WO2014153165A1

WO2014153165A1 - Hybrid lateral vein introducer

Info

Publication number: WO2014153165A1
Application number: PCT/US2014/029382
Authority: WO
Inventors: Seth Worley; Andrew Armour; Paul Kurth
Original assignee: Pressure Products Medical Supplies Inc.
Priority date: 2013-03-14
Filing date: 2014-03-14
Publication date: 2014-09-25
Also published as: EP2968848A4; US20160001042A1; EP2968848A1

Abstract

A hybrid lateral vein introducer which includes a conventional splittable hemostatic valve, which comprises two symmetrical wing extending from a splittable hub. A conventional splittable proximal sheath portion is coupled to and extends from the hub. The sheath portion is a conventional soft pliable sheath, which has limited torqueability, but adequate flexibility to be maneuvered in the cardiac vascular system. At a predetermined distance from the valve, the sheath is coupled to a reinforced sheath portion. Reinforced sheath portion is reinforced sufficiently to allow for good integrity and crush resistance while maintaining flexibility of the sheath portion. A proximal segment of the sheath portion is reinforced, but still splittable. Alternatively, the entire length of the sheath portion including the proximal segment and distal portions are rendered splittable.

Description

HYBRID LATERAL VEIN INTRODUCER

[013 Related Applications

[023 The present application is related to U.S. Provisional Patent Application, serial so. 61/783,527, filed on March 14, 2013, which is incorporated herein by reference and to which priority is claimed,

[03J Background

[04] J. Field of the Invention

OSji l¾^e invention relates to sheaths and introducers, which a e utilized in a human heart, which has been altered by heart disease. More particularly, the invention relates to a hybrid spl suable introducer for lateral vein catmuiation. 63 2. Description of (he Prior Arc

[0?3 The coronary sinus is the largest cardiac vein and serves as a conduit for access to various locations within the heart. Depending on the depth of insertion of the medical device into the coronary sinus, both the left and ri ght atria and the left and right ventricles of the heart can be accessed and analyzed. However, introduction of a medical device into the ostium of the coronary sinus is quite difficn.lt as a result of the structure of the bean, the difficulty in locating the coronary sinus using conventional medical technology and the constantly changing shape of the heart while beating as well as the altered anatomy of Ac heart with cardiomyopathy.

[083 The anatomy of the coronary sinus branc h vein presen ts novel problems for cannuiation and pacemaker lead insertion. During pacemaker implantation the delivery system must be steerable to properly locate and to be inserted into the appropriate coronary sinus branch vessel. Thereafter, the deliver device must have the ability to be steered through a highly branched vasculature of smaller and smaller vessels, yet it must not be so stiff or biased, to be traumatic to the vessels, The delivery system must also provide adequate support within the vessel to avoid kinking, crushing, or otherwise restricti ng the lumen of the introducer to allo for delivery of the pacemaker lead therethrough. The delivery system must also be extremely flexible at the distal end to navigate the highly tortuous venous anatomy laterally extending from the coronary sinus. After implantation the delivery system must then be able to be removed without displacing the highly flexible, pacemaker lead, which is then disposed in the lumen of the introducer.

09] Two approaches arc commonly used for placement of a medical device within the coronary sinus lateral veins, an inferior approach from below the heart, and a superior approach from above the heart. In the superior approach, the device is advanced through either the right or left cephalic or right or left subclavian vein through the superior vena cava into the right atrium until it is directed toward the coronary sinus. In the inferior approach, the device is generally advanced through the femoral vein through the inferior vena cava into the right atrium. The tip of the device is then directed toward the ostium of the coronary sinus and subsequently a lateral vein extending from the coronary sinus. The superior approach is the preferred approach and. is the approach for which the introducer of the presen invention is optimized.

[1 OI With conventional non-splittable and non-sliceable introducers, the maximum diameter of the pacemaker lead that can be inserted is no larger than the lumen of the introducer. This limitation created a significant problem because of the nature of pacemaker leads.

