Medical device delivery system having integrated introducer

• US 8,192,351 B2
• Filed: 09/23/2009
• Issued: 06/05/2012
• Est. Priority Date: 08/13/2007
• Status: Expired due to Fees

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Fishler, Matthew G., Klenk, Alan R., Wallin, Joshua, Martin, Peter M.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US12/565,669
• Publication Number:
  US 20100081867A1
• Time in Patent Office: 986 Days
• Field of Search: 600/7, 600/8, 600/37, 128/897, 128/898
• US Class Current: 600/37
• 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 17/0293 with ring member to support retractor elements
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/308 with suction cups
• 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

Abstract

An apparatus for delivering a medical device onto a heart includes a housing within which is releasably disposed the medical device. The housing in one embodiment comprises inner and outer deflectors between which is delivered the medical device. Both deflectors are self-expanding. A deflector compression sheath is slidable longitudinally over the housing to a delivery position at which it moves the deflectors to a collapsed configuration. The compression sheath is retracted to a deployment position to permit the deflectors to deploy by self-expanding to their larger diameters. The outer deflector has an expanded diameter sufficient to engage the inner surface of the pericardium to hold it away from the delivery site while the second deflector guides the medical device into position over the heart while protecting the heart. In another embodiment, the housing includes only an outer deflector. The apparatus also functions as an introducer when the compression sheath is moved to the delivery or “introducer” position at which configuration, the apparatus functions as an introducer.

Claims

1. An apparatus for delivering a cardiac harness onto a heart, comprising:

an elongate body having a proximal portion and a distal portion, the distal portion having a tubular housing sized to contain the cardiac harness in a compacted configuration, the tubular housing having a proximal end, an open distal end, an inner surface, and an outer surface;

a plurality of elongate push rods longitudinally movable with respect to the elongate body, the cardiac harness releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the cardiac harness from the compacted configuration in the housing to an expanded configuration outside the housing;

an outer deflector having a distal end and a proximal end, the outer deflector being flexible and configured so that it can be collapsed into a delivery configuration, and can be flared radially outwardly to a deployed configuration at which it has a first diameter at its distal end;

an inner deflector having a distal end and a proximal end, the inner deflector being flexible and configured so that it can be collapsed into a delivery configuration, and can be flared radially outwardly to a deployed configuration at which it has a second diameter at its distal end;

a deflector sheath slidably mounted over the outer surface of the tubular housing and having a delivery position at which the sheath retains the outer and inner deflectors in a collapsed, delivery configuration; and

the deflector sheath being further slidably mounted over the outer surface of the tubular housing to a deployment position at which the outer and inner deflectors flare radially outwardly in deployed configurations so that the outer deflector engages the pericardium and the push rods and cardiac harness slide under the outer deflector and over the inner deflector as the harness slides over the heart.

2. The apparatus for delivering a cardiac harness of claim 1, wherein the inner deflector comprises a plurality of petals, the plurality of petals being configured to be collapsed into the deflector sheath in a delivery configuration and flared radially outwardly in a deployed configuration at which the petals have a second diameter at a distal end, the second diameter being smaller than the first diameter of the outer deflector.

3. The apparatus of claim 1, wherein the plurality of petals number in the range from four to twenty petals.

4. The apparatus of claim 2, wherein the petals are formed from a polymer material.

5. The apparatus of claim 4, wherein the polymer material is taken from the group of polymers including polyamides, polyamide copolymers such as PEBAX, silicone rubber, polyurethanes, and nylons.

6. The apparatus of claim 2, wherein the proximal ends of the petals are biased radially outwardly to form a flared configuration.

7. The apparatus of claim 1, wherein the housing has a substantially circular cross-sectional shape having a diameter, and wherein at least a portion of the housing is compressible to a substantially elliptical cross-sectional shape having a minor axis that is less than the diameter.

8. The apparatus of claim 1, wherein the housing has a cross-sectional shape having a first perimeter, and wherein at least a portion of the housing is compressible to a reduced cross-sectional shape having a second perimeter that is less than the first perimeter.

9. The apparatus of claim 1, wherein the cross-sectional shape is adapted for advancing through a minimally invasive surgical entry path.

10. The apparatus of claim 1, wherein the housing tapers from a first cross-sectional shape having a first perimeter at the proximal end of the housing to a second cross-sectional shape having a second perimeter at the distal end of the housing, the second perimeter being smaller in size than the first perimeter.

11. A method of delivering a cardiac harness onto a heart, comprising:

advancing an elongated delivery device through a minimally invasive access site;

deploying an outer deflector from the delivery device to engage the pericardium and open a space between the pericardium and the heart;

deploying an inner deflector from the delivery device to engage the heart;

advancing a cardiac harness out of the delivery device under the outer deflector and over the inner deflector;

flaring the cardiac harness outwardly over the inner deflector and onto the heart; and

withdrawing the delivery device with the inner and outer deflectors through the access site.

12. The method of claim 11, further comprising:

extending a suction cup from a distal end of the delivery device;

engaging the heart with the extended suction cup; and

applying a vacuum to the suction cup to firmly attach the cup onto the heart.

13. The method of claim 12, wherein the inner deflector extends over the suction cup.

14. The method of claim 11, wherein the step of expanding the inner deflector to engage the heart further comprises guiding delivery of the harness onto the heart with the second deflector.

15. The method of claim 11, wherein the step of expanding the inner deflector out of the delivery housing to engage the heart further comprises protecting the heart with the second deflector during delivery of the medical device.