Source: https://patents.google.com/patent/US20070213761
Timestamp: 2018-07-21 10:02:33
Document Index: 400488186

Matched Legal Cases: ['arts 60', 'art 58', 'art 56', 'art 56', 'art 56', 'arts 56', 'art.\n44', 'art.\n47']

US20070213761A1 - Minimally invasive intravascular treatment device - Google Patents
US20070213761A1
US20070213761A1 US11710266 US71026607A US2007213761A1 US 20070213761 A1 US20070213761 A1 US 20070213761A1 US 11710266 US11710266 US 11710266 US 71026607 A US71026607 A US 71026607A US 2007213761 A1 US2007213761 A1 US 2007213761A1
US11710266
A device for treating a target area of a vessel wall of a vessel within a man or animal body, the device comprising: an expandable portion for radially expanding the device from a contracted configuration allowing travel within the vessel to the target area to an expanded configuration allowing treatment of the target area; a protective sheath stretch-fitted over the expandable portion to exert a compressive force on the expandable portion for radially contracting the device from its expanded configuration to its contracted configuration, and for exerting a compressive force on the expandable portion in its contracted configuration; and at least two spaced apart treatment implements extending radially outwardly from the expandable portion, wherein in the device's contracted configuration the implements are shielded within the protective sheath, and in its expanded configuration the thickness of the sheath-decreases to expose the implements for contact with the target area of the vessel wall. A protective sheath for fitting to a device for treating a target area of a vessel wall of a vessel within a human or animal body, a balloon catheter sheath loading device and method for loading a tubular sheath onto a balloon catheter, and a method of treating one or more target areas of a vessel wall within a human or animal body are also disclosed.
For example, the rate of increase in obesity in Irish society was brought to public attention in a recent front-page Irish national newspaper article, “Tipping the scales: Child obesity levels triple” (The Irish Examiner Nov. 22, 2004). Furthermore, the statistics for cause of death present the true magnitude of the problem, in Ireland during the period 1998-2003 (inclusive) 40% of deaths within the state were caused by diseases of the circulatory system (source: Irish Central Statistics Office). This trend is not only a national problem, it is echoed internationally in 1998 in the United States 39% of all deaths were caused by diseases of the circulatory system (National Vital Statistics Reports 2000, Vol. 48, No. 11, July 24).
U.S. Patent application number 2005/0137617 discloses a cutting balloon which aims to overcome this disadvantage. An elastically distensible folding member is disclosed which can be formed with a wall that is substantially shaped as a tube when the folding member is in a relaxed (i.e. unstressed) state. The tubular shaped folding member defines a tube axis and can have an axially aligned slit that extends through the wall. The folding member can be used to cover an incising element that is attached to the balloon and positioned in the lumen of the tubular folding member. During balloon inflation, the folding member can be deformed to expose the tip of the incising element to allow for a tissue incision.
U.S. Pat. No. 6,369,039 (Palasis et al.) entitled “High efficiency local drug delivery” discloses a method of site-specifically delivering a therapeutic agent to a target location within a body cavity, vasculature or tissue. The method comprises the steps of providing a medical device having a substantially saturated solution of therapeutic agent associated therewith; introducing the medical device into the body cavity, vasculature or tissue; releasing a volume of the solution of therapeutic agent from the medical device at the target location at a pressure of from about 0 to about 5 atmospheres for a time of up to about 5 minutes; and withdrawing the medical device from the body cavity, vasculature or tissue. One problem with this device is its low delivery pressures.
The above are all examples of infusion catheters, with no needles involved. In vivo studies show that these catheters have inferior clinical results in comparison to other drug delivery methods. Infusion has been shown to be an inferior drug delivery method to needles.
U.S. Pat. No. 5,336,178 (Kaplan et al) describes an intravascular catheter for infusing an agent into a treatment site. It employs a series of apertures to infuse the liquid agent. An internal elastomeric sleeve is described in certain embodiments (see FIGS. 13 and 14A). The device does not have to deal with treatment implements such as needles or cutting blades.
U.S. Pat. No. 6,051,001 (Borghi), EP 0 697 226 (Igaki), U.S. Pat. No. 6,018,857 (Duffy et al) and WO 98/22044 all describe devices for loading of stents for example onto a catheter.
It is an object of the invention to provide an efficient and effective catheter based local therapeutic device which may be adapted for the delivery of gene therapy products (or drugs) directly to target sites, and/or which may be provided with cutting implements which can be used to treat a site within the body.
