Hollow needle for delivering a guidewire

Abstract

A device (1600) for delivering a guidewire to a target location within a patient's body includes a hollow needle (1604) having a lumen configured to receive the guidewire, a body section, and a biasing section, the biasing section configured to bend relative to the body section, the biasing section located on a distal end of the hollow needle. The device includes a catheter (1602) having a catheter lumen configured to receive the hollow needle (1604) and maintain the biasing section and the body section in relative alignment in a first configuration. The hollow needle (1604) is configured to bend the biasing section relative to the body section in a second configuration in response to the biasing section extending out of the catheter (1602).

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 308,454, filed February 9, 2022, and entitled “SHAPE SET HYPODERMIC NEEDLE,” the disclosure of which is hereby incorporated by reference in its entirety. [Background technology]

[0002] The present disclosure relates generally to the field of implant delivery devices and implant technology.

[0003] Description of Related Art Heart failure can occur when the heart becomes enlarged and dilated due to a variety of conditions, such as chronic hypertension, myocardial infarction, mitral valve insufficiency, and other dilated cardiomyopathies. Treating such cardiac insufficiency can involve implanting devices into the heart, either temporarily or permanently. Such devices may need to be delivered to the heart using an implant delivery device that uses a guidewire that can be introduced into the heart chambers via a subcutaneous needle. Summary of the Invention

[0004] Described herein are one or more methods and / or devices for facilitating delivery of a guidewire into the heart, or other anatomical structure. The guidewire can then be used to deliver an implant or other medical device. In certain examples, a curved needle can facilitate delivery of the guidewire while avoiding certain problems, such as tissue tenting, by allowing for a smaller profile delivery system of the guidewire.

[0005] One general aspect includes an apparatus for delivering a guidewire to a target location in a patient's body. The apparatus includes a hollow needle having a lumen configured to receive the guidewire, a body section, and a biasing section, the biasing section configured to bend relative to the body section, the biasing section located on a distal end of the hollow needle. The apparatus includes a catheter having a catheter lumen configured to receive the hollow needle and maintain the biasing section and the body section in relative alignment in a first configuration. The hollow needle is configured to bend the biasing section relative to the body section in a second configuration in response to the biasing section extending out of the catheter.

[0006] Implementations of the device may include one or more of the following features. The device may include a plurality of notches made in the biasing section that allow the biasing section to bend. The plurality of notches may be uniform and aligned parallel along the curved inner surface of the biasing section. The plurality of notches may number at least 10 notches. The plurality of notches may be laser cut. The device may include a sealant over the plurality of notches. The biasing section may include a needle tip, the orientation of the needle tip changing at least 90° when the device transforms from the first configuration to the second configuration. The biasing section may have a radius of about 13.5 mm and an arc of about 106°. The biasing section may form a U-shape in the second configuration. The device may include a ramp formed in the catheter lumen, the ramp configured to bias the biasing section of the hollow needle relative to the body section. The body section and the biasing section may form an angle of 90° or less in the second configuration. The catheter may include an opening to the catheter lumen located on a side thereof, the opening configured to provide exit from the catheter lumen for the hollow needle.

[0007] One general aspect includes a method for delivering a guidewire to a target location in a patient's body using a hollow needle deployed from a catheter. The method also includes advancing the hollow needle within the catheter to a first position, where the hollow needle includes a biasing section and a body section, where the biasing section and the body section are maintained in relative alignment by the catheter in a first configuration. The method also includes advancing the biasing section of the hollow needle through an opening in the catheter. The method also includes deploying the biasing section of the hollow needle through an opening in the catheter to a second configuration, where the biasing section is configured to bend relative to the body section in response to the biasing section extending from the catheter. The method also includes placing the guidewire from the hollow needle to the target location.

[0008] Implementations of the device may include one or more of the following features: Deploying the biased section of the hollow needle may include penetrating a tissue wall using the hollow needle to reach the target location. The method may include deploying a medical implant at the target location using a guidewire. The biased section may include a needle tip, and the orientation of the needle tip changes at least 90° when transforming from a first configuration to a second configuration. The biased section may form a U-shape in the second configuration. The method may include withdrawing the hollow needle from the target location while retaining the hollow needle within the catheter after deploying the guidewire. The hollow needle may be made at least in part from nylon or nitinol.

[0009] One general embodiment includes a hollow needle for delivering a guidewire to a target location in a patient's body. The hollow needle also includes a lumen configured to receive the guidewire. The needle also includes a hollow needle body section. The needle also includes a hollow needle biasing section located on a distal end of the hollow needle. The biasing section may include a needle tip and a plurality of cuts aligned in parallel along a same side of the biasing section, which may be a curved inner surface formed by the biasing section, and the plurality of cuts are configured to bend the biasing section relative to the body section.

[0010] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features are described. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein. [Brief description of the drawings]

[0011] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements.

[0012] [Figure 1] FIG. 1 shows the human cardiac anatomy. [Diagram 2] FIG. 2 shows a top view of the human heart. [Diagram 3] FIG. 3 shows an example of a tenting technique in which the tissue captures the needle or part of the needle. [Figure 4A] FIG. 4A shows a perspective view of a curved needle according to one or more embodiments. [Figure 4B] FIG. 4B illustrates an axial view of a curved needle according to one or more embodiments. [Figure 4C] FIG. 4C illustrates a side view of a curved needle according to one or more embodiments. [Figure 4D] FIG. 4D illustrates a cross-sectional view of a needle within a catheter in a first configuration with the needle within the catheter, a transition configuration, and a second configuration with a bent portion of the needle outside the catheter, according to one or more embodiments. [Figure 4E]FIG. 4E illustrates a cross-sectional view of a needle within a catheter in a first configuration with the needle within the catheter, a transition configuration, and a second configuration with a bent portion of the needle outside the catheter, according to one or more embodiments. [Figure 4F] FIG. 4F illustrates a cross-sectional view of a needle within a catheter in a first configuration with the needle within the catheter, a transition configuration, and a second configuration with a bent portion of the needle outside the catheter, according to one or more embodiments. [Diagram 5] FIG. 5 illustrates another embodiment of a curved needle having different structures and materials, according to one or more embodiments. [Figure 6] FIG. 6 illustrates an embodiment of a catheter for an implant delivery device, according to one or more embodiments. [Figure 7] FIG. 7 illustrates an embodiment of a catheter for an implant delivery device, according to one or more embodiments. [Figure 8] FIG. 8 illustrates a block diagram of a system for implanting and / or monitoring an implant device according to one or more embodiments. [Figure 9] Figures 9-1, 9-2, and 9-3 (collectively referred to as Figure 9) provide a flow diagram illustrating a process for using an implant delivery device to perform a medical procedure using a curved needle according to one or more embodiments disclosed herein. [Figure 10] 10-1, 10-2, and 10-3 (collectively referred to as FIG. 10) provide views of an implant delivery device within the heart when the process of FIG. 9 is performed, according to one or more embodiments disclosed herein. [Figure 11] FIG. 11 illustrates various embodiments of needle ends (also called needle points) that may be used with the needle embodiments described in the figures above, according to one or more embodiments disclosed herein. [Figure 12A] FIG. 12A illustrates a cut pattern that may be used with the needle embodiment described in the above figures, according to one or more embodiments disclosed herein. [Figure 12B]FIG. 12B illustrates a cut pattern that may be used with the needle embodiment described in the above figures, according to one or more embodiments disclosed herein. [Figure 12C] FIG. 12C illustrates a cut pattern that may be used with the needle embodiment described in the above figures, according to one or more embodiments disclosed herein. [Figure 13] FIG. 13 illustrates a needle that uses a wire stiffener to maintain its shape, according to one or more embodiments disclosed herein. [Figure 14] FIG. 14 illustrates a needle 1400 that maintains its shape using wire stiffeners 1406 along its internal bends, according to one or more embodiments disclosed herein. [Figure 15] 15A-15C illustrate various embodiments of wire reinforcement according to one or more embodiments disclosed herein. [Figure 16A] FIG. 16A shows a diagram of a device comprising a needle using a wire stiffener and a sheath according to one or more embodiments disclosed herein. [Figure 16B] FIG. 16B shows a diagram of a device with a needle using a wire stiffener and a sheath according to one or more embodiments disclosed herein. [Figure 16C] FIG. 16C shows a diagram of a device comprising a needle using a wire stiffener and a sheath according to one or more embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0014] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular embodiment, the order of description should not be construed as implying that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all such aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0015] Certain reference numbers are reused across different figures of the set of figures of the present disclosure as a matter of convenience for devices, components, systems, features, and / or modules having characteristics that may be similar in one or more respects. However, with respect to any of the embodiments disclosed herein, the reuse of common reference numbers in the figures does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art may be informed by the context as to the extent to which the use of common reference numbers may imply similarity between the referenced subject matter. The use of a particular reference number in the context of a description of a particular figure may be understood as relating to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number may be interpreted as sharing features or as being entirely independent of each other.

