Patent Description:
Some patients suffer from medical conditions that impair the patient's ability to swallow food and liquids. Such medical conditions can include, for example, cancer, coma, stroke, diabetes, Crohn's disease, neurological disorders, and HIV. Gastrostomy tubes (also referred to as "G-tubes") can be used to provide a path for nutrition delivery directly into the stomach of a patient, bypassing the mouth and esophagus of the patient. In the United States, approximately <NUM>,<NUM> gastrostomy tubes are placed annually. Some methods of placing a gastrostomy tube include creating incisions through an abdominal wall and a stomach wall of a patient and securing a gastrostomy tube within the incisions such that one end of the tube is disposed in the stomach and the second end is disposed outside of the patient. The creation of incisions, however, can cause harmful bleeding and is associated with the risk of accidentally perforating an organ. Thus, highly-skilled specialists such as gastroenterologists (e.g., using endoscopy) or interventional radiologists (e.g., via percutaneous radiologic gastrostomy using imaging modalities such as fluoroscopy or computerized tomography) are often needed to place gastrostomy tubes.

Thus, there is a need for systems, apparatus, and methods of placing a gastrostomy tube which reduce risks to the patient and allow for the gastrostomy tube to be quickly and easily placed and secured in communication with the stomach.

<CIT> discloses a guidewire retrieval catheter includes a guidewire retrieval lumen extending lengthwise of a catheter body. An inflatable member at the distal end of the catheter body defines an inflation chamber for selectively receiving fluid to configure the inflatable member from deflated configuration to an inflated configuration. The inflatable member has an inner wall defining a guidewire retrieval cavity in communication with the guidewire retrieval lumen to facilitate insertion of the guidewire into the guidewire retrieval lumen when the inflatable member is in the inflated configuration. The guidewire retrieval catheter is used to retrieve a guidewire in a body lumen.

<CIT> relates to a vascular catheter having a central lumen adapted to slidably receive a guidewire therein with an inflatable collar or other suitable means to releasably secure or fix the guidewire within the lumen so that the catheter and guidewire can be advanced through a patient's vasculature as a unit. The catheter system is particularly suitable in balloon dilatation catheters for use in percutaneous transluminal coronary angioplasty procedures.

<CIT> discloses a device for use in minimally invasive placement of intragastric devices.

In <CIT>, a system and method places a percutaneous gastrostomy device into a body cavity of a patient using a magnetic gastrostomy tube and a medical detection sensing device.

Further aspects are defined in dependent claims <NUM>-<NUM>. Systems, apparatus, and methods for placing a guidewire for a gastrostomy tube are described herein. In some embodiments, a system includes an elongated tube, an inflatable member, and a guidewire assembly. The elongated tube can have a first end, a second end, and can define a lumen. The inflatable member can be coupled to the first end of the elongated tube and can be fluidically coupled to the lumen such that the inflatable member can receive fluid via the lumen. The guidewire assembly can include a guidewire having a first end and a second end. The first end of the guidewire assembly can include a coupling member, the coupling member configured to couple to the inflatable member such that translation of the elongated tube translates the guidewire assembly. The different methods of use described herein, e.g. <FIG>, do not form part of the claimed invention and are left for illustrative purposes.

In some embodiments, a system includes an elongated tube, an inflatable member, and a guidewire assembly. The elongated tube can have a first end, a second end, and can define a lumen. The inflatable member can be coupled to the first end of the elongated tube and can be fluidically coupled to the lumen such that the inflatable member can receive fluid via the lumen. The guidewire assembly can include a guidewire having a first end and a second end. The first end of the guidewire assembly can include a coupling member, the coupling member configured to couple to the inflatable member such that translation of the elongated tube translates the guidewire assembly.

In some embodiments, a method (not claimed) can include translating an inflatable member of an elongated tube through an orifice of a patient, through an esophagus of the patient, and into a stomach of the patient. The inflatable member can then be inflated via a lumen of the elongated tube such that the inflatable member transitions from an uninflated configuration to an inflated configuration. A coupling member of a guidewire assembly can be translated through a stomach wall of the stomach. The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end disposed outside the patient, the guidewire extending through the stomach wall. The coupling member can be coupled to the inflatable member. The elongated tube can be withdrawn through the orifice such that the coupling member and the first end of the guidewire are withdrawn from the orifice and such that the guidewire extends through the esophagus, stomach, and stomach wall of the patient and the second end of the guidewire is disposed outside of the patient.

In some embodiments, a method (not claimed) can include translating an inflatable member of an elongated tube through an orifice of a patient and to a first location within the patient. The inflatable member can then be inflated via a lumen of the elongated tube such that the inflatable member transitions from an uninflated configuration to an inflated configuration. A coupling member of a guidewire assembly can be translated through a tissue wall of the patient to a second location within the patient near the first location. The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end disposed outside the patient. The guidewire can extend through the tissue wall when the coupling member is disposed in the second location. The coupling member can then be coupled to the inflatable member. The elongated tube can then be withdrawn through the orifice such that the coupling member and the first end of the guidewire are withdrawn from the orifice and such that the guidewire extends through the orifice, the first location, and the tissue wall of the patient and the second end of the guidewire is disposed outside of the patient.

<FIG> is a schematic illustration of a portion of a patient P. The patient P has an orifice O, an esophagus E, and a stomach S. The orifice O can be, for example, an oral orifice or a nasal orifice. The orifice O is coupled to the esophagus E and the esophagus E is coupled to the stomach S at the gastroesophageal junction J. Thus, the stomach S is accessible from the orifice O via the esophagus E. The stomach S includes a stomach wall W such that the interior of the stomach S can be accessed via piercing the stomach wall W.