It is a further object of the invention to provide a local catheter based therapeutic delivery device capable of use in a number of product applications.
It is a further object of the invention to provide a delivery device which can be used at more than one site of treatment within a vessel/artery. This feature is particularly useful in diffuse peripheral disease or for arteries with numerous vulnerable plaques.
It is a further object of the device to provide a delivery device which experiences quick and safe deflation after use.
It is a further object of the invention to provide a delivery device with sufficient flexibility so as to allow the catheter to navigate tortuous arteries.
It is a further object of the invention to provide a delivery device wherein drugs may be delivered (and thus distributed) evenly compared to catheters available at present.
It is a further object of the invention to provide an improved cutting implement for use in opening blocked vessels.
In one embodiment the treatment implements may be blades for cutting or scoring the vessel wall. Alternatively, the treatment implements may take a different form, for example needles (such as hollow needles or micro-needles) wherein the device may act as a drug delivery device for the delivery of therapeutic substances to the vessel wall. When needles are used, preferably the device further comprises a drug delivery system in fluid communication with the needles for delivery of therapeutic compound through the needles into the vessel wall. The drug delivery system may comprise a plurality of reservoirs in the protective sheath. Alternatively, the drug delivery system may comprise a (multi-lumen) supply hose connected via (flexible) tubing to the needles. The sheath thus provides the opportunity to adapt a balloon catheter into a device with one or more implements for treating target sites.
The device may be fitted with a nose-cone. The nose-cone provides a transitional profile between the catheter and the sheath on a leading end thereof. This means that during forward travel the device is less likely to encounter resistance to travel due to the difference in size (diameter) of the catheter and a sheath mounted thereon. The nose-cone will allow for more gradual stretching of the vessel in which the device is traveling. Similarly for retraction of the device from its working position a tail-cone may be provided which provides a transitional profile between the catheter and the sheath on the trailing end thereof. This again allows for ease of retraction.
The protuberances may be provided in pairs and desirably at least one pair of protuberances are provided—each on opposing sides of the treatment implement. This ensures effective shielding of the implements. Desirably the at least one protuberance has a curved exterior surface. This curved profile again allows for ease of movement of the device with the vessel—there are no angular shapes for catching/snagging. In this respect having the curved exterior surface as a convex surface is useful.
Presented in the drawings is a catheter based device for the treatment of internal body cavities such as arteries/veins or other hollow organs in accordance with the present invention. Also presented is a retrofit sheath and a sheath loading device in accordance with the present invention.
FIG. 5 depicts three embodiments of devices in accordance with the invention, labeled A-C. Embodiment A is a particularly flexible embodiment based on a modular design where the sheath 14 is provided with a plurality of rings 30 of material. These rings 30 may be completely separate from one another or may be connected by one or more interconnecting links. Embodiment B has a short balloon 4, and the sheath 14 comprises treatment implements 2 adjacent the balloon's leading end. This embodiment is most suitable to treating chronic total occlusions, as therapeutic delivery will occur as close as is possible to the blockage. This ensures that the therapeutic solution could instigate remodeling of the vasculature as close as possible to the diseased section, for example angiogenesis promoters would allow collaterals to form immediately upstream of the blockage ensuring that all areas of the limb/organ are supplied with blood flow. Embodiment C is a proximal and distal restenosis module suitable for attachment to a stent-loaded catheter. A stent 70 is shown in situ around the central portion of the balloon 4, between the sheath rings 30 which are confined to either end of the balloon 4. This module has the capability to deliver therapeutic agents to the artery wall immediately distal, proximal or both, of the area where a stent is being implanted, this would remove or reduce the risk of edge restenosis.
FIG. 6 shows a retrofit sheath 32 according to one embodiment of the invention. The sheath is a two part sheath comprising an inner 34 and outer sheath 36. The inner sheath 34 has concave reservoirs 38 in (for example molded into) its outer surface 40, while the outer sheath 36 has small holes 39 defined within it to allow the needles sit within. A needle/plate assembly 42 sits beneath the outer sheath 36. The height h of the outer sheath 36 is greater than the height H of the needles 44. Once the needle assemblies 42 are in place, with the plates 46 positioned over the concave reservoirs, the outer sheath 36 is mounted over the inner sheath 34 to form the completed sheath shown in FIGS. 7 and 8. When the sheath is loaded on the catheter the therapeutic solution is stored within the sheath in the concave cavities/reservoirs. After the catheter has been maneuvered to the site of vascular disease the balloon is dilated. Upon dilation of the balloon, the sheath is stretched and the cavities within the sheath reduce in volume. This decrease in volume causes the therapeutic solution to be expelled from the reservoir and delivered to the site of disease.
