Equipment for puncturing and expanding biological tissue

Abstract

An apparatus for dilating tissue of a patient includes an elongate introducer assembly (100) adapted to be positioned proximate a puncture hole in a tissue wall. In use, the distal tip (122) and the distal end (120) are advanced through the puncture aperture (920) and the distal dilation portion is selectively positioned relative to the puncture aperture. The outer sliding shaft (110) may be advanced relative to the inner shaft (112) causing radial expansion of the distal expansion portion and an increase in the outer diameter of the elongate introducer assembly at the distal expansion portion. Dilation of the puncture hole occurs as the distal dilation portion in the dilated configuration passes through or spans the puncture hole.

Description

Technical Field

[0001] The present disclosure relates to devices and methods for selectively dilating a puncture in a tissue wall. More specifically, the device is configured to selectively dilate a puncture site formed in the fossa ovalis of the heart. Background Art

[0002] Transseptal puncture is a procedure that is typically performed when a physician needs to access the left chamber of the heart, such as the left atrium or ventricle. The venous vasculature is accessed percutaneously, and a catheter is used to facilitate delivery of a puncture device from the percutaneous access site to the fossa ovalis of the right atrium. The fossa ovalis is a thin flap of tissue covering the foramen ovale, which is a remnant of the fetal heart and is the optimal site for puncture via a puncture device. Once the initial puncture hole is formed in the tissue, the puncture hole must be expanded to allow a therapeutic sheath to be delivered through the site. As treatments continue to evolve in their complexity and capabilities, larger and larger therapeutic sheaths are required to pass through the puncture hole formed in the fossa ovalis. Known methods of expanding the puncture hole include using a dilator with a tapered distal end that gradually expands the puncture hole as the dilator is advanced through the fossa ovalis. Known dilators have a larger outer diameter so that the puncture hole is further expanded to accommodate a therapeutic sheath with a larger outer diameter. However, dilators with larger outer diameters may be more difficult to advance through the puncture because their distal ends only taper over their length and may damage anatomical structures if they are too long. Forming a shorter tapered end that must quickly taper to a larger outer diameter may be difficult, requiring a higher force input to force the dilator through the puncture. In addition, a larger fixed outer diameter will also dilate the percutaneous approach site, which may be undesirable.

[0003] Known sheaths can expand their static internal lumen size in response to a larger device being inserted through the internal lumen. The sheath folds onto itself in a static configuration, and when a larger object is passed through, the sheath unfolds to expand the internal lumen. Unfortunately, inserting a larger object through the lumen of a known expandable sheath also expands the percutaneous access site, which may be undesirable. In addition, this requires introducing another device into the patient's vasculature via the expandable sheath lumen, increasing the risk of air embolism and / or thromboembolism.

[0004] Known basket catheters are often used with electroanatomical mapping systems. They have a splined distal end that can be selectively expanded to expand the outer diameter of the distal end, where the splines are used to facilitate effective mapping of the heart via electrodes placed along the splines. The distal expansion can also be selectively reduced to accommodate smaller anatomical structures and to remove the device from a percutaneous access site. These basket catheters are complex to manufacture and typically have splines contained by a separate outer tubular member in addition to a separate inner tubular member. In addition, the splines are flexible structures that are easily bunched and are designed to be non-invasive to the anatomical structure when the user intentionally contacts them against the anatomical structure in the heart. In view of this, the splines are not strong enough to expand the tissue puncture hole.

