Abstract:
The inventions disclosed herein relate to systems for securing medical devices to a blood vessel of a patient, including securing a vessel deforming component to a blood vessel. Certain embodiments relate to wraps configured to be secured around a blood vessel, including wraps configured to hold a vessel deformer adjacent a blood vessel, and further including, for example, a pulsatile balloon adjacent the aorta.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application 61/989,280, filed May 6, 2014 and entitled “Wrap and Related Systems and Methods, which is hereby incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The various embodiments disclosed herein relate to heart assist devices and systems, and more specifically to a wrap configured to be secured around a blood vessel. Specific embodiments include wraps configured to hold a vessel deformer adjacent an arterial vessel, including, for example, a pulsatile balloon adjacent the aorta. 
     BACKGROUND OF THE INVENTION 
     Certain mechanical heart assist device systems include vessel deforming components in the form of inflatable balloons or chambers which form part of implantable counter-pulsation heart assist devices. In certain specific embodiments, the vessel deforming components are cyclically inflated and deflated and used to compress the patient&#39;s ascending aorta during diastole and release the compression during systole, thereby assisting with pushing blood to the patient&#39;s body. 
     The balloon or chamber are generally secured to the aorta (or other blood vessel) by a substantially flexible, non-elastic, non-distensible wrap or sheath, which is secured around a section of the aorta with the balloon or chamber therebetween. For the heart assist device to function efficiently, it is necessary that the wrap be a snug fit around the aorta when the balloon or chamber is deflated. 
     In use, the securing of the balloon to the aorta with the wrap can be awkward or difficult. That is, it can be difficult to position a wrap around the aorta during surgery for various reasons, including the fact that wrap is made of a flexible material that is not easily directed around and between various organs and vessels in the chest cavity. An additional complication can arise based on the size of the patient&#39;s aorta—the variance in aorta size depending on the patient can result in a situation in which the wrap is not the optimal size for securing the vessel deforming component to the aorta. Further, another difficulty relates to affixing the fastening components to the wrap. Attempting to hold the wrap in position around the aorta while securing the wrap in that position in a permanent fashion can be very difficult to accomplish with two hands. 
     There is a need in the art for an improved wrap and improved methods of securing that wrap to the target vessel. 
     BRIEF SUMMARY OF THE INVENTION 
     Discussed herein are various systems for coupling a vessel deforming component to a blood vessel, including specific wrap embodiments for use in those systems. 
     In Example 1, a system for coupling a vessel deforming component to a blood vessel comprises a wrap and a vessel deforming component operably coupled to the wrap. The wrap comprises a body, size markings disposed on the body, and a plurality of pairs of sutures extending from a proximal end of the body, wherein each of the sutures comprises a needle disposed at a distal end of the suture. 
     Example 2 relates to the system according to Example 1, further comprising a suture carrier comprising an elongate body, a plurality of foldable sections defined in the elongate body, at least one engagement structure associated with each foldable section, and insertion markings disposed on at least one of the foldable sections. Each of the at least one engagement structures is removably coupleable with the needle of one of the sutures of the plurality of pairs of sutures. The insertion markings are configured to indicate insertion positions of the plurality of pairs of sutures. 
     Example 3 relates to the system according to Example 1, wherein each pair comprises a color that is different from either adjacent pair of sutures. Example 4 relates to the system according to Example 1, wherein the body comprises non-traumatic outer edges. 
     Example 5 relates to the system according to Example 4, wherein the non-traumatic edges comprise a coated polymer, a coated elastomer, or a soft, stretchable fabric. 
     Example 6 relates to the system according to Example 1, wherein the wrap further comprises a lead member coupled to a distal end of the body. 
     In Example 7, a system for coupling a vessel deforming component to a blood vessel comprises a wrap and a suture carrier comprising an elongate structure. The wrap comprises a body, size markings disposed on the body, and a plurality of sutures extending from a proximal end of the body. The elongate structure comprises a plurality of foldable sections, wherein each of the foldable sections comprises at least one engagement structure. 
     Example 8 relates to the system according to Example 7, wherein the plurality of sutures are arranged in a plurality of pairs, wherein each suture comprises a needle disposed at a distal end of the suture. 
