Devices and methods for intracardiac procedures

• US 5,814,097 A
• Filed: 05/14/1996
• Issued: 09/29/1998
• Est. Priority Date: 12/03/1992
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/645,692
• Time in Patent Office: 868 Days
• Field of Search: 623/2, 623/900, 606/99, 606/1
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2039/027 : having a particular valve, seal or septum
• CPC Class Codes: A61M 2039/0279 : for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2202/047 : cardioplegic
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

The invention provides devices and methods for performing less-invasive surgical procedures within an organ or vessel. In an exemplary embodiment, the invention provides a method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel. According to the method, the patient'"'"'s heart is arrested and cardiopulmonary bypass is established. A scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest is used to view an internal portion of the patient'"'"'s chest. An internal penetration is formed in a wall of the heart or great vessel using cutting means introduced through a percutaneous penetration in an intercostal space in the patient'"'"'s chest. An interventional tool is then introduced, usually through a cannula positioned in a percutaneous intercostal penetration. The interventional tool is inserted through the internal penetration in the heart or great vessel to perform a surgical procedure within the internal cavity under visualization by means of the scope. In a preferred embodiment, a cutting tool is introduced into the patient'"'"'s left atrium from a right portion of the patient'"'"'s chest to remove the patient'"'"'s mitral valve. A replacement valve is then introduced through an intercostal space in the right portion of the chest and through the internal penetration in the heart, and the replacement valve is attached in the mitral valve position.

Claims

1. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane, the valve prosthesis also having a movable valve portion; and

a holder releasably attached to the valve prosthesis and having a holder body with a holder height in the axial direction, the holder body including a handle coupling configured to receive an elongated handle for introducing the prosthesis assembly into the patient, the handle coupling having a coupling axis along which the tip of the handle is received, the handle coupling being positioned such that the coupling axis is at an angle substantially greater than zero relative to the axial direction;

wherein the holder and valve prosthesis together have a profile having a height in the axial direction of less than about 20 mm.

3. The prosthesis assembly of claim 1 further comprising:

a handle having a distal end coupled to the holder and having a length of at least about 20 cm.

4. The prosthesis assembly of claim 1 wherein the valve prosthesis and holder are contained in a sterile pack.

5. The prosthesis assembly of claim 1 wherein the valve prosthesis is a mechanical valve prosthesis.

6. The prosthesis assembly of claim 5 wherein the mechanical valve prosthesis is a bi-leaflet prosthesis.

7. The prosthesis assembly of claim 5 wherein the attachment ring comprises a sewing ring.

8. The prosthesis assembly of claim 1 wherein the holder comprises a releasing mechanism configured to release the valve prosthesis from the holder.

9. The prosthesis assembly of claim 8 wherein the holder comprises a first arm for engaging a first portion of the valve prosthesis and a second arm for engaging a second portion of the valve prosthesis, at least one of the first and second arms being movable for releasing the valve prosthesis from the holder.

10. The prosthesis assembly of claim 9 wherein the releasing mechanism comprises a pull wire coupled to the at least one of the first and second arms of the holder, wherein pulling the pull wire moves the first arm relative to the second arm.

11. The prosthesis assembly of claim 8 further comprising:

at least one suture coupled to the holder, whereby cutting the suture allows the valve prosthesis to be removed from the holder.

12. The prosthesis assembly of claim 1 wherein the handle has a proximal end and a longitudinal axis, the longitudinal axis being approximately parallel to the coupling axis when the tip is received in the handle coupling.

15. The prosthesis assembly of claim 3, wherein:

the handle includes a pivoting actuator near the proximal end, the pivoting actuator being manually operable for actuating the pivoting mechanism and pivoting the handle relative to the valve prosthesis.

16. The prosthesis assembly of claim 1 wherein the handle coupling comprises an aperture in the holder body for receiving the tip of the handle.

2. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane;

a holder releasably attached to the valve prosthesis, the holder having a holder body with a holder height in the axial direction; and

a handle coupled to the holder, the handle having a length sufficient to reach a patient'"'"'s heart when a proximal end of the handle is positioned outside the patient'"'"'s chest cavity;

wherein the holder, handle and valve prosthesis have a profile having a height in the axial direction;

the attachment ring of the valve prosthesis having an outer diameter which is greater than the height of the profile.

13. The prosthesis assembly of claim 2 wherein:

the attachment ring has an outer diameter of at least about 20 mm.

14. The prosthesis assembly of claim 2, wherein:

the handle includes a releasing mechanism having an actuator at the proximal end, the actuator being manually operable to release the valve from the holder.

17. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane, the valve prosthesis also having a movable valve portion;

a holder releasably attached to the valve prosthesis and having a holder body with a holder height in the axial direction;

wherein the holder and valve prosthesis together have a profile having a height in the axial direction of less than about 20 mm; and

a releasing mechanism for releasing the valve prosthesis from the holder,

wherein the handle includes an actuator operably coupled to the releasing mechanism for releasing the valve prosthesis from the holder, the actuator being positioned near a proximal end of the handle.

18. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane, the valve prosthesis also having a movable valve portion; and

a holder releasably attached to the valve prosthesis and having a holder body with a holder height in the axial direction, the holder body and valve prosthesis together having a profile having a height in the axial direction of less than about 20 mm;

a handle coupled to the holder; and

a pivoting mechanism for pivoting the valve prosthesis relative to the handle with the holder remaining coupled to the valve prosthesis.

20. The prosthesis assembly of claim 18 wherein the pivoting mechanism is pivotable about a 90°

angle.

19. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane, the valve prosthesis also having a movable valve portion; and

a holder releasably attached to the valve prosthesis and having a holder body with a holder height in the axial direction, wherein the holder body and valve prosthesis together have a profile having a height in the axial direction of less than about 20 mm;

a handle coupled to the holder body; and

a pivoting mechanism for pivoting the valve prosthesis relative to the handle, wherein the handle has a longitudinal axis, the pivoting mechanism being operative to pivot the valve prosthesis to a position in which the longitudinal axis of the handle is generally perpendicular to the axial direction.

21. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane;

a holder releasably attached to the valve prosthesis, the holder having a holder body, the holder body having a holder height in the axial direction; and

an elongated handle having a distal end attached to the holder body, a proximal end opposite the distal end, and a longitudinal axis;

wherein the handle, holder body and valve prosthesis together have a profile height in a direction perpendicular to the longitudinal axis less than about 20 mm.

28. The prosthesis assembly of claim 21, wherein:

the attachment ring has an outer diameter of at least about 20 mm.

22. A prosthesis assembly for introduction into a patient'"'"'s heart, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane; and

a holder releasably attached to the valve prosthesis, the holder having a holder body and a coupling configured for attachment to a distal end of an elongated handle, the coupling being configured to attach to the handle such that at least a distal portion of the handle is approximately perpendicular to the axial direction, the valve prosthesis and holder having a combined height in the axial direction less than about 20 mm.

23. A prosthesis assembly for introduction into a patient'"'"'s heart, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane;

a holder releasably attached to the valve prosthesis; and

an elongated handle having a distal end attached to the holder, a proximal end, and a longitudinal axis;

wherein the holder is configured to attach to the handle such that the longitudinal axis is approximately perpendicular to the axial direction, the valve prosthesis, holder and handle having a combined height in the axial direction of less than about 20 mm.

24. A prosthesis assembly for introduction into a patient'"'"'s heart, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart;

a holder releasably attached to the valve prosthesis, the holder having a holder body configured to engage the valve prosthesis;

an elongated handle having a distal end, and a proximal end; and

a pivoting mechanism on the handle for pivoting the valve prosthesis and the holder relative to the handle through an angle of at least about 90 degrees.

25. The prosthesis assembly of claim 24 wherein:

the pivoting mechanism is pivotably mounted to the distal end of the handle so that the valve prosthesis is movable between a first orientation and a second orientation relative to the distal end of the handle.

29. The prosthesis assembly of claim 24, wherein:

the handle includes a release actuator for releasing the valve prosthesis from the holder, the release actuator being positioned near the proximal end of the handle.

30. The prosthesis assembly of claim 24, wherein:

the handle includes a pivoting actuator for pivoting the pivoting mechanism, the pivoting actuator being positioned near the proximal end of the handle.

31. The prosthesis assembly of claim 24, wherein:

the pivoting mechanism is a holder coupling at the distal end of the handle, the holder coupling being configured for attachment to the holder.

32. The prosthesis assembly of claim 24, wherein:

the handle has a length of at least about 20 cm.

26. A prosthesis assembly for introduction into a patient'"'"'s heart, the heart being within a chest defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the prosthesis assembly comprising:

a valve prosthesis having an attachment ring for attaching to cardiac tissue in the heart, the attachment ring defining a valve plane and an axial direction which is perpendicular to the valve plane,

a holder releasably attached to the valve prosthesis, the holder having a holder body with a holder height in the axial direction; and

a handle coupled to the holder, the handle having a length sufficient to reach a patient'"'"'s heart when a proximal end of the handle is positioned outside the patient'"'"'s chest cavity;

wherein the holder, handle and valve prosthesis have a profile having a height in the axial direction;

the attachment ring of the valve prosthesis having an outer diameter which is greater than the height of the profile and wherein the handle includes a displacing mechanism configured to move the valve relative to the handle, the handle also including an actuator near the proximal end, the actuator being manually operable to actuate the displacing mechanism for moving the valve relative to the handle.

27. The prosthesis assembly of claim 26, wherein:

the displacing mechanism is a pivoting mechanism.