Device for tissue puncture during pericardiocentesis - Patent application

Abstract

Disclosed are methods and devices for an elongate introducer assembly and an elongate guidewire assembly. The elongate introducer assembly is manipulated and positioned proximate a first biological wall. The elongate guidewire assembly is selectively manipulated along the elongate introducer assembly and comprises a distal tip, a distal portion, and an elongate shaft section. The distal portion may further comprise a flexible, pre-defined spatial geometry including a distal length and a distal deflection portion. The distal tip is used to pierce the first biological wall, and the distal deflection portion directs the distal length away from a second biological wall positioned proximate the first biological wall.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to devices and methods for puncturing biological walls, and more particularly, the device is configured for puncturing the pericardium of the heart. [Background technology]

[0002] Pericardiocentesis is a procedure performed when excessive fluid accumulates in the space between the pericardial sac and myocardium of the heart, necessitating drainage of the fluid from said space. Performing a pericardiocentesis procedure involves puncturing the pericardium surrounding the myocardium of the heart (without puncturing the myocardium). It is known that a mechanical needle can be used to puncture the pericardial layer, but the user must take great care to control the force of the needle's advancement to puncture the pericardium as best as possible while avoiding damage to the underlying myocardium.

[0003] Known pericardiocentesis devices and methods also involve the use of a puncture guidewire with a sharp distal tip to form a perforation. Unfortunately, the known puncture guidewire has a preset distal curve that quickly deflects away from the desired puncture direction to avoid inadvertent puncture and damage to the myocardium immediately adjacent to the pericardium. This quickly deflecting sharp distal tip can hinder puncture of the pericardium when there is a layer of fat covering the pericardium or when the patient has a thick pericardium, because the puncture wire may begin to deviate before protruding from the lumen of the hollow needle and penetrating the full thickness of the pericardial layer. In a pericardiocentesis procedure, the pericardium is positioned further away from the myocardium than usual due to fluid accumulation, and therefore, the puncture wire for this procedure does not require a distal curve that deflects so slightly from the distal tip.

[0004] Known pericardiocentesis techniques also involve the use of radiofrequency (RF) puncture devices, such as needles or guidewires, that use momentarily activated RF energy to selectively vaporize tissue through a blunt electrode. The use of such RF devices requires the setup of cables, generators, and other electrical equipment, which can require longer than recommended times to perform a pericardiocentesis procedure in situations where there is an urgent need to drain the fluid. Therefore, there is a need for an apparatus and method for puncturing a first biological wall while avoiding inadvertent puncture of a second biological wall, i.e., the myocardium, and reducing the number, complexity, and time required for device replacement. Summary of the Invention

[0005] In one broad aspect of the present disclosure, a device is provided that includes a synergistic combination of an elongate introducer assembly and an elongate guidewire assembly. The elongate introducer assembly is configured to be positioned near a first biological wall and to slidably receive the elongate guidewire assembly. The elongate guidewire assembly has a distal portion with a flexible, preset spatial geometry that can be selectively manipulated along the elongate introducer assembly. A distal tip on the elongate guidewire assembly is used to pierce the first biological wall, and a distal deflection portion, when manipulated externally of the elongate introducer device, directs a distal length away from a leading edge of the elongate guidewire assembly.

[0006] According to one aspect of the present disclosure, there is provided an apparatus for engaging and penetrating tissue of a patient having a first biological wall and a second biological wall proximate the first biological wall. The apparatus includes an elongate introducer assembly configured to be manipulated toward and positioned proximate the patient's first biological wall. The elongate introducer assembly is configured to slidably receive an elongate guidewire assembly having a distal portion with a flexible, preset spatial geometry configured to be selectively manipulated along the elongate introducer assembly. The elongate guidewire assembly has a distal tip configured to at least partially form a perforation through the first biological wall, the distal portion adopting a straight state when inside the elongate introducer assembly and a preset spatial geometry when manipulated outside the elongate introducer assembly. The preset spatial geometry begins at a minimum length of 4 mm from the distal tip and includes a distal deflection portion that deflects the distal length away from the second biological wall. In one embodiment, the distal portion is constructed from a resilient material such as nitinol or stainless steel. The distal tip is configured to penetrate the first biological wall to at least partially form the perforation. The distal portion may be flat with a height, for example, between 0.003 inches (0.0762 mm) and 0.005 inches (0.127 mm).

