Patent Description:
The present disclosure relates to illuminable needle devices, systems, and methods.

A tricuspid valve is the valve located between the right atrium and the right ventricle in a mammalian heart. In a normally functioning tricuspid valve, when the valve is open, blood is allowed to be pumped from the right atrium into the right ventricle. When the valve is closed, blood is blocked from passing back from the right ventricle to the right atrium. Tricuspid valve regurgitation occurs when the tricuspid valve fails to open and close properly such that blood is allowed to flow backwards from the right ventricle to the right atrium of the heart.

Tricuspid valve regurgitation can be treated by an annular reduction repair procedure that can be performed using open heart surgery. During the surgery, the physician can open the right atrium to gain access to the coronary sinus, annulus and posterior leaflet. A standard "serpentine" stich may be started at the coronary sinus ostium and stitched through the annulus around the posterior leaflet. After placing the stitch, it can be drawn tight to perform the reduction. In the current practice, annular reduction procedures can require placing patients on cardiopulmonary bypass, which involves stopping the heart and using an artificial pump to bypass the heart and lungs. The bypass procedures are associated with risks and recovery time that can deter surgeons from performing this procedure on certain patients.

<CIT> relates to treatment of mitral or tricuspid valve prolapse and suggests a simple but effective device and corresponding surgical, minimally invasive or transvascular procedure to reduce mitral valve regurgitation.

<CIT> pertains to methods and apparatus employed to locate body vessels and occlusions in body vessels finding particular utility in cardiac surgery, particularly minimally invasive cardiac surgery to locate cardiac arteries and occlusions in cardiac arteries. In one of embodiments it discloses a vessel lumen probe comprising a light emitter, e.g. a light conducting fiber or pipe, that is movable axially within a light pipe sheath lumen of a light pipe sheath having a distal sheath opening.

The present invention relates to a illuminable needle device as defined by claim <NUM>. Further aspects of the invention are defined by the dependent claims.

The drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

While the devices and system provided herein are amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the present disclosure to the particular embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.

Referring to <FIG>, some embodiments of a system <NUM> provided herein can be used for penetrating tissue in a minimally invasive catheter-based procedure, such as a percutaneous transluminal procedure for repairing a heart valve (e.g., a tricuspid heart valve or mitral heart valve). In particular, certain embodiments of the system <NUM> can be used to perform a reduction of a heart valve (e.g., stitching together portions of the heart valve tissue) during a heart valve repair procedure by using a minimally invasive approach. Various embodiments of the system <NUM> provided herein can include an illuminable needle device <NUM>, a visualization device <NUM> (e.g., a radiation-detecting device) and components relating thereto, and introducer assembly for introducing the illuminable needle system.

The illuminable needle system <NUM>, in the depicted embodiment, can include the illuminable needle device <NUM> having a proximal end <NUM>, a distal end <NUM>, and an elongate, flexible shaft <NUM> between the proximal and distal ends <NUM>, <NUM>. The depicted embodiment of the device <NUM> includes a handle <NUM> at the proximal end <NUM> of the device <NUM> and an illuminable needle tip <NUM> at the distal end <NUM> of the device <NUM> for visibly penetrating tissue during a minimally-invasive surgical procedure (e.g., a tricuspid valve repair procedure). In some cases, during the heart valve repair procedure, an illuminable needle device <NUM> (e.g., catheter) may be introduced into a patient's vasculature through a femoral incision (or, alternatively, through other incision sites such as a jugular or a subclavian incision). The flexibility of the shaft <NUM> and distal end <NUM> of the illuminable needle device <NUM> allows for a practitioner to advance the device <NUM> through a tortuous vasculature until the distal end <NUM> of the device <NUM> reaches a desired target site, such as the right ventricle of the heart.

Although some embodiments of the devices and systems provided herein relate to the repair procedure, a wide variety of other types of medical procedures, such as vascular percutaneous transluminal procedures or medical procedures accessing an anatomical luminal pathway (e.g., an air pathway or a gastrointestinal pathway) may be contemplated by a person of ordinary skill.

