Method and device for forming an arteriotomy corresponding to the center via a catheter

Abstract

Disclosed are various embodiments of an arteriotomy forming system comprising a central puncture device and an arteriotomy forming device, and related methods. The central puncture device may include a puncture element that forms a perforation along the wall of a first blood vessel at a position corresponding to the center of the catheter passage of the catheter. The arteriotomy forming device may comprise a tissue fixation element, a tissue capture element, and a tissue resection element. The arteriotomy forming device may form an arteriotomy along the first blood vessel such that the arteriotomy is centered with respect to the catheter passage.

Description

Background Art

[0001] When attaching an anastomosis to a blood vessel, the blood vessel can be clamped distal and proximal to the intended access site to that blood vessel. Such a clamping operation can completely interrupt blood flow for a period of time (e.g., about 10 minutes to about 35 minutes) necessary to attach a conduit to the blood vessel at the intended access site, for example. This can result in blood vessel damage, blood vessel dissection, and patient discomfort. In patients suffering from collateral blood flow insufficiency, complete interruption of blood flow is not tolerable.

[0002] In addition, if an arteriotomy is formed prior to attachment of the anastomosis, the arteriotomy may not be centered at the inner diameter of the anastomosis. This can lead to tracking problems of the device due to friction with the arteriotomy, obstruction of the anastomosis, and / or expansion of the arteriotomy outside the suture line of the anastomosis. Furthermore, it can be difficult to safely and effectively form an arteriotomy along the blood vessel through the attached anastomosis. Thus, methods and devices for overcoming problems related to arteriotomy and anastomosis procedures are desired.

Summary of the Invention

[0003] Aspects of the present subject matter described herein relate to embodiments of an arteriotomy formation system and related methods. In one aspect, the arteriotomy formation system is described as comprising a central puncture device. The central puncture device may comprise an elongate cylindrical body having an outer wall that slidably engages an inner guide wall of a catheter that is joined to a first blood vessel. The elongate cylindrical body may comprise a centering passage that extends along a longitudinal axis of the elongate cylindrical body. The central puncture device may further comprise a puncture element that is movable along the centering passage. The puncture element is movable between a retracted configuration and an extended configuration, and a distal end of the puncture element may be disposed inside the centering passage in the retracted configuration. The distal end of the puncture element extends outside the elongate cylindrical body in the extended configuration, and the puncture element extends along the longitudinal axis of the elongate cylindrical body to enable formation of a puncture along a wall of the first blood vessel at a position corresponding to the center of the catheter passageway.

[0004] The arteriotomy formation system may further comprise an arteriotomy formation device, the arteriotomy formation device comprising a tissue fixation element comprising an elongate body having a fixation passage that extends along a length of the tissue fixation element. The arteriotomy formation device may further comprise a tissue capture element configured to form a first configuration having a first outer diameter and a second configuration having a second outer diameter that is larger than the first outer diameter. The first configuration may enable the capture element to pass through the puncture, and the second configuration may enable the tissue capture element to capture tissue excised from the wall of the first blood vessel. The arteriotomy formation device may further comprise a tissue resection element movable relative to the tissue fixation element and the tissue capture element to form an arteriotomy along the wall of the first blood vessel. The tissue resection element may comprise an outer resection wall that slidably engages an inner guide wall of the catheter and may form an arteriotomy along the first blood vessel corresponding to the center of the catheter passageway.

[0005] In some variations, one or more of the following features may optionally be included in any feasible combination. The tissue capture element may include an inflatable balloon. This inflatable balloon is in a disc shape in the second form. The first outer diameter may be smaller than the diameter of the perforation. The tissue resection element may include a radiofrequency (RF) electrode. The tissue resection element may include a distal probe configured to perform electrocautery. The tissue resection element may include at least one expandable blade. The elongated cylindrical body may include an inclined distal end. The conduit may include a sheath or a second blood vessel. The puncture element may include a removable guide wire extending through the puncture element. The capture element may be configured to move slidably along this guide wire.

[0006] In another aspect related to each other of the present subject matter, a method of an arteriotomy formation system may include forming a perforation along the wall of a first blood vessel of a patient. This perforation may be formed at a position corresponding to the center with respect to the conduit passage of the conduit by the central puncture device of the arteriotomy formation system. The central puncture device may include an elongated cylindrical body having an outer wall that slidably engages with the inner conduit wall of the conduit joined to the first blood vessel, and this elongated cylindrical body may include a centering passage extending along the longitudinal axis of the elongated cylindrical body. The central puncture device may include a puncture element movable along the centering passage, and this puncture element may be movable between a retracted form and an extended form. The distal end of the puncture element may be disposed inside the centering passage when in the retracted form, and the distal end of the puncture element may extend outside the elongated cylindrical body when in the extended form. The puncture element enables the formation of the perforation along the wall of the first blood vessel at a position corresponding to the center with respect to the conduit passage of the conduit by extending along the longitudinal axis of the elongated cylindrical body.