When the patient P has difficulty swallowing food and/or liquid, a gastrostomy tube can be placed via a gastrostomy tract created in the stomach wall W such that nutrition can be provided directly through the gastrostomy tube to the stomach. For example, the stomach wall W can be serially dilated to create the gastrostomy tract. External serial dilation of the gastrostomy tract, however, is time-intensive. As another example of gastrostomy placement, a first end of a stiff catheter can be fluoroscopically directed through a preformed gastrostomy tract in the stomach wall W, through the stomach S, and through the esophagus E to the gastroesophageal junction J. After the first end of the stiff catheter has been translated through the gastroesophageal junction J, a guidewire can be translated through the catheter, out of the first end of the catheter, and through the orifice O of the patient. A gastrostomy tube can then be translated over the guidewire and secured in the gastrostomy tract in engagement with the stomach wall W. For example, the gastrostomy tube can be pushed over the guidewire from the orifice O, through the esophagus E, into the stomach S, and into engagement with the stomach wall W. Alternatively, the gastrostomy tube can be coupled to the first end of the guidewire (e.g., a looped end) extending from the orifice O and pulled through the orifice O, through the esophagus E, into the stomach S, and into engagement with the stomach wall W by the guidewire. Navigation of the catheter and the guidewire through the patient, however, can be challenging and pose risks to the patient. For example, the extended use of fluoroscopy to navigate the stiff catheter through the patient carries the risk of radiation-induced injuries to the patient. Furthermore, if internal guidance (e.g., fluoroscopy) is not used to navigate the catheter and guidewire through the patient, the catheter may need to be stiffer to traverse the route through the patient. Catheters with increased stiffness, however, are more likely to damage tissue via unintended tears and/or perforations.

In some embodiments, however, a guidewire can be inserted through a stomach wall of a patient and coupled to an elongated tube within the stomach such that the guidewire can be pulled through the esophagus and orifice (e.g., nasal or oral) of a patient. For example, <FIG> is a schematic representation of a system <NUM>. The system <NUM> includes an inflation assembly <NUM> and a guidewire assembly <NUM>. The inflation assembly <NUM> can include an elongated tube <NUM> and an inflatable member <NUM>. The elongated tube <NUM> can have a first end <NUM> and a second end <NUM>. In some embodiments, the elongated tube <NUM> can have a length sufficient to extend from at least an oral or nasal orifice of a patient to the stomach of a patient via an esophagus of the patient. The inflatable member <NUM> can be coupled to the elongated tube <NUM> at or near the first end <NUM> of the elongated tube <NUM>. The inflation assembly <NUM> can include an inflation lumen <NUM> in fluid communication with the inflatable member <NUM>. In some embodiments, the inflation lumen <NUM> can be disposed within and/or be defined by the elongated tube <NUM>.

In some embodiments, the inflatable member <NUM> can surround the elongated tube <NUM> in an inflated and/or uninflated configuration. In some embodiments, the inflatable member <NUM> can extend laterally from the elongated tube <NUM> in an inflated and/or uninflated configuration. In some embodiments, the inflatable member <NUM> can extend distally from the first end <NUM> of the elongated tube <NUM> in an inflated and/or uninflated configuration. In some embodiments, the inflatable member <NUM> can be disposed on the elongated tube <NUM> such that a portion of the elongated tube <NUM> extends distally of the inflatable member <NUM> when the inflatable member <NUM> is in an inflated and/or uninflated configuration. In some embodiments, the inflatable member <NUM> can have two ends (e.g., cuffs), and each end can be sealed to an outer surface of the elongated tube <NUM>. The elongated tube <NUM> can define one or more inflation holes such that the inflation lumen <NUM> can be in fluid communication with the interior of the inflatable member <NUM> for transitioning the inflatable member <NUM> between an uninflated and an inflated configuration. In some embodiments, the inflatable member <NUM> can be formed on or as a part of a rigid subassembly, and the rigid subassembly can receive the elongated tube <NUM> within an orifice of the subassembly and the elongated tube <NUM> can then be sealed to the subassembly.

In some embodiments, the inflatable member <NUM> can be formed in any suitable shape, in any suitable size, and of any suitable material. For example, the inflatable member <NUM> can be elliptical, spherical, cylindrical, rectangular, tear drop, or any other suitable shape. In some embodiments, the shape can be chosen based on the particular application of the system <NUM>. For example, the shape of the inflatable member <NUM> may be selected to improve ultrasound visualization in particular regions of a patient's body. Furthermore, the inflatable member <NUM> can be sized for improved engagement and retention between the inflatable member <NUM> and the guidewire assembly <NUM>.

The inflatable member <NUM> is to be sufficiently pliable such that the inflatable member <NUM> (e.g., when inflated) is punctured (e.g., by a needle) to define a pinhole in the wall of the inflatable member <NUM> rather than bursting or tearing as a result of puncture. In some embodiments, the inflatable member <NUM> can be formed of, for example, polyurethane, silicone, and/or polyvinyl chloride (PVC). In some embodiments, the inflatable member <NUM> can have any suitable material properties, wall thicknesses, and/ or inflated outermost diameters.

In some embodiments, for example, the inflatable member <NUM> can be elliptical in shape and formed of a low durometer urethane. The inflatable member <NUM> can have an outermost diameter ranging from about <NUM> to about <NUM> in an inflated configuration, and a length of about <NUM>. The inflatable member <NUM> can have a diameter at each end ranging from about <NUM> to about <NUM>. The wall thickness at the maximum balloon diameter in the inflated configuration can be between about <NUM> and about <NUM>. The inflatable member <NUM> can be filled with up to, for example, about <NUM> of fluid in the inflated configuration.

The guidewire assembly <NUM> can include a guidewire <NUM> having a first end <NUM> and a second end <NUM> and a coupling member <NUM> disposed at the first end <NUM> of the guidewire <NUM>. The coupling member <NUM> can be configured to couple to the inflatable member <NUM> such that, when coupled, translation of the inflation assembly <NUM> (e.g., translation of the elongated tube <NUM> via pulling on the second end <NUM>) can translate the guidewire assembly <NUM>. For example, if the inflatable member <NUM> is moved in a first direction due to a force applied to the elongated tube <NUM>, the coupling of the coupling member <NUM> to the inflatable member <NUM> can cause the coupling member <NUM> and the guidewire <NUM> to also move in the first direction. The coupling member <NUM> can be configured to couple with the inflatable member <NUM> via, for example, being captured by the inflatable member <NUM>, caught within an interior region of the inflatable member, or engaged with a surface of the inflatable member <NUM>.

