Source: https://patents.google.com/patent/US6096074A/en
Timestamp: 2019-04-23 22:42:28
Document Index: 434463040

Matched Legal Cases: ['art 56', 'art 56', 'art 56', 'art 56', 'art 56', 'art 56', 'art 56', 'art 56', 'art.\n2', 'art.\n5', 'art.\n14']

US6096074A - Stapling apparatus and method for heart valve replacement - Google Patents
Stapling apparatus and method for heart valve replacement Download PDF
US6096074A
US6096074A US09/013,836 US1383698A US6096074A US 6096074 A US6096074 A US 6096074A US 1383698 A US1383698 A US 1383698A US 6096074 A US6096074 A US 6096074A
US09/013,836
1998-01-27 Application filed by United States Surgical Corp filed Critical United States Surgical Corp
1998-01-27 Priority to US09/013,836 priority Critical patent/US6096074A/en
1998-01-27 Assigned to UNITED STATES SURGICAL CORPORATION reassignment UNITED STATES SURGICAL CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PEDROS, ROBERT
2000-08-01 Publication of US6096074A publication Critical patent/US6096074A/en
There are disclosed various systems and methods for installing a synthetic, artificial heart valve within a patient. One system generally includes a plurality of sutures, each suture having a staple attached to a distal end thereof; a surgical stapler for radially discharging the staples into a heart at a location adjacent a site for installing the heart valve; a support assembly for releasably supporting the plurality of sutures; and a heart valve setter assembly, the heart valve setter assembly being operable to move the heart valve into position within the site in the heart. A method of installing a heart valve within a patient utilizing the system is provided and generally includes the steps of accessing a site within a heart from which a natural heart valve has been removed; positioning a surgical stapler within the site; discharging a plurality of staples, having sutures attached thereto, from the surgical stapler into the heart; lowering the heart valve along the sutures into position within the site in the heart; and securing the heart valve to the heart with the sutures.
Once access to the thoracic cavity has been achieved, surgery on the heart to effect valve replacement may be performed. During some procedures, the heart beat is arrested by infusion of a cardioplegic fluid, such as potassium chloride (KCI), to paralyze the myocardium while blood flow circulation is maintained through known heart bypass techniques. Alternatively, the heart is allowed to beat to maintain circulation, while a localized area of the heart, on which surgery is to be performed, is locally immobilized by various instruments.
The heart is incised and the defective valve is cut away leaving a surrounding area of locally tougher tissue. Known heart valve replacement techniques typically include individually passing sutures through the tough tissue by hand to form an array of sutures. Free ends of the sutures are extended out of the thoracic cavity and laid, spaced apart, on the patient's body. The free ends of the sutures are then individually threaded through an edge around the circumference of the replacement valve or a supporting cuff. This is also typically accomplished by hand. Once all sutures have been run through the valve, all the sutures are pulled up taut and the valve is slid or "parachuted" down, by hand, into place adjacent the tough tissue. Thereafter, the replacement valve is secured in place using the sutures. Since the conventional heart valve replacement techniques are exclusively manual procedures, they are typically time consuming and difficult.
Where replacement is performed utilizing an artificial valve, hand held instruments in the form of a stick may be affixed to the valve and used to manipulate the replacement valve into place. The commercially available replacement valves are typically provided with a detachable holder structure which can be engaged by the hand tools.
The method of installing a heart valve within a patient, as described above, is preferably provided wherein the sutures have needles attached to an end opposite the staples. The method further includes the step of securing the sutures at a location above the site within the heart with a support assembly. Also, prior to the step of lowering the heart valve along the sutures, the sutures are threaded through a cuff of the heart valve to facilitate lowering the heart valve along the sutures into position within the site in the heart. Lastly, prior to the step of securing the heart valve to the heart, the heart valve installation assembly is removed from the accessed site.
FIG. 3 is a partial cross-sectional side view of the support assembly of FIG. 2 having a surgical stapler positioned therein;
Referring now to the drawings in detail, and initially to FIG. 1, access to the heart through the thoracic cavity is accomplished using well known surgical procedures. Generally, an incision 50 is made through the sternum of a patient 52 to access the thoracic cavity 54 and expose the heart 56.
