Device for tissue puncture in pericardium paracentesis

Abstract

A method and apparatus for an elongated introducer assembly and an elongated guidewire assembly are disclosed. The elongate introducer assembly is manipulated and positioned proximate the first biological wall. The elongate guidewire assembly is selectively manipulated along the elongate introducer assembly and includes a distal tip, a distal portion, and an elongate shaft section. The distal portion further includes a flexible pre-set spatial geometry including a distal length and a distal deflection portion. The distal tip is for puncturing a 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] The present disclosure relates to devices and methods for puncturing biological walls. More specifically, the device is configured for puncturing the pericardium of the heart. Background Art

[0002] Pericardiocentesis is a procedure performed when there is excess fluid accumulation in the space between the pericardial sac and the heart's myocardium, and it is necessary to drain the fluid from that space. Performing a pericardiocentesis involves puncturing the pericardium that surrounds the heart's myocardium (without puncturing the myocardium). It is well known that the pericardium can be punctured using a mechanical needle, wherein the user must very carefully control the input force of the needle to puncture the pericardium while minimizing damage to the underlying myocardium.

[0003] Known pericardiocentesis devices and methods also include the use of a puncture guidewire with a sharp distal tip to create the puncture hole. Unfortunately, known puncture guidewires have a preset distal bend shape, wherein the sharp distal tip rapidly deflects away from the desired puncture direction to avoid accidentally puncturing or damaging the myocardium directly adjacent to the pericardium. In situations where there is a layer of fat covering the pericardium, or in situations where the patient has a thickened pericardium, the rapidly deflecting sharp distal tip may hinder pericardiocentesis because the puncture wire extends from the lumen of the hollow needle and may begin to deviate before it pierces the entire thickness of the pericardial layer. During a pericardiocentesis procedure, the accumulation of fluid causes the pericardium to be farther away from the myocardium than is normally the case, and therefore, the puncture wire used for such an application does not require a distal bend shape that deflects at such a short distance from the distal tip.

[0004] Known pericardiocentesis methods also include the use of radiofrequency (RF) puncture devices (such as needles or guidewires) that selectively vaporize tissue via a blunt electrode using RF energy activated for a fraction of a second. Use of these RF devices requires the setup of cables, generators, and other electrical equipment, which may take longer than performing a pericardiocentesis in situations where the accumulation of fluid is an emergency and immediate drainage of the fluid is required. Therefore, there is a need for an apparatus and method for puncturing a first biological wall while avoiding accidental puncture of a second biological wall or myocardium, while reducing device replacement, complexity, and time. Summary of the invention

[0005] In a broad aspect of the present disclosure, a device is provided, which includes a synergistic combination of an elongated introducer assembly and an elongated guide wire assembly. The elongated introducer assembly is configured to be positioned proximate to a first biological wall and to slidably receive the elongated guide wire assembly. The elongated guide wire assembly has a distal portion having a flexible preset spatial geometry that can be selectively manipulated along the elongated introducer assembly. The distal tip on the elongated guide wire assembly is used to puncture the first biological wall, and when manipulated out of the elongated introducer device, the distal deflection portion guides the distal length away from the front edge of the elongated guide wire assembly.

[0006] According to one aspect of the present disclosure, a device for engaging and puncturing a patient's tissue having a first biological wall and a second biological wall proximate to the first biological wall is provided. The device includes an elongated guide assembly configured to be manipulated toward the first biological wall of the patient and positioned proximate to the first biological wall. The elongated guide assembly is configured to slidably receive an elongated guide wire assembly, and the elongated guide wire assembly has a distal portion having a flexible preset spatial geometry configured to be selectively manipulated along the elongated guide assembly. The elongated guide wire assembly has a distal tip configured to at least partially form a puncture hole extending through the first biological wall; and the distal portion adopts a straightened state when inside the elongated guide assembly, and adopts a preset spatial geometry when manipulated out of the elongated guide assembly. The preset spatial geometry has a distal deflection portion that starts from a minimum length range of 4 mm from the distal tip and deflects a distal length away from the second biological wall. In one embodiment, the distal portion comprises an elastic material, such as nitinol or stainless steel. The distal tip is configured to pierce the first biological wall to at least partially form a puncture hole. The distal portion is, for example, a flat structure with a height between 0.003" and 0.005".

