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    • 专利摘要:
    METHOD OF POSITIONING A PEG DEVICEThe present invention is about a stoma dilatation device, which includes a tubular support, which defines a continuous path through the device; an inflatable expansion balloon located on the tubular support, the inflatable expansion balloon including an expansion region, which forms a first portion of the device, and a retention region, which forms a second portion of the device; and a balloon inflation lumen. The balloon retention region is configured to have a diameter, upon full, unrestricted inflation, that is greater than the diameter of the dilatation region.
    公开号:BR112013007171A2
    申请号:R112013007171-0
    申请日:2011-09-27
    公开日:2020-12-15
    发明作者:Kok-Ming Tai；Donald J. McMichael；John A.Rotella；Nathan C. Griffith；Emily A. Reichart；Esteven A.Holley；Edward B. Madsen；Courtney E.Rowe
    申请人:Kimberly-Clark Woerldwide, Inc.；
    IPC主号:
    专利说明:

    "DTSPOSITIVE AND STOMA DILATING STTEM, METHOD OF POSTING A PEG DTSPOSTTTVO"
    BACKGROUND This invention relates to catheters, such as COR10 feeding tubes, and their placement in a patient's body.
    Many situations exist in which a cavity in the body needs to be catheterized in order to achieve a desired medical goal. A relatively common situation is the delivery of nutritional solutions or medications directly to the stomach or intestines. A stoma is formed in the wall of the stomach or intestine and a catheter is placed through the stoma. This opening and/or surgical procedure to create the opening is commonly referred to as a "gastrostomy". Feeding solutions can be injected through the catheter to deliver nutrients directly to the stomach or intestines (known as enteral feeding). A variety of different catheters intended for enteral feeding have been developed over the years, including some featuring a "low profile" in relation to the portion of the catheter that sits on a patient's skin, as well as those having the configuration more traditional or non-low profile. These percutaneous transconduit catheters (which are sometimes referred to as "percutaneous transconduit tubes") are often referred to as "gastrostomy catheters", "percutaneous gastrostomy catheters", "PEG catheters" or "percutaneous catheters". of enteral feeding". U.S. Patent No. 6,019,746 for a "Low Profile Balloon Feeding Device," issued to Pichia, et al., February 1, 2000, provides an example of such a device.
    These catheters are often placed in a procedure called a percutaneous endoscopic gastrostomy (which is often referred to as PEG). Traditionally, a PEG tube is placed using endoscopic guidance or X-ray guidance.
    35 In a conventional PEG procedure, which places a PEG tube in a patient's stomach, an endoscope is used to see if
    "-------2115,. —:_ the patient's esophagus is unobstructed and to inspect and inflate the stomach to see if the area selected for gastrostomy can be distended.
    If the location is suitable, this point will be selected 5. Prior to placement of any feeding tube, it has been found useful to anchor the anterior wall of the gastric lumen (eg, stomach) to the abdominal wall, as a step before creating the stoma tract through the two. Insufflation of the gastric lumen has also been recognized as successful in keeping the lumen in close proximity to the abdominal wall in some procedures. This procedure is also applicable to the jejunostomy or gastrojejunostomy, as well as the gastrostomy procedure referred to above. Similar procedures may also be applicable or desirable for other catheter tubes, such as peritoneal drainage tubes.
    After the wall of the lumen is anchored, a needle is inserted into the patient at the appropriate site area. Additionally, a small incision can be made in the skin. An endoscopist will then typically look through the endoscope as a needle penetrates through the patient's skin, then through the abdominal wall, and enters the gastric lumen in the selected area to form a needle tract. A guide wire is passed through the needle into the gastric lumen (eg, "25 stomach). The endoscopist will use an endoscopic snare to hold the guide wire firmly.
    UI through endoscope operating channel, firmly grips guide axis. Both the endoscope and the trap are then withdrawn together through the patient's mouth, pulling the guide wire 30 with them. The end of the guide wire, which extends out of the patient's mouth, is subsequently attached to a PEG tube and the other end of the guide wire remains outside the patient's e-skin in the abdominal region.
