Source: http://www.google.com/patents/US7736299?dq=7,249,099
Timestamp: 2016-02-14 00:28:17
Document Index: 194332465

Matched Legal Cases: ['art.\n7', 'Application No. 60', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172']

Patent US7736299 - Introducer for a cardiac harness delivery - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA system for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device, including a tubular introducer sleeve and a tubular dilator sleeve insertable into the introducer sleeve. The introducer sleeve has a slot and a distal portion biased in a reduced...http://www.google.com/patents/US7736299?utm_source=gb-gplus-sharePatent US7736299 - Introducer for a cardiac harness deliveryAdvanced Patent SearchPublication numberUS7736299 B2Publication typeGrantApplication numberUS 11/187,276Publication dateJun 15, 2010Filing dateJul 21, 2005Priority dateNov 15, 2002Fee statusLapsedAlso published asUS20050256368Publication number11187276, 187276, US 7736299 B2, US 7736299B2, US-B2-7736299, US7736299 B2, US7736299B2InventorsAlan Klenk, Joshua WallinOriginal AssigneeParacor Medical, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (265), Non-Patent Citations (7), Referenced by (7), Classifications (15), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetIntroducer for a cardiac harness delivery
US 7736299 B2Abstract
A system for creating a passage through the pericardium of a patient to permit access of a cardiac harness delivery device, including a tubular introducer sleeve and a tubular dilator sleeve insertable into the introducer sleeve. The introducer sleeve has a slot and a distal portion biased in a reduced opening. The distal end being positioned within an incision through the pericardium. Insertion of the dilator sleeve into the introducer sleeve causes it to push outwardly against the reduced opening, thereby expanding the reduced opening of the introducer sleeve sufficiently to permit a cardiac harness delivery device to access the epicardium. The introducer sleeve is releasably locked to the dilator sleeve by operation of a slot on the introducer sleeve and a protrusion on the dilator sleeve, which slides within the slot. The slot has detents that releasably lock the dilator sleeve at alternative positions within the introducer sleeve, thereby maintaining the reduced opening or, alternatively, the expanded opening to facilitate operation of a cardiac harness delivery device.
Images(46) Claims(41)
1. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness delivery device to the heart, comprising:
an introducer sleeve having an outer wall defining a proximal end and a distal end, the outer wall having a reduced-diameter portion adjacent to the distal end, the reduced-diameter portion defining a reduced orientation having a first diameter;
the introducer sleeve having a slot;
a dilator sleeve being sized and shaped to be insertable into the introducer sleeve to urge the reduced-diameter portion into an expanded orientation having a second diameter, larger than the first diameter, the second diameter being sufficient to permit the cardiac harness delivery device to pass therethrough; and
the dilator sleeve having an outwardly extending protrusion, the protrusion being sized and shaped to slide within the slot.
2. The apparatus of claim 1, additionally comprising a biasing member surrounding the outer wall of the introducer sleeve, the biasing member being configured to bias the reduced-diameter portion in the reduced orientation.
3. The apparatus of claim 2, the biasing member comprising an elastic ring.
4. The apparatus of claim 1, wherein the introducer sleeve is a thin-walled tubular element having a substantially circular cross-sectional shape.
5. The apparatus of claim 1, wherein the introducer sleeve is a thin-walled tubular element having a substantially elliptical cross-sectional shape.
6. The apparatus of claim 1, wherein the introducer sleeve is of a length sufficient to span the entire distance of a minimally invasive pathway to the heart.
7. The apparatus of claim 1, wherein the introducer sleeve comprises a plurality of cut out portions extending parallel to a longitudinal axis of the outer wall, the cut out portions extending at least through the reduced-diameter portion of the outer wall.
8. The apparatus of claim 1, wherein the introducer sleeve additionally comprises a plurality of elongate strips, the elongate strips extending from the distal end of the introducer sleeve through the reduced-diameter portion.
9. The apparatus of claim 8, wherein the elongate strips extend about the distal-most two-thirds of the length of the introducer sleeve.
10. The apparatus of claim 8, wherein the elongate strips extend about the distal-most one-quarter to one-half of the length of the introducer sleeve.
11. The apparatus of claim 8, wherein the elongate strips have flared portions at the distal end, the flared portions biased outwardly from a longitudinal axis of the introducer sleeve at a first angle comprising the reduced orientation.
12. The apparatus of claim 11, wherein the flared portions bias outwardly from the longitudinal axis at a second angle comprising the expanded orientation, the second angle being greater than the first angle.
13. The apparatus of claim 8, wherein the elongate strips are spaced apart from each other, the flared portions at the distal end widen in a direction generally transverse to a longitudinal axis of the introducer sleeve.
14. The apparatus of claim 8, wherein the reduced orientation comprises the elongate strips abutting each other at the distal end of the introducer sleeve.
15. The apparatus of claim 8, wherein the expanded orientation comprises the elongate strips being spaced apart from each other at the distal end of the introducer sleeve.
16. The apparatus of claim 1, wherein the reduced orientation comprises the outer wall at the distal end of the introducer sleeve having a distal diameter greater than the first diameter at the reduced-diameter portion of the introducer sleeve, the distal diameter being sized to permit the distal end to engage the interior surface of the pericardium surrounding the incision.
17. The apparatus of claim 1, wherein the expanded orientation comprises the outer wall at the distal end of the introducer sleeve having a distal diameter greater than the second diameter at the reduced-diameter portion of the introducer sleeve, the distal diameter being sized to permit the distal end to be locked onto the interior surface of the pericardium surrounding the incision.
18. The apparatus of claim 1, wherein the introducer sleeve additionally comprises at least one outwardly extending flange at the proximal end, the flange being sized for pulling the introducer sleeve.
19. The apparatus of claim 1, wherein the slot extends distally from the proximal end of the introducer sleeve.
20. The apparatus of claim 19, wherein the slot extends distally in a substantially helical configuration.
21. The apparatus of claim 1, wherein the slot comprises a first detent, the protrusion engaging the first detent for releaseably locking the dilator sleeve at a first position within the introducer sleeve, the first position corresponding to the reduced orientation.
