Patent Application
20230105889
Embodiments of the disclosure are directed to interventional gastroenterology devices. Particular embodiments relate to catheters adapted to irrigate walled off necrotic sites as well as, in some embodiments, adapted to provide a route for enteral feeding or stomach-in fluid aspiration.
Patients suffering from acute necrotizing conditions such as pancreatitis can develop walled-off necrosis, filled with fluid and cellular debris, that can be cleared with interventional irrigation or flushing treatment. In medical literature, these sites may be referred to by the acronym “WON” (walled-off necrosis) or the acronym “WOPN” (walled-off pancreatic necrosis) when specifically applicable to the pancreas. Earlier terminology has referred to these pancreatic sites as a pancreatic absess or an infected pancreatic pseudocyst. Endoscopic drainage and flushing of the walled-off site is commonly performed with catheters designed for other purposes, such as use of the Cook nasal biliary drainage catheter that is actually designed for draining the bile duct.
Embodiments of the present disclosure are directed toward an irrigation catheter having features that are adapted for the anatomy of a walled-off necrotic site, and appropriate for the anatomy of the path by which the catheter approaches and is withdrawn from a targeted treatment site.
The present disclosure provides a gastrointestinal catheter, a gastrointestinal catheter kit and a method of flushing a first treatment site with the same, and a method of treating treatment sites in a gastrointestinal tract with the same.
In a first aspect of the present disclosure, there is provided a gastrointestinal catheter, the gastrointestinal catheter for insertion into a treatment site in a patient, the site in need of medical treatment, the treatment site comprising at least one of a first treatment site and a second treatment site, the catheter comprising: a treatment member, the treatment member comprising at least one of a first treatment member and a second treatment member and comprising a lumen, a proximal portion, a distal portion, and a distal end region within the distal portion; wherein the first treatment member is sized and configured for insertion of its distal end into the first treatment site in an upper portion of a gastrointestinal tract, and wherein the second treatment member is sized and configured for placement of its distal end into the second treatment site within a bowel or a stomach of the patient; wherein the distal end region of the first treatment member comprises an anchoring configuration, the treatment member being capable of assuming a linear constrained configuration, wherein the anchoring configuration is adapted to anchor the distal end region within the first treatment site; wherein the distal end region of the first treatment member comprises one or more fluid ports in communication with the lumen, wherein the fluid ports are configured to allow through flow of a fluid; wherein the proximal portions of the first and second treatment members are detachably or slidably conjoinable side by side, and wherein the distal portions of the first and second treatment members are separated from each other.
In a second aspect of the present disclosure, there is provided a gastrointestinal catheter kit, the gastrointestinal catheter kit comprises the gastrointestinal catheter of the first aspect; and a pusher member sized and configured to fit within the endoscope, the pusher member comprising a lumen, wherein the pusher member is configured to stabilize a position of the gastrointestinal catheter in at least one of the first treatment site and the second treatment site.
In a third aspect of the present disclosure, there is provided a method of flushing a first treatment site with the gastrointestinal catheter of the first aspect, comprising: placing a percutaneous endoscopic gastrostomy (PEG) tube in the patient thereby providing an entry route for the at least one of the first treatment member and the second treatment member into a gastrointestinal tract of the patient; advancing the second treatment member distally to a second treatment site in a small bowel or a stomach of the patient; advancing the first treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within a first treatment site; withdrawing the guidewire proximally from the first treatment member, thereby anchoring the distal end region of the first treatment member within the first treatment site; flowing an irrigation fluid through the treatment member and into the treatment site to flush the first treatment site; and flowing a solution through the second treatment member to the second treatment site to conduct enteral feeding or aspirating a fluid at the second treatment site through the second treatment member.
In a fourth aspect of the present disclosure, there is provided a method of treating treatment sites in a gastrointestinal tract with the gastrointestinal catheter of the first aspect, the method comprising: placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient thereby providing an entry route for the double lumen gastrointestinal catheter into a gastrointestinal tract of the patient, the catheter comprising (1) a first treatment member comprising a first lumen and (2) a second treatment member comprising a second lumen; distally advancing the second treatment member into a second treatment site in a small bowel or a stomach of the patient; distally advancing the first treatment member to a position such that a distal end region of the first treatment member is positioned within a first treatment site; anchoring the distal end region of the first treatment member within the first treatment site; flowing an irrigation fluid through the first treatment member and into the first treatment site; and flowing a solution through the second treatment member into the second treatment site or aspirating a fluid at the second treatment site through the second treatment member.
The preferred configuration of distal end region 30, as exemplified by a single loop 33a or multiple loops 33b (
Embodiments of treatment member 12 typically have a length on the order of about 230 cm, but may range in length from about 50 cm to about 350 cm, and a typical outer diameter (OD) of about 2.3 mm (7 French), but may range from about 1.66 mm to about 3.66 mm (5-11 French). Embodiments of the proximal portion 20 are configured to accept a fitting that will connect with an irrigation fluid source. The internal diameter (ID) of treatment member 12 is sized to accept a guidewire (having a diameter of about 0.035 in to about 0.038 in) that can be used to facilitate endoscopic placement.
Distal portion 30 and proximal portion 20 differ from each other with regard to stiffness, the stiffness of distal portion 30 being higher than that of proximal portion 20. The relative stiffness of distal portion 30, and particularly of distal end region 32 is advantageous in that the stiffness allows the distal end region to maintain its preferred anchoring configuration, as noted above. The relative softness or compliance of proximal portion 30 of treatment member 12 is advantageous in that such compliance is friendly to the patient, mitigating the discomfort that can be associated with its presence in the nose and as it emerges externally from the body and contacts or comes to be wrapped around the patient’s face, head, or neck. As soft or compliant as proximal portion 30 may be, it still needs to be stiff enough to resist kinking or collapse. Physical or structural aspects of proximal port 20 and distal portion 30 that underlie differing stiffness are described further below in the context of
Stiffness is commonly characterized in terms of the modulus of elasticity; the distal portion of the treatment member of embodiments of gastrointestinal catheter has a higher modulus of elasticity than that of the proximal portion. Regardless of the particular value of elastic modulus of the distal portion of the treatment member, it is sufficiently high that upon insertion into the treatment site and release from a substantially linear constrained configuration, the distal end region assumes its preferred anchoring configuration.
In various embodiments, the distal portion of the treatment member may have an elastic modulus in the range of about 40,000 psi to about 600,000 psi, in the range of about 40,000 psi to about 300,000 psi, in the range 40,000 psi to about 150,000 psi, or in the range of about 40,000 psi to about 75,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 6333, having an elastic modulus of 41,300 psi.