    The PEG tube is guided into the patient's mouth 35 (while the endoscope is completely removed from the patient) and pulled into the patient's gastric lumen as the guide wire is pulled from the end remaining on the outside of the B * · _ _ - -- _.-.-- -. - - --- —-- —--—— —- —.—-- —- - —, _ 3/15 — --.——. — — . patient's skin. Once the peg tube is in the gastric lumen, it is pulled partially through the gastric and abdominal walls until a peg tube buffer is fitted against the gastric mucosa. However, in order for the peg tube 5 to be pulled partially through the gastric and abdominal walls and skin, the original needle tract has to be dilated. This dilation is accomplished with conventional dilation devices, which employ a tapered dilator at the distal end of the PEG tube so that it dilates the opening as it is pulled through the gastric mucosa. During such dilation, . the endoscope is passed back to the patient and used subsequently to visually observe that c) the PEG tube damper is fitted against the gastric mucosa. In other conventional PEG tube 15 placement procedures, endoscopy is not used at all. Instead, X-ray techniques are used to help select a particularly suitable location in the patient's body (eg, the stomach) for the introduction of the PEG tube. X-rays are used to guide the placement of 20 PEG tube and for inspection of the final position of the PEG tube.
    In yet another procedure, known as gastropexy, a needle is used to pierce a patient's abdominal wall to position one or more fasteners in a patient's gastric lumen. A fastener, such as a "T-bar 25" fastener, carried at or near the needle tip is desirably installed by the needle so that it can be positioned against an inner wall of the gastric lumen. A tensioning suture is connected to the fastener and, at an opposite end of the suture on the external surface of the patient's body, the suture is desirably also connected to a suture retainer, which allows adjustment of tension in the suture. In this way, when the suture is taut, the wall of the patient's gastric lumen will be more closely positioned relative to the external surface of the patient's body, and the gastric lumen will be stabilized in one position. Usually at least three and, desirably, four fasteners are positioned in a urn.
    -- —" _4_/15 triangular, square, or diamond-shaped configuration through a patient's skin and into the gastric lumen.
    While there are some problems associated with these conventional procedures, including an increased risk of esophageal trauma associated with multiple passes of an endoscope in and out of a patient or positioning the PEG in an inappropriate location, a significant problem is related to complications. additional anchorages from the gastric lumen wall to the abdomen. It would be desirable to avoid the complications of the additional steps of such a procedure and/or the additional trauma caused by mechanical anchoring (even temporarily) of the gastric lumen wall to the abdomen. Although avoiding these complications may be desirable, there is a lack of adequate devices or procedures. Consequently, there is a demand for a device, system and method for positioning a non-vascular catheter tube, such as a peg tube, in a patient that reduces these risks and traumas and is easy to perform.
    SUMMARY In response to the difficulties and problems discussed herein, this invention describes an inflation device and a dilatation system. The dilatation device is an inflatable device, which is used for positioning catheter tubes in a non-vascular lumen, desirably under direct visualization using an endoscope.
    In accordance with this invention, a conventional endoscope is advanced into the stomach to inflate and allow palpation to locate a suitable site. Once the appropriate site is located, a needle is inserted. into the stomach through the abdomen, from the Eora side of the body, to form a needle tract. A guide wire is then introduced into the stomach through the needle, and a system is provided for: placement of a dilating device in the needle tract; maintaining the dilatation device in the desired position; dilatation of the needle tract and removal of the dilator device.
    .