[0007] In one embodiment, the elongate introducer assembly may further comprise a stylet configured to be slidably received by the elongate introducer assembly to provide enhanced rigidity for guiding the elongate introducer assembly through tissue surrounding the abdominal and thoracic cavities to position the introducer near the pericardium. In another embodiment, the distal section of the elongate introducer assembly may incorporate an ultrasound-visible marker configured to be detectable by a medical imaging system. In one embodiment, the ultrasound-visible marker may be made of platinum, tungsten, gold, or any material that attenuates sound waves used in the medical imaging system.

[0008] In another embodiment, the distal length of the elongate guidewire assembly includes a first distal length section and a second distal length section, whereby the second distal length section includes the distal tip and is deflected from the first distal length section generally opposite the distal deflection portion. The width of the distal tip can be, for example, 0.001 inches (0.0254 mm) or less.

[0009] In another embodiment, the elongate guidewire assembly includes a detectable marker configured to be detectable by a medical imaging system. In another embodiment, the detectable marker includes a metal coil disposed on the elongate shaft section or the distal portion. In certain embodiments, the detectable marker may comprise a groove, etching, cut, or roughened area on the elongate shaft section or the distal portion.

[0010] In another feature, the elongate introducer assembly has a central female luer connector and a proximal hub with a hemostatic valve.

[0011] In another broad aspect, the disclosure provides devices and methods for engaging tissue of a patient having a first biological wall and a second biological wall proximate the first biological wall. In one embodiment, an elongate guidewire assembly having a distal portion with a flexible, preset spatial geometry is slidably received by the elongate introducer assembly and manipulated through the introducer toward the first biological wall. A distal tip at the end of the distal length on the elongate guidewire assembly is used to pierce the first biological wall, and a distal deflectable portion orients the distal length away from a leading edge of the elongate guidewire assembly as the distal portion relaxes back to its preset spatial geometry upon exiting the elongate introducer assembly.

[0012] In a further embodiment, the device (or apparatus) and method include introducing and positioning an elongate introducer assembly (including a lumen longitudinally disposed therethrough) into a first biological wall and slidably inserting an elongate guidewire device having a distal portion, a distal deflection portion, a distal length, and a distal tip into the hollow lumen. The distal portion is then advanced toward the first biological wall to form a perforation in the first biological wall and to intersect with the distal tip. The distal length is then deflected away from the second biological wall via a distal deflection portion disposed a minimum of 4 mm from the distal tip. The elongate introducer assembly is then removed from the patient with the elongate guidewire device positioned through the perforation and across the first biological wall. After removing the elongate introducer assembly, an elongate catheter device having a distal exit portal is slidably advanced over the elongate guidewire device and across the first biological wall through the distal exit portal.

[0013] In yet another aspect, the method includes advancing an elongate introducer assembly including a lumen disposed longitudinally therethrough into a first biological wall and slidably inserting a stylet slidably received by the hollow lumen of the elongate introducer assembly. In one embodiment, the stylet is removed from the elongate introducer assembly following advancement of the elongate introducer assembly toward the first biological wall of the patient and placement of the introducer assembly proximate the first biological wall.

[0014] In another embodiment, the elongate introducer assembly has a proximal hub with a hemostatic valve for injecting or aspirating fluids at any stage of the method.

[0015] Example 1 is a device for engaging tissue of a patient, the device including a first biological wall and a second biological wall, the second biological wall being disposed proximate the first biological wall of the patient. The device includes an elongate introducer assembly configured to be manipulated toward the first biological wall of the patient and disposed proximate the first biological wall. The elongate introducer assembly is configured to slidably receive an elongate guidewire assembly. The elongate guidewire assembly has a distal portion having a flexible, preset spatial geometry configured to be selectively manipulated along the elongate introducer assembly. The distal portion adopts a straight state when inside the elongate introducer assembly and adopts a preset spatial geometry when manipulated outside the elongate introducer assembly. The elongate guidewire assembly includes an elongate shaft section and a distal tip. The distal tip is configured to at least partially form a perforation through the first biological wall. The preset spatial geometry has a distal deflection portion beginning at a minimum length extent of 4 mm from the distal tip and deflecting the distal length portion away from the second biological wall.

