ES2366248T3 - SUTURE DEVICE WITH DOUBLE WATER. - Google Patents

Abstract

Double needle suture device (300) for use in surgery, comprising: a housing (312); a body part (314) extending distally from the housing; a first jaw (316) mounted at a distal end of the body part, the first jaw being configured to receive a pair of surgical incision elements (304) therein; a second jaw (318) mounted at the distal end of the housing, the second jaw being configured to receive the pair of surgical incision elements therein; at least one handle (326) mounted in the housing, the second jaw being able to move with respect to the first jaw in response to the actuation of at least one handle; and characterized in that it comprises a fixing mechanism (328) functionally associated with the first jaw and the second jaw, the fixing mechanism being able to be operated to alternately fix the pair of surgical incision elements in the first jaw and the second jaw.

Description

Background

one.

Technical field

The technical field refers in general to surgical suture instruments and, more particularly, to surgical suture devices that have an angled jaw structure for using cardiac valvuloplasty surgery and disposable loading units comprising surgical needles intended to be used with the surgical suture apparatus.

2.

Background of the related technique

Diagnosis and treatment of coronary heart disease and related disorders often require repair or replacement of heart valves. Various factors, such as, for example, calcification, can cause the mitral or aortic valves to deteriorate or stop functioning, requiring replacement. When cardiac valvuloplasty is indicated, in general, the damaged valve is cut and replaced with an artificial synthetic heart valve or with a transplanted porcine heart valve. The replacement valve is usually sutured in the place of the original valve.

It is common to access the heart in the thoracic cavity of a patient by making a longitudinal incision in the chest. Said procedure, known as a middle sternotomy, comprises cutting the sternum and separating the two opposite halves of the rib cage to allow access to the thoracic cavity and, therefore, to the heart.

Once the thoracic cavity has been accessed, cardiac valvuloplasty surgery can be performed. During some procedures, the heartbeat is stopped by injecting a cardioplegic fluid, such as potassium chloride (KCl), to paralyze the myocardium, while maintaining blood circulation using known vascular bypass techniques. Alternatively, the heart is allowed to beat to maintain circulation, while a localized area of the heart is immobilized, in which the surgical intervention is to be performed.

An incision is made in the heart and the damaged valve is removed leaving a surrounding area with a locally harder tissue. Known valvuloplasty techniques usually comprise passing particular stitches separately through hard tissues to form a set of stitches. The free ends of the stitches extend to the outside of the thoracic cavity arranged, separated, in the patient's body. The free ends of the stitches are then basted separately through an edge around the circumference of valvuloplasty or a support sleeve. Once all the stitches have been made through the valve, all stitches are tensioned and the valve slides or "drops" downward in its place adjacent to the hard tissue. Next, the replacement valve is fixed in place using the stitches.

Although the procedures described above are sufficient to satisfactorily perform sutures in the tissues of the heart valves and provide an artificial heart valve in the heart and subsequently suture the valve in the tissue, they are particularly slow. Therefore, there is a need for apparatus and procedures to quickly and efficiently suture artificial heart valves in the heart.

US Patent No. 3,470,875 discloses a surgical grip and suture instrument, in which the needles are advanced upwardly through a part of the tissues held between the surfaces of the tweezers towards openings intended to receive the needles. The needles remain fixed in their position in the openings, the same being held by friction coupling with spring elements arranged in the openings, as the forceps are opened.

Summary

A suture device or a surgical suture instrument is disclosed for use in cardiac valvuloplasty surgery that generally comprises a housing and an elongated body part that extends distally from the housing. A first or fixed jaw is disposed at a distal end of the body part and is oriented at a predetermined angle with respect to a longitudinal axis of the body part, the predetermined angle being greater than 0 ° with respect to the longitudinal axis of the part of the body. A second or movable jaw is also disposed at the distal end of the elongated body part and can be moved between a first position adjacent to the fixed jaw and a second position separated from the fixed jaw. The first jaw can also be displaced with respect to the body part. At least one handle is provided and can be rotatably disposed in the housing, the movable jaw being able to move in response to the actuation of the handle. A clamping mechanism is also provided to alternatively engage and release a surgical needle within at least one of the fixed and movable jaws.

Also, a disposable loading unit for use with the surgical suture apparatus is disclosed. The loading unit has a base and a structure to receive the device arranged in a movable way in the base. The structure that houses the apparatus is configured to receive a distal end of the surgical suture apparatus. There is a movable mode at the base of a needle supply station having a needle support element, the needle support element being configured to hold so that at least one surgical needle can be released in the same. Preferably, the reception structure of the apparatus is rotatably arranged in the base. The needle support element is preferably arranged in a rotating manner in the base. The needle support member can be displaced between a first position that has a first surgical needle at the distal end of the surgical suture apparatus and a second position that has a second surgical needle at the distal end of the surgical suture apparatus.

The receiving structure of the apparatus is preferably arranged in a movable way in the first plane, and the needle support element can be moved in a second plane substantially perpendicular to the first plane.

A second embodiment of the present invention comprises a suture device with a double needle for use in cardiac valvuloplasty surgery generally comprising a housing, a body part that extends distally from the housing and a first or fixed jaw disposed in a distal end of the housing, the fixed jaw being configured to receive a pair of surgical needles or surgical incision elements in the recesses thereof.

The double needle suture device also comprises a second or movable jaw disposed at the distal end of the housing, the movable jaw being also configured to receive the pair of surgical needles or surgical incision elements in the recesses thereof. The first jaw can also be displaced with respect to the body part. At least one handle is disposed in a movable way in the housing, the movable jaw being able to move with respect to the fixed jaw in response to the actuation of at least one handle. A clamping mechanism is associated in a functional way to the movable jaw and the fixed jaw is also provided. The clamping mechanism can be operated to alternately fix the pair of surgical incision elements in the fixed jaw and the movable jaw.

An alternative disposable loading unit is also disclosed for use with the double needle suture device having a needle holder with a plurality of needle supply stations therein, each needle supply station being configured to retain releasably a pair of surgical needles connected by a simple extension of the suture material. A suture support is attached to the needle support, the suture support having at least one conduit for receiving the extension of the suture material. Each needle station of the plurality of needle stations has a central stud and a first and second flexible arms adjacent to the central stud, a first needle of the pair of needles being retained between the first flexible arm and the stud and a second needle retained. the pair of needles between the second flexible arm and the stud.

A method of suturing an artificial heart valve to the cardiac tissue is also disclosed by providing a suture device having a first jaw and a second jaw, and a pair of needles, connected by a simple extension of suture material, which is retains in a releasable manner in one of the first and second jaws. The jaws are then arranged adjacent to the cardiac tissue and the jaws are closed to pierce the cardiac tissue with the pair of needles. The pair of needles are released after the first and second jaws and are held inside the other of the first and second jaws. The first and second jaws open to extract the extension of the suture material through the tissue until a compress of suture material adjacent to the tissue is removed. Preferably, the compress in the suture is performed in the heart tissue. Next, the needles are removed from the suture and a posterior needle or suture pin is used for the suture thread through the artificial heart valve sleeve. Once all the sutures have passed through the cuff, the heart valve assembly is displaced or "dropped" downward toward the sutures, instead in the cardiac tissue, and the sutures are closed.

