METHODS AND DEVICES FOR TRANSXIPHOID ACCESS TO THE MAMMARY ARTERIES
20220354479 · 2022-11-10
Inventors
Cpc classification
A61B17/0469
HUMAN NECESSITIES
A61B1/04
HUMAN NECESSITIES
A61B17/0206
HUMAN NECESSITIES
A61B2017/0225
HUMAN NECESSITIES
A61B1/00135
HUMAN NECESSITIES
A61B17/3423
HUMAN NECESSITIES
A61B17/06061
HUMAN NECESSITIES
A61B1/3137
HUMAN NECESSITIES
A61B17/02
HUMAN NECESSITIES
A61B2017/0287
HUMAN NECESSITIES
A61B1/05
HUMAN NECESSITIES
International classification
A61B17/02
HUMAN NECESSITIES
A61B1/00
HUMAN NECESSITIES
A61B1/05
HUMAN NECESSITIES
Abstract
A trans-xiphoid procedure for gaining entry to the chest cavity of a patient, sometimes also referred to herein as a “TRAX” procedure. The procedure may be used for, among other things, mobilization of the mammary arteries and performing coronary artery bypass surgery in which the mammary artery of the patient or other conduit is joined to a coronary artery of the patient, such as the left anterior descending (LAD) coronary artery.
Claims
1. A suction device useful for separating the mammary arteries of a subject from the internal chest wall of the subject, comprising: an elongate shaft having a proximal end and a distal end configured for placement internally in a subject during use; a handle on the shaft proximal end; an aspiration fitting on the shaft proximal end; and a suction fitting on the shaft distal end, the suction fitting having a outwardly or convexly curved top surface portion and an inwardly or concavely curved bottom surface portion, an end terminal portion, and at least one distal suction opening in the end terminal portion, the suction opening in fluid communication with the aspiration fitting through the shaft.
2. The suction device of claim 1, wherein the elongate shaft is rigid or flexible.
3. The suction device of claim 2, wherein the at least one suction opening is an elongate continuous suction opening oriented substantially perpendicularly to the shaft.
4. The suction device of claim 1, wherein the at least one suction opening comprises a plurality of separate suction openings aligned along an arc, which arc is oriented substantially perpendicularly to the shaft.
5. The suction device of claim 1, wherein the suction fitting comprises: (i) a rigid inner body portion; and (ii) a resilient cushioning outer shell on the body portion.
6. The suction device of claim 1, further comprising a suction control opening formed in either the handle or in the shaft adjacent the handle, the suction control opening in fluid communication with both the aspiration fitting and the distal suction opening.
7. The suction device of claim 1, in sterile form sealed in a sterile package.
8. A suture retention device, comprising: a body having a top portion, a bottom portion, a width dimension, and a transverse channel formed in the top portion, the transverse channel extending the entire width dimension of the body; an adhesive member connected to the body bottom portion, with the channel extending therethrough; a suture retainer connected to the body and positioned within the transverse channel.
9. The retention device of claim 8, wherein the suture retainer comprises a coil, a comb, a viscous gel, or a gum.
10. The suture retention device of claim 8, the body having an opening formed therein, the opening extending from the top portion to the bottom portion, with the opening laterally aligned with and oriented substantially perpendicularly to the top channel with the opening substantially aligned with the center axis of the body.
11. The suture retention device of claim 8, further comprising a protective cover removably connected to the adhesive member.
12. The suture retention device of claim 10, wherein the transverse channel includes an outwardly flared segment opposite the suture retainer with the opening positioned therebetween to aid in guiding suture into the transverse channel and the suture retainer.
13. The suture retention device of claim 8, wherein the body is cylindrical or polygonal.
14. The suture retention device of claim 8, in sterile form sealed in a sterile package.
15. A mammary artery dissecting device, comprising: (a) an elongate shaft having a proximal end, a distal end, and a central opening formed therein, sand central opening configured to removably receive an endoscope for visualizing a mammary artery during dissection thereof; (b) a dissection tip connected to the distal end, the dissection tip including a transparent portion configured to form a visualization window therein through which a mammary artery may be visualized with an endoscope in the central opening; (c) at least one elongate cutting instrument and/or elongate cauterizing instrument axially aligned with and slideably connected to the elongate shaft, each instrument configured for slideably advancing the instrument out of the proximal end to facilitate cutting and/or cauterizing of tissues or vessels during dissection of a mammary artery, and then slideably retracting the instrument back into the proximal end when cauterizing or cutting is completed.