    -— ---_.-_ _5GL5 the dilatation device includes an inflatable balloon including an expansion region, which forms a first portion of the device, and a retention region, which forms a second portion of the device, an inflation lumen for inflating and deflating the inflatable balloon, a tubular support and a continuous path through the device, which accommodates a guide wire. The inflatable balloon can be compliant, semi-compliant or non-compliant. The inflatable balloon (also referred to as a "dilation balloon") is positioned towards the distal end 10 of the device. The dilatation balloon" includes a distal section and an opposing proximal section. The dilatation balloon is of a predetermined diameter length when fully inflated to fit a specifically sized catheter tube device. Alternatively, q 15" balloon Dilation can be dilated to various effective diameters using respectively different inflation pressures to fit various catheter tubes. The section proximal to the dilation balloon (that portion of the dilation balloon which is positioned in the nonvascular lumen) can be designed to have substantially the same diameter characteristics of the distal section or it may have a section with a diameter greater than any diameters of the distal section. The balloon section with the largest diameter is referred to as the "retention section" or the "proximal retention balloon component". Once this section is inflated, it functions to provide retention of the dilator device within the non-vascular lumen (eg, the stomach). The proximal retention balloon component can be compliant, semi-compliant, or non-compliant. The inflatable balloon (i.e., the diatation balloon) has two opposing open ends. These 30 open ends are attached to the tubular support.
    The tubular support of the dilatation device supports the dilatation balloon. The dilatation device also has at least one inflation lumen for inflating and deflating the dilatation balloon component. It is contemplated that any one of the inflation lumens included in the dilatation device may serve as the tubular support for the dilatation balloon. In others
    __ _ ;6/_15 words, the tubular support can define the relevant inflation lumens.
    The dilatation device may have a single continuous path through its entirety to accommodate a guide wire 5. This route may include the inflation lumen for the dilatation balloon and the tubule support; or it may be a separate lumen. that is contained within the walls of an inflation lumen of the tubular support; or combinations thereof.
    In accordance with this invention, the dilatation device can be used in "inside-out" or "outside-in" dilatation procedures. Inside-out dilatation procedures involve attaching the dilator device to the guidewire outside the patient's mouth or inside the nonvascular lumen (eg, the stomach or other space). A non-limiting example of fixation outside the patient's mouth might involve the following steps: insertion of an endoscope, which extends from the outside of the mouth to the inside of the stomach; conventional positioning of a guide wire through the skin, abdominal wall and stomach wall using a needle; insertion of a standard endoscope forceps or an endoscopic trap through the operating channel of the endoscope; use of forceps or trap to grasp the portion of guidewire that is in the stomach and then pull the guidewire through the operating channel of the endoscope and out of the patient's mouth current, where the entire endoscope is removed from the patient); firmly attaching the end of the dilatation device which is closest to the dilatation balloon (not the retention balloon portion of the dilatation device) to the end of the guide wire extending from the patient's mouth; pull the guide wire and the attached dilatation device back through the operating channel of the endoscope so that the balloon is exiting the operating channel into the stomach via the portion of the guide wire that remains on the left side out of the skin. A non-limiting example of attaching the dilator device to the guidewire inside the patient's stomach may involve the following features and/or steps: o
    " _" - '— - · — — _. _._ _ . _ 4 _ ._ ' —7 / 1 5 dilatation device contains an accessory (magnet, hook, loop, trap, etc.) at the end closest to the dilatation balloon (the side that enters the mouth first of all); the dilator device is pushed through the operating channel 5 of the endoscope, so that the attachment exits the operating channel; . the accessory is fixed under view of the enoscope by connecting the accessory to the guide wire (which has been inserted through the needle); pulling the portion of the guide wire that remains outside the skin, so that the dilator device is pulled through 10' of the operating channel and directed into the stomach.
    Regardless of the steps taken to position c) the dilatation device in the stomach, after placement in the stomach, it is pulled in and partially through the needle tract so that at least a portion of the deflated dilatation balloon extends through the abdominal tissue and skin and that the retention balloon resides in the stomach.
    Outside-in dilatation procedures differ from inside-out procedures in that they do not pass the dilatation device through the operating channel of the endoscope in order to position the dilator device in the stomach. , nor is there any need to attach the dilator device to a guide wire extending from the patient's stomach through the mouth.
    Outside-in procedures may involve the following steps: Insertion of an endoscope. that it extends through the mouth to the inside of the stomach; conventional initial placement of a guidewire through the skin, abdominal wall, and stomach wall through an inserted needle and then removing the needle with the guidewire in place; mounting the dilatation device over the end of the guide wire which is outside the patient's skin; partial insertion of the dilator device into the needle tract so that the retention balloon enters the stomach before any portion of the dilatation balloon.