In some embodiments, the coupling member <NUM> can be distinct from the guidewire <NUM> and fixedly coupled to the guidewire <NUM> (e.g., via adhesive). For example, in some embodiments, the coupling member <NUM> can include a first magnetic member configured to couple to a second magnetic member of the inflatable member <NUM>.

In some embodiments, the guidewire <NUM> can include the coupling member <NUM>. For example, the coupling member <NUM> can be monolithically formed with a shaft of the guidewire <NUM> such that the guidewire assembly <NUM> is a one piece structure. Similarly, in some embodiments, the coupling member <NUM> and the guidewire <NUM> can be formed of the same material or materials. In some embodiments, the coupling member <NUM> can be shaped such that the coupling member <NUM> can engage with at least one portion of a wall of the inflatable member <NUM>. For example, the coupling member <NUM> can have a planar or a multiplanar shape and can be formed as a pigtail, hook, coil, or corkscrew-shaped end to the guidewire <NUM>. Thus, in some embodiments, the first end <NUM> of the guidewire <NUM> can be retained within or near the inflatable member <NUM> by the coupling member <NUM> when the coupling member <NUM> is disposed within the inflatable member <NUM>. In some embodiments, the coupling member <NUM> can be disposed outside of the inflatable member <NUM> with the guidewire <NUM> passing through a first wall portion and a second, oppositely disposed wall portion of the inflatable member <NUM> such that the guidewire <NUM> is retained by the inflatable member <NUM> due to the interaction between the coupling member <NUM> and the first wall portion of the inflatable member <NUM>. In some embodiments, the coupling member <NUM> can be partially disposed within the inflatable member <NUM> and partially disposed outside of the inflatable member <NUM> such that the guidewire assembly <NUM> is coupled to the inflatable member <NUM> for translation of the guidewire assembly <NUM> via movement of the inflation assembly <NUM>.

The coupling member <NUM> is configured to transition between a first configuration for insertion and a second configuration for retention or coupling. For example, the coupling member <NUM> has a smaller lateral extent (e.g., outermost diameter) relative to a central axis of the guidewire <NUM> in the first configuration than in the second configuration such that the coupling member <NUM> can fit inside the lumen <NUM> of the needle <NUM> in the first configuration and can expand to retain the guidewire <NUM> relative to the inflatable member <NUM> in the second configuration. In some embodiments, the coupling member <NUM> can have a first shape in the first configuration and a second shape in the second configuration such that the coupling member <NUM> can travel through an opening in at least one sidewall of the inflatable member <NUM> in the first configuration and can engage a sidewall of the inflatable member <NUM> in the second configuration such that the coupling member <NUM> is retained by the inflatable member <NUM>. In some embodiments, the coupling member <NUM> can be biased toward the second configuration such that, in the absence of external forces on the coupling member <NUM>, the coupling member <NUM> will assume the second configuration. In some embodiments, in the first configuration the coupling member <NUM> can be elongated such that the coupling member is shaped as a straight wire. The second configuration can correspond to an unbiased shape or configuration of the coupling member (e.g., a pigtail, hook, coil, or corkscrew-shape). In some embodiments, the guidewire <NUM> and/or the coupling member <NUM> can be formed of a shape-memory material such as, for example, Nitinol.

In some embodiments, when the coupling member <NUM> is within the lumen <NUM> of the needle <NUM>, the needle <NUM> can compress the coupling member <NUM> such that the coupling member is in the first configuration. Thus, the coupling member <NUM> can have a smaller lateral extent relative to a central axis of the guidewire <NUM> (e.g., outermost diameter) when disposed within the lumen <NUM> of the needle <NUM> than when not within the needle <NUM>. In some embodiments, the lumen <NUM> and the coupling member <NUM> can be structured and sized such that the coupling member <NUM> can be straight or substantially straight within the lumen <NUM> of the needle <NUM>. For example, the lumen <NUM> can have an inner diameter similar to an outer diameter of the coupling member <NUM> (e.g., an outer diameter of a wire forming the coupling member <NUM> portion of the guidewire assembly <NUM>) such that the coupling member <NUM> can be laterally compressed to a shape with a smaller outer diameter and/or elongated within the lumen <NUM> of the needle <NUM>. In some embodiments, the outer diameter of a wire forming the coupling member <NUM> and the inner diameter of the lumen <NUM> can be relatively sized such that the outer diameter of the wire forming the coupling member <NUM> is slightly smaller than the inner diameter of the lumen <NUM> and the coupling member <NUM> and the inner surface of the needle <NUM> defining the lumen <NUM> can have a slip fit engagement. Thus, when the coupling member <NUM> is threaded into the lumen <NUM> of the needle <NUM>, the wire forming the coupling member <NUM> is straightened out to correspond to the shape of the lumen <NUM>. As the coupling member <NUM> is translated out of the first end <NUM> of the needle <NUM>, the coupling member <NUM> can transition from the first configuration to the second configuration. For example, as the coupling member <NUM> is extended from the first end <NUM> of the needle <NUM>, the portion of the coupling member <NUM> extending from the first end <NUM> can transition toward the second configuration due to being biased toward the second configuration, while the portion of the coupling member <NUM> remaining within the lumen <NUM> of the needle <NUM> can remain in the first configuration. When the coupling member <NUM> is entirely outside of the needle <NUM>, the coupling member <NUM> can be entirely in the second configuration.