22. The apparatus of claim 21, wherein the introducer sleeve additionally comprises an inner wall adjoining the reduced-diameter portion, the dilator sleeve additionally comprises a distal tip, the distal tip being pressed against the inner wall of the introducer sleeve, the inner wall exerting resistance to insertion of the dilator sleeve within the introducer sleeve.
23. The apparatus of claim 1, wherein the slot comprises a second detent, the protrusion engaging the second detent for releaseably locking the dilator sleeve at a second position within the introducer sleeve, the second position corresponding to the expanded orientation.
24. The apparatus of claim 1, wherein the dilator sleeve is a thin-walled tubular element having a substantially circular cross-sectional shape.
25. The apparatus of claim 1, wherein the dilator sleeve is a thin-walled tubular element having a substantially elliptical cross-sectional shape.
26. The apparatus of claim 1, wherein the dilator sleeve additionally comprises an inner diameter equal to or greater than the outer diameter of the cardiac harness delivery device, thereby permitting the cardiac harness delivery device to be advanced therethrough.
27. The apparatus of claim 1, wherein the dilator sleeve additionally comprises a distal portion, the distal portion having an outer diameter, the proximal end of the introducer sleeve having an inner diameter equal to or greater than the outer diameter of the distal portion of the dilator sleeve, thereby permitting the dilator sleeve to be advanced within the introducer sleeve.
28. The apparatus in 27, wherein the outer diameter of the distal portion of the dilator sleeve is greater than the first diameter of the reduced-diameter portion of the introducer sleeve, thereby permitting the dilator sleeve to dilate the reduced-perimeter portion.
29. The apparatus of claim 1, wherein the dilator sleeve additionally comprises a proximal portion, the proximal portion having an enlarged diameter relative to the distal portion, the proximal end of the introducer sleeve having an inner diameter smaller than the enlarged diameter of the proximal portion of the dilator sleeve, thereby limiting advancement of the dilator sleeve within the introducer sleeve.
30. The apparatus of claim 29, wherein the enlarged diameter portion comprises a stop flange, the stop flange being of a size for moving the dilator sleeve relative to the introducer sleeve.
31. The apparatus of claim 1, wherein the dilator sleeve additionally comprises a distal tip, the distal tip being tapered sufficiently to ease insertion of the dilator sleeve through the introducer sleeve.
32. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness delivery device to the heart, comprising:
the introducer sleeve having a plurality of slots;
the dilator sleeve having a plurality of outwardly extending protrusions, the protrusions being sized and shaped to slide within the slots.
33. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness delivery device to the heart, comprising:
the introducer sleeve having an inwardly extending protrusion;
the dilator sleeve having a slot, the slot being sized and shaped to permit the protrusion to slide within the slot.
34. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness delivery device to the heart, comprising:
the introducer sleeve having an outwardly extending protrusion;
the dilator sleeve having a latch, the latch having a slot, slot being sized and shaped to permit the protrusion to slide within the slot.
35. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness delivery device to the heart, comprising:
an introducer sleeve having an outer wall defining a proximal end and a distal end, the outer wall having a reduced-perimeter portion adjacent to the distal end, the reduced-perimeter portion defining a reduced orientation having a first perimeter;
a dilator sleeve being sized and shaped to be insertable into the introducer sleeve to urge the reduced-perimeter portion into an expanded orientation having a second perimeter, larger than the first perimeter, the second perimeter being sufficient to permit the cardiac harness delivery device to pass therethrough;
36. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness device to the heart, comprising:
an introducer sleeve having a slot and a distal portion biased in a reduced opening;
a dilator sleeve being sized and shaped to be insertable into the introducer sleeve to urge the distal portion into an expanded opening, larger than the reduced opening, the expanded opening being of a size sufficient to permit the cardiac harness delivery device to pass therethrough; and
37. The apparatus of claim 36, wherein the slot comprises a first detent, the protrusion engaging the first detent for releaseably locking the dilator sleeve at a first position within the introducer sleeve, the first position corresponding to the distal portion of the introducer sleeve having the reduced opening.
38. The apparatus of claim 36, wherein the slot comprises a first detent, the protrusion engaging the first detent for releaseably locking the dilator sleeve at a first position within the introducer sleeve, the first position corresponding to the distal portion of the introducer sleeve having an intermediate opening, the intermediate opening being larger than the reduced opening and smaller than the expanded opening.
39. The apparatus of claim 36, wherein the slot comprises a second detent, the protrusion engaging the second detent for releaseably locking the dilator sleeve at a second position within the introducer sleeve, the second position corresponding to the distal portion of the introducer sleeve having the expanded opening.
40. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness device to the heart, comprising:
an introducer sleeve, the introducer sleeve having a slot and a narrowing distal portion relative to a proximal portion, the distal portion having a plurality of elongate strips, the elongate strips having flared portions, the flared portions positioned at a distal end of the introducer sleeve for engaging an incision in the pericardium of the heart;
a dilator sleeve, the dilator sleeve having an inner wall and an outer wall, the outer wall perimeter being sized to permit the dilator sleeve to slide within the introducer sleeve for deflecting the elongate strips of the introducer sleeve, the inner wall perimeter being sized to permit a cardiac harness delivery device to pass therethrough; and
41. An apparatus for creating a passage through a pericardium of a heart to permit access of a cardiac harness device to the heart, comprising:
an introducer sleeve, the introducer sleeve having a slot and a contracted distal end, the distal end having a plurality of flared portions for engaging an incision in the pericardium of the heart;
a dilator sleeve, the dilator sleeve having an inner wall and an outer wall, the outer wall perimeter being sized to permit the dilator sleeve to slide within the introducer sleeve for expanding the distal end of the introducer sleeve, the inner wall perimeter being sized to permit a cardiac harness delivery device to pass therethrough; and
the dilator sleeve having an outwardly extending protrusion, the protrusion being sized and shaped to slide within the slot. Description
The present application is a continuation-in-part of U.S. Ser. No. 10/715,150 filed Nov. 17, 2003 now U.S. Pat. No. 7,189,203 which is related to, and claims priority from, U.S. Provisional Patent Application No. 60/427,079, filed Nov. 15, 2002, the entirety of each of which is hereby incorporated by reference.