The elastic modulus ranges of various embodiments of the distal portion of the gastrointestinal catheter do not necessarily exclude embodiments of the proximal portion from those ranges so long as the elastic modulus of the proximal portion is less than that of the distal portion. Accordingly, when not overlapping with the elastic modulus of the distal portion, the proximal portion of the treatment member may have an elastic modulus in the range of about 1,000 psi to about 75,000 psi or in the range of about 1,500 psi to about 42,000 psi. In some embodiments, the proximal portion of the treatment member comprises an elastic modulus in the range of about 1,700 psi to about 25,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 2533, having an elastic modulus of 1,750 psi and PEBAX® 633having an elastic modulus of 41,300 psi.
Fluid port embodiments 40A-40E are of various dimensions, according to their configuration, but conform generally to the requirement that they are large enough to allow free flow or fluid, but not so large as to compromise the stiffness of the loop structure. As shown in
Fluid port embodiments 40A-40E are arranged such that their perpendicular axes may be disposed at multiple angles with respect to the axis of the main catheter lumen to ensure adequate flow with a wide spread pattern to minimize occlusion due to inadvertent contact with a tissue surface. The fluid flow rate through fluid port embodiments 40A-40E may vary according to a flow rate of irrigant being pushed through the catheter, the number of fluid ports, and the particularities of size and shape of the fluid ports. Fluid port embodiments 40A-40E may be distributed at substantially consistent intervals throughout the length of a distal loop, but in some embodiments, distribution intervals may be of variable length, and in the example of a multi-loop configuration, fluid ports may be disproportionately distributed among the individual loops. In one example, one distal loop of a multi-loop embodiment may be substantially or relatively free of fluid ports, the overall stiffness of the loop thus being uncompromised by fluid ports, the loop thereby having a greater stability in the preferred configuration and having greater anchoring capability.
As noted elsewhere, embodiments of distal anchoring loops 32 and 33 are relatively stiff by virtue of a stiff material or geometry that resists deformation and straightening, enabling it to resist pullout from the target wound. Anchoring loop embodiments commonly have an outer diameter OD of about 25 mm (but can range from 13-50 mm OD). In the instance of a double-loop or multi-loop embodiment 33, the loops are typically about the same size, but diameters of individual loops within a plurality of loops may vary from each other.
The first treatment member 412 is provided with a traction wire 482, and before the first treatment member 412 enters into the patient’s body through the connection member 480 and is fixed and sealed at the first treatment site of the patient’s body, the traction wire 482 can be pulled in a direction facing outside of the patient, so that the distal end region 432 of the distal portion of the first treatment member 416 (i.e. the region on the side where the first treatment site is located) assumes a loop-like configuration. The loop-like configuration is used to fix the distal end region 432 of the distal portion of the first treatment member 412 to the first treatment site, so as to prevent the distal end region 432 of the distal portion of the first treatment member 412 from detaching from the first treatment site. A third sealing cap 483 is arranged at the end of the proximal portion of the first treatment member 412 to prevent the liquid of the first treatment member 412 from flowing out of the body through a first lumen of the first treatment member 412. The connection member 480 may be T-shaped, Y-shaped, etc., and the present disclosure does not define forms thereof.
After the first treatment member 412 enters the percutaneous endoscopic gastrostomy (PEG) tube 473 through any one of the first connection end and the second connection end of the connection member 480, the second treatment member 460 can enter the percutaneous endoscopic gastrostomy (PEG) tube 473 through the other connection end of the first connection end and the second connection end of the connection member 480; or after the second treatment member 460 may enter the percutaneous endoscopic gastrostomy (PEG) tube 473 through any one of the first connection end and the second connection end of the connection member 480, the first treatment member 412 may enter the percutaneous endoscopic gastrostomy (PEG) tube 473 through the other connection end of the first connection end and the second connection end of the connection member 480, so that the first treatment member 412 and the second treatment member 460 may be put into or pulled out of the patient’ body metachronously.
The gastrointestinal catheter 410 further includes a straight rectifying tube 490, which is a straight hollow tube and has openings at both ends. The straight rectifying tube 490 has a length enough to straighten the loop-like configuration of the distal end region 432 of the distal portion of the first treatment member 412 (i.e. the region on the side where the first treatment site is located), usually has a length of 50-200 mm, and a diameter of the straight rectifying tube 490 is adapted to or slightly larger than the diameter of the distal end region 432 of the distal portion of the first treatment member 412, so that the distal end region 432 of the distal portion of the first treatment member 412 may pass inside the straight rectifying tube 490.
The distal end region 432 of the distal portion 430 the first treatment member 412 is in a linear constrained configuration; after the guidewire is pulled out, the distal end region 432 of the distal portion of the first treatment member 412 recovers to the substantial loop configuration, which may be formed by pulling the traction wire 482 disposed on the first treatment member 412.
In some embodiments, the second treatment member is configured to provide an enteral feeding solution into the small bowel of a patient or is placed into the stomach to aspirate fluid. This would allow for a closed-circuit mechanism whereby fluid is instilled into the walled-off necrosis (WON) through the first treatment member and then aspirated (or suctioned out) through the second treatment member (a capability/ability of aspirating such fluid through the second treatment member is called as stomach-in fluid aspiration capability/functionality in the context of the present disclosure). This would be desirable in a patient with, for example, gastroparesis to prevent reflux of fluid contents collecting in the stomach. The ability to aspirate through the second treatment member may also be of benefit solely for decompression of the stomach on an ‘as needed’ basis (can be activated when needed or desired). As a specific example, aspiration would be desirable when hydrogen peroxide is instilled into the WON since this bubbles up and expands, which may result in reflux and aspiration of hydrogen peroxide if not suctioned out in a closed-circuit manner.
Four basic embodiments of the disclosure are provided as devices; embodiments of the disclosure further include methods of placing and operating embodiments of these devices. In the description that follows, each embodiment as depicted in
A first embodiment of the disclosure includes a gastrointestinal catheter sized and configured for access into the gastrointestinal tract, the catheter including a treatment member configured to treat an anatomical site in medical need of flushing with an irrigating fluid. Some embodiments of the first embodiment include a single lumen and are sized and configured for a nasal pathway into the gastrointestinal tract.
A second embodiment of the disclosure includes a double-lumen gastrointestinal catheter sized and configured for nasal entry into the gastrointestinal tract, the catheter including a first and a second treatment member, where the first treatment member has a first lumen and the second treatment member has a second lumen, and the proximal portions of the first treatment member and the second treatment member are detachably and slidably conjoinable side by side. The first treatment member is configured to treat an anatomical site in medical need of flushing with an irrigating fluid; in some embodiments, the second treatment member is configured to provide an enteral feeding solution into the small bowel of a patient or aspirate fluid in the stomach of a patient. There are advantages to the dual functionality of this embodiment; it is common for a patient in need of having a necrotic site flushed (as, for example, by a first treatment member) to also have a need for enteral feeding (as, for example, by a second treatment member), or for a patient in need of flushing a necrotic site (as, for example, by a first treatment member) and meanwhile having a need for aspirating fluid in the stomach of a patient (as, for example, by a second treatment member). This embodiment, thus, advantageously and efficiently provides for both capabilities in a single device.
