Device for controlled endoscopic penetration of injection needle

• US 6,371,963 B1
• Filed: 11/17/1998
• Issued: 04/16/2002
• Est. Priority Date: 11/17/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Nishtala, Srinivas, Ward, Tim E.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/192,591
• Time in Patent Office: 1,246 Days
• Field of Search: 606/1, 606/110, 606/113, 606/114, 606/127, 606/151, 606/205-211, 606/167, 606/170, 606/171, 606/172, 606/185, 604/272, 604/187, 604/264
• US Class Current: 606/113
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/062 penetration depth

Abstract

An endoscopic needle device having a handle and a catheter sheath connected to the handle, wherein the catheter sheath has at least one lumen, for example a needle lumnen and a stabilization lumen, extending there through. A needle is selectively movable within the needle lumen between a needle retracted position and a needle extended position and a stabilization element is selectively movable within the stabilization lumen between a stabilizer retracted position and a stabilizer extended position. A linking mechanism may operatively connect the needle and the stabilization element so that when the needle is in the needle retracted position the stabilization element is in the stabilizer extended position and when the needle is in the needle extended position the stabilization element is in the stabilizer retracted position.

Claims

1. An endoscopic needle device, comprising:

a handle;

a catheter sheath connected to the handle, the catheter sheath having at least one lumen extending therethrouqh;

a needle at least Partially disposed within the lumen and selectively movable within a first range between a needle retracted position and a needle extended position;

a stabilization element at least partially disposed within the lumen and selectively movable within a second range between a stabilizer retracted position and a stabilizer extended position, the needle being independently movable through at least part of the first range and the stabilization element being independently movable through at least part of the second range; and

a linking mechanism operatively connecting the needle and the stabilization element so that movement of the needle and the stabilization element are linked through second parts of the first and second ranges.

2. The endoscopic needle device according claim 1, the linking mechanism comprising:

a needle base disposed within the handle, the needle base being connected to the needle, wherein a plurality of teeth are formed along at least a portion of an inner side of the needle base;

a wire base disposed within the handle opposite the needle base, the wire base being connected to the stabilization element via a stabilization wire, wherein a plurality of teeth are formed along at least a portion of an inner side of the wire base facing the inner side of the needle base; and

a gear operatively connected between the needle base and the wire base, wherein the needle base, the wire base, and the gear form a rack-and-pinion arrangement.

3. The endoscopic needle device according to claim 2, wherein the stabilization element is a loop.

4. The endoscopic needle device according to claim 2, wherein the stabilization element is a barb, the barb being a substantially longitudinal member having at least one proximally slanting barb element disposed thereon.

5. The endoscopic needle device according to claim 2, wherein the stabilization element is a J-hook.

6. The endoscopic needle device according to claim 2, wherein the stabilization element is a grasper, the grasper including a plurality of flexible longitudinal members which, when in the stabilizer retracted position, extend substantially parallel to an axis of the catheter sheath and, in the stabilizer extended position, extend distally along the axis and outwardly from the axis, each of the longitudinal members having an inwardly-bent distal tip.

7. The endoscopic needle device according to claim 2, further comprising a control tab connected to the wire base and extending outside the housing.

8. The endoscopic needle device according to claim 7, wherein the control tab includes a thumb loop.

9. An endoscopic needle device, comprising:

a handle;

a catheter sheath connected to the handle, the catheter sheath having at least one lumen extending therethrough;

a needle selectively movable within the at least one lumen between a needle retracted position and a needle extended position;

a stabilization element selectively movable within the at least one lumen between a stabilizer retracted position and a stabilizer extended position; and

a substantially longitudinal needle hub rotatably coupled to the handle, wherein a channel extending substantially longitudinally through the needle hub includes a threaded surface,

wherein an outer surface of the needle is threadably coupled to the threaded surface of the channel so that, when the needle hub is rotated in a first direction, the needle moves distally to increase a maximum penetration depth of the needle and, when the needle hub is rotated in a second direction opposite the first direction, the needle moves proximally to decrease the maximum penetration depth of the needle.