16. The dissecting device of claim 15, wherein the shaft is configured for rotation during dissection of a mammary artery to thereby position a cutting and/or cauterizing instrument away from the mammary artery during use.
17. The dissecting device of claim 15, wherein the dissecting tip is conical.
18. The dissecting device of claim 15, wherein the dissecting tip is formed from a single, visually transparent, material.
Description
DESCRIPTION OF THE FIGURES
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DETAILED DESCRIPTION
[0035] In this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a lumen” is intended to mean a single lumen or a combination of lumens, “a fluid” is intended to mean one or more fluids, or a mixture thereof.
1. Definitions
[0036] Subjects or patients on whom the invention may be carried out are, in general, mammalian subjects, particularly human subjects, but also including animal subjects (dogs, cats, horses, cattle, sheep, goats) for veterinary purposes. Subjects may be male or female and may be of any age, including neonate, infant, juvenile, adolescent, adult, and geriatric subjects.
[0037] “Proximal” and “distal” as used herein refer to direction closer to and away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would insert a device (e.g., an instrument of the present invention) into the patient, such that the distal end of the device is the end that is inserted inside a patient's body, while the end outside the patient's body would be the proximal end.
[0038] “Endoscope” as used herein is a small rigid or flexible tube with a light and lens that may be used to view an organ or body part via a cannula or a portal or a trocar.
[0039] “Epicardial surface” as used herein is the outer surface of the heart. The term epicardial surface is also used to refer to the innermost of the two layers of pericardium.
[0040] “Endocardium” as used herein is the membrane that lines the cavities of the heart and forms part of the heart valves—i.e., the innermost layer of the heart.
[0041] “Pericardial surface” as used herein is the outer surface of the pericardial sac. The pericardium is a double-walled sac that contains the heart and the roots of the great vessels.
[0042] “Pleural surface” as used herein is the outer surface of the lung (visceral pleura) and the inside of the chest wall (parietal pleura). The pleura is a thin membrane sac that covers the structures in the left and right thoracic cavities respectively.
[0043] 1. Overview of TRAX Procedure and TRAX Mammary Harvest
[0044] As noted above and schematically illustrated in
[0045] Once a sufficient segment of mammary artery is dissected free, that mammary artery is then joined to the coronary artery in need of bypass (such as the left anterior descending coronary artery of the subject) by conventional anastomosis techniques. To aid in positioning the heart for the anastomosis, a cushion elevator such as described below, and in
[0046] Exposure may be additionally aided by fastening a retention suture attached to the pericardium at various locations to a suture retainer device as described below, and in
[0047] Dissection of the mammary arteries may be additionally aided by using the mammary artery dissecting device described below, and in
[0048] During the procedure, the patient's lungs stay inflated when the pericardium or the pleural spaces are entered because the patient is under general endotracheal anesthesia with positive pressure lung ventilation. The pressure of the ventilator keeps the lungs inflated and, as long as there is no defect made in the surface of the lung, the lungs will remain inflated once the operation is complete. Because, in the procedures described herein, the procedures is performed over the diaphragm, not through the diaphragm, there is limited pulmonary compromise.
[0049] 2. Mammary Exposure Device.
[0050] As shown in
[0051] The exposure device is securely attached to the patient's bed as shown in
[0052] The body member 12 is configured for insertion of the distal end 16 into the chest cavity of a subject through the subject's upper abdomen and through or above the diaphragm into a position overlying the subject's heart and underlying the subject's sternum, with both the right and left mammary arteries of the subject positioned above and accessible by a surgeon through the access channel 22.
[0053] In some embodiments an endoscope tunnel (or other mounting member or scope holder) 24 is positioned on the top surface, and (for example) configured to house either a 5 or 10 mm or other size endoscope which can be variably positioned along the length of the mammary exposure device (e.g., configured for extending an endoscope from proximal to distal through the access channel, and into the patient) so that the mammary arteries can be optimally illuminated and visualized. In certain embodiments the endoscope tunnel is elevated from the bottom member on a narrow platform or pedestal.