Brief description of the drawings

Various embodiments are described herein with reference to Figures 26 to 46, in which:

Figure 1 is a perspective view of a surgical suture apparatus having an angled jaw structure and a disposable loading unit for installing a surgical needle in the angled jaw structure;

Figure 2 is a perspective view of the handle part of the surgical suture apparatus of Figure 1 with a housing removed halfway;

Figure 3 is a perspective view, with the parts separated, of the handle part of the suture apparatus

surgical figure 1; Figure 4 is a perspective view, with the parts separated, of the distal part of the surgical suture apparatus of figure 1;

Figure 4A is a cross-sectional view taken along line 4A -4A of Figure 4; Figure 4B is a view taken along line 4B -4B of Figure 4A; Figure 4C is a view taken along line 4C -4C of Figure 4A; Figure 5 is a perspective view of a surgical suture needle; Figure 6 is an additional perspective view of the surgical suture needle; Figure 7 is a perspective view of the surgical suture needle with an extension of suture material

looking at it;

Figure 8 is a top plan view of a disposable loading unit with surgical needles arranged in the same; Figure 9 is a perspective view of the loading unit of Figure 8; Figure 10 is a perspective view, with the separate parts, of the loading unit of Figure 8; Figure 11 is an enlarged area of a detail view of Figure 10; Figure 11A is a perspective view of the bottom of the loading unit of Figure 8; Figure 11B is a view similar to Figure 11A, with a needle support member rotated from a first

position to a second position;

Figure 12 is a perspective view of the loading unit of Figure 8 and the distal end of the surgical apparatus of suture in the preparation for mounting the surgical suture apparatus in the loading unit; Figure 13 is a perspective view of the distal end of the surgical suture apparatus disposed in the unit of

disposable loading in preparation for loading a needle;

Figure 14 is a top plan view of the distal end portion of the surgical suture apparatus in the disposable loading unit and corresponding to figure 13; Figure 15 is a top plan view illustrating the installation of a surgical needle in the structure of the

jaw of the surgical suture apparatus;

Figure 16 is a cross-sectional view of the distal end portion of the surgical suture apparatus with the surgical needle fixed in a fixed jaw; Figure 17 is a sectional view taken along line 17-17 of Figure 16; Figure 18 is a sectional view taken along line 18-18 of Figure 16; Figure 19 is a sectional view taken along line 19 -19 of Figure 16; Figure 20 is a perspective view of the distal end portion of the surgical suture apparatus with the needle

Surgical installed therein disposing adjacent to a cuff of a heart valve structure and

of cardiac tissue; Figure 21 is a sectional view showing the closure of the jaw structure and the penetration of the surgical needle through the sleeve structure of the cardiac valve of the sleeve and cardiac tissue;

Figure 22 is a view similar to Figure 21 depicting the opening of the jaw structure and the removal of the surgical needle and surgical suture through the sleeve structure of the cardiac valve of the sleeve and cardiac tissue; Figure 23 is a sectional view of the part of the distal end of the surgical suture apparatus with the surgical needle again disposed in the structure of the fixed jaw and in position to re-pierce the sleeve structure of the heart valve and the cardiac tissue to form another suture point;

Figure 24 is a perspective view similar to Figure 20 after several passes of the surgical needle through the sleeve structure of the heart valve and cardiac tissue;

Figure 25 is a sectional view of a valvuloplasty and the valve sleeve disposed in the cardiac tissue; Figure 26 is a perspective view of a double needle suture device and a loading unit disposable for use in cardiac valvuloplasty surgery, according to an embodiment of the invention;

Figure 27 is a perspective view, with the parts separated, of a part of the distal end of the device

double needle suture of figure 26; Figure 28 is a perspective view of a stabilizer disposed within the distal end portion of the figure 27;

Fig. 29 is a side view, partially shown in section, of a part of the distal end portion of Figure 27; Figure 30 is a sectional view taken along line 30-30 of Figure 29; Figure 31 is a sectional view taken along line 31-31 of Figure 29; Figure 32 is a perspective view, with the separate parts, of the disposable loading unit of Figure 26;

Figure 33 is a partial top plan view of the disposable loading unit of Figure 26; Figure 34 is a side view of the jaw structure of the suture device of Figure 26 advancing towards an end carrying a needle of the disposable loading unit of figure 26;

Figure 35 is a view similar to Figure 34 and represents the jaw structure closing on a needle

of suture held in the disposable loading unit; Figure 36 is a perspective view of the distal end of the suture device of Figure 26 with a suture with double needle, which has a compress, installed in the jaw structure thereof;

Figure 37 is a view taken along line 37-37 of Figure 36;

Figure 38 is a sectional view taken along line 38-38 of Figure 37 and depicting the needle retaining in a jaw by means of a blade associated with the jaw; Figure 39 is a perspective view of the distal end portion of the suture device of Figure 26 with the

double needle and suture installed in it and in position to proceed to suture the sleeve of a valve cardiac associated with valvuloplasty in cardiac tissue;

Figure 40 is a sectional side view showing a surgical needle installed in the movable jaw; Figure 41 is a sectional side view showing the approach of the movable jaw towards a jaw fixed to pierce the cardiac tissue;

Figure 42 is a perspective view of a surgical needle for suturing the heart valve sleeve in the

heart tissue; Figure 43 is a perspective view of cardiac tissue with various sets of suture pads. installed in it and in position to pass through the sleeve of an artificial heart valve using the surgical needle of figure 42;

Figure 43A is a perspective view similar to Figure 43 and depicting the use of the surgical needle

to pass one end of the suture through the cuff; Figure 43B is a perspective view similar to Figure 43A with all ends of the suture passed through of the cuff and the artificial heart valve moving down the suture towards the tissue cardiac;

Figure 43C is a perspective view of an alternative procedure for suturing the heart valve tissue;

Figure 44 is a partial view of an alternative jaw structure;

Figure 45 is a view similar to Figure 44 depicting a pair of surgical needles and the associated suture installed therein in a first configuration; Y

Figure 46 is a view similar to Figure 45 with the surgical needle installed in a second configuration.

Description of the preferred embodiments

Referring to Figure 1, a surgical suture apparatus 10 is shown, which is particularly suitable for arranging and passing a surgical needle through dense tissue structures and prostheses in areas of limited access, such as, for example, in the Cardiac valvuloplasty suture during heart valve surgery. The apparatus 10 does not constitute an embodiment of the present invention. Although the following description of the apparatus 10 is provided with respect to its use cardiac valvuloplasty surgery, it is specifically provided that the apparatus 10 can be used in other surgical procedures. Surgical suture devices 10 generally comprise housing for a handle 12 which has the halves of the housing 12a and 12b at a proximal end and an elongated tubular housing or part of the body 14 extending distally from the handle 12. As used in herein, the term "proximal" refers to the part of the apparatus, or element thereof, closest to the user, while the term "distal" refers to the part of the apparatus or element thereof, further away from the user. .

A pair of jaws for receiving the needles comprising a first fixed jaw 16 and a second or mobile jaw 18 are mounted at a distal end of the body part 14. The first or fixed jaw 16 can also be mobile, as will be described. then. The fixed jaw 16 is disposed with a predetermined angle α with respect to a longitudinal axis of the body part 14 to facilitate access when used in the surgery of the heart valves. The angle α is greater than 0 ° and obviously not 180 °. Preferably, the fixed jaw 16 is disposed at an angle between approximately 60 degrees with respect to the body part 14. A pair of handles 20 are provided in the handle housing 12 and control the movement of the movable jaw 18 with respect to the fixed jaw 16. Preferably, the movable jaw 18 travels through an arc approximately 50 degrees with respect to the fixed jaw 16. It is to be appreciated that, alternatively, both jaws can be movable.

The surgical suture apparatus 10 further comprises a fixing mechanism 22 which is provided to fix a surgical needle within the fixed jaw 16 and the movable jaw 18 in a releasable and alternative manner. A loading mechanism 24 is provided to control the mechanism. of fixation 22 and allow loading a surgical needle in one or both jaws. To accommodate the surgical needle therein, the fixed jaw 16 comprises a recess for receiving the needle 26 and the movable jaw 18 comprises a recess for receiving the needle 28.

A new disposable loading unit 30 is provided to supply one or more surgical needles 32 having an extension of suture material 34 attached to the surgical suture apparatus 10. The disposable loading unit 30 generally comprises a part of the body 36 and the structure of receiving the apparatus 38 disposed in a removable manner in the body part 36. The housing structure of the apparatus 38 is configured to receive the body part 14 of the surgical suture apparatus 10 and the position jaws 16 and 18 on the needle surgical 32 in a position such that surgical needle 32 can be accurately and positively disposed within recesses 26 and 28 of jaws 16 and 18, respectively.

