Anti-obesity balloon placement system

• US 4,723,547 A
• Filed: 05/07/1985
• Issued: 02/09/1988
• Est. Priority Date: 05/07/1985
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Giusto, Joseph, Kullas, Karen E.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US06/731,673
• Time in Patent Office: 1,008 Days
• Field of Search: 128/1 R, 128/303 R, 128/329 R, 128/325, 128/344
• US Class Current: 606/185
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices

Abstract

An anti-obesity balloon and a placement system for the balloon includes a balloon with a needle-pierceable, self-sealing plug and an insertion catheter having a needle at its distal end. The needle is movable between an extended position in which it protrudes distally of the insertion catheter and a retracted position in which it is withdrawn interiorly of the insertion catheter. A handle arrangement is provided at the proximal end of the insertion catheter to control the position of the needle. Means are provided for aspirating and inflating the balloon. The balloon structure and insertion catheter structure protect and enclosed the sharp tip of the needle at all times during insertion and withdrawal of the insertion catheter. The insertion catheter is detachable from the balloon, after the balloon has been inflated in the patient'"'"'s stomach, in a manner which imposes no force or load on the balloon.

Claims

1. An apparatus for placing an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is pierceable by a needle, the apparatus comprising:

an insertion catheter comprising an inner, elongate tube;

an outer, elongate sheath;

the inner tube being slidable within the sheath;

a hollow needle mounted at the distal end of the insertion catheter, the needle being attached to the distal end of the inner tube, the needle being adapted to pierce the plug;

the catheter having conduit means in communication with the needle to enable a balloon attached to the needle to be inflated and deflated;

said catheter including means for sheilding the needle to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient, said shielding means comprising the needle being mounted for movement between a first position in which the needle is extended out of the distal end of the insertion catheter and a second position in which the needle is withdrawn into the distal end of the insertion catheter and means for effecting said movement of the needle between said first and second positions;

said inner tube and outer sheath being relatively movable between positions in which said needle is in said first and said second positions;

handle means at the proximal end of the insertion catheter, the handle means being connected to each of the sheath and the tube, the handle means being constructed and arranged to effect said relative movement between the inner tube and outer sheath;

said handle means having two lockable positions corresponding, respectively, to said first position and said second position of the needle.

2. An apparatus for placing an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is piercable by a needle, the apparatus comprising:

an insertion catheter comprising an inner, elongate tube;

an outer, elongate sheath;

the inner tube being slidable within the sheath;

a hollow needle mounted at the distal end of the insertion catheter, the needle being attached to the distal end of the inner tube, the needle being adapted to pierce the plug;

the catheter having conduit means in communication with the needle to enable a balloon attached to the needle to be inflated and deflated;

said catheter including means for sheilding the needle to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient, said sheilding means comprising the needle being mounted for movement between a first position in which the needle is extended out of the distal end of the insertion catheter and a second position in which the needle is withdrawn into the distal end of the insertion catheter and means for effecting said movement of the needle between said first and second positions;

said inner tube and outer sheath being relatively movable between positions in which said needle is in said first and said second positions;

handle means at the proximal end of the insertion catheter, the handle means being connected to each of the sheath and the tube, the handle means being constructed and arranged to effect said relative movement between the inner tube and outer sheath;

a body;

a slide slidably mounted on the body;

said tube being connected to one of said body or slide;

said sheath being connected to the other of said body or slide.

3. An apparatus as defined in claim 2 wherein said tube is connected to the slide and the sheath is connected to the body of the handle.

4. An apparatus as defined in claim 3 further comprising:

said body and slide of said handle having two lockable positions corresponding to the first and second positions of the needle, said lockable positions being defined by a latch on one of said body and slide and a detent on the other of said body and said slide.

5. An apparatus as defined in claim 4 further comprising:

said detent means comprising a pair of slots formed in and spaced longitudinally along the body;

said latch means comprising a locking member and means biasing the member in a direction which, when the member is in longitudinal alignment with the slot, will bias the lock member toward and into the slot, said latch member being releasable.

6. An apparatus as defined in claim 2 further comprising means for inflating and deflating the balloon.

7. An apparatus as defined in claim 6 wherein said means for inflating and deflating the balloon comprises:

the handle having a passage formed therethrough in communication with the tube;

a conduit connected to the handle to be in communication with the passage; and

means for selectivity inflating or aspirating through the conduit.

8. An apparatus as defined in claim 7 wherein said means for selectivity inflating or aspirating comprises a syringe connected to the passage through a valve means, the valve means being operable to selectively communicate the syringe with the conduit or with the atmosphere.

