opening 1006 of the handle 1023. When the positioning element 1046 is fully inflated, the second indicator 1003b can be seen through the opening 1006 of the handle 102

[0208] Any of the sealant delivery devices detailed in this specification can be components of a system including, but not limited to, a guide wire or an expander. The guide wire can have any of the functional features described for the guide wire 799 above. The expander can also have one or more of the functional features described for the expander 790 above and / or the expander 1190 (Figs. 30A - 30B) and the expander 1290 (Figs. 31A - 31C) described below. As described with reference to the guide wire 799 above, the guide wire can have any of the functional features described above. As described with reference to the expander 790 above and / or the expander 1190 (Figs. 30A - 30B) and the expander 1290 (Figs. 31A - 31C) described below, the expander can have one or more of the functional features described above. As shown and described in Figs. 30A - 31C, the expander can have a fluid lumen through which blood can flow from an inflow opening near the distal tip of the expander to an outflow opening near the proximal end of the expander. When the tip of the sheath enters the blood vessel, blood flows out from the proximal port. Advance the sheath further to ensure that the distal tip of the sheath is within the blood vessel lumen.

[0209] As shown in Figs. 30A - 30D, the expander 1190 has an elongated body 1191 through which a lumen passes. The expander 1190 can further have a proximal portion 1193 having an expander hub 1196 that engages the sheath and / or a distal portion 1192 having a tapered end. As shown in Fig. 30A, the expander hub 1196 can be U - shaped. The U - shaped expander hub 1196 defines an opening for receiving the proximal end of the sheath. The expander hub 1196 can further have hub members 1197a, 1197b configured to engage the outer surface of the sheath.

[0210] The expander hub 1196 can further have one or more flanges that engage corresponding functional features of the sheath. For example, as shown in Fig. 30A, the expander hub 1196 can be U - shaped. The U - shaped expander hub 1196 defines an opening for receiving the proximal end of the sheath. The expander hub 1196 can further have hub members 1197a, 1197b configured to engage the outer surface of the sheath. The expander hub 1196 can further have one or more flanges that engage corresponding functional features of the sheath. For example, as shown in Fig. 30A, the expander hub 1196 can be U - shaped. As such, the hub members 1197a, 1197b can have flanges 1198a, 1198b, and / or the hub 1196 can have flanges 1199a, 1199b near the top surface of the expander hub. The expander 1190 can further be provided with a backflow function feature that helps determine the direction of entry of the end portion 1192 of the expander 1190 into the blood vessel. For example, the expander 1190 can have one or more inflow openings 1194 in the end portion 1192 of the expander 1190. As shown in FIG. 30A, the expander 1190 can have two inflow openings 1194. The inflow openings 1194 can be arranged at the proximal end side of the tapered portion of the elongated body 1191 and / or along the same plane perpendicular to the longitudinal axis of the expander 1190. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196.

[0211] The lumen penetrating the elongated body 1191 can have a variable diameter. For example, the lumen can have a first diameter 1189 at the end portion 1192 and the proximal end portion 1193 of the elongated body 1191, and a second diameter 1 between the end portion 1192 and the proximal end portion 1193. The expander 1190 can further be provided with a backflow function feature that helps determine the direction of entry of the end portion 1192 of the expander 1190 into the blood vessel. For example, the expander 1190 can have one or more inflow openings 1194 in the end portion 1192 of the expander 1190. As shown in FIG. 30A, the expander 1190 can have two inflow openings 1194. The inflow openings 1194 can be arranged at the proximal end side of the tapered portion of the elongated body 1191 and / or along the same plane perpendicular to the longitudinal axis of the expander 1190. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further be provided with a backflow function feature that helps determine the direction of entry of the end portion 1192 of the expander 1190 into the blood vessel. For example, the expander 1190 can have one or more inflow openings 1194 in the end portion 1192 of the expander 1190. As shown in FIG. 30A, the expander 1190 can have two inflow openings 1194. The inflow openings 1194 can be arranged at the proximal end side of the tapered portion of the elongated body 1191 and / or along the same plane perpendicular to the longitudinal axis of the expander 1190. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further be provided with a backflow function feature that helps determine the direction of entry of the end portion 1192 of the expander 1190 into the blood vessel. For example, the expander 1190 can have one or more inflow openings 1194 in the end portion 1192 of the expander 1190. As shown in FIG. 30A, the expander 1190 can have two inflow openings 1194. The inflow openings 1194 can be arranged at the proximal end side of the tapered portion of the elongated body 1191 and / or along the same plane perpendicular to the longitudinal axis of the expander 1190. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196. The expander 1190 can further have one or more outflow openings 1195 arranged on the proximal end side of the expander hub 1196. As shown in FIG. 30A, the expander 1190 can have one outflow opening 1195. The outflow opening 1195 can be arranged along the same plane as one of the inflow openings 1194. The expander hub can have a direction indication feature 1197 indicating the direction in which the blood flow exits. As shown in FIG. 30C, the direction indication feature 1197 can be an arrow along the top surface of the expander hub 1196.