    In the positioning of the deflation device, the clalation balloon must be in a deflated state so that the dilatation device easily slides through the operating channel of the endoscope and/or penetrates the needle tract without excessive force. The dilating device in this deflated state desirably wraps and bends around the tubular support as much as possible to minimize the effective cross-sectional area of the dilating device during insertion through the endoscope and/or needle tract. Such folding and wrapping is accomplished by intentionally folding the walls of the balloon into pre-planned arrangements, through the use of a pleating and/or folding fabrication apparatus, or by overlapping and non-folding randomly made possible by the "flexible and thinness of the balloon walls.
    In accordance with one aspect of this invention, the dilator device contains only one balloon. The expansion balloon of the expansion device can be inflated by gradually introducing controlled amounts of fluid (eg, liquid or gas) to increase the pressure in the balloon. As previously described, the dilatation balloon may have a length of a single diameter or it may have variable diameters. The portion of the balloon having a length of a single diameter is positioned in the needle tract and inflates radially to provide non-traumatic inflation (as compared to serial dilation) of the entire needle tract to create the stoma tract. The proximal retention balloon component portion of the device inflates inside the stomach and not in the needle tract. It is used to stabilize the device and to help prevent the device from being pulled out of the stoma tract during c) procedure.
    A better understanding of the foregoing and many other features and advantages of the flow indicator liquid dispensing device may be gained from a consideration of the detailed description of this invention below, particularly if such consideration is taken in conjunction with the accompanying drawings. .
    BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side cross-sectional view illustrating an exemplary dilatation device, which features a tubular support on which the inflatable dilatation balloon is mounted.
    "r . ——- -- - --- 9L15 __ _ _ _, - --. - - - _ . _,_ ——-—- —— Figure 2 is a cross-sectional view
    Side H illustrating the position of an exemplary dilator device pulled through the gastric lumen wall and abdominal wall prior to inflating the device. Figures 3A and 3B are side cross-sectional views of an exemplary dilatation device showing an inflated dilatation balloon and inflated retention stabilizing the lumen wall against the abdominal wall. . - -In Figure 3A, the inflatable dilatation balloon is in position with the retention portion inside the lumen, but the yumen is not properly adjusted against the inside of the abdominal wall. In Figure 3B, the gastric lumen had been properly pulled against the inside of the abdominal wall.
    DETAILED DESCRIPTION Reference will now be made to the drawings, in which the various elements of the present description will be assigned numerical designations, and in which the invention will be discussed in order to enable one skilled in the art to embody and use the invention. It is to be understood that the following description is only exemplary of the principles of the present invention, and should not be construed as a limitation of the appended claims. Those skilled in the art will appreciate that aspects of the various wodalities discussed may be interchanged and modified without departing from the scope and spirit of the. invention.
    25 Since the stomach is a common example of a non-vascular lumen, for the purpose of describing this invention, the use of the words "gastric lumen" or "stomach" is representative of all other lumens or non-vascular spaces (e.g. , duodenum, jejunum, ileum, peritoneal cavity, etc.). unless 30 otherwise specified.
    Turning now to the drawings, in Figure 1, an exemplary stoma dilatation device 100 is shown in lateral cross-sectional view, which includes a tubular support 102, which defines at least one continuous path 104 through the device 35. . the continuous path is configured to accommodate the guide wire.
    -" -- --60/-1-5 -- — -..- --L- J "_..:_.
    The tubular support 102 has a length, a width and a longitudinal axis "LA". The tubular support 102 must be flexible, but not too flexible, so as to readily collapse or twist when pressure is applied radially or axially. The width of the tubular holder must be small enough so that it can fit into the operating channel of an endoscope. For example, the tubular support may have a width of from about 0.2 to about 2 millimeters. -More desirably, the tubular support may have a width of from about 0.5 to about 1.75 millimeters. The tubular support can be made from a variety of suitable materials. Exemplary materials include thermoplastic polyurethanes, such as TECOFLEX® medical grade aliphatic polyether polyurethanes, available from Lubrizol Advanced Materials, Ihc., ThermedicsTM Polymer Products, Wilmington, Massachusetts, USA.