[0016] Certain standard terms of location are used herein to refer to certain device components / features and, for some embodiments, animal, i.e., human, anatomical structures. While certain spatially relative terms and similar terms, such as "outer," "inner," "upper," "lower," "lower," "upper," "vertical," "horizontal," "top," "bottom," "down," "upper," "upper side," "lower," and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationships between the elements / structures illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or beside such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa.

[0017] The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, if a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.

[0018] The present disclosure relates to systems, devices, and methods for delivering an implant to a target location within a patient's body, such as the heart. In particular, certain embodiments utilize a bent hollow needle to deliver a guidewire to the target location. The use of such a needle can reduce the cross-section of at least some portions of the implant delivery device, thereby avoiding or reducing the possibility of certain problems, such as tenting. The implant delivery device of the present disclosure includes one or more of a catheter, a tube within the catheter, a hollow needle such as a hypodermic needle formed on a distal end of the tube, and one or more guidewires configured to be delivered to a target site within the tube. The guidewires can be used to deliver one or more implants to the target site. In some embodiments, the hypodermic needle is biased to bend after leaving the catheter. In a first configuration, with the hypodermic needle inside the catheter, the hypodermic needle is mostly straight. In a second configuration, with the hypodermic needle outside the catheter, the hypodermic needle is bent. Certain examples of implant delivery devices are disclosed herein in terms of cardiac implant devices. However, while certain principles disclosed herein are particularly applicable to cardiac anatomy, it will be understood that an implant delivery apparatus in accordance with the present disclosure may be utilized with any suitable or desired anatomy.

[0019] Cardiac Physiology The anatomical structure of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, and flow between its associated chambers and vessels is controlled, at least in part, by various cardiac valves, namely, the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to at least in part control the flow of blood to respective regions of the heart and / or vessels (e.g., the pulmonary artery, the aorta, etc.) in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole).

[0020] 1 and 2 respectively illustrate vertical / frontal and horizontal / superior cross-sectional views of an exemplary heart 1 with various functional / anatomical structures relevant to certain embodiments of the present disclosure. Heart 1 includes four chambers: left atrium 2, left ventricle 3, right ventricle 4, and right atrium 5. With respect to blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery 11 via the pulmonary valve 9, which separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped towards the lungs and to close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.

[0021] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in the circulation of blood therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps or leaflets and generally may close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3, and to close during systole to prevent blood from flowing back into the left atrium 2 when functioning properly. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood leaving the left ventricle 3 to enter the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0022] A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, and a number of leaflets or cusps attached to the annulus. Generally, the size of the leaflets or cusps may be such that when the heart contracts, the increased blood pressure generated within the corresponding heart chamber causes the leaflets to at least partially open, thereby allowing flow from the heart chamber. When pressure within a heart chamber decreases, the subsequent pressure within the heart chamber or blood vessel may prevail and push the leaflets back. As a result, the leaflets / cusps appose each other, thereby closing the flow path. Dysfunction of a heart valve and / or associated leaflets (e.g., pulmonary valve dysfunction) may result in valve leakage and / or other health complications.

[0023] Atrioventricular (i.e., mitral and tricuspid) heart valves further include a collection of chordae tendineae and papillary muscles (not shown) that anchor the leaflets of each valve to promote and / or facilitate proper coaptation of the leaflets and prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The leaflets of the valve are connected to the papillary muscles by the chordae tendineae.

[0024] A muscular wall called the septum separates the left and right heart chambers. In particular, interatrial septal wall portion 18 (referred to herein as the "atrial septum," "atrial septum," or "septum") separates the left atrium 2 and the right atrium 5, while interventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates the left ventricle 3 and the right ventricle 4. The inferior tip 26 of the heart 1, called the apex, is generally located in the fifth intercostal space, at or near the midclavicular line.

[0025] The coronary sinus 16 includes a collection of veins that combine to form a relatively large vessel that collects blood from the heart muscle (myocardium). The ostium 14 (see FIG. 2 ) of the coronary sinus 16, which may be at least partially protected in some patients by the Thebesian valve, opens into the right atrium 5 as shown. The coronary sinus extends along the posterior aspect of the left atrium 2 and supplies less oxygenated blood to the right atrium 5. The coronary sinus generally extends laterally within the left atrioventricular groove, which is located on the posterior side of the heart.

[0026] Certain physiological conditions or parameters associated with the anatomy of the heart can affect the health of a patient. For example, congestive heart failure is a disease associated with the heart and / or the relatively slow movement of blood through the body, which causes an increase in fluid pressure in one or more chambers of the heart. As a result, the heart does not pump enough oxygen as the body needs. The various chambers of the heart may respond to the increased pressure by stretching to hold and pump more blood, or by becoming relatively stiff and / or thickened. Over time, the walls of the heart may weaken and may not be able to pump efficiently. In some cases, the kidneys may respond to the heart's failure by retaining fluid within the body. Fluid may accumulate in the arms, legs, ankles, feet, lungs, and / or other organs, causing the body to become congested, which is referred to as congestive heart failure. Acute decompensated congestive heart failure is a major cause of morbidity and mortality, and thus, treatment and / or prevention of congestive heart failure is a major medical concern. Treatment for this condition may require the implantation of various medical devices into the heart.

[0027] Implant Delivery Device As mentioned above, treatment of certain cardiac conditions may involve the implantation of devices, such as those designed to shunt blood from one chamber or vessel of the heart to another. Disclosed herein is an implant delivery device that utilizes a hollow needle (e.g., a hypodermic needle) that forms a first shape in a first configuration and a second shape in a second configuration. For example, the first shape may be a relatively straight configuration when the hypodermic needle is inside the catheter. The relatively straight configuration may facilitate movement of the needle through the catheter. The second shape may be a curved configuration when the hypodermic needle is released from the catheter. The curved configuration may facilitate entry to a target location (e.g., a location to the side of the catheter rather than in front of it) and may allow for a smaller profile that reduces the chance of getting caught in a tissue wall. In some examples, the hollow needle comprises a flexible or semi-flexible material that is biased to form a curve when released from the catheter. For example, the hollow needle may be made at least in part from a shape memory alloy, such as nickel-titanium alloys (e.g., Nitinol), copper-aluminum-nickel alloys, iron-based, and copper-based alloys. Other types of materials, such as nylon or other synthetic polymers, may also be used. Such materials may allow the needle to be set into a particular shape or set of shapes, or to return to that shape after being otherwise deformed or changed into a different shape.

[0028] For purposes of this disclosure, components and sub-components of the implant delivery device are described as distal or proximal with respect to their direction along the axis of the implant delivery device. Distal components are those components that are directed toward a target tissue site within a patient during surgery, and proximal components are those components that are directed toward a user or machine that manipulates the implant delivery device outside of the patient. For example, a needle tip may be at the distal end of the implant delivery device and a catheter handle may be at the proximal end of the implant delivery device.