In some embodiments, the coupling member <NUM> can be configured to be translated in a first direction by the inflatable member <NUM> if a translation force on the inflatable member <NUM> is greater than a force in a direction opposite of the translation force on the coupling member <NUM>. If the force on the coupling member <NUM> is opposite and greater than the translation force on the inflatable member <NUM>, the coupling member <NUM> and the inflatable member <NUM> can be configured to decouple. For example, in some embodiments in which the coupling member <NUM> is a pigtail-shaped end to the guidewire <NUM>, the application of sufficient force to the coupling member <NUM> in a direction opposite a force being applied to the inflatable member <NUM> can cause the pigtail-shaped end to straighten and decouple from the inflatable member <NUM>. Thus, in some embodiments the coupling member <NUM> and the inflatable member <NUM> can be decoupled via applying oppositely directing pulling forces to each of the coupling member <NUM> and the inflatable member <NUM>. In some embodiments, the coupling member <NUM> and the inflatable member <NUM> can be engaged such that the release force (e.g., via oppositely directing pulling forces) necessary to separate the coupling member <NUM> from the inflatable member <NUM> is a force greater than the maximum force applied to the guidewire <NUM> (and therefore coupling member <NUM>) in an opposite direction than the inflatable member <NUM> during withdrawal of the coupling member <NUM> from the patient via pulling on the inflation assembly <NUM>. Thus, the release force is sufficiently high such that the inflatable member <NUM> and the coupling member <NUM> will not be separated during the withdrawal of the coupling member <NUM> of the guidewire <NUM> inadvertently during withdrawal, but can be separated via, for example, pulling by the user when the inflatable member <NUM> and the coupling member <NUM> are outside of the patient's body. For example, in some embodiments, the release force can be at least about <NUM> N (<NUM> lbs of force), at least about <NUM>. 22N (<NUM> lbs of force), or at least about <NUM>. 67N (<NUM> lbs of force). In some applications of the system <NUM>, such as non-gastrostomy applications, the release force may be greater or smaller depending on the resistive forces the coupling member <NUM> and guidewire <NUM> may experience during withdrawal via a withdrawal force on the inflation assembly <NUM>.

In some embodiments, the coupling member <NUM> can be configured to pierce the inflatable member <NUM> such that the coupling member <NUM> can be inserted into and/or through the inflatable member <NUM>. In some embodiments, the system <NUM> can optionally include a needle <NUM> having a first end <NUM>, a second end <NUM>, and defining a lumen <NUM>. The first end <NUM> can have any suitable shape configured to pierce and create access to the inflatable member <NUM>. For example, the first end <NUM> can have a sharpened tip that can be tapered. The lumen <NUM> can be sized such that the coupling member <NUM> of the guidewire assembly <NUM> can be translated through the second end <NUM>, through the lumen <NUM>, and through the first end <NUM> of the needle <NUM>. In some embodiments, the needle <NUM> can be inserted through a stomach wall of the patient and through a sidewall of the inflatable member <NUM>. The coupling member <NUM> and a portion of the guidewire <NUM> can then be translated through the lumen <NUM> of the needle <NUM> such that at least one of the coupling member <NUM> and a portion of the guidewire <NUM> is at least partially disposed within inflatable member <NUM>. The needle <NUM> can then be removed from the inflatable member <NUM> via translating the needle <NUM> along the guidewire <NUM>.

In some embodiments, the inflatable member <NUM> can be filled and/or inflated with a fluid (e.g., a liquid or a gaseous fluid) after being disposed in the stomach of the patient. For example, the inflatable member <NUM> can be filled and/or inflated with a fluid and/or contrast medium such that the inflatable member <NUM> defines an echogenic space detectable using ultrasound imaging. In some embodiments, the inflatable member <NUM> can be filled and/or inflated with a contrast medium such that the location of the inflatable member <NUM> can be visualized using fluoroscopy. Inflating the inflatable member <NUM> can also increase the surface tension of the sidewall of the inflatable member such that the needle <NUM> and/or the guidewire <NUM> can more easily pierce the sidewall. Further, inflation of the inflatable member <NUM> can create a larger interior space within which the coupling member <NUM> can expand and/or be disposed. Inflation of the inflatable member <NUM> can also increase the target size of the inflatable member for visualization and targeting of the inflatable member <NUM> with the needle <NUM> and/or coupling member <NUM>.

In use, the inflation assembly <NUM> can be inserted through an orifice of a patient (e.g., a nose or mouth of a patient), through an esophagus of the patient, and into a stomach of the patient such that the inflation member <NUM> is disposed with the stomach of the patient and the elongated tube <NUM> extends from the inflation member <NUM> in the stomach, through the esophagus, and out of the orifice of the patient. Fluid can then be delivered to the inflatable member <NUM> via the inflation lumen <NUM>. As described above, the fluid can include a fluid and/or contrast medium such that the inflatable member <NUM> is detectable via imaging (e.g., ultrasound or fluoroscopy). The inflatable member <NUM> can then be visualized such that the location of the inflatable member <NUM> can be identified.

While visualizing the location of the inflatable member <NUM>, the guidewire assembly <NUM> can be inserted through a stomach wall of the stomach and coupled to the inflatable member <NUM>. For example, the needle <NUM> can be inserted through the abdominal wall and stomach wall of the patient and through a sidewall of the inflatable member <NUM> such that the first end <NUM> of the needle <NUM> (e.g., the tip) is disposed within the inflatable member <NUM>. The coupling member <NUM> and a portion of the guidewire <NUM> can be inserted through the lumen <NUM> of the needle <NUM> and translated (e.g., pushed) through the lumen <NUM>. The coupling member <NUM> can then be translated out from the first end <NUM> of the needle <NUM> such that the coupling member <NUM> is disposed within the inflatable member <NUM>. The needle <NUM> can then be withdrawn from the patient via translation of the needle <NUM> relative to the coupling member <NUM> and the guidewire <NUM>, leaving the coupling member <NUM> within the inflatable member <NUM> and the guidewire <NUM> extending through a wall of the inflatable member <NUM>. Additionally, the inflatable member <NUM> can be deflated in preparation for being withdrawn in tandem with the coupling member <NUM> through the esophagus.

