Pericardium management tool for intra-pericardial surgical procedures
Tools for managing the pericardium during intra-pericardial procedures such as the delivery of cardiac support devices. One embodiment of the tool includes a tubular body of low friction material having a diameter, a fixed lip on an exterior end and an extendable lip on an interior end. The extendable lip moves with respect to the body between a retracted state and an expanded state. The tool is inserted through an incision in the pericardium and deployed by moving the lip to the expanded state. When deployed a barrier portion of the body engages the edges of the incision and the extendable lip lines the inside of the pericardium around the incision.
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The invention is a device for manipulating the pericardium during surgical or other procedures requiring access to the pericardial space.
BACKGROUND OF THE INVENTIONThe pericardium is a multi-layer membranous fibro serous sac that surrounds the heart. An inner layer of the pericardium, known as the serous pericardium, is adjacent to the outer layer of the heart, also known as the epicardium. An outer layer of the pericardium is known as the fibrous pericardium. Between the fibrous pericardium and serous pericardium is a space known as the pericardial space. The term “pericardium” is often used, however, to refer only to the fibrous pericardium. Similarly, the term “pericardial space” is often used to refer generally to the space between the fibrous pericardium and the heart.
Certain surgical or other procedures on the heart require access to the pericardial space through the pericardium. Known approaches for accessing the pericardium and heart from outside the body include sternotomy and sub-xyphoid approaches. One such surgical procedure that requires access to the pericardial space is the delivery of cardiac support devices. Cardiac support devices are structures, sometimes referred to as jackets, that surround all or portions of a diseased heart. These devices are intended to treat chronic heart failure or other cardiac disease, which may be associated valvular dysfunction, by constraining expansion of the heart. They can be delivered and implanted using conventional cardiothoracic surgical techniques or minimally invasive surgical procedures. Devices of these types and associated delivery tools and methods are shown, for example, in the following U.S. patents, all of which are incorporated herein by reference in their entirety.
Tools and methods for accessing the pericardial space and for introducing other instruments and therapeutic devices such as cardiac support devices into that space are also known. Examples of tools and methods of these types are shown in the following U.S. patents and published applications, all of which are incorporated herein by reference in their entirety.
Cardiac support devices of the type described above are typically delivered through an incision in the pericardium near the apex of the heart. Visualizing the heart and mounting the devices through the incision can involve moving the incision and manipulating the pericardium. In the course of these procedures the pericardium can sometimes interfere with the delivery of the device.
There is, therefore, a continuing need for improved devices and methods for managing the pericardium during intra-pericardial procedures. Devices and methods that can enhance cardiac support device delivery procedures would be especially desirable.
SUMMARY OF THE INVENTIONThe present invention is an improved device for managing a patient's pericardium during intra-pericardial procedures. The efficiency of procedures such as the delivery of cardiac support devices can be greatly enhanced by the device.
One embodiment of the invention is a tool including a tubular body having a diameter and first and second ends. A lip on one or both of the first and second ends of the body is extendable with respect to the body between a retracted state and an expanded state. In the expanded state the lip extends from and has a diameter greater than the diameter of the body. In some embodiments the body and lip are formed from a single piece of flexible and lubricious material. Other embodiments of the tool are formed from a plurality of strips of lubricious material.
In the embodiment shown in
In the embodiment of pericardium management tool 10 shown in
The extendable lip 22 is moved between its retracted and expanded states in this embodiment by a flexible elongated element such as wire 24 that is inserted into and withdrawn from a tubular pocket 26 in the internal end 16 of the body 12. Pocket 26 can be formed by folding and hemming the fabric on the end 16 of the body 12. By forcing the wire 24 in a direction generally parallel to its length into the pocket 26 through a hole (not shown), the wire is be formed into a hoop of increasing circumference and diameter that stretches the fabric of the body 12 to expand the lip 22. The lip 22 is retracted by withdrawing the wire 24 from the pocket 26.