[0029] FIG. 3 shows an example of a tenting technique, where tissue captures the needle or a portion of the needle. Some implant delivery devices 300 utilize a needle 302 having a jacket 304 that covers the needle. The needle is typically solid and is used to penetrate into the left atrium 2. After reaching the left atrium, the needle is withdrawn, leaving the jacket 304 within the left atrium. The jacket from which the needle is withdrawn provides a lumen through which a guidewire can be inserted into the left atrium. The guidewire can then be used to help deliver the implant into the left atrium.

[0030] However, using a needle 302 with a jacket 304 increases the overall diameter of the distal end of the implant delivery device 300. This can result in tenting issues, as shown in FIG. 3. With the needle extending out of the jacket, the jacket can form a ledge 306 where the distal end of the jacket meets the side of the needle. This ledge can catch on tissue of the atrial wall 308 as the needle penetrates. Therefore, it may be beneficial to utilize a needle that does not require a jacket.

[0031] 4A-4F show views of a curved needle 400 of an implant delivery device, according to certain embodiments. In particular, FIG. 4A shows a perspective view and FIG. 4B shows a front or axial view. FIG. 4C shows a side view with a close-up of the needle tip and a portion of the surface cut on the needle. FIGS. 4D-4E show the needle in a first configuration within the catheter and then transition to a second configuration where the curved portion of the needle is outside the catheter. Unlike the implant delivery device 300 of FIG. 3, the curved needle 400 is used with an implant delivery device that does not require the use of a jacket over the needle. Instead, the needle 400 is hollow, and the implant delivery device uses the hollow needle 400 to deliver a guidewire to a target location instead of using a tubular jacket to deliver the guidewire.

[0032] 4A-4B, a curved distal end of a needle 400 is shown. The needle 400 may comprise a generally straight needle body 402 and a curved needle end 404 located distally from the needle body 402. Thus, the needle 400 may include a biased section (needle end 404) that is curved relative to the body section (needle body 402) or at least relative to the distal end of the needle body 402 connected to the needle end 404. The needle body 402 section of the needle may extend proximally to the catheter handle and may be much longer than the needle end 404 section of the needle 400 (e.g., several centimeters). Because the needle body 402 may be quite long (e.g., 10-100 centimeters) and routed through the patient's body, the needle body may not be straight for its entire length, but rather may have relatively straight portions with curved portions between such straight portions. In some embodiments, such curved portions of the needle body may vary by several degrees (e.g., 20° or less than 30°). A guidewire may be inserted into the needle body 402 through the handle or may be pre-inserted into the needle body 402 prior to use on a patient. In the illustrated example, the needle 400 forms a lumen 406 within its body to provide a passageway for the suture to be delivered to the target site. The needle may be manufactured in different diameters to facilitate different use cases, some of which may require a larger lumen size. For example, one embodiment of the needle may have an inner diameter of about 1.20 mm and an outer diameter of about 1.52 mm. Another embodiment of the needle may have an inner diameter of about 2.16 mm and an outer diameter of about 2.77 mm. The thickness of the needle wall surrounding the lumen 406 may also vary depending on the use case and the desired structural strength of the needle.

[0033] In one embodiment, the bent needle end 404 includes a number of notches 408 on one side of its surface. In the embodiment shown, the notches begin a short distance (e.g., 6 mm, 1-10 mm, etc.) from the tip of the needle and continue proximally along the bent needle end. The notches can bend the needle end 404 by creating a bias or tendency for the needle end 404 to bend inward along the surface in which the notches are made.

[0034] 4C shows a side view of needle 400. In the illustrated embodiment, the curve is formed by an arc of about 106° with a radius of about 13.5 mm. As will be apparent, various embodiments of the needle may have different arcs and radii as desired. For example, the bent needle end 404 may be longer (e.g., a radius greater than 13.5 mm and / or an arc greater than 106°) or shorter (e.g., a radius less than 13.5 mm and / or an arc less than 106°). Some possible embodiments of the needle may have a curve with an arc of about 80° to 125° and / or a radius of about 11 mm to 16 mm.

[0035] In the embodiment shown, there are 20 incisions. However, the number of incisions 408 may vary, with variations in the laser cut affecting the curvature of the bent needle end 404. For example, some embodiments may have less than 10 incisions, 10-20 incisions, more than 20 incisions, at least 10 incisions, etc. Adding more incisions increases the curvature, while decreasing the number of incisions decreases the curvature. As shown, the incisions may extend about halfway through the needle contour and be about 1 mm or less wide. However, the depth and / or width of the incisions may vary depending on the desired characteristics of the needle. The incisions may be spaced apart by a few millimeters. In some embodiments, the incisions are uniform. The incisions may be aligned side by side along the same side or surface of the needle end 404, which forms the inner curve of the bent needle end 404. The cuts may be made mechanically, via a laser, or by a blade or other cutting mechanism.

[0036] The incision may expose the lumen 406 formed by the wall of the needle. In a sample operation, the guidewire moves along the inner surface of the lumen wall and away from the incision, not capturing the incision. However, in some embodiments, a sheath, sealant, or other covering may be placed over the incision to allow the needle to flexibly bend while maintaining the integrity of the lumen. Some embodiments of the implant delivery device may be configured to detect changes in pressure, so using a sheath can make the pressure in the lumen more consistent by reducing the ingress and egress of fluid into and out of the lumen 406.

[0037] In the illustrated embodiment, the tip of the needle 400 is cut at an angle (e.g., about 25°) to create a sharp tip. The sharp tip can help the needle penetrate the tissue wall. In one exemplary manufacturing process, the needle tip is cut with a laser at the desired angle prior to shaping of the needle. A notch 408 can then be made by the laser to provide the needle with the desired curvature.

[0038] 4D-4F show the needle 400 transitioning from a first configuration to a second configuration as the needle leaves the catheter 420. In the illustrated embodiment, the catheter 420 has two lumens 422, 424 with the needle 400 in the first lumen 422. The first lumen 422 includes an opening 428 to the outside of the outer wall 426 of the catheter 420. In the first configuration shown in FIG. 4D, the needle 400 is in a generally straight configuration. However, there may be one or more slight bends in the needle to facilitate the needle moving through the catheter 420. The needle end 404 is configured to bend, but the material of the needle end 404 is sufficiently flexible that the walls of the catheter lumen 422 are sufficient to keep the needle end 404 relatively straight. Relatively straight may mean that there is one or more slight bends of a few degrees in the needle end 404, but the needle end 404 remains sufficiently straight to allow the needle 400 to advance through the catheter. Meanwhile, the needle body 402 may bend further as the needle body 502 bends its way along various body lumens to the heart. One way to measure the difference between the first and second configurations is to measure the change in direction pointed by the needle tip, which may be a change of tens of degrees. For example, if in the first configuration the needle tip is pointing forward (approximately 180° reflected in FIG. 4D), and then in the second configuration the needle tip is pointing up and to the right (approximately 75° reflected in FIG. 4F), the change in tip direction is approximately 105°. In some examples, the direction of the needle tip changes by at least 90° when the needle end 404 transforms from the first configuration to the second configuration.

[0039] As the needle end 404 approaches the opening 428, the natural bias of the needle end 404 to bend may cause the needle end 404 to begin to exit the catheter 420, as shown in FIG. 4E. As the needle 400 advances further through the catheter 420, the entire needle end 404 exits the catheter 420, allowing the needle end 404 to enter its bent second configuration, as shown in FIG. 4F. Another way to measure the difference between the first and second configurations is to draw a line from the tip to the needle to the deflection point where the needle end 404 bends away from the needle body and measure the angle created. In the illustrated example of FIG. 4F, the tip of the needle end 404 relative to the needle body 402 forms an angle of about 110°. Some embodiments may form an angle of about 90-135°. Some embodiments have an angle of less than 90° such that the needle end 404 forms a U-shape, or hook, with the end pointing toward the proximal end.

