Devices, kits, and methods for endoscopy-assisted insertion of balloon retention gastrointestinal tubes

Abstract

Described herein are accessories to aid the manipulation or insertion into a body of flexible single or multi-lumen tubes to drain or introduce fluids into or from body cavities. Exemplary embodiments include, apparatuses, assemblies, devices, kits, methods, and systems of and for endoscopic placement, replacement, and exchange of balloon gastrostomy tubes. Balloon retention gastrointestinal tubes for endoscopy-assisted insertion, together with devices, dilators, sheaths, and kits therefor, as well as methods of their use, are disclosed. The embodiments herein can be used in one or more tubular organ or hollow area of the body of a human or other living being, or in other settings.

Description

[0001] TITLE: Devices, Kits, and Methods for Endoscopy- Assisted Insertion of Balloon Retention Gastrointestinal Tubes

[0002] INVENTOR: lyunni, Venkata Sesha Sayi Nath

[0003] FIELD OF THE INVENTION

[0004]

[0001] Described herein are invention embodiments for endoscopic placement, replacement, and exchange of balloon retention gastrointestinal tubes. Embodiments disclosed herein include accessories to aid the manipulation or insertion into a body of flexible single or multi-lumen tubes to drain or introduce fluids into or from body cavities.

[0005] BACKGROUND OF THE INVENTION

[0006]

[0002] Neurologic injuries, cancer, and other conditions can give rise to a need for a gastrostomy tube (G-tube), jejunostomy tube (J-tube), gastrojejunostomy tube (GJ-tube), or other gastrointestinal tube. A gastrostomy commonly refers to an opening created in the stomach wall, and a G-tube may refer to any of many catheters and / or tubes that can be inserted through a gastrostomy. A jejunostomy commonly refers to an opening created in the wall of a portion of jejunum, and a J-tube may refer to any of many catheters and / or tubes that can be inserted through a jejunostomy. A GJ-tube may refer to any of many catheters and / or tubes that can be inserted through a gastrostomy with at least one lumen terminating in the stomach and at least one lumen traversing the pylorus and terminating in the small bowel. A gastrostomy or jejunostomy usually connects to and / or communicates with the outside of the body through a skin and soft tissue tract. While certain embodiments herein are discussed primarily in the context of gastrostomies and G-tubes, persons having ordinary skill in the art will readily appreciate the embodiments apply to jejunostomies and J-tubes or other gastrointestinal tubes. By way of non-limiting example, embodiments concerning G-tubes for anatomically unaltered patients may be substituted for J-tubes in patients who have a history of bariatric surgery (e.g., Roux-en-Y gastric bypass) or other anatomic alteration.

[0007] Page 1 of 43

[0008] 137272040.1 1

[0003] Gastrointestinal tubes, including G-tubes, may: have one or more channels; be used to remove gastroenteric contents, such as for venting; be used to insert contents, such as providing food, tube or other feeds, nutrition, and / or medicines (e.g., in liquid or solid form, such as granules and / or pills or tablets, which may be crushed); and / or be deployed temporarily, short-term, long-term, or essentially permanently.

[0009]

[0004] G-tubes can be placed de novo, through a newly created gastrostomy, or replaced through an existing gastrostomy and tract. For example, a G-tube could be replaced for a newer, otherwise identical G-tube, whether as a matter of routine maintenance or due to, e.g., issues encountered in the use or positioning of the old G-tube. A G-tube can also be replaced if the old G-tube was dislodged or removed inadvertently. Similar to replacements, G-tubes can also be exchanged through an existing gastrostomy and tract. A G-tube can be exchanged for a different G-tube, such as when a different size is desired (e.g., an ‘upsize’) or if a different number of channels (i.e., lumens) is desired. An exchange can also be done for a different device or other type of gastrointestinal tube, such as a gastrojejunostomy tube (GJ- tube). A GJ-tube often comprises at least one lumen communicating with the stomach, at least one lumen communicating with small intestine (most often specifically the jejunum), and sometimes an additional port for flushing the GJ-tube. Persons of ordinary skill in the art will readily appreciate that, except where context indicates otherwise, descriptions of embodiments herein using words like placement and placed etc. may also apply to replacement, exchange, upsizing, insertion, positioning, and similar terminology used in the art and vice versa, the foregoing applicable to all gastrointestinal tubes.

[0010]

[0005] Gastrointestinal tube placement may often be achieved through percutaneous techniques, as opposed to surgical techniques involving open skin incision and direct visualization. Percutaneous G-tube placement may often be achieved through adjunct

[0011] Page 2 of 43

[0012] 137272040.1 1 visualization techniques, commonly radiologically and / or endoscopically. Radiologic visualization may be via fluoroscopy, e.g. live radiography without and with administration of an endoluminal liquid contrast agent for image enhancement. Endoscopic visualization may involve live screen display of camera-acquired images from inside the body. G-tube replacement and exchange may also be done with adjunct visualization and / or imaging.

[0013]

[0006] Visualization techniques may help avoid more common risks of G-tube placement, such as bleeding, infection, and / or injury to a nearby structure. E.g., in creating a gastrostomy: puncture of a major artery could result in hemorrhage; introduction of gastroenteric and / or dermal flora to the abdomen or subcutaneous tissues could result in cellulitis or other infectious etiology; and injury to bowel could result in intraperitoneal leak and / or other complications. One of the more commonly feared injuries is specifically inadvertent puncture of the transverse colon, and a particularly bad outcome could be sepsis from intraabdominal leak and infection.

[0014]

[0007] Radiologic G-tube placement may involve serial advancements of instruments from the skin of the abdominal wall into the stomach. Since the G-tube is ‘pushed’ from the skin of the abdominal wall into the stomach, this can be referred to as a push technique. Endoscopic G-tube placement may involve a ‘pull’ technique, where the placement step may involve pulling a G-tube inserted from the mouth, through the esophagus, into the stomach, and then partially out of the abdominal wall and skin. Persons having ordinary skill in the art will readily appreciate there are numerous techniques, endoscopically and otherwise, for G- tube placement. Examples may include, but are not limited to, the Ponsky, Russell, and / or Sacks-Vine procedures / methods.

[0015]

[0008] Radiologic G-tube placement may involve steps of: (i) advancing a hollow needle with a sharp canula through the skin and into the stomach; (ii) removing the

[0016] Page 3 of 43

[0017] 137272040.1 1 sharp canula and placing a guidewire through the center of the hollow needle; (iii) removing the hollow needle while leaving the guidewire traversing the skin and soft tissue with its tip inside the stomach; (iv) advancing hollow dilators over the guidewire to increase the caliber of the skin and soft tissue tract; (v) advancing the G-tube over the guidewire such that the tip of the G-tube is in the stomach; (vi) removing the guidewire; and (vii) securing the G-tube. Guidewire positioning and / or manipulation may be assisted with one or more guiding catheters. Pre-procedurally a nasogastric or orogastric tube can be placed and the stomach insufflated (e.g., with carbon dioxide or room air) to assist the procedure. Traditionally correct positioning may be confirmed with intermittent radiographic imaging between one or more steps, e.g. with administration of contrast, which can be through the hollow needle, catheter, and / or G-tube, etc. Steps (i) through (iii) will be recognized by persons having ordinary skill in the art as a form or variant of Seidinger technique and / or establishing percutaneous access.

[0018]

[0009] Persons having ordinary skill in the art will readily appreciate that, before and during the placement (or replacement or exchange) of a gastrointestinal tube under any technique, certain baseline prerequisite conditions should be met. For example., the procedure should be considered properly indicated pursuant to a clinical evaluation, the patient should be deemed a good candidate and safe to proceed, informed consent should be obtained, sterile technique should be observed and maintained throughout including preparation and draping, periprocedural antimicrobial prophylaxis should be administered, and adequate and appropriate pain control should be provided (e.g., per os, topical, focal, and / or systemic analgesics, moderate sedation, local anesthesia, monitored anesthesia care, and / or general anesthesia).

[0019]

[0010] An example endoscopic G-tube placement may be divided in two stages, where the first stage may involve steps of: (i) advancing an endoscope from the mouth, through

[0020] Page 4 of 43

[0021] 137272040.1 1 the esophagus, and into the stomach; (ii) visualizing and selecting a target point along the inside of the gastric wall for the gastrostomy; (iii) inserting a hollow needle with a sharp cannula through the skin of the abdominal wall and into the stomach at the corresponding target area; (iv) removing the sharp cannula and placing a looped guidewire, with its loop end first, through the hollow center of the needle; (v) removing the hollow needle while leaving the guidewire traversing the skin and soft tissue with its looped tip inside the stomach; (vi) endoscopically snaring the guidewire tip and retracting the guidewire through the esophagus and out the mouth; and (vii) securing the guidewire to a preassembled combination G-tube and dilator. Steps (iii) through (v) will be recognized by persons having ordinary skill in the art as a form or variant of Seidinger technique and / or establishing percutaneous access.

[0022] [Oi l] A combination assembly can comprise a dilator at the end of the G-tube that will ultimately rest exteriorly to the patient, i.e. opposite the end of the G-tube that will ultimately rest interiorly in the stomach. The dilator may commonly be tapered and oriented so that the dilator’ s broader base apposes the G-tube (at the G-tube’ s exterior end) and the dilator’ s narrower tip is free.