The expansion of lip 22 can then be initiated by forcing the wire 24 into the pocket 26 as shown in
Tool 10 can be efficiently inserted and deployed. The deployed tool 10 surrounds the incision 34 in the pericardium 30 and provides a low-friction access port to the pericardial space 36. Since the edges of the pericardium 30 at the incision 34 are covered and protected, they will not interfere with surgical or other procedures being performed through the deployed tool 10. The deployed tool 10 also engages the pericardium 30 around the incision 34 to such a degree that the tool can be manipulated to lift, shift or otherwise move the location of the barrier portion 18, and therefore the access port, as desired during the surgical procedure. The surgeon can thereby effectively enhance his or her visualization of and access to the pericardial space 36 without interference from the edges of the pericardium 30. The characteristics of the tool 10 also enable the device to continually resize and conform to changes in the shape or size of the incision 34 that might be caused during the surgical procedure.
Upon completion of the surgical or other procedure the tool 10 can be removed from the incision 34. This removal can be facilitated by returning the lip 22 on the internal end 16 to its retracted state (e.g., by withdrawing the wire 24). The above described advantages of the tool 10 are thereby achieved by a device that can be efficiently removed following the completion of the procedure.
Pericardial management tools in accordance with the invention and having features and advantages such as those described above in connection with tool 10 can take other forms. By way of example, and not shown, in other embodiments of the invention the barrier portion 18 and lip 20 on external end 14 can be formed of rigid materials such as polymers. The lip 20 on the external end 14 need not be fixed, but instead can have structures such as those of the lip 22 on the internal end 16 that can be moved between retracted and expanded states. The extendable lip 22 can also be formed from different materials, including rigid materials, and different structures and methods can be used to move the lip between its retracted and expanded states. In still other embodiments, the tool includes a low friction material coating (e.g., in solid or liquid form) on the interior surfaces of the body 12 or at least on the barrier portion 18. The entire tool 10, or just portions, can be constructed from any suitable material such as, for example, fabrics, metals, polymers or biologic materials. The exterior surface of the tool 10 near the lips 20 and/or 22 can also include adhesive elements or coatings, or other tissue-engaging structures or material, that will facilitate the attachment of the lips to the adjacent tissue when the device is deployed. Although the tubular body 12 has a circular cross section in the illustrated embodiment, other embodiments (not shown) have other cross sectional shapes.
The body 112 of tool 110 is then expanded within the pericardial space 136 by radially extending the free ends of the material strips 172 in a fanned arrangement under the pericardium 130. The portions of the material strips 172 on the internal end 116 of the body 112 are thereby expanded in diameter and circumference with respect to the diameter and circumference of a barrier portion 118 that engages the edges of the pericardium 130 at the incision 134. These steps can be done by hand (e.g., by the surgeon using his or her fingers to tuck the material strips 172 under the pericardium 130) or with the assistance of instruments. The portions of the material strips 172 on the ends 116 of the body 112 form a lip 122 under the pericardium 130. This expansion operation continues until the lip 122 is in its expanded state shown in
As perhaps best shown in
The lip 122 extends beyond and around the edges of the incision 134 and forces the material strips 172 to be positioned on or adjacent to the interior surfaces of the pericardium 130 around the incision, thereby lining the pericardium around the incision. When deployed, the illustrated embodiment of tool 110 has gaps in the lip 122 between the material strips 172. However substantial portions of the pericardium 130 around the incision 134 are still lined by the lip 122 (e.g., sufficient portions to reduce or prevent the pericardium from interfering with the surgical procedure). Following this deployment operation the external lip 120 will typically be located on or at least adjacent to the external surface of the patient's skin 131, with the material of strips 172 at the lip 120 and body 112 extending beyond and around the opening over the external surface of the skin.
Pericardium management tool 110 can be efficiently inserted and deployed to surround the incision and provide a low-friction access port to the pericardial space 136.