[0005] Known balloon catheters have an expandable balloon at the distal end of the device, which can be used to expand a puncture, such as a balloon septostomy. The unexpanded balloon section of the catheter is positioned to pass through the puncture site, and the balloon is then expanded so that the puncture site is expanded to the size of the expanded balloon. However, these devices are complex to manufacture, and it is difficult to selectively control the specific extent to which the balloon is expanded, making it difficult to selectively control the extent to which the puncture is expanded. Indiscriminate expansion of the puncture site may be harmful to the health of the patient; therefore, the puncture site should only be expanded to the extent required by the necessary treatment sheath that must subsequently be inserted. In addition, the use of a balloon catheter requires the insertion of an additional device into the patient, increasing the risk of air embolism and / or thromboembolism. Therefore, there is a need for an apparatus and method for selectively expanding a puncture in a tissue wall while reducing device replacement, surgical complexity and time. Summary of the invention

[0006] In one broad aspect of the present disclosure, an elongated introducer assembly 100 includes an outer sliding shaft 110 and an inner shaft 112. The elongated introducer assembly 100 is configured to be inserted into a patient 900 and positioned proximate a tissue wall 910. The distal tip 122 is inserted through a puncture hole 920 in the tissue wall 910. The distal end 120 expands the puncture hole 920 until the distal end 120 extends from the puncture hole 920. The outer sliding shaft 110 is selectively advanced on the inner shaft 112, radially expanding a distal expansion portion, which can take several forms as shown by different elements 140, 140a and 140b, and which is adjacent to the outer sliding shaft 110, thereby increasing the outer diameter of the elongated introducer assembly 100 at the distal expansion portions 140, 140a, 140b. When the distal expansion portions 140, 140a, 140b span across the puncture 920, the distal expansion portions 140, 140a, and 140b can be in an expanded configuration, thereby selectively expanding the puncture 920. Alternatively, the elongated introducer assembly 100 can be retracted and / or advanced through the puncture 920, allowing the distal expansion portions 140, 140a, 140b in the expanded configuration to pass through the puncture 920, thereby selectively expanding the puncture 920. After the puncture 920 is expanded, the outer sliding shaft 110 can be selectively retracted on the inner shaft 112 to return the distal expansion portions 140, 140a, 140b to the reduced expanded configuration.

[0007] In some examples, the elongated introducer assembly 100 further includes a hollow lumen 118 extending along all or part of the length of the elongated introducer assembly 100, which can slidably receive the puncture device 200. The hollow lumen 118 can be centered or offset relative to the cross-sectional profile of the elongated introducer assembly 100. When the distal tip 122 is close to the tissue wall 910, the puncture device 200 can be pushed forward and pushed through the distal tip 122 to form a puncture hole 920 in the tissue wall 910. The puncture device 200 can be a sharp needle, a guide wire, a radiofrequency electrode, or any combination thereof.

[0008] In some embodiments, the distal expansion portion 140, 140a of the elongated introducer assembly 100 includes one or more distal flexion members 114 that are less stiff than the outer sliding shaft 110. When the outer sliding shaft 110 is advanced over the inner shaft 112, the distal flexion members 114 flex to a degree that depends on the relative amount of selective advancement of the outer shaft 110 relative to the inner shaft 112. This flexion causes the elongated introducer assembly 100 to radially expand at the distal expansion portion 140, 140a and causes the outer diameter of the elongated introducer assembly 100 to increase at the distal expansion portion 140 and 140a. Retraction of the outer sliding shaft 110 relative to the inner shaft 112 from any selective advancement state of the outer sliding shaft 110 relative to the inner shaft 112 will in turn reduce the degree of flexion at the distal flexion members 114 and cause the outer diameter of the elongated introducer assembly 100 to decrease at the distal expansion portion 140, 140a.

[0009] In another embodiment, the distal expansion portion 140 includes one or more expansion members 116 adjacent to one or more distal flexure members 114. The expansion member 116 has a higher stiffness than the distal flexure members 114 and can be positioned such that the expansion member 116 spans the puncture hole 920. The expansion member 116 can be a distal portion of the outer sliding shaft 110. When the outer sliding shaft 110 is advanced relative to the inner shaft 112, the expansion member 116 radially expands and causes expansion of the puncture hole 920 spanned by the expansion member 116. Alternatively, the elongated introducer assembly 100 can be retracted and / or advanced through the puncture hole 920, allowing the distal expansion portion 140 in the expanded configuration to pass through the puncture hole 920, thereby selectively expanding the puncture hole 920.