The elongated tube <NUM> can then be translated (e.g., pulled) through the orifice of the patient such that the inflatable member <NUM> translates the coupling member <NUM> and the guidewire <NUM>. For example, the elongated tube <NUM> can be translated relative to the orifice until the inflatable member <NUM>, the coupling member <NUM>, and the first end <NUM> of the guidewire <NUM> have been translated through the esophagus and out of the orifice and the guidewire extends from the first end <NUM>, through the orifice, through the esophagus, into the stomach, and through the stomach wall to the second end <NUM> disposed outside of the patient. Thus, the first end <NUM> of the guidewire <NUM> can extend from the nose or mouth of the patient and be accessible near the patient's head, and the second end <NUM> of the guidewire <NUM> can extend from the stomach wall of the patient and be accessible near the patient's abdomen. A feeding tube (not shown) can then be pushed over the first end <NUM> of the guidewire <NUM> and translated along the guidewire <NUM> through the esophagus, into the stomach, and through the stomach wall until a portion of the feeding tube is disposed outside of the patient near or on the skin of the patient and a portion of the feeding tube is disposed within the patient's stomach. Then, the guidewire <NUM> can be removed from the patient via applying a retraction (e.g. pulling) force to the first end <NUM> of the guidewire <NUM> such that the second end <NUM> of the guidewire <NUM> is pulled through the stomach wall of the patient, through the stomach, through the esophagus, and out of the patient's oral or nasal orifice. Alternatively, the guidewire <NUM> can be removed from the patient via applying a retraction force to the second end <NUM> of the guidewire <NUM> such that the first end <NUM> of the guidewire <NUM> is pulled through the patient's oral or nasal orifice, through the esophagus, through the stomach, out of the stomach wall, and out of the skin of the patient. Thus, the feeding tube can provide direct access to the stomach of the patient such that food or liquid can be disposed in the stomach via the feeding tube without traversing the esophagus.

In some embodiments, rather than moving the coupling member <NUM> outside of the patient's body via the esophagus, the inflatable member <NUM> can be used to move the coupling member <NUM> to another region of the body (e.g., another region of the stomach or outside of the stomach).

<FIG> is a flow chart of a method <NUM>, according to an embodiment. The method <NUM> can be implemented using any of the systems or devices described herein, such as the system <NUM> described above. The method <NUM> includes translating <NUM> an inflatable member of an elongated tube through an orifice of a patient, through an esophagus of the patient, and into a stomach of the patient. Fluid (e.g., a liquid or a gaseous fluid) can be provided <NUM> to the inflatable member via a lumen of the elongated tube such that the inflatable member transitions from an uninflated configuration to an inflated configuration. In some embodiments, the fluid can include a contrast medium, and the method <NUM> can optionally include visualizing the location of the inflatable member via ultrasound or fluoroscopy. A coupling member of a guidewire assembly can be translated <NUM> through a stomach wall of the stomach. The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end disposed outside the patient. The guidewire can extend through the stomach wall. In some embodiments, a needle can be inserted through the stomach wall of the stomach and through a sidewall of the inflatable member, and the coupling member of the guidewire assembly can be at least partially translated through a lumen of the needle.

The coupling member can be coupled <NUM> to the inflatable member. In some embodiments, the inflatable member can have a first sidewall portion and a second sidewall portion and the needle can be translated through both the first and second sidewall portions such that the coupling member of the guidewire assembly can be disposed outside of the inflatable member and the guidewire can pass through the first sidewall and the second sidewall such that the coupling member is coupled to the inflatable member. In some embodiments, the coupling member is configured to transition between a first configuration in which the coupling member is coiled and a second configuration in which the coupling member is straight, the coupling member being biased toward the first configuration. The coupling of the coupling member to the inflatable member can then include translating the coupling member distally of a distal end of the needle such that the coupling member at least partially transitions from the second configuration to the first configuration and withdrawing the needle relative to the coupling member such that the coupling member is retained in the stomach by the inflatable member.

The elongated tube can be withdrawn <NUM> through the orifice such that the coupling member and the first end of the guidewire are withdrawn from the orifice and such that the guidewire extends through the esophagus, stomach, and stomach wall of the patient and the second end of the guidewire is disposed outside of the patient.

<FIG> are schematic illustrations of a system <NUM> in various stages of operation. The system <NUM> can be the same or similar in structure and/or function to any of the systems or devices described herein, such as the system <NUM> described above. As shown in <FIG>, an inflation assembly <NUM> can include an elongated tube <NUM> and an inflation member <NUM> disposed near a first end <NUM> of the elongated tube <NUM>. A portion of the inflation assembly <NUM> can be inserted through an orifice O of a patient (e.g., a nose or mouth of a patient), through an esophagus E of the patient, and into a stomach S of the patient such that the inflation member <NUM> is disposed with the stomach S of the patient and the elongated tube <NUM> extends from the inflation member <NUM>, through the esophagus E, and out of the orifice O of the patient.

As shown in <FIG>, fluid (e.g., a liquid or a gaseous fluid) can be delivered to the inflatable member <NUM> via an inflation lumen (not shown) of the elongated tube <NUM> such that the inflatable member <NUM> is filled and/or inflated. For example, the inflatable member <NUM> can be filled and/or inflated with a fluid and/or contrast medium such that the inflatable member <NUM> defines an echogenic space detectable using ultrasound imaging. In some embodiments, the inflatable member <NUM> can be filled and/or inflated with a contrast medium such that the location of the inflatable member <NUM> can be visualized using fluoroscopy. The inflatable member <NUM> can then be visualized using imaging (e.g., ultrasound or fluoroscopy) such that the location of the inflatable member <NUM> can be identified.

As shown in <FIG>, a needle <NUM> can be inserted through the stomach wall W of the patient and through a sidewall portion <NUM> of the inflatable member <NUM> such that a first end <NUM> of the needle <NUM> (e.g., the tip) is disposed within the inflatable member <NUM>. The needle <NUM> can be target toward and into engagement with the inflatable member using imaging (e.g., ultrasound or fluoroscopy). As shown in <FIG>, a guidewire assembly <NUM> including a coupling member <NUM> and a guidewire <NUM> can be inserted through a lumen of the needle <NUM> and translated (e.g., pushed) through the lumen of the needle <NUM> until the coupling member <NUM> is disposed within the inflatable member <NUM>. As shown in <FIG>, the coupling member <NUM> can be configured to transition to a pigtail shape when extended from the first end <NUM> of the needle <NUM>. Although shown as transitioning to a pigtail shape, the coupling member <NUM> can be configured to transition to any suitable shape, such as, for example, hook, coil, or corkscrew shapes.

As shown in <FIG>, the needle <NUM> can then be withdrawn from the patient via translation of the needle <NUM> relative to the coupling member <NUM> and the guidewire <NUM>, leaving the coupling member <NUM> within the inflatable member <NUM> and the guidewire <NUM> extending through the wall portion <NUM> of the inflatable member <NUM>. Additionally, the inflatable member <NUM> can be deflated in preparation for being withdrawn through the esophagus.

