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US6030364A Expired / Lapsed US ⏱️ 0.0 years remaining

Apparatus and method for percutaneous placement of gastro-intestinal tubes

Assignee: Boston Scientific Corp
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Filing: 1997-10-03
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Granted: 2000-02-29
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Expires: 2017-10-03
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Abstract

Abstract A method and apparatus for the percutaneous placement of gastro-intestinal tubes, the apparatus comprising a longitudinal penetration device; a hollow, tapered dilator; and a sheath having a central lumen extending therethrough. The penetration device is placed within the sheath, pushed distally to penetrate the target organ, and then removed from the sheath. After the penetration device is removed, the dilator is inserted into the central lumen of the sheath until it penetrates the target organ, so that the sheath and the penetration are radially dilated as the dilator passes through the sheath. The sheath is then pulled in the proximal direction to counter-balance the distal insertion force. A gastro-intestinal tube is inserted into the hollow center, and pushed distally until it exits the distal end of the dilator. The dilator and sheath are then removed from the target organ.

Inventors

  • 👤 Russ Durgin
  • 👤 Sheila Caira

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 10:59
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/34; A61B17/3415; A61B17/3417; A61J; A61J15/00; A61J15/0015; A61J15/0023; A61M; A61M25/00; A61M25/01; A61M25/02; A61M25/04; A61B17/3421; A61B17/3439; A61J15/0026; A61J15/003; A61J15/0034; A61J15/0038; A61J2200/00; A61J2200/60

