Exchangeable system for minimally invasive beating heart repair of heart valve leaflets

• US 9,044,221 B2
• Filed: 12/29/2011
• Issued: 06/02/2015
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: NeoChord, Inc.
• Original Assignee: NeoChord, Inc.
• Inventors: Zentgraf, John, Parins, David Joseph, Saini, Arun
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US13/339,865
• Publication Number:
  US 20120184971A1
• Time in Patent Office: 1,251 Days
• Field of Search: 606/108, 606139-150, 623/1.11
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/0042 with special provisions for gripping
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0406 : Pledgets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/3419 : Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/349 : Trocar with thread on outside
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 5/0044 : for the heart
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61M 2039/064 : Slit-valve
• CPC Class Codes: A61M 2039/0653 : Perforated disc
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

Improved methods and apparatuses for heart valve repair in a beating heart of a patient utilize an exchangeable heart valve repair system. Heart valve repair system can include a port adapted to be seated in the heart wall and an imaging catheter slidable within the port. The imaging catheter can be selectively locked relative to the port for insertion into the heart and unlocked once the port is seated to allow the imaging catheter to move distally towards target tissue. A deployment catheter slidably disposed in the imaging catheter and a repair cartridge slidably disposed in the deployment catheter can be used to capture the target tissue and deploy a repair device into the tissue after proper capture is confirmed. System elements can be selectively removed from and replaced within port to deploy additional repair devices while port maintains a seal while elements are and are not inserted.

Claims

1. A system for repairing a heart valve in a beating heart of a patient, comprising;

a port adapted to span a wall of the heart of the patient, the port having an opening extending therethrough and including a sealing portion including at least one seal configured to be positioned in the opening between an interior and an exterior of the heart;

an imaging catheter slidably insertable into the opening of the port, the imaging catheter having at least one lumen therethrough and including at least one imaging element;

a deployment catheter slidably insertable into the at least one lumen of the imaging catheter, the deployment catheter carrying a deployment mechanism and including at least one lumen therethrough, wherein a distal end of at least one of the imaging catheter and the deployment catheter forms a first portion of a jaw assembly for grasping target tissue for repair in the heart;

a repair cartridge slidably insertable into the lumen of the deployment catheter, the repair cartridge at least partially carrying a repair device adapted to repair the target tissue that is deployed onto the target tissue in conjunction with the deployment mechanism, the repair cartridge having a shaft with a tip at a distal end of the shaft, and wherein a proximally facing surface of the tip forms a second portion of the jaw assembly; and

an elongate removable locking mechanism selectively removable from contact with both the imaging catheter and the port and configured to engage the imaging catheter longitudinally along a length of an outer circumferential surface of the imaging catheter to prevent the imaging catheter from moving distally towards the target tissue relative to the port when the removable locking mechanism is engaged with the imaging catheter and a proximal force is applied to the imaging catheter for inserting the imaging catheter into the heart of the patient, the removable locking mechanism configured to move together with the imaging catheter when engaged with the imaging catheter;

wherein the imaging catheter is free to slide distally relative to the port to access the target tissue in the heart when the removable locking mechanism is not engaged with the imaging catheter to capture the target tissue with the jaw assembly;

wherein the at least one imaging element confirms proper capture of the target tissue with the jaw assembly; and

wherein the at least one seal substantially prevents blood from escaping the heart through the port while providing for selective insertion and removal of the imaging catheter, deployment catheter and repair cartridge through the port while the heart of the patient is beating.

2. The system of claim 1, further comprising a second repair cartridge at least partially carrying a second repair device, the second repair cartridge adapted to replace the repair cartridge in the system following deployment of the repair device.

3. The system of claim 2, further comprising a second deployment catheter, wherein the second repair cartridge is inserted into the second deployment catheter.

4. The system of claim 1, wherein the repair device is a suture.

5. The system of claim 4, further comprising a pledget to which the suture is attached following deployment of the suture, the pledget adapted to directly interface with the target tissue.

6. The system of claim 1, wherein the at least one imaging element comprises a plurality of fiber optics carried within at least one dedicated lumen in the imaging catheter.

