Apparatus and methods for cardiac restraint

• US 6,569,082 B1
• Filed: 02/08/2001
• Issued: 05/27/2003
• Est. Priority Date: 08/10/1999
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Origin Medsystems Inc. (Boston Scientific Corporation)
• Inventors: Chin, Albert K.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/779,715
• Time in Patent Office: 838 Days
• Field of Search: 600/37, 600/139, 600/148, 600/18, 600/16, 600/17, 623/902, 623/2.1, 623/1, 623/3, 607/129, 606/139, 606/148, 128/644, 128/897, 601/153
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

Apparatus and methods for using the apparatus are disclosed for cardiac restraint. More specifically, the apparatus and methods are directed to accessing the pericardium, accessing the heart within the pericardium, and restraining the heart by at least partially enclosing the heart with the apparatus. An embodiment of a cardiac restraint apparatus according to the present invention comprises a jacket, the jacket having a rim which defines an opening for receiving a heart. The apparatus also comprises a knot pusher that has a hollow elongate body, as well as a strand that extends around the rim of the jacket and is tied into a slipknot. The strand is positioned such that at least one end portion of the strand extends through the knot pusher such that a distal end of the knot pusher can be moved into engagement with the slipknot, whereby pulling the end portion of the strand away from the heart while pushing the knot pusher against the slipknot and reducing the diameter of the opening defined by the rim. In addition, the apparatus comprises one or more guide elements that are attached to the jacket.

Claims

1. A cardiac restraint apparatus, comprising:

a jacket having a rim disposed to substantially surround a heart received within the jacket;

a hollow elongated body having a proximal end and having a distal end disposed near the rim of the jacket;

a strand extending around the rim of said jacket and being tied into a slipknot near the distal end of the elongated body with at least one end portion of the strand extending through said elongated body with the distal end thereof positioned for selective engagement with the slipknot in response to tension exerted on said strand away from the heart with respect to the elongated body engaged with said slipknot to reduce the opening defined by said rim; and

one or more guide elements attached to said jacket for facilitating the placement of said jacket around the heart.

2. A cardiac restraint apparatus according to claim 1, wherein said guide elements are removably attached to said rim.

3. A cardiac restraint apparatus according to claim 2, wherein said guide elements are hollow tubes.

4. A cardiac restraint apparatus according to claim 3, wherein at least one of the hollow guide elements includes a lumen dimensioned to receive a surgical instrument.

5. A cardiac restraint apparatus according to claim 3, wherein at least one of the guide elements includes a lumen dimensioned to receive a tacking instrument.

6. A cardiac restraint apparatus according to claim 1, wherein said strand is a suture strand.

7. A cardiac restraint apparatus according to claim 6, wherein said suture strand is composed of nylon.

8. A cardiac restraint apparatus according to claim 1, wherein said guide elements are one or more handles attached to said jacket.

9. A cardiac restraint apparatus according to claim 8, wherein said one or more handles are composed of suture strands.

10. A cardiac restraint apparatus according to claim 1, wherein said guide elements are one or more handles attached to said rim of said jacket.

11. A cardiac restraint apparatus, comprising:

a) at least one elastic band having a first position terminating at a first end and a second portion terminating at a second end, said first portion and said second portion being joined together at a location between said first end and said second end; and

b) a sheath, said sheath including a generally cylindrical body having a proximal end and a distal end, said sheath body defining perforations along said sheath body, whereby said sheath can be removed from said apparatus by tearing said sheath body along said perforations and removing the torn body.

12. A cardiac restraint apparatus according to claim 11, wherein said sheath further comprises a pull tab attached to said proximal end of said sheath body for removing said sheath by proximal movement of said pull tab.

13. A cardiac restraint apparatus according to claim 11, wherein said elastic band includes calibrated markings for calibrating the tension of said elastic band.

14. A cardiac restraint apparatus according to claim 11, wherein said first and second ends of said elastic band are configured to be engaged by a grasping instrument.

15. A cardiac restraint apparatus comprising:

a jacket having a rim that defines an opening for receiving a heart;

a generally cylindrical sheath enclosing the jacket folded in compact state within the sheath for expansion to non-compact state outside the sheath, said sheath including perforations therein to facilitate tearing the sheath for release of the jacket from the compact state and for removal of the torn sheath from the apparatus;

a knot pusher having a hollow elongated body;

a strand extending around the rim of the jacket and being tied into a slip knot with at least one end portion of the strand extending through the knot pusher with a distal end thereof moveable into engagement with the slip knot to facilitate reducing the opening defined by the rim in response to pulling on the end portion of the strand away from the heart, and to pushing the distal end of the knot pusher into engagement with the slip knot; and

at least one guide element attached to the jacket to facilitate placement of the jacket around the heart.

16. A cardiac restraint apparatus according to claim 15, wherein the sheath further comprises a pull tab extending from a proximal end of the sheath for pulling the sheath away from the apparatus by pulling the pull tab away from the jacket.