The present invention relates generally to a device for delivering a cardiac harness onto the heart of a patient.
Accordingly, a need exists for an introducer that overcomes the disadvantages of the prior art in providing access of a cardiac harness delivery device to the heart. In one embodiment, the introducer includes an introducer sleeve with a distal portion biased in a reduced opening that is placed inside an incision through the pericardium of the patient, and a dilator sleeve that is insertable into the introducer sleeve for expanding the reduced opening sufficiently to allow a cardiac harness delivery device to pass through an expanded opening and to access the epicardial surface of the heart. In this embodiment, the outer walls of the introducer sleeve and the dilator sleeve have substantially circular cross-sections. Further, the introducer is configured with a releasable locking system so that the dilator sleeve may be releasably locked within the introducer sleeve. Accordingly, the introducer includes an axially extending slot on the introducer sleeve and an outwardly extending protrusion on the dilator sleeve, which protrusion slides within the slot. Preferably, the slot has detents that releasably lock the dilator sleeve at alternative positions within the introducer sleeve, thereby maintaining the reduced opening or, alternatively, the expanded opening while a cardiac harness delivery device is passed therethrough and operated.
In another embodiment, the outer walls of the introducer sleeve and the dilator sleeve have substantially elliptical or oval cross-sections. With such cross-section, access for a cardiac harness delivery device is provided through minimally invasive openings to the body cavity of the patient, thereby reducing damage to tissue or bone surrounding the introducer.
In yet another embodiment, the introducer sleeve has outwardly extending flanges at the proximal end, the flanges being sufficiently sized to serve as a grip. With the flanges, the introducer sleeve may be easily held in place by the doctor while inserting the dilator sleeve. Once an expanded opening is achieved, the flanges allow the doctor to pull back the introducer, thereby creating a space between the pericardium and epicardium, which facilitates insertion of a cardiac harness delivery device.
In another embodiment, the outer wall of the introducer sleeve is surrounded by an annular member being configured to bias the distal portion into a reduced opening.
In yet another embodiment, the distal portion includes flared portions for better holding open an incision in the pericardium.
In a further embodiment, the distal tip of the dilator sleeve is tapered to ease insertion through the introducer sleeve. The taper reduces friction when pushing the dilator sleeve against the reduced opening of the introducer sleeve.
In another embodiment, the base of the dilator sleeve has an annular stop flange, which limits insertion of the dilator sleeve within the introducer sleeve. Also, the stop flange is sized to serve as a grip for moving the dilator sleeve relative to the introducer sleeve.
In yet another embodiment, the slot in the introducer sleeve extends helically, instead of extending axially. With such a configuration, twisting the dilator sleeve relative to the introducer sleeve causes the dilator sleeve to insert within the introducer sleeve.
In another embodiment, the releasable locking system includes a plurality of slots on the introducer sleeve and a plurality of outwardly extending protrusions on the dilator sleeve. With more than one slot and one protrusion, greater stability in the operation of the introducer is achieved.
In another embodiment, the slot and the protrusion are reversed, such that the dilator sleeve has a slot instead of an outwardly extending protrusion, and the introducer sleeve has an inwardly extending protrusion instead of a slot
In yet another embodiment, the dilator sleeve has a latch with a slot instead of an outwardly extending protrusion, and the introducer sleeve has an outward protrusion instead of a slot.
FIG. 28A is a cross-sectional view of one of the plurality of push rods illustrating the formation of an initial loop in the line comprising the releasable stitch for securing the cardiac harness to the push rod.
FIG. 28B is a partial cross-sectional view of the push rod of FIG. 28A illustrating the initial formation of a second loop.
FIG. 28C is a view of the push rod of FIG. 28B illustrating the second loop being passed through the initial loop.
FIG. 35A is a side elevational view of the introducer assembly, illustrated in an unassembled condition and including an introducer sleeve with a slot and a dilator sleeve with a protrusion.
FIG. 35B is a side elevational view of the dilator sleeve in FIG. 35A rotated ninety degrees on its central axis.
FIG. 35C is a cross-sectional view of the dilator sleeve in FIG. 35A, taken along line 35C-35C in FIG. 35A.
FIG. 35D is a plan view of the introducer sleeve in FIG. 35A, taken in the direction of line 35D-35D in FIG. 35A.
FIG. 36 is a side elevational view of the introducer assembly in FIG. 35A, illustrated in an assembled condition wherein the protrusion on the dilator sleeve has advanced into the slot in the introducer sleeve.
FIG. 37A is a side elevational view of the introducer assembly in FIG. 35A, illustrated in an assembled condition wherein the protrusion on the dilator sleeve has engaged a first detent in the slot in the introducer sleeve.
FIG. 37B is a plan view of the introducer assembly in FIG. 37A, taken in the direction of line 37B-37B in FIG. 37A.
FIG. 38 is a side elevational view of the introducer assembly in FIG. 35A, illustrated in an assembled condition wherein the protrusion on the dilator sleeve has advanced beyond the first detent on the slot in the introducer sleeve.
FIG. 39 is a side elevational view of the introducer assembly in FIG. 35A, illustrated in an assembled condition wherein the protrusion on the dilator sleeve has engaged a second detent on the slot in the introducer sleeve.
FIG. 40 is a proximal plan view of the introducer sleeve having an oval cross-section.
FIG. 41 is a side elevational view of the introducer sleeve having a slot extending helically.
FIG. 42 is a proximal plan view of the introducer sleeve having two slots.
FIG. 43 is a distal plan view of the dilator sleeve having two protrusions.
FIG. 44A is a side elevational view of the introducer assembly, illustrated in an unassembled condition and including an introducer sleeve with a protrusion and a dilator sleeve with a slot.
FIG. 44B is a plan view of the introducer sleeve in FIG. 44A, taken in the direction of line 44B-44B in FIG. 44A.
FIG. 44C is a cross-sectional view of the dilator sleeve in FIG. 44A, taken along line 44C-44C in FIG. 44A.
FIG. 45 is a side elevational view of the introducer assembly in FIG. 44A, illustrated in an assembled condition wherein a first detent in the slot in the dilator sleeve has engaged the protrusion on the introducer sleeve.