[0007] The method may further include forming an arteriotomy along the wall of the first blood vessel. This arteriotomy may be formed at a position corresponding to the center with respect to the conduit passage of the conduit by an arteriotomy forming device. The arteriotomy forming device may include a tissue fixation element having an elongated body with a fixation passage extending along the length of the tissue fixation element, and a tissue capture element configured to form a first form having a first outer diameter and a second form having a second outer diameter larger than the first outer diameter. The first form may enable the capture element to pass through the perforation, and the second form may enable the tissue capture element to capture tissue cut from the wall of the first blood vessel. The arteriotomy forming device may include a tissue resection element movable relative to the tissue fixation element and the tissue capture element for forming an arteriotomy along the wall of the first blood vessel, and the tissue resection element may include an outer resection wall that slidably engages with the inner conduit wall of the conduit to form an arteriotomy along the first blood vessel such that the arteriotomy corresponds to the center with respect to the conduit passage.

[0008] In some variations, one or more of the following features may be optionally included in any practicable combination. The method may further include capturing tissue cut from the wall of the first blood vessel using the tissue capture element and removing the captured tissue from the patient. The tissue capture element may include an inflatable balloon. This inflatable balloon may form a disc shape in the second form. The first outer diameter may be smaller than the diameter of the perforation. The tissue resection element may include a radiofrequency (RF) electrode. The tissue resection element may include a distal probe configured to perform electrocautery. The tissue resection element may include at least one expandable blade. The elongated cylindrical body may include an inclined distal end. The conduit may include a sheath or a second blood vessel. The puncture element may include a removable guide wire extending therethrough. The capture element may be configured to slidably move along this guide wire.

[0009] Details regarding one or more variations of the subject matter described in this specification are set forth in the accompanying drawings and the following description. Other features and advantages of the subject matter described in this specification will become apparent from the description, the drawings, and the claims.

Brief Description of the Drawings

[0010] To further clarify the above and other advantages of the present invention, as well as the features of the present invention, a more specific description of the present invention is made by referring to the specific embodiments thereof shown in the accompanying drawings. These drawings depict only the embodiments for explaining the present invention, and thus are not considered to limit the scope of the present invention. The present invention is described and explained with additional specific examples and details by using the accompanying drawings.

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5

Figure 6

Figure 7

Figure 8

[0011] The same or similar reference numerals represent the same or similar or equivalent structures, features, aspects, or elements according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0012] The disclosed methods, devices, and systems are directed to efficiently and effectively forming an arteriotomy, for example, during a procedure related to anastomosis. For example, various embodiments of an arteriotomy formation system are disclosed that include a central puncture device and an arteriotomy formation device. The central puncture device aids in extending along a conduit and forming a puncture along the wall of a blood vessel that is disposed substantially centrally with respect to the passage of the conduit. For example, the arteriotomy formation device may utilize the puncture disposed centrally by the central puncture device to form an arteriotomy (e.g., a blood vessel wall opening that is expanded compared to the puncture) that is disposed centrally with respect to the passage of the conduit. The arteriotomy formation system can efficiently and consistently form an arteriotomy that is centered and of a known and desired size (e.g., with respect to an adjacent conduit). As such, the arteriotomy formation system can minimize the risk of bleeding and tissue damage, maximize the ease of device tracking (e.g., by reducing friction with the tissue around the arteriotomy), and maximize the ability to oppose short circuit blood flow to minimize embolism. Other benefits associated with the arteriotomy formation system may include the ability to minimize or prevent damage to the formed anastomosis by the appropriately sized and centered anastomosis, e.g., the ability to prevent expansion of the arteriotomy outside of the suture line of the anastomosis.

[0013] Furthermore, embodiments of the arteriotomy formation system disclosed herein may form an arteriotomy after anastomosis or conduit attachment. This can at least reduce the length of time required for complete interruption of blood flow at one or more locations in the body, thus potentially reducing the likelihood of vascular damage and / or enabling a patient suffering from circulatory insufficiency to undergo an anastomosis procedure.

[0014] In some embodiments, the arteriotomy forming system comprising the central puncture device and the arteriotomy forming device can be sized to assist in performing arteriotomies related to various procedures, including anastomosis procedures related to various parts of the body. As such, the arteriotomy forming system can be used in various vascular structures, including, without departing from the scope of the present disclosure, the common femoral artery, the subclavian artery, the carotid artery, the jugular vein, the inferior vena cava, the aorta, the apex of the left or right ventricle of the heart, and the like. Further, the arteriotomy forming system can be used with one or more of various access systems and various sheaths.

