JP2003513696A - Apparatus and method for placing multiple sutures during an anastomosis - Google Patents

Abstract

Abstract: A device (10) for placing a plurality of sutures during an anastomosis of a physiological vessel has a plurality of strands (20) connected together by one or more circular bands (25). Including a crown (15) portion. Each strand has a point at one end and has a curved hook (45) at the same end. The curved hook (45) acts as a suture and holds one or more vessels. An alternative embodiment includes multiple strands or wires (170) that are inserted through one or more vessels to place multiple sutures simultaneously. The present invention also includes a method of using a device to simultaneously place a plurality of sutures.

Description

Detailed Description of the Invention

(Reference to Prior Application) This application is based on Gregory E. Sancoff, John T. et al. Ric
e, and Frederic P.E. Claims the benefits of pending US Provisional Patent Application No. 60 / 163,680 filed November 5, 1999 by Field. The aforementioned documents are incorporated herein by reference.

FIELD OF THE INVENTION The present invention relates generally to devices and methods for surgery. More particularly, the present invention relates to devices and methods for surgical formation of an anastomosis of a physiological vessel.

BACKGROUND OF THE INVENTION Joining two or more surgical vessels together, such as the intestinal tract and blood vessels, is a common surgical procedure. The three main types of connections include end-to-end connections, end-to-end connections, and side-to-side connections. Since these structures often carry fluids, the connections formed must be at least substantially complete around the entire surface. Conventional means of connecting these structures together include the use of sutures or staples.

Manual placement of sutures around a vessel is often very difficult and cumbersome due to various factors. These factors include space limitations at a typical surgical site, and attachment or containment of desired surgical vessels to various other structures. Such limitations impede the procedure and make it difficult to access the remote side of the desired surgical vessel.

Furthermore, blood vessels such as coronary arteries, or the blood vessels used to form a bypass, are small in diameter and have very thin walls. The thin walls cause these vessels to assume a collapsed shape during handling, making vessel handling and positioning difficult.

It is an object of the present invention to provide a device for deploying multiple sutures during an anastomosis of a physiological vessel. Another object of the present invention is to provide a method of deploying multiple sutures during an anastomosis of a physiological vessel.

SUMMARY OF THE INVENTION A device for deploying multiple sutures during an anastomosis of a physiological vessel includes a crown portion having multiple strands connected to each other by one or more circular bands. The strands each make a point at one end and the curved hooks are at the same end. The curved hook acts as a suture and holds one or more vessels.

An alternative embodiment includes multiple strands or wires that are inserted through one or more vessels to deploy multiple sutures simultaneously. The present invention also includes a method of simultaneously deploying multiple sutures using the device.

Detailed Description of the Preferred Embodiments FIGS. 1-3 show an apparatus 10 for surgical formation of an anastomosis. In the preferred embodiment, the device 10 includes a crown 15 having a plurality of strands 20 joined by at least two crown rings 25. Each strand 20 has a first end 3
It has a pointed jaw 35 at the second end 40, which is connected to the ring 25 adjacent to 0. Strand 20 includes a chin 35 and a bend 45 adjacent the second end 40. The curved portion 45 may have a hook shape.

FIG. 2A shows the crown 15 with a retaining ring 50 for retaining the hooks 45 of each strand 20. Retaining ring 50 allows positioning of second end 40 of crown 15 adjacent physiological vascular tissue. Removal of the retaining ring 50 positions the hook 45 so that it is secured to one or more physiological vessels.

3 and 4A-4N describe a surgical procedure for creating a vascular anastomosis called the abduction technique. In FIG. 3, the device 10 is positioned on one end of a physiologic vessel 55 with a scope 60 positioned therethrough. The handle 56 attached to the crown 15 is
It is provided to operate the device 10. The handle 56 includes a separating means 57, which includes, but is not limited to, a pre-made break point.

FIG. 4A shows the coronary portion 15 advanced over the length of the vessel 55. Crown 1
After 5 is placed at the appropriate distance along vessel 55, the end of vessel 55 is folded back and pierced on hook 45 as shown in FIG. 4B. The crown 15 surrounding the vessel 55 is then placed within the vessel 65, as shown in Figure 4D and as shown in the cross-sectional view of Figure 4E. The cross-sectional view of FIG. 4E shows the retaining ring 50,
The retaining ring 50 is accessible to the outside of the device 10. The retaining ring 50 is removed by cutting through it. Alternatively, retaining ring 50
May be removed from the hook 45 by other methods such as repositioning in an area adjacent to the crown ring 25.