Pericardium management tools in accordance with the invention having features and advantages such as those described above in connection with tool 110 can take other forms. By way of example, and not shown, in other embodiments if the invention the portions of the strips 172 (e.g., flexible members) that are positioned on the outside and/or the inside of the pericardium 130 can be formed of rigid material, and the portions of the strips forming the barrier portion 118 can be formed of flexible material or have hinge structures that enable the ends to be fanned out within the pericardial space 136. Malleable metals or other material or structures can be added to the material strips 172 at the barrier portion 118 to cause the strips to retain their expanded state positions. The strips need not be formed of low friction material, but can instead be formed of other materials and have a coating of low friction material on at least those portions forming the interior surface of barrier portion 118. The material strips 172 can also be curved or otherwise shaped to reduce or eliminate the size of the gaps between the strips at the lips 120 and/or 122 when the tool 110 is deployed. Adhesive or other structures (e.g., hook and loop fasteners) on the material strips (e.g., on the edges) can be used to secure the strips to one another. Other features of the tool 10 described above can also be incorporated into tool 110.
A retractor 200 in accordance with another embodiment of the invention is shown in
Blades 204 each have an upright wall portion 210 and a lip 212 extending from the wall portion. Wall portions 210 have a convex surface in the embodiment shown. Similarly, in the embodiment shown the lips 212 have a convex outer edge. In other embodiments of the invention the wall portions 210 and the outer edges of the lips 212 have other shapes (e.g., are flat or straight).
Handle 202 is an elongated member in the embodiment shown and has a proximal end 214 and a distal end 216. One of the blades 204 (i.e., a fixed blade) is mounted to the distal end 216 of the handle 202 with the lip 212 facing the proximal end 214. An elongated member such as shaft 215 can mount the fixed blade 204 to the handle 202. Actuating member 208 includes a U-shaped arm 217 with a proximal end 218 movably mounted to the handle 202 and a distal end 220 mounted to the other blade 204 (i.e., the movable blade). The blade 204 is mounted to the distal end 220 of arm 217 with the lip 212 of the blade facing away from the distal end 216 of the handle 202. In the embodiment shown, the proximal end 218 of arm 217 is slidably mounted to a slot 222 in the handle 202 by an a slide 224.
The operation of retractor 200 can be described with reference to
Retractor 200 can be efficiently operated. The retractor 200 provides functions and advantages that are the same or similar to those described above in connection with tool 10. Retractor 200 can be used alone to access the pericardial space 236. Alternatively, tools such as 10 and 110 described above can be used in connection with the retractor 200 by inserting them into the opening created by the retractor.
Tool 410 is deployed by inserting the material strips 472 individually into an incision 434 in the pericardium 430. Internal ends 416 are then tucked under the internal surface of the pericardium 430, and the external ends 414 are bent over the outside of the pericardium 430 or body. Adjacent side edges 475 of the material strips 472 can be joined together. In the embodiment shown in
Pericardium management tool 410 can be efficiently inserted and deployed to surround the incision 434 and provide a low-friction access port to the pericardial space 436. The tool 410 can be removed from the incision 434 following the completion of the intra-pericardial procedure by pulling the body 412 out of the incision. The functions and advantages provided by pericardial management tool 410 are the same or similar to those of tools 10 and 110 described above.
Pericardium management tools in accordance with the invention having features and advantages such as those described above in connection with tool 410 can take other forms. By way of example,
Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention. For example, although not shown, tools and methods in accordance with the invention can be incorporated into delivery tools for cardiac support devices.
Claims
1. A tool for managing a patient's pericardium during an intra-pericardial procedure, including:
- a tubular body having a diameter and first and second ends;
- a lip on one or both of the first and second ends of the body, the lip extendable with respect to the body between a retracted state and an expanded state to form a lip extending from and having a diameter greater than the diameter of the body.
2. The tool of claim 1 and further including an actuating member attached to the lip for extending the lip between the retracted and expanded states.
3. The tool of claim 2 wherein the actuating member is a hand-actuated member.
4. The tool of claim 2 wherein the actuating member includes an elongated wire member attached to the lip and forming a hoop that is movable between a first diameter state and a second, enlarged diameter state, for moving the lip between the retracted and expanded states.