[0015] Various embodiments of an arteriotomy forming system that can include a central puncture device and an arteriotomy forming device are described below, along with exemplary arteriotomy procedures and related methods of use in anastomosis procedures.

[0016] FIG. 1 shows one embodiment of a central puncture device 102 of an arteriotomy forming system 100. The central puncture device 102 may be configured to be inserted into the proximal end of a conduit, such as a conduit connected to the wall of a blood vessel. For example, the central puncture device 102 may extend along the length of the conduit passage of the conduit and form a puncture through the wall of the blood vessel. The formed puncture may extend generally along the longitudinal axis of the central puncture device and the conduit. As disclosed in more detail below, the centrally located puncture can provide a guide for efficiently and effectively forming an arteriotomy of a desired shape and size along the wall of the blood vessel that is centered with the conduit passage.

[0017] As shown in FIG. 1, the central puncture device 102 may include an elongated cylindrical body 105 extending from the connecting end 106 of the central puncture device 102. For example, the elongated cylindrical body 105 may include an outer wall 107 having a diameter that is the same as or slightly smaller than the inner wall diameter of the conduit (e.g., a diameter that is approximately 1 mm smaller), along which the elongated cylindrical body 105 may extend to form a puncture. For example, the outer wall 107 of the elongated cylindrical body 105 may have a diameter such that the outer wall 107 is substantially in a slip fit or slip engagement with the inner wall of the conduit. The slip fit between the outer wall 107 of the elongated cylindrical body 105 and the inner wall of the conduit may enable the elongated cylindrical body 105 to move along the conduit, for example, to place the distal end of the elongated cylindrical body 105 at or adjacent to the distal end of the conduit while centering the elongated cylindrical body 105 with respect to the conduit. By centering the elongated body 105 with respect to the conduit, the central puncture device 102 may efficiently and effectively form a puncture through the wall of a blood vessel at a position that is substantially at the center point of the distal opening of the conduit.

[0018] As shown in FIG. 1, the elongated cylindrical body 105 may include a centering passage 108, which includes a longitudinal axis of the passage that is collinear with the longitudinal axis of the elongated cylindrical body 105. As such, the centering passage 108 extends centrally along the elongated cylindrical body 105 as shown in FIG. 1. The central puncture device 102 may also include a puncture element 110 that is movable along the centering passage 108. The puncture element 110 may have an elongated puncture body 111 with a sharp and / or inclined distal end 112 for penetrating tissue, e.g., penetrating a blood vessel. The elongated puncture body 111 may have an outer diameter that is smaller than the inner wall 109 of the centering passage 108. In some embodiments, the puncture element 110 may form a slip fit (e.g., a slip engagement) with the inner wall 109 of the centering passage 108, thereby enabling the puncture element 110 to be centered with respect to the elongated cylindrical body 105.

[0019] The piercing element 110 can be movable between a retracted configuration and an extended configuration. In this retracted configuration, the distal end 112 of the piercing element 110 can be disposed within the centering passage 108. In the extended configuration, the distal end 112 of the piercing element 110 can extend outside the elongated cylindrical body 105, for example, to form a perforation that is centered with respect to the centering passage.

[0020] In some embodiments, the distal end 114 of the elongated cylindrical body 105 includes a distal surface 113 that is disposed at an angle with respect to the longitudinal axis of the elongated cylindrical body 105, thereby forming an angled or beveled shape at the distal end 114 of the elongated cylindrical body 105. The angled or beveled shape can enable the distal surface 113 of the piercing element 110 to substantially contact the wall of the blood vessel and to align the elongated cylindrical body 105 at an angle with respect to the wall of the blood vessel, for example, to extend the catheter at the same or a similar angle (with respect to the blood vessel to which it is joined). Without departing from the scope of the present disclosure, other shapes or features can be included at the distal end 114 of the elongated cylindrical body 105. For example, the distal surface 113 can be perpendicular to the longitudinal axis of the elongated cylindrical body 105. For example, the elongated cylindrical body 105 can have an outer wall diameter that is approximately the same as or approximately 1 mm smaller than a catheter (e.g., catheter 120 in FIG. 2B), and the elongated cylindrical body 105 extends along the catheter. In some embodiments, the elongated cylindrical body 105 has a length of approximately 5 cm to approximately 35 cm, which depends on the length of the catheter.