Claims Analysis

Total Claims: 47
Claim 1
Independent Claim 151 words
An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising: a hollow dilator having a distal tapered section formed of longitudinal fingers, and an untapered tubular section proximal thereto, wherein the longitudinal fingers of the distal tapered section open radially in response to a force applied from inside the hollow center of the dilator; a sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said sheath having a first inner diameter at the distal end, and a second inner diameter at the proximal end, wherein the second inner diameter is greater than the first inner diameter, and wherein said dilator is receivable within the central lumen of the sheath; a penetration device having proximal and distal ends, and a piercing means on the distal end, wherein said penetration device is receivable within the central lumen of the sheath.
Claim 2
Independent Claim 151 words
An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising: a hollow dilator having a distal tapered section formed of longitudinal fingers, and an untapered tubular section proximal thereto, wherein the longitudinal fingers of the distal tapered section open radially in response to a force applied from inside the hollow center of the dilator; a sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said sheath having a first inner diameter at the distal end, and a second inner diameter at the proximal end, wherein the second inner diameter is greater than the first inner diameter, and wherein said dilator is receivable within the central lumen of the sheath; a penetration device having proximal and distal ends, and a piercing means on the distal end, wherein said penetration device is receivable within the central lumen of the sheath.
Claim 3
Dependent Claim 22 words
An apparatus as in claim 1, wherein the longitudinal fingers of the dilator are formed such that the finger width decreases distally.
Claim 4
Dependent Claim 27 words
An apparatus as in claim 1, wherein the distal tapered section of the dilator is formed such that the longitudinal fingers are normally tapered to a point.
Claim 5
Dependent Claim 27 words
An apparatus as in claim 1, wherein the distal tapered section of the dilator is formed such that the longitudinal fingers of the dilator are normally untapered.
Claim 6
Dependent Claim 18 words
An apparatus as in claim 1, wherein the dilator is made of metal, thermoplastic, thermostat, or a composite.
Claim 7
Dependent Claim 16 words
An apparatus as in claim 1, wherein the dilator has a hub on the proximal end.
Claim 8
Dependent Claim 14 words
An apparatus as in claim 6, wherein the hub portion has a locking mechanism.
Claim 9
Dependent Claim 15 words
An apparatus as in claim 1, wherein the sheath is made of an expandable material.
Claim 10
Dependent Claim 26 words
An apparatus as in claim 1, wherein the outside surface of the sheath is treated to provide increased friction between the sheath and the abdominal tissue.
Claim 11
Dependent Claim 27 words
An apparatus as in claim 1, wherein the sheath has a thin, rigid coating which splits as the dilator passes through the central lumen of the sheath.
Claim 12
Dependent Claim 14 words
An apparatus as in claim 10, wherein the thin, rigid coating is longitudinally scored.
Claim 13
Dependent Claim 17 words
An apparatus as in claim 11, wherein the hub portion of the sheath has a locking mechanism.
Claim 14
Dependent Claim 20 words
An apparatus as in claim 11, wherein the hub portion has a valve for controlling the escape of insufflation gas.
Claim 15
Dependent Claim 26 words
An apparatus as in claim 13, wherein the valve consists of a thin, elastomeric disc having an opening capable of receiving the penetration device and dilator.
Claim 16
Dependent Claim 26 words
An apparatus as in claim 1, wherein the sheath has an elastomeric coating which expands as the dilator passes through the central lumen of the sheath.
Claim 17
Dependent Claim 13 words
An apparatus as in claim 15, wherein the elastomeric coating is longitudinally scored.
Claim 18
Dependent Claim 44 words
An apparatus as in claim 1, wherein the sheath has a coating which extends past the distal end of the sheath, whereby the coating forms a valve capable of limiting the amount of insufflation gas that can enter the distal end of the sheath.
Claim 19
Dependent Claim 17 words
An apparatus as in claim 1, wherein the sheath has a hub portion on the proximal end.
Claim 20
Dependent Claim 25 words
An apparatus as in claim 1, wherein the sheath has a diameter at its distal end which is less than or equal to 5 mm.
Claim 21
Dependent Claim 32 words
An apparatus as in claim 1, wherein sheath has a diameter at its proximal end which is greater than or equal to 7 mm. and less than or equal to 20 mm.
Claim 22
Dependent Claim 59 words
An apparatus as in claim 1, wherein the sheath has a distal minor diameter section and a major diameter section proximal thereto, with the minor diameter section comprising longitudinal fingers; wherein the longitudinal fingers of the distal minor diameter section of the sheath are capable of receiving the dilator as it passes through the central lumen of the sheath.
Claim 23
Dependent Claim 21 words
An apparatus as in claim 21, wherein the longitudinal fingers of the sheath are formed by slitting the sheath body longitudinally.
Claim 24
Dependent Claim 23 words
An apparatus as in claim 21, wherein the longitudinal fingers of the sheath are formed by removing longitudinal slices from the sheath body.
Claim 25
Dependent Claim 19 words
An apparatus as in claim 23, wherein the longitudinal slices are formed such that the finger width decreases distally.
Claim 26
Dependent Claim 21 words
An apparatus as in claim 21, wherein the minor diameter section of the sheath is formed by folding the longitudinal fingers.
Claim 27
Dependent Claim 21 words
An apparatus as in claim 21, wherein the minor diameter section of the sheath is formed by overlapping the longitudinal fingers.
Claim 28
Independent Claim 147 words