A third embodiment of the disclosure includes a gastrointestinal catheter sized and configured for abdominal percutaneous access into the gastrointestinal tract, the catheter including a treatment member configured to treat an anatomical site in medical need of flushing with an irrigating fluid.
A fourth embodiment of the disclosure includes a double-lumen gastrointestinal catheter sized and configured for abdominal percutaneous access into the gastrointestinal tract, the catheter including a first and a second treatment member, where the first treatment member has a first lumen and the second treatment member has a second lumen, and the proximal portions of the first treatment member and the second treatment member are detachably or slidably conjoinable side by side. The first treatment member is configured to treat an anatomical site in medical need of flushing with an irrigating fluid; the second treatment member is configured to provide an enteral feeding solution into the small bowel of a patient or aspirate fluid in the stomach of a patient. There are advantages to the dual functionality of this fourth embodiment; it is common for a patient in need of having a necrotic site flushed (as, for example, by a first treatment member) to also have a need for enteral feeding (as, for example, by a second treatment member), or for a patient in need of flushing a necrotic site flushed (as, for example, by a first treatment member) and meanwhile having a need for aspirating fluid in the stomach of a patient (as, for example, by a second treatment member). This fourth embodiment, thus, advantageously and efficiently provides for both capabilities in a single device, which requires only one site of entry into the gastrointestinal tract by way of an abdominal percutaneous access site.
In a first embodiment of the disclosure, a gastrointestinal catheter configured for treatment of a site in medical need of treatment by flushing, irrigation, or drainage is provided. This first embodiment of a gastrointestinal catheter includes a lumen, is sized and configured to enter the body by way of a nasal entry route and to reach a treatment site in the gastrointestinal tract. One example of a site in need of such treatment is the pancreas, where acute or chronic pancreatitis can result in infected or necrotic encapsulated pockets that are commonly referred to as walled-off pancreatic necrosis. Aspects of the first embodiment of the disclosure are described further below in the context of the description of
Accordingly, a gastrointestinal catheter for insertion into a treatment site in a patient includes a treatment member sized to fit within an endoscope, the treatment member including a lumen, a proximal portion, a distal portion, and a distal end region within the distal portion. The distal end region of the treatment member has a preferred configuration, but the treatment member is capable of elastically assuming a substantially linear constrained configuration, as may occur when, for example, a guidewire is disposed within the lumen, or when the treatment member is being hosted within the working channel of an endoscope. The preferred configuration is adapted to anchor the distal end region within the treatment site, and absent constraint, will assume its preferred and anchoring configuration. The distal portion of the treatment member has a higher level of stiffness than that of the proximal portion of the treatment member. The distal end region of the treatment member includes one or more fluid ports, in communication with the lumen, that are configured to allow through flow of a fluid.
Stiffness may be characterized in terms of the modulus of elasticity; the distal portion of the treatment member of embodiments of gastrointestinal catheter has a higher modulus of elasticity than that of the proximal portion. Accordingly, in some embodiments, the distal portion of the treatment member has an elastic modulus in the range of about 40,000 psi to about 600,000 psi. In some embodiments, the distal portion of the treatment member has an elastic modulus in the range of about 40,000 psi to about 300,000 psi. In some embodiments, the distal portion of the treatment member has an elastic modulus in the range of about 40,000 psi to about 150,000 psi. And in some embodiments, the distal portion of the treatment member has an elastic modulus in the range of about 40,000 psi to about 75,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 6333, having an elastic modulus of 41,300 psi.
The elastic modulus ranges of various embodiments of the distal portion of the gastrointestinal catheter do not necessarily exclude embodiments of the proximal portion from those ranges so long as the elastic modulus of the proximal portion is less than that of the distal portion. Accordingly, when the distal portion of the treatment member has an elastic modulus greater than about 75,000 psi, the proximal portion of the treatment member can have an elastic modulus in the range of about 1,000 psi to about 75,000 psi. When the distal portion of the treatment member is greater than about 42,000 psi, the proximal portion of the treatment member can have an elastic modulus in the range of about 1,500 psi to about 42,000 psi.
In a functional sense, in some embodiments of the gastrointestinal catheter, the distal portion of the treatment member has a sufficiently high elasticity that upon insertion into the treatment site and release from a substantially linear constrained configuration, the distal end region assumes the preferred and anchoring configuration.
In some embodiments, the proximal portion of the treatment member comprises an elastic modulus in the range of about 1,700 psi to about 25,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 2533, having an elastic modulus of 1,750 psi and PEBAX® 633 having an elastic modulus of 41,300 psi.
In a functional sense, in some embodiments of the gastrointestinal catheter, the proximal portion of the treatment member comprises an elastic modulus that provides a level of compliance that mitigates a possibility of injury to the patient in a facial area proximate a nasal site of entry of the treatment member.
In some embodiments, the distal end region of the treatment catheter is substantially equivalent in length to the distal portion of the treatment catheter. In other embodiments, the distal end region of the treatment catheter is less in length than the total length distal portion of the treatment catheter.
Various physical and structural properties of the treatment member of the gastrointestinal catheter can underlie the difference in elastic modulus between the proximal and distal portions of the treatment member. Accordingly, in some embodiments, the elasticity of the distal end region of the treatment member is higher than that of the proximal portion by virtue of a difference in a material composition.
In some embodiments, the elasticity of the distal portion of the treatment member is higher than that of the proximal portion by virtue of a difference in a sidewall structure of the treatment member. For example, in some embodiments, the difference in a sidewall structure of the treatment member includes a difference in thickness of the sidewall, as when the distal portion of the treatment member includes a region of greater sidewall thickness than that of the proximal portion of the treatment member. In some embodiments, the difference in a sidewall structure of the treatment member includes a plurality of indents or inward axial convolutions in the sidewall of the proximal portion of the treatment member, wherein an outer diameter of the indents or inward convolutions is less than an outer diameter of the distal portion of the treatment member. In still further embodiments, the difference in a sidewall structure of the treatment member includes variation in one or more layers of varying elastic modulus in the sidewall.
A treatment site for which embodiments of a gastrointestinal catheter is medically appropriate is typically an anatomical cavity, often the anatomical cavity is inflamed, infected, necrotizing, or otherwise abnormal or pathological. One particular example of such an anatomical cavity is an encapsulated or walled-off necrotic site involving the pancreas, wherein the distal end region of the treatment member is sized and configured for insertion into such an encapsulated pancreatic necrotic site.
Some embodiments of a gastrointestinal catheter include a guidewire hosted within the lumen of the treatment member. In a functional sense, this embodiment typically occurs as the treatment member is passed over the guidewire, as the treatment member is being advanced toward a treatment site. In particular embodiments, the guidewire is sufficiently stiff to maintain the distal end of the treatment member (in which it is disposed) in a substantially linear constrained configuration.
As noted above, in some embodiments, the preferred configuration of the distal end region of the treatment member is one that anchors that region in the treatment site, and accordingly, anchors the treatment member, as a whole. Merely by way of example, an anchoring configuration may take the form of a loop or multiple loops.