[0016] Example 2 is the device of Example 1, wherein the elongate introducer assembly comprises a stylet configured to be slidably received by the introducer assembly.

[0017] Example 3 is the device of Example 1, wherein the distal portion comprises a resilient material selected from nitinol and stainless steel.

[0018] Example 4 is the device of Example 1, wherein the distal tip is configured to penetrate the first biological wall to at least partially form the perforation.

[0019] Example 5 is the device of Example 4, wherein the distal portion is a flattened shape having a height between 0.003 inches (0.0762 mm) and 0.005 inches (0.127 mm).

[0020] Example 6 is the device of Example 4, wherein the distal length comprises a first distal length section and a second distal length section, the second distal length section including the distal tip and being deflected from the first distal length section generally opposite the distal deflection portion.

[0021] Example 7 is the device of Example 4, wherein the distal tip has a width of 0.001 inches (0.0254 mm) or less.

[0022] Example 8 is the device of Example 1, wherein the elongate guidewire assembly comprises a detectable marker configured to be detectable by a medical imaging system.

[0023] Example 9 is the device of Example 8, wherein the detectable marker further comprises a metal coil disposed on the elongate shaft section or the distal portion.

[0024] Example 10 is the device of Example 8, wherein the detectable marker comprises a groove, etch, cut, or roughened area in the elongate shaft section or the distal portion.

[0025] Example 11 is the device of Example 1, wherein the elongate introducer assembly has a proximal hub.

[0026] Example 12 is the device of Example 11, wherein the proximal hub further comprises a female luer connector.

[0027] Example 13 is the device of Example 12, wherein the proximal hub further comprises a hemostatic valve.

[0028] Example 14 is the device of Example 1, wherein an ultrasound-visible marker is disposed on a distal section of the elongate introducer assembly, whereby the ultrasound-visible marker is configured to be detectable by a medical imaging system.

[0029] Example 15 is the device of Example 14, wherein the ultrasound-visible marker comprises platinum, tungsten, or gold.

[0030] Example 16 is a method for engaging tissue of a patient having a first biological wall and a second biological wall. The method includes advancing an elongate introducer assembly toward the first biological wall within the patient and positioning the elongate introducer assembly near the first biological wall. The method includes slidably inserting an elongate guidewire assembly into a hollow lumen of the elongate introducer assembly and urging a distal portion of the elongate guidewire assembly toward the first biological wall. The method includes forming a perforation in the first biological wall with a distal tip on the elongate guidewire assembly. The method includes deflecting a distal length including the distal tip away from the second biological wall via a distal deflection section positioned at least 4 mm from the distal tip.

[0031] Example 17 is the method of Example 16, wherein the perforation is dilated by the elongate introducer assembly.

[0032] Example 18 is the method of Example 16, wherein the elongate introducer assembly is removed from the patient while the elongate guidewire assembly remains in position through the fenestration and across the first biological wall, and an elongate catheter device slidably receives the elongate guidewire assembly through a distal exit portal of the elongate catheter device, the elongate guidewire assembly being used to guide the elongate catheter device into the patient and across the first biological wall.

[0033] Example 19 is the method of Example 16, wherein the elongate introducer assembly further comprises a stylet slidably received by the hollow lumen of the elongate introducer assembly.

[0034] Example 20 is the method of Example 16, wherein a hemostatic valve is attached to the proximal hub of the elongate introducer assembly, and fluids may be injected or aspirated at any stage. [Brief explanation of the drawings]