A number of protuberances are formed as part of the sheath 80. Each protuberance is in the form of elliptical protuberance 81 each with a hollow internal pocket 82 In the embodiment the pockets 82 run along substantially the entire(working) length of the sheath 80 and formed on annular ring 85 of the sheath. It will be appreciated however that as the protuberances shield the implements from contact with the lumen when the device is being moved for travel within the lumen, the length and position of the protuberances can be adjusted according to be required shielding function. Each pocket 82 is hollow being formed by a fold of sheath material.
As can be seen from the drawings, the protuberances are provided in pairs. In the embodiment there are three pairs of protuberances. Each one of a given pair are on opposing sides of the treatment implements. In the embodiment each of the protuberances has a curved exterior surface 84. The surface 84 is convex in the shape. As can be seen from the drawings of the protuberances are substantially elliptical in cross-sectional shape. Each pair of protuberances converge towards each other (along their major axes) to any point above the working implements. In this way, the protuberances are profiled (so the highest point is) toward the working implements to ensure that each working implement is effectively shielded (laterally). In this configuration the working implements are nested within the protuberances.
The next stage in the process which is shown in FIG. 26, is the removal of the fingers 144. This is done by gripping a handle 147 of the mounting portion 145 which mounts three fingers. The three fingers are maintained in a spaced apart configuration by a guide 154. The guide 154 has apertures 155 therein through which the fingers extend. As shown in FIG. 26 the fingers 144 can be retracted by pulling on the grips 155 as indicated by arrow 156. This pulls the fingers 144 out from under the sheath and releases the sheath onto the catheter 142. This leads to the configuration of FIG. 27 where the fingers are no longer underneath the sheath. That means that the mounting portion can be taken away to leave the sheath 141 in place on the catheter 142. The catheter 142 with the sheath 141 loaded thereon is shown in FIG. 28. It will be appreciated that the expanding members (the fingers) are flexible.
FIGS. 34 to 38 show the sheath-loading process. As shown in FIG. 34, a balloon catheter 66 is placed within the inner tubes 56 and 58 of the complete assembly 2231 As shown in FIG. 386, to begin disassembly of the assembly, parts 60 and 62 are held by the operator and part 58 is pulled back in the direction of the large arrow and removed from the catheter. This allows the slotted end of part 56 to drop onto the balloon catheter 66 and relieve some of the pressure that the sheath exerts on part 56. It also make it easier to remove part 56.
Parts 56, 58, 60 and 62 can be made of any material, however the most preferable material would be a transparent material, so that the operator can see where the sheath is being mounted.
c) at least two spaced apart treatment implements extending radially outwardly from the expandable portion, wherein in the device's contracted configuration the implements are shielded within the protective sheath, and in its expanded configuration the thickness of the sheath decreases to expose the implements for contact with the target area of the vessel wall.
3. A device according to claim 1 wherein the treatment implements are blades.
4. A device according to claim 1 wherein the treatment implements are needles.
5. A device according to claim 4 further comprising a delivery system in fluid communication with the needles for delivery of therapeutic compound through the needles into a vessel wall.
6. A device according to claim 5 wherein the drug delivery system comprises a plurality of reservoirs in the protective sheath.
7. A device according to claim 5 wherein the drug delivery system comprises a supply hose connected via tubing to the needles.
8. A device according to claim 1 wherein the protective sheath comprises an elastic polymer.
9. A device according to claim 8 wherein the elastic polymer comprises polyurethane or silicone.
10. A device according to claim 1 wherein the protective sheath has defined therein a plurality of holes in which the treatment implements are seated.
11. A device according to claim 1, further comprising at least one marker to aid positioning of the device.
12. A device according to claim 1 further comprising a nose-cone arranged to provide a transitional profile between the catheter and the sheath on a leading end thereof.
13. A device according to claim 1 further comprising a tail-cone arranged to provide a transitional profile between the catheter on a trailing end thereof.
