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Title:
DEVICES AND METHODS FOR HANDLING A PLURALITY OF SUTURE ELEMENTS DURING A SUTURING PROCEDURE
Document Type and Number:
WIPO Patent Application WO/2002/002017
Kind Code:
A1
Abstract:
A device (10) for assisting in a suturing procedure is provided. The device (10) can advantageously be used to hold a suture holder (40) carrying a plurality of suture elements (42) during a suturing procedure. The device (10) comprises a mount (12) for releasably mounting the device (10) on a support (11) held in a stationary position relative to a patient and a suture holder bracket (14) connected to the mount (12), the suture holder bracket (14) being arranged releasably to engage the suture holder (40) during the suturing procedure so as to hold the suture holder (40) relative to the support (11) and the patient thereby to assist in the suturing procedure.

Inventors:
ISBELL LEWIS (US)
JACKSON JASPER (US)
WHITIN KATHERINE (US)
Application Number:
PCT/US2001/020332
Publication Date:
January 10, 2002
Filing Date:
June 26, 2001
Export Citation:
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Assignee:
ABBOTT LAB (US)
ISBELL LEWIS (US)
JACKSON JASPER (US)
WHITIN KATHERINE (US)
International Classes:
A61B17/06; A61B17/04; (IPC1-7): A61B17/06; A61B17/04
Foreign References:
US5385569A1995-01-31
US4586614A1986-05-06
US5848714A1998-12-15
US5972030A1999-10-26
US5353974A1994-10-11
Attorney, Agent or Firm:
Dillahunty, Gene T. (Doane Swecker & Mathi, L.L.P. P.O. Box 1404 Alexandria VA, US)
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Claims:
WHAT IS CLAIMED IS:
1. A device for assisting in a suturing procedure, the device comprising: a mount for releasably mounting the device on a support normally held in a stationary position relative to a patient; and a suture holder bracket connected to the mount, the suture holder bracket being arranged releasably to engage a suture holder, on which a plurality of suture elements are held, during a suturing procedure so as to hold the suture holder relative to the support and the patient thereby to assist in the suturing procedure.
2. The device of claim 1, wherein the suture holder bracket is connected to the mount by means of an elongate arm.
3. The device of claim 2, wherein the arm is bendable to permit a position of the bracket to be varied relative to the support while the mount is mounted on the support by bending the arm.
4. The device of claim 3, wherein the arm comprises a plurality of arm elements and pivotal connections frictionally connecting one arm element to another, the arm being bendable by displacing the arm elements relative to one another about the pivotal connections.
5. The device of claim 4, wherein each arm element comprises a socket formation and an opposed ball formation, the ball formation of one arm element being received in the socket formation of another arm element.
6. The device of claim 1, wherein the suture holder bracket defines opposed jaw formations arranged to engage the suture holder releasably between them.
7. The device of claim 6, wherein the jaw formations are resiliently biased into an engaging condition to resiliently engage the suture holder between them.
8. The device of claim 7, wherein the jaw formations are arranged to engage a suture holder defining a crosssectionally circular outer surface, at least one of the jaw formations then defining a complementary crosssectionally part circular recess for snugly seating against the outer surface of the suture holder when engaged between the jaw formations.
9. The device of claim 1, wherein the mount comprises a clamp for clamping the device to a support in the form of a support rail.
10. The device of claim 9, wherein the clamp comprises a body defining opposed walls, a screw threaded shank extending through one of the walls and a vice member carried on the screw threaded shank so as to be selectively displaceable toward the other wall in response to rotation of the shank so that the clamp can be clamped to the support rail by positioning the support rail between the other wall and the vice member and rotating the shank to clamp the support rail between the vice member and the other wall.
11. A system for use in a suturing procedure, the system comprising: a suture holder for carrying a plurality of suture elements; and a device for assisting in the suturing procedure, the device comprising a mount, for releasably mounting the device on a support normally held in a stationary position relative to a patient, and a suture holder bracket connected to the mount, the suture holder bracket being arranged releasably to engage the suture holder during a suturing procedure so as to hold the suture holder relative to the support and the patient thereby to assist in the suturing procedure.