[0040] 5 illustrates another embodiment of a curved needle 500 having different structures and materials, according to one or more embodiments. In the illustrated embodiment, at least a portion of the needle 500 is formed using a flexible material, such as nylon or a similar polymer. Materials such as nylon, which have excellent shape retention with good elastic recovery behavior, can be used to form the needle. In some embodiments, the needle end 504 is formed of nylon or the like, and the needle body 502 is formed of another material, such as steel.

[0041] The needle 500 of FIG. 5 may operate similarly to the needle 400 of FIGS. 4D-4F, with the needle end 504 in a first configuration while in the catheter, but in a second configuration upon exiting the catheter. In the first configuration, the internal catheter wall maintains the needle end 504 in a relatively straight position relative to the needle body 502, although there may be a slight bend of a few degrees in the needle end. In addition, the needle body 502 may bend further as the needle body 502 curves its way along various body lumens to the heart. However, the needle end 504 and the needle body 502 may be considered aligned when both sections point in the same direction (e.g., the distal end of the needle end 504 and the distal end of the needle body 502) toward the target tissue location. In the second configuration, the needle end 504 returns to its natural shape, which is the bent shape shown in FIG. 5. Similar to needle 400 of FIGS. 4D-4F, nylon needle 500 is hollow, allowing a guidewire to be delivered within needle 500 to a target site.

[0042] A cross section 510 of needle 500 taken at line 508 shows the internal structure of needle 500, according to certain embodiments. In the illustrated embodiment, needle 500 includes a first lumen 512 and a second lumen 514. A lumen wall 516 may extend from one side of the outer wall to another side of the outer wall, dividing the first lumen from the second lumen. The wall may be straight or curved, depending on the desired shape of the lumen. Lumen wall 516 may provide additional stiffness to the needle by damping the outer wall of the needle.

[0043] As shown in cross section 510, first lumen 512 is circular and second lumen 514 is crescent shaped. Other embodiments may use different lumen shapes depending on the desired characteristics of the needle. For example, a circular shaped lumen may be shaped for a guidewire. Using a crescent shaped lumen that partially surrounds the circular shaped lumen 512 can increase the space available within needle 500 for the lumen.

[0044] As will be apparent, other embodiments of needle 500 may have a different number of lumens or lumens of different shapes. For example, one embodiment may have a single lumen and other embodiments may have three or more lumens. Although cross section 510 above shows a circular needle body, other needles may use different shapes. For example, the needle cutting surface is triangular in shape and has three cutting edges for penetrating hard tissue. The needle reverse cutting surface has cutting surfaces on protruding edges and is suitable for hard tissue such as tendons or subcutaneous suturing. Because these types of needles do not have a circular shape, other lumen shapes (e.g., triangular) may use the space within their needle body more efficiently.

[0045] 6 and 7 show different embodiments of a catheter for an implant delivery device, according to one or more embodiments. In FIG. 6, the catheter 600 functions similarly to the catheter of FIGS. 4D-4F, in that the catheter has an opening 602 in its outer wall. The opening 602 allows the needle 604 to exit its lumen 606 within the catheter. This type of catheter 600 can work well with the needle 604 being biased to bend towards the opening 602. As the needle 604 passes through the opening, it has a natural bending tendency that pushes the end 608 of the needle out of the catheter. The needle then leaves the catheter.

[0046] 7 shows a catheter 700 having a ramp 702, according to certain embodiments. As the needle 704 advances through its lumen 706, it approaches an opening 708 and the ramp 702. In some embodiments, the ramp 702 closes off the distal end of the lumen 706. In the illustrated embodiment, a curved surface 710 of the ramp forms part of the wall of the opening 708. As the needle 704 advances downward along the lumen and along the curved surface 710, the distal end of the needle 712 is directed out of the catheter 700, through the opening, along the direction indicated by the arrow.

[0047] Deflecting the needle 704 using the ramp 702 can allow for needle designs that do not naturally bend. Rather, as long as the needle 704 is flexible, the ramp 702 can deflect the needle 704 and reorient the needle 704 out of the lumen 706. Thus, in some embodiments, the catheter 700 can be combined with a hollow needle 704 that may be straight when removed from the catheter 700. Rather, the ramp 702 causes the needle 704 to bend rather than inherently bend when the needle 704 itself is not constrained by the walls of the catheter lumen 706. In a first configuration, before hitting the ramp, the needle 704 remains relatively straight. In a second configuration, after hitting the ramp, the needle 704 is bent or flexed due to the ramp.

[0048] FIG. 8 illustrates a block diagram of a system 840 for implanting and / or monitoring an implant device in a patient 844, according to one or more embodiments. The system may monitor one or more physiological parameters (e.g., left atrial pressure and / or volume). The patient 844 may have a medical implant device 830 implanted in the heart (not shown) or associated physiological structure of the patient 844 using an implant delivery device 835, such as, for example, those described in the previous figures. For example, the implant device 830 may be at least partially implanted within the left atrium and / or within the coronary sinus of the patient's heart. The implant device 830 may be a shunt implant device or other type of implant, such as a device associated with a sensor device to facilitate monitoring. The implant device 830 may include one or more sensor transducers, such as one or more microelectromechanical system (MEMS) devices (e.g., MEMS pressure sensors or other types of sensor transducers).

[0049] The implant device 830 may be placed using an implant delivery device 832. The implant delivery device 832 may include a catheter, a handle, and a curved needle. Examples of curved needles are shown in Figures 4-7. The curved needle may be used to facilitate delivery of the implant device 830 to a target location (e.g., within the heart).

[0050] In certain examples, the system 840 provides the monitoring function using at least two subsystems, including an implantable internal subsystem or device 830. The implant device 830 may include control circuitry including one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters (e.g., antenna coils). The system 840 may further include an external (e.g., non-implant) subsystem including an external reader 842 (e.g., coil), which may include a wireless transceiver 848, electrically and / or communicatively coupled to the particular control circuitry. In certain embodiments, both the internal 830 and external 842 subsystems include one or more corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween. The sensor implant device 830 may be any type of implant device. For example, in some examples, the implant device 30 includes a pressure sensor integrated with another functional implant structure 39, such as an artificial shunt or stent device / structure.

[0051] In certain examples, the implant device 830 can be configured to generate electrical signals that can be wirelessly transmitted to a device located outside the patient's body, such as the illustrated local external monitor system 842. To perform such wireless data transmission, the implant device 830 can include signal processing circuitry and radio frequency (RF) (or other frequency band) transmission circuitry, such as an antenna. The antenna may comprise an antenna coil implanted inside the patient. The control circuitry may include any type of transceiver circuitry configured to transmit electromagnetic signals, where the signals can be radiated by an antenna, which may comprise one or more conductive wires, coils, plates, or the like. The control circuitry of the implant device 830 can include, for example, one or more chips or dies configured to perform some degree of processing on signals generated and / or transmitted using the device 830. However, due to size, cost, and / or other constraints, the implant device 830 may not include independent processing capabilities in some examples.

[0052] The wireless signals generated by the implanted device 830 may be received by a local external monitoring device or subsystem 842, which may include a reader / antenna interface circuit module disposed at least partially within the patient 44 and configured to receive the wireless signal transmissions from the implanted device 830. For example, the circuit module may include a transceiver device / circuitry.

[0053] The external local monitor 842 can receive wireless signal transmissions from the implanted device 830 using an external antenna, such as a wand device, and / or can provide wireless power to the implanted device 830. In some embodiments, the local monitoring device 842 can act as an intermediate communication device between the implanted device 830 and the remote monitor 846. The local monitoring device 842 can be a dedicated external unit designed to communicate to the implanted device 830. For example, the local monitoring device 842 can be a wearable communication device or other device that can be easily placed in close proximity to the patient 844 and the implanted device 830. The local monitoring device 842 can be configured to continuously, periodically, or sporadically query the implanted device 830 to extract or request sensor-based information from the implanted device 830. In certain embodiments, the local monitor 842 includes a user interface that allows a user to view sensor data, request sensor data, or otherwise interact with the local monitoring system 842 and / or the implanted device 830.