Preferably, access to the cavity is maintained with the assistance of a retractor 58, such as, for example, the Mini-CABG* retractor and related accessories available from United States Surgical Corporation, Norwalk, Conn. Retractor 58 generally includes an oval planar base 60 and is positioned on patient 52 such that an opening 62 defined by base 60 overlies incision 50. A plurality of retractor blades 64, 66, 68 . . . are slidably mounted on base 60 and engage and retract the tissue edges of incision 50. Optionally, additional instruments may be affixed to base 60 to manipulate and/or stabilize the heart 56 to facilitate surgery thereon. Blood flow circulation may be maintained using known techniques. Thus, access to heart 56 is achieved and maintained. Other known open surgical procedures to access the heart are also contemplated and may be substituted for the procedure described herein. Once access to heart 56 has been obtained, heart 56 is opened and a dysfunctional valve is removed using known surgical procedures.
Referring now to FIG. 2, there is disclosed a support assembly 80 for supporting and housing apparatus required for the replacement of a heart valve. Support assembly 80 includes a two-piece support member 82 which is preferably formed as a "quad-pod" which may be configured to be mounted on retractor base 60 shown in FIG. 1. Support member 82 includes a two-piece circular ring 84 and four legs 86. Ring 84 is attached to each of the four legs 86 at proximal ends 87 thereof. Each half of ring 84 contains a tab 88 extending therefrom on opposing sides thereof, the tabs 88 being configured and dimensioned to fit within an opening in the opposing ring half 84 to removably couple the two halves of ring 84. As used herein, the term "distal" refers to that portion of the assembly, or component thereof, further from the user, while the term "proximal" refers to that part of the assembly, or component thereof, closer to the user.
A plurality of staples 96, which are preassembled with sutures 94 and needles 92, are loaded into staple retainer housing 112 prior to being discharged into the intended surrounding tissue. Actuator handle 108 is configured such that a lever 116 is moved in the direction of arrow A to cause one or more staples to be simultaneously discharged from staple retainer housing 112 in a radial direction as indicated by arrows B illustrated adjacent staple retainer housing 112. Preferably, stapler 104 is configured to discharge a plurality of staples 96 in a single shot i.e., a single actuation of lever 116. Alternatively, stapler 104 may be configured to hold and discharge a single staple 96 in response to an actuation of lever 116. Thus, stapler 104 is a means for attaching a distal end of sutures to a heart.
As illustrated in FIG. 3, distal end 114 of stapler 104 is positioned within a bore 118 in heart 56 which was created by the removal of a dysfunctional heart valve. Typically, following removal of a dysfunctional heart valve, the surrounding area includes tougher tissue which is amenable to retaining staples and sutures. Once lever 116 is depressed, staples 96 are discharged into the circumference of bore 118 formed in heart 56, and stapler 104 may be removed from support assembly 80. Following removal of stapler 104, support assembly 80 may remain positioned above the thoracic cavity of a patient and ready to receive additional tools. Sutures 94 extend proximally from staples 96, which are secured to heart 56, and are attached to needles 92 which are removably secured within ring 84 and needle guard 98.
Referring now to FIG. 4, there is disclosed a heart valve setter assembly 120 for use with support assembly 80 during heart valve replacement surgery. Heart valve setter assembly 120 includes a heart valve holder assembly having a handle 122 connected to a proximal end of a shaft 124, a heart valve holder 126 connected to a distal end of shaft 124 and a valve setting instrument 128 having a longitudinal bore therein for slidably mounting on shaft 124. Valve setting instrument 128 includes a shaft 130 having a knurled proximal portion 132 and a needle grasper 134 connected to a distal end. Similar to needle guard 98, needle grasper 134 has a permeable felt insert 135 therein.