    Device 100 includes an inflatable expansion balloon 106, located in tubular support 102, having at least one inflatable expansion section 108, in a distal portion 110 of the device, and at least one inflatable retention balloon component 112, located in a proximal portion of device 114 (i.e., proximal retention balloon component 112). The inflation balloon 106 has at least one balloon inflation lumen 116 to inflate and deflate the balloon. Desirably, the inflation lumen 116 is integrated with the tubular support 102. In this regard, the tubular support 102 may define multiple lumens. In other words, the tubular support may define a continuous path 104, at least one balloon inflation lumen 116, to inflate and deflate the expansion balloon 106. It is contemplated that the inflation lumens may be separate from the tubular support. and that can-n be in. in the form of pilot tubes or the like. In accordance with this invention, the proximal retention balloon member 112 is configured to have an effective cross-section upon full, unconstrained inflation that is greater than the largest diameter of cross-section. of the expansion section 108 after inflation, as is generally illustrated in Figure 1. the expansion section 108
    ¶ -·------11/15— ------ ' "":-----: " of the balloon has a length and a circular cross section with a predetermined diameter after full inflation, in order to fit to a specifically sized catheter tube device. Alternatively, the dilatation section,108 may be dilated to several effective diameters using respectively different inflation pressures to fit various catheter tubes. As a non-limiting example, the inflated diameter The effective inflated diameter of the expansion section 108 can vary from about 3 to about 10 millimeters. As another non-limiting example, the effective inflated diameter of the expansion section 108 can vary from about 2 to about 8 millimeters. having a length and having a non-circular cross-section along the contour, for example elliptical or oval, is also contemplated.
    The proximal portion 114 of the balloon 106 15..._(that portion of the balloon that is positioned in the nonvascular lumen) incorporates the retention section 112 (which is also referred to as the "proximal retention balloon component" ) having a substantially larger cross-section or diameter than any diameters of the Retaining section 108. Generally speaking, the prox:magnetic retention balloon component may have a cross-section or diameter that is about 1.5 times about 3 times the diameter of the dilatation section 108. Once this proximal retention balloon component 112 is inflated, it functions to stabilize the lumen wall and/or to provide retention of the dilator device within the nonvascular lumen (eg e.g. the stomach).
    Proximal retention balloon member 112 may have a circular or non-circular cross-section, as long as it is capable of functioning as described above. (The reception balloon may have or may lack a cross-section with an axis of symmetry. The proximal retention balloon component 112 may, for example, be square, rectangular, triangular, elliptical, oval, or other geometry. and/or additionally, the proximal retention balloon component 112 may incorporate lobes, pawls (fingers) or projections that contribute to its overall cross section such that it is larger than the diameter of the r section.
    . and
    "" """" ""7271"5 - - -- - - —"—- -- —- -.. -:--_ _" _ ,. _ _ _ __ _,,, _
    Dilation 108. Dilatation balloon 106 desirably includes two opposing open ends.
    The open ends can be fixed to the tubular support.
    The expansion balloon 106 may have open ends 118 and 120. The expansion balloon may be formed of materials such that the balloons are compliant, non-compliant or non-compliant.
    In other words, a balloon can be relatively elastic (eg, compliant), so that it stretches as well as expands. when inflation.
    Balloon 10 can also be somewhat elastic (eg, semi-compliant) so that it expands but has limited stretch after inflation.
    The balloon may be inelastic (eg, non-compliant), so that it expands without significantly stretching upon inflation.
    Desirably, the balloons can _15 --be-formed- from material .de, ,polyurethane identified with the
    Pellethane® 2363-90A, available from Lubrizol Advanced Materia1s;
    Inc., ThermedicsTM PQlymer Products.
    This invention also covers a system for dilating a stoma and inserting a non-vascular catheter tube, the system includes a stoma dilatation device as described above.