The functional purpose of the preferred configuration of the distal end region of the treatment member is to anchor it in a treatment site, such as, merely by way of example, a walled off necrotic site involving the pancreas. By the distal end region anchoring in the treatment site, the gastrointestinal catheter, as a whole, is anchored in the treatment site. By way of exemplifying an anchoring configuration, the preferred configuration of the distal end region of the distal portion of the treatment may be configured as a loop. In some embodiments, the preferred configuration includes two or more loops.
It is also advantageous that the distal end of the treatment member not injure the treatment site; accordingly, in some embodiments the distal end region of the treatment member includes an atraumatic tip. In some embodiments, the distal end region of the treatment member also includes a distal end fluid port in communication with the lumen.
Another aspect of the distal end region of embodiments of the gastrointestinal catheter relates to the fluid ports referred to above. In some embodiments, the fluid ports are positioned within the distal end region of the first treatment member such that when the distal end is anchored within the treatment site, the fluid ports are disposed in their substantial entirety within the treatment site.
Various aspects of the distal end region of the treatment member of the first embodiment of a gastrointestinal catheter relate to that region being formed, at least in part, by a shape memory composition. Accordingly, some embodiments of the gastrointestinal catheter have a higher level of stiffness in the distal portion of the treatment member (compared to the proximal portion) that is at least partly attributable to a segment disposed within the distal portion having a shape memory composition. Some embodiments of the distal end region of the treatment member have a segment that includes a shape memory composition, such as a shape memory polymer or a shape memory metal alloy. In some embodiments, the segment having a shape memory composition has a preferred configuration that is adapted to anchor the distal end of the treatment member within the treatment site.
By way of example, the shape memory composition may include nitinol in any appropriate form or configuration, such as wires in the form of any of a braid or axially-aligned linear wires. In some embodiments of the gastrointestinal catheter, the distal end region consists in its substantial entirety of nitinol. In some embodiments, the shape memory alloy segment is disposed within the lumen of the treatment member, against an inner surface of a treatment member sidewall. In some embodiments, the shape memory alloy segment is disposed within a sidewall of the treatment member, sandwiched between an inner and an outer polymer layer.
The dimensions of embodiments of the treatment member of a gastrointestinal catheter be appropriate both for conveyance through an endoscope and appropriate for the anatomical dimensions of the routing to a treatment site. Accordingly, in some embodiments of the gastrointestinal catheter, the outer diameter of the treatment member ranges from about 3 French to about 13 French. In some embodiments, the outer diameter of the treatment member ranges from about 5 French to about 11 French. In typical embodiments, the length of the treatment member is appropriate and sufficient to reach the treatment site by way of a route that originates in the nostril of the patient.
Some embodiments of the disclosure include a gastrointestinal catheter and other ancillary items to form of a complete kit. Accordingly, such a kit includes a gastrointestinal catheter is described above, a pusher member sized and configured to fit within the endoscope, the pusher member having a lumen. In some embodiments, the kit may further include a guidewire sized and configured to be hosted within the lumens of both the pusher member and the treatment member. The guidewire has a distal tip, and the guidewire is of sufficient length that its distal tip can extend beyond the distal end region of the treatment member.
Embodiments of the disclosure also include a method of flushing a treatment site with an embodiment of a gastrointestinal catheter as described above, by way of the treatment member. Accordingly, the method includes distally advancing an endoscope from an oral entry site to a position wherein a distal end of the endoscope is positioned proximate or within an entry route into the treatment site, the treatment member hosted in a working channel of the endoscope. The method further includes advancing the treatment member distally from the endoscope, a distal end of the treatment member thereby entering the treatment site, and then anchoring the distal end region of the treatment member within the treatment site. The method then further includes withdrawing the endoscope from the patient, and then flowing an irrigation fluid through the treatment member and into the treatment site.
In typical embodiments of the method, as described elsewhere, following the withdrawal of the endoscope, the proximal portion of the treatment member is rerouted from its oral entry site to the nasal passage, where it remains during a course of medical treatment.
Some embodiments of the method of flushing a treatment site make use of a treatment member in which the distal end region of the treatment member has a preferred anchoring configuration but is also capable of elastically assuming a substantially linear constrained configuration. In such embodiments of the method, anchoring the distal end region of the treatment member within the treatment site may include releasing the distal end region from confinement within the endoscope, thereby allowing the distal end region to reconfigure into its preferred anchoring configuration.
Some embodiments of the method of flushing a treatment site make use of a treatment member in which the distal end region of the treatment member includes a segment having a shape memory composition. In such embodiments of the method, allowing the distal end region to reconfigure into its preferred anchoring configuration includes the shape memory segment reconfiguring from the constrained linear configuration to the preferred configuration.
Some embodiments of the method of flushing a treatment site make use of a pusher member to assist in the placement of a treatment member in a treatment site. Accordingly, in some embodiments of the method, withdrawing the endoscope from the patient comprises simultaneously (a) withdrawing the endoscope from the patient while (b) distally advancing a pusher member within the endoscope so as to stabilize the anchored position of the distal end region of the treatment member within the treatment site. This type of maneuver may be referred to as a “one-to-one scope exchange” technique by physicians practiced in the art. In some embodiments of the method, a stylet or guidewire is inserted into the treatment member and advanced until its distal end is within the distal end region of the treatment member. The advancement of the straight stylet or guidewire within the distal end region straightens the end region from its preferred and anchoring configuration, and allows for an easy withdrawal of the distal end region from the anatomical site in which it had been anchored.
Some embodiments of the method of flushing a treatment site make use of guidewire to facilitate placement of a treatment member in a treatment site. Accordingly, in some embodiments of the method, prior to distally advancing the endoscope from the oral entry site, the method includes advancing a guidewire from the oral entry site until a distal tip of the guidewire is situated within the treatment site. In some embodiments, distally advancing the endoscope may include advancing the treatment member within the endoscope over the guidewire until the distal end of the treatment member is within the treatment site. Some embodiments of the method further include withdrawing the guidewire from treatment site, leaving the distal end of the treatment member there within, the distal end of the treatment member thereby being allowed to assume its preferred configuration and anchoring within the treatment site.
In practicing an embodiment of the method of flushing a treatment site, entry of the distal end of the treatment member into the treatment site may be difficult. In such an incident, the method (prior to distally advancing the endoscope to a position such that the distal end of the endoscope is positioned proximate an entry route into the treatment site) may include placing a stent within the entry route into the treatment site, and thus advancing the treatment member distally from the endoscope may include advancing the treatment member through an opening provided by the stent.