As described further below, the illuminable needle device <NUM> in the depicted embodiment can also be included in the system <NUM> along with other devices, such as the visualization device <NUM>, to form a visualization system that provides visual feedback to a user, such as a practitioner, in a percutaneous medical procedure. The visualization device <NUM>, for example, can be used in conjunction with the illuminable needle device <NUM> to provide the benefit of allow the practitioner to visualize needle penetration location and depth of the illuminable needle device <NUM> during the medical procedure. In some cases, the visualization device <NUM> includes a receiver <NUM>, such as an optical receiver (e.g., a digital camera), or an ultrasound (US) receiver (e.g., an ultrasound probe), to provide visual feedback of needle penetration information to the practitioner. The receiver <NUM> may be located at a desired location along the visualization device <NUM>. For example, in some cases, the visualization device <NUM> can include an elongate shaft (not shown) that has the receiver <NUM> located at a distal tip portion of the shaft. In some cases, the receiver (e.g., optical receiver) can be adapted for detecting the intensity of the radiation being emitted from the illuminable needle tip <NUM> located within a predetermined distance (e.g., less than <NUM>) from the receiver <NUM>, or within a field of view of the receiver <NUM>. In some cases, the receiver <NUM> (e.g., digital camera) can be adapted to form an image of a tissue region and receive information corresponding to light intensity from the illuminable needle device <NUM>.

Various methods can be applied to localize a portion of the illuminable needle device <NUM> (e.g., the needle tip <NUM>) during a surgical procedure of a heart valve. In some cases, visual receivers (e.g., a visual camera), or ultrasound components, such as an ultrasound transmitter and an ultrasound receiver (e.g., an ultrasound probe) can be used to localize a portion of the illuminable needle device <NUM> within the heart. The visual receivers may be connected to a power source and the ultrasound components may be connected to an ultrasound source. The ultrasound transmitter emits highfrequency sound waves directed to a targeted tissue region and the receiver receives reflected sound waves that can be used to characterize the targeted tissue region.

In some cases, the receiver <NUM> can be configured for detecting radiation (e.g., light) emanating from the tip <NUM> of the illuminated needle device <NUM> and obtaining information regarding the radiation signal, such as an intensity. In some cases, the receiver can be adapted to detect x-ray, visible light, UV, or IR electromagnetic radiation. In some cases, the receiver <NUM> can be configured for detecting a light intensity such that the intensity data can be transmitted to a processor <NUM> for analysis. In some cases, the light intensity can be analyzed and correlated to a needle location by the processor <NUM>. In some cases, the light intensity data received by the optical receiver <NUM> can be transferred to the processor <NUM> using a software algorithm, such as commercially available software algorithm, for example, Visionscape®, or a customized software algorithm, such that light intensity data can be correlated to needle penetration depth and/or a needle location data.

The visualization device <NUM> can be a separate device used in conjunction with the illuminable needle device <NUM>. Accordingly, the visualization device <NUM> and the illuminable needle device <NUM> can be separate devices containing separate electrical connections. For example, the illuminable needle device <NUM> can include a first electrical connection to an electrical source and the visualization device <NUM> include a second electrical connection to the same or different electrical source that is independent of the first electrical connection.

Certain embodiments of the illuminable needle system <NUM> can include an ancillary device, such as an introducer assembly (not shown) to releasably engage both the visualization device <NUM> and the illuminable needle device <NUM> during a medical procedure. In particular, some embodiments of the introducer assembly include a lumen sized for insertion and lateral displacement of the distal end <NUM> of the illuminable needle device <NUM> therein to allow for the introduction of the device <NUM> into a patient's body. In some cases, the introducer assembly may define a distal opening to allow the shaft <NUM> of the illuminable needle device <NUM> to advance out of the introducer assembly into an anatomical area, such as the right ventricle of the heart.