[0010] In another embodiment, the distal expansion portion 140b includes a distal portion of the outer sliding shaft 110 and a predefined inclined geometric configuration 128 on the inner shaft 112. Advancement of the outer sliding shaft 110 causes the distal portion to travel along the predefined inclined geometric configuration 128, resulting in radial expansion of the distal expansion portion 140b of the elongated introducer assembly 100. The distal portion of the outer sliding shaft 110 that travels along the predefined inclined geometric configuration 128 of the inner shaft 112 can be configured as a plurality of separate distal outer shaft segments 130 along the length of the outer sliding shaft 110. The separate distal outer shaft segments 130 can be advanced at any time on the predefined inclined geometric configuration 128 and cause the distal expansion portion 140b to radially expand.

[0011] In some examples, the outer sliding shaft 110 can be advanced by an outer sliding shaft advancer 126. The outer sliding shaft advancer 126 can be advanced and / or retracted along the elongated guide assembly 100 via a button that is selectively depressed and released, enabling the outer sliding shaft 110 to be advanced and / or retracted relative to the inner shaft 112 when depressed, and locking the position of the outer sliding shaft when released. A further advancement manner of the outer sliding shaft advancer 126 includes rotationally driven advancement, whereby rotation of the outer sliding shaft advancer 126 causes advancement and / or retraction of the outer sliding shaft 110 via a threaded path around the elongated guide assembly 100. Yet another advancement manner of the outer sliding shaft advancer 126 can include friction forces that must be overcome when advancing and / or retracting the outer sliding shaft 110 relative to the inner shaft 112.

[0012] In some embodiments, an indicator is positioned along the length of the elongated introducer assembly 100 that corresponds to the outer diameter of the distal expansion portion 140, 140a, 140b. When the outer sliding shaft 110 is advanced relative to the inner shaft 112, the indicator corresponds to the outer diameter of the distal expansion portion 140, 140a, 140b together with the amount that the outer sliding shaft 110 is advanced relative to the inner shaft 112.

[0013] In some embodiments, the elongated introducer assembly 100 includes a proximal hub 124 that can be grasped or held when using the device. The proximal hub 124 can include features such as a female Luer connector, enabling known accessories such as syringes and / or hemostatic valves to be attached.

[0014] In another broad aspect of the present disclosure, a method is provided for selectively dilating a puncture 920 in a tissue wall 910. The distal tip 122 of the elongated introducer assembly 100 is positioned proximate to the puncture 920 in the tissue wall 910. The distal tip 122 of the elongated introducer assembly 100 is then advanced through the puncture 920, followed by advancement of the distal end 120. The distal expansion portion 140, 140a is positioned until the distal expansion portion 140 spans the puncture 920, and then the outer shaft 110 is advanced over the inner shaft 112 of the elongated introducer assembly 100, causing the distal expansion portion 140, 140a to radially expand.

[0015] In another aspect, the method includes positioning the distal tip 122 of the elongated introducer assembly 100 proximate to the tissue wall 910. The puncture device 200 is advanced through the hollow lumen 118 of the elongated introducer assembly 100 and extended from the distal tip 122 to form a puncture hole 920 in the tissue wall 910. After the puncture hole 920 is formed with the puncture device 200, the puncture hole 920 can be expanded using the methods previously described.

[0016] In another aspect, the method includes radially expanding the distal expansion portion 140, 140a before the distal expansion portion 140, 140a crosses the puncture hole 920. Then, the slender introducer assembly 100 can be advanced through the puncture hole 920, causing the puncture hole 920 to further expand. The method can alternatively include expanding the distal expansion portions 140, 140a, 140b after the distal expansion portions 140, 140a, 140b completely cross the puncture hole 920. Then, the slender introducer assembly 100 is retracted through the puncture hole 920, causing the puncture hole 920 to further expand.

[0017] In some embodiments, the elongate introducer assembly 100 has a proximal hub 124 that includes a female Luer connector for connecting a syringe and / or a hemostasis valve to facilitate injection and / or aspiration of fluids during any step of the method. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to facilitate understanding of the present invention, embodiments of the present invention are shown by way of example in the accompanying drawings.