4F and 4G show that device 10 drives hook 45 through vessel 65 after retaining ring 50 is removed. As shown in FIG. 4G, a space 75 may be created between vessel 55 and vessel 65 during the abduction technique.

In one embodiment of the invention, as shown in FIGS. 4H-4K, seal ring 7
0 is used with crown 15 to form device 10. The seal ring 70 is
It is formed from a pierceable and implantable material, such as an elastic material including, but not limited to, plastic or elastomer.

FIG. 4G again shows a space 75 between vessel 55 and vessel 65 created by the abduction technique. In order to eliminate the space 75 and protect the hook 45, FIG.
A seal ring 70 is disposed on the crown 15 as shown at H-4I. In FIG. 4J, because the seal ring 70 has been pierced on the sharp jaw 35,
It can be seen that the outer surface of seal ring 70 is in contact with vessel 55 and vessel 65. This simultaneous contact makes it possible to eliminate all passages created by the space 75. In addition, a seal with an appropriately sized cross-sectional radius
The ring 70, in addition to the vessels 55 and 65, can contact the crown 15 on the hook 45, thus providing a tighter seal in the space 75.

In FIG. 4K, an alternative embodiment is located around device 10 and includes vessels 55 and 65.
Includes a plurality of sutures 80 that close the space 75 between and. The seal ring 70 may be used to protect the sharpened jaw 35, as described above, in addition to positioning the suture 80 to close the space 75.

4L-4N, another preferred embodiment includes a clover leaf bender 82 and drives the end of the hook 45, including the sharpened jaw 35, toward the vessel 65. The clover leaf vendor 82 has a series of protrusions 83 and recesses 84 formed therein. As shown in FIG. 4L, the clover leaf vendor 82 has a vessel 55
And vessel 65 are placed around crown 15 after they have been attached to each other. In FIG. 4M, the recesses 84 include the ends of the hooks 45 extending outward and the protrusions 83 therebetween. Next, as shown in FIG. 4N, the clover leaf bender 82 is rotated to drive the end of the hook 45 radially and downward toward the vessel 65. In one embodiment of the invention, the clover leaf bender 82 is rotated to drive the end of the hook 45 substantially parallel to the vessel 65, after which the clover leaf bender 82 is removed from the crown 15. In another embodiment, the clover leaf bender 82 is rotated enough to deflect the end of the outwardly extending hook 45, leaving it in contact with the hook 45. The clover leaf vendor 82, when left attached to the crown 15, acts similar to the seal ring 70.

5A-4C show an alternative configuration in which the coronary portion 15 is located within the physiological vessel 55. As shown in FIG. 5A, a lock ring 85 is provided to secure the crown 15 within the vessel 55 and the hook 45 is restrained by the retaining ring 50 prior to insertion into the vessel 65. In FIG. 5B, the lock ring 85 is shown between the coronary ring 25 and the vessel 5.
The first end 30 of coronary portion 15 (shown in FIG. 5A) is inserted into vessel 55 while firmly secured on 5. The hook 45 is still blocked by the retaining ring 50 for inserting the second end 40 (shown in FIG. 5A) of the crown 15 into the vessel 65. FIG. 5C shows the second end 40 of the crown 15 during insertion into the vessel 65. The retaining ring 50 is removed, preferably by cutting, and the hook 45 is placed to secure the crown 15 to the vessel 65, as described above. In addition, the seal
Other embodiments described herein, such as ring 70 and / or suture 80, may be implemented to further seal vessel 55 and handle 56.

6A-6B, 7A-7B, 8A-8B show an alternative embodiment, where the strand 20 attaching the hook 45 to the crown ring 25 exhibits greater flexibility. The embodiment shown in Figures 6A and 6B provides additional flexibility with each strand 20 including a bend 90. The embodiment shown in FIGS. 7A and 7B provides additional flexibility with each strand 20 including a spring 95. In the embodiment shown in FIGS. 8A and 8B, each strand 20 uses spring structure 100 to attach one of the crown rings 25. Strand bend 90, strand spring 95, spring structure 100 are advantageous in that less force is required to place hook 45 with retaining ring 50 or other instrument. In addition, the strand bend 90, the strand spring 95, and the spring structure 100 allow the material of the strand 20 to be warped to a greater extent without damaging it, thus increasing the force of the hook 45 and penetrating the vessel 65.

In FIG. 9, vessel 55 and vessel 65 have been attached at an angle to each other using an abduction technique. In FIG. 10, vessel 55 and vessel 65 have been attached in series with each other using an abduction technique. FIG. 11 is a view seen from the inside of a vascular vessel 65 attached to the vascular vessel 55 by the hook 45 around the attachment portion.