[0054] In some embodiments, a mounting element 26, such as a body with an aperture for mounting the device 10 onto a bar or mounting structure as shown in
[0055] In some embodiments there may be one or a plurality of anchor elements 28 on the top surface of the channel (e.g., hooks, open or closed loops (optionally with toggle elements), etc., preferably configured in a non-entrapping manner to avoid snagging or catching of fingers, instruments or the like), to attach elastic mammary artery retractor bands (discussed below), to the mammary exposure device so that the mammary artery may be secured to the device by the stretchable bands with stretching resistance or retracting tension. In certain instances, stretchable or elastic bands may be attached to the sides of the device, or at anchor elements arranged in spaced apart variable locations on the top surface from proximal to distal, and/or at variable locations at the proximal portion of the device, to provide a variable resistance platform to retract the mammary artery for optimal visualization.
[0056] The mammary exposure device 10 is mounted to the bed to secure position for stability. It may have an independent arm for connection to the bed that has an incorporated member to lift the sternum or may be associated with an existing commercially available device that mounts to the bed and lifts the sternum.
[0057] 3. Elastic Mammary Artery Retractor Band.
[0058] As noted above, the systems and apparatus described herein may also utilize an elastic mammary artery retractor band 30 as shown in
[0059] As noted below, in some embodiments the end loop members are larger in size than the cross-members.
[0060] In some embodiments, the plurality of cross-members are uniformly sized and spaced from one another.
[0061] The retractor band may be integrally formed of an elastic polymer material (e.g., silicone, latex, etc.), and may be provided in sterile form sealed in a sterile package.
[0062] A non-limiting embodiment of such a retractor band is shown in
[0063] 4. Suction Device.
[0064] Non-limiting examples of a suction device 40 useful for carrying out a TRAX procedure are given in
[0065] The suction fitting 50 may have an outwardly or convexly curved top surface portion 52, and/or an inwardly or concavely curved bottom surface portion 54. The suction fitting 50 includes an end terminal portion 56 with at least one distal suction opening 58 formed therein, with the suction opening in fluid communication with the aspiration fitting through the shaft 42.
[0066] In use, as a mammary artery is dissected from the sternum through the shaft the suction device may be inserted between the sternum and the freed mammary artery, and progressively advanced along the sternum. The convex top surface serves as a bumper against the sternum, and the concave bottom surface serves to guide and capture the freed mammary artery during dissection.
[0067] The shaft may be rigid, or may be flexible and resilient, depending upon the choice of the operator. As such, the shaft may be formed of any suitable material, including stainless steel and flexible polymers.
[0068] In the illustrated embodiment, as best shown in
[0069] In some embodiments, the suction fitting includes: (i) a substantially rigid inner body portion (e.g., formed of a polymer material), and (ii) a resilient cushioning outer shell on the body portion. The outer shell may be formed of any suitable material, typically a cushioning polymer, and may be formed by any suitable technique, such as by overmolded on the (more rigid) inner body portion.
[0070] For the convenience of the operator, a suction control opening can be formed in either the handle or in the shaft adjacent the handle, with the suction control opening in fluid communication with both the fitting and the distal suction opening. By the operator alternately covering or uncovering the opening with a finger, the suction opening may be active of inactive (e.g., the vacuum bypassed through the control opening), so that the operator may modulate the vacuum force through the suction opening.
[0071] The suction device may be sterilized and sealed in a sterile package to provide the device in pre-packaged form ready for use.
[0072] 5. Cushion Elevator.
[0073] Non-limiting examples of a cushion elevator 80 useful for carrying out a TRAX procedure are given in
[0074] The device may include an external fluid supply (not shown) such as a syringe or bulb) operatively associated with the proximal end of each the inflation line. Where multiple chambers are included, each chamber may be provided with a dedicated fluid supply, or a single fluid supply with associated valve may be included.
[0075] The fluid supply or supplies may be removably connected to the inflation lines, or permanently affixed thereto. Where permanently affixed, the fluid supply (e.g., the syringes) may be pre-loaded with an amount of fluid matched to and appropriate for the expansion chamber with which they are associated. Also, when permanently affixed, the fluid supply may include a label, color code, or other identifier for the chamber with which they are associated (which identifier may alternatively be on the inflation line).
[0076] The cushion itself may be symmetric in shape, or may be asymmetric, with the asymmetry of the cushion matching the asymmetry of the dorsal surface of the typical patient's heart.