[0019] in:

[0020] Figure 1A A partial cross-sectional view of an elongated introducer assembly is depicted.

[0021] Figure 1B A partial cross-sectional view of an elongated introducer assembly with an expanded distal expansion portion is depicted.

[0022] Figure 2A A partial cross-sectional view of an elongated introducer assembly is depicted.

[0023] Figure 2B A partial cross-sectional view of an elongated introducer assembly with an expanded distal expansion portion is depicted.

[0024] Figure 3A A partial cross-sectional view of an elongated introducer assembly is depicted.

[0025] Figure 3B Depicted is a cross-sectional view of an elongated introducer assembly with an expanded distal expansion portion.

[0026] Figure 3C A cross-sectional view of the elongated introducer assembly and a cut-away view of the distal expansion portion are depicted.

[0027] Figure 3D Depicted are a cross-sectional view of an elongated introducer assembly and a cross-sectional view of an expanded distal expansion portion.

[0028] Figure 4A Depicted is a partial cross-sectional view of an elongated introducer assembly positioned proximate a puncture in a tissue wall.

[0029] Figure 4B A partial cross-sectional view of an elongated introducer assembly is depicted with the distal tip extending through a puncture in a tissue wall.

[0030] Figure 4C A partial cross-sectional view of an elongated introducer assembly is depicted with a dilation member spanning a puncture in a tissue wall.

[0031] Figure 4D A partial cross-sectional view of an elongated introducer assembly is depicted with an expanded distal expansion portion spanning a puncture in a tissue wall.

[0032] Figure 4E A partial cross-sectional view of an elongated introducer assembly is depicted with an expanded distal expansion portion removed from an expanded puncture hole in a tissue wall.

[0033] Figure 5A A partial cross-sectional view of an elongated introducer assembly is depicted with a distal expansion portion spanning a puncture in a tissue wall.

[0034] Figure 5B A partial cross-sectional view of an elongated introducer assembly is depicted with an expanded distal expansion portion spanning a puncture in a tissue wall.

[0035] Fig. 6A A partial cross-sectional view of an elongated introducer assembly is depicted with a distal expansion portion extending through a puncture in a tissue wall.

[0036] Figure 6B A partial cross-sectional view of an elongated introducer assembly is depicted with an expanded distal expansion portion extending through a puncture in a tissue wall.

[0037] Figure 6C A partial cross-sectional view of an elongated introducer assembly is depicted with an expanded distal expansion portion removed from an expanded puncture hole in a tissue wall. DETAILED DESCRIPTION

[0038] Now specifically refer to the accompanying drawings in detail, it should be emphasized that the details shown are only examples and are only used for illustrative discussions of certain embodiments of the present invention. Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not limited to the details of the construction and arrangement of the parts set forth in the following description or shown in the accompanying drawings. The present invention can have other embodiments or can be practiced or carried out in various ways. In addition, it should be understood that the wording and terminology adopted herein are for the purpose of description and should not be regarded as limiting.

[0039] As further described below, the present invention provides an apparatus and method for dilating a puncture in a tissue wall. An elongated introducer assembly having a distal dilation portion is used to span the puncture and the puncture is dilated by advancing an outer sliding shaft on the elongated introducer assembly relative to an inner shaft.