[0023]

[0012] The dilator’s narrow tip may also have a free hollow loop, and securing the guidewire to such a combination assembly may be accomplished via interlocking loops. For example, the guidewire’s looped tip (while folded) may be wholly threaded through the dilator’s loop; then the interior end of the G-tube may be threaded through the guidewire’s loop. Subsequently pulling the combination assembly opposite the guidewire would result in their respective loops interlocking at the dilator tip.

[0024]

[0013] The second stage may involve steps of: (i) pulling on the guidewire, from the skin at the abdominal wall, such that the combination assembly is pulled into the mouth and threaded through the esophagus and into the stomach; (ii) continuing to pull, with

[0025] Page 5 of 43

[0026] 137272040.1 1 the dilator tip and dilator performing dilation from the gastrostomy through the soft tissue tract and out the skin at the abdominal wall; (iii) continuing to pull until the G-tube’s exterior end is outside the skin but with the interior end of the G-tube still inside the stomach; (iv) cutting the G-tube at its exterior end to detach the dilator; and (v) securing the G-tube. An adaptor may be affixed to, and / or inserted in, the G-tube’s exterior end, to facilitate use of the G-tube. A G- tube may have a bumper (e.g., a broad-based and / or disc-shaped) for securing the G-tube against the interior of the stomach wall, and such a bumper may be what limits how far a G- tube can be pulled in the second stage steps.

[0027]

[0014] Endoscopically placed G-tubes known to the prior art include, e.g., the CORFLO ® and MIC ™ PEGs (Avanos Medical Inc., Alpharetta GA). These and other gastrointestinal tubes can include, e.g., conical or ring shaped bumpers. Bumpers are often rigid or semirigid, and may comprise, e.g., polyurethane. A bumper could result in complications, such as less than ideal clearing of gastric or enteric contents around the bumper due to its shape or configuration. More serious complications of gastrointestinal tubes with bumpers include buried bumper syndrome (BBS). BBS may result from prolonged tension of a bumper against a gastric or enteric wall, e.g. due to tight positioning of the gastrointestinal tube against the abdominal wall from its placement. BBS may refer to erosion and / or migration, in whole or in part, of a bumper outside of a stomach or bowel. In BBS, a portion or all of a bumper could be anywhere between the stomach or bowel wall and the skin. Depending on its severity and the degree of migration, BBS could be salvaged via endoscopic techniques, although advanced cases could require surgical intervention.

[0028]

[0015] Gastrointestinal tubes, including endoscopically placed G-tubes, can be exchanged to a version with a balloon retention device (e.g., a balloon retention gastrointestinal tube). Such exchange can be prompted by a complication, like dislodgement, BBS, or any other

[0029] Page 6 of 43

[0030] 137272040.1 1 issue, or can be performed routinely and / or prophylactically. Gastrointestinal tubes with an inflatable balloon for retention may operate via inflating a balloon disposed around the tube and inside the gastrointestinal lumen, thus operating as an anchor. Balloon G-tubes, e.g., may be preferred as being gentler on a stomach wall and less prone to causing erosion, irritation, or other injury; better in shape for accommodating the flow of gastric contents; and less likely to result in complications like BBS or even dislodgement. Bumpers may be generally fixed in size; balloons may be inflated to greater diameters relative to the size of the gastrostomy (or jejunostomy or other enterostomy), helping secure the gastrointestinal tube in place. A balloon G-tube known to the prior art includes, e.g., the Entuit ® Gastrostomy BR Balloon Retention Feeding Tube (Cook Medical Technologies LLC, Bloomington IN).

[0031]

[0016] The balloon on a balloon retention gastrointestinal tube should be deflated at time of insertion, so that the tube can pass through the skin and soft tissue tract and gastrostomy (or enterostomy), but inflatable once the tube has been positioned just right to where the balloon is inside the desired gastrointestinal lumen, so then the tube cannot be unintentionally removed, pulled, or dislodged across the gastrostomy (or enterostomy) and soft tissue tract and skin. For the balloon to be inflatable, there needs to be a dedicated lumen or channel along the length of the tube through which fluid, e.g. a liquid (sterile water, normal saline, etc., possibly with contrast) and / or gas, may be injected to inflate the balloon. An inflation lumen needs to be coupled to a port where manual manipulation (i.e., inflation, deflation) can be performed by a user. Inflation lumens are generally small in profile so as to not interfere with the main channel(s) of a tube, and thus not typically amenable to the adaptor and / or inflation port being removable or one that is applied by hand. However, for an inflation port to be usable, e.g. by a human / preferably by hand, it is generally large and rigid enough such that it should not be traversing an oral cavity or esophagus, let alone a gastrostomy (or

[0032] Page 7 of 43

[0033] 137272040.1 1 enterostomy) and soft tissue tract. Further, an inflation port can be at an oblique angle relative to the tube for ease of use — e.g., when a tube has more than one channel (such as a main lumen and an inflation lumen), the port for each channel can often be combined in a V-shaped adaptor that flares out from the tube — again limiting the ability to pull it through a body, especially in the direction of oral cavity, esophagus, and gastrointestinal wall then abdominal wall.

[0034]

[0017] An issue with current technologies is balloon G-tubes cannot be placed endoscopically via ‘pull’ techniques described above. Inflation port configurations can be too big (and / or inappropriate in shape, orientation, direction, configuration, etc.) to be safely pulled through the mouth, esophagus, and stomach and out through the gastrostomy and soft tissue tract and skin. Yet inflation lumens can be too small to allow for cutting of an exterior end of a G-tube (as can be done in endoscopic placement) because an operator cannot easily or reliably reattach an inflation port reattached by hand in the procedure. As a result, most if not all balloon G-tubes are currently placed via ‘push’ technique, where the inflation port comes pre-coupled to the inflation lumen as manufactured, the inflation port need not enter the body, and the inflation lumen need not be cut.

[0035]

[0018] The embodiments described herein address shortcomings in the prior art and current technologies described above. It shall be understood the examples herein are not limiting. Many other examples within the scope will be readily apparent to persons having ordinary skill in the art.

[0036] SUMMARY OF THE INVENTION

[0037]

[0019] The embodiments described herein overcome particular problems in the prior art related to endoscopy-assisted placement, replacement, and exchange of balloon retention gastrointestinal tubes.

[0038] Page 8 of 43

[0039] 137272040.1 1

[0020] In certain embodiments, a gastrointestinal tube insertion device may comprise a leading end and a rear end, the leading end having a conical dilator and a first wire connector, and the rear end having a hollow sheath and a second wire connector. The leading end may be smaller in caliber than the rear end. The conical dilator may taper from a tip at the leading end to a base apposing the hollow sheath. The tip may be, e.g., 3 mm in diameter or less. The base may be, e.g., between 6 mm and 12 mm in diameter. The conical dilator may be semi-rigid. The conical dilator may comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, and / or silicone. The first wire connector may comprise a loop configured to interlock with a first looped tip of a first wire. The first wire connector may comprise a catch, clamp, clasp, clip, hook, lock, snap, and / or vice. The first wire connector may comprise carbon fiber, metal, metal alloy, nickel, nickel -titanium alloy, nitinol, nylon, poly tetrafluorethylene, stainless steel, and / or titanium. The second wire connector may comprise a loop configured to interlock with a second looped tip of a second wire. The second wire connector may comprise a catch, clamp, clasp, clip, hook, lock, snap, and / or vice. The second wire connector may comprise carbon fiber, metal, metal alloy, nickel, nickel -titanium alloy, nitinol, nylon, polytetrafluorethylene, stainless steel, and / or titanium. The hollow sheath may be cylindrical. The hollow sheath may be configured to receive a gastrointestinal tube, and may comprise an inner sheath diameter that is larger than an outer tube diameter of the gastrointestinal tube. The inner sheath diameter may be at least 3 mm larger than the outer tube diameter. The inner sheath diameter may be between 6 mm and 12 mm. The hollow sheath may be semi-rigid. The hollow sheath may comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, and / or silicone.

[0040]

[0021] In certain embodiments, a gastrostomy tube insertion device may comprise (i) a leading end having a tapered conical dilator and a first loop configured to

[0041] Page 9 of 43

[0042] 137272040.1 1 interlock with a first looped tip of a first wire and (ii) a rear end having a cylindrical hollow sheath and a second loop configured to interlock with a second looped tip of a second wire, wherein (a) the tapered conical dilator is semi-rigid and tapers down from a tip at the leading end to a base that apposes the cylindrical hollow sheath, and (b) the cylindrical hollow sheath comprises an inner sheath diameter and is configured to receive a gastrostomy tube having an outer tube diameter at least 3 mm less than the inner sheath diameter.

[0043]

[0022] In certain embodiments, a gastrointestinal tube insertion kit may comprise a first wire; a second wire; and a gastrointestinal tube insertion device having a leading end with a conical dilator and a first wire connector, and a rear end with a hollow sheath and a second wire connector. The first wire may have a first looped tip. A gastrointestinal tube insertion kit may further comprise a gastrointestinal tube. The gastrointestinal tube may comprise an inflatable balloon retention anchor.