12. The system of claim 11, wherein the suture holder bracket is connected to the mount by means of an elongate arm.
13. The system of claim 12, wherein the arm is bendable to permit a position of the bracket to be varied relative to the support while the mount is mounted on the support by bending the arm.
14. The system of claim 13, wherein the arm comprises a plurality of arm elements and pivotal connections frictionally connecting one arm element to another, the arm being bendable by displacing the arm elements relative to one another about the pivotal connections.
15. The system of claim 14, wherein each arm element comprises a socket formation and an opposed ball formation, the ball formation of one arm element being received in the socket formation of another arm element.
16. The system of claim 11, wherein the suture holder bracket defines opposed jaw formations arranged to engage the suture holder releasably between them.
17. The system of claim 16, wherein the jaw formations are resiliently biased into an engaging condition to resiliently engage the suture holder between them.
18. The system of claim 17, wherein the jaw formations are arranged to engage a suture holder defining a crosssectionally circular outer surface, at least one of the jaw formations then defining a complementary crosssectionally part circular recess for snugly seating against the outer surface of the suture holder when engaged between the jaw formations.
19. The system of claim 11, wherein the mount comprises a clamp for clamping the device to a support in the form of a support rail.
20. The system of claim 19, wherein the clamp comprises a body defining opposed walls, a screw threaded shank extending through one of the walls and a vice member carried on the screw threaded shank so as to be selectively displaceable toward the other wall in response to rotation of the shank so that the clamp can be clamped to the support rail by positioning the support rail between the other wall and the vice member and rotating the shank to clamp the support rail between the vice member and the other wall.
21. A method of suturing a patient, the method comprising: mounting a suture holder bracket on a support which is stationary relative to the patient; and attaching a suture holder, which carries a plurality of suture elements, to the suture holder bracket, whereby the suture elements on the suture element holder are held stationary relative to the patient.
22. The method of claim 21, wherein the suture holder bracket comprises cooperating jaw formations, attaching the suture holder to the suture holder bracket comprising causing the suture holder to be engaged between the jaw formations.
23. The method of claim 22, wherein the jaw formations are resiliently displaceable away from each other, causing the suture holder to be engaged between the jaw formations comprising resiliently displacing the jaw formations away from each other, positioning the suture holder between the jaw formations and permitting the jaw formations to displace resiliently toward each other to engage the suture holder therebetween.
24. The method of claim 23, wherein the jaw formations are arranged to engage a suture holder defining a crosssectionally circular outer surface, at least one of the jaw formations then defining a complementary crosssectionally partcircular recess for snugly seating against the outer surface of the suture holder when engaged between the jaw formations, causing the suture holder to be engaged between the jaw formations comprising seating the outer surface of the suture holder in the recess.
25. The method of claim 21, wherein mounting the suture holder bracket on the support comprises mounting a mount to which the suture holder bracket is connected on the support.
26. The method of claim 25, wherein mounting the mount on the support comprises manipulating the mount to cause the mount to be clamped on a support in the form of a support rail.
Description:
DEVICES AND METHODS FOR HANDLING A PLURALITY OF SUTURE ELEMENTS DURING A SUTURING PROCEDURE BACKGROUND OF THE INVENTION This invention relates to suturing a surgical site on a patient body. In particular, the invention relates to a device for assisting in a suturing procedure, a system for use in a suturing procedure and a method of suturing a patient.