An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising: a hollow, needle-nosed dilator having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section formed of longitudinal fingers proximal and an untapered tubular section proximal thereto, whereby the distal tapered section consists of a distal straight section and a proximally-adjacent graduated section such that: the straight section has a minor diameter; and the untapered tubular section has a major diameter which is greater than the minor diameter, and the graduated section has a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section; wherein the longitudinal fingers of the distal tapered section radially expand in response to a distal force from inside the hollow center of the dilator.
Claim 29
Independent Claim 147 words
An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising: a hollow, needle-nosed dilator having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section formed of longitudinal fingers proximal and an untapered tubular section proximal thereto, whereby the distal tapered section consists of a distal straight section and a proximally-adjacent graduated section such that: the straight section has a minor diameter; and the untapered tubular section has a major diameter which is greater than the minor diameter, and the graduated section has a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section; wherein the longitudinal fingers of the distal tapered section radially expand in response to a distal force from inside the hollow center of the dilator.
Claim 30
Dependent Claim 18 words
An apparatus as in claim 27, wherein the dilator has a piercing means detachably-secured to the distal end.
Claim 31
Dependent Claim 21 words
An apparatus as in claim 28, wherein the piercing means of the needle-nosed dilator is made of a biocompatible polymer-based material.
Claim 32
Dependent Claim 20 words
An apparatus as in claim 28, wherein the piercing means of the needle-nosed dilator is made of a biodegradable material.
Claim 33
Dependent Claim 17 words
An apparatus as in claim 27, wherein the distal tapered section is covered with an elastomeric coating.
Claim 34
Dependent Claim 13 words
An apparatus as in claim 31, wherein the elastomeric coating is longitudinally scored.
Claim 35
Dependent Claim 17 words
An apparatus as in claim 27, wherein the tapered section is covered with a thin, rigid coating.
Claim 36
Dependent Claim 14 words
An apparatus as in claim 33, wherein the thin, rigid coating is longitudinally scored.
Claim 37
Independent Claim 178 words
A method for percutaneously placing a medical device within a target organ, said method comprising: penetrating a target organ wall with an assembly of a sheath and a penetration device, the sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, and the penetration device having a piercing means at the distal end, and wherein the assembly is such that the penetration device is within the central lumen of said sheath such that the piercing means extends past the distal end of the sheath; removing the penetration device from within the central lumen of the sheath in such a manner that the sheath remains within the target organ after removal of the penetration device; inserting into the central lumen of the sheath a hollow dilator having a tapered distal end; and pushing said dilator distally through the central lumen of the sheath until it penetrates the target organ wall, while simultaneously pulling proximally on the sheath, whereby the diameter of the penetration in the target organ wall is increased.
Claim 38
Independent Claim 178 words
A method for percutaneously placing a medical device within a target organ, said method comprising: penetrating a target organ wall with an assembly of a sheath and a penetration device, the sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, and the penetration device having a piercing means at the distal end, and wherein the assembly is such that the penetration device is within the central lumen of said sheath such that the piercing means extends past the distal end of the sheath; removing the penetration device from within the central lumen of the sheath in such a manner that the sheath remains within the target organ after removal of the penetration device; inserting into the central lumen of the sheath a hollow dilator having a tapered distal end; and pushing said dilator distally through the central lumen of the sheath until it penetrates the target organ wall, while simultaneously pulling proximally on the sheath, whereby the diameter of the penetration in the target organ wall is increased.
Claim 39
Dependent Claim 67 words
The method as in claim 35, further comprising: placing a gastro-intestinal tube having a proximal and a distal end into the hollow center of the dilator; pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube end exits the dilator; removing the dilator from the target organ, while leaving the gastro-intestinal tube in place; and removing the sheath from the target organ.
Claim 40
Independent Claim 310 words
A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising: insufflating a target organ; penetrating a target organ wall with an assembly of an penetration device and a sheath in which the penetration device has a proximal end, a distal end, and a piercing means at its distal end, and the sheath has a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, the sheath further having a distal minor diameter section comprising longitudinal fingers formed such that the diameter at the distal end of the sheath is capable of penetrating body tissue, wherein the penetration device is within the central lumen of said sheath with the piercing means is distal of the distal end of the sheath; removing said penetration device from said sheath in such a manner that the sheath remains within the target organ wall after removal of the penetration device; inserting into the central lumen of the sheath a hollow dilator having a distal minor diameter section formed of longitudinal fingers and an untapered tubular section proximal thereto; pushing said dilator through the central lumen of said sheath until the dilator penetrates the target organ wall, while simultaneously pulling proximally on the sheath to counter-balance the distal force, whereby the diameter of the penetration in the target organ wall is thereby increased; placing a gastro-intestinal tube into the hollow center of said dilator; pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the longitudinal fingers of the dilator are opened radially; removing said sheath from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ; and removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.
Claim 41
Independent Claim 310 words