[0054] System 840 may include a secondary local monitor 847, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for displaying and / or interacting with the monitored cardiac pressure data. In one example, local monitor 842 may be a wearable device or other device or system configured to be placed in close physical proximity to the patient and / or implanted device 830, and is primarily designed to transmit signals to and / or receive signals from implanted device 830 and provide such signals to secondary local monitor 847 for viewing, processing, and / or manipulation. External local monitor system 842 may be configured to receive and / or process certain metadata, such as device ID or the like, from or associated with implanted device 830, which may also be provided via a data link from implanted device 830.

[0055] The remote monitoring subsystem 846 can be any type of computing device or collection of computing devices configured to receive, process, and / or present monitor data received over the network 849 from the local monitoring device 842, from the secondary local monitor 847, and / or from the implanted device 830. For example, the remote monitoring subsystem 846 can be advantageously operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient 844. While certain examples disclosed herein describe communication from the implanted device to the remote monitoring subsystem 846 indirectly via the local monitoring device 842, in certain embodiments, the implanted device 830 can include a transmitter that can communicate to the remote monitoring subsystem 846 over the network 849 without the need to relay information via the local monitoring device 842.

[0056] Although the above has described implant delivery device 832 as part of a monitoring system, implant delivery device 832, including the curved needle embodiment described in the previous figures, may be utilized with non-monitoring implants, such as shunts, balloons, valves, etc. Additionally, implant delivery device 832 may be used with manual medical instruments, and not necessarily with computerized medical instruments and systems.

[0057] 9-1, 9-2, and 9-3 (collectively referred to as FIG. 9) provide a flow diagram depicting a process 900 for using an implant delivery device to perform a medical procedure using a curved needle, according to one or more embodiments disclosed herein. A medical practitioner, such as a surgeon, can use the process 900 to perform a medical procedure (e.g., installation of a stent, valve, or other implant) during a transseptal, transaortic, transfemoral, transradial, transapical, or other surgical approach. Additionally, for ease of explanation, label numbers from previous figures are used below to refer to specific structures or components. However, the process is not limited to the specific embodiments illustrated in these figures. For example, the embodiments of FIGS. 4A-4F, 5-7, and other embodiments of anchor placement devices can perform the process 900.

[0058] Corresponding Figures 10-1, 10-2, and 10-3 (collectively referred to as Figure 10) provide views of an implant delivery device within the heart as process 900 is performed.

[0059] At block 902, the process 900 includes accessing the right atrium 5 of the patient's heart with a catheter-based implant delivery device 111 (labeled 111a and 111b in FIG. 10). Image 1001 of FIG. 10-1 illustrates various catheter / sheath type delivery devices / systems 111 that may be used with the implant device according to aspects of the present disclosure. The implant delivery device 111 may advantageously be steerable and have a relatively small cross-sectional profile to allow traversal of various blood vessels and heart chambers through which it may be advanced en route to, for example, the right atrium 5, the coronary sinus 16, the left atrium 2, or other anatomical structure or heart chamber. Catheter access to the right atrium 5, the coronary sinus 16, or the left atrium 2 with certain transcatheter solutions may be achieved via the inferior vena cava 29 (indicated by catheter 111a) or the superior vena cava 19 (indicated by catheter 111b).

[0060] Although access to the right and / or left atrium is illustrated and described in connection with certain embodiments as via the right atrium and / or vena cava, such as through a transfemoral or other transcatheter procedure, other access routes / methods may be performed in accordance with embodiments of the present disclosure. For example, other access routes may be employed to the left atrium 2 if septal crossing through the atrial septal wall is not possible. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable, resulting in further injury to the patient. Furthermore, in some patients, the septal wall may be occupied with one or more implant devices or other treatments, and crossing the septal wall is unsustainable in light of such treatments. As an alternative to transseptal access, transaortic access may be performed, with a delivery catheter passing through the descending aorta 32, the aortic arch 12, the ascending aorta, and the aortic valve 7, through the mitral valve 6, and into the left atrium 2. Alternatively, transapical access may be performed to access the target anatomical structure.

[0061] Process 900 may involve placing a guidewire 59 into the left atrium 2 via a pathway through the coronary sinus. For example, such guidewire placement may involve one or more of the acts associated with blocks 908 and 910, which, like any other of the blocks of process 900, may be considered optional acts. The acts associated with blocks 904 and 906 relate to creating a puncture through the wall of the coronary sinus for advancing the guidewire 59 into the left atrium.

[0062] Any of several access routes, visible and / or apparent in image 1001, may be implemented for maneuvering guidewires and delivery systems / catheters in and around the heart to perform any of the operations associated with the various blocks of process 900. For example, access may be from above, via either the subclavian or jugular vein, into the superior vena cava 19, into the right atrium 5, and from there into the coronary sinus 16. Alternatively, the access route may begin in the femoral vein and enter the heart through the inferior vena cava 29. Other access routes may also be used, each typically utilizing a percutaneous incision through which a guidewire and / or catheter is inserted into the vascular system, usually through a sealed introducer, from which the physician controls the distal end of the device from outside the body.

[0063] At block 904, the process 900 includes advancing a catheter 51 through the coronary sinus 16. Within the catheter is a hollow, curved needle 52, such as those depicted in Figures 4-7, according to some embodiments. As mentioned above, the needle can be in at least two configurations. In a first configuration, the needle is relatively straight within the catheter 51. The walls of the catheter can constrict the needle and prevent it from bending.

[0064] The catheter 51 may be introduced into the body through the proximal end of an introducer sheath (not shown). The introducer sheath may be configured to provide access to the particular vascular pathway being used (e.g., the jugular vein or subclavian vein) and may have one or more hemostatic valves associated therewith. While holding the associated introducer sheath in a fixed position, the surgeon may manipulate the catheter 51 to the implantation site. One or more radiopaque markers may be placed on the catheter 51 to assist the surgeon in determining the exact advancement distance of the catheter within the coronary sinus.

[0065] Because the coronary sinus 16 is largely continuous around the left atrium 2, there are a variety of possible acceptable placements for an implant, or other medical device. The site selected for placement of the implant (and thus for puncture through the tissue wall 21) may be within an area where the tissue of a particular patient is thin or less dense, as previously determined by non-invasive diagnostic means, such as a CT scan, or radiography, such as fluoroscopy or intravascular coronary vasculature echo. Image 1002 in FIG. 10-2 shows a catheter 51 being advanced from the right atrium 5 into the coronary sinus 16 through its ostium or opening 14.

[0066] At block 906, process 900 includes deploying the needle from the catheter into the left atrium 2 into its second configuration, as seen in images 1003 and 1004. The needle 52 is configured to puncture the tissue wall 21 to gain access to the left atrium 2. Image 1003 shows the needle beginning to deploy from the catheter 51. When the end portion of the needle is biased to bend, it exerts tension against the interior wall of the catheter, which prevents the end portion from bending. When the distal end of the needle slides through an opening in the catheter wall, the tension against the wall is released and the end portion of the needle is released and begins to bend. This bending causes the distal end of the needle to angle upward into the wall 21. As the needle 52 advances forward, the needle tip penetrates the wall. Advantageously, the bend in the needle can also orient the needle toward the left atrium 2 when deployed from the catheter 51.

[0067] At block 908, the process 900 includes deploying a guidewire 59 through the needle 52 and into the left atrium 2. In some embodiments, the needle is hollow (e.g., a hypodermic needle), allowing the guidewire 59 to be pushed through the needle and into the left atrium 2, or into whatever target site the needle 52 is placed in. Image 1005 in FIG. 10-3 shows the guidewire 59 deployed from the needle 52.