[0044]

[0023] In certain embodiments, a method of inserting a balloon gastrostomy tube, using a balloon gastrostomy tube insertion device having a leading end with a dilator and a first wire connector and a rear end with a hollow sheath and a second wire connector, may comprise the steps of: (i) securing percutaneous access from an abdominal wall into a stomach with a first wire having a first wire tip; (ii) endoscopically snaring the first wire tip in the stomach; (iii) retracting the first wire tip through an esophagus and out an oral cavity; (iv) connecting the first wire tip to the first wire connector and connecting a second wire tip of a second wire to the second wire connector; (v) pulling the first wire at the abdominal wall to advance the balloon gastrostomy tube insertion device through the oral cavity and the esophagus and into the stomach; (vi) pulling the first wire at the abdominal wall to advance the dilator outside the abdominal wall and the hollow sheath across the abdominal wall; (vii) detaching the dilator from the balloon gastrostomy tube insertion device; (viii) securing in place

[0045] Page 10 of 43

[0046] 137272040.1 1 the remaining hollow sheath traversing the abdominal wall with the rear end in the stomach; (ix) inserting a balloon gastrostomy tube through the sheath traversing the abdominal wall until a balloon of the balloon gastrostomy tube is in the stomach; (x) releasing and retracting the remaining balloon gastrostomy tube insertion device by pulling the second wire; and (xi) inflating the balloon of the balloon gastrostomy tube in the stomach.

[0047]

[0024] In certain embodiments, the first wire tip may comprise a first looped tip, and the first wire connector may comprise a first loop configured to interlock with the first looped tip. The second wire tip may comprise a second looped tip, and the second wire connector may comprise a second loop operable to interlock with the second looped tip.

[0048]

[0025] In certain embodiments, securing in place the remaining hollow sheath may comprise applying at least one forceps to a portion of the hollow sheath at the abdominal wall. The forceps may be surgical forceps, surgical clamp, medical forceps, medical clamp, arterial forceps, pean forceps, hemostatic clamp, Hemostat, mosquito forceps, vascular forceps, Hartman mosquito forceps, Halstead mosquito forceps, straight mosquito forceps, curved mosquito forceps, Kelly clamp, Kelly Hemostat forceps, curved Kelly clamp, vessel clamp, vascular clamp, Beck clamp, Guyon-Pean clamp, Satinsky clamp, rubber shod forceps, Adson rat tooth forceps, Adson forceps, rat tooth forceps, tissue forceps, Adson-Brown forceps, Adson-Brown tissue forceps, Bonney forceps, and / or Debakey forceps.

[0049]

[0026] In certain embodiments, securing percutaneous access may comprise the Seidinger technique. In certain embodiments, securing percutaneous access may comprise advancing a catheter through an existing conduit, such as a skin and soft tissue tract, and advancing the first wire through the catheter. In certain embodiments, inflating the balloon of the balloon gastrostomy tube may comprise injecting a fluid. The fluid may be gas, liquid, air, room air, water, sterile water, saline, normal saline, contrast, and / or iodinated contrast.

[0050] Page 11 of 43

[0051] 137272040.1 1

[0027] In certain embodiments, a method of inserting a balloon gastrostomy tube may further comprise the step of securing the balloon gastrostomy tube to the abdominal wall. Securing the balloon gastrostomy tube to the abdominal wall may comprise applying at least one suture.

[0052]

[0028] In certain embodiments, a gastrointestinal tube insertion device may comprise a leading end and a rear end, the leading end having a conical dilator and a first wire connector, and the rear end having a hollow sheath and a second wire integrally connected. The leading end may be smaller in caliber than the rear end. The conical dilator may taper from a tip at the leading end to a base apposing the hollow sheath. The tip may be, e.g., 3 mm in diameter or less. The base may be, e.g., between 6 mm and 12 mm in diameter. The conical dilator may be semi-rigid. The conical dilator can comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, and / or silicone. The first wire connector may comprise a loop configured to interlock with a first looped tip of a first wire. The first wire connector may comprise a catch, clamp, clasp, clip, hook, lock, snap, and / or vice. The first wire connector may comprise carbon fiber, metal, metal alloy, nickel, nickel -titanium alloy, nitinol, nylon, polytetrafluorethylene, stainless steel, and / or titanium. The hollow sheath may be cylindrical. The hollow sheath may be configured to receive a gastrointestinal tube, and may comprise an inner sheath diameter that is larger than an outer tube diameter of the gastrointestinal tube. The inner sheath diameter may be at least 3 mm larger than the outer tube diameter. The inner sheath diameter may be between 6 mm and 12 mm. The hollow sheath may be semi-rigid. The hollow sheath may comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, and / or silicone.

[0053]

[0029] In certain embodiments, a gastrostomy tube insertion device may comprise (i) a leading end having a tapered conical dilator and a first loop configured to

[0054] Page 12 of 43

[0055] 137272040.1 1 interlock with a first looped tip of a first wire and (ii) a rear end having a cylindrical hollow sheath and a second wire integrally connected, wherein (a) the tapered conical dilator is semirigid and tapers from a tip at the leading end to a base that apposes the cylindrical hollow sheath, and (b) the cylindrical hollow sheath comprises an inner sheath diameter and is configured to receive a gastrostomy tube having an outer tube diameter at least 3 mm less than the inner sheath diameter.

[0056]

[0030] In certain embodiments, a gastrointestinal tube insertion kit may comprise a first wire; and a gastrointestinal tube insertion device having a leading end with a conical dilator and a first wire connector, and a rear end with a hollow sheath and a second wire integrally connected. The first wire may have a first looped tip. A gastrointestinal tube insertion kit may further comprise a gastrointestinal tube. The gastrointestinal tube may comprise an inflatable balloon retention anchor.

[0057]

[0031] In certain embodiments, a method of inserting a balloon gastrostomy tube, using a balloon gastrostomy tube insertion device having a leading end with a dilator and a first wire connector and a rear end with a hollow sheath and a second wire integrally connected, may comprise the steps of: (i) securing percutaneous access from an abdominal wall into a stomach with a first wire having a first wire tip; (ii) endoscopically snaring the first wire tip in the stomach; (iii) retracting the first wire tip through an esophagus and out an oral cavity; (iv) connecting the first wire tip to the first wire connector; (v) pulling the first wire at the abdominal wall to advance the balloon gastrostomy tube insertion device through the oral cavity and the esophagus and into the stomach; (vi) pulling the first wire at the abdominal wall to advance the dilator outside the abdominal wall and the hollow sheath across the abdominal wall; (vii) detaching the dilator from the balloon gastrostomy tube insertion device; (viii) securing in place the remaining hollow sheath traversing the abdominal wall with the rear end

[0058] Page 13 of 43

[0059] 137272040.1 1 in the stomach; (ix) inserting a balloon gastrostomy tube through the sheath traversing the abdominal wall until the balloon of the balloon gastrostomy tube is in the stomach; (x) releasing and retracting the remaining balloon gastrostomy tube insertion device by pulling the second wire; and (xi) inflating the balloon of the balloon gastrostomy tube in the stomach.

[0060]

[0032] In certain embodiments, the first wire tip may comprise a first looped tip, and the first wire connector may comprise a first loop configured to interlock with the first looped tip.

[0061]

[0033] In certain embodiments, securing in place the remaining hollow sheath may comprise applying at least one forceps to a portion of the hollow sheath at the abdominal wall. The forceps may be surgical forceps, surgical clamp, medical forceps, medical clamp, arterial forceps, pean forceps, hemostatic clamp, Hemostat, mosquito forceps, vascular forceps, Hartman mosquito forceps, Halstead mosquito forceps, straight mosquito forceps, curved mosquito forceps, Kelly clamp, Kelly Hemostat forceps, curved Kelly clamp, vessel clamp, vascular clamp, Beck clamp, Guyon-Pean clamp, Satinsky clamp, rubber shod forceps, Adson rat tooth forceps, Adson forceps, rat tooth forceps, tissue forceps, Adson-Brown forceps, Adson-Brown tissue forceps, Bonney forceps, and / or Debakey forceps.

[0062]

[0034] In certain embodiments, securing percutaneous access may comprise the Seidinger technique. In certain embodiments, securing percutaneous access may comprise advancing a catheter through an existing conduit, such as a skin and soft tissue tract, and advancing the first wire through the catheter. In certain embodiments, inflating the balloon of the balloon gastrostomy tube may comprise injecting a fluid. The fluid may be gas, liquid, air, room air, water, sterile water, saline, normal saline, contrast, and / or iodinated contrast.

[0063]

[0035] In certain embodiments, a method of inserting a balloon gastrostomy tube may further comprise the step of securing the balloon gastrostomy tube to the abdominal

[0064] Page 14 of 43

[0065] 137272040.1 1 wall. Securing the balloon gastrostomy tube to the abdominal wall may comprise applying at least one suture.

