WO2010075288A1

WO2010075288A1 - Anastomosis devices and methods including backflow prevention

Info

Publication number: WO2010075288A1
Application number: PCT/US2009/069008
Authority: WO
Inventors: Kory P. Hamel
Original assignee: Ams Research Corporation
Priority date: 2008-12-23
Filing date: 2009-12-21
Publication date: 2010-07-01

Abstract

An anastomosis device has a mechanism to prevent the backflow of bodily fluids into the actuation mechanism of the device. The anastomosis device is able to prevent backflow while also allowing manipulation of actuation wires connected to the actuation mechanism.

Description

ANASTOMOSIS DEVICES AND METHODS INCLUDING BACKFLOW PREVENTION

Priority Claim The present application claims priority to U.S. Provisional Application Serial No.

61/140,211, filed December 23, 2008 and entitled "BACKFLOW PREVENTER FOR ANASTOMOSIS DEVICE", which is herein incorporated by reference in its entirety.

Field of the Invention The present invention relates generally to anastomosis devices and their associated methods of use in reconnecting tissue. More particularly, the present application relates to an improved anastomosis device utilizing a backflow prevention device to prevent backflow of body fluids into an actuation mechanism of the anastomosis device.

Background of the Invention

Anastomosis procedures are required for connecting or re-connecting certain body tissues, e.g., as part of a surgical procedure. Typically, these tissues define a body lumen such as a blood vessel, intestinal, digestive or urinary tissue that are severed and/or reconnected as part of a successful treatment. One representative example can include a radical prostatectomy procedure in which, a surgeon removes all or most of a patient's prostate. The procedure generally leaves a severed urethral stump and a severed bladder neck, which must be reconnected to so as to restore proper urinary functions.

A representative procedure describing the use of an anastomosis device in connecting a severed urethral stump and a severed bladder neck is described in U.S. Patent Publication No. 2005/0070938A1, which is commonly assigned to the assignee of the present application, American Medical Systems of Minnetonka, Minnesota. Through the use of a combination of retention features including an inflation balloon and a plurality of tissue approximating structures described as extendable tines, the urethral stump and bladder neck can be aligned and retained in contact throughout a healing period for the tissue. While the urethral stump and bladder neck forcibly hold the tissue during healing, the anastomosis device provides a drainage lumen allowing bodily fluids and other materials to pass during the healing period. While the aforementioned anastomosis device effectively reconnects tissue during surgical procedures, it would be advantageous to improve upon present designs to enhance the functionality, reliability and safety associated with use of anastomosis devices.

Summary of the Invention

The present invention is generally directed to an anastomosis device which provides a backflow prevention mechanism to prevent the backflow of bodily fluids into an actuation lumen and a corresponding actuation mechanism of the anastomosis device. The backflow prevention mechanism is able to prevent the backflow while also allowing manipulation of the actuation wires. In this way, bodily fluids do not interfere with or otherwise prevent successful operation of the actuation mechanism. In addition, medical professionals are not exposed to bodily fluids from an unexpected source on the anastomosis device.

In one aspect of the present disclosure, a representative anastomosis device of the present invention includes a backflow prevention mechanism in an actuation lumen so as to prevent backflow of bodily fluids into an actuation mechanism. In one embodiment, the backflow prevention mechanism comprises a Tuohy-Borst valve at a connecting portion of the actuation lumen. The Tuohy-Borst valve can be configured such that when the Tuohy-Borst valve is in an open configuration, actuation wires controlling approximation structures can be advanced or retracted. When the Tuohy-Borst valve is in a closed configuration the area around the wires is sealed to prevent bodily fluids such as blood and urine from flowing from the anastomosis site to the actuation lumen and into the actuation mechanism.

In another aspect of the present disclosure, a method for preventing backflow of a bodily fluid into an actuation mechanism during an anastomosis procedure can comprise providing a backflow prevention mechanism in an actuation lumen. In some embodiments, the backflow prevention mechanism can comprise a Tuohy-Borst valve that is adjustable between an open disposition in which actuation wires can be advanced or retracted and a closed disposition in which the bodily fluid is prevented from infiltrating the actuation lumen and correspondingly, the actuation mechanism.

The above summary of the invention is not intended to describe each illustrated embodiment or every implementation of the present invention. The figures and the detailed description that follow more particularly exemplify these embodiments.

Brief Description of the Drawings The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

Figure IA is a perspective view of an embodiment of an anastomosis device according to the prior art.

Figure IB is a section view of the anastomosis device of Figure IA taken at line IB- IB.