[0007] In one embodiment, the elongated introducer assembly further comprises a stylet configured to be slidably received by the elongated introducer assembly to provide enhanced rigidity to guide the elongated introducer assembly through tissue surrounding the abdominal and thoracic cavities and position the introducer proximate the pericardium. In another embodiment, the distal segment of the elongated introducer assembly can incorporate an ultrasound visible marker configured to be detectable by a medical imaging system. In one embodiment, the ultrasound visible marker can be made of platinum, tungsten, gold, or any material that attenuates sound waves used by a medical imaging system.

[0008] In another embodiment, the distal length of the elongated guidewire assembly includes a first distal length segment and a second distal length segment, whereby the second distal length segment includes a distal tip and is deflected from the first distal length segment and is generally opposite the distal deflection portion. The width of the distal tip can be, for example, equal to or less than 0.001".

[0009] In another embodiment, the elongated guidewire assembly has a detectable marker configured to be detectable by a medical imaging system. In another embodiment, the detectable marker includes a metal coil positioned on the elongated shaft section or distal portion. In a specific embodiment, the detectable marker may include a groove, etching, cutout, or rough area on the elongated shaft section or distal portion.

[0010] As another feature, the elongated introducer assembly has a proximal hub including a female central Luer connector and a hemostasis valve.

[0011] In another main aspect, the present disclosure provides a device and method for engaging tissue of a patient having a first biological wall and a second biological wall proximate to the first biological wall. In one embodiment, a slender guide wire assembly having a distal portion is slidably received by an elongated introducer assembly and is manipulated through the introducer toward the first biological wall, the distal portion having a flexible preset spatial geometry. A distal tip at the end of the distal length on the elongated guide wire assembly is used to puncture the first biological wall, and a distal deflection portion guides the distal length away from a leading edge of the elongated guide wire assembly when the distal portion relaxes and returns to its preset spatial geometry after leaving the elongated introducer assembly.

[0012] In another embodiment, the device (or equipment) and method include introducing an elongated guide assembly into a first biological wall and positioning the elongated guide assembly, the elongated guide assembly including a lumen arranged longitudinally therethrough, and a slender guide wire device having a distal portion, a distal deflection portion, a distal length, and a distal end slidably inserted into the hollow lumen. Then, the distal portion is advanced toward the first biological wall for generating a puncture hole in the first biological wall and intersecting with the distal end. Then, the distal length is deflected away from the second biological wall via the distal deflection portion, and the distal deflection portion is positioned to be at least 4mm away from the distal end. The elongated guide assembly is then removed from the patient's body, while the elongated guide wire device remains in a position to traverse the first biological wall through the puncture hole. After removing the elongated guide assembly, an elongated catheter device having a distal outlet orifice is slidably advanced on the elongated guide wire device via the distal outlet orifice and straddles the first biological wall.

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

[0014] In another embodiment, the elongate introducer assembly has a proximal hub that includes a hemostatic valve for injecting fluids or aspiration at any step of the method.

[0015] Example 1 is a device for engaging tissue of a patient, the tissue of the patient comprising a first biological wall and a second biological wall, wherein the second biological wall is positioned proximal to the first biological wall of the patient. The device comprises an elongated guide assembly configured to be manipulated toward the first biological wall of the patient and positioned proximal to the first biological wall. The elongated guide assembly is configured to slidably receive an elongated guide wire assembly. The elongated guide wire assembly has a distal portion having a flexible preset spatial geometry configured to be selectively manipulated along the elongated guide assembly. The distal portion adopts a straightened state when in the elongated guide assembly, and adopts a preset spatial geometry when manipulating out of the elongated guide assembly. The elongated guide wire assembly comprises an elongated shaft segment and a distal end. The distal end is configured to at least partially form a puncture hole extending through the first biological wall. The preset spatial geometry has a distal deflection portion that starts from a minimum length range of 4 mm from the distal tip and deflects the distal length away from the second biological wall.

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

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

[0018] Example 4 is the device of Example 1, wherein the distal tip is configured to pierce the first biological wall, thereby at least partially forming the puncture hole.