Some embodiments of the method of flushing a treatment site, as above, prior to flowing the irrigation fluid through the treatment member, may include rerouting the proximal end of the treatment member from its original emergence through the patient’s mouth to an emergence through the patient’s nose or nasal passage. In particular embodiments of the method, wherein the proximal portion of the treatment member has an elastic modulus in the range of 1,000 psi to about 75,000 psi, this elastic modulus range (a) facilitates the rerouting of the treatment member and (b) mitigates a risk of patient injury during a treatment period in comparison to an ease in rerouting a treatment member and the risk of patient injury were treatment member to have an elastic modulus greater than 75,000 psi. Mitigation of risk follows from the compliance of tubing having a low elastic modulus. In general, compliant tubing is more patient-friendly than less compliant tubing.
In addition to flowing a fluid into the treatment site, as above, embodiments of the method may include removing fluid from the treatment site. Accordingly, some embodiments of the method include draining fluid from the treatment site. Draining fluid from the treatment site may further include removing cellular debris from the treatment site. Draining fluid from the treatment site may include both (a) draining an irrigation fluid that has been injected into the site as well as (b) draining a fluid from any other source within the treatment site. In particular embodiments of the method, draining fluid may include withdrawing a fluid from the treatment site through fluid ports within the distal end region of the treatment member. Draining fluid from the treatment site may be facilitated by a vacuum or suction-based draw of fluid in a distal to proximal path.
Some embodiments of the method of flushing a treatment site, as above, may include mixing an active agent into the irrigation fluid prior to the flowing the irrigation fluid into the treatment site. By way of example, an active agent may include any of an anti-biotic agent or an anti-infective agent, or any pharmaceutically effective agent. In some embodiments, the active agent may be considered to be substantially inert, pharmaceutically, but serve another medical purpose, such as may be provided by an imaging compound.
Embodiments of the method of flushing a treatment site, as above, may be directed to any gastrointestinal site in need of such treatment. In a particular example, the treatment site is a walled-off pancreatic necrotic site. In typical embodiments of the method, the treatment member remains in place, the distal end region of the treatment member within the treatment site, for a treatment period whose duration is determined by a physician. Upon completion of a medically appropriate duration, the method concludes by withdrawing the treatment member from the treatment site.
A second embodiment of the disclosure includes a double lumen gastrointestinal catheter for insertion into a gastrointestinal tract of a patient in need of a gastrointestinal intervention at a first treatment site and a second treatment site. The embodiment is sized and configured to gastrointestinal access by way of a nasal passage entry route.
Such a double lumen gastrointestinal catheter includes a first treatment member and a second treatment member, each member having a lumen, a proximal portion, a distal portion having a distal end. The first treatment member substantially corresponds to the treatment member provided in the first embodiment of the disclosure, as described above. Aspects of the second embodiment of the disclosure are described further below in the context of the description of
The proximal portions of the first and second treatment members are detachably or slidably conjoinable side by side, the proximal portions of the first and second treatment members are conjoined; the distal portions of the first and second treatment members are separate from each other. The first treatment member is sized and configured for insertion of its distal end into the first treatment site in an upper portion of the gastrointestinal tract; the second treatment member is sized and configured for placement of its distal end into a second treatment site in a small bowel or in the stomach of the patient. The distal end region of the first treatment member has a preferred configuration, the first treatment member is also capable of elastically assuming a substantially linear constrained configuration, wherein the preferred configuration is adapted to anchor the distal end region within the targeted treatment site. The distal portion of the first treatment member has a higher level of stiffness than that of the proximal portion of the first treatment member. The distal end region of the first treatment member includes one or more fluid ports in communication with the lumen; fluid ports are configured to allow through flow of a fluid. The fluid ports are positioned within the distal end of the first treatment member such that when the distal end is anchored within the first treatment site, the fluid ports are disposed within the first treatment site.
Embodiments of the disclosure also include a method of flushing a first treatment site and feeding a patient directly at a second treatment site with a double lumen gastrointestinal catheter that include providing a double lumen gastrointestinal catheter having a first treatment member and a second treatment member, where the first treatment member has a first lumen and the second treatment member has a second lumen, and the proximal portions of the first treatment member and the second treatment member are detachably or slidably conjoinable side by side. The method includes distally advancing the second treatment member into the second treatment site in a small bowel of the patient, followed by distally advancing the first treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within the first treatment site. The method continues by withdrawing the guidewire proximally from the first treatment member, thereby anchoring the distal end region of the first treatment member within the first treatment site, and then withdrawing the endoscope from the patient. The method then continues by flowing an irrigation fluid through the first treatment member and into the first treatment site, and flowing a solution through the second treatment member into the second treatment site or aspirating a fluid at the second treatment site through the second treatment member.
In a third embodiment of the disclosure, a gastrointestinal catheter for insertion into a gastrointestinal tract of a patient in need of a gastrointestinal intervention at a site that has become necrotic, infected and/or encapsulated. The embodiment is sized and configured to gastrointestinal access by way of an abdominal percutaneous entry route.
Accordingly, this third embodiment includes a treatment member that has a lumen, a proximal portion, a distal portion having a distal end region. The distal portion of the treatment member has a higher level of stiffness than that of the proximal portion of the first treatment member.
The distal end region of the treatment member of catheter includes a number of features; it has a preferred anchoring configuration that is adapted to anchor the distal end region within the first treatment site; the distal end region of first treatment member is further capable of elastically assuming a substantially linear constrained configuration. The distal end region of the treatment member has one or more fluid ports in communication with the lumen through the sidewall of the treatment member that are configured to allow through flow of a fluid.
Embodiments of the disclosure also include a method of flushing a treatment site with an embodiment of a third embodiment of the disclosure as described above, by way of a treatment member. Accordingly, a method of flushing a treatment site with a treatment member includes placing a percutaneous endoscopic gastrostomy (PEG) tube in the patient thereby providing an entry route for the treatment member. The method includes distally advancing the treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within a treatment site, and then withdrawing the guidewire proximally from the first treatment member, thereby anchoring the distal end region of the treatment member within the first treatment site. The method then continues with withdrawing the endoscope from the patient, followed by flowing an irrigation fluid through the treatment member and into the treatment site.
In a fourth embodiment of the disclosure, a double lumen gastrointestinal catheter for insertion into a gastrointestinal tract of a patient in need of a gastrointestinal intervention at a first treatment site and at a second treatment site is provided. Accordingly, this fourth embodiment includes a first treatment member and a second treatment member, wherein the first treatment member has a proximal portion, a distal portion having a distal end region, and a lumen through both the proximal and distal portions, where the first treatment member has a first lumen and the second treatment member has a second lumen. The proximal portions of the first and second treatment members are detachably or slidably conjoinable side by side. In one embodiment, the proximal portions of each of the first and second treatment members may be adapted to be conjoinable side-by-side, and the distal portions of the first and second treatment members may be separate from each other.
The first treatment member of the double lumen gastrointestinal catheter is sized and configured for insertion of its distal end into the first treatment site in an upper portion of the gastrointestinal tract and the second treatment member is sized and configured for placement of its distal end into a second treatment site within a bowel of the patient. In some embodiments, the distal portion of the first treatment member has a higher level of stiffness than that of the proximal portion of the first treatment member.