[0212] The lumen penetrating the elongated body 1191 can have a variable diameter. For example, the lumen can have a first diameter 1189 at the end portion 1192 and the proximal end portion 1193 of the elongated body 1191, and a second diameter 1 between the end portion 1192 and the proximal end portion 1193. The lumen penetrating the elongated body 1191 can have a variable diameter. For example, the lumen can have a first diameter 1189 at the end portion 1192 and the proximal end portion 1193 of the elongated body 1191, and a second diameter 1 between the end portion 1192 and the proximal end portion 1193. The lumen penetrating the elongated body 1191 can have a variable diameter. For example, the lumen can have a first diameter 1189 at the end portion 1192 and the proximal end portion 1193 of the elongated body 1191, and a second diameter 1 between the end portion 1192 and the proximal end portion 1193. can have 188. The first diameter 1189 is smaller than the second diameter 1188 and can be. The first diameter 1189 is larger than the outer diameter of the guide wire, and the second diameter 1188 can be smaller. In some embodiments, the first diameter 11 89 is at least about half of the second diameter 1188, and / or smaller than or equal to about 3 / 4 of the second diameter 1188 and can be. In some embodiments, the first diameter 1189 is about 2 / 3 of the second diameter 1188.

[0213] The lumen diameter can be variable while the outer diameter of the elongated body 1191 remains the same. For example, the proximal end portion 1193 can have the same outer diameter as the portion between the proximal end portion 1193 and the distal end portion 1192. With the variable diameter, the proximal end portion 1 193 and the distal end portion 1192 of the dilator 1190 can form a seal around the guide wire. In this way, blood flows to the outflow opening 1195 only via the inflow opening 1194. Thus, blood flows to the outflow opening 1195 only via the inflow opening 1194.

[0214] Figures 31A - C have an elongated body 1291 through which the lumen passes. The dilator 1290 further can have a proximal end portion 1293 having a dilator hub 1296 that engages with the sheath, and / or a distal end portion 1292 having a tapered end. As shown in Figure 31A, the dilator hub 1296 can have hub members 1297a, 1297b configured to engage the outer surface of the sheath. For example, the sheath can have corresponding functional features that accommodate the hub members 1297a, 1297b. The hub members 1297a, 1297b further can have one or more flanges that engage the corresponding functional features of the sheath and can It can be cut. For example, as shown in FIG. 31A, the hub members 1297a, 1297b have outward flanges 1298a, 1298b and / or inward flanges 1299a, 1299b. The flanges can be disposed in the vicinity of the hub members 1297a, 1297b (e.g., flanges 1299a, 1299b) and / or at the end portions (e.g., flanges 1298a, 1298b). The dilator 1290 can further have a backflow function feature useful for determining the time when the end portion 1292 of the dilator 1290 enters the blood vessel. For example, the dilator 1290 can have one or more inflow openings 1294 at the end side portion 1292 of the dilator 1290. As shown in FIG. 31A, the dilator 1290 can have two inflow openings 1294. The inflow openings 1294 can be disposed at the proximal side of the tapered portion of the elongated body 1291 and / or along the same plane orthogonal to the longitudinal axis of the dilator 1290. The dilator 1290 can further have one or more outflow openings 1295. As shown in FIG. 31A, the dilator 1290 can have one outflow opening 1295. In some embodiments, the outflow opening 1295 can be disposed along the same plane as one of the inflow openings 1294. In other embodiments, the outflow opening 1295 can be disposed in a plane different from any of the inflow openings 1294. For example, the outflow opening 1295 can be disposed on a plane orthogonal to the plane passing through the inflow openings 1294. The lumen penetrating the elongated body 1291 can have a variable diameter. For example, the lumen