7. The system of claim 1, wherein the removable locking mechanism engages an outer surface of the imaging catheter and prevents the imaging catheter from moving distally towards the target tissue by providing a physical barrier sandwiched between a proximal surface of the port and a distal surface of a portion of the imaging catheter that is raised relative to the outer surface of the imaging catheter with which the removable locking mechanism is engaged.

8. The system of claim 1, wherein the tip of the repair cartridge has a tapered distal end.

9. The system of claim 1, wherein the sealing portion of the port includes at least a first seal and a second seal, the first seal having an opening adapted to seal around an outer surface of the imaging catheter and the second seal having a plurality of slits that remain generally sealed when the imaging catheter is not inserted through the second seal.

10. The system of claim 1, wherein the port includes a stabilizing portion that is configured to engage with and seal with the heart wall and is configured to extend into the heart to provide access to the interior of the heart through the port.

11. A method of providing instruments and instructions for repairing a valve leaflet comprising:

providing the device of claim 1; and

providing instructions for operating the device of claim 1 to repair the valve leaflet.

17. The system of claim 1, wherein the repair device is a suture.

18. The system of claim 17, further comprising a pledget to which the suture is attached following deployment of the suture, the pledget adapted to directly interface with the target tissue.

12. A system for repairing a heart valve in a beating heart of a patient, comprising:

a port adapted to span a wall of the heart of the patient, the port having an opening extending therethrough configured to be positioned between an interior and an exterior of the heart;

a catheter slidably insertable into the opening of the port, the catheter including at least one imaging element and a deployment mechanism and having a distal end that forms a first portion of a jaw assembly adapted to grasp target tissue for repair in the heart;

a repair cartridge slidably insertable into the catheter, the repair cartridge at least partially carrying a repair device that is deployed into the target tissue in conjunction with the deployment mechanism and having a shaft with a tip at a distal end of the shaft that forms a second portion of the jaw assembly, wherein the imaging element confirms proper capture of the target tissue with the jaw assembly;

an elongate removable locking mechanism adapted to engage the catheter longitudinally along a length of an outer circumferential surface of the catheter to prevent the catheter from moving distally towards the target tissue relative to the port when the removable locking mechanism is engaged with the catheter and a proximal force is applied to the catheter for inserting the catheter into the heart of the patient, the removable locking mechanism configured to move together with the catheter when engaged with the catheter and the catheter being free to slide distally relative to the port to access the target tissue in the heart when the removable locking mechanism is not engaged with the catheter; and

a seal positioned within the opening of the port, the seal adapted to substantially prevent blood from escaping the heart through the port while providing for selective insertion and removal of the catheter and repair cartridge through the port while the heart of the patient is beating.

13. The system of claim 12, wherein the catheter comprises an imaging catheter carrying the imaging element and a separate deployment catheter carrying the deployment mechanism.

14. The system of claim 13, wherein the deployment catheter is slidably insertable into a lumen of the imaging catheter.

15. The system of claim 13, wherein the deployment catheter and imaging catheter are selectively insertable into a common lumen in the catheter.

16. The system of claim 12, further comprising a second repair cartridge at least partially carrying a second repair device, the second repair cartridge adapted to replace the repair cartridge in the system following deployment of the repair device.

19. The system of claim 12, wherein the removable locking mechanism engages an outer surface of the catheter and prevents the catheter from moving distally towards the target tissue by providing a physical barrier sandwiched between a proximal surface of the port and a distal surface of a portion of the catheter that is raised relative to the outer surface of the catheter with which the removable locking mechanism is engaged.

20. The system of claim 12, wherein the at least one seal includes at least a first seal and a second seal, the first seal having an opening adapted to seal around an outer surface of the catheter and the second seal having a plurality of slits that remain generally sealed when the catheter is not inserted through the second seal.

21. A method of providing instruments and instructions for repairing a valve leaflet, comprising:

providing the device of claim 12; and

providing instructions for operating the device of claim 19 to repair the valve leaflet.