Referring now in general to Figures 1 and 2 and in particular to Figure 3, in order to open and close the movable jaw 18 with respect to the fixed jaw 16, the surgical suture apparatus 10 has a central rod 40 which extends through the body part 14 towards the handle of the housing 12. As indicated above, the handles 20 are disposed in a removable manner in the halves of the housing 12a and 12b to move the movable jaw 18 with respect to the fixed jaw 16. Specifically, the handles 20 are rotatably disposed in the handle housing 12 by means of the handle screws 42 that function as rotating pins and extending through the holes in the handle 44 and into the rotating holes 46 made in the Housing halves 12a and 12b. The handles 20 are connected to the central rod 40 via a pair of connections

48. The projections 50 at the distal end of the connections 48 are coupled with the holes 52 made in the handles 20 while a proximal end of the connections 48 is fixed to a proximal end of the central rod 40 by a pin 54. The pin 54 extends through the holes 56 and the connections 48 and through a hole in the central rod 58 in the central rod 40. Thus, by turning the handles 20 with respect to the housing halves 12a and 12b the central rod 40 will produce an alternative movement within the body part 14. Specifically, when the handles 20 are closed towards the handle housing 12, the connections 48 pull the central rod 40 proximally to close the movable jaw 18 against the jaw fixed 16, at the same time as the displacement of the handles 20 away from the handle housing 12 causes the connections 48 to drive the central rod 40 distally to open the movable jaw 18 moving away from the fixed jaw 16, in a manner that will be described in more detail herein.

As indicated above, the surgical suture apparatus 10 comprises a fixing mechanism 22 for releasably fixing a surgical needle in the fixed jaw 16 or in the movable jaw 18. The fixing mechanism 22 generally comprises an oscillating mechanism 60 having an articulated wheel 62 arranged in a rotating manner between the halves of the housing 12a and 12b. The articulated wheel 62 comprises a pair of levers 64 which are operated with the thumb and extend outwardly from the handle housing 12. The articulated wheel 62 is arranged in a rotating manner between the handle housings 12a and 12b by means of a pair of mounting projections 66 found in grooves 68a and 68b made in housing halves 12a and 12b.

The fixing mechanism 22 further comprises a pair of upper and lower channel elements 70 and 72 that extend through the body part 14 and which are provided to transmit the movement of the articulated wheel 62 to the jaws and help fix a surgical needle inside the fixed jaw 16 and the mobile jaw 18, respectively. The upper channel element 70 is fixed to the articulated wheel 62 by means of a pin 74 which is located in a drive groove 76 made in the articulated wheel 62. The pin 74 extends through a hole 78 at the proximal end of the element of the upper channel 70. Similarly, the lower channel element 72 is fixed to the articulated wheel 62 by means of a pin 80 extending through an actuation slot 82 made in the articulated wheel 62 and through a hole 84 made in the lower channel element 72. Thus, by rotating the articulated wheel 62 inside the handle housing 12, the upper and lower channel elements, 70 and 72, respectively, alternately oscillate within the body part 14, such that they alternately fix a surgical needle inside the fixed jaw 16 or the movable jaw 18 in a way that will be described later in more detail.

Surgical suture devices 10 further comprise a locking structure that prevents displacement of the articulated wheel 62 when the central rod 40 is in the most distal position with movable jaw 18 separated from the fixed jaw 16. Specifically, the central rod 40 it comprises a pin 86 that engages an upper notch 88 of the articulated wheel 62 when the articulated wheel 62 is rotated to arrange the upper channel element 70 in the most proximal position and the lower channel element 72 is in the most position distal The coupling of the pin 86 with the upper notch 88 prevents the rotation of the articulated wheel 62 to fix a needle in the movable jaw 18. Instead, when the surgical needle is fixed to the fixed jaw 16 and upper channel element 70 is located in the most distal position with the lower channel element 72 in the most proximal position, the pin 86 engages with a lower notch 90 made in the articulated wheel 62 and prevents rotation thereof. Furthermore, when the handles 20 are compressed against the handle housing 12 to thereby remove the central rod 40 to a proximal position, the pin 86 moves out of both the upper notch 88 and the lower notch 90 and allows rotation free of the articulated wheel 62. This corresponds to a state in which the movable jaw 18 is closed against the fixed jaw 16.

To load a surgical needle into the fixed jaw 16 and / or the mobile jaw 18, it is necessary to be able to move the upper and lower channel elements 70, 72, respectively, simultaneously in a distal direction for the reasons described below. Therefore, as indicated above, the surgical suture apparatus 10 has a loading mechanism 24, which comprises the control structure of the block 92. The control structure of the block 92 allows the articulated wheel 62 to slide distally within housing halves 12a and 12b. Specifically, the articulated wheel 62 is suspended in a U-shaped channel 94. The channel 94 has a hole 96 to remove the central rod and 40 therethrough and holes 98 to receive the projections 66. The shaped channel of U 94 has upper slots 100 and lower slots 102 to receive sliding pins 74 and 80. The articulated wheel 62 and the U-shaped channel 94 are fixed in a fixed position with respect to the halves of the housing 12a and 12b by means of a pair of plungers 104. The plungers 104 have buttons with the reduced diameter 106 extending therefrom. Plungers 104 are located in holes 108a and 108b made in housing halves 12a and 12b, respectively. A pair of slots 110a and 110b extend distally from holes 108a and 108b. By pressing the plungers 104 inwards against the halves of the housing 12a and 12b, the plungers 104 are removed from the holes 108a and 108b and allow the push buttons 106 to travel distally in the slots 110a and 110b thereby displacing the entire mechanism for fixing the needle 22 distally in the surgical suture apparatus 10. A pair of sliding elements 112a and 112b are arranged on an outer surface of the housing halves 12a and 12b and comprise holes 114a and 114b to receive the push buttons 106. The tabs 116a and 116b of the sliding elements 112a and 112b move longitudinally in the grooves 118a and 118b made in the halves of the housing 12a and 12b.

In order to move the handles 20 away from the housing halves 12a and 12b and, therefore, to arrange the jaw structure in an open position, a C-shaped ring 120 attached to the central rod 40 is provided. it provides the C-shaped ring 120 to realize a support surface of a spring element (not shown) that disposes the central rod 40 in the most proximal position corresponding to an open state of the jaw. Furthermore, the halves of the housing 12a and 12b are preferably fixed to each other by means of the screws of the halves of the housing 122. Although they are shown as fixed by means of the screws 122, the halves of the housing 12a and 12b can be fixed by any other suitable means, such as, for example, adhesives, welding, etc.

Referring to Figure 4 and as indicated above, the body part 14 extends distally from the handle housing 12 and is fixed thereto. Specifically, the body part 14 comprises a pair of slots of the housing 124 that are configured to engage with the projections of the body 126a and 126b made in the halves of the housing 12a and 12b, respectively (see Figure 3.).

As indicated above, the fixed jaw 16 and the movable jaw 18 are disposed at a distal end of the body part 14. The distal end of the body part 14 comprises a pair of jaw support arms protruding distally 128. The fixed jaw 16 and the movable jaw 18 are fixed to the distal end of the body part 14 by means of a jaw support pin 130 extending through holes 132 of the jaw support arms 128 and through holes 134 and 136 of fixed jaw 16 and mobile jaw 18, respectively.

As indicated above, the central rod 40 is provided to oscillate longitudinally within the body part 14 in order to open and close the movable jaw 18 with respect to the fixed jaw 16. Therefore, the central rod 40 has a pivot shaft 138 which is disposed within a hole 140 at a distal end of the central rod 40. The pivot shaft 138 is disposed in a straight groove 142 made in a mounting portion 144 of the fixed jaw 16 and extends towards an angular groove 146 made in a mounting part 150 of the movable jaw 18. The central rod 40 with the pivot axis 138 stabilizes in its longitudinal oscillation within the body part 14 as the pivot axis 138 moves within a pair of longitudinal grooves 152 made in the support arms of the jaw 128.

Thus, as the central rod 40 travels to the most distal position, by turning the pivot shaft 138 to a first end 154 of the angular groove 146, the jaw 18 is driven to an open position separated from the jaw fixed 16. Instead, as the central rod 40 is removed proximally within the body part 14, the pivot shaft 138 is withdrawn to a second end 156 within the angular groove 146 to thereby rotate the movable jaw 18 to a closed position substantially adjacent or very well aligned with the fixed jaw 16. The straight groove 142 is aligned with the longitudinal axis of the central rod 40 such that the displacement of the central rod 40 drives the axis of rotation 138 within the straight groove 142. Said particular alignment of the straight groove 142 allows the fixed jaw 16 to remain motionless as the central rod 40 oscillates. However, it is specifically contemplated that the fixed jaw 16 is removable with respect to the body part 14. This is easily accomplished by orienting the alignment of the straight groove 142 such that the displacement of the axis of rotation 138 within the groove 142 move the fixed jaw 16 in the same way as the mobile jaw 18.