Referring to <FIG>, another exemplary illuminable needle device <NUM> includes an outer member <NUM> and an inner member <NUM>. In the depicted embodiment of the illuminable needle device <NUM>, the outer member <NUM> includes an elongate body <NUM> that has a proximal end <NUM> that is directly or indirectly coupleable to a handle <NUM> and a distal end portion <NUM> that includes a sharp tip (e.g., the needle <NUM>) configured for penetrating tissue. The outer member <NUM> defines a lumen <NUM> that extends from the proximal end <NUM> to the distal end portion <NUM>. The lumen <NUM> can be sized for receiving the inner member <NUM>. As shown in <FIG>, a distal end portion <NUM> of outer member <NUM> can be beveled to create the sharp tip for penetrating tissue as the outer member <NUM> is axially translated in a distal direction into tissue, such as myocardium tissue. The tip's sharpness can advantageously enhance the ability of needle device <NUM> to tunnel through tissue during a surgical procedure. While outer member <NUM> can have a single-angle beveled tip, some embodiments of the outer needle designs can include other styles of sharp distal end portions, such as a bi-beveled, tri-beveled, or trocar needle tip.

Certain embodiments of the illuminable needle device <NUM> provided herein can include a device <NUM> configured for various medical procedures (e.g., a percutaneous transluminal procedure for repairing a mammalian heart valve). In some cases, the device can be sized such that its length and outer profile can be delivered to a mammalian heart using a percutaneous transluminal procedure. The length and profile of the illuminable needle device <NUM> is scalable to a range of sizes. A suitable length of the illuminable needle device <NUM>, or components thereof (e.g., the outer member <NUM>, inner member <NUM>, or both) can range from about <NUM> centimeters (cm) to about <NUM> (about <NUM> inches to <NUM> inches), e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM> (e.g., from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches). In some cases, the outer and inner members <NUM>, <NUM> can each have a length of about <NUM> (about <NUM> inches).

A suitable profile (outer diameter) of the outer member <NUM> can range from about <NUM> millimeter (mm) to about <NUM> (about <NUM> inches to about <NUM> inches), e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM> (e.g., from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches).

The size of the outer member <NUM> and/or needle <NUM> can be scalable to a range of sizes. For example, in some cases, a <NUM> (<NUM>-gauge) hypotube, or a <NUM> (<NUM>-gauge) hypotube can be used to make the outer member <NUM> or needle <NUM>. In some cases, the size of the outer member <NUM> or needle <NUM> can range from about <NUM> (<NUM> gauge) to about <NUM> (<NUM> gauge). For example, the needle size can be about <NUM> (<NUM> gauge), <NUM> (<NUM> gauge), <NUM> (<NUM> gauge), <NUM> (<NUM> gauge), <NUM> (<NUM> gauge), <NUM> (<NUM>-gauge), or <NUM> (<NUM>-gauge). In some cases, the outer member <NUM> and/or needle <NUM> can be larger than <NUM> (<NUM> gauge), or smaller than <NUM> (<NUM>-gauge). In some cases, the outer member <NUM> and/or needle <NUM> can be made with various wall thicknesses. For example, in some cases, the needle <NUM>, or the outer member <NUM>, can have a wall thickness ranging from about <NUM> to about <NUM> (from about <NUM> inches to about <NUM> inches). The needle <NUM>, or the outer member <NUM>, may be manufactured by using various metal drawing processes, such as bar drawing, wire drawing, tube drawing, or a combination thereof.

The inner member <NUM> of the illuminable needle device <NUM>, best shown in <FIG>, is sized to slidably move distally, or proximally, within the lumen <NUM> of the outer member <NUM>. The inner member <NUM> can have an elongate body <NUM> that includes a proximal end <NUM> (<FIG>) and a distal end <NUM> (<FIG>). In some cases, the inner member <NUM> can include a generally tubular body <NUM>. The distal end <NUM> of the inner member <NUM>, in some cases, can include one or more radiation emitting element <NUM>. The inner member <NUM> can be configured to emit radiation from the radiation emitting element <NUM> at the distal end portion <NUM> of the outer member <NUM> such that an intensity of the radiation is detectable by a receiver (e.g., the receiver <NUM> of <FIG>). In some cases, radiation emitting element <NUM> can include a light-emitting element, such as a LED or an optical fiber (see optical fiber <NUM> of <FIG>). In some cases, the inner member <NUM> includes a distal end portion <NUM> including a plurality of radiation emitting elements <NUM> aligned longitudinally along the distal end portion <NUM>.