    The system also includes a non-vascular catheter tube configured to fit over the Miatation balloon (i.e., dilatation section 108) fully or partially inflated through the dilated stoma tract and into the portion of the non-vascular lumen stabilized by the retention section (ie, the proximal retention balloon component). In accordance with the system, the stoma dilator device is configured to be deflated and at least a portion of the device withdrawn through the non-vascular catheter tube. 30 In an exemplary, non-limiting description of device placement, an endoscope may be advanced into a nonvascular lumen (e.g., the stomach) to inflate and allow palpation to locate a catheter tube placement site (e.g., the stomach). , a PEG positioning site). Once the site is located, a needle can be inserted into the stomach through the abdomen and a guide rod can be introduced into the stomach through the needle.
    . — - - —-- —- - —L3 /4.5 - - — - Standard endoscopic forceps, an endoscopic trap, or a balloon attachment accessory can be inserted through the operating channel of the endoscope. Forceps, snare or attachment are used to grasp the guide wire and the guide wire is pulled through the operating channel of the endoscope and out of the patient's mouth.
    A dilator device, with its inflation lumen attached, is attached to the end of the guide wire and is pulled through the operating channel of the endoscope using the guide wire in 10 direction to the stomach. The dilatation device may feature a dilatation balloon having a distally positioned dilatation section having a predetermined volume and diameter upon inflation, and a proximal retention balloon component having a diameter, after complete inflation, which is greater than 15 of than the diameter. of the expansion section. When these balloons are in a folded or tightly wrapped state, the dilatation device will have a diameter that fits within the operating channel of the endoscope. Typically, the diameter is in the range of about 2 millimeters or less. 20 The needle is removed from the stomach while retaining the guide wire in the needle tract. The device. The dilatation device is pulled in and partially through the needle tract so that it reaches the abdominal tissue and skin on the outside of the patient, as illustrated in Figure 2. 25 Referring now to Figures 3A and 3B, the balloon expansion device 106 of the expansion device 100 is then inflated by gradually introducing controlled amounts of fluid (e.g. liquid or gas) to increase the pressure in the balloon so that the expansion section 108 expands gently and gradually move the needle tract to a stoma tract. The proximal retention balloon component 112 of the dilatation balloon 106 is also inflated as the dilatation section 108 is inflated. complete, it will stabilize the stomach wall "SW" by bringing it against the abdominal wall "AW", as "illustrated in Figure 3B. In accordance with one aspect of this invention, the fully inflated diameters of the dilatation balloon can be selected from a range to match the diameter of the catheter tube device (eg, .PEG device) that will be inserted. As shown in Figure 1a in Figures 3A and 3B, the The dilatation section 106 may have variable diameters, such that the dilatation section 108 may have at least one diameter and the retention section 112 (the proximal retention balloon component) may have at least one diameter, which is greater than to if dilation 108. 10 . After the dilatation device has its attached balloon fully inflated, a peel-away wrap is placed over the most distal portion of the dilatation device (ie from the outside of the patient). The dilatation balloon of the dilatation device is partially deflated by only a small amount (e.g., partially deflated) to allow the rejuvenation envelope to be partially deflated. pass over the distal end of the dilatation device and through the stoma tract into the stomach.
    A catheter tube (e.g. a PEG device 20) is then passed over the guide wire and the distal end of the peg device is inserted through the removable sheath. The distal end of the PEG device is now in a position to hold the gastric lumen against the abdominal wall; thus, the expansion desk can be completely deflated and withdrawn through the removable wrapper. Note that the syringe inflation connector must be separated from the inflation lumen in order to withdraw the diatation device through the abdominal wall. The removable wrap is then detached and removed from the stoma tract. Any other positioning tools 30 are removed, and a retainer on the inner distal end of the PEG device holds c) the PEG device in place.
    Alternatively, the PEG device can be inserted over the deflated dilatation without using the removable wrap 35. This places the PEG device in a position to c) the gastric lumen against the abdominal wall so that the
    '+ 15/15 dilatation balloon can be completely deflated and withdrawn through the PEG device.