12A-12D show an alternative embodiment of the device and method, where the crown 1 is shown.
5 is punched from one sheet 105 and etched. FIG. 12A shows the sheet 10 in its complete condition, prior to making the crown 15 by stamping or etching.
5 is shown. An imaginary line 110 on the sheet 105 shows the shape of punching or etching. The crown 15 is then stamped or etched from the sheet 105 to form a planar crown 115, as shown in FIG. 12B. The flat crowns have a first end 120 and a second end 125 at opposite ends of the crown ring 25.
And connect the strands 20 together. The flat crown portion 115 is rounded to form
First end 120 is connected to second end 125 to form crown 15, as shown at C. The crown portion 15 formed by the flat crown portion 115 has a substantially straight strand 20.
Have. Next, the hook 45 is formed as shown in FIG. 12D. In this configuration, the crown 15 is used as in the other cases described herein.

13A and 13B show an alternative embodiment in which the crown ring 25 of the crown 15 is a unitary structure 130. The crown 15 with the unitary structure 130 is formed by either one of the techniques described above, or by molding a single element, or using other known processes. Then, the hook 45 is formed as shown in FIG. 13B. The crown 15 is attached to at least one vasculature using the techniques described herein.

14A, 14B show an alternative embodiment of the crown 15, which has hooks 45 on both the first end 30 and the second end 40. As shown in FIG. 14B, after attaching the vessel 55 to the hook 45 at the first end 30, attach the vessel 65 to the second.
Attach to hook 45 at end 40 to complete the surgical anastomosis of the vessel. In addition, other embodiments and methods described herein may be incorporated into this embodiment.

15A and 15B show an alternative embodiment for restraining a hook 45 that includes a pointed jaw 35. Each strand 20 includes a joint 132 by which the hook 45 is arranged around and the pointed jaw 35 is arranged on the rear side of the strand 20 towards the first end 30 of the crown 15. It becomes possible to do. To place the hook 45, the second end 40 of the crown 15 is placed within the vessel. The hook 45 then bows outwardly through the vessel 65 and then the strand 20 as shown in FIG. 15B.
Vessels 55 and 65 are captured by returning and snapping around.

The pointed jaw 35 includes a range of structures including, but not limited to, the embodiments shown in FIGS. In FIG. 16, the sharpened jaw 20 is formed in a conical shape at the end of the cylindrical strand 20. In FIG. 17, a sharp jaw portion 20 is formed from a cylindrical strand 20 at an acute angle cut. In FIG. 18, a sharp jaw 20 is formed at a pair of acute-angled cuts at the ends of the rectangular strand 20. In FIG. 19, the strand 20 is formed in a pyramid shape at the end of the rectangular strand 20.

A preferred embodiment of the present invention includes a sealant to facilitate closure of the space 75 or other opening. The sealant is included on the crown 15 adjacent the hook 45. Sealing agents include, but are not limited to, various adhesives and coagulants. After placing the crown 15 and performing a surgical anastomosis, these sealants also help to close any spaces and openings.

An alternative embodiment of the present invention, shown in FIG. 20, has a vessel 55 placed inside the coronary portion 15 and positioned inside the vessel 55 between the two coronary rings 25. Includes devices and methods for securing crown 15 with inner locking ring 135. The lock ring 135 exerts an outward force to retain the vessel 55 against the crown 15.

21A-21F illustrate another embodiment device and method of using a metal suture wire to form an anastomotic connection between vessel 55 and vessel 65. Flange-shaped end 14
A flexible mandrel 140 having a number 5 is inserted into the vessel 55 such that the distal end of the vessel 55 flares against the flanged end 145 of the mandrel 140.