[0035] In order that the invention may be more readily understood, embodiments thereof are illustrated by way of example in the accompanying drawings, in which: [Figure 1] FIG. 1 shows a cross-sectional view of an elongate introducer assembly. [Figure 2] FIG. 2 shows a cross-sectional view of an elongate introducer assembly with a stylet. [Figure 3] FIG. 3 shows a cross-sectional view of the proximal hub shown in FIG. 1 with a hemostatic valve. [Figure 4] FIG. 4 shows a cross-sectional view of the proximal hub shown in FIG. 1 having a hemostatic valve with a lateral female Luer connector. [Figure 5] FIG. 5 shows a cross-sectional view of the proximal hub shown in FIG. 1 with an alternative configuration of the hemostatic valve. [Figure 6] FIG. 6 shows a cross-sectional view of the proximal hub shown in FIG. 1 with a hemostatic valve inside the lumen. [Figure 7] FIG. 7 shows a side view of the proximal hub and hemostatic valve with the syringe attached. [Figure 8] FIG. 8 shows a side view of the proximal hub with the syringe attached. [Figure 9] FIG. 9 shows a side view of an elongated guidewire assembly having a 180 degree bend. [Figure 10] FIG. 10 shows a side view of an elongate guidewire assembly having a 270 degree bend. [Figure 11] FIG. 11 shows a side view of the elongate guidewire assembly with the distal tip 210 slightly curved. [Figure 12] FIG. 12 shows a cross-sectional view of an elongate introducer assembly positioned near a first biological wall. [Figure 13] FIG. 13 shows a cross-sectional view of the elongate introducer assembly with the stylet positioned adjacent the first biological wall. [Figure 14] FIG. 14 shows a cross-sectional view of an elongate introducer assembly with an elongate guidewire assembly contained within the lumen and positioned adjacent a first biological wall. [Figure 15] FIG. 15 shows a cross-sectional view of the elongate introducer assembly with the elongate guidewire assembly piercing the first biological wall. [Figure 16] FIG. 16 shows a cross-sectional view of the elongate introducer assembly with the elongate guidewire assembly inserted through the perforation in the first biological wall. [Figure 17] FIG. 17 shows a cross-sectional view of an elongate introducer assembly dilating a perforation in a first biological wall over an elongate guidewire assembly. [Figure 18] FIG. 18 shows a cross-sectional view of an elongate catheter device being inserted over an elongate guidewire assembly that has been inserted through a perforation in a first biological wall. [Figure 19] FIG. 19 depicts a cross-sectional view of an elongate catheter device being inserted over an elongate guidewire assembly through a perforation in a first biological wall.

[0036] List of reference numbers used in the drawings [Table 1] DETAILED DESCRIPTION OF THE INVENTION

[0037] With specific reference to the drawings in detail, it is emphasized that the details set forth are shown by way of example and for purposes of specific discussion of certain embodiments of the invention only. Before describing at least one embodiment of the invention in detail, it will be understood that the invention is not limited to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being implemented or carried out in various ways. It will also be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0038] As further described below, the present invention provides devices and methods for puncturing a first biological wall positioned adjacent a second biological wall, wherein an elongate introducer assembly is used synergistically with an elongate guidewire assembly to puncture the first biological wall and avoid, at least in part, damage to the second biological wall.

[0039] Referring to FIG. 1 , elongate introducer assembly 100 is configured with a hollow lumen 110. The outer diameter of elongate introducer assembly 100 may be any size suitable for insertion through tissue surrounding the thoracic and abdominal cavities as well as the pericardium of the heart. The outer diameter of hollow lumen 110 may be any size that accommodates a desired accessory device. The diameter of hollow lumen 110 may be any size that accommodates a desired accessory device. The overall length of elongate introducer assembly 100 may be any length that facilitates insertion through a subxiphoid incision to the apex of the heart. However, elongate introducer assembly 100 is not so long that it substantially bends or distorts under its own weight when in use. The bending stiffness of elongate introducer assembly 100 is at least 0.002 Nm 2 The elongated introducer assembly 100 may be formed from any biocompatible material, such as stainless steel, HDPE, LDPE, or any combination thereof. The distal section 112 of the introducer assembly 100 tapers downward from the outer diameter of the main shaft to enhance the ability of the elongated introducer assembly 100 to advance through body tissue. In some embodiments, the distal section 112 may incorporate an ultrasound-visible marker 114 configured to be detectable by the medical imaging system 500. The ultrasound-visible marker may be made of platinum, tungsten, gold, or any material that attenuates sound waves used with the medical imaging system 500 in such a way that ultrasound is visually distinguishable. This allows a user to monitor the position of the distal section 112 and use the information to aid in the placement of the elongated introducer assembly 100. In some embodiments, the elongated introducer assembly 100 includes a proximal hub 116 that may be used to grasp or insert an accessory device during use. Proximal hub 116 may incorporate a central female luer connector 118 that facilitates connection of luer-like accessories to elongate introducer assembly 100 .