During many different surgical procedures it is required to join, or secure, patient tissue together. One way often employed by surgeons, or medical assistants, or the like, to secure patient tissue together, is by using suture elements in a suturing procedure. During such a suturing procedure, suture elements are typically located, or placed, at a surgical site on a patient body and opposed portions of the suture elements are then tied to form sutures, or stitches, at the surgical site so as to secure the patient tissue together. Traditionally, such suturing procedures have been performed by using suture carrying needles to locate one or more suture elements through tissue, pulling the suture elements through the tissue to bring the tissue together and then tying opposed portions of the suture elements together to secure the tissue together.

Multi-suture deployment devices have been proposed by means of which a plurality of suture elements can be located, or placed, at a surgical site on a patient body generally at the same time. It has been found that such multi-suturing devices can be used advantageously to perform a variety of surgical tasks, such as, for example, to form an anastomosis during a coronary artery bypass procedure, or the like. Typically, after such a multi-suture deployment device has been used to locate the suture elements, the suture elements are held, or carried, on a suture holder of the multi-suture device. The located suture elements then extend between the surgical site and the suture holder. Typically, to complete the suturing procedure, opposed portions of each suture element are then removed, or

picked up, from the suture holder and tied together so as to secure the patient tissue together at the surgical site.

It has been found that managing the opposed portions of a plurality of suture elements after having been located on the patient body so as to extend between a surgical site and a suture holder can be rather tedious. In particular, if appropriate care is not taken, the opposed portions of the suture elements can become mixed up, or twisted, so that identifying which portion of a suture element corresponds with which opposed portion of the same suture element can become a rather arduous task. Furthermore, if the suture holder is merely left dangling from the surgical site, the suture elements can very easily become entangled with other medical instruments, a surgeon or assistants person, or the like. Should the suture elements be located on a graft, or the like, during a coronary artery bypass operation, it could happen that the graft becomes damaged if the suture holder is accidentally snagged, or jerked, or the like.

It would be advantageous if such suture holders of such multi-suturing devices could be supported, or held, at a convenient location relative to the surgical site so as to inhibit the suture elements carried on the suture holders from becoming entangled after the suture elements have been located at the surgical site and while extending between the surgical site and the suture holder. Furthermore, it would be advantageous if the suture holders could be supported, or held, at a position which is comfortable for a surgeon, or the like, performing the suturing procedure, so that the suture elements can be readily removed from the suture holders when it is desired to do so, such as, when it is desired to tie opposed portions of the suture elements together to secure the patient tissue together at the surgical site, for example.

SUMMARY OF THE INVENTION Accordingly, in accordance with the invention, there is provided a device for holding suture holders relative to a surgical site, while a plurality of suture elements extend between the surgical site and the suture holder, so as to assist in the performance of a suturing procedure at the surgical site.

In accordance with one aspect of the invention, there is provided a device for assisting in a surgical procedure. The device comprises a mount for releasably mounting the device on a support normally held in a stationary position relative to a patient. The device further comprises a suture holder bracket connected to the mount, the suture holder bracket being arranged releasably to engage a suture holder, on which a plurality of suture elements are held, during a suturing procedure so as to hold the suture holder relative to the support and the patient thereby to assist in the suturing procedure.

By providing such a device, the suture elements extending between the surgical site and the suture holder can be managed so as to assist in preventing the suture elements from becoming entangled. The device can be mounted on a stationary support and the suture holder can be engaged with the device while the device is mounted on the support so that the suture holder can be held at a convenient location relative to the surgical site such that the suture elements extend from the surgical site in a manner comfortable to the surgeon.

In accordance with another aspect of the invention, there is provided a system for use in a suturing procedure. The system comprises a suture holder for carrying a plurality of suture elements. The system further comprises a device for assisting in the suturing procedure, the device comprising a mount, for releasably mounting the device on a support normally held in a stationary position relative to a patient, and a suture holder bracket connected to the mount. The suture holder bracket is arranged releasably to engage the suture holder during a suturing

procedure so as to hold the suture holder relative to the support and the patient thereby to assist in the suturing procedure.

By providing such a device together with the suture holder, the availability of the device can be ensured when a suturing procedure employing a suture holder carrying a plurality of suture elements is to be performed. Furthermore, it would then not be necessary to carry the device as a separate inventory item.

In accordance with yet another aspect of the invention, there is provided a method of suturing a patient. The method comprises mounting a suture holder bracket on a support which is stationary relative to the patient. The method further comprises attaching a suture holder, which carries a plurality of suture elements, to the suture holder bracket, whereby the suture elements on the suture holder are held stationary, or immobilized, relative to the patient.

