Extensible internal bolster for a medical device

• US 8,715,244 B2
• Filed: 07/07/2010
• Issued: 05/06/2014
• Est. Priority Date: 07/07/2009
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Prechtel, Ericka, Thorne, David L.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/831,644
• Publication Number:
  US 20110009828A1
• Time in Patent Office: 1,399 Days
• Field of Search: 604175-179, 604/910
• US Class Current: 604/177
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0034 Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61M 2039/0255 for access to the gastric or digestive system
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2202/0482 Enteral feeding product
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

An internal bolster for use securing a medical device, such as a feeding tube, within a body of a patient is disclosed. In one embodiment, a feeding tube includes an internal bolster, comprising one or more bolster arms that each include a first end hingedly connected to a distal end of the medical device and a free second end. The bolster arms are selectively deployable between a first position wherein the bolster arms are substantially in-line with an axis of feeding tube, and a second position wherein the bolster arms are substantially deflected from the axis of the feeding tube to enable securement of the feeding tube within a stoma or other opening defined in the body. Various means for selectively moving the bolster arms between the first and second positions are disclosed. Related methods of use are also disclosed.

Claims

1. An internal bolster for securing a medical device within a body of a patient, the internal bolster comprising:

at least two bolster arms, each including a first end hingedly connected to a distal end of a tubular medical device and a free second end, and

webbing disposed between adjacent bolster arms,

wherein the at least two bolster arms are selectively deployable between a first position wherein the at least two bolster arms are substantially in-line with an axis of the medical device and a second position wherein the at least two bolster arms are substantially deflected from the axis of the medical device to enable securement of the medical device within the body.

2. The internal bolster as defined in claim 1, wherein the first end of the at least two bolster arms is hingedly connected to an outer perimeter of the distal end of the tubular medical device.

3. The internal bolster as defined in claim 2, wherein the tubular medical device further includes a plunger movable within an elongate cavity of the tubular medical device to selectively engage a base of the at least two bolster arms and reversibly deploy the at least two bolster arms from the first position to the second position.

4. The internal bolster as defined in claim 1, wherein the at least two bolster arms are positioned contiguously with one another and define a tapered atraumatic distal end of the medical device when in the first position, and wherein the bolster arms move radially outward with respect to one another in unison when deployed from the first to the second position such that the webbing can form a seal about a stoma in the body when the medical device is secured within the body.

5. The internal bolster as defined in claim 1, wherein the at least two bolster arms include a resilient material and further include a reinforcement structure to stiffen the bolster arm.

21. The internal bolster as defined in claim 1, wherein the webbing is folded.

6. A medical device, comprising:

an elongate body;

an internal bolster, comprising a plurality of bolster arms each including a first end that is attached to a distal end of the elongate body and a free second end, each bolster arm being pivotable between a first position wherein the bolster arm is substantially parallel with the medical device body and a second deployed position wherein the bolster arm is substantially non-parallel with the medical device body; and

a plunger that is slidable with respect to the elongate body, the plunger including a channel and an engagement surface for deploying the bolster arms from the first position to the second position, the engagement surface including a radially extending annular lip proximate a distal end of the plunger, and wherein the plunger is slid proximally such that the bolster arms are pressed between the annular lip and an O-ring disposed about the medical device so as to deploy the bolster arms radially outward to the second position.

7. The medical device as defined in claim 6, wherein each bolster arm is hingedly attached via a living hinge proximate a distal end of the elongate body, and wherein the bolster arms cover a distal end opening of the elongate body when in the first position, the distal end opening being at least partially uncovered when the bolster arms are in the second position.

8. The medical device as defined in claim 6, wherein the bolster arms when in the first position are contiguous with one another and together define an outer diameter that does not exceed an outer diameter of the distal portion of the medical device, and wherein the bolster arms are radially spread apart from one another when in the second position to secure the distal portion of the medical device within the body of the patient after insertion thereof.

9. A medical device, comprising:

an elongate body;

an internal bolster, comprising a plurality of bolster arms each including a first end that is attached to a distal end of the elongate body and a free second end, each bolster arm being pivotable between a first position wherein the bolster arm is substantially parallel with the elongate body and a second deployed position wherein the bolster arm is substantially non-parallel with the elongate body;

a reinforcing collar disposed radially about at least a portion of the distal end of the elongate body;

a plurality of spines that each extend into one of the plurality of bolster arms; and

means for selectively moving the bolster arms between the first and second positions.

10. The medical device as defined in claim 9, wherein the means for selectively moving the bolster arms includes a portion external to the body of the patient for manually deploying the bolster arms from the first position to the second position and for retracting the bolster arms from the second position to the first position in preparation for removal of the medical device from the body of the patient.

11. The medical device as defined in claim 9, wherein the means for selectively moving the bolster arms includes a plunger that is slidable with respect to the elongate body, the plunger including an engagement surface for deploying the bolster arms from the first position to the second position.