[0040] Referring to FIG. 2 , the elongate introducer assembly 100 is shown having a stylet 122 inside the hollow lumen 110. The stylet 122 is comprised of a stylet shaft 124 and a stylet hub 126. The stylet 122 is fully removable from the hollow lumen 110 and can be used to add additional rigidity to the elongate introducer assembly 100 during insertion and placement in use. Additionally, the stylet 122 can also prevent the hollow lumen 110 from receiving tissue during insertion through the chest and / or abdomen. In other words, the use or presence of a stylet can be embedded in the cavity of the hollow lumen 110 during insertion and placement of the elongate introducer assembly 100 to help reduce foreign tissue material that may be deposited in the pericardial space following puncture. This foreign tissue material in the pericardial space, if accumulated, can cause irritation and inflammation. Thus, occupying the hollow lumen 110 space with the stylet 122 during insertion and placement of the elongate introducer assembly 100 is advantageous in that it prevents extraneous tissue material from occupying the hollow lumen 110. The stylet shaft 124 may have an outer diameter that allows the stylet to be slidably received inside the hollow lumen 110. The stylet shaft 124 may be constructed of a rigid material, such as stainless steel, and may have a length that allows the stylet to protrude no more than 3 mm from the tip of the distal section 112 of the elongate introducer assembly 100. The stylet hub 126 may be made of any material that allows it to be grasped and manipulated. The stylet hub may allow the stylet to be temporarily secured to the central female luer connector 118 or any other location on the proximal hub 116.

[0041] 3, proximal hub 116 is shown with a removable hemostatic valve 120 attached to a central female luer connector 118. Hemostatic valve 120 prevents leakage or spillage of fluids while also allowing for insertion and manipulation of accessory devices.

[0042] 4, proximal hub 116 is shown with a removable hemostatic valve 120 attached to a central female luer connector 118 that is integrated into the proximal hub. A lateral female luer connector 119 is shown integrated onto hemostatic valve 120 to allow for the connection of a luer-like accessory device while also providing an additional port for ease of insertion and manipulation of the accessory device.

[0043] 5, the proximal hub 116 is shown with a hemostatic valve 120 permanently integrated (non-removably) into the proximal hub 116. A lateral female Luer connector 119 is shown on the hemostatic valve to facilitate connection of a Luer-like accessory device while also providing an additional port for ease of insertion and manipulation of the accessory device.

[0044] 6, proximal hub 116 is shown with a hemostatic valve 120 that prevents backflow of fluids from the proximal hub while also allowing for insertion and manipulation of accessory devices. A lateral female Luer connector 119 is shown integrated into the proximal hub, allowing for the connection of Luer-like accessory devices.

[0045] 7, the proximal hub 116 is shown with a central female luer connector 118 and a syringe 400 attached to the central female luer connector 118. This attachment of the syringe 400 to the proximal hub 116 facilitates the user's injection and withdrawal of fluids.

[0046] 8, proximal hub 116 is shown with an integrated hemostasis valve 120 and a lateral female luer connector 119. A syringe 400 is attached to the lateral female luer connector 119, which facilitates the injection and withdrawal of fluids by the user while also allowing for the insertion and manipulation of accessory devices through hemostasis valve 120.