[0215] The dilator 1290 can further have a backflow function feature useful for determining the time when the end portion 1292 of the dilator 1290 enters the blood vessel. For example, the dilator 1290 can have one or more inflow openings 1294 at the end side portion 1292 of the dilator 1290. As shown in FIG. 31A, the dilator 1290 can have two inflow openings 1294. The inflow openings 1294 can be disposed at the proximal side of the tapered portion of the elongated body 1291 and / or along the same plane orthogonal to the longitudinal axis of the dilator 1290. The dilator 1290 can further have one or more outflow openings 1295. As shown in FIG. 31A, the dilator 1290 can have one outflow opening 1295. In some embodiments, the outflow opening 1295 can be disposed along the same plane as one of the inflow openings 1294. In other embodiments, the outflow opening 1295 can be disposed in a plane different from any of the inflow openings 1294. For example, the outflow opening 1295 can be disposed on a plane orthogonal to the plane passing through the inflow openings 1294. The lumen penetrating the elongated body 1291 can have a variable diameter. For example, the lumen The dilator 1290 can further have a backflow function feature useful for determining the time when the end portion 1292 of the dilator 1290 enters the blood vessel. For example, the dilator 1290 can have one or more inflow openings 1294 at the end side portion 1292 of the dilator 1290. As shown in FIG. 31A, the dilator 1290 can have two inflow openings 1294. The inflow openings 1294 can be disposed at the proximal side of the tapered portion of the elongated body 1291 and / or along the same plane orthogonal to the longitudinal axis of the dilator 1290. The dilator 1290 can further have one or more outflow openings 1295. As shown in FIG. 31A, the dilator 1290 can have one outflow opening 1295. In some embodiments, the outflow opening 1295 can be disposed along the same plane as one of the inflow openings 1294. In other embodiments, the outflow opening 1295 can be disposed in a plane different from any of the inflow openings 1294. For example, the outflow opening 1295 can be disposed on a plane orthogonal to the plane passing through the inflow openings 1294. The lumen penetrating the elongated body 1291 can have a variable diameter. For example, the lumen The dilator 1290 can further have a backflow function feature useful for determining the time when the end portion 1292 of the dilator 1290 enters the blood vessel. For example, the dilator 1290 can have one or more inflow openings 1294 at the end side portion 1292 of the dilator 1290. As shown in FIG. 31A, the dilator 1290 can have two inflow openings 1294. The inflow openings 1294 can be disposed at the proximal side of the tapered portion of the elongated body 1291 and / or along the same plane orthogonal to the longitudinal axis of the dilator 1290. The dilator 1290 can further have one or more outflow openings 1295. As shown in FIG. 31A, the dilator 1290 can have one outflow opening 1295.

[0216] The lumen penetrating the elongated body 1291 can have a variable diameter. For example, the lumen The lumen may have a first diameter 1289 at the distal end portion 1292 and the proximal end portion 1293 of the elongated structure 1291, and a second diameter 1288 between the distal end portion 1292 and the proximal end portion 1293. The first diameter 1289 may be smaller than the second diameter 1288. The first diameter 1289 may be larger than the outer diameter of the guide wire and smaller than the second diameter 1288. In some embodiments, the first diameter 1289 may be at least about half of the second diameter 1288 and / or less than or equal to about 3 / 4 of the second diameter 1288. In some embodiments, the first diameter 1289 is about 2 / 3 of the second diameter 1288. The lumen diameter can be variable while the outer diameter of the elongated structure 1291 remains the same. For example, the proximal end portion 1293 can have the same outer diameter as the portion between the proximal end portion 1293 and the distal end portion 1292. With the variable diameter, the proximal end portion 1293 and the distal end portion 1292 of the dilator 1290 can form a seal around the guide wire. In this way, blood flows to the outflow opening 1295 only via the inflow opening 1294. In any of the dilators described above, the diameter of any outflow opening can be smaller than the diameter of any inflow opening. For example, the diameter of any outflow opening can be smaller than or equal to half of the diameter at any inflow opening. Figures 32A - 32E show how any of the positioning assemblies described above engages with the sheath. Figure 32A shows the device 1310 before introducing the device 1310 into the sheath 1380.