10. The endoscopic needle device according to claim 9, wherein the handle includes a depth gauge for indicating a depth of maximum needle penetration and a penetration window for allowing visual access to the depth gauge, the maximum penetration depth being determinable based on a position of the depth gauge within the penetration window.

11. An endoscopic needle device, comprising:

a handle;

a catheter sheath connected to the handle, the catheter sheath having a needle lumen and a stabilization lumen extending therethrough;

a needle selectively movable within the needle lumen between a needle retracted position and a needle extended position;

a vacuum hood disposed at a distal end of the catheter sheath; and

a valve arrangement including;

a vacuum lumen connected to the stabilization lumen; and

a piston movable between a piston extended position in which the piston blocks a connection between the vacuum lumen and the stabilization lumen and a piston retracted position in which the connection between the vacuum lumen and the stabilization lumen is at least partially unblocked.

12. The needle device according to claim 11, further comprising:

a needle base disposed within the handle, the needle base being connected to the needle and having a plurality of teeth disposed along an inner side thereof;

a vacuum base disposed within the handle opposite the needle base, the vacuum base being connected to the piston and having a plurality of teeth disposed along an inner side thereof so that the vacuum base teeth face the needle base teeth; and

a gear operatively connected between the needle base teeth and the vacuum base teeth, the needle base, the vacuum base, and the gear forming a rack-and pinion arrangement, so that, when the needle base moves distally, the vacuum base moves proximally and the piston moves towards the retracted position and, when the needle base moves proximally, the vacuum base moves distally and the piston moves towards the extended position.

13. A method of injecting a needle into an injection site using an endoscopic needle device, the endoscopic needle device including a handle, a catheter sheath connected to the handle, a stabilization element disposed at a distal end of the needle device, and a needle disposed at the distal end of the needle device, comprising:

inserting the needle device into a body;

delivering the needle device to an injection site;

applying the stabilization element to stabilize the injection site; and

penetrating the injection site with the needle while maintaining the stabilization element and the injection site substantially immobile with respect to the distal end of the needle device.

14. The method according to claim 13, wherein the step of applying the stabilization element includes looping a loop around the injection site.

15. The method according to claim 13, wherein the step of applying the stabilization element includes looping a J-hook around the penetration site.

16. The method according to claim 13, wherein the step of applying the stabilization element includes positioning a grasper around the penetration site.

17. The method according to claim 13, further comprising the following, which is performed after applying the stabilization element and prior to penetrating the injection site with the needle:

partially drawing the injection site towards the catheter sheath.

18. A method of injecting a needle into an injection site using an endoscopic needle device, the endoscopic needle device including a handle, a catheter sheath connected to the handle, a stabilization element disposed at a distal end of the needle device, and a needle disposed at the distal end of the needle device, comprising:

inserting the needle device into a body;

delivering the needle device to an infection site;

applying the stabilization element to stabilize the injection site; and

penetrating the infection site with the needle while maintaining the stabilization element and the injection site substantially immobile with respect to the distal end of the needle device;

wherein the step of applying the stabilization element includes scraping a barb along the surface of the penetration site to embed barb elements in the site.

19. A method of injecting a needle into an injection site using an endoscopic needle device, the endoscopic needle device including a handle, a catheter sheath connected to the handle, a stabilization element disposed at a distal end of the needle device, and a needle disposed at the distal end of the needle device, comprising:

inserting the needle device into a body;

delivering the needle device to an injection site;

applying the stabilization element to stabilize the injection site; and

penetrating the injection site with the needle while maintaining the stabilization element and the injection site substantially immobile with respect to the distal end of the needle device;

wherein the step of applying the stabilization element includes inserting a barb into the penetration site.

20. A method of infecting a needle into an injection site using an endoscopic needle device, the endoscopic needle device including a handle, a catheter sheath connected to the handle, a stabilization element disposed at a distal end of the needle device, and a needle disposed at the distal end of the needle device, comprising:

inserting the needle device into a body;

delivering the needle device to an injection site;

applying the stabilization element to stabilize the injection site; and

penetrating the injection site with the needle while maintaining the stabilization element and the injection site substantially immobile with respect to the distal end of the needle device;

wherein the step of applying the stabilization element includes applying a vacuum to the penetration site, the vacuum being created within a vacuum hood.