FIG. 46 is a side elevational view of the introducer assembly in FIG. 44A, illustrated in an assembled condition wherein a second detent in the slot in the dilator sleeve has engaged the protrusion on the introducer sleeve.
FIG. 47A is a side elevational view of the introducer assembly, illustrated in an unassembled condition and including an introducer sleeve with a protrusion and a dilator sleeve with a latch.
FIG. 47B is a side elevational view of the dilator sleeve in FIG. 47A rotated ninety degrees on its central axis.
FIG. 48 is a side elevational view of the introducer assembly in FIG. 47A, illustrated in an assembled condition wherein a stop flange on the dilator sleeve is disposed against a proximal end of the introducer sleeve.
FIG. 49 is a side elevational view of the introducer assembly 47A, illustrated in an assembled condition wherein a slot in the latch on the dilator sleeve has engaged the protrusion on the introducer sleeve.
In an alternative arrangement, the retaining loop 86 a may not be looped around the retaining rod 68, but may be inhibited from unraveling by an alternatively suitable arrangement. For example, it is contemplated that the retaining loop 86 a may be formed approximately the same size as the remainder of the interconnected loops 82 a-h and may be tucked between the adjacent loop 82 h and the outward facing surface 40 a of the push rod 40. Thus, the retaining loop 86 a is inhibited from unraveling by a frictional force of the adjacent loop 82 h holding the retaining loop 86 a against the outward facing surface 40 a. When a sufficient pulling force is applied to the end portion 100, the retaining loop 86 a overcomes the frictional force of the loop 82 h and the outward facing surface 40 a and is drawn through the opening 64 h , thus permitting unraveling of the releasable stitch.
In the illustrated embodiment, the push rods are supported generally in the center of the passages 114 a-f , with their respective inner surfaces 40 a arranged generally tangentially to the center axis of the shaft 34. In addition, with reference also to FIG. 10, a center portion 40 c of each push rod 40 is generally semicircular in cross-section such that the inward facing surface 40 a defines a recess 152. Preferably, the recess 152 is configured to accommodate one of the lines 60 a-f, respectively, as described above in relation to FIG. 5. As shown in FIG. 10, the line 60 a consists of the retaining loop 86 a and the free end 100 a, as is also described above in relation to FIG. 5.
With reference next to FIGS. 7A-C, a plurality of channels, referred to generally by the reference numeral 122, are defined by a proximal end surface of the body portion 112 of the control assembly 38. Each of the channels 122 interconnect two of the passages 114 a- 114 f and are configured to accommodate a portion of one or more lines, such as the line 60 a, as is described in greater detail below. Specifically, in a preferred arrangement, a first channel 122 a extends generally parallel to the vertical axis Av and interconnects the passages 114 a and 114 c. Similarly, a second channel 122 b extends generally parallel to the channel 122 a and interconnects the passages 114 d and 114 f. Third and fourth channels 122 c, 122 d interconnect the passages 114 a and 114 b and passages 114 b and 114 c, respectively. Similarly, fifth and sixth channels 122 e, 122 f interconnect passages 114 f and 114 e and passages 114 e and 114 d, respectively.
Preferably, each of the channels 122 a-f are arranged to generally intersect a center of the passages 114 that they interconnect. The channels 122 a, 122 c and 122 d form a triangular shape on the right-hand side of the vertical axis AV. The channels 122 b, 122 e and 122 f form a triangular shape on the left-hand side of the vertical axis AV,which shape is a mirror image of the triangular shape defined by channels 122 a, 122 c and 122 d. An additional channel 134 interconnects the passages 114 a and 114 f and extends in a direction generally parallel to a horizontal axis AH as depicted in FIGS. 7A-C. The channel 134 is defined by a proximal surface of the body portion 112 and, preferably, is substantially larger in both width and depth than the channels 122 a-f. Preferably, the channel 134 has a width approximately one-half the diameter of the passages 114 a, 114 f and is semicircular in cross-sectional shape. Desirably, the channel 134 passes approximately through the centers of the passages 114 a, 114 f. The control assembly 38 also includes a release member 136 that preferably is configured to selectively release the releasable stitch, thereby releasing the cardiac harness 42 from the delivery device 30. With reference also to FIG. 9, a portion of the release member 136 preferably is received within a cavity 137 of the body portion 112, which is located on an opposite side of the horizontal axis AH from the channel 134. The cavity 137 defines a support surface 138 which, along with a corresponding portion of the distal surface of the cover 116 (see FIG. 6), supports a portion of the release member 136.
With regard to the retention loops 86, retention loop 86 b extends from passage 114 b through channel 122 c into channel 134 and is looped around the tight rod 68 a. Loop 86 c extends from passage 114 c through channel 122 a into channel 134 and is looped about the right rod 68 a. Retention loop 86 d extends from passage 114 d through channel 122 b into channel 134 and is looped about the left rod 68 b. Retention loop 86 e extends out of passage 114 e through channel 122 e into channel 134 and is looped about the left rod 68 b. Retention loop 86 f extends from passage 114 f into channel 134 and is looped about the left rod 68 b. In operation, the release member 136 is configured to release loops 86 a-f, unravel the lines 60 a-f from the push rods 40 and thereby release the cardiac harness 42 from the push rods 40. More specifically, and with reference to FIG. 7C, as the release member 136 is pulled away from the body 112 of the control assembly 38, the rods 68 a-b are also pulled through the channel 134 such that the retention loops 86 a-f are released from the rods 68 a-b. Simultaneously, because the free ends 100 a-f of the lines 60 a are tied onto one of the holes 148 of the attachment portion 146, the release member 136 pulls on the free ends 100 a-f. Since the retention loops 86 a-f are released from the rods 68 a-b , pulling of the free ends 100 a-f unravels the lines 60 a-f, thereby releasing the cardiac harness 42 from the push rods 40, as is described further below in connection with FIGS. 11A-C.