Frequently, the pacemaker lead's proximal end includes an electrical connector for connection to the pulse generator. Because the size of the connecter is often larger than, the diameter of the lumen of conventional cardiac introducers or sheaths, standard practice for implantable cardiac pacemakers and defibrillator lead placement are introducers or sheaths that are separable, splittable, sliceable or tearable to assist in the insertion of these electrode leads. Once the introducer directs the placement of the medical device, such as an electrode lead, into the body, the separable, splittable, sliceable or tearable introducer is separated lengthwise as it is withdrawn from the body over the electrical connector of the pacemaker lead. By being separable by some means, the size of the lumen of the splittable, sliceable or tearable introducer can remain relatively small as it need be no larger than is necessary for passage of the distal tip of me medical device through the lumen of the introducer. In addition, the prior art uses a splittable hemostatic valve, such as shown in U.S. Patents 5,125,904 and 5,312,355, which is utilized in combination with a splittable sheath for introduction of a pacemaker electrode into a patient.

[11] It is a matter of preference, but generally speaking, a non-reinforced splittable introducer is much easier to remove from the body than a braided sliceable introducer without disrupting the implanted pacing or defihrillatiiig lead. This is due to the fact that the material of the splittable sheath has much less structural integrity than a reinforced catheter, and the act of splittin is more constant and less jerky than when slicing a braided sliceable introducer. When considerable time has been spent in placement of the lead tip in an acceptable anatomical and physiological position, having the lead tip displaced when removing the introducer is extremely

7 disruptive to the procedure and can even result m subopiiraal lead positioning. This being said, the majority of physicians would prefer to remove a spiittable introducer o ver a sliceable introducer following lead placemen t.

[12] Lateral vein introducers are well known and applied to a variety of operations.

These introducers consist of a braided sheath (guide) construction for torqueabiiity and support, and have sufficient flexibility to be manipulated around irregular paths, such as occur within the coronary sinus branch vessels. The introducers by themselves are not capable of negotiating the branch vessels of the coronary sinus, but instead rely on the navigation of a guidewire to control the direction for subsequent additional braided guide catheters to follow, it is desirable to have ^'both a radially flexible introducer sheath, braided catheter, and guidewire to avoid trauma to the vessel walls and to more easily track m a tortuous or highly branched venous system, while at th same time to be shaped to minimize the potential, for kinking or crushing when traversing acute bends in the vessel Generally, to be torqueable and radially flexible at the same time meant that the introducer had to include a braided reinforcement in or on it. However, a non-braided introducer sheath, supported by a braided guide has been shown to have equivalent results,

[133 Current non-braided (or non-reinforced) introducer sheaths, however, are unable to be radially ilexible enough to atraumatically navigate the tortuous or highly branched venous system without kinking or crushing. Therefore, what is needed is a highly flexible, kink resistant, crush resistant, introducer than can be spiittable while being removed from the body.

[143 Brief Summary

[15] The ill ustrated embodiments of the invention include a cardiac introducer comprising a spiittable hemostatic valve, a i ontorqueahle, spiittable proximal sheath portion coupled to and fiuidiciy communicated to the hemostatic valve, and a, separable distal sheath portion coupled to and fiuidiciy communicated to the nontorqueahle, spiittable proximal sheath portion.

[16] The separable distal sheath portion is nonsplittable.

[173 The nonsplittable distal sheath portion is more torqueable than the proximal sheath portion.

[183 The nonsplittable distal sheath portion is biased into shape adapted for use in a prcdetemiraed cardiac application.

The nonsplittable distal sheath portion is reinforced to provide improved integrity and crush resistance. [20] The reinforcement mciudes fiber, wire, fiat wire, braid, spiral or coil reinforcement, material selection, fillers, or cladding with sfcririkable tubing or coatings.

[21] The distal sheath portion sheath comprises a plurality of subportions which are integral and identical in all characteristics with each other or may be comprised of the materiai. identical or similar to the proximal sheath portion, or may assume material characteristics distinct from both other sheath subportions or the proximal sheath portion.