[0040] refer to Figure 1A , the elongated introducer assembly 100 is configured with a distal expansion portion 140. It should be understood that Figure 1AShown in partial cross-section, as other partial cross-sections further described herein, such that the portion to the right of the wavy cutting line is a cross-section, while the portion to the left of the wavy cutting line is not shown in cross-section. Likewise, the wavy cutting line is provided to indicate that the length of the assembly 100 is variable. The outer diameter of the elongated introducer assembly 100 can be similar to other common percutaneous access devices used in the heart, and has an outer diameter of approximately 7-8.5 Fr, however, any size that enables the device to be percutaneously inserted and reach the heart through the intended vascular system is suitable. The overall length of the elongated introducer assembly 100 can be any length that facilitates the device to travel through the intended vascular system to reach the target tissue in the heart; a length of approximately 60-110 cm may be suitable. The distal expansion portion 140 is configured with a first distal flexion member 114a, an expansion member 116, and a second distal flexion member 114b. The elements that make up the distal expansion portion 140 are adjacent to the outer sliding shaft 110. The outer sliding shaft 110 is an elongated member that surrounds all or a portion of the inner shaft 112. The first and second distal flexure members 114a, 114b have a lower mechanical stiffness than the outer sliding shaft 110 and the expansion member 116. The lower stiffness of the first and second distal flexure members 114a, 114b can be achieved by using a material with a lower stiffness than the outer sliding shaft 110 and the expansion member 116, removing material forming the flexure members, flattening the material forming the flexure members, using a smaller cross-sectional area for the flexure members, or any combination thereof. Any suitable biocompatible material can be used to form the first and second distal flexure members 114a, 114b, the outer sliding shaft 110, and the inner shaft 112, such as stainless steel, Nitinol, high density polyethylene (HDPE), low density polyethylene (LDPE), or any combination thereof. One suitable embodiment will provide that the outer sliding shaft 110 is made of a high density polymer, while the flexure members 114a, 114b are made of a superelastic metal (such as Nitinol). The second distal flexure member 114b is rigidly fixed to the inner shaft 112 at its distal end. The manner of affixing the second distal flexure member 114b can be facilitated by adhesive, welding, reflow, use of fasteners, or any suitable combination thereof. The length of the expansion member 116 can be at least 1 mm so that the expansion member 116 can completely span the thickness of the tissue wall 910, but any length that accommodates the desired expansion is suitable. The expansion member 116 can be made of any suitable material and be stiffer than the first distal flexure section 114a or the second distal flexure section 114b.

[0041] Still refer to Figure 1A, a distal end 120 terminating in a distal tip 122 includes the elongated introducer assembly 100 distally. The outer diameter of the distal tip 122 can be between 0.035" and 0.060", but any diameter that can be inserted through the desired biological tissue is suitable. Starting from the distal tip, the outer diameter of the distal end 120 can gradually taper to match the outer diameter of the rest of the segment including the outer sliding shaft 110 and the distal expansion portion 140. The elongated introducer assembly 100 can have a hollow lumen 118 that extends along all or part of the length of the elongated introducer assembly 100. The hollow lumen can be used for injection and / or aspiration of fluids and insertion of auxiliary devices (such as guide wires and / or needles). The hollow lumen 118 can be centered or offset relative to the cross-sectional profile of the elongated introducer assembly 100, with a diameter of 0.032" to 0.060", but any diameter that facilitates insertion of the desired accessory device is suitable. The proximal hub 124 can be located proximally on the elongated introducer assembly 100 and provide a gripping position for the user during use. The proximal hub 124 can also incorporate a female Luer connector (known and not depicted) to facilitate the connection of Luer-compatible devices, such as syringes and / or hemostatic valves (known and not depicted). Along the length of the elongated introducer assembly 100 is an external sliding shaft pusher 126, which is used to advance the external sliding shaft 110 relative to the internal shaft 112. The external sliding shaft pusher 126 can be actuated in any suitable manner. For example, the external sliding shaft pusher 126 can be advanced and / or retracted along the elongated introducer assembly 100 via a button (not shown), which is selectively pressed and released, allowing the external sliding shaft 110 to advance and / or retract relative to the internal shaft 112 when pressed, and locking the position of the external sliding shaft when released. A further advancement manner of the outer sliding shaft advancer 126 may include rotationally driven advancement (not shown), whereby rotation of the outer sliding shaft advancer 126 causes advancement and / or retraction of the outer sliding shaft 110 via a threaded path around the elongated introducer assembly 100. Yet another advancement manner of the outer sliding shaft advancer 126 may include friction forces (not shown) that must be overcome when advancing and / or retracting the outer sliding shaft 110 relative to the inner shaft 112.