The distal end region of the first treatment member of double lumen gastrointestinal catheter includes a number of features; it has a preferred anchoring configuration that is adapted to anchor the distal end region within the first treatment site; the distal end region first treatment member further being capable of elastically assuming a substantially linear constrained configuration. The distal end region of the first treatment member has one or more fluid ports in communication with the lumen through the sidewall of the treatment member that are configured to allow through flow of a fluid.
Various features of double lumen gastrointestinal catheter are related to stiffness or the elastic modulus of the first treatment member closely parallel the analogous features of the treatment member of the first embodiment of a gastrointestinal catheter, as described above. As noted above, in some embodiments, the distal portion of the first treatment member has a higher level of stiffness than that of the proximal portion of the first treatment member.
Stiffness may be characterized in terms of the modulus of elasticity; the distal portion of the first treatment member of the double lumen gastrointestinal catheter has a higher modulus of elasticity than that of the proximal portion. Accordingly, in some embodiments, the distal portion of the first treatment member has an elastic modulus in the range of about 40,000 psi to about 600,000 psi. In some embodiments, the distal portion of the first treatment member has an elastic modulus in the range of about 40,000 psi to about 300,000 psi. In some embodiments, the distal portion of the first treatment member has an elastic modulus in the range of about 40,000 psi to about 150,000 psi. And in some embodiments, the distal portion of the first treatment member has an elastic modulus in the range of about 40,000 psi to about 75,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 6333, having an elastic modulus of 41,300 psi.
The elastic modulus ranges of various embodiments of the distal portion of the double lumen gastrointestinal catheter do not necessarily exclude embodiments of the proximal portion from those ranges so long as the elastic modulus of the proximal portion is less than that of the distal portion. Accordingly, when the elastic modulus of the distal portion of the first treatment member is greater than about 75,000 psi, the proximal portion of the first treatment member can have an elastic modulus in the range of about 1,000 psi to about 75,000 psi. When the distal portion of the first treatment member is greater than about 42,000 psi, the proximal portion of the first treatment member can have an elastic modulus in the range of about 1,500 psi to about 42,000 psi.
In a functional sense, in some embodiments of the double lumen gastrointestinal catheter, the distal portion of the first treatment member has a sufficiently high elasticity that upon insertion into the treatment site and release from a substantially linear constrained configuration, the distal end region assumes the preferred and anchoring configuration.
In some embodiments, the proximal portion of the first treatment member of the double lumen gastrointestinal catheter has an elastic modulus in the range of about 1,700 psi to about 25,000 psi. By way of example, a product of Arkema provides a polyether block amide product, PEBAX® 2533, having an elastic modulus of 1,750 psi and PEBAX® 633 having an elastic modulus of 41,300 psi. In a functional sense, in some embodiments of the double lumen gastrointestinal catheter, the proximal portion of the first treatment member comprises an elastic modulus that provides a level of compliance that is patient friendly by being more comfortable and less likely to cause irritation or injury.
In some embodiments, the distal end region of the first treatment catheter is substantially equivalent in length to the distal portion of the treatment catheter. In other embodiments, the distal end region of the first treatment catheter is less in length than the total length distal portion of the treatment catheter.
Various physical and structural properties of the first treatment member of the double lumen gastrointestinal catheter can underlie the difference in elastic modulus between the proximal and distal portions of the first treatment member. Accordingly, in some embodiments, the elasticity of the distal end region of the first treatment member is higher than that of the proximal portion by virtue of a difference in a material composition.
In some embodiments, the elasticity of the distal portion of the first treatment member is higher than that of the proximal portion by virtue of a difference in a sidewall structure of the first treatment member. For example, in some embodiments, the difference in a sidewall structure of the first treatment member includes a difference in thickness of the sidewall, as when the distal portion of the first treatment member includes a region of greater sidewall thickness than that of the proximal portion of the first treatment member. In some embodiments, the difference in a sidewall structure of the first treatment member includes a plurality of indents or inward axial convolutions in the sidewall of the proximal portion of the first treatment member, wherein an outer diameter of the indents or inward convolutions is less than an outer diameter of the distal portion of the first treatment member. In still further embodiments, the difference in a sidewall structure of the first treatment member includes variation in one or more layers of varying elastic modulus in the sidewall.
A first treatment site for which the double lumen gastrointestinal catheter is medically appropriate is typically an anatomical cavity, often the anatomical cavity is inflamed, infected, necrotizing, or otherwise abnormal or pathological. One particular example of such an anatomical cavity is an encapsulated or walled-off necrotic site involving the pancreas, wherein the distal end region of the treatment member is sized and configured for insertion into such an encapsulated pancreatic necrotic site.
A second treatment site for which the double lumen gastrointestinal catheter is medically appropriate is located in a small bowel or a stomach of the patient, or at any location in the gastrointestinal tract that is appropriate for enteral feeding or stomach-in fluid aspiration.
Some embodiments of the double lumen gastrointestinal catheter include a guidewire hosted within the lumen of the first treatment member. In a functional sense, this embodiment typically occurs as the first treatment member is passed over the guidewire, as the first treatment member is being advanced toward a treatment site. In particular embodiments, the guidewire is sufficiently stiff to maintain the distal end of the treatment member (in which it is disposed) in a substantially linear constrained configuration.
As noted above, in some embodiments, the preferred configuration of the distal end region of the first treatment member of the double lumen gastrointestinal catheter is one that anchors that region in the first treatment site, and accordingly, anchors the first treatment member, as a whole, therein. Merely by way of example, an anchoring configuration may take the form of a loop or multiple loops.
The functional purpose of the preferred configuration of the distal end region of the first treatment member is to anchor it in a first treatment site, such as, merely by way of example, a walled off necrotic site involving the pancreas. By the distal end region of the first treatment member anchoring in the first treatment site, the gastrointestinal catheter, as a whole, is anchored in the treatment site. By way of exemplifying an anchoring configuration, the preferred configuration of the distal end region of the distal portion of the treatment may be configured as a loop. In some embodiments, the preferred configuration includes two or more loops. ∘
It is also advantageous that the distal end of the first treatment member not injure the treatment site; accordingly, in some embodiments the distal end region of the first treatment member includes an atraumatic tip. In some embodiments, the distal end region of the first treatment member also includes a distal end fluid port in communication with the lumen.
Another aspect of the distal end region of the first treatment member embodiments of the double lumen gastrointestinal catheter relates to the fluid ports described to above. In some embodiments, the fluid ports are positioned within the distal end region of the first treatment member such that when the distal end is anchored within the first treatment site, the fluid ports are disposed in their substantial entirety within the treatment site.
Various aspects of the distal end region of the first treatment member of the double lumen gastrointestinal catheter relate to that region being formed, at least in part, by a shape memory composition. Accordingly, some embodiments of the gastrointestinal catheter have a higher level of stiffness in the distal portion of the first treatment member (compared to the proximal portion) that is at least partly attributable to a segment disposed within the distal portion having a shape memory composition. Some embodiments of the distal end region of the first treatment member have a segment that includes a shape memory composition, such as a shape memory polymer or a shape memory metal alloy. In some embodiments, the segment having a shape memory composition has a preferred configuration that is adapted to anchor the distal end of the treatment member within the treatment site.