[22] The illustrated embodiments of the invention include a method of using any of the cardiac introducers of any of introducers described above.

[23] The illustrated embodiments of the invention include a method of manufacturing any of the cardiac introducers of any of the introducers described above.

[24] More particularly, the illustrated embodiments of the invention include a cardiac introducer including a spiittable hemostatic valve, and a sheath coupled to and fiuidicly communicated to the hemostatic valve. The sheath includes a nontorqueabie, spiittable proximal portion coupled to and .fiuidicly communicated to the hemostatic valve, and a reinforced, non- sphttable, sliceable, flexible distal portion coupled to and fiuidicly communicated to the nontorqueabie, spiittable proximal portion.

[25] The reinforced, non-sphttable slice-able, flexible distal portion of the sheath is biased into a shape adapted for use in left ventricle access.

[26] The reinforced, non-spitttable, siieeabk, flexible distal portion of the sheath is soft but crash resistant.

[27] The reinforced, non-spUtiable, sliceable, flexible distal portion of the sheath is reinforced with fiber, wire, flat wire, braid, spiral coil reinforcement, material selection, .fillers, or cladding with shrinkable tubing or coatings so that a lumen defined therein remains substantially open.

[28] The reinforced, non-sphttable, sliceable, flexi ble distal portion of the sheath comprises a plurality of subportions which are each comprised of a material the same as or similar to the proximal portion of the sheath.

[29] The reinforced, noo-sphitahle, sliceable, flexible distal portion of the sheath comprises a plurality of subportions each of which are comprised of different materials containing different material characteristics distinct from each other or from the proximal portion of the sheath.

[30] The illustrated embodiments of the invention also include a cardiac introducer which, mciudes a spiittable hemostatic valve, and a sheath coupled to and fiuidicly communicated to the hemostatic valve. The sheath includes a nontorqueable, spliitabie proximal portion coupled to and fluidicly communicated to the hemostatic valve, and a braid reinforced, spliitabie, distal portion coupled to and fluidicly communicated to the nontorqueable, spliitabie proximal sheath portion.

[31] The braid reinforced, spliitabie, distal portion of the sheath is biased into a shape adapted for use in left ventricle access,

[32] The braid reinforced, splittable, distal portion of the sheath is highly flexible and crush, resistant.

[33] The nontorqueable, splittable, proximal portion of the sheath is reinforced.

[34] The reinforcement of the dis tal and proximal portions of the sheath comprises fiber, wire, flat wire, or formed braid reinforcement

[35] The braid reinforced, splittable distal portion of the sheath comprises a plurality of subportions which are each comprised of a material the same as or similar to the proximal portion of the sheath.

[38] The braid reinforced, splittable di stal portion of the sheath comprises a plurality of subportions which are eac comprised of different materials containing different material characteris tics distinct from each other or from the proximal portion of the sheath.

[37] The illustrated embodiments still further include a method of using a cardiac introducer including the steps of inserting the cardiac introducer including a sheath into the coronary sinus of a patient, navigating a distal end. of the sheath to a desired position, and removing the introducer from the pa tient by separating at least a portion of the introducer sheath without the aid of any tool and separating another portion of the introducer sheath with the aid of a tool,

[38] The step of removing the introducer from the patient by separating at least a portion of the introducer sheath without, the aid of an tool includes peeling apart a proximal portion of the sheath.

[39} The step of removing the introducer from the patient by separating at least a portion of the introducer sheath with the aid of a tool includes slicing apart a distal portion of the sheath.

[40] The step of removing the introducer from the patient by separating at least a portion of the introducer sheath without: the aid of any tool includes separating both a proximal and a dis tal portion of the sheath without the aid of any tool, hi such a case either ano ther part of the sheath will be separated with a tool or the method of using a cardiac introducer includes the steps of inserting the cardiac introducer including a sbeaih into the coronary sinus of a patient, navigating a distal end of the sheath to a desired position, and removing the introducer from the patient by separating the entire introducer sheath without the aid of an tool, namely both the proximal and distal portions, there being no portion that is to he separated with, the aid of a tool [41] The step of separating another portion of the introducer sheath with the aid of a tool includes cutting the distal portion of the sheath with an introducer cutting knife.