The body section 150 is overlaid on the vessel 55. The section 150 comprises a tubular section 155 with a flanged end 160 that mates with the flanged end of the flexible mandrel 140. A wire tube 165 including a short piece of metal wire 170 extends axially a short distance from the interior of the flanged end 160 of the body. Above the tube 165 is a sleeve 175 that slides along the outside of the body 150. Inside the wall of the sleeve 175 is a receiving hole 180 for the wire tube 165, from which a plunger 185 extends. The receiving hole 180, together with the wire tube 165, forms a telescoping tube pair 190 that supports the wire 170 when the sleeve end is advanced. Body 150
Sliding the sleeve 175 toward the flange-shaped end 160 of the plunger causes the plunger 185 to push down the wire 170, which penetrates into the tissue of the vessel 55.
Normally, this load causes the wire 170 to bend, but here the tube 190
Supports the sides. When the tip of the wire 170 reaches the flanged end 145 of the flexible mandrel 140, the die surface 195 (shown in FIG. 23B) deflects the wire 170 outward rearward, ie, proximally. At this point, the tip of wire 170
Penetrating the walls of vessel 55 and vessel 65 and further advancement of sleeve 175, the tip of wire 170 penetrates the vessel 65 wall outwardly due to the deflection caused by die surface 195. Bends toward the opposite direction. Outer wire
When the tube 190 reaches the bottom of the receiving hole 180 in the sleeve 175, the wire advancement ceases. The body 150 is then pulled away from the suture site along the vascular axis, leaving the wire 170 in its deployed position.

22A-22D show four possible end shapes in which the tip of wire 170 maintains tissue access. If the wire 170 is made of a resilient material such as nitinol, the wire 170 may be preformed into these shapes so that the wire recovers these shapes when extruded from the wire tube 165. can do. As the tissue does not have an exit path unless the wire 170 is bent, FIG.
The wires 170 shown at A, 22C and 22D hold the tissue in place.
The wire 170 shown in FIG. 22B has a distal end looping around a section of the proximal strand, or vice versa, whereby the proximal strand loops around the distal end, thereby Holds tissue more securely.

In the case of the malleable metal suture wire 170, the suture wire 170 in the section passing through the die surface 195 can be formed into various shapes depending on the geometry of the die surface 195. The smaller the radius of die surface 195, the tighter the curvature of the end shape of suture wire 170. See Figures 23A-23F.

Both body 150 and sleeve 175 circumscribe the post-sewn vessel 55, thus providing a method of removing body 150 and sleeve 170 after placement of the suture wire. Body 150 and sleeve 1 divided vertically and having a hinge on one side
75 embodiments are shown in FIG. 24A. Sleeve 1 after placement of suture wire 170
Open 75 and pull apart, then pull body 150 in the same manner.

Once the bond is achieved, the flexible mandrel 140 must also be removed. FIGS. 25A and 25B show a flexible mandrel 140 having an inflatable flange-shaped end that expands the die surface 195. The fluid pressure spreading the mandrel 140 comes from the catheter 210, which is also used to deliver fluid from within or outside the body. Since the die surface 195 must be stiff, the die surface 195 is disposed on a surface 220 separate from the flange 200 that spreads while maintaining stiffness and deflecting the wire 170.

The device of the present invention provides a means to position and secure suture wires around a vessel during anastomosis.

[Brief description of drawings]

1A through 1E show an embodiment of a crown for deploying a plurality of sutures.

[Fig. 2]   2A through 2D show a crown including a retaining ring.

[Figure 3]   It is a figure which shows the crown part containing a handle.

4A-4N show various embodiments of an apparatus for performing a surgical anastomosis using an everting technique.

[Figure 5]   5A to 5C are views showing an internal version of the crown.

6A-6B are diagrams illustrating various embodiments of strands having a structure for additional flexibility.

7A-7B are diagrams illustrating various embodiments of strands having a structure for additional flexibility.

8A-8B are diagrams illustrating various embodiments of strands having a structure for additional flexibility.

[Figure 9]   FIG. 6 illustrates various abduction techniques that use crowns.

[Figure 10]   FIG. 6 illustrates various abduction techniques that use crowns.

FIG. 11   FIG. 6 illustrates various abduction techniques that use crowns.

[Fig. 12]   12A to 12D are views showing a crown made of a planar material.

[Fig. 13]   13A and 13B are views showing a crown having an integral ring structure.

14A and 14B are views showing an embodiment of the present invention having hooks at both ends of a crown portion.

15A-15B illustrate one embodiment of the present invention having self-locking hooks.

FIG. 16   FIG. 6 shows various tips of strands.

FIG. 17   FIG. 6 shows various tips of strands.

FIG. 18   FIG. 6 shows various tips of strands.

FIG. 19   FIG. 6 shows various tips of strands.

FIG. 20   FIG. 7 shows an external version of the crown.

21A-21F show a device for placing and securing sutures to create an anastomotic connection.

FIG. 22   22A through 22 are diagrams showing various wire end configurations.

23A-23F show various die surface embodiments of a device for placing and securing sutures to create an anastomosis connection.

24A-24B illustrate an embodiment of a hinged device that positions and secures sutures to create an anastomosis connection.

25A-25B show an inflatable mandrel at the end of a catheter for a device for placing and securing sutures to create an anastomotic connection.