[0019] Example 5 is the device of Example 4, wherein the distal portion is flat and has a height between 0.003 inches and 0.005 inches.

[0020] Example 6 is the apparatus of Example 4, wherein the distal length comprises a first distal length segment and a second distal length segment. The second distal length segment includes a distal tip and is deflected from the first distal length segment and is generally opposite the distal deflection portion.

[0021] Example 7 is the device of Example 4, wherein the width of the distal tip is no greater than 0.001 inches.

[0022] Example 8 is the apparatus of Example 1, wherein the elongated guidewire assembly includes 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 positioned on the elongated shaft segment or the distal portion.

[0024] Example 10 The device of Example 8, wherein the detectable marker comprises a groove, etching, cut, or roughened area in the elongated shaft segment or the distal portion.

[0025] Example 11 is the apparatus of Example 1, wherein the elongated 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 apparatus of Example 12, wherein the proximal hub further comprises a hemostasis valve.

[0028] Example 14 is the apparatus of Example 1, wherein the ultrasound-visible marker is positioned at a distal segment of the elongated introducer assembly, whereby the ultrasound-visible marker is configured to be detectable by a medical imaging system.

[0029] Example 15 is the apparatus of Example 14, wherein the ultrasonically 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 elongated introducer assembly toward the first biological wall in the patient's body, and positioning the elongated introducer assembly near the first biological wall. The method includes slidably inserting an elongated guide wire assembly into a hollow lumen of the elongated introducer assembly, and pushing a distal portion of the elongated guide wire assembly toward the first biological wall. The method includes generating a puncture hole in the first biological wall with a distal end located on the elongated guide wire assembly. The method includes deflecting a distal length including the distal end away from the second biological wall via a distal deflection portion positioned at a minimum of 4 mm from the distal end.

[0031] Example 17 is the method of Example 16, wherein the puncture hole is dilated by a slender introducer assembly.

[0032] Example 18 is the method of Example 16, wherein the elongated introducer assembly is removed from the patient while the elongated guidewire assembly is maintained in position across the first biological wall through the puncture, and wherein the elongated catheter device slidably receives the elongated guidewire assembly via a distal exit orifice of the elongated catheter device. The elongated guidewire assembly is used to guide the elongated 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 hemostasis valve is attached to the proximal hub of the elongated introducer assembly and fluid is injected or aspirated at any step. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to facilitate the understanding of the present invention, examples of the present invention are shown by way of example in the accompanying drawings, in which:

[0036] Figure 1 depicts a cross-sectional view of an elongated introducer assembly; and

[0037] Figure 2 depicts a cross-sectional view of an elongated introducer assembly including a stylet; and

[0038] Figure 3 Depicts a hemostatic valve Figure 1 A cross-sectional view of the proximal hub depicted in; and

[0039] Figure 4 Depicted Figure 1 a cross-sectional view of a depicted proximal hub having a hemostasis valve with a female lateral Luer connector; and

[0040] Figure 5 yes Figure 1 A cross-sectional view of the proximal hub depicted in , the proximal hub having an alternative configuration of the hemostasis valve; and

[0041] Figure 6 Depicted Figure 1 A cross-sectional view of a proximal hub depicted in FIG. 5 having a hemostatic valve within the lumen; and

[0042] Figure 7 depicts a side view of the hemostasis valve and proximal hub with a syringe attached; and

[0043] Figure 8 depicts a side view of the proximal hub with a syringe attached; and

[0044] Fig. 9 depicts a side view of an elongated guidewire assembly having a 180 degree bend; and

[0045] Fig.10 depicts a side view of an elongated guidewire assembly having a 270 degree bend; and

[0046] Fig.11 depicts a side view of an elongated guidewire assembly having a slightly curved distal tip 210; and

[0047] Fig.12 depicts a cross-sectional view of an elongated introducer assembly positioned proximate to a first biological wall; and

[0048] Fig.13 depicts a cross-sectional view of an elongated introducer assembly with a stylet positioned proximate a first biological wall; and

[0049] Fig.14 depicts a cross-sectional view of an elongated introducer assembly with an elongated guidewire assembly contained within a lumen and positioned proximate to a first biological wall; and