[42] The step of navigating a distal end of the sheath to a desired position includes accessing the left ventricle of the heart.

[43| The step of navigating a distal end of the sheath to a desired position includes torquing the distai end of the sheath through the coronary si BUS without restricting the lumen of the introducer sheath.

[44| While the apparatus and method has or will he described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any wa by the construction of "means" or "steps" limitations, but are to be accorded the full scope of the mea ing and equivalents- of the defini tion provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 1 12 are to be accorded full Statutory equivalents under 35 USC 1 12. The disclosure can be better visualized by turning now to the following drawings wherein like elements are referenced by like numerals.

[45J Brief Description of the Drawings

[46] Fig. I is a top view of the hy brid lateral vein in troducer of the illustrated embodiment.

[47| Fig. 2 is a side view-' of a conventional cutter with a partially split portion of the proximal sheath used in the illustrated embodiment.

[48] Fig. 3 is a top view of the embodiment of the spiiUable hybrid lateral vein introducer seen in Fig. 1 wherein a portion of the length of the sheath is pro vided with a peelabie means.

[49] Fig. 4 is a top view of an alternative embodiment of the splittable hybrid lateral vein introducer seen in Fig. 1 wherein the entire length of the sheath, is provided with a peelabie means. [50] The disclosure and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the embodiments defined in the claims. Tt is expressly understood that the embodiments as defined by the claims may be broader than the illustrated embodiments described below. f 51 J Detailed ^'Description of the Preferred Embodiments

[52] Fig. 1 is a top view of the hybrid lateral v ein introducer of the illustrated

embodiment. The introducer 10 iiicludes a conventional splittable hemostatic valve 12, which in the illustrated embodiment shows two symmetrical wings 14 extending from a splittable hub 16, A conventional splittable or separable proximal sheath portion 18 is coupled to and extends from hub 1 . introducer 10 may be separable or splittable in any way now know or later devised. The means for rending all or part of the introducer sheath separable or splittable include any .means known for splitting, peeling or peeling away a sheath such as score lines, slits, skives, extruded scores, extruded microlumens. molded relief channels, moiecularly aligned lines of weakness, oriented materia], such as P^'TFE, .mechanically or adhesivel connected separable or separated portions, thermally separable connected portions or any mechanism that allows portions to be connected and then to be separated without the use of a cutter or other took Siieeable for the purposes of this specification will include any extruded, molded, or otherwise formed sheath or hub that is only separable with a cutter, slitter, or other tool. In the illustrated embodiment sheath portion 18 is separable using a conventional introducer cutting knife 20 seen in Fig. 2 with a cutting blade 22 specially shape to fit into sheath portion 18 and to simultaneousl make a longitudinal cut into sheath portion 18 as knife 20 is drawn or pushed down, the longi udinal length of sheath portion 18.

[53] Introducer 1 in the illustrated embodiment is provided with a flushing line 32 fiuidiciy communicated to valve 12 and a flushing stop valve 34 to open or close the .flushing port (the output of valve 34), or to fluidiely communicate flushing line 32 to one or one of two or more access ports 36.