[0066] BRIEF DESCRIPTION OF THE DRAWINGS

[0067]

[0036] Other features of the invention embodiments disclosed herein will become apparent from the attached drawings. The following drawings are illustrative examples and do not further limit any claims that may eventually issue. For purposes of explanation, several embodiments are set forth in the following figures, wherein:

[0068]

[0037] FIG. 1A illustrates a lengthwise view of a gastrointestinal tube insertion device according to an embodiment described herein;

[0069]

[0038] FIG. IB illustrates a cross-sectional view of a gastrointestinal tube insertion device according to an embodiment described herein;

[0070]

[0039] FIG. 2 illustrates an embodiment of a gastrostomy tube insertion device with an anchoring rod;

[0071]

[0040] FIGS. 3 A-N illustrate examples of a first wire connector and a second wire connector according to certain embodiments of the present invention;

[0072]

[0041] FIG. 4 is a flow diagram of an exemplary method for inserting a gastrostomy tube;

[0073]

[0042] FIGS. 4A-H illustrate steps in a method of inserting a gastrostomy tube according to an embodiment described herein;

[0074]

[0043] FIGS. 5A-E illustrate steps in a method of inserting a gastrostomy tube according to an embodiment described herein;

[0075]

[0044] FIG. 6A illustrates a gastrointestinal tube insertion device according to an embodiment with a second wire integrally connected; and

[0076] Page 15 of 43

[0077] 137272040.1 1

[0045] FIG. 6B illustrates a gastrointestinal tube insertion device according to an embodiment with a second wire integrally connected and an anchoring rod.

[0078] DETAILED DESCRIPTION

[0079]

[0046] Certain embodiments herein can be used with any catheter, cannula, shunt, stent, trocar, tube, or tubular structure. Examples include, but are not limited to, cystostomy tube, chest tube, pleural drainage catheter, gastrostomy tube, gastrojejunostomy tube, gastroenteric tube, nasogastric tube, orogastric tube, nasojejunal tube, feeding tube, enteric tube, biliary tube, biliary drainage catheter, nephrostomy tube, nephroureteral stent, ventriculoperitoneal shunt, etc.

[0080]

[0047] Certain embodiments herein can be used in one or more tubular organs or hollow areas of the body of a human or other living being, including but not limited to any enteric structure, enteric space, mouth, oral cavity, nasal cavity, pharynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectum, anus, gallbladder, biliary duct, pancreatic duct, sphincter of Oddi, ampulla of Vater, peritoneum, peritoneal structure, peritoneal space, retroperitoneal structure, retroperitoneal space, pelvic structure, pelvic space, etc., or any combination thereof. In addition to tubular organs or hollow areas, certain embodiments of the invention may be used in other areas, including but not limited to any dermatologic, connective or soft tissue, or musculoskeletal or fascial structure, space, plane, or compartment, etc., or any combination thereof. Further, embodiments may be used in applications not related to a living being.

[0081]

[0048] FIGS. 1 A and IB depict an embodiment of a gastrointestinal tube insertion device in a lengthwise view in FIG. 1A and a cross-sectional view in FIG. IB. Device 100 comprises a leading end 110 and rear end 120. Leading end 110 has a dilator 101 and a first wire connector 102. Rear end 120 has a hollow sheath 121 and a second wire connector 122.

[0082] Page 16 of 43

[0083] 137272040.1 1 As shown in FIG. IB, sheath 121 comprises an outer sheath diameter 123a and an inner sheath diameter 123b.

[0084]

[0049] A dilator 101 may be smaller in caliber toward leading end 110 and larger in caliber toward rear end 120. Dilators 101 may be tapered, and / or may be conical. As seen in FIG. 1 A, a dilator 101 may be conical and taper from a tip 103 at leading end 110 to a base 104 toward rear end 120. In exemplary embodiments, base 104 apposes sheath 121. In certain embodiments, the tip 103 may be less than 3 mm in diameter, and / or the base 104 may be between 6 mm and 12 mm in diameter.

[0085]

[0050] A dilator 101 may be semi-rigid. Dilators 101 may comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, silicone, or any combination thereof.

[0086]

[0051] A sheath 121 may be cylindrical. A sheath 121 may be configured to receive a gastrointestinal tube with an outer tube diameter (not illustrated in FIGS. 1 A-B). In certain embodiments, the inner sheath diameter 123b of sheath 121 is larger than the outer tube diameter of the tube. In exemplary embodiments, the outer tube diameter is smaller than inner sheath diameter 123b by about 3 mm, or more. In certain embodiments, inner sheath diameter 123b is between 6 mm and 12 mm. Gastrointestinal tubes in accord with the embodiments herein may include, e.g., G-tubes known to those having ordinary skill in the art, and / or a tube sized between 12 French and 24 French.

[0087]

[0052] A sheath 121 may be semi-rigid. Sheaths 121 may comprise carbon fiber, medical grade plastic, latex, nylon, polyurethane, silicone, or any combination thereof.

[0088]

[0053] In exemplary embodiments, a device 100 may further comprise a rod 105, as shown in FIG. 2. Rod 105 may be an anchoring rod. Rod 105, such as an anchoring rod, may help in mounting the gastrointestinal tube (not illustrated in FIG. 2) to be received by sheath 121 and / or temporarily stabilizing said tube. For example, rod 105 may hold the tube until the

[0089] Page 17 of 43

[0090] 137272040.1 1 release and / or retraction of device 100 and / or sheath 121, after having satisfactorily positioned the tube (as further explained elsewhere herein). In certain embodiments, a rod 105 may extend to base 104, and / or may extend from rear end 120.

[0091]

[0054] In exemplary embodiments, a device 100 may further comprise at least one stopper 181, as shown in FIG. 2. At least one stopper 181 can help prevent mispositioning of device 100 (e.g. pulling device 100 too far out from a stomach across an abdominal wall), and / or can help reduce leakage of gas (e.g. air) from a stomach or abdominal cavity (e.g., through a gastrostomy or enterostomy during insertion of a gastrointestinal tube), as further explained elsewhere herein.

[0092]

[0055] Stopper 181 may comprise a protrusion from sheath 121, which may be externally located and / or outwardly projecting. Stopper 181 may be circumferential and / or continuous, like a ring, such as stopper 181 as drawn in FIG. 2. A stopper 181 may be discontinuous and / or partial, whether projecting outwardly in an interrupted fashion and / or via protrusion distances from sheath 121 that vary in exaggeration. A stopper 181 may be any other geometric or non-geometric shape. A device 100 may comprise more than one stopper 181, which may be respectively positioned at equivalent or different distances from rear end 120 and / or leading end 110, and / or may be positioned along the same or different axes circumferentially about device 100. In exemplary embodiments, a stopper 181 is between about 7 to 8 cm from tip 103 toward rear end 120. In exemplary embodiments, a stopper 181 projects outwardly from the exterior of sheath 121 by a protrusion distance of about 2 mm. In other embodiments, the protrusion distance may be a different distance; and there may be more than one protrusion distance on a given sheath 121, such as with partial, discontinuous, and / or irregularly shaped stoppers 181.

[0093] Page 18 of 43

[0094] 137272040.1 1

[0056] In certain embodiments of device 100, the first wire connector and / or the second wire connector may comprise a catch, clamp, clasp, clip, hook, lock, snap, vice, or any combination thereof. The first wire connector and / or the second wire connector may comprise carbon fiber, metal, metal alloy, nickel, nickel -titanium alloy, nitinol, nylon, polytetrafluorethylene, stainless steel, titanium, or any combination thereof. Other variations will be readily apparent to those having ordinary skill in the art.

[0095]

[0057] Turning to FIGS. 3 A-N, an exemplary embodiment is illustrated regarding the first wire connector and the second wire connector. In certain embodiments of device 100, at least one wire connector may comprise a loop configured to interlock with a looped tip of a wire. For example, in FIGS. 3A-N, device 100’s first wire connector 102 comprises a first loop 131 and its second wire connector 122 comprises a second loop 132; and device 100 is shown interacting with a first wire 151, which can have a first looped tip 151a and first end 151b, and a second wire 161, which can have a second looped tip 161a and second end 161b.

[0096]

[0058] FIGS. 3A-D show first looped tip 151a of first wire 151 being threaded through first loop 131 as the first wire connector 102 at leading end 110 of device 100. FIGS. 3D-G show second loop 132 (as well as sheath 121 and dilator 101) then being threaded through first looped tip 151a. Subsequently pulling device 100 opposite first wire 151 results in first loop 131 and first looped tip 151a interlocking, which can be pulled taught as shown in FIG. 3H resulting in a first interlocked segment 171.

[0097]

[0059] A similar process can be completed at rear end 120 of device 100 between second loop 132 (as the second wire connector 122 of device 100) and second wire 161. FIGS. 3I-L show second loop 132 (then sheath 121 and dilator 101) being threaded through second looped tip 161a. FIGS. 3L-M show the second end 161b of second wire 161 then being threaded through second loop 132. Subsequently pulling device 100 opposite second wire 161 results in

[0098] Page 19 of 43

[0099] 137272040.1 1 second loop 132 and second looped tip 161a interlocking, which can be pulled taught as shown in FIG. 3N resulting in a second interlocked segment 172.

[0100]

[0060] The interlocking described in FIGS. 3 A-N may provide reliable connection for wires with looped tips (e.g., first wire 151, second wire 161) to a device 100, which would not readily come undone if device 100 is pulled in one direction or another via said wires, yet would remain reversible for manual detachment if desired. The interlocking outlined in FIGS. 3 A-N, and variants thereof, will be readily appreciated by persons having ordinary skill in the art.