By attaching the suture holder to the suture holder bracket while the suture holder bracket is mounted on the support, the suture holder can be held stationary relative to the patient so as to inhibit the suture holder from being accidentally knocked around during the suturing procedure. By holding the suture holder stationary in this fashion, suture elements extending between the patient and the suture holder can be managed, and a risk of the suture elements becoming entangled can at least be reduced.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described, by way of example, with reference to the accompanying diagrammatic drawings, in which: Fig. 1 shows a schematic three-dimensional view of a device, in accordance with the invention, for assisting in a suturing procedure; Fig. 2 shows a schematic three-dimensional view of a mount of the device shown in Fig. 1;

Fig. 3 shows a schematic three-dimensional view of a suture holder bracket of the device shown in Fig. 1; Fig. 4 shows a plan view of the suture holder bracket shown in Fig. 3; Fig. 5 shows a three-dimensional view of a suture holder bracket of another device, in accordance with the invention, for assisting in a suturing procedure; Fig. 6 shows a schematic cross-sectional view of a part of an arm of the device shown in Fig. 1; and Fig. 7 shows a three-dimensional schematic view of a suture holder, on which a plurality of suture elements are held, or carried, being releasably engaged in the suture holder bracket of Figs. 3 and 4.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS A device for assisting in a suturing procedure, in accordance with the invention, is generally indicated by reference numeral 10 in Fig. 1.

The device 10 comprises a mount, generally indicated by reference 12 for releasably mounting the device 10 on a support, in the form of a support rail 11, for example, normally held in a stationary position relative to a patient. The support rail can be attached to a stand, an operating table, a surgical instrument being used to perform a sternotomy, or the like, or any other appropriate support normally held stationary relative to a patient during the course of a surgical procedure.

The device 10 further comprises a suture holder bracket, generally indicated by reference numeral 14, connected to the mount 12. The suture holder bracket 14 is connected to the mount 12 by means of an elongate arm 16.

The arm 16 is bendable to permit a position of the bracket 14 to be varied relative to the support 11 when the mount 12 is mounted on the support 11 during a surgical procedure. The arm 16 typically comprises a plurality of arm elements

16.1 frictionally connected one to another with pivotal connections so that the arm elements 16.1 can be angularly displaced relative to one another about the pivotal connections such that the arm elements 16.1 are frictionally held in position by the pivotal connections after having been displaced relative to one another.

As can best be seen with reference to Fig. 6, each arm element 16.1 comprises a socket formation 16.2 and an opposed ball formation 16.3. The ball formation 16.3 of one element 16.1 is received in the socket formation 16.2 of an adjacent arm element 16.1 to define a pivotal connection between the arm elements. It will be appreciated that when the arm 16 is bent, the ball formations 16.3 pivot in the socket formations 16.2 and are frictionally held in position, so that the position of the bracket 14 relative to the mount 12 can be changed by bending the arm 16. Optionally, the arm 16 can be shrouded in a sheath, or the like, to inhibit the arm from being snagged by gloves, or the like, for example.

The suture holder bracket 14 will now be described in greater detail.

Referring to Fig. 7, the suture holder bracket 14 is arranged to engage a suture holder 40 defining a cross-sectionally circular outer surface 44.

As can best be seen with reference to Figs. 3 and 4 of the drawings, the suture holder bracket 14 defines opposed jaw formations 14.1,14.1 arranged releasably to engage, or clasp, the suture holder 40 between them. The jaw formations 14.1,14.1 are resiliently biased into an engaging condition, so that the suture holder 40 can be engaged resiliently between the jaw formations 14.1,14.1.

To locate the suture holder 40 in the suture holder bracket 14, the jaw formations 14.1,14.1 are resiliently displaced away from each other, as indicated by arrow 20, to enable the suture holder 40 to be positioned between the jaw formations 14.1,14.1. When the jaw formations 14.1,14.1 are then released, the suture holder 40 is resiliently engaged between the jaw formations 14.1,14.1. The jaw formations 14.1,14.1 are resiliently displaced away from one another by pinching opposed legs 14.2,14.2, as indicated by arrows 22, which legs 14.2,14.2 are

operatively connected to the jaw formations 14.1,14.1. The jaw formations 14.1, 14.1 and the legs 14.2,14.2 are connected together by means of a biasing element, or portion, 14.3. The suture holder bracket 14 is typically of one piece construction. Conveniently, it can be integrally formed from an appropriate resilient material in a molding process. It can be formed from an appropriate synthetic plastics material, such as, for example, a polycarbonate, or the like.