The fixing mechanism 22, which, as indicated above, is provided to alternatively fix a surgical needle within both the fixed jaw 16 and the movable jaw 18, further comprises the upper and lower needle fixing blades 158 and 160. Preferably, the upper and lower needle fixing blades 158 and 160 are fixed to the upper and lower channel elements 70, 72 by means of the blade pins 166 and 168. However, other connection means of blades 158 and 160 with the elements of the channel 70, 72. In particular, an upper pin 162 extends through a hole of the blade 166 in the upper needle fixing blade 158 and through one of the holes in the channel 170 in the channel 70 element. Similarly, a lower pin 164 extends through a hole in the blade 168 in the fixing needle of the lower needle 160 and is fixed to the channel 72 extending through one of the holes of the channel 172. Thus, as the oscillating mechanism 60 moves, the elements of the channel 70, 72 alternately oscillate the upper and lower needle fixing blades 158, 160. With more precisely, the upper and lower needle fixing blades 158, 160 oscillate in the holding parts of the fabrics 174 and 176 of the fixed jaw 16 and the movable jaw 18, respectively.

Referring to Figures 4a to 4c, the details of a tissue holding part of a jaw will be described below, for example, the tissue holding part 174 of the fixed jaw 16. As indicated above, each structure of the jaw comprises a needle receiving recess, for example, the needle receiving recess 26 of the tissue holding part 174 of the fixed jaw 16. The needle receiving recess 26 comprises a flared end 178 to help guide a surgical needle toward the needle receiving recess 26 and a part with narrow or reduced area 180 to prevent a surgical needle from completely passing through the needle receiving recess 26.

In addition, the tissue holding portion 174 of the jaw 16 comprises a slot of the blade 182 extending along the tissue holding portion 174. The slot of the blade 182 is configured to slidably receive the blade of fixing the upper needle 158 therein. Although not specifically represented, the movable jaw 18 comprises a corresponding flared end and a part with the reduced area in the needle recess 28. In addition, the movable jaw 18 comprises a longitudinally extending blade groove 196 ( Figure 19), which intersects with the needle receiving recess 28, to slidably receive the lower needle fixing blade 160.

As shown in Fig. 4A, the groove of the blade 182 in the fixed jaw 16 intersects with the recess of receiving the needle 26. In order to fix a surgical needle in one of the jaw structures, for example, the upper jaw 16, the upper needle fixing blade 158 is advanced distally through the groove of the blade 182 until a coupling edge of the needle 184 (Figure 4) of the upper needle fixing blade 158 is fits the corresponding structure of a surgical needle (see Figures 16 and 17). To release the surgical needle from the fixed jaw 16, the upper needle fixation blade 158 retracts proximally until the fixation edge of the needle 184 no longer engages the surgical needle in the part where it is crosses with the groove of the blade 182 and the receiving recess of the needle 26. Similarly, the upper needle fixing blade 160 comprises a needle fixing edge 186 (Figure 4) which, when advancing in the corresponding connection of its blade groove 196 with the recess of receiving the needle 28, is coupled with the corresponding structure of the surgical needle and firmly engages the surgical needle in the movable jaw 18. It should be indicated that when the blade of needle fixation 158 is in the most distal position by fixing a surgical needle in the fixed jaw 16, the needle fixing blade 160 is in the most proximal position in movable jaw 18 away from the recess e 28, and vice versa.

To facilitate loading of a surgical needle into one or both of the fixed jaw 16 and movable jaw 18, the upper and lower needle fixing blades 158 and 160 have load recesses 188 and 190, respectively. As indicated above, when the articulated wheel travels distally within the housing halves 12a and 12b, the elements of the channel 70, 72 distally move so that the needle fixing blades 158, 160 distally move inside of the corresponding grooves of the upper jaw 16 and the lower jaw 18. This corresponds to a position in which the load recesses 188 and 190 are adjacent to the receiving recesses of the needle 26 and 28, respectively, and therefore so much no structure of the needle can be blocked or attached.

A terminal piece 192 may be disposed at a proximal end of the body part 14 to help stabilize the body part 14 with respect to the housing handle 12 and ensure an appropriate seal. In addition, the C-shaped ring 120 is disposed in one part with the reduced area 194 of the central rod 40.

Referring to Figures 5 to 7, a new surgical needle 200 suitable for use with a surgical suture apparatus 10 and particularly suitable for use in cardiac valvuloplasty surgery will now be described. The surgical needle 200 generally comprises a part of the curved body 202 having an elongated penetration part 204 extending from a first end 206 of the body part 202. A pointed part 208 is made adjacent to the second end 210 of part of the body 202. The elongate penetration portion 204 is particularly useful for facilitating penetration into the resistant material, such as, for example, plastic or fabric meshes of the type employed in cardiac valvuloplasty structures. The body part 202 further comprises a reception opening of the suture 212 intended to receive the extension of the suture material 34. A shoulder 214 is made adjacent to the reception opening of the suture 212 such that when one end of the Extension of the suture material 34 is introduced into the receiving opening of the suture 212, the shoulder 214 can be compressed inwardly to thereby fix the extent of the suture material 34 within the receiving opening of the suture 212 ( figure 7). By providing additional material in the form of shoulder 214, after compression, the body part 202 maintains a relatively uniform outside diameter.

As indicated above, surgical suture devices 10 are specially designed to alternately pass surgical needle 200 between fixed jaw 16 and movable jaw 18. Therefore, the reception structure of the apparatus in the form of a receiving recess of housing the first blade 216 and a reception recess of the second blade 218 are made in of the body part 202. The reception recess of the first blade 216 has a substantially symmetrical cross-section and is configured to receive the edge of coupling of the needle 184 of the upper needle fixing blade 158 to thereby fix the surgical needle 200 in the fixed jaw 16. In order to pass the surgical needle 200 to the movable jaw 18, the recess for receiving the second blade 218 is configured to accommodate the needle fixing edge 186 of the lower needle fixing blade 160 to thereby fix the needle q 200 on the movable jaw 18. The receiving recess of the second blade 218 has an asymmetric cross section with a chamfered edge 220. The chamfered edge 220 is provided to prevent the surgical needle 200 from attaching or "hanging" "in the tissue material or structure of the heart valve as surgical needle 200 is pushed therethrough.

Referring to Figures 8 to 11, the new disposable loading unit 30 is provided to supply one or more surgical needles 200 to the surgical suture apparatus 10. More accurately, the loading unit 30 is provided to precisely arrange the structure of the angular jaw of the surgical suture apparatus 10 in the surgical needle 200 to facilitate loading therein. Referring initially to Figures 8 and 9, and as indicated above, the loading unit 30 substantially comprises the part of the body 36 that has the receiving structure of the apparatus 38 therein. The body part 36 comprises a needle supply station 222 made in a first part 224 of the body part 36. The needle supply station 222 is provided to align and maintain a surgical needle 200 in a position to be held by the jaws 16 and 18 of the surgical suture apparatus 10.

The needle supply station 222 further comprises a needle support element 226 that securely and releasably retains one or more surgical needles 200 in a first groove 228 made therein. The surgical needle 200 is housed in the first groove 228 adjusted by friction. A platform 230 is made in the first part 224 of the body part 36 to keep the fixed jaw 16 and the movable jaw 18 at a predetermined level such that the surgical needle 200, arranged in the first groove 228, is aligned with the receiving recesses of the needle 26 and 28, in the fixed jaw 16 and the mobile jaw 18, respectively.

Needle supply station 222 further comprises a fixing mechanism 232 comprising a pair of asymmetric wings 234 and 236 protruding towards the needle support member 226. A defined gap 238 between wings 234 and 236 allows the jaws 16 and 18 of the surgical suture apparatus that are lifted out of the loading unit 30 once the surgical suture apparatus has been loaded with a surgical needle 200 and the jaws 16 and 18 are moved to a closed position. The wing 234 is shorter than the wing 236 to provide space for the elongated penetration portion 204 of surgical needle 200 as the surgical suture apparatus 10 rises away from the loading unit 30.