[0021] In some embodiments, the connection end 106 may include at least one valve 115 for controlling a fluid line that may communicate with the central puncture device. For example, valve 115 may include one or more of a hemostatic valve, a rotary hemostatic valve (RHV), a Tuohy Borst valve, a Luer lock, and / or other similar valves. As shown in FIG. 1, the connection end 106 may include an extension 116 that may provide and / or control the working passage of the puncture element 110 along the centering passage 108. For example, the extension 116 may be advanced distally to move the puncture element 110 to the extended configuration, or retracted proximally to move the puncture element 110 to the retracted configuration. Without departing from the scope of the present disclosure, other configurations and couplings may be provided at the connection end 106 of the central puncture device 102.

[0022] Figures 2A-2D illustrate portions of an exemplary arteriotomy procedure using the central puncture device 102. As shown in FIG. 2A, the conduit 120 may be attached to the wall W of the blood vessel V, and the distal conduit end 122 of the conduit 120 may be sutured to the wall W of the blood vessel V. For example, the conduit 120 may be another blood vessel (e.g., formed from tissue). In some embodiments, the conduit 120 may be a sheath and / or may be formed from one or more of a variety of materials including biocompatible materials. As shown in FIG. 2A, the distal conduit end 122 of the conduit 120 may be securely attached to the blood vessel V, for example, using sutures. In some embodiments, the conduit 120 may not be attached to the blood vessel V, and instead, the distal conduit end 122 may be positioned against or adjacent to the blood vessel V. As shown in FIG. 2A, the conduit 120 may include a conduit passage 124 and an inner conduit wall 125 that defines the conduit passage 124.

[0023] After the distal catheter end 122 is positioned and / or fixed at a desired location along the wall W of the blood vessel V, the elongated cylindrical body 105 of the central puncture device 102 may be inserted and advanced along the catheter passage 124. As shown in FIG. 2B, the distal end 114 of the elongated cylindrical body 105 may be advanced along the catheter 120 until the distal surface 113 contacts and / or is adjacent to the wall W of the blood vessel V. The distal surface 113 may be angled with respect to the longitudinal axis of the elongated cylindrical body 105 such that the elongated cylindrical body 105 extends along the length of the catheter 120 and the catheter 120 is coupled to the blood vessel V at an angle while aligning the distal surface 113 substantially parallel to the wall W of the blood vessel. This allows the distal end 112 of the puncture element 110 to be efficiently and effectively aligned with the longitudinal axis of the catheter 120 and form a puncture 131 through the wall of the blood vessel along the longitudinal axis of the catheter 120, as shown in FIG. 2C.

[0024] In some embodiments, the distal opening 126 of the catheter 120 may be defined by or along the inner catheter wall 122 at the distal catheter end 122. As shown in FIG. 2C, the distal opening may define a blood vessel wall region 127 along the wall W of the blood vessel V that communicates with the catheter passage 124. Thus, in some embodiments, the blood vessel wall region 127 may be determined by the distal catheter end 122. To reduce friction and damage to the wall W of the blood vessel V, the puncture and / or arteriotomy may be formed at a position corresponding centrally to the distal opening 126 of the catheter 120.

[0025] As shown in FIG. 2C, the guide wire 119 may extend out from the distal end 112 of the puncture element 110 after the distal end 112 of the puncture element 110 has passed through the wall W of the blood vessel V. After the puncture 131 is formed through the wall W of the blood vessel V, the central puncture device 102 may be removed from the catheter 120. In some embodiments, the guide wire 119 remains extending through the puncture 131 to assist, for example, in guiding one or more features of one embodiment of this arteriotomy forming device to the location of the puncture 131 to form an arteriotomy.

[0026] Figures 3A and 3B show one embodiment of an arteriotomy forming device 150 of an arteriotomy forming system 100 for forming an arteriotomy centered on a conduit (e.g., an anastomosis), which can at least guarantee a reduction in damage caused by device tracking, tissue damage, and embolization.

[0027] As shown in FIGS. 3A and 3B, the arteriotomy forming device 150 may include a tissue fixation element 152 configured to contact a portion of the wall of the blood vessel (e.g., the blood vessel wall region 127). In some embodiments, the tissue fixation element 152 may have an elongated tubular shape and may be formed from a material that is rigid enough to allow the tissue fixation element 152 to apply a force to the blood vessel wall region 127. As shown in FIG. 3A, the tissue fixation element 152 may extend from one embodiment of the connection end 206 of the arteriotomy forming device 150. The connection end 206 of the arteriotomy forming device 150 may include at least some of the features described above with respect to the connection end 106 of FIG. 1. In some embodiments, the tissue fixation element 152 may be movable along the longitudinal axis of the arteriotomy forming device 150, for example, with respect to a portion of the connection end 106. For example, the tissue fixation element 152 may be formed from a metal or plastic material, such as one or more stainless steels and biocompatible materials.