[0050] Fig.15 depicts a cross-sectional view of the elongated introducer assembly with the elongated guidewire assembly piercing a first biological wall; and

[0051] Fig.16 depicts a cross-sectional view of an elongated introducer assembly with an elongated guidewire assembly inserted through a perforation in a first biological wall; and

[0052] Fig.17 depicting a cross-sectional view of an elongated introducer assembly over an elongated guidewire assembly enlarging a perforation in a first biological wall; and

[0053] Fig.18 depicts a cross-sectional view of an elongated catheter device inserted over an elongated guidewire assembly, the elongated catheter device being inserted through a puncture in a first biological wall; and

[0054] Fig.19 A cross-sectional view of an elongated catheter device is shown inserted over an elongated guidewire assembly through a puncture in a first biological wall.

[0055] LIST OF REFERENCE NUMBERS USED IN THE DRAWINGS

[0056] Elongated introducer assembly 100

[0057] Hollow lumen 110

[0058] Distal section 112

[0059] Ultrasound visible markers 114

[0060] Proximal hub 116

[0061] Female Center Luer Connector 118

[0062] Female side Luer connector 119

[0063] Hemostatic valve 120

[0064] Stylet 122

[0065] Stylet shaft 124

[0066] Stylet Hub 126

[0067] Slim guidewire assembly 200

[0068] Distal end 210

[0069] Distal portion 212

[0070] Flexible preset spatial geometry 214

[0071] Distal deflection portion 216

[0072] Elongated shaft section 218

[0073] Detectable marker 228

[0074] Distal length 230

[0075] First distal length section 232

[0076] Second distal length section 234

[0077] Front edge 240

[0078] Slim catheter device 300

[0079] Distal exit orifice 310

[0080] Syringe 400

[0081] Medical Imaging System 500

[0082] Patient 900

[0083] First biological wall 910

[0084] Second biological wall 912

[0085] Pericardial Space 914

[0086] Puncture hole 920 DETAILED DESCRIPTION

[0087] With specific reference now to the detailed drawings, it is emphasized that the details shown are by way of example and are only for the purpose of illustrative discussion of certain embodiments of the invention. Before explaining at least one embodiment of the invention in detail, it should be understood that the invention is not limited in its application to the details of the construction and arrangement of the components set forth in the following description or shown in the drawings. The invention is capable of other embodiments or can be practiced or performed in various ways. In addition, it should be understood that the words and terms used herein are for descriptive purposes only and should not be considered restrictive.

[0088] As further described below, the present invention provides an apparatus and method for puncturing a first biological wall positioned proximate to a second biological wall. An elongated introducer assembly is used in conjunction with an elongated guidewire assembly to puncture the first biological wall and at least partially avoid damage to the second biological wall.

[0089] Reference Figure 1 , the elongated introducer assembly 100 is configured with a hollow lumen 110. The outer diameter of the elongated introducer assembly 100 can be any size suitable for insertion into the chest and abdominal cavities and the pericardial tissue surrounding the heart. The diameter of the hollow lumen 110 can be any size to accommodate the desired accessory devices. The overall length of the elongated introducer assembly 100 can be any length that is convenient for insertion into the apex of the heart through an incision below the xiphoid process. However, the elongated introducer assembly 100 cannot be so long that it bends or deforms under its own weight when in use. The bending stiffness of the elongated introducer assembly 100 can be at least 0.002 N·m 2 . The elongated introducer assembly 100 can be made of any biocompatible material, such as stainless steel, HDPE, LDPE, or any combination thereof. The distal segment 112 of the introducer assembly 100 tapers downward from the outer diameter of the main shaft and enhances the ability of the elongated introducer assembly 100 to be advanced through body tissue. In some embodiments, the distal segment 112 can incorporate an ultrasound-visible marker 114 that is configured to be detectable by the medical imaging system 500. The ultrasound-visible marker can be made of platinum, tungsten, gold, or any material that attenuates sound waves for use with the medical imaging system 500 in such a way that the ultrasound appears visually different. In this way, the user can monitor the position of the distal segment 112 and use this information to help position the elongated introducer assembly 100. In some embodiments, the elongated introducer assembly 100 includes a proximal hub 116 that can be used to grasp or insert an accessory device during use. The proximal hub 116 may incorporate a female central luer connector 118 to facilitate connecting a luer-compatible accessory to the elongated introducer assembly 100 .