The inner member <NUM> can include a lumen <NUM> therethrough its body <NUM>. A source of radiation can be arranged at the distal tip/the radiation emitting element <NUM> or can be arranged proximally and connected to the radiation emitting element <NUM> by guiding means. For example, the guiding means can include the lumen <NUM> sized to receive at least one electrical connector (not shown) (e.g., an electrical wire), which is configured to provide an electrical connection between the handle <NUM> and the radiation emitting element <NUM> (e.g., a LED or a laser diode). The handle <NUM> can be connectable to a power source such as a battery, or a power-supply outlet, by a power-supply connector (see power-supply connector <NUM> of <FIG>). The handle can optionally include an on-off switch <NUM> to emit radiation from the radiation emitting element <NUM>, as desired. In some cases, the inner member <NUM> can be removed from the lumen <NUM> of the outer member <NUM> completely by proximally retracting the inner member <NUM> and pulling the inner member <NUM> out from the proximal end <NUM> of the outer member <NUM>.

Referring to <FIG>, the distal end portion <NUM> of the inner member <NUM> can include a reduced profile configured for securing and positioning the radiation emitting element <NUM>. For example, as shown, the inner member <NUM> can include tubular body having a semi-cylindrical end portion having a semi-circular cross-section at its distal end portion <NUM>. A distal most end <NUM> of the inner member <NUM> may be positioned flush with a distal most end <NUM> of the outer member <NUM> to emit radiation (e.g., light) from the needle <NUM> of the illuminable needle device <NUM>. In some cases, the distal most end <NUM> of the inner member <NUM> may be positioned proximal to the distal most end <NUM> of the outer member <NUM> to emit radiation from the needle lumen <NUM>. For example, in some cases, the inner member's distal end <NUM> may be proximally positioned about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM> from the distal most end <NUM> of the outer member <NUM> to emit detectable radiation from the needle <NUM>. In some cases, the inner member <NUM> and/or the outer member <NUM> may contain a stop feature (not shown) to prevent the inner member <NUM> from extending beyond the outer member's distal most end <NUM>. For example, in some cases, the outer member <NUM> can include reduced luminal diameter (e.g., a tapered or stepped luminal surface) and/or the inner member <NUM> can include a radial protrusion (not shown) for engaging with the outer member <NUM>.

As shown in <FIG>, the distal end portion <NUM> of the inner member <NUM> can include a distal surface <NUM> that defines an opening <NUM> and orients the radiation emitting element <NUM> (e.g., LED). The distal surface <NUM> can be shaped to facilitate seating of a surface of the radiation emitting element <NUM> at the distal end portion <NUM> of the inner member <NUM>. In some cases, the inner member <NUM> can include a tubular body defining a radially-facing distal opening <NUM> disposed on a planar surface parallel to a central axis of the semi-cylindrical distal portion, in which the planar surface is configured to receive the radiation emitting element <NUM>. In some cases, the distal surface <NUM> can include a surface contour that is complementary of a surface contour of the radiation emitting element <NUM>. For example, in some cases, the distal surface <NUM> can include a planar surface, or a curved surface. In some cases, the distal surface <NUM> can be parallel to a central axis "X1" of the inner member <NUM>. In some cases, the distal surface <NUM> can be configured to orient the radiation emitting element <NUM> at the distal end portion <NUM> of the inner member <NUM> such that radiation emitted from the element <NUM> in a radial direction. A radially-directed radiation emitting element <NUM> can be oriented to emit radiation from the beveled opening of the outer member <NUM> when the inner member's distal most end <NUM> is positioned flush with, or proximately located near the outer member's distal most end <NUM>, to maximize intensity of the radially-directed radiation being emitted by the illuminable needle device <NUM>. A radially-directed radiation emitting element <NUM> can be advantageous for visualization systems in which a receiver (e.g., the receiver <NUM> of <FIG>) is peripherally located to the distal end portion <NUM> of the illuminable needle device <NUM>. In some cases, the inner member <NUM> can include one or more radiation emitting element <NUM> connected to an axial face <NUM> of a distal most end <NUM> of the inner member <NUM>. An axial-directed radiation emitting element <NUM> can be beneficial in visualization systems in which the receiver is located at a location axial to the distal end portion <NUM> of the illuminable needle device <NUM>.