[0028] As shown in FIGS. 3A and 3B, the arteriotomy forming device 150 may include a tissue resection element 154 including a distal resection end 155 configured to cut into the wall of the blood vessel to form an arteriotomy. For example, the tissue resection element 154 may have an elongated tubular body with a sharp and / or beveled distal resection end 155. In some embodiments, the tissue resection element 154 may be movable along the longitudinal axis of the arteriotomy forming device 150, for example, with respect to a portion of the connection end 206 and / or the tissue fixation element 152. As shown in FIG. 3A, the tissue resection element 154 may have an inner passage 156 having a diameter larger than that of the tissue fixation element 152 such that the tissue fixation element 152 is disposed along the inner passage 156.

[0029] In some embodiments, the distal resection end 155 of the tissue resection element 154 may have a circular shape, thereby forming a circular arteriotomy along the wall of the blood vessel. Other shapes of the distal resection end 155 are also within the scope of the present disclosure. In some embodiments, the tissue resection element 154 may comprise an outer resection wall 157 having a diameter smaller than the diameter of the conduit along which it is to be extended. For example, the outer resection wall 157 may have a slip fit or a sliding engagement with the inner conduit wall (e.g., the inner conduit wall 125 shown in FIG. 2A), thereby enabling at least the tissue resection element 154 to be centered with respect to its surrounding conduit. This may also enable elements disposed within the tissue resection element 154, such as the tissue fixation element 152 and the like, to be centered with respect to its surrounding conduit.

[0030] For example, the tissue resection element 154 may be formed from a metal or plastic material, such as one or more stainless steels and biocompatible materials. The size of the tissue resection element 154 depends on the size of the conduit used in the procedure. For example, in some embodiments, the tissue resection element 154 may have an outer diameter of approximately 3 mm to 10 mm. In some embodiments, the tissue resection element 154 may have an inner diameter of approximately 2.5 mm to approximately 9.5 mm.

[0031] As shown in FIG. 3A, the tissue fixation element 152 may include a fixation passage 158 that enables the capture element 160 to extend along the fixation passage 158. In some embodiments, the capture element 160 includes a balloon catheter 161 with an inflatable balloon 162 disposed adjacent to the distal end of the balloon catheter 161. For example, the balloon catheter 161 may include a fluid line that allows a fluid source in communication with the connection end 206 to provide fluid (e.g., air) to inflate the balloon 162 to form an inflated configuration as shown in FIG. 3B. For example, the inflated balloon 162 may have a disc shape as shown in FIG. 3B, however, other shapes are also within the scope of the present disclosure. Additionally, the fluid line along the balloon catheter 161 allows fluid to be removed from the balloon 162 to deflate the balloon 162 to form a deflated configuration as shown in FIG. 3A.

[0032] In some embodiments, the capture element 160 may be movable along the longitudinal axis of the arteriotomy forming device 150, for example, relative to the connection end 206 and / or a portion of the tissue fixation element 152. The capture element 160 may have various shapes and sizes. For example, the balloon 162 may be sized based on the size of the tissue resection element 154. In some embodiments, the balloon 162 may have a diameter (when inflated) of approximately 3 mm to approximately 10 mm. In some embodiments, the balloon catheter 161 may have an outer diameter of approximately 0.035 inches (0.889 mm) to approximately 0.040 inches (1.016 mm). For example, the capture element 160 may be formed from one or more of an elastic material, a plastic material, polyurethane, silicon, and a biocompatible material. Although the capture element 160 is described as having an inflatable balloon 162, the capture element 160 may include one or more various features to assist in capturing tissue.

[0033] In some embodiments, the balloon catheter 161 of the capture element 160 has an outer diameter that is smaller than the diameter of the inner fixing wall 159 that defines the fixing passage 158 of the tissue fixing element 152. For example, the outer diameter of the balloon catheter 161 may be sized such that the balloon catheter 161 is in substantially a sliding fit with the inner fixing wall 159 of the tissue fixing element 152. In that way, the tissue fixing element 152 may assist in guiding the balloon 162 and the distal end of the balloon catheter (as well as the surrounding conduit) along the longitudinal axis of the tissue resection element 154, whereby the distal end of the balloon catheter 161 and the balloon 162 are enabled to pass through the perforation 131 formed along the blood vessel to form an arteriotomy that is centered with respect to the distal opening 126 of the conduit 120. In some embodiments, the balloon catheter 161 may comprise a guide wire passage that enables the balloon catheter 161 to move slidably along a guide wire, such as the guide wire 119 that passes through the perforation 131.