[54] In the illustrated embodiment sheath portion .1 is a conventional soft pliable sheath, which has limited torqueability, but adequate flexibility to be maneuvered in the cardiac vascular system. At a predetermined distance from valve 12, sheath 18 is coupled to a reinforced sheath portion 24. Sheath portion 24 is sufficiently reinforced to allow for good integrity and lumen crush resistance while maintaining flexibility of sheath portion 24. The reinforcement may be inrplemented by any means or measure now known or later devised, including without limitation fiber, wire, flat wire, braid, spiral coil reinforcement, material selection, fillers, or cladding with shrinkable tubing or coatings. Sheath portion 24 extends via sheath portion 26 and tip portion 28 to the distal tip 30 of introducer 10. Sheath portion 26 and tip paction 28 may be integral and identical in al characteristics with s heath portion 24 or may be comprised of the materia] identical or similar to sheath portion ί 8, or may assume material characteristics distinct from both sheath portions 18 and 24,

[55| In the illustrated embodiment, sheath portions 24, 26 and 28 are biased or shaped for a particular cardiac application, namely left ventricle access. However, other shapes and other cardiac applications may be accommodated by conventional design principles and still be within the scope of the invention. In the illustrated embodiment portions 24, 26 and 28 are composed of material of increasing dorometer respectively. For example, an embodiment is also contemplated where a proxim l portion of sheath portion ί 8 is reinforced for torqueahtlity similar to sheath portion 24, and extends to an intermediate portion along sheath portion 18 where it is coupled to a non-reinforced portion, for the remainder of sheath portion 18, where it is coupled to sheath portion 24. The benefit of this embodiment is that the most proximal sheath portion will have additional integrity and tor ueahility.

[56]: Fig. 3 is a top view of the splittable hybrid lateral vein introducer 10 of the illustrated embodiment in. which a proximal segment 19 of the sheath portion. 18 is reinforced, but still splittable or separable. In the illustrated embodiment a proximal segment 19 of the sheath _.portion 18 is reinforced by braiding or other means known or disclosed above and then split, sliced or cut along its entire length during manufacture to form two tubular halves or semi- cylinders. The two semi-cylinders are then placed back together and heated to fuse or otherwise bonded together. The polymer material of the sheath 18 softens and. bonds with a thin connecting layer between the two semi-cylindrical, braid reinforced halves. There are many other ways in which the same structure can be made and it is to be understood that the invention is not to be limited by the disclosed ma ufacturing method. The resulting sheath IS is easily splittable or separable on the two opposing l ines of separation formed by the fused interconnecting layer of polymer material without the aid of any tool, while still having braided or reinforced halves. In the embodiment of Fig. 3, only the proximal segment 1.9 of the sheath portion 18 is splittable and the distal portions 24, 26 and 2$ are reinforced and may be sliceabie with the aid of a kniie 20 or scalpel (not shown), in the alternative embodiment seen in Fig. 4, die entire length of the sheath portion 18 including portions 19, 24, 26 and 28 are rendered splittable by the above

manufacturing method or other known manufacturing methods. [57} Many alterations and modifications may be made by those having ordinary skill in the art wiihoist departing from the spirit and scope of the embodiments. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the embodiments as defined by the following embodiments and its various embodiments.

[58} Therefore, it must be understood that the illustrated, embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the

embodiments as defined b the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the embodiments includes other combinations of fewer, more or different elements, which arc disclosed in above e ven when, not initially claimed in such combinations, A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed clement of the embodiments is explicitly contemplated as within the scope of the embodiments.

[59] The words used, in this specification to describe the various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in mis specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element ca be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic, to all possible meanings supported b the specificati n: and by the word itself.

[80] The definitions of the words or elements of the following claims ate, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but ail equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result, in this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described, above as acting in certain combinations and even, initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some eases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a

subcombination. [613 losubsiaoiial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being cqoivalentty within, the scope of die claims. Therefore, obvious substitutions now or later known to one with ordinary skill m the art are defined to be within the scope of the defined elements.

[62} The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionaliy equivalent, what can be obviovtsiv substituted and also what essentially incorporates the essential idea of the embodiments.

Claims

We claim:

1. A cardiac introducer comprising:

spiittable hemostatic valve; and

a sheath coupled to and fhudicly communicated to the hemostatic valve, wherein the sheath further comprises:

a nontorqueable, spiittable proximal portion coupled to arid fluidieiy communicated to the hemostatic valve; and

a reinforced, non-splittabk, sliceabk, flexible distal portion coupled to and fluidicly communicated to the no.ntorqueab.le, splittabk proximal portion.