    In yet another alternative, the dilatation device, once it has its balloon completely deflated and while it is still attached to the guide wire, can be removed through the operating channel of the endoscope, by withdrawing the guide wire through the endoscope operating channel. This requires that the peg be installed in the manner described above, for example, partial deflation of the expansion balloon and installation of the PEG through the removable wrap prior to removal of the expansion device.
    While the present invention has been described in connection with certain preferred embodiments, it should be understood that the subject matter encompassed by this description should not be limited to those specific embodiments. On the contrary, it is intended, for the subject matter of this invention, to include all alternatives, modifications and equivalents, as they may be included within the spirit and scope of the following claims.
    权利要求:
    Claims (10)
    [1]
    1. Stoma dilatation device, comprising a tubular support defining a continuous path 5 through the device; an inflatable expansion balloon located in the tubular support, the inflatable balloon including an expansion region, which forms a first portion of the device, and a retention region, which forms a second portion of the device; and 10 a balloon dimmer; where the retention region is configured to have a diameter, when unconstrained, full inflation, that is greater than c) diameter of the expansion region upon inflation. 15
    [2]
    2. A stoma dilatation device, according to ""according to claim 1, made by the fact that ""the inflatable balloon is made of a compliant material, a non-compliant material or a semi-compliant material and combinations of the same.
    [3]
    3. Stoma dilatation device, according to claim 2, ça,r,a,ct,e,r,í.z, due to the fact that the dilatation region and the retention region of the inflatable balloon are, each made of different materials.
    [4]
    4. Stoma dilatation device, 25,c,a,r,a,c,t,e,r,í.za,do, comprising: a tubular support having a length, a width and a longitudinal axis , the tubular support defining a continuous path through the device; an inflatable expansion balloon axially oriented 30 in the tubular support, the inflatable balloon including an expansion region forming a first portion of the device and a retention region forming a second portion of the device; and .
    a balloon inflation lumen; 35 where the retention region is configured to have a diameter, when unrestricted inflation,
    ,_ 2./4 . -- — -— --- -.--' -- --— '-— -— --- -"- '""" complete, which is greater than c) diameter of the dilatation region when of inflation.
    [5]
    5. Stoma dilatation device, according to claim 4, ,c,a,r,a,c,t,e,r,iz,ado, due to the fact that the inflatable balloon 5 is made of a compliant material, a non-compliant material or a semi-compliant material and combinations thereof.
    [6]
    6 . Stoma dilatation device, according to claim 5, ça,r,a,c,t,e,r,izated, due to the fact that the LO dilatation region and the retention region of the inflatable balloon are, each made of different materials.
    [7]
    7. System for dilating a stoma and for inserting a non-vascular catheter tube, ,c,ar,ac,te,r,í.za,do, comprising: a stoma dilatation device - 'comprising: " """"" a tubular support having a length, a width and a longitudinal axis, the tubular support defining a continuous path through the device; an inflatable dilatation balloon axially oriented on the tubular support, the inflatable balloon including an expansion region forming a first portion of the device and a retention region forming a second portion of the device; and a balloon inflation lumen; wherein the retention region is configured to have a diameter upon full, unrestricted inflation that is greater than the diameter of the dilatation region upon inflation, and a non-vascular catheter tube configured to fit over the region fully or partially inflated dilatation device through the dilated stoma tract and into the portion of the nonvascular lumen stabilized by the retention region, wherein the stoma dilatation device is configured to be deflated and at least a portion of the device withdrawn through the non-vascular catheter tube.
    " -3 /4 _ ._ _. _ --
    [8]
    8. Device for stoma dilatation, according to claim 7, ,e,a,r,a,cte,r,í.z, due to the fact that the inflatable balloon is made of a compliant material, of a non-compliant or a semi-compliant material and combinations thereof.
    [9]
    9. Stoma dilatation device, according to claim 8, ,c,a,ra,c,t,e,r,í,z,a, due to the fact that the ailation region and the retention region of the inflatable balloon are each made of different materials.