[0090] Reference Figure 2, the elongated introducer assembly 100 is shown having a stylet 122 within the hollow lumen 110. The stylet 122 includes a stylet shaft 124 and a stylet hub 126. The stylet 122 can be completely removed from the hollow lumen 110 and can be used to further increase the rigidity of the elongated introducer assembly 100 during insertion and positioning when in use. In addition, the stylet 122 can also prevent the hollow lumen 110 from receiving tissue during insertion through the thoracic cavity and / or abdomen. In other words, the use or presence of the stylet helps to reduce foreign tissue material that may become embedded in the cavity of the hollow lumen 110 during insertion or positioning of the elongated introducer assembly 100, which may be deposited in the pericardial space after puncture. If such foreign tissue material is deposited in the pericardial space, it may cause irritation and inflammation. Thus, during insertion and positioning of the elongated introducer assembly 100 through the stylet 122, occupying the hollow lumen 110 space may be advantageous because it prevents foreign 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 within the hollow lumen 110. The stylet shaft 124 may be constructed of a rigid material, such as stainless steel, and have a length that allows the stylet to extend no more than 3 mm from the end of the distal section 112 of the elongated 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 female central Luer connector 118 or any other location on the proximal hub 116.

[0091] refer to Figure 3 , shows a proximal hub 116 having a removable hemostatic valve 120 attached to a female central luer connector 118. The hemostatic valve 120 prevents leakage or flow of fluids while still allowing insertion and manipulation of accessory devices.

[0092] Reference Figure 4 , a proximal hub 116 is shown having a removable hemostasis valve 120 attached to a female central luer connector 118 that is integrated into the proximal hub. A female lateral luer connector 119 is shown integrated onto the hemostasis valve 120 and allows for the connection of a luer-compatible accessory device while also providing an additional port to facilitate insertion and manipulation of the accessory device.

[0093] refer to Figure 5 , a proximal hub 116 is shown, into which a hemostasis valve 120 is permanently integrated (non-removable). A female lateral Luer connector 119 is shown on the hemostasis valve to facilitate connection of a Luer-compatible accessory device, while also providing an additional port to facilitate insertion and manipulation of the accessory device.

[0094] refer to Figure 6, shows a proximal hub 116 having a permanently integrated (non-removable) hemostasis valve 120 that prevents fluid backflow from the proximal hub while still allowing insertion and manipulation of accessory devices. A female lateral Luer connector 119 is shown integrated into the proximal hub, allowing connection of a Luer-compatible accessory device.

[0095] refer to Figure 7 , shows a proximal hub 116 having a female central luer connector 118 and a syringe 400 attached to the female central luer connector 118. Attaching the syringe 400 to the proximal hub 116 facilitates the user to inject and withdraw fluids.

[0096] Reference Figure 8 , showing the proximal hub 116 with an integrated hemostasis valve 120 and a female lateral Luer connector 119. A syringe 400 is attached to the female lateral Luer connector 119, facilitating the user to inject and aspirate fluids while also being able to insert and manipulate accessory devices through the hemostasis valve 120.