     Example 9 relates to the system according to Example 8, wherein each pair comprises a color that is different from either adjacent pair of sutures. 
     Example 10 relates to the system according to Example 7, wherein at least one of the foldable sections comprises insertion markings configured to indicate a sequential order of insertion of the plurality of sutures. 
     Example 11 relates to the system according to Example 7, wherein the body comprises non-traumatic outer edges. 
     Example 12 relates to the system according to Example 11, wherein the non-traumatic edges comprise a coated polymer, a coated elastomer, or a soft, stretchable fabric. 
     Example 13 relates to the system according to Example 7, wherein the wrap further comprises a lead member coupled to a distal end of the body. 
     Example 14 relates to the system according to Example 7, further comprising a vessel deforming component operably coupled to the wrap. 
     In Example 15, a method of coupling a vessel deforming component to a blood vessel comprises positioning a lead member behind an aorta of a patient, urging the lead member distally around the aorta such that the wrap is positioned around the aorta, sequentially removing sutures of the plurality of sutures from engagement structures in a suture carrier and sequentially inserting the sutures into a desired location on the size markings, and tightening the sutures. The lead member is operably coupled to a distal end of a wrap. The wrap comprises a body, size markings disposed on the body, and a plurality of sutures extending from a proximal end of the body. 
     Example 16 relates to the method according to Example 15, further comprising removing the lead member from the wrap after urging the lead member distally around the aorta. 
     Example 17 relates to the method according to Example 15, further comprising folding the body of the wrap to narrow a width of the body prior to urging the lead member distally around the aorta and then unfolding the body of the wrap after urging the lead member distally around the aorta. 
     Example 18 relates to the method according to Example 15, further comprising opening the suture carrier and separating at least one foldable section from the suture carrier prior to sequentially removing sutures. 
     Example 19 relates to the method according to Example 15, further comprising cutting excess length of the sutures and excess portions of the body after tightening the sutures. 
     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a front view of a wrap, according to one embodiment. 
         FIG. 1B  is a perspective view of the wrap of  FIG. 1A . 
         FIG. 1C  is an expanded view of the markings of the wrap of  FIG. 1A . 
         FIG. 2A  is a front view of a wrap with a suture carrier, according to one embodiment. 
         FIG. 2B  is a front view of the wrap of  FIG. 2A . 
         FIG. 2C  is an expanded view of the suture carrier of the wrap of  FIG. 2A . 
         FIG. 3  is a front view of another wrap, according to a further embodiment. 
         FIG. 4  is a perspective view of a step of a method of attaching a wrap to an aorta, according to one embodiment. 
         FIG. 5  is a perspective view of another step of a method of attaching a wrap to an aorta, according to one embodiment. 
         FIG. 6  is a perspective view of a further step of a method of attaching a wrap to an aorta, according to one embodiment. 
         FIG. 7  is a perspective view of a wrap attached to an aorta, according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     The various embodiments disclosed herein relate to improved wraps and improved methods of using such improved wraps to secure a vessel deforming component to or against a patient&#39;s blood vessel.  FIGS. 1A, 1B, and 1C  depict a wrap  10  according to one embodiment having a first end  12  and a second end  14 . As best shown in  FIG. 1A , this wrap  10  has sutures  16  fixedly attached to the wrap  10  near the second end  14 . Further, the wrap  10  has size markings  18  on the wrap  10  near the first end  12 . 
     The sutures  16  in this particular embodiment are arranged in suture pairs as best shown in  FIG. 1A , with the proximal end  20  of each suture being fixedly attached to the wrap  10  and the distal end  22  having a needle  24  affixed thereto. Alternatively, the sutures  16  need not be arranged in pairs and can have any known configuration. According to another embodiment, both threads of each pair of sutures  16  are the same color, but each pair has a different color from the adjacent pairs on both sides. In a specific example, there are two suture  16  colors that alternate across the suture  16  pairs such that if a first pair is the first color, then the second pair is the second color and the third pair is the first color, etc. For example, the two suture  16  colors are green and white, according to one embodiment. Alternatively, the two suture  16  colors can be any two different colors. In a further alternative, there are three or more different colors that alternate across the suture  16  pairs. 