With particular reference to FIG. 14, the dilator sleeve 164 preferably is a thin-walled, tubular member, which is also substantially circular in cross-section. An outer diameter of the dilator sleeve 164 is configured to be slightly smaller than an inner diameter of the introducer sleeve 162. Accordingly, the dilator sleeve 164 may be slidably inserted within the introducer sleeve 162, as illustrated in FIG. 15. The dilator sleeve 164 may also have an enlarged diameter portion 170 on its proximal most end to limit the insertion within the introducer sleeve 162. Further, a releasable locking system may be provided so that the dilator sleeve 164 may be releasably engaged within the introducer sleeve 162.
With reference to FIG. 21, the control assembly 38 continues to be advanced until the cardiac harness 42 is properly positioned on the heart 172. Once the cardiac harness 42 is properly positioned, the release member 136 is pulled away from the main body 112 of the control assembly 38, as indicated by the arrow 192. Accordingly, the cardiac harness 42 is released from the plurality of push rods 40, preferably in a manner similar to that described above with reference to FIGS. 11A-C.
Although the delivery device 30 is especially well suited for use in a minimally invasive delivery procedure, the device 30 may also be used for open chest procedures, wherein the sternum of the patient is split to provide access to the heart 172. Accordingly, the delivery device 30 may be used with or without the delivery arrangement illustrated in FIGS. 13-18. In addition, although the device 30 described herein utilizes a plurality of push rods 40, other suitable structures may also be used as support structures to support the cardiac harness 42, when being advanced over the heart. For example, an expandable sleeve can serve as a support structure. Furthermore, it is to be understood that a cardiac harness 42 may be releasably supported in an expanded, or substantially expanded, configuration to a variety of support structures by the releasable stitch described herein, or by a similar releasable stitch arrangement.
With reference next to FIGS. 24-27, an embodiment of a cardiac harness loading device 200 is illustrated. The loading device 200 is configured to cooperate with the delivery device 30 to support the plurality of push rods 40 in all outwardly splayed orientation so that the cardiac harness 42 may be secured to the push rods 40. The loading device 200 May also be useful to assist in urging the cardiac harness 42 from an expanded or at rest configuration to a compacted configuration, so as to be insertable into the housing 36 of the delivery device 30.
With reference to FIG. 28 c, preferably an instrument, such as a hook 220 is passed through the loop 82 a and grasps a portion of the line 60 a below the upper row 66 a of the cardiac harness 42. The line 60 a is pulled through the through hole 64 a and through the initial loop 82, to secure the upper row 66 a of the cardiac harness 42 to the push rod 40. With reference to 28 c, the line 60 a is pulled further through the loop 82 a to create the second loop 82 b. This process is repeated until each of the rows 66 a-h are secured to each of the plurality of push rods 40. With reference again to FIG. 5, the final loop, or retention loop 86 a, preferably is retained by the rod 68 a of the release member 136, as previously described. In addition, preferably the end 100 a of the line 60 a is tied off, on the release member 136, as also described above.
With particular reference to FIG. 29, the body portion 242 includes a first and a second friction brake assembly 246, 248. Preferably, each friction brake assembly 246, 248 is constructed in a manner similar to the assembly 102 described above in connection with FIGS. 6-9. However, the pivoting direction and orientation of the brake element 104 portion in the first brake assembly 246 is reversed relative to such orientation in the second brake assembly 248. As such, axial movement of the control assembly 238 over the shaft 34 can be selectively inhibited ill either a distal or proximal direction by selectively engaging the first or second brake assembly 246, 248.
With more particular reference to FIG. 31, a distal tip 249 of the push rod 240 comprises a generally barrel-shaped atraumatic tip portion 260. It is to be understood, however, that the atraumatic tip 260 can be shaped in several different ways in order to minimize the likelihood that the tip will puncture, scratch or otherwise traumatize tissue. For example, the tip can be folded over, be generally teardrop shaped, or be generally cylindrical.
With particular reference next to FIGS. 30 and 32, a proximal region 266 of the push rod 240 comprises a plurality of ribs 270 attached to a spine 271 of the rod 240. The ribs 270 extend outwardly and function to increase the rigidity of the rod in the proximal region 266. An elongate passage 272 is formed between the ribs, and defines a line path 272 configured to accommodate a line 60 a extending therethrough. The ribs 270 increase the rigidity of the push rod 240 in the proximal region 266. As such, the push rod 240 is more flexible in a distal region 273 than in the proximal region 266. It is to be understood that, in other embodiments, further structural or material strategies can be used to further vary the flexibility of the push rods along their length.
With reference next to FIG. 34, an interior view of the control assembly 238 of FIG. 29 is shown. In this embodiment, the line and stitching arrangement of FIG. 33 is employed. As such, only a single line 100 a extends into the control assembly 238 from each push rod 240, and no loop extends into the control assembly 238. An end of each line 100 a-f is tied onto the release member 268. As shown in FIG. 34, (channels 284 a,b , 286 a,b extend between each control assembly passage line portion to the release member 268 in order to accommodate each line 100 a-f. The lines 100 a-f associated with each push rod 240 extend through the associated channels 284 a,b 286 a,b to the release member 268. As such, when the release member 268 is pulled outwardly, the lines 100 a-f are pulled so as to release the loops holding the harness 42 onto the push rod.
Introducer Assembly with Releasable Locking System
In one embodiment of the invention, the introducer assembly includes an introducer sleeve and a dilator sleeve. For more details regarding the introducer assembly, refer to U.S. Ser. No. 10/715,150 filed Nov. 17, 2003, the entire contents of which are incorporated herein by reference. The present invention includes a releasable locking system for releasably locking the dilator sleeve within the introducer sleeve, thereby assuring that an incision in the pericardium remains dilated during delivery of a cardiac harness device.
As shown in FIGS. 35A-43, alternative embodiments of an introducer assembly 300 include a dilator sleeve 302 with at least one protrusion 304 and an introducer sleeve 306 with at least one slot 308. With particular reference to FIG. 35A, the single slot 308 is located adjacent to the proximal end 310 of the introducer sleeve 306 and preferably extends axially, meaning substantially parallel to a longitudinal axis AS of the introducer sleeve. Preferably, the slot 308 includes a first detent 312 and a second detent 314 distal to the first detent 312.