[0077] While, in the illustrated embodiments, two chambers are shown, it will be appreciated that additional chambers may be included. In addition, the chambers may be symmetric (as in
[0078] In general, the cushion 82 is formed of at least one elastic polymer. The inflation lines are also formed of a flexible polymer, though in some embodiments a different polymer less susceptible to inflation. The cushion itself may be formed of multiple different polymers, as indicated in
[0079] As with the suction device, the cushion elevator device may be sterilized and sealed in a sterile package to provide the device in pre-packaged form ready for use.
[0080] 6. Suture Retainer Device.
[0081] Non-limiting examples of a suture retainer device 120 useful for, among other things, carrying out a TRAX procedure are given in
[0082] In some embodiments, and as illustrated the transverse channel 128 includes an outwardly flared segment opposite the suture retainer (e.g., with the opening positioned therebetween) to aid in guiding suture into the transverse channel and the suture retainer.
[0083] Also, in some embodiments, and as illustrated, the body 122 has an opening formed therein, the opening extending from the top portion to the bottom portion, with the opening laterally aligned with and oriented substantially perpendicularly to the top transverse channel (e.g., with the opening substantially aligned with the center axis of the body). In some embodiments, the suture retainer is configured to partially overlaps or partially occludes the opening, so that, when suture is passed through the opening (as may be done in some but not all uses of the device), the suture may more easily engage the retainer.
[0084] In the illustrated embodiment, the suture retainer 132 is a coiled wire, but any suitable suture retainer may be used, including but not limited to combs, viscous gels, gums, etc. Also, while the illustrated embodiment is cylindrical or round in shape (when viewed from the top), it may be configured with any suitable cross-section, including oval and polygonal (e.g., square, hexagonal, octagonal, etc.). The suture retainers may optionally be provided in sets of multiple retainers, each with a different cross-section, to provide tactile identification associated with different sutures drawn therethrough.
[0085] A protective cover or sheet may be removably connected to the adhesive member, for removal just prior to use, to help preserve the adhesive properties of the adhesive member.
[0086] As with the suction device and the cushion elevator device, the suture retainer device may be sterilized and sealed in a sterile package to provide the device in pre-packaged form ready for use.
[0087] 7. Mammary Dissecting Device
[0088] Non-limiting examples of a mammary dissecting device 150 useful for carrying out a TRAX procedure are given in
[0089] In use, the dissecting tip is positioned between the mammary artery and the surrounding fascia and/or chest wall and, as the mammary dissecting device is advanced from proximal to distal (from external to internal) the graduated size of the tip expands the space between the mammary artery and the surrounding fascia and/or chest wall under endoscopic visualization.
[0090] The device (including shaft and tip) may be of any suitable length, but typically will be no longer than 18 inches (50 cm) and no shorter than 6 inches (15 cm) for mammary harvest.
[0091] The dissecting device may have a clamp, securement screw, sleeve, spring, or other attachment mechanism connected to the proximal (external) end of the shaft to secure the endoscope in place and limit motion of the endoscope during mammary dissection.
[0092] In use, as a mammary artery dissection device is freely rotated and advanced to separate the mammary artery from surrounding attachments. While dissecting the mammary artery from the sternum with the device, fascia surrounding the mammary artery may be encountered. These fascial attachments can be divided using the incorporated instrument, such as a knife or cautery device 170 (preferably contained in a second instrument lumen or elongate opening, which instrument lumen or opening is separate from the central opening that carries the endoscope) by advancing and retracting the knife or cautery device under endoscopic vision. The mammary artery is protected during fascia division by rotating the mammary dissecting device to position the mammary artery away from the knife or cautery device (for example, rotating 180° away). The dissecting device thus facilitates safe separation of the mammary artery from the knife and/or cautery. During mammary artery dissection using the mammary dissecting device, branches of the mammary artery may be encountered. These branches may be liberated for a safe distance from their mammary artery origin with the dissecting device to then be safely cauterized in a position away from (e.g. 180° away from) the mammary artery, under endoscopic visualization.
[0093] The shaft of the mammary dissecting device may be rigid, or may be flexible and resilient, depending upon the choice of the operator. As such, the shaft may be formed of any suitable material, including stainless steel and flexible polymers.
[0094] In the non-limiting illustrated embodiment, as shown in
[0095] The foregoing is illustrative of the present invention, and is not to be construed as limiting thereof. The invention is defined by the following claims, with equivalents of the claims to be included therein.