     The size markings  18  are depicted in further detail in  FIG. 1C , according to one implementation. The markings  18  are provided to indicate the possible attachment points for the sutures  16 , depending on the size of the aorta (or other vessel) around which the wrap  10  is intended to be positioned. That is, the markings  18  are configured to provide for at least two different sets of indicia that mark attachment points for the sutures  16 , thereby providing for two different wrap  10  circumferences when the wrap  10  has been secured to the aorta. Alternatively, the markings  18  on the wrap  10  embodiments contemplated herein can have any number of different sets of indicia (described in further detail below), thereby providing for a wrap  10  that can fit around and be secured to vessels of any number of different sizes. 
     As best shown in  FIG. 1C , the markings  18  in this exemplary implementation provide for six different sizes, as shown by the six different numbers  40  (the actual numbers being  106  through  121 ) and associated indicia discussed below. Alternatively, That is, each number  40  and associated indicia represents a different set of attachment points for the sutures  16  and thus a different size for the wrap  10 . For example, the number  106  identifies the set of indicia that constitute the attachment points for the smallest circumference of this wrap  10 . The markings for  106  represent nine indicia: a first indicia  42 A (in this case, a box), a second indicia  42 B (in this case, a dot), a third indicia  42 C, a fourth indicia  42 D (in this case, another dot), a fifth indicia  42 E (in this case, an X-like object), a sixth indicia  42 F (in this case, another dot), a seventh indicia  42 G, an eighth indicia  42 H (in this case, a dot), and a ninth indicia  42 I (in this case, a box). The indicia  42 A- 42 I, in some embodiments, identify the set of points or locations where the various sutures  16  can be inserted through the wrap  10  to achieve the desired circumference for the wrap  10  when it is fully secured to the blood vessel using the sutures  16 . It is understood that, as shown in  FIG. 1C , equivalent indicia are provided for each of the other numbers  40  as well. 
     In this specific implementation, the nine indicia  42 A- 42 I are shapes that are intended to be attachment points, with each shape  42 A- 42 I being an attachment point for a pair of sutures  16 . More specifically, one of the two sutures  16  is inserted along one side of the shape (any one of the shapes  42 A- 42 I) and the other of the two sutures  16  in the pari is inserted along the other side. Alternatively, the attachment points can be represented by any type of shapes or other indicia that indicates whether the sutures  16  should be inserted through the wrap  10 . It is also understood that the number of indicia can vary in amount based on the number of sutures  16  to be inserted through the wrap  10 . 
     For purposes of this implementation, the larger the aorta, the greater the number  40  (and thus set of attachment points) that is chosen. Thus, if the aorta is smaller, the number  40  chosen might be  106 ,  109 , or  112 , while if the aorta is larger, then a larger number  40  will be chosen. 
     In one embodiment, the numbers  40  indicate the actual circumference of the wrap  10  when the sutures  16  are attached at that particular number  40 . For example, in the specific embodiment depicted in  FIG. 1C , the numbers  40  represent the circumference of the wrap  10  in millimeters, with the smallest size being 106 millimeters and the largest size being 121 millimeters. 
     According to one embodiment, a set of wraps (such as wrap  10 ) of different sizes can be provided. For example, in one specific implementation, a set of three wraps is provided, with the first wrap having six sizes (sets of attachment points), ranging from 91 to 106 mm, the second wrap having six sizes ranging from 106 to 121 mm, and the third wrap having six sizes ranging from 118 to 133 mm. Alternatively, the set of wraps can have any number of wraps with any number of size ranges to encompass any target blood vessel size. 
       FIGS. 2A, 2B, and 2C  depict a second embodiment of a wrap  60 . This wrap  60  has a first end  62  and a second end  64 , with sutures  66  fixedly attached to the wrap  60  near the second end  64  and size markings  68  on the wrap  10  near the first end  62 . 