Figure 2 is a perspective view of an embodiment of a manipulation portion of an anastomosis device of the present invention.

Figure 3 is a plan view of an embodiment of a manipulation portion of an anastomosis device of the present invention.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Detailed Description of the Drawings Referring now to Figures IA and IB, a representative embodiment of an anastomosis device 10 is illustrated, which includes an elongated catheter shaft 12 having a central drainage lumen 14 that extends generally along the length of catheter shaft 12. Catheter shaft 12 further includes an actuation wire lumen 16 through which an actuation wire for the tissue approximating structure can extend, and an inflation lumen 18 used for inflation and deflation of a balloon near the tip of the device. Catheter shaft 12 can also include at least one cable or wire 20 that acts as a reinforcement structure and extends through the wall of catheter shaft 12 along at least part of its length. This cable or wire 20 is made of a material that provides added strength to the device 10 to prevent or minimize stretching or deformation of catheter shaft 12 during manipulation of device 10 and/or to protect the integrity of the device if it is subjected to unanticipated loads, such as impact loads. Thus, cable or wire 20 is preferably chosen or designed to be as thin and lightweight as possible so as to not add unnecessary weight or bulk to device 10, while still providing the desired amount of protection for the device. In addition, cable or wire 20 should be of a size and shape that maintains a relatively flexible catheter shaft 12 for patient comfort. More than one cable or wire 20 may be used in a particular catheter shaft 12, where multiple wires 20 within a single device may be spaced from each other within the wall of catheter shaft 12. Cable or wire 20 may be coextruded within the wall of catheter shaft 12, or may instead extend through a central opening of catheter shaft 12. In a further alternative, cables or wires 20 may be located on the outside of catheter shaft 12 and may be secured to shaft 12 by adhesive mechanical attachment, wrapping of wire 20 about shaft 12, and the like. Cables or wires 20 may be solid lengths of material such as metal, plastic, fabrics, woven materials, and the like, or may instead be hollow tubular structures. Each cable or wire 20 may comprise more than one piece of the same or different materials that are woven or otherwise attached to each other along their lengths.

Figure 2 discloses an embodiment of the present invention where a backflow preventer is being utilized. Generally, the proximal end 22 of the anastomosis device is seen in this Figure 2. The proximal end 22 is primarily comprised of a catheter funnel 24. This funnel divides into an inflation lumen section 26, a drainage lumen section 28, and an actuation lumen section 34 connected to an actuation mechanism 30. The inflation lumen section 26 is connected to the inflation lumen 18 shown in Figure IB and is the passage by which air or other gas is forced in order to inflate a balloon or like device at the distal tip of the device. The drainage lumen section 28 is connected to the central drainage lumen 14 and provides a drainage pathway through which blood and urine being drained from the body can pass. The actuation mechanism 30 is a device which is connected to the assembly via the actuation lumen section 34 and an actuation wire traveling through actuation wire lumen 16. Actuation mechanism 30 can be used to manipulate one or more actuation wires for controlling the tissue approximating structures for use in the anastomosis procedure. It is desirable for this actuation mechanism to not be exposed to drainage passing through the lumen. The device shown is able to provide a means to prevent backflow of bodily fluids, such as blood or urine, into the actuation mechanism 30. The device of the present invention is able to prevent this backflow through use of a valve assembly 32 which, at the same time, allows manipulation of actuation wires extending from the actuation mechanism 30.

In one embodiment, valve assembly 32 is a Tuohy-Borst valve placed in the end of the actuation lumen 34 near the actuation mechanism 30. When the Tuohy-Borst valve is in the open position, the actuation wires can be advanced or retracted. When the Tuohy-Borst valve is in the closed position, the area around the wires is sealed to prevent fluids from flowing from the anastomosis site to the actuation mechanism 30. In one embodiment, the valve assembly 32 is selectively controllable with the actuating mechanism 30.

Figure 3 discloses an embodiment of the present invention where a strain relief feature 34 is included in the proximal section 22 of the anastomosis device. The valve assembly 32 is located adjacent the actuation mechanism 30, similar to the location shown in Figure 2.

Accordingly, as shown in Figure 3, a variety of catheter funnel designs of various shapes and sizes may utilize valve assemblies in accordance with the present invention.

Although specific examples have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that any arrangement calculated to achieve the same purpose could be substituted for the specific example shown. This application is intended to cover adaptations or variations of the present subject matter. Therefore, it is intended that the invention be defined by the attached claims and their legal equivalents.