With continued reference to FIG. 35A, the introducer sleeve preferably has at least one outwardly extending flange 316 at the proximal end 310. The illustrated embodiment includes two flanges 316; only one flange is shown in FIG. 35A, the other flange being on the other side of the introducer sleeve 306. In operation, the flanges 316 serve as a grip for maneuvering the introducer sleeve 306 through an opening in the body cavity of a patient, for holding the introducer sleeve 306 in place while inserting or twisting the dilator sleeve 302 therethrough, and for slightly pulling the introducer assembly 300 proximally to create a space between the pericardium 174 and the epicardium of the heart 172. Such a space is desirable when advancing the cardiac harness delivery device 30 through the introducer assembly 300 to the heart 172. The flanges 316 are also for pulling the introducer assembly 300 out of the patient.
With further reference to FIG. 35A, the outer wall 318 of introducer sleeve 306 has a reduced diameter portion 320 adjacent to the distal end 322 of the introducer sleeve 306. Preferably, the introducer sleeve 306 has a plurality of cut out portions 324 that extend axially. The cut out portions 324 preferably extend at least through the reduced diameter portion 320, thereby forming a plurality of elongate strips 326 at the reduced diameter portion 320. Preferably, the elongate strips 326 bend inwardly, meaning toward the longitudinal axis AS, such that the reduced diameter portion 320 defines a reduced orientation having a first diameter 321. The reduced orientation eases insertion and removal of the distal end 322 into and out of an incision 176 in the pericardium 174.
It is to be understood that in another embodiment wherein the elongate strips 326 do not bend inwardly, a resilient annular member, such as an elastic ring, is positioned at or adjacent the reduced diameter portion 320 of the introducer sleeve 306. Desirably, the elastic ring is configured to bend the elongate strips 326 inwardly, thereby biasing the reduced diameter portion 320 into the reduced orientation.
With reference to FIG. 35B illustrating only the dilator sleeve 302, the protrusion 304 extends outwardly from the outer wall 332. Preferably, the protrusion is in the shape of a cylindrical pin to facilitate sliding within the slot 308 in the introducer sleeve 306. A distal tip 334 of the dilator sleeve 302 is preferably tapered to ease insertion of the dilator sleeve 302 within the introducer sleeve 306. Further, a base 336 of the dilator sleeve preferably includes an annular stop flange 338 for limiting insertion of the dilator sleeve 302 within the introducer sleeve 306. The stop flange also serves as a grip for advancing and withdrawing the dilator sleeve 302 into and out of the introducer sleeve 306.
With reference next to FIG. 35C illustrating the dilator sleeve 302 in cross-section, the outer wall 332 preferably has a substantially circular cross-section. Preferably, the stop flange 338 includes notches 340 to allow the user to grasp the dilator sleeve 302 and twist it relative to the introducer sleeve 306. It is contemplated that outwardly extending tabs may be employed as an alternative to or in combination with the notches 340. As discussed further below, inserting and releasably locking the dilator sleeve 302 within the introducer sleeve 306 may be achieved by twisting the dilator sleeve 302 relative to the introducer sleeve 306 in the illustrated embodiments.
With reference to FIG. 35D illustrating only the introducer sleeve 306, a reduced opening 342 is defined by the elongate strips 326 including a section of an inner wall 344 of the introducer sleeve 306 nearest the longitudinal axis AS. Preferably, the inner wall 344 and the outer wall 318 have a substantially circular cross-section. The slot 308 penetrates the inner wall 344 and the outer wall 318, which allows the protrusion 304 on the dilator sleeve 302 to be visible within the slot 308 as an indicator to the doctor of whether the dilator sleeve 302 is releasably locked. In a further embodiment, the introducer sleeve 306 has a rib that rises above the outer wall 318 and extends along the edges of the slot 308. Desirably, the rib is of a height sufficient for keeping the doctor's surgical glove from entering the slot 308 and becoming pinched by the protrusion 304 sliding within the slot 308.
It is to be understood that in other embodiments, the slot 308 does not penetrate the outer wall 318, such that the slot 308 is a shallow groove in the inner wall 344 of the introducer sleeve 306 for receiving the protrusion 304. Thus, the possibility of a surgical glove becoming pinched by the protrusion 304 during operation is eliminated. Further, it is to be understood that while the illustrated embodiment has six elongate strips 326 and two flanges 316, other embodiments can include any suitable number of elongate strips 326 and flanges 316.
It further embodiments, the protrusion 304 on the dilator sleeve 302 may be locked at one or more points along a slot or groove without the dilator sleeve twisting relative to the introducer sleeve 306. For example, it is contemplated that the protrusion 304 may be mounted on an elongate, flexible member that is configured for plastic deformation along a length of the flexible member. As such, the protrusion 304 can snap into and out of a detent defined by a through hole located along a shallow groove on the inner wall the introducer sleeve. With such a configuration, releasably locking the dilator sleeve 302 within the introducer sleeve 306 may be achieved, without twisting, by applying additional axial force when pushing or pulling the dilator sleeve 302 relative to the introducer sleeve 306.
FIGS. 36-37B show the introducer assembly 300 with the dilator sleeve 302 at a first position within the introducer sleeve 306. The first position corresponds to a distal portion 328 of the introducer sleeve 306 having an intermediate opening described below. The first position also corresponds to the reduced diameter portion 320, within the distal portion 328, defining the reduced orientation having a first diameter 321. With particular reference to FIG. 36, the dilator sleeve 302 has been inserted into the introducer sleeve 306, with the protrusion 304 on the dilator sleeve 302 having slid within the slot 308 in the introducer sleeve 306 and being disposed adjacent to the first detent 312 on the slot 308. A space created by the first detent 312 allows the dilator sleeve 302 to twist relative to the introducer sleeve 306 in the direction of arrow 37A.
As the user advances the dilator sleeve 302 further into the introducer sleeve 306, the protrusion 304 abuts an angled portion 309 (FIG. 36) of the slot 308 adjacent to the first detent 312. With continued advancement of the dilator sleeve, the protrusion slides along the angled portion 309, which causes the dilator sleeve to twist automatically. Alternatively, the user may simply twist the dilator sleeve 302 relative to the introducer sleeve 306 when the protrusion 304 abuts the angled portion 309. The angled portion 309 also serves as a safety catch during subsequent withdrawal of the dilator sleeve from the introducer sleeve. When pulling the dilator sleeve axially during withdrawal, the dilator sleeve is caught at the first position and the elongate strips 326 are prevented from pinching wires or electrical leads, as discussed below in connection with FIG. 37B.