     In this implementation, the wrap  60  also has a suture carrier  70 . In  FIG. 2A , the suture carrier  70  is shown in its collapsed or closed configuration, while in  FIGS. 2B and 2C , the carrier  70  is shown in its expanded or open configuration. The carrier  70  is a foldable (or collapsible) elongate structure  70  made up of foldable sections  72 . In one embodiment, the carrier  70  has the same number of foldable sections  72  as there are suture pairs. Further, the foldable sections  72  are joined to each other along foldable joints that are perforated (or otherwise easily separable) such that any combination of sections  72  can be removed from the carrier  70  to allow for easy and flexible placement during procedures and further to prevent tangling. Each foldable section  72  has two engagement structures  74 A,  74 B operably coupled to the section  72 . Each of the engagement structures  74 A,  74 B is intended to receive and retain one of the needles (not shown) of one of the sutures  66 . That is, each needle (not shown) of each suture  68  is inserted into an engagement structure  74 A,  74 B to retain the needle (not shown) in the engagement structure  74 A,  74 B. In one embodiment, the two engagement structures  74 A,  74 B are intended to receive one of the suture pairs, such that each foldable section  72  is configured to receive one of the pairs of sutures  66 , with one of the sutures  66  being inserted into one of the engagement structures  74 A and the other of the sutures  66  being inserted into the other structure  74 B. 
     In one implementation, the foldable sections  72  can have printed text on each section  72  that indicates the sequential order of the suture pairs  66  attached or inserted through each section. This text can help to prevent tangling and guide correct installation order. In a further embodiment, printed text or some type of markings can be provided on certain sections  72  that represents or indicates the intended or target location on the wrap  60  that each suture pair would ideally or preferably be inserted, thereby helping to guide installation. For example, the text or markings can indicate that the pair of sutures  66  should be inserted at a location in the middle of the wrap  60 , towards the root of the aorta, or towards the arch of the aorta. 
     In specific examples, the foldable sections  72  can be made of papers (such as, for example, bleached chemical thermo-mechanical pulp (“BCTMP”)), plastics (such as, for example, JPP synthetic—a white mat biaxially oriented polypropylene sheet), or polyethylene sheets. Alternatively, the sections  72  can be made of any known cardboard-like material. The engagement structures  74 A,  74 B can be made of a foam (such as HT-513228 polyethylene foam), plastics, polyurethanes, silicones, or any other known material configured to receive and retain a needle. 
     In one implementation, the various wrap embodiments disclosed and contemplated herein can be produced from woven polyester or similar non-absorbable biostable and biocompatible material. Additional materials include polyethylene, polyurethane, segmented polycarbonates, ePTFE, and silicones. Alternatively, any known flexible material for use in medical devices can be used herein. 
     In accordance with one embodiment, the outer edges of the wrap can have material that has been treated, finished, coated, or designed to minimize trauma to any biological surfaces with which the wrap comes into contact. For example, the outer edges can be coated with a soft biocompatible, biostable polymer or elastomer. Alternatively, the outer edges can be made of a soft, stretchable fabric. These non-traumatic edges can thus reduce any trauma or damage to any biological surfaces during positioning of the wrap or once the wrap has been attached in place as desired. 
     Another embodiment of a wrap system  80  is depicted in  FIG. 3 . This system  80  has a wrap  82  with a first end  84 , a second end  86 , and size markings  88 , a balloon  90 , sutures  92 , and a suture carrier  94 . Further, the system  80  also has an interface line  96  that is coupled to the balloon  90  and allows for transfer of fluid between the balloon  90  and a pump (not shown) for purposes of inflating and deflating the balloon  90  during use. The interface line  96  can also provide for transmission of electrical and/or electronic signals via one or more wires. In addition, this implementation has a lead member  98  that is attached to the first end  84  of the wrap  82  to help insert or otherwise position the first end  84  during placement of the wrap  82 . That is, the lead member  98  can be umbilical tape or any other relatively narrow elongate object that can be inserted behind the aorta of the patient more easily than the wrap  82  itself during implantation. Further, the lead member  98  can also be used for measurement of the aorta or other biological features of the patient during implantation. 
     It is understood that any of the wrap embodiments disclosed or contemplated herein can also include any of the wrap materials and/or configurations disclosed in U.S. Pat. Nos. 8,206,278 and 8,469,873, both of which are hereby incorporated herein by reference in their entireties. 