2. The cardiac introducer of claim 1 where the reinforced, noa-spHttable sheeable, flexible distal portion of the sheath is biased into a shape adapted for use in left ventricle access.

3. The cardiac introducer of claim 1 where ihe reinforced, non-splittabk, sliceabk, flexible distal portion of the sheath is soft but crush resistant.

4. The cardiac introducer of claim 1 where the reinforced, non-splittabk, sliceabk, flexible distal portion of the sheath is reinforced with fiber, wire, flat wire, braid, spiral coil reinforcement, material selection, fillers, or cladding with shrinkabk tubing or coatings so that a lumen defined therein remains substantially open.

5. The cardiac introducer of claim 1 where the reinforced, non-splittabk, sliceabk, flexible distal portion of the sheath comprises a plurality of subporiions which are each comprised of a material the same as or similar to the proximal portion of the sheath.

6. The cardiac introducer of claim 1 where the reinforced, nort-sphttab!e,. sliceabk, flexible distal portion of the sheath comprises a plurality of subportions each of which are comprised of different materials containing different material characteristics distinct from each other or from the proximal portion of the sheath.

A cardiac introducer comprising;

a spiittable hemostatic valve; and a sheath coup!ed to and fluidiciy communicated to the hemostatic valve, wherein the sheath further comprises;

a riontor ueable, splittabie proximal portion coupied to and fluidiciy communicated to the hemostatic valve; and

a braid reinforced, splittabie, distal portion coupled to and fluidiciy communicated to the nontorqueable, splittabie proximal sheath portion.

8. The cardiac introducer of claim. 7 where the braid reinforced, splittabie, distal portion of the sheath is biased into a shape adapted for use in left ventricle access.

9. The cardiac introducer of claim 7 where the braid reinforced, splittabie, distal portion of the sheath is highly flexible and crush resistant.

10. The cardtae introducer of claim 7 where the tio orcjueahle, splittabie, proximal portion of iiic sheath is reinforced.

1 1. The cardiac introducer of claim 1 where the reinforcement of the distal and proximal portions of the sheath comprises fiber, wire, fiat wire, or formed braid reinforcement.

12. The cardiac in troducer of claim 7 where the braid reinforced, splittabie distal portion of the sheath comprises a plurality of sub-portions which are each comprised of a material the same as or similar to the proximal portion of die sheath ,

13. The cardiac mtroducer of claim 7 where the braid reinforced, splittabie distal portion of the sheath comprises a plurality of siibportions which are each comprised of different materials con taini ng different material characteristics distinct from each other or from the proximal portion of the sheath.

1 . A method of usin g a cardiac mtroducer comprising:

inserting the cardiac introducer comprising a sheath, in to the coronary sinus of a patient; navigating a distal end of the sheath to a desired position; and

removing the introducer from the patient by separating at least a portion of the introducer sheath without the aid of any tool and separating another portion of the Introducer sheath with the aid of a tool

15. The method of claim 14 where removing the introducer from the patient by separating at least a portion of the introducer sheath without the aid of any tool comprises peeling apart a proximal portion of the sheath,

16. The method of claim 15 where removing the introducer from the patient by separating at least a portion of the introducer sheath with the aid of a too! comprises slicing apart a distal portion of the sheath,

17. The method of claim 14 where removing the introducer from the patient by separating at least a _.portion of the introducer sheath without the aid of any tool comprises separating both a proximal and a distal portion of the sheath without the aid of any tool

1 The method of claim 16 where separating another portion of the introducer sheath with the aid of tool comprises cutting the distal portion of the sheath wi h an introducer cutting knife,

19. The method of claim 14 where navigating a distal end of the sheath to a desired position comprises accessing the left ventricle of the heart.

20. The method of claim 14 where navigating a distal end of the sheath to a desired position comprises torquing tire distal end of the sheath through the coronary sinus without restricting the lumen of the introducer sheath.