14. A protective sheath for fitting to a device for treating a target area of a vessel wall of a vessel within a human or animal body, the device comprising:
a) an expandable portion for radially expanding the device from a contracted configuration allowing travel within the vessel to the target area to an expanded configuration allowing treatment of the target area,
b) at least two spaced apart treatment implements extending radially outwardly from the expandable portion,
the protective sheath adapted to be stretch-fitted over the expandable portion to exert a compressive force on the expandable portion for radially contracting the device from it expanded configuration to its contracted configuration,
wherein in the device's contracted configuration the implements are shielded within the protective sheath, and in its expanded configuration the thickness of the sheath decreases to expose the implements for contact with the target area of the vessel wall.
15. A protective sheath for fitting to a device for treating a target area of a vessel wall of a vessel within a human or animal body, the device comprising:
the protective sheath adapted to be fitted over the expandable portion to exert a compressive force on the expandable portion for radially contracting the device from it expanded configuration toward its contracted configuration,
16. A sheath for fitting to a balloon catheter for treating a target area of a vessel wall of a vessel within a human or animal body, the sheath adapted to be stretch-fitted over the balloon to exert a compressive force on the balloon for radially contracting the balloon from its expanded configuration to its contracted configuration, the sheath comprising:
17. The sheath of any one of claims 14 to 16 wherein the treatment implements are needles.
18. The sheath of claim 17 further comprising:
an inner sheath comprising an outer surface) on which a plurality of reservoirs are provided for storing therapeutic compound;
19. The sheath of any one of claims 14 to 16 wherein the treatment implements are cutting implements.
20. The sheath of any one of claims 14 to 16 wherein the sheath comprises at least one protuberance on its outer surface, wherein in the balloon's contracted configuration each protuberance extends further radially outwardly from the outer surface of the sheath than each treatment implement.
21. The sheath of claim 20 wherein each protuberance is collapsible.
22. The sheath of claim 21 wherein each protuberance has a hollow internal pocket, wherein in the balloon's expanded configuration the deformation of the sheath causes the pocket to flatten out thereby reducing the size of the protuberance in the radial direction to expose each treatment implement.
23. A sheath according to claim 20 wherein at least one pair of protuberances are provided—each on opposing sides of the treatment implement.
24. A sheath according to any one of claims 20 to 23 wherein the at least one protuberance has a curved exterior surface.
25. A sheath according to claim 20 wherein the curved exterior surface is a convex surface.
26. A sheath according to claim 25 wherein the at least one protuberance is substantially elliptical in its cross-sectional shape.
27. A sheath according to claim 23 wherein the pair of protuberances converge toward each other and to a point above the working implement.
28. A sheath according to claim 23 wherein each of the pair of protuberances is substantially elliptical in its cross-sectional shape.
29. A sheath according to any one of claims 20 wherein, in an expanded configuration, the sheath including its at least one protuberance assumes a substantially circular shape when the protuberance flattens.
30. A sheath according to any one of claims 14 to 16 wherein the implement is a cutting implement and a base end of the cutting implement is recessed into the sheath.
31. A sheath according to claim 30 wherein a stretch-resistant element is provided on the sheath proximate the recessed cutting implement, for example below the cutting implement, so as to prevent local stretching of the sheath.
32. A sheath according to any one of claims 14 to 16 wherein the sheath takes the form of an annular ring of material and within the ring at least one hollow internal pocket is formed, wherein, in the balloon's expanded configuration, the deformation of the sheath causes the pocket to flatten out.
33. A sheath according to claim 32 wherein, a treatment implement is housed within at least one hollow pocket, and in the balloon's expanded configuration, the deformation of the sheath causes the pocket to flatten out so as to expose the treatment implement for use.
34. A sheath according to claim 32 wherein the pocket is provided with an aperture through which the working implement extends in the balloon's expanded configuration.
35. A sheath according to claim 33 wherein a plurality of pockets are provided, each housing a working implement.
36. A sheath according to claim 33 herein at least one pocket is provided which does not house a working implement.
37. A sheath according to claim 36 wherein a plurality of pockets are provided each of which does not house a working implement.
38. A balloon catheter sheath loading device for loading a stretchable tubular sheath onto a balloon catheter, the loading device comprising:
the device being adapted so that the balloon catheter can be slid into the sheath while the sheath is stretched.
39. A loading device according to claim 38 wherein the stretching portion comprises a plurality of members which are expandable relative to each other to stretch the sheath.