─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Rice, John Tee             Massachusetts State 01773,             Lincoln, Red Rail Farm             31 (72) Inventor Field, Frederick P.             New Hampshire, United States             03862, North Hampton, Woodrun             De Road 5 F-term (reference) 4C060 BB05 CC03 CC07 CC22

Claims (17)

[Claims] 1. A device for deploying a plurality of sutures during an anastomosis of a physiologic vessel, each strand having a first end and a second end, each strand having a respective first end. A plurality of strands having a first portion and a second portion adjacent one end and the second end; and a plurality of strands adjacent the first portion of the wire strand With at least one circular band coupled to each of the strands, each strand forming a point at the second end, each strand having at least one physiology during anastomosis of a physiological vessel. A device for forming a hook adjacent the second portion for attachment to a target vessel. 2. A means for retaining each hook of each of said plurality of strands in a first position for inserting said second portion of said crown into at least one physiological vessel. The apparatus according to Item 1. 3. A second portion of said hook from said first position to said second position for securing each said hook to at least one physiological vessel during vessel anastomosis. The apparatus of claim 2 comprising means for deploying. 4. A device according to claim 3, wherein the retaining means is a retaining ring. 5. The apparatus of claim 4, wherein the deployment means removes the retaining ring. 6. The device of claim 5, wherein the removing of the retaining ring is accomplished by cutting the retaining ring. 7. The retaining means is an articulation portion on the strand, the articulation portion retaining the hook by positioning the hook about the first end of the strand, 3. The device of claim 2 which allows for deployment by removing it from the strand. 8. A method of deploying a plurality of sutures during an anastomosis of a physiological vessel, each strand having a first end and a second end, each strand having a respective first and second ends. A plurality of strands having a first portion adjoining one end and the second end, and at least one for integrally joining the plurality of strands adjacent to the first portion of each said strand A crown comprising a circular band, each said strand forming a hook adjacent to said second end and having a point at said second end; Attaching a physiological vessel to the crown and attaching a second physiological vessel to the crown such that the first physiological vessel and the second physiological vessel are substantially in relation to each other. A method comprising: being combined. 9. A device for placing a plurality of sutures during an anastomosis of a physiological vessel, comprising a body including a plurality of suture wires, and a mandrel having a die surface corresponding to the plurality of suture wires. The body and mandrel have a first physiologic such that at least a portion of the first physiologic vessel and at least a portion of the second physiologic vessel are positioned between the body and the mandrel. Positioned with respect to a vessel and a second physiological vessel, the suture wire via the at least a portion of the first physiological vessel remote from the die surface and to the second physiological vessel. A device for receiving a force from the body through the at least a portion of a tube to form a plurality of sutures. 10. The apparatus of claim 9, further comprising means for removing the body from the first vessel and the second vessel. 11. The apparatus according to claim 10, wherein said body removing means is a hinged opening. 12. The apparatus of claim 9, further comprising means for removing the mandrel from the first vessel and the second vessel. 13. The apparatus of claim 12, wherein the mandrel is inflatable and the mandrel removal means is a catheter connected to the mandrel. 14. A method of deploying a plurality of sutures during an anastomosis of a physiological vessel, comprising: a device having a body that includes a plurality of suture wires; and a mandrel having a die surface. A first physiological vessel and a second physiological vessel such that at least a portion of the first physiological vessel and at least a portion of the second physiological vessel are contained between the body and the mandrel. Through the at least a portion of the first physiological vessel remote from the die surface of the mandrel for forming a plurality of sutures and forming a plurality of sutures; A method of deploying a plurality of sutures by applying a force from the body to the plurality of suture wires through the at least a portion of a physiological vessel of. 15. The method of claim 14, further comprising the method steps of removing the body from the first physiological vessel and the second physiological vessel. 16. The method of claim 14, further comprising the method steps of removing the mandrel from the first physiological vessel and the second physiological vessel. 17. A method of deploying a plurality of sutures during an anastomosis of a physiological vessel, each strand having a first end and a second end, each strand having a respective first end. A plurality of strands having a first portion adjoining one end and the second end, and at least one for integrally joining the plurality of strands adjacent the first portion of each said strand A crown comprising a circular band, each said strand forming a hook adjacent said second end and providing a crown having a point at said second end, said crown Attaching the first physiologic vessel to the crown by arranging the first vessel therein and inverting one end of the first vessel over the hook; and Attach the physiological vessel of Which method comprises as the first physiological vascular and second physiologic vascular are substantially coupled to each other by.