By way of example, the shape memory composition may include nitinol in any appropriate form or configuration, such as wires in the form of any of a braid or axially-aligned linear wires. In some embodiments of the gastrointestinal catheter, the distal end region consists in its substantial entirety of nitinol. In some embodiments, the shape memory alloy segment is disposed within the lumen of the treatment member, against an inner surface of a treatment member sidewall. In some embodiments, the shape memory alloy segment is disposed within a sidewall of the treatment member, sandwiched between an inner and an outer polymer layer.
The dimensions of embodiments of the first treatment member of a double lumen gastrointestinal catheter be appropriate both for conveyance through an endoscope and appropriate for the anatomical dimensions of the routing to a treatment site. Accordingly, in some embodiments of the gastrointestinal catheter, the outer diameter of the first treatment member ranges from about 3 French to about 13 French. In some embodiments, the outer diameter of the first treatment member ranges from about 5 French to about 11 French. In typical embodiments, the length of the first treatment member is appropriate and sufficient to reach the treatment site by way of a route that originates at a percutaneous gastrostomy site.
In some embodiments of the double lumen gastrointestinal catheter, the proximal portions of the first and second treatment members are reversibly conjoinable by way of mutually engaging axially-aligned conjoining features. In some embodiments, the proximal portions of the first and second treatment members are conjoinable by way of both members being enclosed within a surrounding sheath. And in some embodiments, the proximal portions of the first and second treatment members are conjoinable but, when conjoined, the first and second treatment members are slidable with respect to each other.
In an embodiment of a double lumen gastrointestinal catheter, the first treatment member and the second treatment member are advanced into the patient’s body through the connection member and the percutaneous endoscopic gastrostomy (PEG) tube. When the first treatment member is advanced into the patient’s body, the second treatment member can be slidably advanced into the body relative to the first treatment member, or when the second treatment member is advanced into the patient’s body, the first treatment member may be slidably advanced into the patient’s body relative to the second treatment member. When both the first treatment member and the second treatment member are in the patient’s body, the first treatment member and the second treatment member are detachably or slidably conjoinable side by side at their proximal portions, and the first treatment member and the second treatment member can be pulled out of patient’s body metachronously.
One embodiment of the disclosure is in the form of a kit for a double lumen gastrointestinal catheter. Embodiments of the kit include a double lumen gastrointestinal catheter, as described above, and a guidewire sized and configured to be hosted within the lumen of the first treatment member, the guidewire having a distal tip, the guidewire having sufficient length that its distal tip can extend beyond the distal end region of the treatment member.
Embodiments of the disclosure include a method of flushing a first treatment site and feeding a patient directly at a second treatment site with a single percutaneously-implanted double lumen gastrointestinal catheter. Accordingly, the method includes placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient thereby providing an entry route for the double lumen gastrointestinal catheter into the patient’s gastrointestinal tract, the catheter having (1) a first treatment member comprising a first lumen and (2) a second treatment member comprising a second lumen. The method further includes distally advancing the second treatment member into a second treatment site in a small bowel or a stomach of the patient; and distally advancing the first treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within a first treatment site. Embodiments of the method include advancing the first treatment member before advancing the second treatment member; that sequence, however, may risk dislodgement of the first treatment member during manipulations of the second treatment member. Accordingly, typical embodiments of the method involve placement of the second treatment member at the second treatment site prior to placement of the first treatment member at the first treatment site.
The method further includes withdrawing the guidewire proximally from the first treatment member, thereby anchoring the distal end region of the first treatment member within the first treatment site. The method further includes flowing an irrigation fluid through the first treatment member and into the first treatment site; and further still, flowing a solution through the second treatment member into the second treatment site or aspirating a fluid at the second treatment site through the second treatment member. With respect to the treatment sites, the first treatment site, such as a walled off necrotic site involving the pancreas, is in medical need of being flushed or irrigated with a fluid and the second treatment site is an appropriate site for enteral feeding of the patient.
Some embodiments of the method further include positioning an endoscope in the gastrointestinal tract of the patient to illuminate and allow visualization of the operating field, and to assist in the placement of treatment members of the double lumen gastrointestinal catheter. Accordingly, distally advancing the second treatment member may include towing the second treatment member with the endoscope, as enabled by forceps, to the second treatment site, and distally advancing the first treatment may include towing the first treatment member with the endoscope to a position proximate an entry route into the first treatment site.
Some embodiments of the method are implemented with a double lumen gastrointestinal catheter in which the distal end region of the first treatment member has a preferred anchoring configuration but is also capable of elastically assuming a constrained linear configuration when the guidewire is disposed within the lumen of the first treatment member. Accordingly, in some embodiments of the method, anchoring the distal end region of the first treatment member includes withdrawing the guidewire from the distal end region thereby allowing the distal end region to reconfigure into its preferred anchoring configuration. In particular embodiments of the of the double lumen gastrointestinal catheter, the distal end region of first treatment member includes a shape memory segment; in these embodiments, reconfiguring into the preferred configuration entails the shape memory segment reconfiguring from a constrained linear configuration to its preferred configuration.
In some embodiments of the method, prior to distally advancing the first treatment member over the guidewire, the method includes distally advancing a guidewire through the PEG tube until a distal tip of the guidewire is situated within the treatment site.
In practicing an embodiment of the method, entry of the distal end of the first treatment member into the first treatment site may be difficult. In such an incident, the method (prior to distally advancing the endoscope to a position such that the distal end of the endoscope is positioned proximate an entry route into the treatment site) may include placing a stent within the entry route into the first treatment site, and thus advancing the first treatment member distally from the endoscope may include advancing the treatment member through an opening provided by the stent.
In addition to flowing a fluid into the first treatment site, as above, embodiments of the method may include removing fluid from the first treatment site. Accordingly, some embodiments of the method include draining fluid from the first treatment site. Draining fluid may further include removing cellular debris from the treatment site. Draining fluid from the treatment site may include both (a) draining an irrigation fluid that has been injected into the site as well as (b) draining a fluid from any other source within the treatment site. In particular embodiments of the method, draining fluid may include withdrawing a fluid from the first treatment site through fluid ports disposed within the distal end region of the first treatment member. Draining fluid from the treatment site may be facilitated by a vacuum or suction-based draw of fluid in a distal to proximal path.
Some embodiments of the method of flushing a first treatment site, as above, may include mixing an active agent into the irrigation fluid prior to the flowing the irrigation fluid into the first treatment site. By way of example, an active agent may include any of an anti-infectious agent, or any pharmaceutically effective agent. In some embodiments, the active agent may be considered to be substantially inert, pharmaceutically, but serve another medical purpose, such as may be provided by an imaging compound.