[0217]

[0218]

[0219] ​ is shown. The device 1310 can have any of the functional features of the above-described sealant delivery device. The positioning assembly 1314 engages the sheath 1380, whereby the sheath 1380 can also be moved by the movement of the handle 1 323. For example, the handle 1323 can have a shroud portion 1376 configured to engage the hub 1383 of the sheath 1380. As shown in FIG. 32A, the shroud 1376 has two fork-shaped teeth 1 378, and each fork-shaped tooth 1378 can have a reverse barb 1379 disposed at the end portion of the fork-shaped tooth 1378. The hub 1383 can have an opening 1385 for receiving the fork-shaped teeth 1378. Other clamping mechanisms without fork-shaped teeth, such as snap fits, interference fits, or other screw mechanisms, can also be used to connect the device 1310 to the sheath 1380. As described above, the sealant 1302 is initially disposed at the end portion of the positioning assembly 1314 (see FIG. 32A). Before the positioning assembly 1314 enters the sheath 1380, the sealant sleeve 1350 covers the sealant 1302 to prevent the sealant 1302 from being exposed to the environment. The sealant sleeve 1350 can have any of the functional features of the sealant sleeve 450 as described above. When the positioning assembly 1314 enters the sheath 1380, the sealant 1302 is transferred from the sealant sleeve 1350 to the sheath 13

[0220] 80 (see FIG. 32B). The sheath hub 1383 and / or the shroud 1376 holds the sealant sleeve 1350. The sheath hub 1383 and / or the shroud 137 6 retracts the sheath 1380 (FIG. 32C) or uses the support member 1330 to apply the sealant. As described above, the sealant sleeve 1350 can have any of the functional features of the sealant sleeve 450. When the positioning assembly 1314 enters the sheath 1380, the sealant 1302 is transferred from the sealant sleeve 1350 to the sheath 13 80 (see FIG. 32B). The sheath hub 1383 and / or the shroud 1376 holds the sealant sleeve 1350. The sheath hub 1383 and / or the shroud 137 6 holds the sealant sleeve 1350. The sheath hub 1383 and / or the shroud 137 6 retracts the sheath 1380 (FIG. 32C) or uses the support member 1330 to apply the sealant. Even when tamping (FIG. 32D), the sealant sleeve 1350 is held.

[0221] In some embodiments, as shown in FIG. 33, the fork-shaped teeth engage outside the sheath hub 1483 . For example, the hub 1483 can have a groove 1486 configured to engage the barb 1478 . The sheath hub 1483 further has an inner diameter portion smaller than the outer diameter of the sealant 1450, facilitating the transfer of the sealant from the sealant sleeve 1450 to the sheath 1480 .

[0222] FIGS. 34A-34I show a method of using a system having any of the sealant delivery devices and dilators described herein. This method can have one or more of the steps described below. Insert a treatment sheath (not shown) into the blood vessel wall 1506 from the puncture portion 1504 to secure access to the blood vessel lumen. After passing the guide wire 1502 through the treatment sheath and inserting it into the blood vessel, remove the treatment sheath from the tissue, leave the guide wire 1502 in place, and position the tip at the distal end of the guide wire 1502 within the blood vessel lumen . Next, advance the dilator 1508 into the closure system sheath 1510, and the dilator-sheath assembly can be advanced onto the guide wire 1502 (FIG. 34A). Any of the mechanisms described above (e.g., a bleed-back port in the dilator and / or sheath) can be used to determine when the dilator-sheath assembly enters the blood vessel lumen. After the distal end of the sheath 1510 penetrates into the blood vessel lumen, withdraw the dilator 1508 and the guide wire 1502 in the proximal direction and remove them, and also position the distal end of the sheath 1510 in the blood vessel lumen .