[0047] 9 and 10, an elongate guidewire assembly 200 is shown, which includes a distal portion 212 and an elongate shaft section 218. The distal portion 212 further includes a flexible, pre-set spatial geometry 214, which includes a distal tip 210, a distal length 230, and a distal deflection portion 216. The distal tip 210 may be sharpened to a width of only 0.001 inches (0.0254 mm) and serves to puncture the pericardial tissue. The distal deflection portion 216 is positioned 4 mm back from the distal tip 210 to allow sufficient penetration depth through thick pericardial tissue or pericardial tissue with a thick layer of fat at its tip. The distal deflection portion 216 further functions to direct the distal tip away from the trajectory that the distal length 230 would take through the pericardial tissue upon puncture. In a fully relaxed state, the distal tip 210 is fully deflected away from the leading edge 240 of the elongate guidewire assembly 200. The distal section 212 may be made of a flexible material, such as superelastic nitinol. The elongate shaft section 218 may be rigid or flexible and made of superelastic nitinol. Typically, the guidewire may vary in length between 80 cm and 450 cm and may taper downward from a larger cross-section to a smaller cross-section. With this in mind, the distal section 212 may have a smaller diameter than the elongate shaft section 218. The diameter of this elongate shaft section may be any diameter that fits through the targeted accessory device (e.g., assembly 100, as well as catheter 300). Typically, the guidewire has an outer diameter ranging from 0.014 inches (0.3556 mm) to 0.038 inches (0.9652 mm). In some embodiments, a detectable marker 228 may be placed on the elongate guidewire assembly 200 to facilitate visualization with a medical imaging system 500, such as ultrasound. The detectable marker 228 may be a round wire that may be wrapped around the elongate shaft section 218 or distal portion 212 to form a coil that fits over the elongate shaft section 218 or distal portion 212. The detectable marker 228 may be made of platinum, tungsten, gold, or any material that attenuates ultrasound differently than the material comprising the distal portion 212 or elongate shaft section 218.Additionally, detectable marker 228 may be a surface structure consisting of grooves, etchings, cuts, or roughened areas in the material of elongate guidewire assembly 200, which surface structure sufficiently attenuates ultrasound to be visually distinguishable by medical imaging system 500. Detectable marker 228 may thereby assist the user in monitoring the position of the elongate guidewire assembly during penetration and placement.

[0048] 11 , elongate guidewire assembly 200 is shown with particular emphasis on distal section 212. Distal section 212 includes a flexible, pre-set spatial geometry 214 having a distal tip 210, a distal deflection section 216, and a distal length 230. In some embodiments, distal section 212 has a flattened shape, whereby the shaft forming distal section 212 has a flat, rather than round, cross-section with a flattened height between 0.003 inches (0.0762 mm) and 0.005 inches (0.127 mm). This flattened shape hardens any metal comprising distal section 212 and enhances the positioning of flexible distal curved configuration 214. Furthermore, this flattened shape facilitates greater flexibility of distal section 212, thereby improving the atraumatic nature of distal tip 210 when unsupported by rigid attachment devices and reducing the risk of unwanted tissue damage. In some embodiments, distal length 230 includes first distal length section 232 and second distal length section 234. Second distal length section 234 is constructed in part from distal tip 210 and is deflected away from first distal length section 232 and in a direction substantially opposite distal deflection portion 216. Second distal length section 234 may prevent distal tip 210 from contacting the wall of hollow lumen 110 as shown in FIG. 1 during slidable insertion therethrough without substantially kinking or causing damage to hollow lumen 110 of elongate introducer assembly 100 as shown in FIG. 1.

[0049] Referring to Figures 12-19, a series of exemplary workflow steps are shown in which an elongated introducer assembly 100 and an elongated guidewire device 200 are used to puncture a first biological wall 910 positioned near a second biological wall 912.

[0050] Referring to FIG. 12 , the elongate introducer assembly 100 is shown positioned inside a patient 900 near a first biological pericardial wall 910. Near the first biological wall 910 is a second biological pericardial wall 912. A pericardial cavity 914 exists between the first biological wall 910 and the second biological wall 912. In this example, the pericardial cavity 914 is larger than normal due to a pericardial effusion, resulting in excess fluid accumulation within the pericardial cavity 914 that needs to be drained. The hollow lumen 110 of the elongate introducer assembly slidably receives a compatible accessory device. In some embodiments, the distal section 112 includes an ultrasound-visible marker 114 that is identifiable by a medical imaging system 500, such as ultrasound, thereby allowing a user to visually identify the distal section 112 when it is inside the patient 900.