[0034] Figures 4A-4D illustrate portions of an exemplary arteriotomy procedure using an arteriotomy forming device 150 to form an arteriotomy centered relative to, for example, the distal opening 126 of conduit 120. As shown in Figure 4A, the distal portion of arteriotomy forming device 150 is inserted into conduit 120 and may extend along the length of conduit 120. For example, arteriotomy forming device 150 may be advanced along conduit passageway 124 (e.g., along guidewire 119) until the distal end of arteriotomy forming device 150 reaches or is adjacent to the wall W of blood vessel V. For example, the distal fixation end 151 of tissue fixation element 152 and / or the distal resection end 155 of tissue resection element 154 may be placed in contact with and / or adjacent to the wall W of blood vessel V, for example, along wall region 127 of the blood vessel. After the distal end of arteriotomy forming device 150 is placed against or adjacent to the wall of the blood vessel, capture element 160 may be advanced distally so that balloon 162 (in a collapsed configuration) can be advanced through puncture 131 (e.g., along guidewire 119) as shown in Figure 4A. As disclosed above, puncture 131 through wall W of blood vessel V may be formed by central puncture device 102 and may be located at or near the center point of wall region 127 of the blood vessel and / or distal opening 126 of conduit 120.

[0035] As shown in Figure 4B, balloon 162 may be filled with fluid (e.g., via a fluid passageway along balloon catheter 161) and deformed to an inflated configuration. After balloon 162 is in the inflated configuration, capture element 160 may be advanced proximally until balloon 162 contacts the wall W of the blood vessel as shown in Figure 4B. In this configuration, at least a portion of wall region 127 of the blood vessel is disposed between balloon 162 and both tissue resection element 154 and tissue fixation element 152. This may enable balloon 162 and tissue fixation element 152 to hold the excised blood vessel wall tissue formed during formation of the arteriotomy by tissue resection element 154, as further described below.

[0036] As shown in FIG. 4C, the distal resection end 155 of the tissue resection element 154 can be advanced through the vessel wall W to excise at least a portion of the vessel wall region 127. The tissue resection element 154 can be advanced toward the balloon 162 until or adjacent to the distal resection end 155 reaches the balloon 162. The excised portion of the vessel wall region 127 can be captured between the balloon 162 and the tissue fixation element 152 and can likewise be surrounded by the tissue resection element 154. In this way, the arteriotomy forming device 150 can be withdrawn and removed from the conduit 120 while containing an excised portion of the vessel wall region 127, thereby preventing unwanted embolism. As shown in FIG. 4D, an arteriotomy 170 along the vessel wall W can be formed, and the excised portion of the vessel wall region 127 can be removed by the arteriotomy forming device 150. Further, as shown in FIG. 4D, the formed arteriotomy 170 can be centered with respect to the conduit 120 (e.g., the center of the arteriotomy can be disposed substantially along the longitudinal conduit axis Lc of the conduit).

[0037] Other embodiments of the arteriotomy forming system 100 (comprising the central puncture device 102 and the arteriotomy forming device 150) and related methods are within the scope of the present disclosure, some of which are described in further detail below.

[0038] FIG. 5 shows an embodiment of the arteriotomy forming device 150, such as the arteriotomy forming device 150 described above with respect to FIGS. 3A and 3B, disposed inside a conduit 120 that is not attached to the blood vessel V. For example, the conduit 120 (e.g., a sheath, trocar) may be formed from metal and / or synthetic materials, such as plastic materials and / or biocompatible materials.

[0039] Figure 6 shows another embodiment of the tissue resection element 254 of the arteriotomy forming device 150. The tissue resection element 254 shown in Figure 6 can excise tissue using radiofrequency (RF). For example, the tissue resection element 254 can include an RF electrode 261 at or adjacent to one embodiment of the distal resection end 260 of the tissue resection element 254. As shown in Figure 6, the RF electrode has a circular shape, and this RF electrode can form a circular arteriotomy along the wall of the blood vessel. Other shaped RF electrodes, such as oval-shaped or elliptical-shaped RF electrodes, are also within the scope of the present disclosure. In use, the RF electrode 261 of the tissue resection element 254 can advance distally toward and / or through the wall of the blood vessel, during which RF energy is sent to the wall of the blood vessel to form an arteriotomy along the wall of the blood vessel.

