Extensible internal bolster for a medical device

• US 9,572,751 B2
• Filed: 05/05/2014
• Issued: 02/21/2017
• 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 J., Thorne, David L.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/270,199
• Publication Number:
  US 20140243785A1
• Time in Patent Office: 1,023 Days
• US Class Current: 1/1
• 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. A medical device comprising:

a tubular body;

at least two bolster arms, each including a first end hingedly connected to a distal end of the tubular body and a free second end, 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 a patient'"'"'s body;

webbing disposed between adjacent bolster arms;

a plunger slidable within the tubular body to move the bolster arms between the first position and the second position; and

a locking mechanism configured to lock axial movement of the plunger relative to the tubular body.

2. The medical device according to 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.

3. The medical device according to claim 1, wherein, in the second position, the webbing is configured to form a seal about a stoma in the patient'"'"'s body when secured therewithin.

4. The medical device according to claim 1, wherein the at least two 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 a distal half of the medical device, and wherein the free second end of one of the at least two bolster arms is radially spread apart from the free second end of another of the at least two bolster arms when in the second position to secure a distal portion of the medical device within the patient'"'"'s body after insertion thereof.

5. The medical device according to claim 1, wherein the locking mechanism includes at least one extended surface included on one of the plunger and tubular body, the at least one extended surface seating within a corresponding recess defined on one of the plunger and the tubular body when the plunger has deployed the at least two bolster arms to the second position.

6. The medical device according to claim 1, wherein the locking mechanism includes threads correspondingly defined on the plunger and the tubular body, the plunger being threadably received within the tubular body so as to deploy the at least two bolster arms to the second position.

7. The medical device according to claim 1, wherein the locking mechanism includes at least one pin insertable through the tubular body to engage the plunger so as to prevent movement thereof.

8. The medical device according to claim 1, wherein the plunger includes a central channel configured as a feeding channel through which a patient may be fed.

9. The medical device according to claim 8, wherein the plunger includes an engagement surface for deploying the at least two 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 positioned such that the first end of each of the at least two bolster arms is between the annular lip and an O-ring disposed about the medical device in the second position.

10. The medical device according to claim 1, wherein each of the at least two bolster arms is hingedly attached to the tubular body via a living hinge, and wherein the bolster arms cover a distal end opening of the tubular body when in the first position, the distal end opening being at least partially uncovered in the second position.

11. The medical device according to claim 1, further comprising a reinforcing collar disposed radially about at least a portion of the distal end of the tubular body.

12. The medical device according to claim 11, further comprising a plurality of spines, and at least two bolster arms including at least one spine of the plurality of spines.

13. The medical device according to claim 1, further comprising stoma measuring graduations on an outer surface of the tubular body so as to enable a measurement of a length of a stoma through which the medical device is positioned.

14. A method, comprising:

providing a medical device comprising;

a tubular body;

a first bolster arm hingedly connected to a distal end of the tubular body;

a second bolster arm hingedly connected to the distal end of the tubular body;

a plunger slidable within the tubular body to move the first bolster arm and the second bolster arm between a first closed configuration in which the first bolster arm and the second bolster arm are positioned close together to a second open configuration in which the first bolster arm and the second bolster arm are spaced apart; and

a locking mechanism configured to lock axial movement of the plunger relative to the tubular body;

positioning the medical device in a patient'"'"'s body through a stoma, a distal portion of the medical device positioned inside the patient'"'"'s body, wherein the positioning is performed while the first bolster arm and the second bolster arm are in the first closed configuration;

deploying the first bolster arm and the second bolster arm to the second open configuration to secure the distal portion of the medical device within the patient'"'"'s body; and

locking the locking mechanism such that the plunger is locked in a position that holds the first bolster arm and the second bolster arm in the second open configuration.

15. The method according to claim 14, wherein the medical device includes stoma measuring graduations so as to enable a measurement of a length of the stoma through which the medical device is positioned, further comprising measuring the length of the stoma.

16. The method according to claim 14, wherein the plunger includes a central channel configured as a feeding channel, further comprising feeding the patient through the central channel.

17. The method according to claim 14, wherein the locking mechanism includes threads correspondingly defined on the plunger and the tubular body, and wherein locking the locking mechanism includes threadably engaging the threads of the plunger and the tubular body.

18. The method according to claim 14, wherein the locking mechanism includes at least one pin, and wherein locking the locking mechanism includes positioning the pin through the tubular body such that the pin engages the plunger and prevents movement thereof.

19. A medical device comprising:

a tubular body;

at least two bolster arms, each including a first end hingedly connected to a distal end of the tubular body and a free second end, 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 a patient'"'"'s body;

a plunger slidable within the tubular body to move the bolster arms between the first position and the second position, the plunger comprising;

a central channel configured as a feeding channel through which a patient may be fed; and

an engagement surface for deploying the at least two 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,

wherein the plunger is positioned such that the first end of each of the at least two bolster arms is between the annular lip and an O-ring disposed about the medical device in the second position; and

a locking mechanism configured to lock axial movement of the plunger relative to the tubular body.

20. A medical device comprising:

a tubular body;

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

at least two bolster arms, each including a first end hingedly connected to the distal end of the tubular body and a free second end, 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 a patient'"'"'s body;

a plurality of spines, each of the at least two bolster arms including at least one spine of the plurality of spines;

a plunger slidable within the tubular body to move the bolster arms between the first position and the second position; and

a locking mechanism configured to lock axial movement of the plunger relative to the tubular body.

21. A medical device comprising:

a tubular body;

at least two bolster arms, each including a first end hingedly connected to a distal end of the tubular body and a free second end, 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 a patient'"'"'s body;

at least one elongate wire member interconnecting each of the at least two bolster arms with a movable trigger external to the patient'"'"'s body, wherein movement of the trigger causes the wire member to reversibly deploy the at least two bolster arms from the first position to the second position; and

a locking mechanism configured to lock axial movement of the plunger relative to the tubular body.