Also illustrated in FIG. 4 are heart valve assembly 136, suture retainer ring 138 and needles 92 which are attached to sutures 94. Heart valve assembly 136 includes a valve cuff 142 and a valve ring 140 having a plurality of valve leaflets 144 pivotally mounted therein. Heart valve ring 140 is generally formed by molding or machining a suitable biocompatible material such as, for example, stainless steel. Valve cuff 142 is preferably formed of a permeable felt, to facilitate penetration thereof by needles 92.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, it is noted that variously dimensioned heart valve assemblies may be provided to facilitate replacement of corresponding heart valves. Therefore, the above description should not be construed as limiting but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
1. A system for installing a heart valve within a patient comprising:
a plurality of sutures, each suture having a staple attached to a distal end thereof;
a surgical stapler for discharging the staples into a heart at a location adjacent a site for installing the heart valve;
a support assembly for releasably supporting the plurality of sutures; and
a heart valve setter assembly, the heart valve setter assembly being operable to engage the plurality of sutures with the heart valve and move the heart valve into position within the site in the heart.
2. The system of claim 1, further comprising a plurality of needles attached to proximal ends of the plurality of sutures.
3. The system of claim 1, wherein the surgical stapler discharges at least one staple in a radial direction to engage the heart at a predetermined location.
4. The system of claim 1, wherein the heart valve is moved along the sutures into position within the site in the heart.
5. The system of claim 2, wherein the support assembly includes a plurality of legs and a ring member, the ring member configured to interconnect the plurality of legs at a proximal end thereof.
6. The system of claim 5, wherein the ring member includes a plurality of grooves on an inner surface thereof for releasably securing the plurality of needles.
7. The system of claim 6, wherein the support assembly further includes a ring shaped needle guard mounted on the ring member.
8. The system of claim 1, wherein the heart valve setter assembly comprises a heart valve holder assembly and a heart valve setting instrument.
9. The system of claim 8, wherein the heart valve holder assembly includes a shaft, a handle connected to a proximal end of the shaft, and a heart valve holder connected to a distal end of the shaft.
10. The system of claim 8, wherein the heart valve setting instrument includes a shaft having a knurled proximal portion and a needle grasper connected to a distal end of the shaft.
11. The system of claim 8, wherein the heart valve setting instrument is slidably mounted on the heart valve holder assembly.
12. A system for installing a heart valve within a heart comprising:
a plurality of sutures;
means for attaching a distal end of the plurality of sutures to the heart at a location adjacent a site for installing the heart valve;
a support assembly for releasably supporting the plurality of sutures;
a heart valve setter assembly, the heart valve setter assembly being operable to engage the plurality of sutures with the heart valve and move the heart valve into position within the site in the heart; and
a plurality of needles attached to proximal ends of the plurality of sutures;
wherein the support assembly includes a plurality of legs, a ring member and a ring shaped needle guard mounted on the ring member, the ring member including a plurality of grooves on an inner surface thereof for releasably securing plurality of needles and configured to interconnect the plurality of legs at a proximal end thereof.
13. The system of claim 12, wherein the heart valve is moved along the sutures into position within the site in the heart.
14. The system of claim 12, wherein the heart valve setter assembly comprises a heart valve holder assembly and a heart valve setting instrument.
15. The system of claim 14, wherein the heart valve holder assembly includes a shaft, a handle connected to a proximal end of the shaft, and a heart valve holder connected to a distal end of the shaft.
16. The system of claim 14, wherein the heart valve setting instrument includes a shaft having a knurled proximal portion and a needle grasper connected to a distal end of the shaft.
17. The system of claim 14, wherein the heart valve setting instrument is slidably mounted on the heart valve holder assembly.
US09/013,836 1998-01-27 1998-01-27 Stapling apparatus and method for heart valve replacement Expired - Lifetime US6096074A (en)
US09/013,836 US6096074A (en) 1998-01-27 1998-01-27 Stapling apparatus and method for heart valve replacement
US09/484,520 US6413274B1 (en) 1998-01-27 2000-01-18 Stapling apparatus and method for heart valve replacement
US09/484,520 Division US6413274B1 (en) 1998-01-27 2000-01-18 Stapling apparatus and method for heart valve replacement
US6096074A true US6096074A (en) 2000-08-01
ID=21762029
US09/013,836 Expired - Lifetime US6096074A (en) 1998-01-27 1998-01-27 Stapling apparatus and method for heart valve replacement
US09/484,520 Expired - Fee Related US6413274B1 (en) 1998-01-27 2000-01-18 Stapling apparatus and method for heart valve replacement
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PEDROS, ROBERT;REEL/FRAME:008948/0259