[0040] Figure 7 shows another embodiment of the tissue resection element 354 of the arteriotomy forming device 150. The tissue resection element 354 shown in Figure 7 can excise tissue using electrocautery. For example, the tissue resection element 254 may have a distal probe 370 that supplies an electric current to incinerate or destroy tissue, such as the wall tissue of a blood vessel, to form an arteriotomy. As shown in Figure 7, the distal probe 370 can have a cone shape or a tapered shape that can form a circular arteriotomy along the wall of the blood vessel. Other shaped distal probes 370, such as oval-shaped or elliptical-shaped distal probes 370, are also within the scope of the present disclosure. In use, the distal probe 370 of the tissue resection element 254 can be advanced distally containing an electric current toward and / or through the wall of the blood vessel. In some embodiments, the distal probe 370 can form an arteriotomy without forming excised tissue pieces to be removed by incinerating and destroying the tissue. Thus, some embodiments of the arteriotomy forming device 150 may lack the capture element 160, for example, when the tissue resection element 354 uses electrocautery to form an arteriotomy.

[0041] FIG. 8 shows another embodiment of the tissue resection element 454 of the arteriotomy forming device 150. The tissue resection element 454 shown in FIG. 8 may include one or more expandable blades 482 that can form an arteriotomy in the wall of a blood vessel. The expandable blade may be disposed along a trocar 484 and may form a folded configuration when passing through the wall of the blood vessel (e.g., puncture 131) and an expanded configuration when forming an arteriotomy. The expandable blade 482 may extend radially away from the trocar 484 and / or be tapered so that arteriotomy formation does not involve removal of the wall tissue of the blood vessel. Thus, some embodiments of the arteriotomy forming device 150 may lack the capture element 160, for example, when the tissue resection element 454 having the expandable blade 482 is used to form an arteriotomy. In some embodiments, one or more expandable blades 482 are spring loaded and retract when the tissue resection element 454 is pushed into the wall of the blood vessel. In some embodiments, one or more expandable blades 482 are actively controlled, for example, by a user, to selectively form the folded configuration and the expanded configuration.

[0042] One or more dimensions of the arteriotomy forming system 100, such as the central puncture device 102 and / or the arteriotomy forming device 150, may be changed and customized to size any part of the arteriotomy forming system 100 for one or more procedures, such as anastomosis and / or arteriotomy procedures associated with one or more of various vascular structures and / or conduits. Thus, the arteriotomy forming system 100 includes the central puncture device 102 and / or the arteriotomy forming device 150 and may be changed and customized to have an outer diameter and an inner diameter that are safe and effective for performing procedures within one or more of the various vascular structures and conduits.

[0043] During any stage of a procedure related to the use of an arterial access formation system 100, such as a central access device 102 and / or an arterial access formation device 150, the blood vessel V can be occluded at one or more locations, for example adjacent to the location where an arteriotomy 170 is formed. For example, manual occlusion of the blood vessel V by a clinician at the occlusion location can be effected from the outside of the blood vessel V using a vascular clamp, such as a Rommel tourniquet or a vascular loop, disposed near the sheath insertion site. Occlusion of the blood vessel V can form an occluded section of the blood vessel, preventing blood from flowing therealong. Once the blood vessel V has been treated by the surgeon, the vascular clamp is released to allow resumption of blood flow. Without departing from the scope of the present disclosure, one or more of a variety of methods can be used to occlude the blood vessel V during the procedure.

[0044] These descriptions include many specific examples, but should not be construed as limitations on the scope of the claimed invention or inventions that may be claimed, but rather as descriptions of specific features of particular embodiments. Specific features described herein in the context of separate embodiments may be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented separately in multiple embodiments or in any suitable sub-combination. Further, features are described above as operating in a particular combination and, even if initially claimed as such, in some cases one or more features from the claimed combination may be excluded from that combination, and the claimed combination may be directed to one sub-combination or various sub-combinations. Similarly, although operations are illustrated in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order or series of orders shown, or that all of the operations shown be performed, to achieve the desired result.

[0045] Although specific versions of various method or device embodiments are described in detail herein, it should be understood that there may be other variations, embodiments, ways of use, and combinations thereof. Accordingly, the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.

Claims

1. An arteriotomy forming system, comprising: An elongated cylindrical body having an outer wall that slidably engages an inner duct wall of a duct joined to a first blood vessel, the elongated cylindrical body having a centering passage extending along a longitudinal axis thereof; A piercing element movable along the centering passage, movable between a retracted configuration and an extended configuration, a distal end of the piercing element being disposed inside the centering passage in the retracted configuration and extending outside the elongated cylindrical body in the extended configuration, the piercing element being configured to form a perforation along a wall of the first blood vessel at a position corresponding to a center with respect to a duct passage of the duct by extending along the longitudinal axis of the elongated cylindrical body; A central piercing device comprising; A tissue fixation element comprising an elongated body having a fixation passage extending along a length thereof; A tissue capture element configured to form a first form having a first outer diameter and a second form having a second outer diameter larger than the first outer diameter, the first form enabling the tissue capture element to pass through the perforation and the second form enabling the tissue capture element to capture tissue cut from a wall of the first blood vessel; A tissue resection element movable relative to the tissue fixation element and the tissue capture element for forming an arteriotomy along a wall of the first blood vessel, the tissue resection element having an outer resection wall that slidably engages the inner duct wall of the duct to form an arteriotomy along the first blood vessel such that the arteriotomy corresponds to a center with respect to the duct passage; An arteriotomy forming device comprising; An arteriotomy forming system comprising.