17. A method of at least partially enclosing the heart of a patient with a cardiac restraint apparatus including a jacket having a rim defining an opening for receiving a heart and having a guide tube attached to the rim, the method comprising:

making a surgical incision in the patient to provide an entry point for an endoscopic cannula;

inserting into the surgical incision an endoscopic cannula having at least one lumen there through;

advancing the endoscopic cannula to the pericardium under endoscopic visualization;

introducing a cutting tool through the lumen of the endoscopic cannula toward the pericardium;

forming an opening with the cutting tool in the pericardium to admit the cardiac restraint apparatus;

advancing the cardiac restraint apparatus through a lumen of the endoscopic cannula into engagement with the heart;

advancing a tacking instrument through a lumen of the endoscopic cannula to tack the rim of the jacket to the posterior pericardium; and

manipulating the guide tube to position the jacket over the anterior aspect of the heart to at least partially enclose the heart in the jacket.

18. A method of at least partially enclosing the heart of a patient with a cardiac restraint apparatus including a jacket having a rim defining an opening for receiving a heart and having at least one handle attached to the rim, the method comprising:

making a surgical incision in the patient to provide an entry point for an endoscopic cannula;

inserting into the surgical incision an endoscopic cannula having at least one lumen therethrough;

advancing the endoscopic cannula to the pericardium under endoscopic visualization;

introducing a cutting tool through the lumen of the endoscopic cannula toward the pericardium;

forming an opening with the cutting tool in the pericardium to admit the cardiac restraint apparatus;

advancing the cardiac restraint apparatus through a lumen of the endoscopic cannula into engagement with the heart;

advancing through a lumen of the endoscopic cannula at least one guide strand of sufficient length to extend outside the body of the patient from a position near the heart;

advancing a tacking instrument through a lumen of the endoscopic cannula to tack the at least one guide strand to the posterior pericardium;

passing the at least one guide strand through a handle on the rim; and

manipulating the at least one guide strand to enclose at least a portion of the heart with the jacket.

19. A method of restraining the heart with a cardiac restraint apparatus that includes at least one elastic band having first and second ends, the method comprising:

making a surgical incision to provide an entry point for the cardiac restraint apparatus;

introducing a cutting tool through the incision to make an opening in the pericardium;

advancing the cardiac restraint apparatus through the incision and through the opening into engagement with the heart;

advancing a tacking instrument through the incision to tack the elastic band to the posterior pericardium at a location between the first and second ends;

positioning a first portion of the elastic that includes the first end for tacking to the pericardium overlying the anterior aspect of the heart;

positioning a second portion of the elastic band that includes the second end for tacking to the pericardium overlying the anterior aspect of the heart; and

attaching the first and second portions together at a location over the anterior aspect of the heart.

20. A method according to claim 19, wherein the attaching step is accomplished by tacking the first portion and the second portion together at said location over the anterior aspect of the heart.

21. A method according to claim 19, wherein the steps of positioning the first and second portions of said elastic band are performed using a grasping tool.

22. A method according to claim 19, wherein the step of attaching said first portion and said second portion of said elastic band together is performed using a clip applier.

23. A method of restraining the heart with a cardiac restraint apparatus that includes an elastic band having first and second ends, the method comprising:

making a surgical incision to provide an entry point for an endoscopic cannula;

inserting into the surgical incision an endoscopic cannula having a lumen therethrough;

advancing the endoscopic cannula to the pericardium under endoscopic visualization;

introducing a cutting tool through the lumen of the endoscopic cannula to form an opening in the pericardium;

advancing the endoscopic cannula through the opening in the pericardium;

advancing the cardiac restraint apparatus through a lumen of the endoscopic cannula into engagement with the heart;

advancing a tacking instrument through a lumen of the endoscopic cannula toward the pericardium to tack the elastic band to the posterior pericardium at a point between the first and second ends;

positioning a first portion of the elastic band including the first end for tacking to the pericardium overlying the anterior aspect of the heart;

positioning a second portion of the elastic band including the second end for tacking to the pericardium overlying the anterior aspect of the heart; and

attaching the first and second portions together at a location over the anterior aspect of the heart.

24. A method according to claim 23, wherein the step of attaching said first portion and said second portion of said elastic band together is performed using a clip applier.

25. A method of at least partially enclosing the heart of a patient with a cardiac restraint apparatus that includes a jacket having a rim defining an opening for receiving a heart, the method comprising:

making a surgical incision in the patient to provide an entry point for an endoscopic cannula;

inserting into the surgical incision an endoscopic cannula having a lumen therethrough;

advancing the endoscopic cannula to the pericardium under endoscopic visualization;

introducing a cutting tool through a lumen of the endoscopic cannula to form an opening in the pericardium;

advancing the endoscopic cannula into the peridcardium through the opening;

advancing the cardiac restraint apparatus through a lumen of the endoscopic cannula into engagement with the heart;

advancing a tacking instrument through a lumen of the endoscopic cannula to access the pericardium for tacking the rim of the jacket to the posterior pericardium; and

manipulating the rim of the jacket over the anterior aspect of the heart to at least partially enclose the heart in the jacket.

26. A method according to claim 25, wherein said cardiac restraint apparatus comprises a jacket having a rim defining an opening for receiving a heart, and one or more handles on the rim of the jacket, and wherein in the step of:

advancing a tacking instrument, said tacking instrument includes at least one guide strand attached thereto of sufficient length to enable a proximal end of said guide strand to be grasped outside the patient when a distal end of said guide strand is positioned near the heart; and

including;

tacking each said at least one guide strand to the posterior pericardium using said tacking instrument;

passing each said at least one guide strand through at least one of said one or more handles on the rim of the jacket; and

manipulating each said at least one guide strand to position the jacket at least partially enclosing the heart with said jacket.