[0068] At block 910, the process 900 includes withdrawing the needle 52, leaving the guidewire 59 in the left atrium. Image 1006 shows the needle 52 withdrawn from the catheter 51, from the proximal end (e.g., the catheter handle). However, the needle 52 does not have to be withdrawn completely from the catheter. For example, the needle 52 may remain within the catheter 51 after being withdrawn from the primary target location if the catheter 51 is moved to a secondary target location.

[0069] At block 912, the process 900 includes deploying an implant over the guidewire. For example, the implant may be a balloon 60, as shown in image 1006. In another example, the implant may be a shunt 61. Such a shunt implant device 61 may be placed in the tissue wall 21 to shunt blood from the left atrium 2 to the coronary sinus 16. Image 1007 shows a shunt being deployed from the guidewire. In some situations, multiple medical devices may be used. For example, the balloon 60 may be used to enlarge the opening so that the shunt 61 may be deployed. Although the above describes balloons and shunts, other types of medical implants or devices may be used with the implant delivery system.

[0070] At block 914, the process 900 includes withdrawing the delivery system, including the catheter 51, from the deployment site. Such withdrawal includes the guidewire 59, which is also removed from the patient's anatomy. Image 1007 shows the catheter 51 being withdrawn from the coronary sinus 16.

[0071] Although described in the context of implanting the device in the wall between the coronary sinus and the left atrium, it should be understood that process 900 may be performed, at least in part, to implant or deliver a medical device in other anatomical structures and / or tissue walls, such as the atrial septum or ventricular septum.

[0072] FIG. 11 shows various embodiments of needle ends (also called needle points) that may be used with the hollow needle embodiments described in the previous figures. The needle ends may be formed in various shapes suitable for different uses. For example, tapered point needles provide good penetration of soft tissue. Tapered tips are blunt at the end to reduce the risk of needlestick injury. The needle ends may be straight, bent, or angled depending on the desired use.

[0073] The needle end 1102 includes a needle edge at a relatively shallow angle. The needle edge is formed from one side of the outer needle wall to the other opposite side of the outer needle wall. For example, the angle formed by the needle edge at the point of the needle may be about 40-50°.

[0074] Needle end 1104 includes a needle edge at a sharper angle than needle end 1102. For example, the angle formed at the needle point may be about 10-20°. Needle end 1106 includes a needle edge that forms an angle of about 30-40°. Needle end 1108 includes a needle edge that forms an angle of about 20-30° at the needle point.

[0075] The needle end 1110 includes an angled end with the needle end formed relatively parallel to the needle body section closest to the needle end 1110. The angled needle end can facilitate a change in direction as the guidewire leaves the needle.

[0076] The above are merely examples of needle ends that may be used with the various needles of the implant delivery devices described herein. Depending on the desired use case, such as the entry point or pathway used through the body, different types of needle ends may be more beneficial to use.

[0077] 12A-12C show various cut patterns that may be used on the needle body of the hollow needle embodiment described above. FIG. 12A shows a cut pattern having at least 100 cuts. As discussed above, the number of cuts in the pattern may vary with changes in the cuts (e.g., made using a laser or other cutting tool) affecting the curvature of the bent needle end. Compared to the cuts in FIGS. 4A-4C, the cut patterns in FIGS. 12A-12C may be thinner and closer, of the same size, spread across a larger surface area of ​​the needle, and / or be thinner and cover a larger surface area of ​​the needle. In general, adding more cuts increases the bending, while decreasing the number of cuts decreases the bending of the needle. The cuts may have a width of about 1 mm, 0.8 mm, 0.5 mm, or even narrower. However, the depth and / or width of the cuts may vary depending on the desired characteristics of the needle. The cuts may be spaced apart by a few millimeters or less. In some embodiments, the incisions are uniform. Other embodiments may have a variety of incisions. The incisions may be aligned side by side along the same side or surface of the needle end. The incisions may be in a single row or multiple rows, for example, as shown in Figures 12A-12B. The incisions may also be in a more complex pattern, for example, as shown in Figure 12C.

[0078] 12A shows a needle 1200 with two rows of notches 1202, 1206. The notches are separated by spines 1204 on one side of the needle and the other spine (not shown) on the opposite side. The spines 1204 provide rigidity and support to the needle 1200 while the notches provide flexibility. For example, in an arrangement with spines on the top and bottom, the spines will inhibit up and down movement while the notches will allow side to side movement of the needle 1200. As will be apparent, the needle may be rotated to face the notches in the direction in which flexibility is desired (e.g. up and down, side to side).

[0079] 12B illustrates a needle 1210 with three rows of cuts 1212, 1216, 1218. Between the first row 1212 and the second row 1216 is a first spine 1214. Between the second row 1216 and the third row 1218 is a second spine 1218. Between the third row 1218 and the first row 1212 is a third spine (not shown). By having three rows of cuts, flexibility is provided in three different directions (e.g., 120°, 240°, and 360° relative to the outer diameter of the needle) while the needle remains more stiff along the spines.

[0080] 12C shows needle 1220 with an alternating cut pattern. A first set of cuts are made in a first row and a second set of cuts are opposite the first set of cuts in a second row. Alternating with the first and second sets of cuts is a third set of cuts rotated 90 degrees relative to the first set of cuts, and a fourth set of cuts opposite the third set of cuts. For example, cut 1224 has an opposing cut (not shown) on the opposite side of the needle. Cut 1222 (shown in side profile) has an opposing cut 1223 on the opposite side of the needle.

[0081] In some embodiments, the corners of the cuts are scored to facilitate bending at the corners of the cuts. For example, a first cut has a first score 1226a at one of its corners and a second cut opposite the first cut has a second score 1226b at one of its corners. The first and second cuts have corresponding scores on their other corners (not shown).

[0082] As will be apparent, the above are only a few examples of cut patterns. Other cut patterns can be used to provide flexibility and stiffness along the desired direction. For example, one or more rows of cuts can be used to provide flexibility, while one or more spines can be formed along the needle body to provide stiffness.

[0083] 13 illustrates a needle 1300 that uses a wire stiffener to maintain its shape, according to one or more embodiments. The needle 1300 may be made of a plastic material, such as polycarbonate, polypropylene, acrylonitrile butadiene styrene (ABS), polyethylene terephthalate glycol (PETG), polyethylene, polymethyl methacrylate, polyvinyl chloride (PVC), and / or nylon. Although plastic materials are flexible, such materials may not have enough elasticity to fully restore itself to the intended curvature of the needle 1300. By using a wire stiffener 1306, a metal material that has better elasticity than plastic can be used to improve the overall elasticity of the needle 1300, allowing the needle 1300 to restore its curvature after it leaves the introducer sheath or catheter.

[0084] The needle 1300 may operate similarly to the needle 400 of FIGS. 4D-4F, with the needle end 1304 being in a first configuration while in the catheter, but in a second configuration upon exiting the catheter. In the first configuration, the internal catheter wall may maintain the needle end 1304 in a relatively straight position relative to the needle body 1302, although there may be a slight curve of a few degrees in the needle end. In addition, the needle body 1302 may bend further as the needle body 1302 bends its path along various body lumens to the heart. However, the needle end 1304 and the needle body 1302 may be considered aligned, with both sections pointing in the same direction (e.g., the distal end of the needle end 1304 and the distal end of the needle body 1302) toward the target tissue location. In the second configuration, the needle end 1304 returns to its original or intended shape, which is the bent shape shown in FIG. Similar to needle 400 of FIGS. 4D-4F, needle 1300 is hollow, allowing a guidewire to be delivered to a target site within needle 500.

[0085] A cross section 1310 of the needle 1300 taken at line 1308 shows the internal structure of the needle 1300, according to certain embodiments. In the illustrated embodiment, the needle 1300 includes a first lumen 1312 and a second lumen 1314. A lumen wall 1316 may extend from one side of the outer wall to another side of the outer wall, dividing the first lumen from the second lumen. The wall may be straight or curved, depending on the desired shape of the lumen. The lumen wall 1316 may provide additional stiffness to the needle by damping the outer wall of the needle. The wire stiffener 1306 may be configured to fit into the second lumen 1314. Meanwhile, the first lumen 1312 may be used to deliver a guidewire, or other device, to a target tissue site.