     In use, a wrap  100  can be positioned around a blood vessel such as an aorta  110  as shown in  FIGS. 4-7 . 
     Prior to positioning the wrap around the target blood vessel, the circumference of the target vessel is measured to determine the desired circumference of the wrap. Based on this measurement, the appropriate wrap can be selected (from a set of wraps as discussed above) and the appropriate set of attachments points (as described above) can be selected on that wrap. 
     Once the appropriate wrap is selected, the suture carrier (such as the carrier  70  of  FIGS. 2A-2C ) is opened as shown in  FIGS. 2B and 2C  to access the sutures. Alternatively, the suture carrier (such as carrier  70 ) can be opened after the first end  102  of the wrap  100  is positioned around the back side of the aorta  110  as discussed below. Once the carrier (such as carrier  70 ) is opened, the surgeon or user can select the first desired pair of sutures for insertion through the desired location on the size markings (such as the markings  18  depicted in  FIGS. 1A-1C ) as discussed in further detail below. 
     The first end  102  of the selected wrap  100  is positioned to be inserted behind the vessel  110  (in this case, the aorta  110 ) as best shown in  FIG. 4 . In those embodiments in which a lead member (such as lead member  98  discussed above) is attached to the first end  102  of the wrap  100 , the lead member can be inserted behind the aorta  110  to more easily pull the first end  102  of the wrap  100  distally. 
     Whether a lead member (such as lead member  98 ) is used or not, the first end  102  of the wrap  100  is positioned around the back side of the aorta  110  and pulled toward the user on the other side as shown in  FIG. 5 , thereby positioning the wrap  100  around the aorta  110 . 
     At this point, a vessel deforming component  112  (such as a balloon  112 ) can be positioned between the wrap  100  and the aorta  110  in the desired position (as shown, for example, in  FIG. 6 ). Alternatively, the vessel deforming component  112  could be positioned with the wrap  100  when the wrap  100  is inserted around the aorta  110  such that both the vessel deforming component  112  and wrap  100  are positioned together. In a further alternative, the vessel deforming component  112  is previously attached or otherwise coupled to the wrap  100 . 
     Once the wrap  100  and the vessel deforming component  112  are positioned as desired, the sutures  106  are inserted through the chosen set of attachment points on the size markings  104 . That is, each of the pairs of sutures  106 —one after another—is removed from the engagement structures (such as engagement structures  74 A,  74 B discussed above) of the carrier (such as carrier  70 ) and is inserted through the wrap  100  at the appropriate attachment point on the markings  104 . As described above, the needle of the one of the sutures  106  of each pair is inserted through the wrap  100  on one side of the corresponding attachment point (such as one of the nine indicia described above and in  FIG. 1C ), and then the needle of the second of the pair of sutures  106  is inserted on the other side of the same attachment point. Alternatively, the pair of sutures  106  are inserted into any type of indicia that might be provided in any known fashion. Once the two sutures  106  of the pair are both inserted through the wrap  100 , the needles are removed and the newly needle-less ends of the two sutures  106  are tied or otherwise fastened together (and the excess lengths of the sutures  106  removed) as best shown in  FIG. 7 . 
     This process is repeated for each of the suture pairs, with the surgeon or user sequentially selecting and inserting each of the desired pairs of sutures into the markings (such as markings  18 ) in the desired order until the wrap  100  is secured around the aorta  110  and the sutures  106  are secured in the wrap  100 . In one exemplary embodiment, the sequential order can be selecting the middle pair of sutures on the carrier, following by selecting the pairs on the ends of the carrier, and then sequentially selecting the remaining pairs. Alternatively, any order can be used. 
     Alternatively, the sutures  106  can be attached in any known fashion using the size markings  104  to secure the wrap  100  around the target vessel. 
     Once the sutures  106  are tied and the excess length of each suture  106  removed, any excess length of the wrap  100  is removed as shown in  FIG. 7 . 
     While multiple embodiments are disclosed, still other embodiments will be apparent to those skilled in the art from the above detailed description, which shows and describes illustrative embodiments. As will be realized, these various embodiments are capable of modifications in various obvious aspects, all without departing from the spirit and scope of the inventions. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.