Claims

CLAIMS 1. An anastomosis device comprising: an elongated catheter shaft having a proximal end and a distal end, the elongated catheter shaft having a central lumen and an actuation wire lumen extending through the elongated catheter shaft between the proximal end and the distal end; at least one actuation wire extending through the actuation wire lumen; a catheter funnel disposed at the proximal end of the elongated catheter shaft, the catheter funnel branching into a drainage lumen and an actuation lumen, wherein the drainage lumen is connected to the central lumen and the actuation lumen is connected to an actuation mechanism which is connected to and configured to manipulate the actuation wire; and a valve assembly positioned within the actuation lumen, the valve assembly configured to allow the actuation mechanism to manipulate the at least one wire when in an open position and configured to seal an area between the at least one wire and an inner surface of the actuation lumen when in a closed position.

2. The device of claim 1, wherein the valve assembly comprises a Tuohy-Borst valve.

3. The device of claim 1, wherein the valve assembly is positioned at a distal end of the actuation lumen where the actuation lumen intersects the drainage lumen.

4. The device of claim 1, further comprising an inflation lumen extending through the elongated catheter shaft between the proximal end and the distal end and wherein the catheter funnel further branches into an inflation lumen portion which is connected to the inflation lumen and is configured to allow inflation and deflation of an inflatable device positioned on the distal end of the elongated catheter shaft.

6. The device of claim 1, further comprising at least one reinforcement member extending through a wall of the elongated catheter shaft that provides added strength to the elongated catheter shaft.

7. The device of claim 1 , further comprising a means for strain relief in the catheter funnel.

8. The device of claim 7, wherein the means for strain relief is disposed on the drainage lumen.

9. The device of claim 1, wherein the valve assembly is configured to be opened and closed with the actuation mechanism.

10. An anastomosis device comprising: an elongated catheter shaft having a proximal end and a distal end; a central lumen extending through the elongated catheter shaft between the proximal end and the distal end; an actuation wire lumen extending through the elongated catheter shaft between the proximal end and the distal end; at least one actuation wire extending through the actuation wire lumen; a catheter funnel disposed at the proximal end of the elongated catheter shaft, the catheter funnel including a drainage lumen and an actuation lumen, the drainage lumen connected to the central lumen and the actuation lumen connected to an actuation mechanism connected to and configured to manipulate the actuation wire; and means for preventing backflow of bodily fluids into the actuation mechanism.

11. The device of claim 10, wherein the means for preventing backflow is positioned at a distal end of the actuation lumen where the actuation lumen intersects the drainage lumen.

12. The device of claim 10, further comprising an inflation lumen extending through the elongated catheter shaft between the proximal end and the distal end connected to an inflation lumen portion in the catheter funnel configured to allow inflation and deflation of an inflatable device positioned on the distal end of the elongated catheter shaft.

13. The device of claim 10, further comprising at least one reinforcement member extending through a wall of the elongated catheter shaft that provides added strength to the elongated catheter shaft.

14. The device of claim 10, further comprising a means for strain relief in the catheter funnel.

15. The device of claim 14, wherein the means for strain relief is disposed on the drainage lumen section.

16. The device of claim 10, wherein the means for preventing backflow is selectively controllable with the actuation mechanism.

17. A method for performing an anastomosis procedure comprising: providing an anastomosis device including an elongated catheter portion connected to a catheter funnel, the catheter funnel including a drainage lumen connected to a central lumen in the elongated catheter portion and an actuation lumen connected to an actuation mechanism which is connected to at least one actuation wire extending through an actuation wire lumen in the elongated catheter portion, wherein a valve assembly is disposed in the actuation lumen; positioning a distal end of the anastomosis device within a body of a patient; opening the valve assembly; manipulating the at least one actuation wire with the actuation mechanism; closing the valve assembly; and allowing bodily fluids to be drained from the body by flowing through the central lumen, into the drainage lumen, and out of the anastomosis device wherein the valve assembly prevents the fluids from flowing into the actuation mechanism.

18. The method of claim 17, wherein the steps of opening the valve assembly and closing the valve assembly are done using the actuation mechanism.

19. The method of claim 17, wherein the step of providing the anastomosis device includes providing an anastomosis device further comprising an inflation lumen extending through the elongated catheter shaft and wherein the catheter funnel further includes an inflation lumen portion which is connected to the inflation lumen and wherein the method further comprises inflating a balloon positioned at the distal end of the anastomosis device using the inflation lumen portion and inflation lumen.