[0042] refer to Figure 1B , the same implementation example Figure 1A14. The outer sliding shaft 110 is advanced on the inner shaft 112 via the outer sliding shaft advancer 126. The advancement of the outer sliding shaft 110 causes the flexion at the first distal flexion member 114a and the second distal flexion member 114b, which causes the expansion member 116 to be raised (i.e., radially displaced) from the surface of the inner shaft 112. The elevation of the expansion member 116 from the surface of the inner shaft 112 forms a radial expansion of the elongated introducer assembly 100 at the distal expansion portion 140. An indicator can be located along the length of the elongated introducer assembly 100, which is related to the outer diameter of the radial expansion of the distal expansion portion 140. When the outer sliding shaft 110 is advanced relative to the inner shaft 112, the indicator corresponds to the outer diameter of the distal expansion portion 140 together with the amount by which the outer sliding shaft 110 is advanced relative to the inner shaft 112. The distal expansion portion 140 can have an outer diameter of 8.5-20 Fr when expanded, however, any desired outer diameter that provides suitable expansion for the intended application is suitable.

[0043] refer to Figure 2A , shows an alternative embodiment of the elongated introducer assembly 100. The distal expansion portion 140a includes a distal flexion member 114 and a distal portion of the outer sliding shaft 110. The distal flexion member 114 is rigidly fixed to the inner shaft 112 at the distal end of the distal flexion member 114. Securing the distal flexion member can be facilitated by adhesives, welding, reflow, using fasteners, or any combination thereof.

[0044] refer to Figure 2B , the same implementation example Figure 2A 140a is displaced radially outward. The outer sliding shaft 110 is advanced on the inner shaft 112 via the outer sliding shaft advancer 126. The advancement of the outer sliding shaft 110 causes the distal flexion member 114 and the distal portion of the outer sliding shaft 110 to flex. This flexion forms a radial expansion of the distal expansion portion 140a and an increase in the outer diameter of the elongated introducer assembly 100 at the distal expansion portion 140a.

[0045] refer to Figure 3A , an alternative embodiment of the elongated introducer assembly 100 is shown. The distal expansion portion 140b includes a distal portion of the outer sliding shaft 110 and a predefined inclined geometric configuration 128 on the inner shaft 112.

[0046] refer to Figure 3B , the same implementation example Figure 3A14. The outer sliding shaft 110 is advanced via the outer sliding shaft advancer 126. The distal portion of the outer sliding shaft 110 travels along the predefined inclined geometric configuration 128, thereby forming a radial expansion of the distal expansion portion 140b of the elongated guide assembly 100. The radial expansion of the distal expansion portion 140b increases the outer diameter of the elongated guide assembly 100 at the distal expansion portion 140b. During the advancement of the outer sliding shaft 110 relative to the inner shaft 112, the portion of the outer sliding shaft 110 that travels along the predefined inclined geometric configuration can be the same material or a different material as the rest of the outer sliding shaft 110. In addition, the distal portion of the outer sliding shaft that is part of the distal expansion portion 140b can also have a cross-sectional area different from the rest of the outer sliding shaft 110.

[0047] refer to Figure 3C , the same implementation example Figure 3A 140b. A cross-sectional view of the distal expansion portion 140b is shown. In this configuration, the outer sliding shaft 110 is fully retracted relative to the inner shaft 112.

[0048] refer to Figure 3D , the same implementation example Figure 3A 12, but now it is shown in an actuated position, wherein the distal expansion portion 140b is displaced radially outward. A cross-sectional view of the distal expansion portion 140b is shown. In this configuration, the outer sliding shaft 110 has been advanced relative to the inner shaft 112. The cross-sectional view depicts a plurality of separated distal outer shaft segments 130a, 130b, 130c, 130d along the length of the outer sliding shaft 110. The separated distal outer shaft segments 130a, 130b, 130c, 130d are sections of the outer sliding shaft 110 that are separated along the length of the outer sliding shaft to enable ready advancement on a predefined inclined geometric configuration 128 and to enable the distal expansion portion 140b to radially expand. The separated distal outer shaft segments 130a, 130b, 130c, 130d are adjacent to the outer sliding shaft 110 and can be the same or different material from the rest of the outer sliding shaft 110. The separated distal outer shaft segments 130a, 130b, 130c, 130d may also have a different cross-sectional area than the rest of the outer sliding shaft 110. Any number of separated distal outer shaft segments 130 may be used, and they may be separated by any length along the outer sliding shaft 110.