Each jaw formation 14.1,14.1 defines a cross-sectionally part-circular recess 14.4,14.4 extending at a radius corresponding to a radius of the outer surface 44 of the suture holder 40 so that when the holder 40 is engaged by the bracket 14, opposed sides of its outer surface 44 are seated snugly in the recesses 14.4,14.4.

Referring now to Fig. 2, the mount 12 will now be described in further detail. The mount 12 is typically in the form of a clamping arrangement for clamping the device 10 to a support in the form of the support rail 11, or the like.

Advantageously, the mount 12 is arranged for clamping the device 10 to a support rail on a surgical instrument used to hold the chest of the patient open after a sternotomy when an operation such as a coronary artery bypass operation, or the like, is to be performed. Accordingly, the mount 12 can be arranged to be mounted on a chest retractor, or the like. The mount 12 comprises a body 12.1 which defines a channel 12.2, a vice member 12.3, and a screw-threaded shank 12.4. The screw-threaded shank 12.4 extends through a wall 12.5 defined by the body 12.1 and into the channel 12.2. The vice member 12.3 is carried on the screw-threaded shank 12.4 so that the clamp 12 can be clamped to the support rail 11 by rotating the shank 12.4, as indicated by arrow 13, so as to cause the vice member 12.3 to displace in the direction of arrow 15 so as to clamp the rail between the vice member 12.3 and an opposing wall 12.6.

Referring to Fig. 5, another suture holder bracket, which can be mounted on the device 10 instead of the bracket 14, is generally indicated by reference

numeral 50. The bracket 50 is similar to the bracket 14 save that each of its jaw formations 50.1,50.1 defines two adjacent cross-sectionally part-circular recesses 50.4,50.5 respectively. The recesses 50.4,50.5 have different radii.

Accordingly, by means of the bracket 50, suture holders having cross-sectionally circular outer surfaces at two different diameters can selectively be engaged in either the recesses 50.4,50.4 or the recesses 50.5,50.5. The bracket 50 further comprises stops 50.6,50.6 to inhibit its legs 50.2,50.2 from being displaced toward each other beyond a predetermined amount thereby to preserve the integrity of its biasing portion 50.3. It will be appreciated that the bracket 14 can be provided with stop formations similar to the stop formations 50.6,50.6.

In use, and as can best be seen with reference to Fig. 7, the device 10 is typically mounted on a support rail (not shown in Fig. 7) which is normally stationary relative to a patient. This is achieved by means of the mount, or clamp 12 vice-fashion. The arm 16 can then be bent to position the bracket 14 at a convenient location relative to a patient. After the suture holder 40 has been used to locate, or place, suture elements 42 at a surgical site on the patient, the suture holder 40 can be positioned between the jaws 14.1,14.1 so as to be held, or gripped, between the jaw formations 14.1,14.1. In this fashion, the holder 40 can be held stationary relative to the support rail 11 and the patient. To vary the position of the holder 40, the arm 16 can be bent while the holder is engaged by the bracket 14 so as to position the holder at a comfortable position for a surgeon, or assistant, or the like.

Although an embodiment of the invention has been described in detail above for purposes of clarity and understanding, it will be appreciated that the invention has been described with reference to the above embodiment by way of example only, and that modifications or changes can be made without detracting from the essence of the invention. For example, the mount can be in any appropriate form and need not be of vice-like construction. The mount could be in

the form of a resilient clamp, or the like. The mount could have a vice member actuated by a spring loaded push button, ratchet like formation, hydraulic arrangement, a magnetic arrangement, or even by making use of an appropriate adhesive, or the like. The mount could be arranged to mount the device to another support such as a table, or drapes, or the like. The arm can be in any appropriate form and need not necessarily be bendable. The arm could be in the form of a longitudinally rigid arm, or the like. Instead of the ball and socket connections, other connections in a bendable arm can be used. Such connections could be stiff enough to remain in position after displacement, or appropriate mechanisms can be used to retain the arm in position after having been bent, such as by using cable or wire mechanisms, or the like. Accordingly, the scope of the invention is defined by the appended claims with due regard to equivalents of the claimed elements or features.




 
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