40. A loading device according to claim 38 wherein the members are arranged for gripping the sheath internally.
41. A loading device according to claim 39 wherein the members are gripping fingers.
42. A loading device according to claim 39 wherein the expandable members expand by moving apart so as to stretch the sheath.
43. A loading device according to claim 42 wherein a push rod, insertable between the expandable members is adapted to move the expandable members apart.
44. A loading device according to claim 43 wherein the push rod is hollow allowing insertion of a catheter through the push rod.
45. A loading device according to claim 38 wherein the catheter is accommodated within a hollow protective member during insertion into the sheath.
46. A loading device according to claim 45 wherein the hollow protective member is a push rod adapted to move the expandable members apart.
47. A loading device according claim 38 wherein the stretching portion can be disassembled to release the stretched sheath onto the catheter.
48. A loading device according to claim 38 wherein the stretching portion is slidably disengageable from the sheath to release the stretched sheath onto the catheter.
49. A balloon catheter sheath loading device for loading a tubular sheath onto a balloon catheter, the loading device comprising:
first and second hollow elongate tubular parts releasably interconnectable in an end to end orientation to form an inner tube having an inner surface defining a central passage through which a balloon catheter may be fed, and an outer surface over which a sheath may be stretch fitted,
first and second hollow sleeve parts releasably interconnectable in an end to end orientation to form an outer sleeve to surround the inner tube and any sheath mounted thereon.
50. A method of treating one or more target areas of a vessel wall within a human or animal body, the method comprising the steps of:
51. The method of claim 50 wherein after exposing the implements for contact with the vessel wall, the method further comprises the step of delivering therapeutic compound through the treatment implements into the vessel wall.
US11710266 2006-02-24 2007-02-23 Minimally invasive intravascular treatment device Abandoned US20070213761A1 (en)
EP20060003797 EP1825824B1 (en) 2006-02-24 2006-02-24 Minimally invasive intravascular treatment device
US11846887 US20080077164A1 (en) 2006-02-24 2007-08-29 Minimally Invasive Intravascular Treatment Device
US11846935 US20080077165A1 (en) 2006-02-24 2007-08-29 Minimally Invasive Intravascular Treatment Device
US20070213761A1 true true US20070213761A1 (en) 2007-09-13
ID=36636615
US11710266 Abandoned US20070213761A1 (en) 2006-02-24 2007-02-23 Minimally invasive intravascular treatment device
US (1) US20070213761A1 (en)
EP (2) EP1825824B1 (en)
JP (1) JP2009527316A (en)
CN (1) CN101420913B (en)
CA (1) CA2642471A1 (en)
DE (1) DE602006010171D1 (en)
ES (1) ES2335520T3 (en)
WO (1) WO2007096856A3 (en)
US20110275884A1 (en) * 2008-12-05 2011-11-10 Ecp Entwicklungsgesellschaft Mbh Fluid pump with a rotor
CN103341231B (en) * 2013-07-17 2016-04-06 成都睿杰森生物科技有限公司 The drug delivery device and method for visualization of the cavity tissue
US8721516B2 (en) * 2008-12-05 2014-05-13 Ecp Entwicklungsgesellschaft Mbh Fluid pump with a rotor
US8998792B2 (en) * 2008-12-05 2015-04-07 Ecp Entwicklungsgesellschaft Mbh Fluid pump with a rotor
WO2011035132A2 (en) * 2009-09-18 2011-03-24 Innovasc Llc Pre-angioplasty serration of atherosclerotic plaque enabling low-pressure balloon angioplasty & avoidance of stenting
WO2011035132A3 (en) * 2009-09-18 2011-09-15 Innovasc Llc Pre-angioplasty serration of atherosclerotic plaque enabling low-pressure balloon angioplasty & avoidance of stenting
EP1996088A2 (en) 2008-12-03 application
CN101420913B (en) 2012-03-21 grant
ES2335520T3 (en) 2010-03-29 grant
EP1825824A1 (en) 2007-08-29 application
DE602006010171D1 (en) 2009-12-17 grant
CA2642471A1 (en) 2007-08-30 application
CN101420913A (en) 2009-04-29 application
WO2007096856A3 (en) 2008-01-03 application
EP1825824B1 (en) 2009-11-04 grant
EP1996088B1 (en) 2011-05-18 grant
JP2009527316A (en) 2009-07-30 application
WO2007096856A2 (en) 2007-08-30 application
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MURPHY, BRUCE PHILIP;LAWLOR, VINCENT PATRICK;REEL/FRAME:019322/0297