[0049] refer to Figure 4A , the same implementation example Figure 1AThe distal tip 122 of the elongated introducer assembly 100 is positioned proximate to a puncture hole 920 in a tissue wall 910 of a patient 900. The puncture device 200 is pushed forward through the hollow lumen 118, past the distal tip 122, and used to form the puncture hole 920.

[0050] refer to Figure 4B , the same implementation example Figure 1A shown and shown Figure 4A The procedure continues. The distal tip 122 is advanced through the puncture hole 920 in the tissue wall 910, and the distal end 120 begins to travel through the puncture hole 920 and gradually expands the diameter of the puncture hole 920 as the distal end 120 is further advanced through the puncture hole 920 and the taper of the distal end 120 expands proximally.

[0051] refer to Figure 4C , the same implementation example Figure 1A shown and shown Figure 4B The procedure continues. The distal end 120 is fully advanced through the puncture hole 920 in the tissue wall 910, and the expansion member 116 spans the puncture hole 920.

[0052] refer to Figure 4D , the same implementation example Figure 1A shown and shown Figure 4C The procedure continues. The outer sliding shaft 110 has been advanced on the inner shaft 112 via the outer sliding shaft advancer 126, causing flexion at the first distal flexion member 114a and the second distal flexion member 114b. The flexion of the first distal flexion member 114a and the second distal flexion member 114b causes the expansion member 116 to rise from the surface of the inner shaft 112, and thereby produces radial expansion of the slender introducer assembly 100 at the distal expansion portion 140. When the tissue including the tissue wall 910 accommodates the increased outer diameter of the slender introducer assembly 100 at the distal expansion portion 140, the radial expansion at the distal expansion portion 140 causes the expansion of the puncture hole 920.

[0053] refer to Figure 4E , the same implementation example Figure 1A shown and shown Figure 4D The procedure continues. The elongated introducer assembly 100 is retracted from the puncture hole 920, and the distal expansion portion 140 no longer spans the puncture hole 920. Due to the radial expansion of the distal expansion portion 140 in the previous procedural step, the expansion degree of the puncture hole 920 is greater than Figure 4C The degree of expansion in the procedural steps shown is greater.

[0054] refer to Figure 5A , the same implementation example Figure 2AThe distal tip 122 and the distal end 120 have been advanced through the puncture hole 920 , and the distal expanded portion 140 a spans the puncture hole 920 .

[0055] refer to Figure 5B , the same implementation example Figure 2A shown and shown Figure 5A The procedure of is continued, but now it is shown in an actuated position, wherein the distal expansion portion 140a is displaced radially outward while being located within the patient tissue (e.g., the fossa ovalis). The outer sliding shaft 110 has been advanced on the inner shaft 112 via the outer sliding shaft advancer 126, causing the distal flexion member 114 and the distal portion of the outer sliding shaft 110 to flex, thereby producing radial expansion of the distal expansion portion 140a and an increase in the outer diameter of the elongated introducer assembly 100 at the distal expansion portion 140a. When the tissue including the tissue wall 910 accommodates the increased outer diameter of the elongated introducer assembly 100 at the distal expansion portion 140a, the radial expansion at the distal expansion portion 140a causes the expansion of the puncture hole 920.

[0056] refer to Fig. 6A , the same implementation example Figure 3A The distal expansion portion 140b is composed of a predefined inclined geometric configuration 128 on the inner shaft 112 and a plurality of separate distal outer shaft segments 130 adjacent to the outer sliding shaft 110. The distal tip 122, the distal end 120 and the distal expansion portion 140b have been advanced through the puncture hole 920.