With reference to FIG. 37A, the dilator sleeve 302 having twisted in the direction of arrow 37A in FIG. 36, the protrusion 304 on the dilator sleeve 302 releasably engages the first detent 312 on the slot 308 such that the dilator sleeve 302 is releasably locked at the first position. Accordingly, the dilator sleeve 302 is prevented from slipping out of or being inadvertently pulled out of the first position. The slot 308 extends axially toward the distal end 322 of the introducer sleeve 306, thereby allowing the protrusion 304 to advance distally. Accordingly, the dilator sleeve 302 at the first position can be inserted further within the introducer sleeve 306 in the direction of arrow 38. At the first position, the distal tip 334 of the dilator sleeve 302 is pressed against the inner wall 344 adjacent to the reduced opening 320 within the distal portion 328 of the introducer sleeve 306. Because the distal portion 328 of introducer sleeve 306 is biased in the reduced opening 342, the inner wall 344 of the introducer sleeve 306 exerts resistance to further insertion of the dilator sleeve 302. Preferably, the resistance is overcome when the doctor applies additional force to the dilator sleeve 302, thereby advancing the dilator sleeve 302. Desirably, the additional force prevents sudden or inadvertent dilation of the incision 176 in the pericardium 174. The dilator sleeve 302 can be released from the first position by twisting the dilator sleeve 302 relative to the introducer sleeve 306 in a direction opposite to arrow 37A in FIG. 36, thereby disengaging the protrusion 304 from the first detent 312.
It is to be understood that after delivery of the cardiac harness 42 to the heart, the introducer sleeve 306, with the dilator sleeve 302 still locked in the first position, can be pulled out of the incision 176 in the pericardium 174. With reference to FIG. 37B illustrating the dilator sleeve 302 still locked in the first position, an intermediate opening 346 is defined by the elongate strips 326 including the section of the inner wall 344 of the introducer sleeve 306 nearest the longitudinal axis AS. Preferably, the reduced opening 342 (shown in FIG. 35D), which is associated with the introducer sleeve 306 without the dilator sleeve 302, is smaller in size than the intermediate opening 346, which is associated with the introducer sleeve 306 having the dilator sleeve 302 in the first position. In operation, the smaller size of the reduced opening 342 facilitates insertion of the distal end 322 of the introducer sleeve 306 into the incision 176 of the pericardium 174. The intermediate opening 346 is preferably of a size that allows the introducer assembly 300 to be pulled out of the incision without interfering with any wires or electrical leads that could be intended to remain connected to the cardiac harness 42 on the heart. Preferably, a small gap is maintained between each of the elongate strips 326 at the intermediate opening so as to avoid pinching any such wires or electrical leads.
Returning to FIG. 37A, the distal end 322 of the introducer sleeve preferably has flared portions 348 that widen or spread into the cut out portions 324 and bend outwardly at an angle θR from the longitudinal axis AS of the introducer sleeve 306. When the distal end 322 is inserted through an incision 176 in the pericardium 174, the bend allows the flared portions 348 to positively hold the inner surface of the pericardium 174. The widening of the flared portions 348 provides increased surface contact with the pericardium 174 to facilitate better holding. Accordingly, the flared portions 348 prevent the introducer sleeve 306 from being inadvertently pulled out of the incision 176. It is contemplated that in a further embodiment, the distal-most edges and corners of the flared portions 348 are rounded or radiused to reduce tearing or puncturing of the pericardium 174.
FIGS. 38 and 39 show the introducer assembly 300 with the dilator sleeve 302 at a second position within the introducer sleeve 306. The second position corresponds to the distal portion 328 of the introducer sleeve 306 having been urged into an expanded opening, larger than the reduced opening 342 (FIG. 35D) and the intermediate opening 346 (FIG. 37B). The second position also corresponds to the reduced diameter portion 320 of the introducer sleeve 306 having been urged into the expanded orientation. With particular reference to FIG. 38, the dilator sleeve 302 has been inserted further into the introducer sleeve 306, with the protrusion 304 on the dilator sleeve 302 having slid beyond the first detent 312 on the slot 308 in the introducer sleeve 306 and being disposed adjacent to the second detent 314 on the slot 308. A space created by the second detent 314 allows the dilator sleeve 302 to be twisted relative to the introducer sleeve 306 in the direction of arrow 39.
With reference to FIG. 39, the dilator sleeve 302 having been twisted in the direction of arrow 39 in FIG. 38, the protrusion 304 on the dilator sleeve 302 releasably engages the second detent 314 on the slot 308 such that the dilator sleeve 302 is releasably locked at the second position. Accordingly, the dilator sleeve 302 is prevented from slipping out of or being inadvertently pulled out of the second position. Preferably, the slot 308 terminates at the second detent 314, leaving no space for the protrusion 304 to advance distally. Also, the stop flange 338 of the dilator sleeve 302 is preferably disposed against the proximal end 310 of the introducer sleeve 306. Accordingly, the dilator sleeve 302 at the second position is prevented from inserting further within the introducer sleeve 306. The dilator sleeve 302 can be released from the second position by twisting the dilator sleeve 302 relative to the introducer sleeve 306 in a direction opposite to arrow 39 in FIG. 38, thereby disengaging the protrusion 304 from the second detent 314.
With continued reference to FIG. 39, the distal portion 328 of the introducer sleeve 306 has been urged into an expanded opening of sufficient size to permit the cardiac harness delivery device 30 to pass through the introducer sleeve 306. Concurrently, the reduced diameter portion 320 within the distal portion 328 has been urged into an expanded orientation having a second diameter 349, larger than the first diameter 321 (shown in FIG. 35A) and sufficient in size to permit the cardiac harness delivery device 30 to pass through the introducer sleeve 306.