As indicated above, the loading unit 30 has the receiving structure of the apparatus 38 for receiving a distal end of the surgical suturing apparatus and having the fixed jaw 16 and the movable jaw 18 on the surgical needle 200. The structure of Receiving the apparatus 38 substantially comprises an oscillating base 240 that is rotatably arranged on a rotation axis 242 made in a second part 244 of the basal part

36. The oscillating base 240 is configured to move through a predetermined arc approximately 25 degrees with respect to the second part 244 in order to move the fixed jaw 16 by aligning it at the second end 210 of the surgical needle 200. The oscillating base 240 comprises an arcuate recess 246 to receive the body part 14 of the surgical suture apparatus 10. In addition, the oscillating base 240 comprises a pair of lateral tabs 248 to keep the body part 14 of the surgical suture apparatus 10 aligned with the base oscillating 240. To ensure an appropriate longitudinal arrangement of the body part 14 within the oscillating base 38, the oscillating base 38 has an alignment stud 250 arranged in the arcuate recess 248 and configured to engage the corresponding structure in the part of the body 14 of the surgical suture apparatus 10. This is particularly intended in operations that require more than one length Suture unit, for example, when using a double needle or a double armed suture with a compress. The use of more than two needle support slots is considered.

Referring to Figures 10 and 11, the needle support element 226 is disposed in a removable manner in a groove 252 made in the first part 224 of the body part 36. The needle support element 226 is arranged preferably for a rotating displacement with respect to the body part 36. A pair of projections 254 is coupled with a hole 256 in the needle support element 226 and allows the needle support element 226 to rotate with respect to the body part 36. As shown, the receiving structure of the apparatus 38 can be displaced in the foreground and the needle support member 226 can be displaced in a second plane substantially perpendicular to the foreground.

As indicated above, the disposable loading unit 30 is provided to supply one or more surgical needles 200 for use in the surgical suture apparatus 10. Therefore, the needle support member 226 may have a second groove 258 to retain a second surgical needle 200 adjusting by friction therewith. A tab 260 is provided on the base of the needle support element 226 to rotate the needle support element between a first position aligned with the first surgical needle 200 supported in the first slot 228 in a position to be held by the apparatus of surgical suture 10 and a second position that would align a surgical needle 200 supported in the second groove 258 in a position to be held by the surgical suture apparatus 10. As shown in Figures 10, 11A and 11B, the support element of the needle comprises seals 259 and 261 that cooperate with a flexible blocking element 263 made in the body part 36 to block the needle support element 222 in any of the first (figure 11A) or second (figure 11B) positions .

As indicated above, the oscillating base 240 is disposed in a movable manner with respect to the body part 36. The axis of rotation 242 extends through a hole 262 made in the oscillating base 240. A first shaped tongue of L 264 is disposed in a lower part of the oscillating base 240 and is coupled with a first groove 266 to fix the oscillating base 240 to the part of the base 36 and guide the oscillating base 240 in its arcuate movement therein. A second L-shaped tongue 268 is also made in a lower part of the oscillating base 240 and runs a second groove 270. In addition to helping to fix the oscillating base 240 to the part of the base 36, the second tongue in the form of L 268 limits the travel of the oscillating base 240 during its arched displacement. In addition, a retainer 272 is made in a lower part of the oscillating base 240 and is coupled with a shoulder 274 made in the second part 244 of the basal part 36 to hold the oscillating base 240 in an initial position to receive the suture apparatus surgical 10.

Although the length of the suture material 34 is shown extending from the needle 200 from the loading unit 30, it is also provided that the extension of the suture material 34 can be stored in different retaining structures, such as, for example: reels, cavities, tracks, etc. arranged on or inside the load unit

30

Referring to Figures 12 to 15, the procedure for loading the surgical needle 200 from the disposable loading unit 30 and toward the jaw structure of the surgical suture apparatus 10 will be described below. Initially referring to Figures 12 and 13, part of the body 14 of the surgical suture apparatus 10 is disposed in the arcuate recess 246 of the receiving structure of the apparatus 38 such that a hole 276 in the body part 14 is disposed on the alignment stud 250 and the body part 14 is frictionally held between the side tabs 248. Arranged in this way, the fixed jaw 16 and the movable jaw 18 rest on the support platform 230 and are in a position that guarantees the correct alignment of the recesses of receiving the needle 26 and 28 with the elongated penetration part 204 and the pointed part 208 of the surgical needle 200. The surgical needle 200 can be loaded there pray on jaws 16 and 18 by moving jaws 16 and 18 around surgical needle 200.

Referring to FIGS. 14 and 15, in a method of closing the fixed jaw 16 and the movable jaw 18 in the surgical needle 200, the part of the tubular body 14, arranged in the oscillating base 240, moves in the direction of the arrow A to arrange the recess of receiving the needle 26 of the fixed jaw 16 at the second end 210 of the surgical needle 200. Simultaneously or subsequently, the handles 20 are closed to remove the central rod 40 in a proximal direction indicated by the arrow D, thereby displacing the pin 138 in the angular groove 146 of the movable jaw 18 thereby moving the movable jaw 18 in the direction of the arrow C to arrange the needle receiving recess position 28 of the jaw movable 18 in the elongate penetration portion 204 of the surgical needle 200. Preferably, however, when the handles 20 are pressed together the jaws 16 and 18 are closed together in the surgical needle 200 and autom Attic, the body part 14 swings in the direction of the arrow A relative to the body part 36 of the loading unit 30. In this way, the surgical needle 200 is precisely arranged in the needle receiving recesses 26 and 28 of the fixed jaw 16 and the mobile jaw 18.

Once the surgical needle 200 is disposed in the receiving recesses of the needle 26 and 28, the articulated wheel 62, which has previously moved to the distal loading position in the manner described above, can be removed proximally to cause the coupling edges of the needle 184 and 186 of the upper and lower needle fixing blades 158 and 160, respectively, to engage with the first and second receiving recesses of the blades 216 and 218 made in the surgical needle 200.

With the jaws in a closed position and the surgical needle 200 fixed to one or both of the fixed jaw 16 and the movable jaw 18, the surgical suture apparatus 10 can be raised upwardly from the loading unit 30. As indicated above, the fixing mechanism 232 comprising the wings 234 and 236 prevents the surgical suture apparatus 10 from being removed before the fixed jaw 16 and the movable jaw 18 are closed and fixedly arranged in the surgical needle 200. Once arranged in this way, jaws 16 and 18 can be lifted through a gap 238 made between wings 234 and 236.

Referring to Figures 16 and 17 and as indicated above, in order to fix the surgical needle 200 in the fixed jaw 16, the articulated lever wheel 64 is rotated so that it advances in the channel 70 and thus displaces the upper needle fixation blade 158 engaging with surgical needle 200. Specifically, as shown in Figure 18, the coupling edge of the needle 184 of the upper needle fixing blade 158 is coupled with the recess of reception of the first blade 216 made in the surgical needle 200.

The body part 14, optionally, may have a seal 198 to prevent body fluids from entering the body part 14. The seal 198 can also function as a support for stabilizing and guiding the upper needle fixing blades and lower 158 and 160, respectively, in body part 14.

Figure 19 depicts the condition of the movable jaw 18 with the fixing needle of the upper needle 160 close to the groove 196 with respect to the recess of receiving the needle 28 made in the movable jaw 18.

Next, the procedure for using the surgical suture apparatus 10 and the surgical needle 20 presenting the extension of the suture material 34 attached thereto to sections of the suture tissue will be described. The following description refers to the use of surgical suture apparatus 10 to suture a cardiac valvuloplasty valve in cardiac tissue. As indicated above, the use of surgical suture apparatus 10 in other procedures is specifically envisaged. In the following description, a cuff of a heart valve associated with a heart valve is illustrated by suturing to the heart tissue. It will be noted that in the actual surgery the entire heart valve will be placed in its sleeve as the cuff is sutured to the cardiac tissue.