Some embodiments of the inner member <NUM> can include a distal end portion <NUM> having one of a variety of tip configurations. In some cases, the distal end portion <NUM> can be blunt or rounded. In some cases, the distal end portion <NUM> can be shaped for penetrating or piercing tissue, for example, a needle. The inner member <NUM> that includes the tissue penetrating tip may be distally advanced relative to the outer member <NUM> when the illuminable needle device <NUM> is penetrating or piercing tissue.

The shaft <NUM> of the illuminable needle device <NUM> can be configured, in various cases, with adequate flexibility for maneuvering within a torturous vascular pathway. In some cases, the shaft <NUM> (which includes the outer and inner members assembled together) can have a bend radius that ranges from about <NUM> to about <NUM> (e.g., from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, from about <NUM> to about <NUM>, or from about <NUM> to about <NUM>). In some cases, the shaft <NUM> can have a bend radius of about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. In some cases, the shaft <NUM> can include a minimum bending radius of about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>. The flexible shaft can provide the benefits of facilitating facile delivery and maneuverability of the illuminable needle device <NUM> when the device <NUM> is used to access anatomical targets, such as the right ventricle of the heart, during a percutaneous transluminal procedure.

Still referring to <FIG>, the needle device <NUM> includes a wavelength adjustment feature <NUM> (see also features <NUM>, <NUM> of <FIG> and <FIG>) configured for allowing a user to change wavelength of electromagnetic radiation (e.g., light) emitted by the light emitting element <NUM>. The wavelength adjustment feature <NUM> can be included in the handle <NUM> of the illuminable needle device <NUM>. In some cases, the illuminating needle device <NUM> can emit electromagnetic radiation in the visible light spectrum (i.e. visible light) that includes a wavelength range from about <NUM> nanometers to about <NUM> nanometers, or a frequency range of about <NUM> THz to about <NUM> THz. For example, the illuminating needle device <NUM> may transmit light with a spectral color that includes, but is not limited to, violet, blue, green, yellow, orange, red, and combinations thereof. In some cases, the illuminating needle device <NUM> can emit radiation in the infrared (IR) spectral region. In some cases, the illuminating needle device <NUM> can emit x-rays, i.e., electromagnetic waves with a wavelength less than about <NUM>-<NUM> meters.

The illuminable needle device <NUM> provided herein can include a radiation (e.g., light) intensity adjuster (see adjuster <NUM> of <FIG>) configured for allowing a user, such as a medical practitioner, to change the intensity of the radiation (e.g., light) emanating from the radiation emitting element <NUM>. In some cases, the radiation intensity adjuster can be included in the handle <NUM> of the needle device <NUM>. For example, in the some cases, the radiation intensity adjuster can include, but is not limited to, a scroll-based switch that includes a scroll wheel, and a depressible (or slidable) multi-settable switch configured to allow the user to adjust the radiation intensity, as desired. The radiation intensity adjuster can provide a benefit of allowing the user to adjust the radiation intensity to improve (e.g., optimize), as desired, detectability of the radiation. In some cases, the radiation intensity adjuster may be adjusted to decrease, or increase, the intensity of the radiation emitted from the radiation emitting element <NUM> to optimize its detectability in tissues of varying densities.