[0057] refer to Figure 6B , the same implementation example Figure 3A shown and shown Fig. 6A The procedure continues while it is in the actuated position, wherein the distal expansion portion 140b is displaced radially outward while adjacent to the patient tissue (e.g., the fossa ovalis). The outer sliding shaft 110 has been advanced on the inner shaft 112 via the outer sliding shaft advancer 126, causing the plurality of separated distal outer shaft segments 130 to travel on the predefined inclined geometric configuration 128 and causing the distal expansion portion 140b to radially expand, and the outer diameter of the elongated introducer assembly 100 at the distal expansion portion 140b to increase.

[0058] refer to Figure 6C , the same implementation example Figure 3A shown and shown Figure 6B The procedure continues while it is in the actuated position. The elongated introducer assembly 100 is retracted from the puncture hole 920, and the distal expansion portion 140b in the expanded configuration has passed through the puncture hole 920. The passage of the distal expansion portion 140b through the puncture hole 920 causes the puncture hole 920 to expand because the tissue including the tissue wall 910 accommodates the outer diameter of the distal expansion portion 140b.

[0059] The embodiments of the present invention described above are intended to be exemplary only. Accordingly, the scope of the present invention is to be limited solely by the scope of the appended claims.

[0060] It should be understood that, for the sake of clarity, certain features of the present invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features of the present invention described in the context of a single embodiment may also be provided separately or in any suitable sub-combination.

[0061] Although the present invention has been described in conjunction with specific embodiments of the present invention, it is apparent that many substitutions, modifications and variations will be apparent to those skilled in the art. Therefore, it is intended to encompass all such substitutions, modifications and variations that fall within the broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the extent that each individual publication, patent or patent application is specifically and individually indicated to be incorporated herein by reference. In addition, citing or identifying any reference in this application should not be construed as admitting that such reference can be used as prior art of the present invention.

Claims

1. A device for expanding a patient's tissue, the device include: an elongated introducer assembly configured to be manipulated toward and positioned proximate to the puncture in the tissue wall; The elongated introducer assembly includes an inner shaft and an outer sliding shaft; The outer sliding shaft is concentrically positioned relative to the inner shaft and is longitudinally movable; and a distal expansion portion adjacent to the outer sliding shaft; Wherein, selective linear movement of the outer sliding shaft relative to the inner shaft actuates radial expansion of the distal expansion portion.

2. The device according to claim 1, in, The distal expansion portion is comprised of one or more distal flexure members having a lower stiffness than the outer sliding shaft.

3. The device according to claim 1, in, The distal expansion portion is comprised of an expansion member and one or more distal flexion members.

4. The device according to claim 3, in, The expansion member is a section of the outer sliding shaft adjacent to the one or more distal flexion members.

5. The device according to claim 3 or 4, in, The distal flexion member has a lower stiffness than the outer sliding shaft and the expansion member.

6. The device according to any one of claims 2 to 5, in, The distal flexure member is comprised of Nitinol.

7. The device according to any one of claims 2 or 6, in, The distal flexure member is formed by laser cutting or any other material removal process.

8. The device according to any one of claims 2 or 7, in, The distal flexure member is formed by flattening.

9. The device according to any one of claims 2 or 8, in, The distal flexure member is constructed of a polymer material.

10. The device according to claim 1, in, The distal expansion portion is comprised of a predefined inclined geometry on the inner shaft and one or more separate distal outer shaft segments on the outer sliding shaft.

11. The device according to claim 1, in, The outer sliding shaft is selectively moved relative to the inner shaft via an outer sliding shaft advancer.

12. The device according to claim 1, in, The elongated introducer assembly includes an indicator along the length of the elongated introducer assembly corresponding to an outer diameter of the distal expansion portion together with a position of the outer sliding shaft relative to the inner shaft.

13. The device according to claim 1, in, The inner shaft includes a hollow lumen.

14. The device according to claim 1, in, The elongated introducer assembly includes a proximal hub.

15. The device according to claim 14, in, The proximal hub has a female Luer connector.

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