Referring to Figures 20 to 24 and initially to Figure 20, as indicated above, the surgical needle 200 is initially disposed in the fixed jaw 16 such that the elongated penetration portion 204 is axially aligned in the tissue cardiac and in a position to pierce a sleeve Y associated with a cardiac valvuloplasty valve and a tissue section X. Referring to Figure 21, the surgical suture apparatus 10 is manipulated to drive the elongated penetration portion 204 of the surgical needle 200 through a tissue section X and a sleeve part of a heart valve Y.

As shown in FIG. 21, the surgical needle 200 is still coupled by means of the fixing needle of the upper needle 158 to the fixed jaw 16. In order to transfer the surgical needle 200 from the fixed jaw 16 to the jaw movable 18, the articulated wheel 62 (figure 2) is reversed in its rotation to cause the upper needle fixing knife 158 to retract with the channel 70 and cause the lower needle fixing knife 160 to advance with the channel 72 and is coupled with the receiving recess of the second blade 218. Referring to Figure 22, once the surgical needle 200 has been released from the fixed jaw 16 and held firmly by the movable jaw 18, the handles 20 are they open to allow the movable jaw 18 to move away from the fixed jaw 16 thereby removing the surgical needle 200 and the attached extension of suture material 34 through the tissue section X and the material of the heart valve Y. As indicated above, the elongated penetration part 204 and the chamfered edge portion 220 of the surgical needle 200 facilitate the passage of the surgical needle 200 through the material the heart valve Y.

It should be noted that it is within the intended scope of the present description to re-penetrate a pair of tissues with the pointed end 208 of the surgical needle 200 and repeatedly pass the surgical needle 200 between the fixed jaw 16 and the Mobile jaw 18. However, in the case of a suture through rigid material, such as for example the material of the heart valve sleeve Y, it is preferred to initially re-pass the surgical needle 200 back to the fixed jaw 16 This is done by closing the movable jaw 18 to place the surgical needle 200 inside the recess of receiving the needle 26 and rotating the articulated wheel 62 so that the surgical needle 200 is again coupled with the fixing blade of the upper needle 158. This releases the surgical needle 20 of the lower needle fixing blade 160 and movable jaw 18. The handles 20 can be moved again to open the structure. jaw seal and return the surgical needle 200 in a position to re-penetrate the tissue section X and the sleeve material of the heart valve Y as shown in Figure 23.

As shown in Figure 24, the material of the heart valve sleeve Y can be fixedly sutured to the tissue section X repeatedly penetrating X and Y with the elongated penetration portion 204 of the surgical needle 200 and removing and wrapping the extension of the suture material 34 around the tissue section X and the sleeve material of the heart valve Y. Alternatively, the surgical suture apparatus 10 can be used to dispose only stitches in the cardiac tissue X alone and a additional needle to pass the ends of the sutures through the material of the heart valve sleeve Y in the manner described below.

Referring to Figure 25, a cardiac valvuloplasty valve 280 is shown associated with the material of the heart valve sleeve Y. As indicated above, the structure of the heart valve 280 was previously fixed to the material of the heart valve sleeve And before the material of the sleeve Y is sutured to the tissue section Y. The heart valve 280 substantially comprises a heart valve ring 282 having a pair of heart valve leaflets 284 and 286 rotatably disposed therein.

Referring to FIG. 26, a new double needle suture device 300 according to an embodiment of the present invention and a disposable loading unit 302 for providing surgical incision elements 304 and associated suture extensions are shown. 308 for use in the suture device 300. The disposable loading unit 302 substantially comprises a support of the incision element 308 configured to releasably retain a plurality of opposing pairs of surgical needles or surgical incision elements 304 in the manner that will describe later. The disposable loading unit 302 also comprises a suture support 310 fixed to the incision support element 308 and configured to release the suture material extensions 306 associated with the pairs of surgical incision elements in a releasable manner so that It will also be described later.

The double needle suture device 300 substantially comprises a housing of the handle 312 and an elongated tubular housing or a part of the body 314 extending distally from the housing of the handle 312. A pair of incision elements or jaws are disposed housing the needle, comprising a first or fixed jaw 316 and a second or mobile jaw 318 at a distal end of the body part 314. The mobile jaw 318 and the fixed jaw 316 are configured to receive a pair of surgical needles or incision elements 304. The body part 314 comprises a first linear part 320, a second linear part 322 and an arcuate part 324 between the first and second linear parts 320 and 322. The second linear part 322 illustratively forms an angle of approximately 20 ° with respect to the first linear part 320 by the angular part 324. Other angles are also provided. The angle of 20 ° or displacement of the second linear part 322 with respect to the first linear part 320 facilitates the use of the suture device 300 during cardiac valvuloplasty surgery. Preferably, the fixed jaw 316 is disposed at a predetermined angle of approximately 60 ° with respect to the longitudinal axis of the second linear part 322, although other angles can also be used.

The handle housing 312 is substantially structurally and functionally identical to the handle housing 12 described above with respect to the surgical suture apparatus 10. The handle housing 312 substantially comprises a pair of wizards 326 arranged in a movable manner in the handle housing 312 to control the movement of the mobile jaw 318 with respect to the fixed jaw 316. Preferably, the mobile jaw 318 moves through an arc approximately 30 ° with respect to the fixed jaw 316. It should be noted that, alternatively, both jaws can Be mobile

The suture device 300 further comprises a fixing mechanism 328 for releasing a pair of surgical incision elements 304 in the fixed jaw 316 and the movable jaw 318 in a releasable and alternative way. A loading mechanism 330 is provided to control the mechanism fixation 328 and allow the pair of surgical incision elements to be loaded at the same time. The loading mechanism 330 is substantially structural and functionally identical to the loading mechanism 24 described above with respect to the apparatus 10.

Referring to FIG. 27, the fixed jaw 316 and the movable jaw 318 are disposed at a distal end 332 of the second linear part 322 by means of a pin 334. The pin 334 extends through the holes 336 of the second linear part 322 and through holes 338, 340 made in fixed jaw 316 and mobile jaw 318, respectively. The movable jaw 318 can freely rotate around the pin 334. As will be described later, the fixed jaw 316 can also rotate on the pin 334.

In a manner similar to that described above with respect to the surgical suture apparatus 10, the movable jaw 318 can be moved approaching and moving away from the fixed jaw 316 in response to the actuation of the handles 326 (Figure 26). However, because the body part 314 comprises an arcuate part 324, the body part 314 has a composite central rod 341 having a distal section of the relatively rigid central rod 342 a proximal section of the relatively rigid central rod 344 and a relatively flexible central section 346 between the proximal and distal sections of the central rod 342, 344, respectively. The central section 346 has a first male adapter 350 at a distal end 352 and a second male adapter 354 at a proximal end 356 thereof. The central section 346 is connected to the distal section of the central rod 342 by coupling the first male adapter 350 with a female adapter 358 made at a proximal end 360 of the distal section of the central rod 342. Similarly, the central section 346 joins the proximal area of the central rod 344 by coupling the second male adapter 354 with a female adapter 362 made at a distal end 364 of the proximal section of the central rod 344.

The proximal section of the central rod comprises a hole 366 at a proximal end 368 thereof to receive a pin associated with a connection (not shown) similar to that described above with respect to the apparatus 10 and connect the proximal section of the central rod with the handles 326. In order to open and close the movable jaw 318 in response to the longitudinal displacement of the distal section of the central rod 342, the distal section of the central rod 342 has a cam pin 370 disposed in a hole 372 in a distal end 374 of the distal section of the central rod 342. The cam pin 370 extends and is guided by the grooves 376 made at the distal end 332 of the second linear part 322. The cam pin 370 moves within an angular groove 378 in the movable jaw 318 to articulate the movable jaw 318 between the open and closed positions in response to the actuation of the handles 326. The pa Cam cam 370 also travels within a longitudinal groove 380 made in the fixed jaw 316. The groove 380 is aligned with the grooves 376 of the second linear part 322 and, therefore, the cam pin 370 does not cause any displacement. of the fixed jaw 316. However, it will be appreciated that the fixed jaw 316 can be easily and preferably movable by making the groove 380 at an angle similar to that of the angular groove 378 of the movable jaw 318 and such as described above with respect to the surgical suture apparatus 10.