9. An apparatus for placing an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is pierceable by a needle, the apparatus comprising:

an insertion catheter having an inner, elongate tube and an outer, elongate sheath, the inner tube being slidable within the sheath;

a hollow needle attached to the distal end of the inner tube, the needle being adapted to pierce the plug;

the catheter having a conduit means in communication with the needle to enable the balloon attached to the needle to be inflated and deflated;

said catheter including means for sheilding the needle to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient, said shielding means comprising the needle being mounted for movement between a first position in which the needle is extended out of the distal end of the insertion catheter and a second position in which the needle is withdrawn into the distal end of the insertion catheter and means for effecting said movement of the needle between said first and second positions;

said inner tube and outer sheath being relatively movable between positions in which said needle is in said first and said second positions;

the needle being mounted to the distal end of the tube by a needle holder, said needle holder comprising an elongate tubular member having a passage therethrough, the needle being secured to the distal end of the passage of the holder, the holder having an enlarged flange at its distal end, the proximal end of the holder being received and being secured within the distal end of the inner tube, the flange of the holder being an abutment with the distal end of the inner tube.

10. An apparatus for placing an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is pierceable by a needle, the apparatus comprising:

an insertion catheter having an inner, elongate tube and an outer, elongate sheath, the inner tube being slidable within the sheath;

a hollow needle attached to the distal end of the inner tube, the needle being adapted to pierce the plug;

the catheter having a conduit means in communication with the needle to enable the balloon attached to the needle to be inflated and deflated;

said catheter including means for sheilding the needle to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient, said shielding means comprising the needle being mounted for movement between a first position in which the needle is extended out of the distal end of the insertion catheter and a second position in which the needle is withdrawn into the distal end of the insertion catheter and means for effecting said movement of the needle between said first and second positions;

said inner tube and outer sheath being relatively movable between positions in which said needle is in said first and said second positions;

the inner tube having a plurality of longitudinally extending ribs formed on its external surface, the ribs being engagable with the internal surface of the other sheath.

11. An anti-obesity balloon for placement in a patient'"'"'s stomach comprising:

a flexible, resilent balloon resistant to gastric fluids having a neck, the neck being everted within the balloon;

a plug secured within the everted neck and not projecting outwardly of the neck, the plug being adapted to be pierced by a hollow needle and to self-seal upon withdrawal of the hollow needle, said plug being constructed to enable free fluid flow to and from the balloon;

means at the inner end of the plug for protecting the balloon from the needle when the needle projects inwardly from the plug;

the means for protecting the needle comprising the inner end of the plug being constructed to define a socket surrounded by a hood, the socket being longer than the maximum depth to which the needle is inserted through the plug whereby when the needle is inserted fully into the plug the distal tip of the needle will remain within the socket and will be surrounded by the hood.

13. An anti-obesity balloon as defined in claims 11 or 12 wherein the balloon is elastic.

12. An apparatus for placement of an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is piercable by a needle, the apparatus comprising:

an insertion catheter;

a hollow needle mounted at the distal end of the insertion catheter, the needle being adapted to pierce the plug to communicate with the interior of the balloon;

the catheter having conduit means in communication with the needle to enable the balloon attached to the needle to be inflated and deflated;

said catheter and said plug including cooperative means for shielding the needle from the interior of the balloon while in communication with the balloon and to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient;

the means associated with the catheter for sheilding the needle comprising the needle being mounted for movement between a first position in which the needle is extended out of the distal end of the insertion catheter and the second position in which the needle is withdrawn into the distal end of the insertion catheter and means for effecting said movement of the needle between said first and second positions;

the insertion catheter comprising an inner, elongate tube;

an outer elongate sheath;

the inner tube being slidable within the sheath;

the needle being attached to the distal end of the inner tube; and

said inner tube and outer sheath being relatively movable between positions in which said needle is in said first and said second positions;

said anti-obesity balloon comprising a resilent, flexible balloon resistant to gastric fluid and having a neck, the neck being everted within the balloon; and

a plug secured within the everted neck, the plug being adapted to be pierced by the needle and to self-seal upon withdrawl of the needle;

means at the inner end of the plug for protecting the balloon from the needle when the needle projects inwardly from the plug; and

said means for projecting the needle comprising the inner end of the plug being constructed to define a socket surrounded by a hood, the socket being longer than the maximum depth to which the needle can be inserted through the plug whereby when the needle is inserted fully into the plug the distal tip of the needle will remain within the socket and will be surrounded by the hood.

14. An apparatus for placing an anti-obesity balloon in a patient, the balloon having a self-sealing plug which is piercable by a needle, the apparatus comprising:

an insertion catheter;

a hollow needle mounted at the distal end of the insertion catheter, the needle being adapted to pierce the plug to communicate with the interior of the balloon;

the catheter having conduit means in communication with the needle to enable the balloon attached to the needle to be infalted and deflated;

said catheter and said plug including cooperative means for sheilding the needle from the interior of the balloon while in communication with the balloon and to enable withdrawal of the needle without exposing the tip of the needle to the balloon or to the patient;

the means associated with the plug for sheilding the needle comprising;

the plug having an inner end which is constructed to define a socket surrounded by a hood, the socket being longer than the maximum depth to which the needle can be inserted through the plug whereby when the needle is inserted fully into the plug, the distal tip of the needle will remain within the socket and will be surrounded by the hood.