[0101]

[0061] In an exemplary embodiment, a gastrostomy tube insertion device may comprise a leading end and a rear end, wherein (i) the leading end may have a tapered conical dilator and a first loop configured to interlock with a first looped tip of a first wire and (ii) the rear end may have a cylindrical hollow sheath and a second loop configured to interlock with a second looped tip of a second wire, further wherein (a) the tapered conical dilator is semirigid and tapers down from a tip at the leading end to a base that apposes the cylindrical hollow sheath and (b) the cylindrical hollow sheath has an inner sheath diameter and is configured to receive a gastrostomy tube having an outer tube diameter at least 3 mm less than the inner sheath diameter.

[0102]

[0062] Other embodiments of the present invention include certain kits. A kit may comprise a device, a first wire, and a second wire. The device may comprise any embodiment of device 100 disclosed herein. The first wire may comprise a first looped tip. Certain kit embodiments may further comprise a gastrointestinal tube. The gastrointestinal tube may comprise an inflatable balloon retention anchor. Other kit variations within the scope will be readily apparent to persons having ordinary skill in the art in light of the disclosures and descriptions herein.

[0103] Page 20 of 43

[0104] 137272040.1 1

[0063] Further embodiments of the present invention include certain methods. FIG. 4 is a flow diagram of an exemplary embodiment for inserting a balloon retention gastrointestinal tube. Method 450 may use a balloon retention gastrointestinal tube insertion device having a leading end with a dilator and a first wire connector and a rear end with a hollow sheath and a second wire connector. Method 450 may comprise the steps of: 451 securing percutaneous access from an abdominal wall into a gastrointestinal lumen with a first wire having a first wire tip; 452 endoscopically snaring the first wire tip; 453 retracting the first wire tip through an esophagus and out an oral cavity; 454 connecting the first wire tip to the first wire connector, and having connected a second wire tip of a second wire to the second wire connector; 455 pulling the first write at the abdominal wall to advance the balloon retention gastrointestinal tube insertion device into the desired gastrointestinal lumen; 456 pulling the first wire at the abdominal wall to advance the dilator outside the abdominal wall and the hollow sheath across the abdominal wall; 457 detaching the dilator from the balloon retention gastrointestinal tube insertion device; 458 securing in place the remaining hollow sheath traversing the abdominal wall with the rear end of the balloon retention gastrointestinal tube insertion device in the desired gastrointestinal lumen; 459 inserting a gastrointestinal tube having a retention balloon through the sheath traversing the abdominal wall until the retention balloon is in the desired gastrointestinal lumen; 460 releasing and retracting the remaining balloon retention gastrointestinal tube insertion device by pulling on the second wire; and 461 inflating the retention balloon in the desired gastrointestinal lumen.

[0105]

[0064] Method 450 applies to placement, replacement, and / or exchange of gastrointestinal tubes. In step 451, securing percutaneous access may comprise establishing a new access or using an existing access. For example, in de novo placement of a gastrointestinal tube, securing percutaneous access may comprise Seidinger technique or other form of

[0106] Page 21 of 43

[0107] 137272040.1 1 establishing new percutaneous access (as further explained elsewhere herein). In replacement or exchange of a gastrointestinal tube, there may be a pre-existing skin and soft tissue tract (and / or, e.g., a gastrocutaneous fistula, enterocutaneous fistula, etc.). As such, securing percutaneous access may comprise inserting a catheter through the skin and soft tissue tract (or gastrocutaneous fistula, etc.) to then guide the insertion of the first wire. Different catheters may be used, such as an angiocatheter and / or fluorinated ethylene propylene catheter, etc. The catheter may be hydrophilic, and / or may have a curved or shaped tip. The tract / fistula may be dilated before proceeding to later steps in method 450. Those of ordinary skill in the art will readily appreciate numerous variations within the scope.

[0108]

[0065] In step 454, the second wire tip may be connected to the second wire connector prior to connecting the first wire tip to the first wire connector. In fact, connecting the second wire tip to the second wire connector may occur prior to steps 453, 452, and / or 451. However, connecting the first wire tip to the first wire connector should occur within step 454 within the sequence of method 450, and connecting the second wire tip to the second wire connector should have occurred before or concurrently with step 454.

[0109]

[0066] The desired gastrointestinal lumen may be, e.g., the inside of a stomach (e.g., in G-tube insertion). However, persons having ordinary skill in the art will readily appreciate the desired gastrointestinal lumen may be small bowel. For example, in a patient status post Roux-en-Y gastrectomy, the desired gastrointestinal lumen may be a portion of jejunum, which may be accessed with endoscopic assistance for snaring according to step 452.

[0110]

[0067] In step 457, persons having ordinary skill in the art will readily appreciate various options for detaching the dilator from the gastrointestinal tube insertion device. E.g., an operator may cut the point where the dilator apposes the sheath, thereby exposing the internal aspect of the hollow sheath. In another example, an operator may cut the sheath itself,

[0111] Page 22 of 43

[0112] 137272040.1 1 thereby detaching the dilator with a portion of sheath, while leaving remaining sheath traversing the abdominal wall. In other examples, the dilator may be configured to be removable from the device, such as having been affixed along a perforated seam, and / or having been assembled or connected in any other predetermined readily detachable manner in accord with the art.

[0113]

[0068] FIGS. 4A-H and 5A-E illustrate steps in exemplary methods of gastrostomy tube insertion, including for de novo placement, replacement, and / or exchange. FIG. 4A shows a schematized patient 400 with an oral cavity 401, which is connected to an esophagus 402, which leads to a stomach 403, which lies deep to soft tissues 404 and overlying skin 405 of an abdominal wall 406.

[0114]

[0069] In FIG. 4B, an endoscope 410 and a first wire 151 have been introduced into patient 400. Endoscope 410 has an endoscope tip 411, and endoscope 410 traverses oral cavity 401 and courses through esophagus 402 until terminating with its endoscope tip 411 lying within stomach 403. First wire 151 has a first looped tip 151a and first end 151b. In FIG. 4B, percutaneous access has been secured with first wire 151 traversing the skin 405 and soft tissues 404 of abdominal wall 406, as well as a gastrostomy 403a created in a wall of stomach 403, until terminating with its first looped tip 151a lying within stomach 403. Securing percutaneous access can be via a form or variant of Seidinger technique, as further explained elsewhere herein, or other technique, all falling within the present scope and all of which will be readily apparent to persons having ordinary skill in the art in light of the disclosures and descriptions herein. In de novo placement of a gastrostomy tube, the percutaneous access can be one that is newly established. In gastrostomy tube replacement or exchange, an existing skin and soft tissue tract is expected (e.g., a gastrocutaneous fistula). As such, the percutaneous access may be secured by introducing first wire 151 through the tract and / or fistula, whether

[0115] Page 23 of 43

[0116] 137272040.1 1 directly or via the guidance of a catheter. In exemplary embodiments, a catheter is first introduced through the tract and / or fistula — traversing abdominal wall 406 into stomach 403 — then first wire 151 is advanced through the catheter (for better patient safety, to decrease likelihood of inadvertent puncture or neighboring injury with atraumatic technique). The catheter used may comprise a soft tip, which may be shaped or curved. If necessary or appropriate, the tract and / or fistula may be separately dilated before and / or during the introduction of the catheter and / or first wire 151 , as will be readily appreciated by those having ordinary skill in the art.

[0117]

[0070] In FIG. 4C, first looped tip 151a of first wire 151 has been snared by endoscope 410. The way(s) to endoscopically snare a wire (or tip thereof), including from within a stomach or other location, is a step that will be readily apparent to persons having ordinary skill in the art. Endoscope 410 is shown being retracted through esophagus 402 toward oral cavity 401.

[0118]

[0071] In FIG. 4D, endoscope 410 has been fully retracted out oral cavity 401, together with first looped tip 151a of first wire 151, and endoscope 410 has been disconnected from the previously snared first wire 151. The way(s) to disconnect an endoscopically snared wire (or tip thereof) is a step that will be readily apparent to persons having ordinary skill in the art. At this stage, first wire 151 traverses patient 400 from oral cavity 401, through esophagus 402, stomach 403 (via gastrostomy 403a), and abdominal wall 406 (including the soft tissues 404 and skin 405), with first end 151b still outside abdominal wall 406 and with first looped tip 151a just outside oral cavity 401.

[0119]

[0072] In FIG. 4E, a device 100 is introduced and attached at its leading end 110 to a first wire 151, as well as at its rear end 120 to a second wire 161. In this embodiment, the wire connection was as described in FIGS. 3A-N. In FIG. 4F-G, first wire 151 is pulled at

[0120] Page 24 of 43

[0121] 137272040.1 1 abdominal wall 406 (e.g., via first end 151b) such that device 100 traverses oral cavity 401, courses through esophagus 402, and enters stomach 403. In FIG. 4H, continued pulling at abdominal wall 406 on first wire 151 causes device 100 to partially exit abdominal wall 406. Dilator 101 leads this process, first dilating gastrostomy 403a, soft tissues 404, and skin 405 to create an adequate tract, across which lies sheath 121. In exemplary embodiments, dilator 101 increases the size of gastrostomy 403a and the tract through abdominal wall 406 enough to accommodate sheath 121 but without significant excess, such that little to no fluid enters stomach 403 unintentionally around sheath 121. In exemplary embodiments, sheath 121 comprises an outer sheath diameter and an inner sheath diameter, the inner sheath diameter being slightly larger than the anticipated outer tube diameter of the gastrointestinal tube (e.g., G-tube) to be inserted, while the outer sheath diameter is also not significantly larger than the inner sheath diameter such that the soft tissue tract is not overly expanded relative to the outer tube diameter of the tube to be left in place. In exemplary embodiments, the caliber / profile of the outer sheath diameter is minimized so as to minimize injury to the soft tissue tract, which also limits the caliber / profile of the dilator, inner sheath diameter, and outer tube diameter.