As shown in <FIG> and <FIG>, the elongated tube <NUM> can then be translated (e.g., pulled) through the orifice O of the patient such that the inflatable member <NUM> translates the coupling member <NUM> and the guidewire <NUM> in tandem. For example, the elongated tube <NUM> can be translated relative to the orifice O until the inflatable member <NUM>, the coupling member <NUM>, and a first end <NUM> of the guidewire <NUM> have been translated through the esophagus E (as shown in <FIG>) and out of the orifice O (as shown in <FIG>), such that the guidewire <NUM> extends from the location of the coupling member <NUM> outside of the patient, through the orifice O, through the esophagus E, into the stomach S, and through the stomach wall W to a second end <NUM> of the guidewire <NUM> disposed outside of the patient. Thus, the first end <NUM> of the guidewire <NUM> can extend from the nose or mouth of the patient and be accessible near the patient's head, and the second end <NUM> of the guidewire <NUM> can extend through the stomach wall of the patient and be accessible near the patient's abdomen.

As shown in <FIG>, the inflatable member <NUM> can then, optionally, be decoupled from the coupling member <NUM> of the guidewire assembly <NUM>. For example, a user can apply a first force on the inflatable member and a second force on the coupling member <NUM> in an opposite direction from the first force. The opposite forces can cause the pigtail-shaped coupling member <NUM> to straighten and decouple from the inflatable member <NUM> (e.g., slide out of the orifice created by the needle <NUM> within which the guidewire <NUM> is disposed).

As shown in <FIG>, the coupling member <NUM> can be separated from the rest of the guidewire assembly <NUM> so that the coupling member <NUM> does not impede a feeding tube from being threaded along the guidewire <NUM>. For example, the guidewire assembly <NUM> can be cut adjacent the coupling member <NUM> near the first end <NUM> of the guidewire <NUM> so that the coupling member <NUM> can be removed from the guidewire <NUM>. The user can then dispose of the coupling member <NUM>. In some embodiments, rather than decoupling the coupling member <NUM> from the guidewire assembly <NUM> prior to separating the coupling member <NUM> from the remainder of the guidewire assembly <NUM>, the inflatable member <NUM> and the coupling member <NUM> can remain engaged during the separation of the coupling member <NUM> from the remainder of the guidewire assembly <NUM>. The user can then dispose of the coupling member <NUM> and the inflatable member <NUM> simultaneously.

As shown in <FIG>, a feeding tube <NUM> can then be pushed over the first end <NUM> of the guidewire <NUM> and translated along the guidewire <NUM> through the esophagus, into the stomach, and through the stomach wall until a portion of the feeding tube <NUM> is disposed outside of the patient near or on the skin of the patient and a portion of the feeding tube <NUM> is disposed within the patient's stomach. For example, as shown in <FIG>, the feeding tube <NUM> can include a tube portion <NUM> and a retention portion <NUM>. The retention portion <NUM> can be engaged with the inner wall of the patient's stomach and the tube portion <NUM> can extend through the patient's stomach wall and outside of the patient. The guidewire <NUM> can then be removed from the patient via applying a retraction (e.g. pulling) force to the first end <NUM> of the guidewire <NUM> such that the second end <NUM> of the guidewire <NUM> is pulled through the stomach wall of the patient, through the stomach, through the esophagus, and out of the patient's oral or nasal orifice, leaving the feeding tube <NUM> in place extending through the stomach wall. Alternatively, the guidewire <NUM> can be removed from the patient via applying a retraction force to the second end <NUM> of the guidewire <NUM> such that the first end <NUM> of the guidewire <NUM> is pulled through the patient's oral or nasal orifice, through the esophagus, through the stomach, out of the stomach wall, and out of the skin of the patient. Thus, the feeding tube <NUM> can provide direct access to the stomach of the patient such that food or liquid can be disposed in the stomach via the feeding tube <NUM> without traversing the esophagus.

Although the system <NUM> shows the coupling member <NUM> disposed within the interior of the inflatable member <NUM>, in some embodiments the coupling member <NUM> can be disposed outside of the inflatable member <NUM> and coupled to an outer surface of the inflatable member <NUM> when the coupling member <NUM> and the inflatable member <NUM> are coupled to each other. For example, as shown in <FIG>, the needle <NUM> can pass through a first sidewall portion and a second oppositely disposed sidewall portion such that the first end <NUM> of the needle <NUM> is disposed outside of the inflatable member <NUM> and the needle <NUM> has created two access orifices in the inflatable member <NUM>. As shown in <FIG>, the coupling member <NUM> can then be extended beyond the first end of the needle <NUM> such that the coupling member <NUM> is disposed outside of the inflatable member <NUM>. As shown in <FIG>, the needle <NUM> can then be withdrawn relative to the coupling member <NUM> such that the guidewire <NUM> attached to the coupling member <NUM> remains disposed within the two access orifices in the inflatable member <NUM> and the coupling member <NUM> is engageable with the outer surface of the inflatable member <NUM>.

As shown in <FIG>, the inflation assembly <NUM> can be translated (e.g., through the esophagus) such that the coupling member <NUM> and the guidewire <NUM> are translated in the same direction as the inflatable member <NUM>, similarly as described with respect to <FIG>. As shown in <FIG>, the inflation assembly <NUM> can be further translated out of a patient orifice (e.g., out of an orifice such as the mouth of a patient) such that the coupling member <NUM> is also translated out of the orifice and such that the guidewire <NUM> extends through the orifice, through a route within the patient, and out of another orifice of the patient (such as an orifice in the patient's stomach wall).