5. The tool of claim 4 wherein the actuating member causes the elongated wire to move in a generally lengthwise direction to move the hoop between the first and second diameter states.
6. The tool of claim 5 wherein the body and lip include flexible material, and wherein the elongated wire is attached to the flexible material at the lip.
7. The tool of claim 1 wherein the body and lip include flexible material.
8. The tool of claim 7 wherein the flexible material includes a plurality of strips of material.
9. The tool of claim 8 wherein portions of the strips of material overlap at a barrier portion when the lip is in the expanded state.
10. The tool of claim 8 wherein portions of the strips of material that form the body are positioned adjacent to one another at a barrier portion when the lip is in the expanded state.
11. The tool of claim 10 wherein portions of the strips of material that form the lip fan out from the portions forming the body.
12. The tool of claim 11 and further including a hoop on the ends of the strips of material for fanning the portions of the strips of material.
13. The tool of claim 12 wherein the lip formed by the hoop and fanned portions of the strips is an external end of the tool.
14. The tool of claim 13 and including a second lip on an internal end of the tool.
15. The tool of claim 7 wherein the body and lip include a single flexible piece of material.
16. The tool of claim 1 wherein the body and lip are formed of flexible material.
17. The tool of claim 16 wherein the body and lip are formed of elastic material.
18. The tool of claim 1 wherein the body has a relatively low friction interior surface.
19. The tool of claim 1 wherein the body and lip are formed of relatively low friction material.
20. The tool of claim 18 wherein the body and lip are formed of fluorinated polymer.
21. The tool of claim 1 wherein the body includes a plurality of strips of material having adjacent side edges.
22. The tool of claim 21 wherein the strips of material include engagement structure for engaging adjacent strips of material.
23. The tool of clam 22 wherein the engagement structure includes adhesive.
24. The tool of claim 21 wherein the strips of material have non-linear side edges.
25. The tool of claim 24 wherein the strips of material have concave side edges.
26. The tool of claim 21 wherein the strips of material have at least portions that are flexible
27. The tool of claim 1 wherein the body includes a polymer member having a lubricious coating.
28. A retractor for managing a patient's pericardium through an incision in the pericardium to provide access to a pericardial space, including:
- a pair of blades, each having an wall portion for engaging an edge of the pericardium and a lip extending from the wall for engaging the pericardium within the pericardial space; and
- an actuating mechanism connected to the blades, for moving the blades between a closed position for insertion into the pericardial space through the incision and an open position into engagement with the pericardium to create an opening into the pericardial space.
29. The retractor of claim 28 wherein the wall portions of the blade have a convex surface for engaging the edge of the pericardium.
30. The retractor of claim 28 wherein the lips have a convex edge.
31. The retractor of claim 28 wherein:
- the wall portions of the blade have a convex surface for engaging the edge of the pericardium; and
- the lips have a convex edge.
32. The retractor of claim 28 wherein the actuating mechanism includes a pair of handles pivotally connected to one another.
33. The retractor of claim 28 wherein the actuating mechanism includes:
- a handle, wherein one of the blades is fixedly mounted to the handle; and
- an actuating member movably mounted to the handle, wherein another of the blades is mounted to the actuating mechanism.
34. A kit for forming a tool to manage a patient's pericardium during intra-pericardial procedures, including a plurality of flexible, lubricious elements that can be inserted into an incision in the pericardium, spaced around an edge of the opening and extended under the pericardium to line the pericardium around the incision.
35. The kit of claim 34 wherein the elements are strips of flexible material.
36. The kit of claim 34 wherein the elements include structures for attaching adjacent elements to one another.
Type: Application
Filed: May 19, 2006
Publication Date: Nov 22, 2007
Applicant: Acorn Cardiovascular, Inc. (St. Paul, MN)
Inventors: Paul Andrew Pignato (Stacy, MN), Aaron J. Hjelle (Champlin, MN), Robert G. Walsh (Lakeville, MN), Richard C. Mattison (Zimmerman, MN)
Application Number: 11/437,838
International Classification: A61B 1/32 (20060101);