The longitudinal displacement of the proximal section of the central rod 344 displaces the distal section of the central rod 342 longitudinally to open and close the movable jaw 318 with respect to the fixed jaw 316 in response to the actuation of the handles 326.

The proximal section of the central rod 344 has a pin 382 that extends through a hole 384 and prevents the fixing mechanism, in particular an articulated wheel, from moving when the distal section of the central rod 342 is located. in a distal position, which corresponds to an open state of the jaw in an identical manner to that described above with respect to the surgical suture apparatus 10. The proximal section of the central rod 344 also has a C-shaped ring 386, which provides a support surface for a predisposing spring (not shown).

As indicated above, the suture device 300 has a fixing mechanism that loosely and alternately fixes a pair of surgical incision elements within the fixed jaws 316 and the movable jaw 318. The fixing mechanism of the device for Suture 300 operates substantially in a manner similar to that related to surgical suture apparatus 10 and, in general, partly comprises an upper channel element 388 having an upper needle fixing blade 390 extending distally therefrom and an element of the lower channel 392 having a lower needle fixing blade 394 extending therefrom. A proximal end 396 of the upper needle fixing blade 390 is disposed at a distal end 398 of the upper channel element 388 by a pin 400. Similarly, a proximal end 402 of the upper needle fixing blade 394 is attached to a distal end 404 of the elements of the channel 392 by a pin 406. A proximal end 408 of the upper channel element 388 has mounting structures 410 configured to engage and operate with an articulated wheel (not shown) substantially of the same a way described with respect to the surgical suture apparatus 10. Similarly, the lower channel element also comprises the mounting structure 412 at a proximal end 414 thereof to engage with the articulated wheel.

As indicated above, the suture device 300 alternately and releasably fixes a pair of surgical incision elements in the fixed jaw 316 and the movable jaw 316. The upper needle fixing blade 390 comprises opposite surfaces of coupling with the needle 416, 418 on an enlarged distal blade surface 420. Each of the surfaces 416, 418 engages with a recess made in a surgical incision element disposed in the fixed jaw 316 when the blade fixing the upper needle 390 advances therein as will be described later. The lower needle fixation blade 394 also comprises a pair of opposite engagement surfaces with the needle 422, 424 on an enlarged distal blade surface 426 and cooperates with the movable jaw 318 to releasably fix a pair of elements. of surgical incision in it.

To prevent the upper and lower needle fixing blades 390 and 394, as well as the central section of 346, bending away from their respective axes or "bending" on the body part, a proximal stabilizing element 428 is provided and a distal stabilizing element 430, which are substantially identical and which are configured to be introduced into body part 314.

Referring to Fig. 28, the distal stabilizer 430 comprises a receiving slot of the upper blade 432, a receiving slot of the lower blade 434 and a receiving slot of the central section 436. The distal stabilizer 430 is sectioned into the points 438 to allow the distal stabilizer 430 to flex slightly and conform to the curve of the arcuate part 324 of the body part 314 (Figure 29).

As shown in FIG. 29, the proximal stabilizer 428 also comprises a receiving slot of the upper blade 440, a receiving slot of the lower blade 442 and a receiving slot of the central section 444. In addition, the stabilizer Proximal distal 428 is also sectioned on one side at points 446 to facilitate folding within arcuate part 324 of body part 314.

Referring to FIG. 30, the upper needle fixing knife 390 is slidably received in the groove 432 and is guided thereon in the distal stabilizer 430. The lower needle fixing knife 394 is received from a similarly in slot 434 and the central section 346 of the central rod is received in slot 436 of the distal stabilizer 430.

As shown in Figures 29 and 31, the upper needle fixing blade 390 is similarly received in the slot 440 of the proximal stabilizer 428, the lower needle fixing blade 394 is received in the slot 442 and the central section 346 of the central rod is received in the slot 444 of the proximal stabilizer 428.

Referring to Figure 32, the details of the disposable loading unit 302, comprising the support of the incision element 308 and the support of the suture 310 will be described below. Suture support 310 is provided to retain a plurality of suture extensions, such as, for example, suture material 306, under sterile conditions. Suture support 310 substantially comprises a support 448 having a cover 450 adhered thereto. The cover 450 adheres to the support 448 in such a way that a plurality of ducts 452 extending longitudinally therein is created. The extension of the suture material 306 is received in the ducts 452.

The support of the incision element 308 substantially comprises a central part 454, a distal part 456 and a proximal part 458. A support edge 460 is made in the intermediate central part 454 and the distal part 456. The support edge 460 is provided to allow alignment of the suture support 310, in order to attach the suture support 310 to the distal part 456. Specifically, a proximal part of the suture support 310 adheres to the distal part 456 using various adhesives with the proximal part 456.

As indicated above, the disposable loading unit 302 is provided to firmly and releasably retain a plurality of pairs of surgical needles or surgical incision elements, such as surgical incision element 304, in a position to be held by the double needle suture device 300. Referring to Figures 32 and 33, the proximal portion 458 substantially comprises a plurality of needle supply stations 470 each comprising a pair of surgical incision elements 304. Such as represented, each needle supply station substantially comprises a first flexible arm of 472, which can be performed as complementary halves 472a and 472b, and a second flexible arm 474 which can also be performed as complementary halves 474a and 474b. A central stud 476 extends between the first flexible arm 472 and the second flexible arm 474. Although various needle supply stations 470 are illustrated in the disposable loading unit 302, the following description will refer to a single disposable loading unit. It will be appreciated that any number of needle supply stations 470 can be provided in the disposable loading unit 302.

In order to maintain the pairs of surgical needles 304 between the first and second flexible arms 472 and 474, and the central stud 476, a first notch 478 is made on the first flexible arm 472. Specifically, each of the flexible arms 472a and 472b incorporates a notch 478A and 478b (not shown). The central stud 476 has a corresponding notch 480. It should be noted that when a suture extension 306 is centrally attached to the surgical incision element 304, the surgical incision element 304 is retained against the first notch of the stud 480 by the notches 478a and 478b. The extension of the suture material 306 can extend between the first and second flexible arms 472a and 472b. Similarly, the second flexible arm 474 comprises the notches of the second flexible arm 482a and 482b (Figure 34), which firmly hold the second surgical incision element 304 against the second notch of the stud.

484. The first and second flexible arms 472 and 474 are sufficiently flexible to allow surgical incision elements 304 to be released from the disposable loading unit 302.

To guide the distal end of the double needle suture device 300 in alignment with the surgical incision elements 304 retained in the disposable loading unit 302, the central stud 476 has a support end 486 that is configured to limit the advance of the double needle suture device 300 between the first flexible arm 472 and the second flexible arm 474. In addition, the first flexible arm 472 has a pair of jaw guides 488a and 488b and the second flexible arm 474 has a pair of second guides. of flexible jaw 490a and 490b. Although the support end 486 limits the advance of the double needle suture device 300 within the needle supply stations 470, the guides of the first and second jaws 488 and 490 serve to guide the fixed jaw 316 and the movable jaw 318 in surgical incision elements 304. In order to avoid involuntary flexion of the flexible arms at adjacent ends of the needle supply stations of the disposable loading unit 302, the disposable loading unit 302 has a pair of protectors relatively rigid sides 492 and 494 that protect the needle supply stations 470.

Referring to Figures 34 to 38, the use of the loading unit 302 to provide a pair of surgical incision elements 304 connected by a single extension of suture material 306 will be described below. Initially referring to Figure 34, the distal end of the suture device 300 with movable jaw 318 in an open state separated from the fixed jaw 316 advances towards one of the needle supply stations of the disposable loading unit 302. In particular, the movable jaw 318 and the jaw fixed 316 move towards the needle supply station such that jaws 316 and 318 pass between, and are guided by, the first guides of jaws 488a and 488b (not shown) and the second guides of jaws 490a and 490b . As indicated above, an element of the surgical incision is retained in a releasable manner between the second notches 482a and 482b in the second flexible arms 474a and 474b and the notch 480 in the central stud 476.

Referring to Figure 35, as the handles 326 (Figure 1) move to a closed position, the movable jaw 318 moves to the fixed jaw 316 to close in the surgical incision element 304.