In some embodiments, the guidewire assembly can have any suitable shape and size. In some embodiments, the shape of a coupling member (e.g., a pigtail) can depend, at least in part, on the diameter of the wire forming the coupling member <NUM> and the number of turns. In some embodiments, these can be selected based on the intended application (e.g., gastrostomy) and/or on the amount of space available within the anatomy for the engagement of the coupling member with an inflatable member and for translation of the inflatable member and the coupling member. In some embodiments, the coupling member of a guidewire assembly can take any suitable number of turns. For example, <FIG> are examples of coupling members having pigtail shapes including various turn shapes. <FIG> shows a coupling member <NUM> including a two-turn pigtail. The coupling member <NUM> can include a distal end portion <NUM>. The coupling member <NUM> can have a diameter D1 of, for example, about <NUM> inches. The coupling member <NUM> can have a distance H1 from a first end to a second end of the outermost turn of, for example, about <NUM> inches. The distal end portion <NUM> can include a straight distal end portion having a length L1 and a curved portion having a radius of curvature of R1. The length L1 can be, for example, about <NUM> inches, and the radius of curvature R1 can be, for example, about <NUM> inches.

<FIG> shows a coupling member <NUM> including a <NUM>-turn pigtail. The coupling member <NUM> can include a distal end portion <NUM>. The coupling member <NUM> can have a diameter D2 of, for example, about <NUM> inches. The coupling member <NUM> can have a distance H2 from a first end to a second end of the outermost turn of, for example, <NUM> inches. The distal end portion <NUM> can include a straight distal end portion having a length L2 and a curved portion having a radius of curvature of R2. The length L2 can be, for example, about <NUM> inches, and the radius of curvature R2 can be, for example, about <NUM> inches.

<FIG> shows a coupling member <NUM> including a <NUM>-turn pigtail. The coupling member <NUM> can include a distal end portion <NUM>. The coupling member <NUM> can have a diameter D3 of, for example, <NUM> inches. The coupling member <NUM> can have a distance H3 from a first end to a second end of the outermost turn of, for example, <NUM> inches. The distal end portion <NUM> can include a straight distal end portion having a length L3 and a curved portion having a radius of curvature of R3. The length L3 can be, for example, about <NUM> inches, and the radius of curvature R3 can be, for example, about <NUM> inches.

<FIG> shows a coupling member <NUM> including a <NUM>-turn pigtail. The coupling member <NUM> can include a distal end portion <NUM>. The coupling member <NUM> can have a diameter D4 of, for example, <NUM> inches. The coupling member <NUM> can have a distance H4 from a first end to a second end of the outermost turn of, for example, <NUM> inches. The distal end portion <NUM> can include a straight distal end portion having a length L4 and a curved portion having a radius of curvature of R4. The length L4 can be, for example, about <NUM> inches, and the radius of curvature R4 can be, for example, about <NUM> inches.

Similarly as shown and described with respect to the pigtail shape, any of the coupling members described herein can include corkscrews of various numbers of turns or hooks of various shapes. For example, <FIG> show a number of possible two dimensional guidewire assembly shapes. Each of the guidewire assemblies shown in <FIG> can be included in any of the systems or methods described herein. For example, <FIG> shows a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> has a first hook-shaped portion and a second hook-shaped portion oppositely oriented in an S-shape. <FIG> shows a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> is shaped as a loop such that the end of the coupling member <NUM> is adjacent or nearly adjacent a portion of the guidewire <NUM>. <FIG> shows a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> is shaped as a partial loop relative to the guidewire <NUM>. <FIG> shows a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> can be shaped as a loop such that a first portion of the coupling member <NUM> overlaps a second portion of the coupling member <NUM>. The coupling member <NUM> can include an end portion <NUM> that is disposed substantially perpendicular to the first portion of the coupling member <NUM> to which the end portion <NUM> is coupled. <FIG> shows a guidewire assembly <NUM> having a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> is shaped as a two-turn pigtail. <FIG> shows a guidewire assembly <NUM> having a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> is shaped as a one-turn pigtail. The end portion of the coupling member <NUM> may be spaced from the guidewire <NUM> by a distance. For example, the distance between the end portion of the coupling member <NUM> and the guidewire <NUM> to which the coupling member <NUM> is coupled may be about half a width of the coupling member <NUM>.

In some embodiments, the coupling members can have any suitable three-dimensional shape. For example, <FIG> shows a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. As shown, the coupling member <NUM> can have a spiral configuration (e.g., a conic spiral configuration). In some embodiments, the coupling member <NUM> can have a helix configuration.

In some embodiments, an inflation assembly, such as any of the inflation assemblies described herein, can include a barrier within an inflatable member such that a coupling member can be engaged with the inflatable member between the barrier and an inner surface of the inflatable member. For example, <FIG> is an illustration of a system <NUM>. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein. The system <NUM> includes an inflation assembly <NUM> and a guidewire assembly <NUM>. The inflation assembly <NUM> can include an elongated tube <NUM> and an inflatable member <NUM>. A barrier <NUM> can be included within the inflatable member <NUM>. The guidewire assembly <NUM> can include a guidewire <NUM> and a coupling member <NUM>. As shown in <FIG>, the coupling member <NUM> can be engaged with the inflatable member <NUM> such that the coupling member <NUM> is retained between the barrier <NUM> and the inner surface of the inflatable member <NUM>. In some embodiments, the barrier <NUM> can prevent the coupling member <NUM> from passing all the way through the inflatable member <NUM>. In some embodiments, the barrier <NUM> can be coupled to the elongated tube <NUM>.

In some embodiments, a system, such as any of the inflation assemblies described herein, can be configured such that a coupling member of a guidewire assembly can be inserted into the interior of an inflatable member of an inflation assembly and retained within the interior of the inflatable member by an inner surface of a wall of the inflatable member. For example, <FIG> is an illustration of a system <NUM>. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein. The system <NUM> includes an inflation assembly <NUM> and a guidewire assembly <NUM>. The inflation assembly <NUM> can include an elongated tube <NUM> and an inflatable member <NUM>. The guidewire assembly <NUM> can include a guidewire <NUM> and a coupling member <NUM>. The coupling member <NUM> can be formed as a pigtail with any suitable number of turns, such as, for example, three. As shown in <FIG>, the coupling member <NUM> can be engaged with the inflatable member <NUM> such that the coupling member <NUM> is retained within the interior of the inflatable member <NUM> by an inner surface of a wall of the inflatable member <NUM>.

