WO2014145764A2

WO2014145764A2 - Hydro dissection needle

Info

Publication number: WO2014145764A2
Application number: PCT/US2014/030583
Authority: WO
Inventors: Henry Holsten; Vincent Lucente
Original assignee: C. R. Bard, Inc.
Priority date: 2013-03-15
Filing date: 2014-03-17
Publication date: 2014-09-18
Also published as: WO2014145764A3

Abstract

A hydro-dissection needle is disclosed having two or more diffusion ports and depth markings for use in dissecting tissue of the pelvic floor.

Description

HYDRO DISSECTION NEEDLE

PRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application

No. 61/790,634, filed March 15, 2013, which is incorporated by reference in its entirety into this application.

TECHNICAL FIELD

[0002] The present application relates to devices used in surgical procedures.

Specifically, as described herein, a needle is provided for use in dissecting tissue by injecting fluid.

BACKGROUND

[0003] The pelvic floor and other anatomical sites of the body are composed of many and diverse organs, muscles, and connective tissues. When surgery is required in such anatomical locations, such as for implanting slings or other devices for urinary incontinence, these tissues are usually dissected. The tissue may be pierced, cut, torn, or otherwise traversed. However, unnecessary damage may be done to this tissue that increases patient discomfort, increases patient recovery times, etc.

BRIEF SUMMARY

[0004] A method and system for dissecting the tissue of the pelvic floor is shown and described. Dissections performed with embodiments of the disclosed needle will allow for full thickness tissue dissection and help maintain blood perfusion in the dissected tissue.

[0005] Embodiments as described herein include a needle with radial ports around an axis of the needle to facilitate full tissue hydro dissection in the pelvic floor. Embodiments may also include distance or depth markings along the needle body to assist in determining needle tip location and promote full tissue dissection. The radial portions along the needle distal end may positioned and/or oriented to achieve a desired fluid flow for the application or tissue area dissected. DETAILED DESCRIPTION

[0006] The following detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention, and are not limiting of the present invention nor are they necessarily drawn to scale.

[0007] Although embodiments of the invention may be described and illustrated herein in terms of pelvic floor tissue dissection, it should be understood that embodiments of this invention are not so limited, but are additionally applicable to other hydro dissection applications and other anatomical locations. Furthermore, although embodiments of the invention may be described and illustrated herein in terms of a specific number and orientation of diffusion ports, it should be understood that embodiments of the invention are also applicable to other port configurations, such as two or more ports on a distal section of the needle.

[0008] FIG. 1 illustrates an exemplary embodiment of the fluid dissection needle having diffusion ports. FIG. 1 illustrates a perspective view of an exemplary fluid dissection needle. FIG. 1A and IB are orthogonal views of a needle tip 14. FIG. 1C and ID are orthogonal views of the needle of FIG. 1. FIG. IE is a cross sectional view of the hub of FIG. 1.

[0009] A needle 10 has a longitudinal length sufficient to traverse a patent's pelvic floor area. The needle 10 includes at a first end a luer connector 12 and a needle tip 14 at a second end. The needle tip 14 may be closed to prevent tissue coring during insertion. The needle may include a longitudinal shaft or generally tubular section extending from the luer connector to the needle tip. The shaft may be generally hollow to pass the fluid used to dissect tissue.

[0010] The needle tip 14 may be a blunt tip to generally dissect tissue or may be a sharp tip to pierce tissue. The needle tip 14 may also include a general wedge profile such that a top surface and bottom surface taper to form a dissecting platform. The top and bottom surface may be flat to form a dissecting surface, that separates tissues as the needle is inserted.

[0011] The distal region of the needle may include two or more diffusion ports 16.

The diffusion ports are positioned near the needle distal end and permit the fluid through the needle to exit the needle distal end. The diffusion ports are located toward the needle distal end to provide fluid diffusion in the region of the needle tip. The diffusion ports are also located sufficient from the needle tip so that the ports may be sufficiently sized to transmit a desired amount of fluid through the port. The ports may be located near the tapered portion of the tip or along a longitudinal shaft of the needle body, or a combination of both.

[0012] As shown in FIG. 1A and IB, a first pair of diffusion ports 16a are positioned along the longitudinal shaft of the needle at its distal end. The pair of diffusion ports 16a are positioned on opposing sides of the needle to maximize the port size while maintaining a strength integrity of the needle. A second pair of diffusion ports 16b are positioned at a proximal end of the tapered tip 14 near the first pair of diffusion ports 16a. The second pair of diffusion ports 16b are oriented perpendicular to the first pair to permit full fluid ejection around the circumference of the needle tip. Therefore, tissue dissection may be achieved regardless of the needle orientation.