With respect to flowing a solution through the second treatment member into a second treatment site, such solution is typically an enteral feeding solution. In some embodiments, the solution may include a pharmaceutically effective agent.
With respect to aspirating a fluid at the second treatment site through the second treatment member, an embodiment of the method includes aspirating a fluid, by the second treatment member, from a patient’s stomach. The fluid may include an irrigation fluid that has been injected into the first treatment site and drained therefrom and collected in the stomach. Correspondingly, aspirating the fluid by the second treatment member may include aspirating, by the second treatment member, the irrigation fluid that has been injected into the first treatment site and drained therefrom and collected in the stomach. The ability to aspirate through the second treatment member may prevent reflux of fluid contents collecting in the stomach, or solely for decompression of the stomach on an ‘as needed’ basis (can be activated when needed or desired).
In typical embodiments of the method, involving implementation of treatment at the first and second treatment site, the treatment needs to occur over a treatment period, as determined by a physician for a treatment duration that may range upward toward several weeks. Accordingly, in some embodiments of the methods the first and second treatment members remain in place the first and second treatment sites, respectively, over the duration of a treatment period. And upon completion of a medically appropriate duration, the method concludes by withdrawing the treatment member from the treatment site.
In another aspect, embodiments of the disclosure include a method of treating treatment sites in a gastrointestinal tract with a percutaneously-implanted double lumen gastrointestinal catheter. The method includes placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient thereby providing an entry route for the double lumen gastrointestinal catheter into the patient’s gastrointestinal tract, the catheter having (1) a first treatment member comprising a first lumen and (2) a second treatment member comprising a second lumen. The method includes distally advancing the second treatment member into a second treatment site in a small bowel or a stomach of the patient. The method further includes distally advancing the first treatment member to a position such that a distal end region of the first treatment member is positioned within a first treatment site, and then anchoring the distal end region of the first treatment member within the first treatment site. Some embodiments of the method involve placement of the second treatment member at the second treatment site prior to placement of the first treatment member at the first treatment site. The method further includes flowing an irrigation fluid through the first treatment member and into the first treatment site; and further still, flowing a solution through the second treatment member into the second treatment site or aspirating a fluid at the second treatment site through the second treatment member. With respect to the treatment sites, the first treatment site, such as a walled off necrotic site involving the pancreas, is in medical need of being flushed or irrigated with a fluid and the second treatment site is an appropriate site for enteral feeding of the patient or aspirating fluid in the stomach of the patient.
In a further aspect, embodiments of the disclosure include a method of flushing a first treatment site and feeding a patient directly at a second treatment site with a single percutaneously-implanted double lumen gastrointestinal catheter. Accordingly, the method includes placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient thereby providing an entry route for the double lumen gastrointestinal catheter into the patient’s gastrointestinal tract, the catheter having (1) a first treatment member comprising a first lumen and (2) a second treatment member comprising a second lumen. The method further includes distally advancing the second treatment member into a second treatment site in a small bowel of the patient; and distally advancing the first treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within a first treatment site, the guidewire constraining the distal end region in a substantially linear configuration. The method further releasing the distal end region from the guidewire constraint, thereby allowing the distal end region to assume an anchoring configuration. The method further includes flowing an irrigation fluid through the first treatment member and into the first treatment site; and further still, flowing a solution through the second treatment member into the second treatment site.
In a further aspect, embodiments of the disclosure include a method of flushing a first treatment site and aspirating a fluid at the second treatment site through the second treatment member with a single percutaneously-implanted double lumen gastrointestinal catheter. Accordingly, the method includes placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient thereby providing an entry route for the double lumen gastrointestinal catheter into the patient’s gastrointestinal tract, the catheter having (1) a first treatment member comprising a first lumen and (2) a second treatment member comprising a second lumen. The method further includes distally advancing the second treatment member into a second treatment site in a stomach of the patient; and distally advancing the first treatment member over a guidewire to a position such that a distal end region of the first treatment member is positioned within a first treatment site, the guidewire constraining the distal end region in a substantially linear configuration. The method further releasing the distal end region from the guidewire constraint, thereby allowing the distal end region to assume an anchoring configuration. The method further includes flowing an irrigation fluid through the first treatment member and into the first treatment site; and further still, aspirating the fluid at the second treatment site through the second treatment member.
An embodiment of the present disclosure includes a method of flushing a first treatment site and feeding a patient directly at a second treatment site with a percutaneously-implanted double lumen gastrointestinal catheter. The method includes placing a percutaneous endoscopic gastrostomy (PEG) tube in a patient’s body, and arranging a connection member on a side of the PEG tube outside the patient’s body, so as to provide an entrance route for the gastrointestinal catheter to enter the patient’s gastrointestinal tract, wherein the gastrointestinal catheter includes a first treatment member and a second treatment member; distally advancing the second treatment member to the second treatment site in the patient’s small bowel or the stomach through the second connection end of the connection member, and connecting the second connection end of the connection member with the second treatment member through the second sealing cap and a corresponding sealing part; advancing the guidewire through the first connection end of the connecting member distally to the first treatment site; after the distal end region of the distal portion of the first treatment member is straightened using a straight rectifying tube, distally advancing the straightened first treatment member over the guidewire, where the straight rectifying tube is disposed on the first treatment member via its seam on its side wall and is used to straighten the first treatment member by advancing the straight rectifying tube on the first treatment member, and before the first treatment member is advanced into the patient’s body, advancing the straight rectifying tube independently distally relative to the first treatment member to make the entire straight rectifying tube be located around the guidewire, then removing the straight rectifying tube along its seam from the guidewire; advancing the distal end region of the first treatment member distally to the first treatment site.
The method further includes, after the distal end region of the first treatment member is advanced to the first treatment site, pulling out the guidewire from the patient’s body, so that the distal end region of the first treatment member can be released from a substantial linear constrained configuration; pulling the traction wire at the proximal portion of the first treatment member, to enable the distal end region of the first treatment member to assume a locked loop-like configuration, so that the distal end region may be anchored at the first treatment site; connecting the first connection end of the connection member with the first treatment member through the first sealing cap and the corresponding sealing part; flushing the first treatment member with a solution flowing through the first treatment member and into the first treatment site; flowing a solution through the second treatment member and entering the second treatment site to feed the bowel or aspirating a fluid in the stomach of the second treatment site through the second treatment member; connecting the third sealing cap with an end port of the proximal portion of the first treatment member.
Any one or more features or steps of any embodiment of the disclosures disclosed herein (device or method) can be combined with any one or more other features of any other embodiment of the disclosures, without departing from the scope of the disclosure. It should also be understood that the disclosures are not limited to the embodiments that are described or depicted herein for purposes of exemplification, but are to be defined only by a fair reading of claims appended to the patent application, including the full range of equivalency to which each element thereof is entitled.
This application claims priority to U.S. Provisional Pat. Application No. 63/247,152, filed on Sep. 22, 2021, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63247152 | Sep 2021 | US |