A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising: insufflating a target organ; penetrating a target organ wall with an assembly of an penetration device and a sheath in which the penetration device has a proximal end, a distal end, and a piercing means at its distal end, and the sheath has a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, the sheath further having a distal minor diameter section comprising longitudinal fingers formed such that the diameter at the distal end of the sheath is capable of penetrating body tissue, wherein the penetration device is within the central lumen of said sheath with the piercing means is distal of the distal end of the sheath; removing said penetration device from said sheath in such a manner that the sheath remains within the target organ wall after removal of the penetration device; inserting into the central lumen of the sheath a hollow dilator having a distal minor diameter section formed of longitudinal fingers and an untapered tubular section proximal thereto; pushing said dilator through the central lumen of said sheath until the dilator penetrates the target organ wall, while simultaneously pulling proximally on the sheath to counter-balance the distal force, whereby the diameter of the penetration in the target organ wall is thereby increased; placing a gastro-intestinal tube into the hollow center of said dilator; pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the longitudinal fingers of the dilator are opened radially; removing said sheath from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ; and removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.
Claim 42
Dependent Claim 38 words
A method as in claim 37, wherein the dilator is pushed distally through the sheath with a distal force while the sheath is simultaneously pulled with a proximal force which is approximately the same as the distal force.
Claim 43
Dependent Claim 43 words
A method as in claim 37, wherein the dilator is pushed distally through the sheath with a distal force while the sheath is simultaneously pulled with a proximal force such that the planar position of the target organ wall remains substantially the same.
Claim 44
Independent Claim 162 words
A method for percutaneously placing a medical device within a target organ, said method comprising: penetrating the body tissue and target organ wall with a hollow needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a straight section towards the distal end wherein the straight section is radially expandable and has a diameter capable of piercing the target organ, said straight section further having a piercing means detachably-secured to the distal end; placing the medical device into the hollow center of said dilator; pushing the medical device distally through the dilator until the distal end of the device exits the dilator, wherein the straight section of the dilator is radially expanded as the device passes through the central lumen of the dilator; and removing said dilator from the body tissue and target organ while maintaining the position of the medical device within the target organ.
Claim 45
Independent Claim 162 words
A method for percutaneously placing a medical device within a target organ, said method comprising: penetrating the body tissue and target organ wall with a hollow needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a straight section towards the distal end wherein the straight section is radially expandable and has a diameter capable of piercing the target organ, said straight section further having a piercing means detachably-secured to the distal end; placing the medical device into the hollow center of said dilator; pushing the medical device distally through the dilator until the distal end of the device exits the dilator, wherein the straight section of the dilator is radially expanded as the device passes through the central lumen of the dilator; and removing said dilator from the body tissue and target organ while maintaining the position of the medical device within the target organ.
Claim 46
Independent Claim 204 words
A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising: insufflating a target organ; penetrating the body tissue and target organ wall with a hollow thin-walled needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section and an untapered tubular section proximal thereto, wherein the distal tapered section formed of longitudinal fingers and consists of a distal straight section and a proximally-adjacent graduated section, the the straight section having a diameter capable of penetrating body tissue, the untapered tubular section having a major diameter capable of receiving a gastro-intestinal tube, and the graduated section having a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section; placing a gastro-intestinal tube into the hollow center of said dilator; pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the diameter of the penetration in the target organ wall is increased; and removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.
Claim 47
Independent Claim 204 words
A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising: insufflating a target organ; penetrating the body tissue and target organ wall with a hollow thin-walled needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section and an untapered tubular section proximal thereto, wherein the distal tapered section formed of longitudinal fingers and consists of a distal straight section and a proximally-adjacent graduated section, the the straight section having a diameter capable of penetrating body tissue, the untapered tubular section having a major diameter capable of receiving a gastro-intestinal tube, and the graduated section having a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section; placing a gastro-intestinal tube into the hollow center of said dilator; pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the diameter of the penetration in the target organ wall is increased; and removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.

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Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2003-02-28 2003-08-30 2004-02-29 $2000.00 Window Closed / Lapsed
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11.5 Years (Year 12) 2011-02-28 2011-08-30 2012-02-29 $7700.00 Window Closed / Lapsed

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