    [10]
    10. Method of positioning a PEG device, characterized by the steps of: advancing an endoscope into a non-vascular lumen to inflate and allow palpation to locate a PEG tube placement site; inserting a needle into a stomach through, ,the.-- Non.vascular yumen_.and introducing_a""guide""wire' through the needle; insert standard endoscopic forceps, an endoscopic snare or a Balloon Attachment through the operating channel of the endoscope; grasping the guide wire and pulling the guide wire up through the endoscope and out of a patient's mouth; attach a dilatation device with its inflation lumen attached to the end of the guide wire and pull it out. dilatation device through the endoscope using the guide wire, and into the stomach; remove the needle from the lumen while | retains the guide wire in the needle tract; pulling the dilatation device in and partially through the needle tract; inflating a balloon of the dilator device by gradually introducing controlled amounts of a fluid to increase the pressure in the balloon so that the balloon gently and gradually expands the needle tract into a stoma tract while driving a wall of the lumen against a wall abdominal; place a removable wrap over the dilatation device, deflate the balloon in just a small
    .,_ _ 4/4_ _--- - ---—-- '— "— ___"" "" " "
    amount to allow the removable wrap to pass over the distal end of the dilatation device and through the stoma tract into c) stomach; . passing a PEG device over the guide wire 5 and inserting the inserted PEG device through the removable wrapper 0;
    completely deflate the balloon and withdraw the balloon through the removable wrap; and detach the removable wrapper and remove it. 10 11. Method of qosicimnation of a device of
    PEG, in accordance with claim 10, £a.ra,c.t.e,r.i.z,ado, by virtue of the fact that the dilatation device comprises:
    a tubular support having a length, a width and a longitudinal axis, the tubular support defining a continuous path through the device; an axially oriented inflatable expansion balloon in the tubular support, the inflatable balloon including an expansion region forming a first portion of the device,
    and a retention region, which forms a second portion of the device, and a balloon inflation lumen; wherein the retention region is configured to have a diameter, upon inflation, which is constrained, complete, which is greater than the diameter of the expansion region 25 upon inflation.
    %"g=
    " "" " "" """ "" 1/2 """ '" "" ""
    11Q,,,,i'6 ' " 118 100
    ' "') ' 1')-'°"'06 klj
    I ' I ,|
    I-' |l lj'( >>w-""
    j" i'j {,iKj:",° 114 l:Y1o4
    FIG 1
    — "- - ' - · "—" - -"""--—- __" " ' "'"' 2"12 """'""" .
    I 100 ^)ÁW Jv FlG. 2 1O6~^ 100 -- --
    AW i:i: FlG. 3A 106 108-- 112' " FlG. 3B q
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    法律状态:
    2017-10-31| B15G| Petition not considered as such [chapter 15.7 patent gazette]|
    2018-01-09| B12F| Other appeals [chapter 12.6 patent gazette]|
    2021-01-12| B25A| Requested transfer of rights approved|Owner name: AVENT, INC. (US) |
    2021-02-09| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: ARQUIVADO O PEDIDO DE PATENTE, NOS TERMOS DO ARTIGO 86, DA LPI, E ARTIGO 10 DA RESOLUCAO 113/2013, REFERENTE AO NAO RECOLHIMENTO DA 9A RETRIBUICAO ANUAL, PARA FINS DE RESTAURACAO CONFORME ARTIGO 87 DA LPI 9.279, SOB PENA DA MANUTENCAO DO ARQUIVAMENTO CASO NAO SEJA RESTAURADO DENTRO DO PRAZO LEGAL, CONFORME O DISPOSTO NO ARTIGO 12 DA RESOLUCAO 113/2013. |
    2021-07-20| B08K| Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]|Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2614 DE 09/02/2021. |
    2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US38679310P| true| 2010-09-27|2010-09-27|
    US61/386,793|2010-09-27|
    US201161446229P| true| 2011-02-24|2011-02-24|
    US61/446,229|2011-02-24|
    US13/245,577|2011-09-26|
    US13/245,577|US20120078039A1|2010-09-27|2011-09-26|Dilation Device for Placing Catheter Tubes|
    PCT/IB2011/054254|WO2012042476A1|2010-09-27|2011-09-27|Dilation device for placing catheter tubes|
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