[0223] After the distal end of the sheath 1510 penetrates into the blood vessel lumen, withdraw the dilator 1508 and the guide wire 1502 in the proximal direction and remove them, and also position the distal end of the sheath 1510 in the blood vessel lumen . Place it within the lumen (Figure 34B). Next, introduce the positioning assembly 1512 into the proximal end portion of the sheath 1510 and advance it distally within the sheath 1510 (Figures 34C - E). As described in this specification, the positioning assembly 1512 can have a sealing material 1516 located at the distal portion of the positioning assembly 1512 before entering the sheath 1510. After protruding the positioning element 1514 from the distal end of the sheath 1510 and inserting it into the blood vessel lumen, the positioning element 1514 can be expanded within the blood vessel lumen (Figure 34F). Next, the positioning assembly 1512 can be withdrawn, the positioning element 1514 can be seated on the blood vessel puncture site 1504, and the sealing material 1516 and the sheath 1510 can be disposed outside the blood vessel wall 1506 (Figure 34G). After that, the sheath 1510 can be partially retracted to expose the sealing material 1516 (Figure 34H). Next, the support member 1518 can be advanced to tamp the sealing material 1516 against the blood vessel wall 1506 (Figure 34I). After that, the positioning element 1514 reduces its cross - section (e.g., constricts) and is retracted proximally so as to pass through the sealing material 1516. The support member 1518 keeps pressing the sealing material while the positioning element 1514 is retracting proximally to maintain the position of the sealing material. After removing the positioning element 1514, if the support member 1518 and the sheath 1510 are still present within the tissue path, they are removed from the patient and the sealing material 1516 is placed adjacent to the blood vessel wall 15056. In one embodiment of the present invention, the positioning element 1514 is an elongated balloon catheter shaft

[0224]

[0225] ​​​​​​​​​​​​​​​It is a balloon that can be inflated and is carried in the distal region of the foot. The balloon catheter shaft has an elongated tubular body through which the central lumen passes, and fluidly connects the inflatable balloon to the inflation medium source which is connected to the proximal end of the shaft. The central core wire passes through at least a part of the central lumen and through the balloon to support the distal end of the balloon. The core wire projects distally beyond the balloon by at least about 2 mm to 10 cm, and preferably at least 3 cm to 5 cm in length to form a flexible advancing segment. This can be achieved.

[0226] The inner diameter of the central lumen is larger than the outer diameter of the core wire and forms an inflation lumen to inflate the balloon.

[0227] The sealing material 1516 is provided with a central lumen and can preferably be pre-attached to the proximal side of the inflatable balloon at the distal end of the balloon catheter shaft. The sealing material 15 16 is formed as a cylindrical plug through which the central lumen passes. As an alternative, the sealing material 15 16 is provided in the form of a sheet or film and can be wound around the catheter shaft to form two, or three, or four, or more layers.

[0228] For example, referring to FIGS. 34F and 34G, the sealing material is pre-disposed at the distal end of the catheter shaft and is spaced a short distance from the proximal side surface of the inflated balloon. This spacing is dimensioned to be related to the expected wall thickness of the blood vessel as shown in FIG. 34G, whereby the inflated balloon is positioned to abut against the inner wall of the blood vessel and the sealing material is positioned adjacent to the outer wall of the blood vessel and disposed at the external puncture site. The distal end of the sealing material and the proximal surface of the balloon ​​​​ The separation distance measured axially between them is typically about 4 mm, and in some embodiments is not greater than about 3 mm or 2 mm.

[0229] Using this configuration, the sealing material is pre - disposed on the balloon catheter shaft at the time of manufacture or at any clinical location prior to introducing the balloon catheter into the patient. Thereafter, the balloon catheter and the sealing material are guided as a single unit by the sheath 1510 into the proximal end of the sheath 1510 from outside the patient and further guided by the sheath 1510 to the blood vessel wall. Thereafter, the balloon is inflated within the blood vessel, and the system can be withdrawn as a unit in the proximal direction from the distal - side position shown in FIG. 34F to the seating position at the proximal - side shown in FIG. 34G without any internal relative movement between the balloon catheter and the sealing material. Thereafter, the sealing material is exposed by the proximal - direction retraction of the outer sleeve. The present invention can be modified in various ways and can take alternative forms. However, specific examples of the present invention have been shown in the drawings and described in detail herein. However, the present invention is not limited to the specific forms or methods described, but on the contrary, the present invention covers all modifications, equivalents, and alternatives within the scope of the claims.

[0230] ​

Claims

1. 1. An apparatus for sealing a puncture in a blood vessel wall, comprising: a positioning element positioned at a distal end portion of the positioning assembly; the positioning assembly having a seal disposed at an end portion; A support member axially advanceable along the positioning assembly and adapted to contact the sealant. Materials and An apparatus comprising:

2. 2. The apparatus of claim 1, wherein the positioning assembly further comprises: the apparatus having a sealant sleeve partially surrounding both the first and second electrodes.