In some cases, the distal end portion <NUM> of the outer member <NUM> may include a plurality of apertures <NUM>, as depicted in <FIG>, to allow radiation (e.g., light) from the radiation emitting element <NUM> (e.g., LED) to emanate from at least portions of the shaft <NUM> of the illuminable needle device <NUM>. In some cases, a plurality of apertures <NUM> are arranged on the outer body <NUM> along a longitudinal axis (X1) defined by the outer member <NUM>. The apertures <NUM> can be optionally slot-shaped. In some cases, each slot-shaped aperture <NUM> can be elongated circumferentially about the outer body <NUM>. Apertures <NUM> along the side wall of the outer member <NUM> can advantageously allow a practitioner to visually detect the trajectory of the needle <NUM> and the depth of needle penetration. The trajectory of the needle <NUM> may be determined by measuring the relative intensity values between the apertures <NUM> along the outer body <NUM>. For example, a distally-located aperture may be less intense than a proximally-located aperture when the needle <NUM> in partially embedded in the targeted tissue. In another example, the proximally-located aperture may be less intense than a distally-located hole aperture when the needle <NUM> has fully pierced through tissue and emerged from a tissue surface. As such, the overall trajectory of the needle <NUM> may be determined by assessing the light intensities of the apertures along the body portion of the illuminable needle device <NUM>.

In some cases, a plastic material (e.g., an epoxy) may be deposited in one or more apertures <NUM>. The deposited plastic material (e.g., epoxy) may be doped with a colorant such that the light transmitted through each epoxied aperture emanates a desired color. In some cases, the dopant may include phosphors, quantum dots (crystals of semiconductor material), fluorescing nanoparticles, or combinations thereof.

The outer member <NUM> can, in some cases, contain medically-compatible metals, polymers, and/or ceramics. In some cases, the outer member <NUM> can include metals, such as, but not limited to, nitinol, stainless steel, chromium cobalt, or combinations thereof. In some cases, the outer member <NUM> can include high-strength polymers, such as polyether ether ketone (PEEK), a polycarbonate, a polyimide, a nylon, or acrylonitrile butadiene styrene (ABS). In some cases, the outer member <NUM> can include combinations of metal, polymer, and ceramic materials, such as a wire-braided polymer shaft, or a ceramic-filled polymer.

Referring to <FIG>, another embodiment of an illuminable needle device <NUM> provided herein includes a proximal end <NUM>, a distal end <NUM>, and an elongate, flexible shaft <NUM> between the proximal and distal ends <NUM>, <NUM>. The depicted embodiment of the device <NUM> includes a handle <NUM> at the proximal end <NUM> of the device <NUM> and an illuminable needle tip <NUM> at the distal end <NUM> of the device <NUM> for visibly penetrating tissue during a minimally-invasive medical procedure, such as a heart valve repair procedure. The shaft <NUM> of the depicted illuminable needle device <NUM> includes an outer member <NUM> and an inner member <NUM>. The outer member <NUM> can have an elongate body <NUM> that includes a proximal end <NUM> that is directly or indirectly couplable to the handle <NUM>. The distal end <NUM> can be formed into a needle tip <NUM> configured for penetrating tissue. The outer member <NUM> can define a lumen <NUM> extending from the proximal end <NUM> to the distal end <NUM> that is sized for receiving the inner member <NUM>.

The inner member <NUM>, in various embodiments of the illuminable needle device <NUM> provided herein, can include an optical fiber <NUM>, as best shown in <FIG>. The inner member <NUM> of the illuminable needle device <NUM> can, in some cases, include multiple optical fibers <NUM>. For example, in some cases, the inner member <NUM> can house two, three, four, five, six, seven, eight, nine, ten, or more than ten optical fibers <NUM> within its lumen <NUM>. Some embodiments of the illuminable needle device <NUM> provided herein include an inner member <NUM> containing multiple lumens for housing multiple optical fibers <NUM> in separate lumens. For example, in some cases, the inner member <NUM> can include at least two lumens, e.g., a first lumen and a second lumen, in which the first lumen houses a first optical fiber and the second lumen houses a second optical fiber.