[0122]

[0073] The continued pulling on first wire 151 at abdominal wall 406 causing device 100 to partially exit abdominal wall 406 may result in inadvertent mispositioning. Namely, too much pulling could result in device 100 fully exiting stomach 403 and / or abdominal wall 406 or being otherwise dislodged. One or more stoppers, such as stopper 181 of FIG. 2, may help prevent this outcome, as illustrated in FIGS. 5A-E.

[0123]

[0074] Turning to FIGS. 5A-E, a device 100 is shown partially in a stomach 403 and partially exiting an abdominal wall 406. In FIG. 5 A, dilator 101 of device 100 has fully exited abdominal wall 406, and device 100 is cut at sheath 121 external to abdominal wall 406 to disconnect dilator 101 from device 100. In exemplary embodiments, although sheath 121 is

[0124] Page 25 of 43

[0125] 137272040.1 1 hollow and air may enter sheath 121, rear end 120 is substantially sealed such that little to no fluid enters stomach 403 unintentionally through sheath 121. In exemplary embodiments, stopper 181 further contributes to this seal at gastrostomy 403a, helping prevent air or other gas or fluid from entering or leaving stomach 403 or the abdominal cavity where not desired. In exemplary embodiments, device 100 is pulled until stopper 181 apposes gastrostomy 403a and / or the wall of stomach 403. In exemplary embodiments, stopper 181 outwardly projects from the exterior of sheath 121, such that stopper 181 contacts the wall of stomach 403 and / or abdominal wall 406 if device 100 is being pulled too far and prevents device 100 from fully exiting stomach 403.

[0126]

[0075] In FIG. 5B, the remaining portion of device 100 still connects the inside of stomach 403 to the exterior across abdominal wall 406. This remaining portion of device 100 comprises the rear end 120 and a portion of sheath 121. The remaining portion of device 100 could likely have most of sheath 121, and possibly all of sheath 121 (e.g., if dilator 101 was cut near or at its base 104 apposing sheath 121), although not necessarily. The rear end 120 is connected to second wire 161 via second wire connector 122. In the illustrated embodiment, wire connection is via interlocking loops, with second interlocking segment 172 depicted. Such remaining portion of device 100 no longer has dilator 101 at leading end 110.

[0127]

[0076] In FIG. 5B, the remaining portion of device 100 is secured in place, effectively with a channel created by sheath 121 across abdominal wall 406 into stomach 403. Securing the remaining portion of device 100 can prevent slippage or loss of the channel, e.g. if some or all of sheath 121 is retracted (e.g., unintentionally) into stomach 403. Persons having ordinary skill in the art will readily appreciate that there are various different options for securing the remaining portion of device 100 within the scope of the present embodiments in light of the disclosures and descriptions herein. In the illustrated example, a forceps 550 is

[0128] Page 26 of 43

[0129] 137272040.1 1 applied at a portion of sheath 121 at its newly created terminus 125 after having been cut in FIG. 5A. Forceps 550 may comprise, for example, a pair oof arterial forceps, a hemostatic clamp, and / or a Hemostat.

[0130]

[0077] Turning to FIG. 5C, a tube 510 is inserted through sheath 121 (or its remaining portion) traversing abdominal wall 406 until the tube tip 511 is inside stomach 403. Tube 510 in FIG. 5C can comprise a gastrostomy tube (or, in other embodiments herein, a different gastrointestinal tube). Tube 510 in FIG. 5C can also comprise a balloon gastrostomy tube (or, in other embodiments herein, a different balloon retention gastrointestinal tube), with a balloon 512 approximating tube tip 511. In balloon G-tube embodiments, insertion of tube 510 can be until both tube tip 511 and balloon 512 are within stomach 403.

[0131]

[0078] Method embodiments described herein may be carried out with devices and / or kits disclosed or described herein. By way of example, device 100 in FIGS. 4A-H is depicted without a rod 105, whereas the device 100 of FIGS. 5A-E is shown comprising a rod 105. As such, in certain embodiments, such as FIG. 5C, inserting tube 510 through sheath 121 can further comprise positioning and / or anchoring tube tip 511 via rod 105.

[0132]

[0079] In FIGS. 5D-E, the remaining portion of device 100 is released (e.g., via removing the forceps and / or clamp, etc.) and retracted (e.g., via pulling on second wire 161 from oral cavity 401). In exemplary embodiments, the remaining portion of device 100 is retracted all the way out of oral cavity 401. FIG. 5E further shows balloon 512 inflated within stomach 403 for retention of tube 510. In exemplary embodiments, stomach 403 is apposed to abdominal wall 406 with no intervening organ(s), and tube 510 traverses the tract connecting skin 405, soft tissues 404, and gastrostomy 403a, with little to no surrounding free space. As such, in exemplary embodiments the outer sheath diameter 123a of sheath 121 is minimally (e.g., no more than 3 mm) larger than inner sheath diameter 123b, which corresponds to a

[0133] Page 27 of 43

[0134] 137272040.1 1 maximal diameter of dilator 101 at base 104, where inner sheath diameter 123b and the maximal diameter of dilator 101 at base 104 are minimally (e.g., no more than 3 mm) larger than an outer diameter of tube 510, so as to minimize stretching of soft tissues 404 and skin 405 of abdominal wall 406 relative to the tube 510 that will be traversing the skin / soft tissue tract. In exemplary embodiments, balloon 512 when inflated exceeds the diameter and / or size of gastrostomy 403a (and the tract involving soft tissues 404 and skin 405).

[0135]

[0080] The step of cutting sheath 121 in FIG. 5 A can be done at an angle relative to sheath 121, i.e. relative to the long axis of device 100 (the axis connecting rear end 120 and leading end 110). Cutting at an angle can result in a slanted terminus 125, as shown in FIGS. 5B-C, which can allow for easier securing (e.g., via forceps) of sheath 121 together with insertion of tube 510 into sheath 121. This can be due to, at least in part, (i) the perimeter of hollow sheath 121 at its terminus 125 and / or (ii) the surface area of the opening created into hollow sheath 121 near leading end 110. Devices and kits herein may include an angled line designed for such cutting along sheath 121. Such a line may be a demarcation and / or perforated segment. Such a line may be at the point where a sheath 121 apposes a base 104 of a dilator 101. In exemplary embodiments of a device 100, a base 104 of a dilator 101 may appose a sheath 121 at an angle, which may be demarcated and / or perforated for cutting or other disconnection or detachment.

[0136]

[0081] In certain embodiments, a method of inserting a balloon gastrostomy tube may comprise steps of: (i) securing percutaneous access from an abdominal wall into a stomach with a first wire having a first wire tip; (ii) endoscopically snaring the first wire tip in the stomach; (iii) retracting the first wire tip through an esophagus and out an oral cavity with a portion of the first wire remaining outside the abdominal wall; (iv) connecting the first wire tip and a second wire tip of a second wire to any embodiment of device 100; (v) pulling the first

[0137] Page 28 of 43

[0138] 137272040.1 1 wire at the abdominal wall wherein the device is advanced dilator-first through the oral cavity and the esophagus and into the stomach with a portion of the second wire remaining outside the oral cavity; (vi) pulling the first wire at the abdominal wall wherein the device partially exits the abdominal wall, further wherein the dilator fully exits and the sheath only partially exits the abdominal wall; (vii) detaching the dilator from the device; (viii) securing in place the remaining sheath traversing the abdominal wall with the rear end of the device in the stomach; (ix) inserting a gastrostomy tube having a balloon through the sheath traversing the abdominal wall until the balloon of the gastrostomy tube is in the stomach; (x) releasing and retracting the remaining portion of the device by pulling the second wire from the oral cavity; and (xi) inflating the balloon of the gastrostomy tube in the stomach.

[0139]

[0082] In further embodiments, the first wire tip may comprise a first looped tip; a first wire connector of the device may comprise a first loop configured to interlock with the first looped tip; and connecting the first wire tip to the device may comprise interlocking the first loop with the first looped tip. In further embodiments, the second wire tip may comprise a second looped tip; the second wire connector of the device may comprise a second loop configured to interlock with the second looped tip; and connecting the second wire tip to the device may comprise interlocking the second loop with the second looped tip.

[0140]

[0083] In further embodiments, securing in place the remaining portion of the device may comprise applying at least one forceps to the sheath traversing the abdominal wall, and releasing the remaining portion of the device may comprise removing the at least one forceps from the sheath. In further embodiments, at least one forceps may comprise a surgical forceps, surgical clamp, medical forceps, medical clamp, arterial forceps, pean forceps, hemostatic clamp, Hemostat, mosquito forceps, vascular forceps, Hartman mosquito forceps, Halstead mosquito forceps, straight mosquito forceps, curved mosquito forceps, Kelly clamp,

[0141] Page 29 of 43

[0142] 137272040.1 1 Kelly Hemostat forceps, curved Kelly clamp, vessel clamp, vascular clamp, Beck clamp, Guyon-Pean clamp, Satinsky clamp, rubber shod forceps, Adson forceps, Adson rat tooth forceps, rat tooth forceps, tissue forceps, Adson-Brown forceps, Adson-Brown tissue forceps, Bonney forceps, and Debakey forceps, or any combination thereof. Other options and / or variations within the scope of the present invention will be readily apparent to persons having ordinary skill in the art in light of the disclosures and descriptions herein.