[0097] refer to Fig. 9 and Fig.10, shows an elongated guidewire assembly 200, which includes a distal portion 212 and an elongated shaft segment 218. The distal portion 212 includes a flexible preset spatial geometry 214, which further includes a distal tip 210, a distal length 230, and a distal deflection portion 216. The distal tip 210 can be sharp, no greater than 0.001" (inch) in width and is used to puncture pericardial tissue. The distal deflection portion 216 is positioned no less than 4 mm from the distal tip 210 to allow sufficient puncture depth through thickened pericardial tissue or through pericardial tissue having a thick fat layer on top of the pericardial tissue. The distal deflection portion 216 is further used to guide the distal tip away from the trajectory of the distal length 230 through the pericardial tissue during puncture. When in a fully relaxed state, the distal tip 210 The distal portion 212 may be completely offset from the front edge 240 of the elongated guidewire assembly 200. The distal portion 212 may include a flexible material, such as superelastic nitinol. The elongated shaft segment 218 may be rigid, or it may be flexible and include superelastic nitinol. Typically, the length of the guidewire may vary between 80 cm and 450 cm, and taper from a larger cross-section to a smaller cross-section. In view of this, the distal portion 212 may have a smaller diameter than the elongated shaft segment 218. The diameter of the elongated shaft segment may be a diameter suitable for passing through the eye. The detectable marker 228 may be positioned on the elongated guidewire assembly 200 to facilitate visibility under a medical imaging system 500 (e.g., ultrasound). The detectable marker 228 may be a ring-shaped wire tightly wound to form a coil that is mounted on the elongated shaft segment 218 or the distal portion 212. The detectable marker 228 may be made of platinum, tungsten, gold, or any material that attenuates ultrasound in a manner different from the material comprising the distal portion 212 or the elongated shaft segment 218. Additionally, the detectable marker 228 may be a surface structure of a groove, etching, cut, or roughened area included in the material of the elongated guidewire assembly 200, wherein such surface structure is sufficient to attenuate ultrasound so as to appear visually different on the medical imaging system 500. In this manner, the detectable marker 228 may help the user monitor the position of the elongated guidewire assembly during puncture and positioning.

[0098] refer to Fig.11, the elongated guidewire assembly 200 is shown with particular emphasis on the distal portion 212. The distal portion 212 includes a flexible preset spatial geometry 214 having a distal tip 210, a distal deflection portion 216, and a distal length 230. In some embodiments, the distal portion 212 can have a flat configuration, whereby the shaft forming the distal portion 212 has a flat, rather than circular, cross-section with a flat height between 0.003" and 0.005". This flat configuration work-hardens any metal comprising the distal portion 212 and enhances retention of the flexible distal curved configuration 214. In addition, the flat configuration facilitates greater flexibility of the distal portion 212, which enhances the atraumatic properties of the distal tip 210 and reduces the risk of undesirable damage to tissue when there is no rigid attachment device support. In some embodiments, the distal length 230 includes a first distal length segment 232 and a second distal length segment 234. The second distal length segment 234 partially includes the distal tip 210 and is deflected away from the first distal length segment 232 and is substantially opposite to the distal deflection portion 216. The second distal length segment 234 can prevent the distal tip 210 from contacting the distal end 210. Figure 1 The wall of the hollow lumen 110 shown can be slidably inserted therein without significantly kinking or otherwise interfering with the Figure 1 The hollow lumen 110 of the elongated introducer assembly 100 is shown to cause injury.

[0099] Reference Figures 12 to 19 , shows a series of exemplary workflow steps in which an elongated introducer assembly 100 and an elongated guidewire device 200 are used to puncture a first biological wall 910 that is positioned proximate to a second biological wall 912.

[0100] Reference Fig.12 , shows an elongated introducer assembly 100 within a patient 900 and positioned proximate a first biological wall 910 of the pericardium. Proximate the first biological wall 910 is a second biological wall 912 of the pericardium. A pericardial space 914 exists between the first biological wall 910 and the second biological wall 912. In this example, the pericardial space 914 is larger than usual due to the presence of a pericardial effusion, wherein excess fluid accumulates in the pericardial space 914 and requires drainage. The hollow lumen 110 of the elongated introducer assembly can slidably receive a compatible accessory device. In some embodiments, the distal segment 112 includes an ultrasound visible marker 114 that is distinguishable on a medical imaging system 500 (such as ultrasound), thereby allowing a user to visually identify the distal segment 112 when the distal segment is within the patient 900.

[0101] Reference Fig.13, shows an elongated introducer assembly 100 within a patient 900, positioned proximal to a first biological wall 910, wherein the first biological wall 910 is the outer layer of the pericardium (parietal pericardium). Proximal to the first biological wall 910 is a second biological wall 912, wherein the second biological wall 912 is the inner layer of the pericardium (visceral pericardium). A pericardial space 914 exists between the first biological wall 910 and the second biological wall 912. In this example, the pericardial space 914 is larger than a typical pericardial space due to the presence of a pericardial effusion, wherein excess fluid accumulates in the pericardial space 914 and needs to be drained. A stylet 122 is shown, wherein a stylet shaft 124 occupies the hollow lumen 110. The stylet 122 can increase the rigidity of the elongated introducer assembly 100, aiding in positioning and advancement toward the first biological wall 910. The stylet 122 can also prevent tissue from accumulating inside the hollow lumen during insertion of the elongated introducer assembly 100 into the patient. This can help prevent clogging of the hollow lumen 110 after puncturing the first biological wall 910 or deposition of tissue inside the hollow lumen 110 into the pericardial space 914. In some embodiments, the distal segment 112 includes an ultrasound visible marker 114 that is distinguishable on a medical imaging system 500 (such as ultrasound), allowing a user to visually identify the distal segment 112 while the distal segment is within the patient 900.