2. The arteriotomy forming system according to claim 1, wherein the tissue capture element includes an inflatable balloon.

3. The arteriotomy forming system according to claim 2, wherein the inflatable balloon forms a disc shape in the second form.

4. The arteriotomy forming system according to claim 2, wherein the first outer diameter is smaller than a diameter of the perforation.

5. The arteriotomy forming system according to claim 1, wherein the tissue resection element includes a radio frequency (RF) electrode.

6. The arteriotomy forming system according to claim 1, wherein the tissue resection element includes a distal probe configured to perform electrocautery.

7. The arteriotomy formation system according to claim 1, wherein the tissue resection element comprises at least one expandable blade.

8. The arteriotomy formation system according to claim 1, wherein the elongated cylindrical body comprises an inclined distal end.

9. The arteriotomy formation system according to claim 1, wherein the conduit comprises a sheath or a second blood vessel.

10. The arteriotomy formation system according to claim 1, wherein the puncture element comprises a removable guide wire extending therethrough.

11. The arteriotomy formation system according to claim 10, wherein the capture element is configured to move slidably along the guide wire.

12. A method of an arteriotomy formation system, the method comprising: forming a perforation along the wall of a first blood vessel of a patient, the perforation being formed by a central puncture device of the arteriotomy formation system at a position corresponding to the center with respect to the conduit passage of the conduit, the central puncture device being an elongated cylindrical body having an outer wall slidably engaged with an inner conduit wall of the conduit joined to the first blood vessel, the elongated cylindrical body comprising a centering passage extending along a longitudinal axis thereof; a puncture element movable along the centering passage, movable between a retracted configuration and an extended configuration, a distal end of the puncture element being disposed inside the centering passage in the retracted configuration and extending outside the elongated cylindrical body in the extended configuration, the puncture element extending along the longitudinal axis of the elongated cylindrical body to enable formation of the perforation along the wall of the first blood vessel at a position corresponding to the center with respect to the conduit passage of the conduit; comprising forming a perforation; forming an arteriotomy along the wall of the first blood vessel, the arteriotomy being formed by an arteriotomy formation device at a position corresponding to the center with respect to the conduit passage of the conduit, the arteriotomy formation device comprising a tissue fixation element comprising an elongated body having a fixation passage extending along a length thereof. A tissue capture element configured to form a first form having a first outer diameter and a second form having a second outer diameter larger than the first outer diameter, wherein the first form allows the tissue capture element to pass through the perforation, and the second form allows the tissue capture element to capture tissue cut from the wall of the first blood vessel. A tissue resection element movable relative to the tissue fixation element and the tissue capture element for forming an arteriotomy along the wall of the first blood vessel, the tissue resection element having an outer resection wall slidably engaged with the inner guide wall of the conduit to form an arteriotomy along the first blood vessel such that the arteriotomy corresponds to the center of the conduit passage. Comprising forming an arteriotomy. A method of an arteriotomy formation system including.

13. The method according to claim 12, further comprising capturing tissue cut from the wall of the first blood vessel using the tissue capture element and removing the captured tissue from the patient.

14. The method according to claim 12, wherein the tissue capture element includes an inflatable balloon.

15. The method according to claim 14, wherein the inflatable balloon forms a disc shape when in the second form.

16. The method according to claim 14, wherein the first outer diameter is smaller than the diameter of the perforation.

17. The method according to claim 12, wherein the tissue resection element includes a radiofrequency (RF) electrode.

18. The method according to claim 12, wherein the tissue resection element includes a distal probe configured to perform electrocautery.

19. The method according to claim 12, wherein the tissue resection element comprises at least one expandable blade.

20. The method according to claim 12, wherein the elongated cylindrical body has an inclined distal end.

21. The method according to claim 12, wherein the conduit includes a sheath or a second blood vessel.

22. The method according to claim 12, wherein the puncture element includes a removable guide wire extending through the puncture element.

23. The method according to claim 22, wherein the capture element is configured to move slidably along the guide wire.

Images