[0086] As shown in cross section 1310, first lumen 1312 has a round cross section and second lumen 1314 has a generally rectangular cross section. Other embodiments may use different lumen shapes or sizes depending on the desired characteristics of the needle. For example, second lumen 1314 may be enlarged to accommodate a thicker wire stiffener 1306 if greater stiffness and / or resilience is desired.

[0087] Figure 14 illustrates a needle 1400 that maintains its shape using a wire stiffener 1406 along its internal curvature, according to one or more embodiments. The needle 1400 of Figure 14 is functionally similar to the needle 1300 of Figure 13, and is differentiated primarily by the location of the wire stiffener 1406. Locating the wire stiffener 1406 along the internal curvature may facilitate better force transfer from the wire stiffener 1406 to the needle body 1402 and needle end 1404, as the wire stiffener 1406 contacts the internal bent surface of the needle 1400.

[0088] Similar to the needle of FIG. 13, the needle 1400 may be made of a plastic material, such as nylon or a similar polymer. The wire stiffener 1406 may use a metallic material to improve the overall resilience of the needle 1400. The needle 1400 may operate similarly to the needle 400 of FIGS. 4D-4F, with the needle end 1404 being in a first configuration while in the catheter, but in a second configuration upon exiting the catheter. Similar to the needle 400 of FIGS. 4D-4F, the needle 1400 is hollow, allowing a guidewire to be delivered to a target site within the needle 1400.

[0089] Needles 1400 made of plastic materials may not be stiff enough to penetrate tissue. In these examples, the wire stiffener 1406 may include a needle tip 1407. In some implementations, the wire stiffener 1406 may be used to penetrate tissue and create an opening in the needle. In one example, the wire stiffener 1406 may be pushed out of the hollow needle such that the needle tip of the wire stiffener 1406 extends beyond the needle end 1404. The extending needle tip 1407 may then be used to penetrate tissue and create an opening in the needle 1400.

[0090] A cross section 1410 of the needle 1400 taken at line 1408 shows the internal structure of the needle 1400, according to certain embodiments. In the illustrated embodiment, the needle 1400 includes a first lumen 1412 and a second lumen 1414. A lumen wall 1416 may extend from one side of the outer wall to another side of the outer wall, dividing the first lumen from the second lumen. The wall may be straight or curved, depending on the desired shape of the lumen. The lumen wall 1416 may provide additional stiffness to the needle by damping the outer wall of the needle. The wire stiffener 1406 may be configured to fit into the second lumen 1414. Meanwhile, the first lumen 1414 may be used to deliver a guidewire, or other device, to a target tissue site.

[0091] As shown in cross section 1410, first lumen 1412 has a round cross section and second lumen 1414 has a crescent shaped cross section. Other embodiments may use different lumen shapes or sizes, as shown in Figure 13, depending on the desired characteristics of the needle. For example, second lumen 1414 may be enlarged to accommodate a thicker wire stiffener 1406 if greater stiffness and / or resilience is desired.

[0092] 15A-15C show various embodiments of a wire stiffener, according to one or more embodiments. The wire stiffener may include a needle tip, which may be of various designs, to aid in penetrating the tissue site. The needle tip may be formed on the wire stiffener using diamond grinding, laser cutting, buffing, and / or other manufacturing processes. The stiffener may be sized to a desired length based on the size of the hollow needle. In some embodiments, the wire stiffener is relatively short, at about 15 centimeters.

[0093] The first wire stiffener 1502 is illustrated as a narrow strip having a pointed end of approximately 30-45°, measured from beveled edge to beveled edge. As shown, the thickness of the wire stiffener 1502 is fairly thin, which may allow the wire stiffener to bend more easily. The second wire stiffener 1504 is illustrated as a relatively wide strip having a pointed end of approximately 45-80°. The third wire stiffener 1506 is illustrated as a relatively wide strip compared to the first wire stiffener 1502, having a pointed end of approximately 90-110°. As will be apparent, the wire stiffeners may be made in a variety of widths and using a variety of needle tips based on the desired performance of the wire stiffener.

[0094] 16A-16C show various views of a device 1600 including a needle 1604 using a wire stiffener 1606 and a sheath 1602 according to one or more embodiments disclosed herein. FIG. 16A shows a side view of the sheath 1602 having an opening 1606 for deploying the needle 1604. Once the needle 1604 extends out of the sheath, the needle 1604 returns to its intended curvature. FIG. 16B shows a close-up view of the needle 1604 from the opposite side to FIG. 16A. In the illustrated view, the wire extender 1606 is shown extending beyond the distal end of the needle 1604. The tip 1607 of the wire extender 1606 can be used to penetrate tissue. FIG. 16C shows a perspective close-up view of the needle 1604 showing the wire extender 1606 extending beyond the distal end of the needle 1604.

[0095] Further description of the embodiment Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Additionally, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0096] Example 1: A device for delivering a guidewire to a target location in a patient's body, the device comprising: a hollow needle comprising a lumen configured to receive the guidewire, a body section of the hollow needle, and a biasing section of the hollow needle, the biasing section configured to bend relative to the body section, the biasing section being located on a distal end of the hollow needle; and a catheter comprising a catheter lumen configured to receive the hollow needle and maintain the biasing section and the body section in relative alignment in a first configuration, the hollow needle configured to bend the biasing section relative to the body section in a second configuration in response to the biasing section extending out of the catheter.

[0097] Example 2: The device of any embodiment described herein, particularly Example 1, further comprising a plurality of notches made in the biasing section, the plurality of notches being configured to enable the biasing section to bend.

[0098] Example 3: Any of the examples described herein, particularly example 2, wherein the multiple notches are uniform and aligned in parallel along the same side of the biasing section, the same side comprising a curved inner surface formed by the biasing section.

[0099] Example 4: Any of the examples described herein, particularly any of Examples 2-3, wherein the number of the plurality of incisions is at least 10 incisions.

[0100] Example 5: The apparatus of any of the examples described herein, particularly any of Examples 2-4, wherein the plurality of cuts are laser cuts.

[0101] Example 6. The device of any embodiment described herein, particularly any of Examples 2-5, further comprising a sealant over the plurality of incisions.

[0102] Example 7: Any of the embodiments described herein, particularly the device described in Example 1, wherein the hollow needle further comprises a second lumen configured to hold a wire stiffener, and the wire stiffener, the body section and the biasing section being made from a plastic material, and the wire stiffener is configured to maintain a relative bend of the biasing section to the body section.

[0103] Example 8: A device according to any of the embodiments described herein, particularly any of the embodiments 1-7, wherein the biasing section further comprises a needle tip, and the direction pointed by the needle tip changes by at least 90° when transformed from the first configuration to the second configuration.

[0104] Example 9: Any of the examples described herein, particularly any of Examples 1-8, wherein the biasing section has a radius of about 13.5 mm and an arc of about 106°.

[0105] Example 10: The device of any embodiment described herein, particularly any of embodiments 1-9, wherein the biasing section, in the second configuration, forms a U-shape.

[0106] Example 11: A device according to any of the embodiments described herein, particularly any of the embodiments 1-10, further comprising a ramp formed within the catheter lumen, the ramp configured to bias the biasing section of the hollow needle relative to the body section.

[0107] Example 12: Any embodiment described herein, particularly any of embodiments 1-11, wherein the angle formed by the body section and the biasing section in the second configuration is less than or equal to 90°.

[0108] Example 13: A device according to any of the embodiments described herein, particularly any of the embodiments 1-12, wherein the catheter comprises an opening into the catheter lumen located along a side of the catheter, the opening configured to provide exit from the catheter lumen for the hollow needle.