12. The medical device as defined in claim 11, wherein the elongate body includes an elongate tube defining a cavity, the plunger being slidable within the cavity of the elongate tube, and wherein the medical device further comprises means for locking axial movement of the plunger relative to the elongate tube.

13. The medical device as defined in claim 12, wherein the means for locking axial movement includes at least one extended surface included on one of the plunger and elongate tube, the at least one extended surface seating within a corresponding recess defined on one of the plunger and the elongate tube when the plunger has deployed the bolster arms to the second position.

14. The medical device as defined in claim 12, wherein the means for locking axial movement includes threads correspondingly defined on the plunger and the elongate tube, the plunger being threadably received within the cavity of the elongate tube so as to deploy the bolster arms to the second position.

15. The medical device as defined in claim 12, wherein the means for locking axial movement includes at least one pin insertable through the elongate tube to engage the plunger so as to prevent movement thereof.

16. The medical device as defined in claim 9, wherein the means for selectively moving the bolster arms includes at least one elongate wire member interconnecting each of the bolster arms with a movable trigger external to the body of the patient, wherein movement of the trigger causes the wire member to reversibly deploy the bolster arms from the first position to the second position.

17. A method for inserting a medical device into a body of a patient, comprising:

inserting a distal portion of the medical device into the body through a stoma, the distal portion including an internal bolster, the internal bolster including at least two bolster arms hingedly connected at a first end to the distal portion of the medical device and including a free second end, the at least two bolster arms including webbing between adjacent bolster arms and being in a first position during insertion wherein the at least two bolster arms are substantially parallel with a longitudinal axis of the medical device; and

radially deploying the at least two bolster arms to a second position wherein the at least two bolster arms are positioned substantially non-parallel with respect to the longitudinal axis of the medical device to secure the distal portion of the medical device within the body, the webbing forming a seal about the stoma when the at least two bolster arms are deployed to the second position.

18. The method for inserting the medical device as defined in claim 17, wherein radially deploying the at least one bolster arm further comprises radially extending each of a plurality of bolster arms about a hinge point to the non-parallel second position.

19. The method for inserting the medical device as defined in claim 17, wherein the medical device includes a stoma measuring device including graduations so as to enable a measurement of a length of a the stoma through which the medical device is inserted.

20. A medical device, comprising

an elongate body defining a cavity and including a distal portion for insertion into a body of a patient;

a plunger movably disposed within the cavity of the elongate body; and

an internal bolster including;

at least one foldable flap including a proximal end attached to a distal portion of the plunger; and

at least one tether connecting the distal portion of the elongate body with a distal end of the at least one foldable flap,

wherein movement of the plunger within the cavity of the elongate body causes folding of the flap from a first unfolded position to a second folded position so as to enable the internal bolster to secure the distal portion of the medical device within the body of the patient.

22. A medical device, comprising:

an elongate body;

an internal bolster, comprising a plurality of bolster arms each including a first end that is attached to a distal end of the elongate body and a free second end, each bolster arm being pivotable between a first position wherein the bolster arm is substantially parallel with the elongate body and a second deployed position wherein the bolster arm is substantially non-parallel with the elongate body;

a reinforcing collar disposed radially about at least a portion of the distal end of the elongate body; and

means for selectively moving the bolster arms between the first and second positions, including a portion external to the body of the patient for manually deploying the bolster arms from the first position to the second position and for retracting the bolster arms from the second position to the first position in preparation for removal of the medical device from the body of the patient.

23. A medical device, comprising:

an elongate body;

an internal bolster, comprising a plurality of bolster arms each including a first end that is attached to a distal end of the elongate body and a free second end, each bolster arm being pivotable between a first position wherein the bolster arm is substantially parallel with the elongate body and a second deployed position wherein the bolster arm is substantially non-parallel with the elongate body;

a reinforcing collar disposed radially about at least a portion of the distal end of the elongate body; and

means for selectively moving the bolster arms between the first and second positions, including a plunger that is slidable with respect to the elongate body, the plunger including an engagement surface for deploying the bolster arms from the first position to the second position.

24. A medical device, comprising:

an elongate body;

an internal bolster, comprising a plurality of bolster arms each including a first end that is attached to a distal end of the elongate body and a free second end, each bolster arm being pivotable between a first position wherein the bolster arm is substantially parallel with the elongate body and a second deployed position wherein the bolster arm is substantially non-parallel with the elongate body;

a reinforcing collar disposed radially about at least a portion of the distal end of the elongate body; and

means for selectively moving the bolster arms between the first and second positions, including at least one elongate wire member interconnecting each of the bolster arms with a movable trigger external to the body of the patient, wherein movement of the trigger causes the wire member to reversibly deploy the bolster arms from the first position to the second position.