[0013] The diffusion ports may be oriented generally perpendicular to the needle body so that the dissection fluid is ejected generally radially from the needle. The diffusion ports may also be configured to direct the dissection fluid in any desired direction depending on the application. For example, the diffusion ports may be oriented to direct the ejected dissection fluid toward the distal end of the needle past the distal tip.

[0014] The body of the needle may also include depth markings 18 along its length.

The depth markings may be chemically or laser etched onto a surface of the needle. The markings may be included in other manners such as printed or otherwise adhered or indicated on the needle surface. The depth markings may be at any desired interval depending on the application.

[0015] In use the needle tip may be used to pierce external tissue and obtain entry to a desired area to dissect. The needle may be coupled through the luer fitting to a fluid source to transmit the dissection fluid, such as water or saline to the tissue to be dissected. The fluid may be ejected from the needle tip to fully dissection a tissue layer and provide access to an interior cavity of a patient. The needle tip may be used to separate any tissue that is not dissected by the injected fluid.

[0016] The exemplary embodiment shown in FIG. 1 is configured for use of dissecting tissue of the pelvic floor. The dimensions may be changed to accommodate different procedures or anatomical areas. In one embodiment, the overall length of the device from tip to hub, LI, is in the range from about 2 inches to about 3 inches, for example 2.4 inches. In one embodiment, the needle length from approximately the distal end of hub to needle tip, L8, is in the range from about 1 inch to about 3 inches, for example about 2 inches. In one embodiment, the ports 16a and 16b have a diameter d5 and d6 in the range from about 0.02 inch to about 0.03 inch, for example about 0.024 inch.

[0017] In one embodiment, the position of the ports from the needle tip is in the range from about 0.1 inch to about 0.3 inch. In one embodiment, the ports 16a are spaced a distance L5 of about 0.125 inches, and ports 16b are spaced a distance L6 of about 0.155 inches. The needle body may include depth markings separated at any desired interval, for example, L7 of 0.185 inches, that have a sufficient thickness to view, such as 0.015 inches wide, L9. In one embodiment, the diameter of the needle body is in the range from about 0.03 inch to about 0.07 inch, for example about 0.05 inch, dl. The needle tip may be generally conical or arcuate conical with a tapered closed tip with an angle Φ in one embodiment of about 25 degrees.

[0018] The hub may be a generally standard luer hub. Therefore, the overall length,

L4, may be approximately 0.5 inch, with the rectangular dimensions d2 and d3 approximately 0.35 inch and L2 approximately 0.24 inch. In one embodiment, the length of the connector, L3, is about 0.16 inch with a diameter, d4, of about 0.2 inches. The end may be of a standard luer taper.

[0019] FIG. 2 illustrates an exemplary epidural needle. Current practices use an epidural needle as a dissection needle of tissue. However, the needle is adapted for traversing the spinal cord and injecting a substance into this area. The needle length is unwieldy for use in dissecting tissue of the pelvic floor. Also, the needle port for injecting a fluid is directed in a singular direction, off-axis. Thus, the needle must be rotated and properly oriented to dissect tissue in different regions unlike the needle embodiments described herein. [0020] Although embodiments of this invention have been fully described with reference to the accompanying drawings, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of embodiments of this invention as defined by the appended claims.

Claims

CLAIMS What is claimed is:

1. A needle, comprising:

a needle body having a closed distal tip;

at least two diffusion ports along a wall of the needle body;

a luer connector at a proximal end of the needle body.

2. The needle of claim 1, further comprising depth markings spaced along the length of the needle body.

3. The needle of claim 2, wherein the depth marking are rings perpendicular to a longitudinal length of the needle occurring at a constant separation interval.

4. The needle of claim 3, wherein the depth markings are chemical or laser etched.

5. The needle of claim 1, wherein the at least two diffusion ports comprises four diffusion ports.

6. The needle of claim 5, wherein a first and second diffusion port are on opposing sides of the needle body.

7. The needle of claim 6, wherein a third and fourth diffusion port are on opposing sides of the needle body.

8. The needle of claim 7, wherein the first and second diffusion ports are longitudinally offset from the third and fourth diffusion ports.

9. The needle of claim 8, wherein the first and second diffusion ports are located on a tapered portion of the needle body distal tip.

10. The needle of claim 8, wherein the third and fourth diffusion ports are located on a straight shaft portion of the needle body.

11. The needle of claim 8, wherein the first and second diffusion ports are on orthogonal sides of the needle body from the third and fourth diffusion ports.

12. The needle of claim 8, wherein the needle body is generally hollow for passing a diffusion fluid.