Referring to Fig. 36, the fixed jaw 316 has a pair of recesses 496 to receive the pair of incision elements 304 retained in a needle supply station. The fixed jaw 316 also comprises a groove 498 that slidably receives the surface of the enlarged distal blade 420 of the upper needle fixing blade 390 (Figure 27). The groove 498 crosses the recesses 496. Similarly, the movable jaw 318 comprises a pair of recesses 500 to receive a pair of incision elements 304 and a groove 502 to receive the surface of the enlarged distal blade 426 of the fixing blade of the lower needle 394 (figure 27). As depicted, preferably, a compress 504 is provided in suture 306 to act as support or support, when a suture point is applied to the cardiac tissue. An example of a 504 compress is described in the pending patent application entitled "SURGICAL SUTURING DEVICE" filed on the same date as the one with the urgent mail service label number IB701310731US.

Referring to Figures 37 and 38, when the lower needle fixation blade 394 moves to the most distal position, the engagement surfaces of the needle 422 and 424 of the surface of the enlarged distal knife 426 intersect with the recesses 500. As shown in Figure 38, the engagement surfaces with the needle 422 and 424 are coupled with the notches that engage with the first blade 506 made in the incision elements 304 to fix the incision elements in the movable jaw 318. The incision elements 304 also comprise the engagement notches with the second blade 508 to receive the engagement surfaces with the needle 416 and 418 of the upper needle fixing element 390 in order to fix the incision elements 304 on the fixed jaw 316.

Referring to Figures 39 to 41, the use of the suture device 300 to make a suture between a tissue section of the cardiac valve X and a cardiac valvuloplasty valve will be described below. It will be appreciated that, although only one cardiac valvuloplasty valve sleeve Y is represented, the suture procedure is performed with a complete cardiac valvuloplasty valve like the one depicted in Figure 25 above. Initially, referring to Figure 39, the fixed jaw 316 is disposed on one side of the fabric X and the movable jaw 318 retaining the incision elements 304 is disposed on an opposite side. As shown in FIG. 40, the incision elements 304 are retained in the movable jaw 318 by coupling with the lower needle fixing element 394, while the upper needle fixing element 390 is in the position more proximal within the fixed jaw 316.

The suture device 300 is actuated by closing the handles 326 (Figure 1) to move the fixed jaw 318 and the incision elements to a closed position adjacent to the fixed jaw 316 thereby causing the incision elements 304 to pierce the cardiac tissue X as shown in Figure 41. As shown, the lower needle fixing element 394 is retracted to the most proximal position to release the incision elements 304 of the movable jaw 318 and the fixing element of the upper needle 390 has advanced simultaneously to the most distal position to firmly hold the incision elements 304 in the fixed jaw 316. Thus, by opening jaws 316 and 318, the pair of incision elements 304 can be removed through of tissue X thereby removing the extension of suture material 306 therethrough until pad 504 comes into contact with tissue X (fig. ura 43A). Suture device 300 is reloaded as described above and the procedures for performing a plurality of sutures as depicted are repeated.

In order to suture each other the circumference of the tissue X and the sleeve of the valve Y, a suture needle of the type described in the application entitled "SUTURE NEEDLE AND METHOD" and presented on the same date as the present with the same urgent mail service label number IB701310720US. Needle 510 preferably has a tissue penetration point 512 at a distal end 514 thereof and a retention loop of suture 516 extending from a proximal end 518 thereof. As shown in Figure 43A, in order to join the sleeve Y with the fabric X, the incision elements 304 are removed from the suture material 306 and a first free end 520 of the suture material 306 is passed through the loop 516. Needle 510 can now be used to make more stitches through tissue X and valve sleeve Y. Needle 510 can be used to repeat the procedure with the other free end 522 of suture material 306.

Referring to Figure 43B, once all free ends 520, 522 of suture material 304 have passed through the sleeve Y of the artificial heart valve, the sutures can be stretched strongly and displace or "drop" the valve cardiac artery descending into place in cardiac tissue X. The sutures can then be joined together, preferably in pairs, to attach the artificial heart valve to tissue X.

Although Figures 43 to 43B depict the heart valve approaching the side of the cardiac tissue adjacent to the compress 504, it is preferred that it access the cardiac tissue from the side opposite to the cardiac tissue, that is, from the side of the free ends of the suture. as depicted in figure 43C.

Referring to Figures 44 to 46 and initially to Figure 44, an alternative jaw structure 524 is shown. The jaw structure 524 comprises a pair of receiving recesses of the distal needle 526, 528 and a pair of receiving recesses of the proximal needle 530, 532. The double incision elements 304 and the associated extension of suture material 306 can be retained in various configurations within the recesses, as depicted. The jaw structure 524 also comprises a groove 534, which crosses the four recesses and slidably receives a needle fixing blade (not shown) to loosely fix the incision elements or surgical needles in the recesses

Alternatively, two parallel grooves can be provided in the jaw structure 524. One of the grooves would intersect with the recesses 526 and 530 on one side of the jaw structure 524, while the other groove that would intersect with the recesses 528 and 532 on the other side of the jaw structure 524.

As shown in FIG. 45, double incision elements 304 may be arranged in recesses 526 and 528 at the distal end of the structure of the alternative jaw 524 to arrange the incision elements 304 as distal as possible in the device. of surgical suture. This will allow suturing in spaces of resistant tissue. Likewise, if two grooves are provided as described above, each incision element 304 may alternatively be fixed and released within its respective recesses 526, 528.

As shown in Figure 46, when it is intended to arrange the stitches in the fabric with an edge of a jaw structure 524, the double incision elements 304 can be arranged in the recesses 526, 530 or in the recesses 528, 532 as depicted. It should be understood that the incision elements 304 can also be arranged in the proximal recess 530, 532 when necessary to make a deep coupling and suture a section of tissue with the structure of the alternative jaw 324.

In addition, it may be intended to arrange the incision element diagonally with respect to each other in recess 526 and 532 or 528 and 530. When used with an arrangement with two grooves as described above, the incision elements can be set and release alternately. In addition, single or multiple cuts can be made.

It will be understood that various modifications can be made to the embodiments described herein. For example, various angular orientations of the jaw structure can be provided as well as part of the elongated body depending on the particular surgical need. Although the above description is provided referring to cardiac valvuloplasty surgery, it is specifically contemplated that the suture instruments described herein can be used in other surgical procedures. Therefore, the above description should not be construed as limiting, but simply as examples of the preferred embodiments. Those skilled in the art may devise other modifications within the scope of the appended claims.

Claims (8)

1. Double needle suture device (300) for use in surgery, comprising: a lodging (312); a body part (314) extending distally from the housing; a first jaw (316) mounted at a distal end of the body part, the first jaw being configured to receive a pair of surgical incision elements (304) therein; a second jaw (318) mounted at the distal end of the housing, the second jaw being configured to receive the pair of surgical incision elements therein; at least one handle (326) mounted in the housing, the second jaw being able to move with respect to the first jaw in response to the actuation of at least one handle; and characterized because it comprises a fixing mechanism (328) functionally associated with the first jaw and the second jaw, the fixing mechanism can be operated to alternately fix the pair of surgical incision elements in the first jaw and the second jaw.

2.

Fixed device with double needle according to claim 1, wherein the first jaw is oriented at a predetermined angle with respect to a longitudinal axis of the body part, the predetermined angle being greater than 0 °.

3.

Double needle suture device according to claim 1, wherein the second jaw moves through an arc of approximately 30 ° with respect to the first jaw in response to the actuation of at least one handle.

Four.

Double needle suture device according to claim 1, wherein each of the first and second jaws defines a pair of recesses (496, 500) inside to receive the pair of surgical incision elements therein.

5.

Double needle suture device according to claim 4, wherein the fixing mechanism includes a needle fixing blade (420, 426) that can be moved into a groove (498, 502) in one of the first and second jaws, crossing the groove both recesses in the respective jaw.

6.

Double needle suture device according to claim 1, wherein at least one of the first and second jaws defines a plurality of recesses (496, 500) therein to receive the pair of surgical incision elements.

7.

Double needle suture device according to claim 6, wherein the fixing mechanism comprises at least one blade (420, 426) that can be moved inside at least one of the first and second jaws to cross with a certain number of the plurality of recesses.

8.

Double needle suture device according to claim 1, wherein the body part has a curved part (324).