[0109] Example 14: A method for delivering a guidewire to a target location within a patient's body using a hollow needle deployed from a catheter, the method comprising: advancing a hollow needle within the catheter to a first location, the hollow needle comprising a biasing section and a body section, the biasing section and the body section being maintained in relative alignment by the catheter in a first configuration; advancing the biasing section of the hollow needle through an opening in the catheter; deploying the biasing section of the hollow needle through the opening in the catheter to a second configuration, the biasing section being configured to bend relative to the body section in response to the biasing section extending out of the catheter; and deploying the guidewire from the hollow needle to the target location.

[0110] Example 15: A method as described in any of the examples described herein, particularly Example 14, wherein the step of deploying the actuated section of the hollow needle includes a step of penetrating a tissue wall using the hollow needle to reach the target location.

[0111] Example 16: The method according to any of the examples described herein, especially example 15, further comprising deploying a medical implant at a target location using a guidewire.

[0112] Example 17: A method as described in any of the examples described herein, particularly any of Examples 14-16, wherein the biasing section further comprises a needle tip, and the direction pointed by the needle tip changes by at least 90° when transforming from the first configuration to the second configuration.

[0113] Example 18: The method of any of the examples described herein, particularly any of Examples 14-16, wherein the biasing section, in the second configuration, forms a U-shape.

[0114] Example 19: The method described in any of the examples described herein, particularly any of Examples 14-16, further comprising the step of withdrawing the hollow needle from the target location after deploying the guidewire while retaining the hollow needle within the catheter.

[0115] Example 20: The method of any of the examples described herein, particularly any of Examples 14-16, wherein the hollow needle is at least partially made from nylon or nitinol.

[0116] Example 21: A hollow needle for delivering a guidewire to a target location in a patient's body, the hollow needle comprising: an inner lumen configured to receive the guidewire; a hollow needle body section; and a hollow needle biasing section located on a distal end of the hollow needle, the biasing section comprising a needle tip and a plurality of notches aligned in parallel along a same side of the biasing section, the same side comprising a curved inner surface formed by the biasing section, the plurality of notches configured to bend the biasing section relative to the body section.

[0117] Example 22: The hollow needle of any of the embodiments described herein, particularly example 20, wherein the plurality of incisions comprises at least 10 incisions that are uniform.

[0118] Example 23: A hollow needle for delivering a guidewire to a target location within a patient's body, the hollow needle comprising an inner lumen configured to receive the guidewire, a hollow needle body section, and a hollow needle biasing section, the biasing section configured to bend relative to the body section, the biasing section located on a distal end of the hollow needle.

[0119] Example 24: Any of the embodiments described herein, particularly Example 23, further comprising a second lumen configured to hold a wire reinforcement, the wire reinforcement having a pointed end configured to penetrate tissue, the body section and the biasing section being made from a plastic material, and the wire reinforcement being configured to maintain a relative bend of the biasing section to the body section.

[0120] Example 25: Any embodiment described herein, particularly example 23, of a hollow needle, further comprising a plurality of notches made in the biasing section, the plurality of notches being configured to enable the biasing section to bend.

[0121] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events are required to practice a process.

[0122] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but not other embodiments. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are required in any way by one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether those features, elements, and / or steps are included or performed in any particular embodiment. Terms such as "comprising," "including," "having," and the like, are synonymous and used in their ordinary sense, and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," for example, when used to connect a list of elements, is used in its inclusive sense (and not its exclusive sense), such that the term "or" means one, some, or all of the elements in the list. Conjunctive language such as "at least one of X, Y, and Z" is understood using context to be used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0123] In the above description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used in conjunction with any other embodiment. Moreover, no component, function, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the invention herein, as disclosed and claimed below, should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the following claims.

[0124] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from another element having a similar or identical name (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0125] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0126] Spatially relative terms such as "outside," "inside," "upper," "lower," "bottom," "up," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as depicted in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0127] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like, are intended to encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. 1. An apparatus for delivering a guidewire to a target location in a patient's body, the apparatus comprising: A hollow needle, a lumen configured to receive the guidewire; a hollow needle body section; and a hollow needle comprising: a biasing section of the hollow needle, the biasing section configured to bend relative to the body section, the biasing section located on a distal end of the hollow needle; a catheter comprising a catheter lumen configured to receive the hollow needle and to maintain the biasing section and the body section in relative alignment in a first configuration; The device, wherein the hollow needle is configured to flex the bias section relative to the body section in a second configuration in response to the bias section extending out of the catheter.

2. The device of claim 1 , further comprising a plurality of notches made in the biasing section, the plurality of notches configured to allow the biasing section to flex.

3. The device of claim 2 , wherein the plurality of cuts are uniform and aligned in parallel along a same side of the biasing section, the same side comprising a curved inner surface formed by the biasing section.

4. The apparatus according to any one of claims 2 to 3, wherein the number of the plurality of cuts is at least 10 cuts.

5. The apparatus of any of claims 2 to 4, further comprising a sealant over the plurality of incisions.

6. The hollow needle is a second lumen configured to hold a wire reinforcement, the wire reinforcement having a pointed end configured to penetrate tissue; The device of claim 1 , wherein the body section and the biasing section are made from a plastic material, and the wire stiffener is configured to maintain the relative bending of the biasing section with respect to the body section.

7. 7. The device of claim 1, wherein the biasing section further comprises a needle tip, and wherein a direction pointed by the needle tip changes by at least 90 degrees when transforming from the first configuration to the second configuration.

8. The apparatus of any preceding claim, wherein the biasing section has a radius of about 13.5 mm and an arc of about 106°.

9. An apparatus according to any preceding claim, wherein the biasing section forms a U-shape in the second configuration.

10. 10. The device of claim 1, further comprising a ramp formed within the catheter lumen, the ramp configured to bias the biased section of the hollow needle relative to the body section.

11. The device of any preceding claim, wherein an angle formed by the body section and the biasing section, in the second configuration, is less than or equal to 90°.

12. 12. The apparatus of claim 1, wherein the catheter comprises an opening into the catheter lumen located along a side of the catheter, the opening configured to provide exit from the catheter lumen for the hollow needle.

13. 1. A method for delivering a guidewire to a target location in a patient's body using a hollow needle deployed from a catheter, the method comprising: advancing the hollow needle within the catheter to a first position, the hollow needle comprising a biasing section and a body section, the biasing section and the body section maintained in relative alignment by the catheter in a first configuration; advancing the biased section of the hollow needle through an opening in the catheter; deploying the bias section of the hollow needle through the opening in the catheter into a second configuration, the bias section configured to bend relative to the body section in response to the bias section extending out of the catheter; deploying the guidewire from the hollow needle to the target location.

14. The method of claim 13 , wherein deploying the biased section of the hollow needle comprises using the hollow needle to penetrate a tissue wall to reach the target location.

15. 15. The method of claim 14, further comprising deploying a medical implant at the target location using the guidewire.

16. The method of any of claims 13 to 15, further comprising the step of withdrawing the hollow needle from the target location after deploying the guidewire while retaining the hollow needle within the catheter.

17. The method according to any of claims 13 to 15, wherein the hollow needle is at least partially made from nylon or nitinol.

18. 1. A hollow needle for delivering a guidewire to a target location in a patient's body, said hollow needle comprising: a lumen configured to receive the guidewire; a hollow needle body section; and a biasing section of the hollow needle, the biasing section configured to bend relative to the body section, the biasing section located on a distal end of the hollow needle.

19. 20. The hollow needle of claim 18, a second lumen configured to hold a wire reinforcement, the wire reinforcement having a pointed end configured to penetrate tissue; 20. The hollow needle of claim 18, wherein the body section and the biasing section are made from a plastic material and the wire stiffener is configured to maintain bending of the biasing section relative to the body section.

20. 20. The hollow needle of claim 18, further comprising a plurality of notches made in the biased section, the plurality of notches configured to allow the biased section to flex.

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