[0143]

[0084] In further embodiments, securing percutaneous access may be via Seidinger technique. Alternatively, securing percutaneous access may be via advancing a catheter through an existing conduit, such as a skin and soft tissue tract, then advancing the first wire through the catheter. In further embodiments, a method may additionally comprise the step of securing the gastrostomy tube to the abdominal wall. In certain embodiments, securing the gastrostomy tube to the abdominal wall may be by applying at least one suture. Other options and / or variations within the scope of the present invention will be readily apparent to persons having ordinary skill in the art in light of the disclosures and descriptions herein, including with respect to embodiments regarding other types of gastrointestinal tubes.

[0144]

[0085] In further embodiments, inflating the balloon of the gastrostomy tube may comprise injecting fluid into the balloon. In further embodiments, the fluid may comprise gas, liquid, air, room air, water, sterile water, saline, normal saline, contrast, iodinated contrast, or any combination thereof.

[0145]

[0086] Also included herein are embodiments of devices without a second wire connector at the rear end. Such variants are shown in FIGS. 6 A and 6B, respectively without versus with an optional rod 105 (e.g., an anchoring rod) and at least one stopper 181. In certain embodiments, a device 600 may comprise a leading end 110 and a rear end 120, with the leading end 110 having a dilator 101 and a first wire connector 102, and with the rear end 120

[0146] Page 30 of 43

[0147] 137272040.1 1 having a hollow sheath 121 and a second wire 180 integrally connected to device 600 at rear end 120. In earlier embodiments discussed herein, a separate second wire is connected to the rear end (e.g., via loop interlocking shown in FIGS. 3I-N). However, a device (e.g., device 600) may simply comprise the second wire (e.g., second wire 180), including as an integrally connected component. Device 600 may comprise one or more other features discussed in the context of device 100, specifically regarding sheath 121, dilator 101, and first wire connector 102. By way of example, dilator 101 in device 600 may comprise a tip 103 and base 104. In light of the disclosures and descriptions herein, persons having ordinary skill in the art will readily appreciate variations to device, kit, and method embodiments with device 600 versus device 100.

[0148]

[0087] The present embodiments are not limited to human applications, as will be readily apparent to persons having ordinary skill in the art. The humanoid depiction in FIGS. 3A-N is for illustrative purposes only. Further, while certain descriptions herein reference a stomach and related verbiage (e.g., gastrostomy, G-tube, etc.), embodiments can have other applications, as well (e.g., jejunostomy, J-tube, etc.).

[0149]

[0088] Wires, tubes, sheaths, kits, dilators, devices, and / or balloons herein, and / or any component thereof, may comprise or consist of materials appropriate and known to one of ordinary skill in the art, e.g., carbon fiber, medical grade plastic, latex, metal, metal alloy, nickel, nickel -titanium alloy, nitinol, nylon, polyester, polytetrafluorethylene, polyurethane, silicone, stainless steel, titanium, etc., or any combination thereof. Wires, tubes, sheaths, kits, dilators, devices, and / or balloons herein, and / or any component thereof, may comprise a coating of material(s) appropriate and known to one of ordinary skill in the art. In certain embodiments, a coating may comprise a hydrophilic material, e.g., hydrophilic coating, hydrophilic polymer, carbon-carbon backbone polymer, heteroatom backbone polymer,

[0150] Page 31 of 43

[0151] 137272040.1 1 thermo-responsive polymer, pH-responsive polymer, poly(acrylic acid) (PAA), poly(acrylamide) (PAAm), poly(ethylene glycol) (PEG), poly(ethylene imine) (PEI), poly(2- methyl-2-oxazoline) (PMeOx), poly(vinyl alcohol) (PVA), poly(vinylpyrrolidone) (PVP), poly(N,N-diethylacrylamide) (PDEA), poly(N,N-dimethylacrylamide) (PDMA), poly(2- (dimethylamino)ethyl methacrylate) (PDMAEMA), poly(2-hydroxypropyl methacrylamide) (PHPMA), poly(oligo ethylene glycol methyl ether methacrylate) (POEGMA), poly([2- methacryloyloxy)ethyl]dimethyl-(3-sulfopropyl)ammonium hydroxide) (PSBMA), etc., or any combination thereof. In exemplary embodiments, a sheath according to one or more embodiments herein may comprise at least one such hydrophilic coating, e.g., along some or all of an inner wall of the sheath. It will be understood hydrophilic coating of a sheath, including specifically inner wall coating, may facilitate easier positioning, manipulation, and / or insertion of a gastrointestinal tube in accordance with embodiments discussed herein. Persons having ordinary skill in the art will readily appreciate additional options and variations of material(s) and configurations thereof.

[0152]

[0089] Wires, tubes, sheaths, kits, dilators, devices, and / or balloons herein, and components thereof, may vary in size, as will be readily apparent to those of ordinary skill in the art. By way of nonlimiting example: wires may comprise 0.035” in diameter and / or 135 cm in length; sheaths may comprise 5-10 cm in length, 6-12 mm in internal sheath dimeter, and / or 7-15 mm in outer sheath diameter; dilators may comprise 3-10 cm in length, 6-12 mm in diameter at the base, and / or <4 mm in diameter at the tip; balloons may be inflated with up to about 10-25 mL of fluid and / or be inflated up to about 1-3.5 cm in diameter; and / or any combination thereof. A bumper may be a ring approximately 2 mm thick situated on a sheath about 7-8 cm away from a dilator. Various different dimensions, all within the scope of the present invention, will be readily apparent to those of ordinary skill in the art.

[0153] Page 32 of 43

[0154] 137272040.1 1

[0090] The embodiments herein solve issues in the prior art and allow for placement of a balloon gastrostomy tube, without needing to worry about the balloon’s inflation port and / or lumen, while using an endoscopy-assisted ‘pull technique,’ such as attaching a device in accord with the present invention to a wire and using the wire to pull the device into an oral cavity, down an esophagus, and out through a gastrostomy and tract crossing soft tissue and skin in an abdominal wall, with a sheath that is left in place to guide placement of the gastrostomy tube, wherein the sheath can itself be retracted by pulling another connected wire with its end still out of the oral cavity.

[0155]

[0091] The foregoing description is of certain embodiments. Other embodiments will be within the scope of the claims. Those having ordinary skill in the art will readily appreciate variations and / or improvements that may be included in alternate embodiments in light of this disclosure.

[0156]

[0092] In the foregoing description of embodiments according to the present invention, details are set forth for purpose of explanation. However, one of ordinary skill in the art will realize that the embodiments described herein may be practiced without the use of all of these specific details. The embodiments (and descriptions) disclosed herein are intended, therefore, to be only illustrative and not limiting. Numerous other variations, all within the scope, will readily occur to those of ordinary skill in the art. Similarly, where examples are used herein, no example is intended to be limiting, unless the context in which the example is used clearly indicates otherwise. Accordingly, “e.g.” or “for example” should be read as “for example, and without limitation,” unless the context clearly indicates that limitation to the given example(s) is intended.

[0157]

[0093] As used herein, the terms “first” and / or “second” etc. are used to differentiate components but not to dictate, limit, mandate, or necessitate any arrangement,

[0158] Page 33 of 43

[0159] 137272040.1 1 configuration, order, or sequence. The reference to a “first” and / or “second” etc. is intended to identify one component from another, and is not intended to specify a number of elements or in defining an order. The meanings of terms used herein shall be apparent, from the description, the figures, and / or the context in which the terms are used, to those of ordinary skill in the art.

[0160]

[0094] While this specification contains many specific details, these should not be construed as limitations on the scope, but rather as descriptions of features that may be specific to particular embodiments. Those of ordinary skill in the art will readily appreciate that: (i) certain features that are described in the context of separate embodiments can also be implemented in combination; (ii) various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination; and (iii) although features may be described or claimed as acting in certain combinations, one or more features can in some cases be excised from the combination, and / or the feature(s) may be directed to any other subcombination or variation of a subcombination.

[0161]

[0095] It is not possible to illustrate examples of all possible embodiments. It will be understood by those of ordinary skill in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the present embodiments without departing from the scope. The claims herein shall not be limited to the embodiments shown in the figures and / or discussed in the detailed description.

[0162] Page 34 of 43

[0163] 137272040.1 1

Claims

We claim:

1. A gastrointestinal tube insertion device comprising: a leading end with a conical dilator and a first wire connector; and a rear end with a hollow sheath and a second wire connector.

2. The gastrointestinal tube insertion device of claim 1, wherein the leading end is a smaller caliber than the rear end.

3. The gastrointestinal tube insertion device of claim 1, wherein the conical dilator tapers from a tip at the leading end to a base, where the tip is 3 mm in diameter or less and the base is between 6 mm and 12 mm in diameter, and the base apposes the hollow sheath.