[0102] Reference Fig.14 , the elongated guidewire assembly 200 is shown occupying the hollow lumen 110 of the elongated introducer assembly 100. The elongated guidewire assembly 200 is selectively manipulated by a user along the elongated introducer assembly 100 and can be pushed toward the first biological wall 910. When contained within the hollow lumen 110, the elongated guidewire assembly 200 generally adopts the internal geometry of the elongated introducer assembly 100. In this manner, when the elongated introducer assembly is properly positioned and pushed toward the first biological wall 910 to create a puncture, the distal tip 210 of the guidewire assembly is directed toward the first biological wall 910.

[0103] Reference Fig.15 , shows the elongated introducer assembly 100 within a patient 900, positioned proximate to a first biologic wall 910. The elongated guidewire assembly 200 is selectively manipulated by a user along the elongated introducer assembly 100 and is further advanced into the pericardial space 914. The distal tip 210 is used to create a puncture hole 920 in the first biologic wall, and the distal deflection portion 216 directs the distal length 230 away from the second biologic wall 912, thereby avoiding damage or puncture to the second biologic wall when the elongated guidewire assembly 200 is further advanced into the pericardial space 914.

[0104] Reference Fig.16, showing the elongated guide wire assembly 100 in a patient 900. The elongated guide wire assembly 200 is selectively manipulated by a user along the elongated guide wire assembly 100. The distal tip 210 is used to create a puncture hole 920 in the first biological wall, and after exiting from the elongated guide wire assembly 100, the distal portion 212 has a flexible preset spatial geometry that is shaped to guide the distal tip 210 away from the leading edge of the elongated guide wire assembly 200. In this way, the elongated guide wire assembly 200 can be further advanced into the pericardial space 914 to ensure that the elongated guide wire assembly 200 forms a passage.

[0105] Reference Fig.17 , shows the elongated introducer assembly 100 expanded and advanced through a puncture hole 920 formed in a first biological wall 910 by a distal tip 210 on an elongated guidewire assembly 200. The elongated guidewire assembly 200 occupies a hollow lumen 110, allowing the elongated guidewire assembly 200 and the elongated introducer assembly 100 to be advanced and retracted relative to each other. The distal portion 212 of the elongated guidewire assembly 200 includes a flexible preset spatial geometry 214 that guides the distal tip 210 away from the leading edge of the elongated guidewire assembly 200, whereby the elongated guidewire assembly 200 can be further advanced into the pericardial space 914 without, at least partially, puncturing or damaging the second biological wall 912. As the elongated introducer assembly 100 is advanced into the pericardial space 914, the user can remove the elongated guidewire assembly 200 from the hollow lumen 110 and drain fluid from the pericardial space 914 through the hollow lumen 110.

[0106] Reference Fig.18 , shows an embodiment of an elongated guidewire assembly 200 positioned within a patient 900 and occupying a pericardial space 914 by traversing a first biological wall 910 through a puncture hole 920 formed in the first biological wall 910 via a distal tip 210, wherein the first biological wall 910 is positioned adjacent to a second biological wall 912. The elongated guidewire assembly 200 depicted here is removed from the patient 900 after the puncture hole 920 is formed and is similar to Fig.17 200 after removing the elongated introducer assembly 100 over the elongated guidewire assembly 200. The distal portion 212 of the elongated guidewire assembly 200 includes a flexible preset spatial geometry 214 that guides the distal tip 210 away from the leading edge of the elongated guidewire assembly 200. The elongated catheter device 300 is shown, which is selectively inserted over the elongated guidewire assembly 200 by insertion through the distal exit orifice 310. In this way, the elongated catheter device 300 can be selectively guided over the elongated guidewire assembly 200 toward the first biological wall 910 and the puncture hole 920.