3. 2. The apparatus of claim 1, further comprising a spring releasably engaging said positioning assembly. An apparatus comprising:

4. 4. The device of claim 3, wherein the sheath has a hub portion, the hub portion being configured to include a sealing member. The apparatus has a cavity configured to receive a sleeve of material.

5. 5. The apparatus of claim 4, further comprising a handle, and wherein the positioning assembly comprises: A hub portion of the sheath extends from the handle and releasably engages the handle. A device.

6. 4. The apparatus of claim 3, wherein the inner diameter of the sheath is smaller than the outer diameter of the sealant sleeve. Please, device.

7. 10. The apparatus of claim 1, wherein the encapsulant is disposed adjacent to the positioning element. 。

8. 1. An apparatus for sealing a puncture in a blood vessel wall, comprising: a positioning assembly having a seal disposed at a distal end portion of the positioning assembly; a sheath within which the positioning assembly is axially advanceable; and A handheld having an outer handle portion configured for relative movement with respect to an inner housing portion. a handle portion removably connected to the sheath; An apparatus comprising:

9. 9. The device of claim 8, further comprising a positioning member movable between a non-expanded state and an expanded state. a positioning element for positioning at a distal end portion of the positioning assembly; Device.

10. 9. The device of claim 8, wherein the handle further comprises: the inner housing portion and the a first actuator configured to isolate movement between the outer handle portion and the Place.

11. 9. The device of claim 8, wherein the handle is adapted to advance a support member within the sheath. and a second actuator configured to:

12. 12. The device of claim 11, wherein the handle further comprises a rack and pinion. and the second actuator is linked to the pinion and moves the rack. A device that makes something happen.

13. 9. The apparatus of claim 8, wherein the handle is attached to the support member of the positioning assembly. and a third actuator configured to control movement relative to the

14. 14. The apparatus of claim 13, wherein the third actuator is adapted to pass through the sealing material. and configured to retract the positioning element.

15. 14. The apparatus of claim 13, wherein the third actuator is disposed in the inner housing portion. A device that allows a sliding motion relative to a surface.

16. 9. The device of claim 8, wherein the sheath has a hub, the hub being detachably attached to the handle. A device that connects to Noh.

17. 17. The apparatus of claim 16, wherein the positioning assembly further comprises: The apparatus has a sealant sleeve.

18. 18. The device of claim 17, wherein the hub is adapted to mount the positioning assembly within the sheath. a cavity that receives a portion of the sealant sleeve when inserted.

19. 9. The apparatus of claim 8, wherein the inner housing portion is attached to the positioning assembly. A device for releasably connecting.

20. 1. A method of sealing a puncture in a blood vessel wall, comprising: a sheath advancing step of advancing a sheath into the blood vessel; Advancing a positioning assembly within the sheath such that a positioning element enters the blood vessel. A positioning assembly advancing step, the positioning assembly The positioning assembly advance stage carries a seal disposed at an end portion of the bridge. Top and a sheath retraction step of retracting the sheath to expose the sealing material to the outside of the blood vessel; The method comprising:

21. 21. The method of claim 20, further comprising the step of expanding the positioning element within the blood vessel. The method has a

22. 21. The method of claim 20, further comprising: retracting the positioning element in a proximal direction; The method includes seating a positioning element against the vessel wall.

23. 21. The method of claim 20, further comprising advancing the positioning assembly within the sheath. and then releasably engaging the positioning assembly and the sheath. How to do it.

24. 24. The method of claim 23, further comprising releasing the positioning assembly from the sheath. The method comprising the steps of:

25. 25. The method of claim 24, further comprising releasing the positioning assembly from the sheath. reengaging the positioning assembly and the sheath after 。

26. 21. The method of claim 20, further comprising advancing a support member to tamp the sealant. The method comprising the steps of:

27. 21. The method of claim 20, further comprising removing the positioning assembly from the support member. Releasing.

28. 21. The method of claim 20, further comprising passing the positioning element through the sealant. retracting to leave the sealant in place.

29. 21. The method of claim 20, wherein the advancement of the positioning assembly causes the sealing material to be sealed. transferring a stopper from a sleeve to the sheath.

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