4. The gastrointestinal tube insertion device of claim 1, wherein the conical dilator is semirigid.

5. The gastrointestinal tube insertion device of claim 1, wherein the conical dilator comprises a material selected from the group consisting of carbon fiber, medical grade plastic, latex, nylon, polyurethane, and silicone.

6. The gastrointestinal tube insertion device of claim 1, wherein the first wire connector comprises a first loop configured to interlock with a first looped tip of a first wire.

7. The gastrointestinal tube insertion device of claim 1, wherein the first wire connector is selected from the group consisting of catch, clamp, clasp, clip, hook, lock, snap, and vice.

8. The gastrointestinal tube insertion device of claim 1, wherein the first wire connector comprises a material selected from the group consisting of carbon fiber, metal, metal alloy,Page 35 of 43137272040.1 1nickel, nickel -titanium alloy, nitinol, nylon, polytetrafluorethylene, stainless steel, and titanium.

9. The gastrointestinal tube insertion device of claim 1, wherein the hollow sheath is cylindrical.

10. The gastrointestinal tube insertion device of claim 1, wherein the hollow sheath is configured to receive a gastrointestinal tube, and comprises an inner sheath diameter that is larger than an outer tube diameter of the gastrointestinal tube.

11. The gastrointestinal tube insertion device of claim 10, wherein the inner sheath diameter is at least 3 mm larger than the outer tube diameter.

12. The gastrointestinal tube insertion device of claim 10, wherein the inner sheath diameter is between 6 mm and 12 mm.

13. The gastrointestinal tube insertion device of claim 1 , wherein the hollow sheath is semirigid.

14. The gastrointestinal tube insertion device of claim 1, wherein the hollow sheath comprises a material selected from the group consisting of carbon fiber, medical grade plastic, latex, nylon, polyurethane, and silicone.

15. The gastrointestinal tube insertion device of claim 1, wherein the hollow sheath further comprises an inner wall, further wherein the inner wall is at least partially coated with a material selected from the group consisting of hydrophilic coating, hydrophilic polymer, carbon-carbon backbone polymer, heteroatom backbone polymer, thermo-responsive polymer, pH-responsive polymer, poly(acrylic acid), poly(acrylamide), poly(ethylene glycol), poly(ethylene imine), poly(2-methyl-2-oxazoline), poly(vinyl alcohol),Page 36 of 43137272040.1 1poly(vinylpyrrolidone), poly(N,N-diethylacrylamide), poly(N,N-dimethylacrylamide), poly(2- (dimethylamino)ethyl methacrylate), poly(2-hydroxypropyl methacrylamide), poly(oligo ethylene glycol methyl ether methacrylate), and poly([2-methacryloyloxy)ethyl]dimethyl-(3- sulfopropyl)ammonium hydroxide),16. The gastrointestinal tube insertion device of claim 1, further comprising at least one stopper protruding from the sheath.

17. The gastrointestinal tube insertion device of claim 16, wherein the stopper outwardly projects from the sheath circumferentially.

18. The gastrointestinal tube insertion device of claim 17, wherein the stopper outwardly projects from the sheath by a continuous protrusion distance.

19. The gastrointestinal tube insertion device of claim 18, wherein the protrusion distance is at least 2 mm.

20. A gastrostomy tube insertion device, comprising: a leading end having a tapered conical dilator and a first loop configured to interlock with a first looped tip of a first wire; and a rear end having a cylindrical hollow sheath and a second loop configured to interlock with a second looped tip of a second wire, wherein: the tapered conical dilator is semi-rigid and tapers down from a tip at the leading end to a base that apposes the cylindrical hollow sheath; andPage 37 of 43137272040.1 1the cylindrical hollow sheath has an inner sheath diameter and is configured to receive a gastrostomy tube having an outer tube diameter at least 3 mm less than the inner sheath diameter.

21. A gastrointestinal tube insertion kit comprising: a first wire; a second wire; and a gastrointestinal tube insertion device having a leading end with a conical dilator and a first wire connector, and a rear end with a hollow sheath and a second wire connector.

22. The gastrointestinal tube insertion kit of claim 21, wherein the first wire has a first looped tip.

23. The gastrointestinal tube insertion kit of claim 21, further comprising a gastrointestinal tube.

24. The gastrointestinal tube insertion kit of claim 23, wherein the gastrointestinal tube comprises an inflatable balloon retention anchor.

25. A method of inserting a balloon gastrostomy tube, using a balloon gastrostomy tube insertion device having a leading end with a dilator and a first wire connector and a rear end with a hollow sheath and a second wire connector, comprising the steps of: securing percutaneous access across an abdominal wall into a stomach with a first wire having a first wire tip; endoscopically snaring the first wire tip in the stomach;Page 38 of 43137272040.1 1retracting the first wire tip through an esophagus and out an oral cavity; connecting the first wire tip to the first wire connector and connecting a second wire tip of a second wire to the second wire connector; pulling the first wire at the abdominal wall to advance the balloon gastrostomy tube insertion device through the oral cavity and the esophagus and into the stomach; pulling the first wire at the abdominal wall to advance the dilator outside the abdominal wall and the hollow sheath across the abdominal wall; detaching the dilator from the balloon gastrostomy tube insertion device; securing in place the remaining hollow sheath traversing the abdominal wall with the rear end in the stomach; inserting a balloon gastrostomy tube through the sheath traversing the abdominal wall until a balloon of the balloon gastrostomy tube is in the stomach; releasing and retracting the remaining balloon gastrostomy tube insertion device by pulling on the second wire; and inflating the balloon of the balloon gastrostomy tube in the stomach.

26. The method of inserting a balloon gastrostomy tube of claim 25, wherein the step of securing in place the remaining hollow sheath comprises applying forceps to a portion of the hollow sheath at the abdominal wall.

27. The method of inserting a balloon gastrostomy tube of claim 26, wherein the forceps is selected from the group consisting of surgical forceps, surgical clamp, medical forceps, medical clamp, arterial forceps, pean forceps, hemostatic clamp, Hemostat, mosquito forceps, vascularPage 39 of 43137272040.1 1forceps, Hartman mosquito forceps, Halstead mosquito forceps, straight mosquito forceps, curved mosquito forceps, Kelly clamp, Kelly Hemostat forceps, curved Kelly clamp, vessel clamp, vascular clamp, Beck clamp, Guyon-Pean clamp, Satinsky clamp, rubber shod forceps, Adson rat tooth forceps, Adson forceps, rat tooth forceps, tissue forceps, Adson-Brown forceps, Adson-Brown tissue forceps, Bonney forceps, and Debakey forceps.

28. The method of inserting a balloon gastrostomy tube of claim 25, wherein the step of securing percutaneous access comprises the Seidinger technique.

29. The method of inserting a balloon gastrostomy of claim 25, wherein the step of securing percutaneous access comprises advancing a catheter through an existing skin and soft tissue tract and advancing the first wire through the catheter.

30. The method of inserting a balloon gastrostomy tube of claim 25, further comprising the step of securing the balloon gastrostomy tube to the abdominal wall.

31. The method of inserting a balloon gastrostomy tube of claim 30, wherein the step of securing the balloon gastrostomy tube to the abdominal wall comprises applying at least one suture.

32. The method of inserting a balloon gastrostomy tube of claim 25, wherein the step of inflating the balloon of the balloon gastrostomy tube further comprises injecting a fluid.

33. The method of inserting a balloon gastrostomy tube of claim 32, wherein the fluid is selected from the group consisting of gas, liquid, air, room air, water, sterile water, saline, normal saline, contrast, and iodinated contrast.

34. A gastrointestinal tube insertion device comprising: a leading end with a conical dilator and a first wire connector; and Page 40 of 43137272040.1 1a rear end with a hollow sheath and a second wire integrally connected.

35. A gastrointestinal tube insertion kit comprising: a first wire; and a gastrointestinal tube insertion device having a leading end with a conical dilator and a first wire connector, and a rear end with a hollow sheath and a second wire integrally connected.

36. A method of inserting a balloon gastrostomy tube, using a balloon gastrostomy tube insertion device having a leading end with a dilator and a first wire connector and a rear end with a hollow sheath and a second wire integrally connected, comprising the steps of securing percutaneous access from an abdominal wall into a stomach with a first wire having a first wire tip; endoscopically snaring the first wire tip in the stomach; retracting the first wire tip through an esophagus and out an oral cavity; connecting the first wire tip to the first wire connector; pulling the first wire at the abdominal wall to advance the balloon gastrostomy tube insertion device through the oral cavity and the esophagus and into the stomach; pulling the first wire at the abdominal wall to advance the dilator outside the abdominal wall and the hollow sheath across the abdominal wall; detaching the dilator from the balloon gastrostomy tube insertion device;Page 41 of 43137272040.1 1securing in place the remaining hollow sheath traversing the abdominal wall with the rear end in the stomach; inserting a balloon gastrostomy tube through the sheath traversing the abdominal wall until a balloon of the balloon gastrostomy tube is in the stomach; releasing and retracting the remaining balloon gastrostomy tube insertion device by pulling on the second wire from the oral cavity; and inflating the balloon of the balloon gastrostomy tube in the stomach.Page 42 of 43137272040.1 1

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