[0107] Reference Fig.19, shows an elongated catheter device 300 in a patient 900, expanded and advanced through a puncture 920 in a first biological wall 910 positioned proximal to a second biological wall 912. An elongated guidewire assembly is used to guide the elongated catheter device through the puncture 920 into the pericardial space 914. The distal portion 212 of the elongated guidewire assembly 200 includes a flexible preset spatial geometry 214 that guides the distal tip 210 away from the leading edge of the elongated guidewire assembly 200. As the elongated catheter device 300 is advanced into the pericardial space 914, the user can remove the elongated guidewire assembly 200 from the elongated catheter device 300 and drain fluid from the pericardial space 914.

[0108] The embodiments of the present invention described above are merely exemplary. Therefore, the scope of the present invention is limited only by the scope of the appended claims.

[0109] It should also 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.

[0110] Although the present invention has been described in conjunction with its specific embodiments, 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 changes, 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 to the extent that each individual publication, patent or patent application is specifically and individually indicated to be incorporated herein by reference. In addition, the citation or identification of any reference in this application should not be construed as admitting that the reference can be used as prior art of the present invention.

Claims

1. A device for engaging tissue of a patient, the tissue of the patient comprising a first biological wall and a second biological wall, the second biological wall being positioned proximate to the first biological wall of the patient, the device comprising: an elongated introducer assembly configured to be manipulated toward a first biological wall of the patient (900) and positioned proximate to the first biological wall; The elongated introducer assembly (100) is configured to slidably receive an elongated guidewire assembly (200); The elongated guidewire assembly has a distal portion (212) having a flexible preset spatial geometry (214) configured to be selectively manipulated along the elongated introducer assembly, the distal portion (212) adopting a straightened state when within the elongated introducer assembly (100) and adopting the preset spatial geometry (214) when manipulated out of the elongated introducer assembly (100); The elongated guidewire assembly (200) has an elongated shaft segment (218) and a distal tip (210) configured to at least partially form a puncture hole (920) extending through the first biological wall (910); and The preset spatial geometry (214) has a distal deflection portion (216) starting from a minimum length range of 4 mm from the distal tip (210) and deflecting a distal length (230) away from the second biological wall (912).

2. The device according to 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 according to claim 1 or 2, wherein: The distal portion (212) comprises a resilient material selected from the group consisting of Nitinol and stainless steel.

4. The device according to any one of claims 1 to 3, wherein: The distal tip (210) is configured to pierce the first biological wall (910), thereby at least partially forming the puncture hole (920).

5. The device according to claim 4, wherein: The distal portion (212) has a flat configuration and a height between 0.003 inches and 0.005 inches.

6. The device according to claim 4, wherein: The distal length (230) includes a first distal length segment (232) and a second distal length segment (234), wherein the second distal length segment (234) includes a distal tip (210) and is deflected from the first distal length segment (232) and is generally opposite to the distal deflection portion (216).

7. The device according to claim 4, wherein: The width of the distal tip (210) is no greater than 0.001 inches.

8. The device according to any one of claims 1 to 7, wherein: The elongated guidewire assembly (200) includes a detectable marker (228) configured to be detectable by a medical imaging system (500).

9. The device according to claim 8, wherein: The detectable marker (228) further comprises a metal coil positioned on the elongated shaft segment (218) or the distal portion (212).

10. The device according to claim 8, wherein: The detectable marker (228) includes a groove, etching, cutout, or roughened area in the elongated shaft segment (218) or the distal portion (212).

11. The device according to any one of claims 1 to 10, wherein: The elongated introducer assembly (100) has a proximal hub (116).

12. The device according to claim 11, wherein The proximal hub (116) further includes a female Luer connector (118).

13. The device according to claim 12, wherein: The proximal hub (116) further includes a hemostatic valve.

14. The device according to any one of claims 1 to 13, wherein: An ultrasound-visible marker (114) is positioned at 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 according to claim 14, wherein: The ultrasonically visible marker (114) includes platinum, tungsten or gold.

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