[0051] 13 , the elongate introducer assembly 100 is shown positioned inside a patient 900 near a first biological wall 910, which is the outer layer of the pericardium (parietal pericardium). Near the first biological wall 910 is a second biological wall 912, which is the inner layer of the pericardium (visceral pericardium). A pericardial cavity 914 exists between the first biological membrane 910 and the second biological membrane 912. In this example, the pericardial cavity 914 is larger than normal due to a pericardial effusion, resulting in excess fluid accumulation in the pericardial cavity 914 that needs to be drained. The stylet 122 is shown with its stylet shaft 124 occupying the hollow lumen 110. The stylet 122 provides rigidity to the elongate introducer assembly 100, thereby aiding in its placement and advancement toward the first biological wall 910. The stylet 122 may also prevent tissue buildup inside the hollow lumen during insertion of the elongate introducer assembly 100 into a patient, which may help to reduce blockage of the hollow lumen 110 or buildup of tissue inside the hollow lumen 110 within the pericardial space 914 upon puncture of the first biological wall 910. In some embodiments, the distal section 112 includes an ultrasound-visible marker 114 that is identifiable by a medical imaging system 500, such as ultrasound, to allow a user to visually identify the distal section 112 when it is inside the patient 900.

[0052] 14 , elongate guidewire assembly 200 is shown occupying hollow lumen 110 of elongate introducer assembly 100. Elongate guidewire assembly 200 can be selectively manipulated by a user along elongate introducer assembly 100 to urge it toward first biological wall 910. When contained within hollow lumen 110, elongate guidewire assembly 200 generally conforms to the interior geometry of elongate introducer assembly 100, such that distal tip 210 of the guidewire assembly is directed toward first biological wall 910 when the elongate introducer assembly is properly positioned and advanced toward first biological wall 910 to form a perforation.

[0053] 15 , elongate introducer assembly 100 is shown positioned inside patient 900 near a first biological wall 910. Elongate guidewire assembly 200 is selectively manipulated by a user along elongate introducer assembly 100 and urged further into pericardial space 914. Distal tip 210 is used to form a perforation 920 in the first biological wall, and distal deflection portion 216 directs distal length 230 away from second biological wall 912, thereby avoiding damage to or puncture of said second biological wall as elongate guidewire assembly 200 is urged further into pericardial space 914.

[0054] 16 , elongate introducer assembly 100 is shown inside patient 900. Elongate guidewire assembly 200 is selectively manipulated along elongate introducer assembly 100 by a user. Distal tip 210 is used to form perforation 920 in the first biological wall upon protruding from elongate introducer assembly 100, and distal portion 212 has a flexible, preset spatial geometry that adopts a shape that orients distal tip 210 away from the leading edge of elongate guidewire assembly 200. This allows elongate guidewire assembly 200 to be advanced further into pericardial space 914, securing the access created by elongate guidewire assembly 200.

[0055] 17 , elongate introducer assembly 100 is shown dilating and advancing through perforation 920 formed in first biological wall 910 by distal tip 210 on elongate guidewire assembly 200. Elongate guidewire assembly 200 occupies hollow lumen 110, allowing elongate guidewire assembly 200 and elongate introducer assembly 100 to advance and retract relative to one another. Distal portion 212 of elongate guidewire assembly 200 is comprised of a flexible, preset spatial geometry 214 that orients distal tip 210 away from the leading edge of elongate guidewire assembly 200, thereby allowing elongate guidewire assembly 200 to be advanced further into pericardial space 914 without at least partially puncturing or damaging second biological wall 912. With elongated introducer assembly 100 advanced into pericardial space 914, the user may remove elongated guidewire assembly 200 from hollow lumen 110 and then drain bodily fluids from pericardial space 914 through hollow lumen 110.

[0056] 18 , one embodiment of elongate guidewire assembly 200 is shown positioned inside a patient 900 in a pericardial space 914 by traversing a first biological wall 910 via distal tip 210 through a perforation 920 formed in the first biological wall 910, with the first biological wall 910 positioned proximate a second biological wall 912. Elongate guidewire assembly 200 is shown herein after elongate introducer assembly 100 has been removed from patient 900 and removed from over elongate guidewire assembly 200 as illustrated in FIG. 17 following the formation of perforation 920. Distal portion 212 of elongate guidewire assembly 200 is comprised of a flexible, preset spatial geometry 214 that orients distal tip 210 away from a leading edge of elongate guidewire assembly 200. The elongate catheter device 300 is shown selectively inserted over the elongate guidewire assembly 200 by insertion through the distal exit portal 310. This allows the elongate catheter device 300 to be selectively guided over the elongate guidewire assembly 200 toward the first biological wall 910 and the fenestrations 920.