Concurrent with the expanded opening and expanded orientation described above, the flared portions 348 of the introducer sleeve 306 have been deflected outward to sufficiently dilate the incision 176 in the pericardium 174 to permit the cardiac harness delivery device 30 to access the epicardial surface of the heart 172. To better hold the dilated incision 176, the flared portions 348 are at an angle θE from the longitudinal axis AS, preferably greater than angle θR corresponding to the dilator sleeve 302 in the first position. Better holding is desirable when pulling the introducer sleeve 306 out slightly to create a space between the pericardium 174 and epicardium for facilitating delivery of the cardiac harness 42 onto the heart 172.
It is to be understood that in other embodiments of the present invention, the slot 308 can include any suitable number of detents for making the introducer assembly 300 adaptable for use with variations of the cardiac harness delivery device 30 that require smaller or greater openings through the pericardium 174 of the heart 172.
With reference to FIG. 40, another embodiment of the introducer sleeve 306 has an elliptical or oval cross-section having a major axis and a minor axis. It is to be further understood that the dilator sleeve 302 and cardiac harness delivery device 30 have corresponding cross-sectional shapes. Further, each of these components may have any desired cross-sectional shape as may be customized for any desired type or shape of minimally invasive surgical entry path.
With reference next to FIG. 41, another embodiment of the introducer sleeve 306 has the slot 308 extending helically, meaning a substantially diagonal direction, from the first detent 312 to the second detent 314. With a helical slot 308, twisting the dilator sleeve 302 relative to the introducer sleeve 306 causes the dilator sleeve 302 to advance into or withdraw from the introducer sleeve 306. Twistably inserting the introducer sleeve provides greater control of insertion of the dilator sleeve 302, which prevents sudden or inadvertent dilation of the incision 176 in the pericardium 174. It is to be further understood that in other embodiments, the slot 308 may have any desired configuration within which the protrusion 304 slides and releasably engages detents therein.
With reference to FIG. 42, an embodiment of the introducer sleeve 306 has two slots 308 for receiving at least one protrusion 304 on dilator sleeve 302. Similarly and with reference to FIG. 43, another embodiment of the dilator sleeve 302 has two protrusions 304. It is contemplated that in other embodiments of the introducer sleeve 306 and the dilator sleeve 302, there can be any suitable number of slots 308 and protrusions 304 for providing greater stability in the operation of the introducer assembly 300.
As shown in FIGS. 44A-46, another embodiment of the introducer assembly 300 includes a dilator sleeve 302 with a slot 350 and an introducer sleeve 306 with a protrusion 356. With particular reference to FIG. 44A, the slot 350 preferably begins from the tapered distal tip 334 and preferably has a first detent 352 and a second detent 354 proximal to the first detent 352.
With reference to FIG. 44B, the protrusion 356 is located at the proximal end 310 and extends inwardly from the inner wall 344 of the introducer sleeve 306. With reference to 44C, the slot 350 is located on the outer wall 332 of the dilator sleeve 302. Preferably, the protrusion 356 on the introducer sleeve 306 has a height such that the slot 350 does not penetrate the inner wall 344 of the dilator sleeve 302, such that the slot 308 is a groove in the outer wall 332. A groove in the outer wall 332 affords the advantage of a continuously smooth inner wall 344 for inserting the cardiac harness delivery device 30.
With reference next to FIG. 45, the dilator sleeve 302 has been inserted into the introducer sleeve 306, and the first detent 352 on the dilator sleeve 302 has releasably engaged the protrusion 356 on the introducer sleeve 306 such that the dilator sleeve 306 is releasably locked within the introducer sleeve 306 at the first position previously described above in association with FIGS. 36-37B.
With reference next to FIG. 46, the dilator sleeve 302 has been inserted further into the introducer sleeve 306, and the second detent 354 on the dilator sleeve 302 has releasably engaged the protrusion 356 on the introducer sleeve 306 such that the dilator sleeve 306 is releasably locked within the introducer sleeve 306 at the second position previously described above in association with FIGS. 38 and 39.
As shown in FIGS. 47A-49, another embodiment of the introducer assembly 300 includes a dilator sleeve 302 with a latch 358 and an introducer sleeve 306 with a protrusion 360. With particular reference to FIG. 47A, the latch 358 includes a slot 362. Preferably, the protrusion 360 is part of one of the flanges 316 on the introducer sleeve 306. A space 364 between the two flanges 316 is sized to permit passage of the latch 358 therethrough. With reference to FIG. 47B, the latch 358 preferably is located on the stop flange 338 of the dilator sleeve 302, and is set off from the outer wall 332 of the dilator sleeve 302, defining a gap 366.
With reference to FIG. 48, the dilator sleeve 302 has been has been inserted into the introducer sleeve 306 to an extent where the stop flange 338 of the dilator sleeve 302 is disposed against the proximal end 310 of the introducer sleeve 306. Concurrently, the latch 358 has passed through the opening 362 between the flanges 316, and the gap 366 has accommodated the introducer sleeve 306. Accordingly, the distal portion 328 of the introducer sleeve 306 has been urged into the expanded opening, and the reduced diameter portion 320 of the introducer sleeve 306 has been urged into the expanded orientation.
With reference next to FIG. 49, the dilator sleeve 302 having been twisted in the direction of arrow 49 in FIG. 48, the slot 362 on the latch 358 engages the protrusion 360 on the introducer sleeve 306 such that dilator sleeve 302 is releasably locked within the introducer sleeve 306 at the second position previously described above in association with FIGS. 38 and 39. The dilator sleeve 302 can be released from the second position by twisting the dilator sleeve 302 in a direction opposite to arrow 49 in FIG. 48, thereby disengaging the slot 362 from the protrusion 360.
Although the present invention has been described in the context of a preferred embodiment, it is not intended to limit the invention to the embodiment described. Accordingly, modifications may be made to the disclosed embodiment without departing from the spirit and scope of the invention. For example, any of a variety of suitable locking system, or other latch mechanism, may be used. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments discussed herein may be made. Accordingly, various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the invention. In addition, although the illustrated device 300 is well suited for passing a cardiac harness delivery device through a minimally invasive procedure, the illustrated device 300, or alternative arrangements thereof, may also be used in an open chest procedure. Accordingly, the invention is intended to be defined only by the claims that follow.
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