<FIG> are images of a distal portion of exemplary illuminable needle device provided herein. The inner member is shown extended distally from an outer member, where a light emitting element is an unilluminated state in <FIG> and in an illuminated state in <FIG>.

The illuminable needle device <NUM> provided herein can be applied in a percutaneous transluminal procedure for repairing the heart valve (e.g., tricuspid valve). In one example, a method of penetrating tissue includes penetrating tissue using a visualization device and an illuminable needle device provided herein. The visualization device can include a receiver adapted to receive information corresponding to radiation intensity. The illuminable needle device can include an outer member includes a body that has a proximal end and a distal end. The body of the outer member can define a lumen therethrough and the distal end of the body includes a needle. The inner member can slidably disposed within the lumen of the outer member. The inner member can include a distal end that includes a radiation emitting element. The outer and inner members can together form a flexible, elongate shaft. The inner member of the needle device system can be configured to emit radiation from the radiation emitting element from a location proximate to the distal end of the outer member such that an intensity of the radiation is detectable by the receiver of the visualization device, in which the receiver is located at a minimum predetermined distance from the distal end of the outer member.

The method can also include emitting radiation from the distal end of the outer member of the illuminable needle device and detecting radiation intensity data from the receiver located at a minimum predetermined distance from the distal end of the outer member of the illuminable needle device.

In another example, a method of visualizing a surgical device can include emitting radiation from a distal end of an outer member of an illuminable needle device. The outer member of the illuminable needle device can include a body that has a proximal end and the distal end. The body can define a lumen therethrough and the distal end of the body includes a needle. The illuminable needle device can include an inner member slidably disposed within the lumen of the outer member. The inner member can include a distal end that has a radiation emitting element. The outer and inner members together can form a flexible, elongate shaft. The inner member can be configured to emit radiation from the radiation emitting element from a location proximate to the distal end of the outer member such that an intensity of the radiation is detectable by the receiver.

The method also may include detecting radiation intensity data from a receiver of a visualization device to determine a position of the distal end of the illuminable needle device. The receiver can be adapted to receive information corresponding to radiation intensity and be located at a minimum predetermined distance from the distal end of the outer member of the illuminable needle device.

It should be understood that one or more design features of the devices provided herein can be combined with other features of other devices provided herein. In effect, hybrid designs that combine various features from two or more of the device designs provided herein can be created, and are within the scope of this disclosure.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosure or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular disclosures.

In addition to being directed to the teachings described above and claimed below, devices and/or methods having different combinations of the features described above and claimed below are contemplated. As such, the description is also directed to other devices and/or methods having any other possible combination of the dependent features claimed below.

Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications may be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the present disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed.

Claim 1:
An illuminated needle device (<NUM>, <NUM>, <NUM>) for performing a heart valve repair by a percutaneous transluminal procedure, the device being a catheter and comprising:
an outer member (<NUM>) includes a body that has a proximal end and a distal end, the body defining a lumen therethrough, the distal end of the body comprising a needle (<NUM>);
an inner member (<NUM>) slidably disposed within the lumen of the outer member (<NUM>), the inner member (<NUM>) including a distal end (<NUM>) comprising a radiation emitting element (<NUM>), wherein the radiation emitting element (<NUM>) is a light-emitting element;
wherein the outer and inner members together forming a flexible, elongate shaft (<NUM>, <NUM>),
and the inner member (<NUM>) being configured to emit radiation from the radiation emitting (<NUM>) element from a location proximate to the distal end of the outer member (<NUM>),
characterized in that the shaft of the outer member (<NUM>) includes a plurality of apertures (<NUM>) such that light from the radiation emitting element (<NUM>) can emanate from at least portions of the shaft (<NUM>, <NUM>) of the illuminable needle device (<NUM>, <NUM>, <NUM>), said plurality of apertures (<NUM>) being configured such that the trajectory of the illuminated needle device can be determined.