In some embodiments, a system, such as any of the inflation assemblies described herein, can be configured such that a coupling member of a guidewire assembly includes only <NUM> turns. For example, <FIG> is an illustration of a system <NUM>. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein. The system <NUM> includes an inflation assembly <NUM> and a guidewire assembly <NUM>. The inflation assembly <NUM> can include an elongated tube <NUM> and an inflatable member <NUM>. The guidewire assembly <NUM> can include a guidewire <NUM> and a coupling member <NUM>. As shown in <FIG>, the coupling member <NUM> can be formed as a pigtail with <NUM> turns. The coupling member <NUM> can be engaged with the inflatable member <NUM> such that the coupling member <NUM> is retained within the interior of the inflatable member <NUM> by an inner surface of a wall of the inflatable member <NUM>.

In some embodiments, a system, such as any of the inflation assemblies described herein, can be configured such that a coupling member of a guidewire assembly includes a loop shape. For example, <FIG> is an illustration of a system <NUM>. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein. The system <NUM> includes an inflation assembly <NUM> and a guidewire assembly <NUM>. The inflation assembly <NUM> can include an elongated tube <NUM> and an inflatable member <NUM>. The guidewire assembly <NUM> can include a guidewire <NUM> and a coupling member <NUM>. As shown in <FIG>, the coupling member <NUM> can be formed as a loop. The coupling member <NUM> can be engaged with the inflatable member <NUM> such that the coupling member <NUM> is retained within the interior of the inflatable member <NUM> by an inner surface of a wall of the inflatable member <NUM>.

In some embodiments, the inflatable member can be deflated after engagement with the coupling member and prior to translation of the inflatable member and coupling member out of the patient's body. For example, <FIG> is an illustration of a system <NUM> in a first inflation state. The system <NUM> can be the same or similar in structure and/or function to any of the systems described herein. For example, the system <NUM> can include an inflation assembly <NUM> including an elongated tube <NUM> and an inflatable member <NUM>. The system <NUM> can also include a guidewire assembly <NUM> including a guidewire <NUM> and a coupling member <NUM>. As shown, the coupling member <NUM> can be engaged with the inflatable member <NUM> such that the coupling member <NUM> is disposed with the outer surface of the inflatable member <NUM> and the guidewire <NUM> passes through two access orifices in the inflatable member <NUM>. The inflatable member <NUM> can be partially deflated (e.g., the fluid can be withdrawn via an inflation lumen).

As shown in <FIG>, which is an illustration of the system <NUM> in a second inflation state, the inflatable member <NUM> can be further deflated. The coupling member <NUM> can be engaged with the outer surface of the inflatable member <NUM> such that movement of the inflatable member <NUM> (e.g., via movement of the elongated tube <NUM>) causes the coupling member <NUM> to move similarly.

Although the systems and methods described herein are described in relation to disposing a feeding or gastrostomy tube in a patient, the systems and methods can be used for any suitable procedure. For example, the systems described herein can be used for other procedures in which the creation of an access opening is needed. In some embodiments, a method can include translating an inflatable member of an elongated tube through an orifice of a patient and to a first location within the patient. The inflatable member can be the same or similar in structure and/or function to any of the inflatable members described herein. Fluid can then be provided to the inflatable member via a lumen of the elongated tube such that the inflatable member transitions from an uninflated configuration to an inflated configuration. A coupling member of a guidewire assembly, such as any of the guidewire assemblies described herein, can be translated through a tissue wall of the patient to a second location within the patient near the first location. The guidewire assembly can include a guidewire having a first end coupled to the coupling member and a second end disposed outside the patient. The guidewire can extend through the tissue wall when the coupling member is disposed in the second location. The coupling member can then be coupled to the inflatable member. The elongated tube can then be withdrawn through the orifice such that the coupling member and the first end of the guidewire are withdrawn from the orifice and such that the guidewire extends through the orifice, the first location, and the tissue wall of the patient and the second end of the guidewire is disposed outside of the patient.

In some embodiments, a system such as any of the systems described herein can be used for a percutaneous cystostomy. For example, an inflation assembly such as any of the inflation assemblies described herein can be inserted through the urethra and a guidewire assembly such as any of the guidewire assemblies described herein can be inserted through a patient's bladder wall such that a coupling member of the guidewire assembly can be engaged with an inflatable member of the inflation assembly. The inflatable member can then be withdrawn through the urethra such that the coupling member of the guidewire assembly is also withdrawn through the urethra. The guidewire assembly can then extend through the urethra, through the bladder, and out of the patient through the bladder wall. In some embodiments, a system such as any of the systems described herein can be used for a percutaneous tracheostomy.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

Claim 1:
A system (<NUM>), comprising:
an elongated tube (<NUM>) having a first end (<NUM>), a second end (<NUM>), and defining a lumen;
an inflatable member (<NUM>) coupled to the first end of the elongated tube (<NUM>), the inflatable member (<NUM>) having a first end (<NUM>) and a second end (<NUM>), each of the first end (<NUM>) and the second end (<NUM>) sealed to an outer surface of the elongated tube (<NUM>), the inflatable member (<NUM>) fluidically coupled to the lumen such that the inflatable member (<NUM>) can receive fluid via the lumen, a wall of the inflatable member (<NUM>) configured to be punctured by a needle to define a pinhole; and
a guidewire assembly (<NUM>) including a guidewire (<NUM>) having a first end (<NUM>) and a second end (<NUM>), the first end (<NUM>) of the guidewire assembly (<NUM>) including a coupling member (<NUM>), the coupling member (<NUM>) configured to transition between a first configuration and a second configuration, the coupling member (<NUM>) having a greater lateral extent relative to a central axis of the guidewire (<NUM>) in the first configuration than in the second configuration, the coupling member (<NUM>) configured to be translated through the pinhole in the second configuration, the coupling member (<NUM>) configured to transition from the second configuration to the first configuration within an interior of the inflatable member (<NUM>) such that the coupling member (<NUM>) can be retained within the interior of the inflatable member (<NUM>) by an inner surface of the wall of the inflatable member (<NUM>) such that translation of the elongated tube (<NUM>) translates the guidewire assembly (<NUM>).