[0057] 19 , an elongated catheter device 300 is shown dilating and advancing through a fenestration 920 in a first biological wall 910 located near a second biological wall 912 inside a patient 900. An elongated guidewire assembly is used to guide the elongated catheter device through the fenestration 920 and into the pericardial space 914. The distal portion 212 of the elongated guidewire assembly 200 is configured with a flexible, preset spatial geometry 214 that orients the distal tip 210 away from the leading edge of the elongated guidewire assembly 200. With the elongated catheter device 300 advanced into the pericardial space 914, the user may remove the elongated guidewire assembly 200 from the elongated catheter device 300 to drain bodily fluids from the pericardial space 914.

[0058] The above-described embodiment(s) of the invention are intended to be exemplary only, and accordingly, the scope of the invention is intended to be limited only by the appended claims.

[0059] It will be understood that certain features of the invention, that is, features which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

[0060] While the present invention has been described in connection with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, 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 same extent as if each individual publication, patent, or patent application was specifically and individually intended to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. 1. A device for engaging tissue of a patient, the device including a first biological wall and a second biological wall disposed proximate the first biological wall, the device comprising: the device includes an elongate introducer assembly and an elongate guidewire assembly; the elongate introducer assembly (100) is configured to be manipulated toward and positioned proximate the first biological wall of the patient (900), and is configured to slidably receive an elongate guidewire assembly (200); the elongate guidewire assembly has a distal portion (212) with a flexible preset spatial geometry (214) and is configured to be selectively manipulated along the elongate introducer assembly, the distal portion (212) being configured to assume a straight state when inside the elongate introducer assembly (100) and to assume the preset spatial geometry (214) when manipulated outside the elongate introducer assembly (100); the elongate guidewire assembly (200) having an elongate shaft section (218) and a distal tip (210), the distal tip configured to at least partially form a perforation (920) through the first biological wall (910); the preset spatial geometry (214) begins at a minimum length extent of 4 mm from the distal tip (210) and has a distal deflection portion (216) that deflects a distal length portion (230) away from the second biological wall (912); Device.

2. The device of claim 1 , wherein the elongate introducer assembly includes a stylet (122) configured to be slidably received by the elongate introducer assembly (100).

3. The device of claim 1 or 2, wherein the distal portion (212) comprises a resilient material selected from nitinol and stainless steel.

4. The device of any one of claims 1 to 3, wherein the distal tip (210) is configured to penetrate the first biological wall (910) to at least partially form the perforation (920).

5. 5. The device of claim 4, wherein the distal portion (212) is flat with a height between 0.003 inches (0.0762 mm) and 0.005 inches (0.127 mm).

6. 5. The device of claim 4, wherein the distal length portion (230) includes a first distal length section (232) and a second distal length section (234), the second distal length section (234) encompassing the distal tip (210) and deflected from the first distal length section (232) normally in a direction opposite the distal deflection portion (216).

7. The device of claim 4, wherein the distal tip (210) has a width of 0.001 inches (0.0254 mm) or less.

8. The apparatus of any one of claims 1 to 7, wherein the elongate guidewire assembly (200) comprises a detectable marker (228) configured to be detectable by a medical imaging system (500).

9. The device of claim 8 , wherein the detectable marker (228) further comprises a metal coil disposed on the elongate shaft section (218) or the distal portion (212).

10. The device of claim 8 , wherein the detectable marker (228) comprises a groove, etch, cut, or roughened area in the elongate shaft section (218) or the distal portion (212).

11. The apparatus of any one of claims 1 to 10, wherein the elongate introducer assembly (100) has a proximal hub (116).

12. The device of claim 11 , wherein the proximal hub (116) further comprises a female luer connector (118).

13. The device of claim 12, wherein the proximal hub (116) further comprises a hemostatic valve.

14. The device of any one of claims 1 to 13, wherein an ultrasound-visible marker (114) is disposed on a distal section (112) of the elongated introducer assembly (100), whereby the ultrasound-visible marker (114) is configured to be detectable by a medical imaging system (500).

15. The device of claim 14, wherein the ultrasound-visible marker (114) comprises platinum, tungsten, or gold.

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