WO2003011109A2

WO2003011109A2 - Upper body convective heat therapy device and method for making and using the same

Info

Publication number: WO2003011109A2
Application number: PCT/US2002/023985
Authority: WO
Inventors: Clifford E. Gammons; Joseph G. Jones
Original assignee: Adroit Medical Systems, Inc.
Priority date: 2001-07-27
Filing date: 2002-07-24
Publication date: 2003-02-13
Also published as: AU2002324547A1; US6689155B2; WO2003011109A3; US20030023292A1; US20030023289A1; US20040220649A1; US6699270B2; US7022130B2

Abstract

A therapy device (10) for providing heated air to the upper body (110) of a patient and a method of making and using the therapy device have been provided. The therapy device (10) is an inflatable U-shaped tube (102) mounted on a base sheet (104)and having a cover sheet (106). The patient is placed on the base sheet (104) with the patient's head located between the legs of the tube (102). The cover sheet (106) is placed over the patient's face. A heated air supply tube (112) is connected to the tube (102) and the heated air inflates the tube and heated air is forced out of the exhaust ports (212) of the tube, thereby providing an environment in which a portion of the patient's body is heated. In one embodiment the exhaust ports (212) are slits cut into the tube sheet material, and the slits are parallel to a tangent line of the tube's sealed edge. The method of fabricating the therapy device includes forming the individual pieces, attaching the tube sheets to form a tube, lancing the tube to form exhaust ports, and attaching the remaining pieces. In another embodiment, the exhaust ports (212) are formed by selectively coating the tube sheets with an air impermeable material except for an area bounded by the exhaust ports.

Description

TITLE OF INVENTION Upper Body Convective Heat Therapy Device and Method of Making and Using Same

CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable

BACKGROUND OF THE INVENTION 1. Field of Invention

This invention relates to the field of heat therapy. More specifically, the present invention relates to a disposable hypothermia article for use with a heat source to supply a source of controlled temperature air to a patient's upper body surface.

2. Description of the Related Art

During and after a surgical procedure, it is well known that the loss of body temperature by the patient can lead to hypothermia. Accordingly, it is well known to apply heat to the patient in order to replace the heat that is lost. While heat loss associated with surgery is discussed herein, it is well known that hypothermia is also caused by other circumstances, such as prolonged exposure to extreme cold. No matter what the cause of hypothermia, it is essential to apply heat to the patient in order to either prevent or overcome hypothermia.

One method for applying heat to a patient is by directing warm air toward the patient. Of specific interest is a generally U-shaped hollow tubular member through which heated air is supplied. Typical of the art are those devices disclosed is U.S. Letters Patent Nos. 5,165,400, titled "Convective H5 erthermia Article," issued to Berke on November 24, 1992; and 5,300,101, titled "Method and Apparatus for Treatment of Pediatric Hypothermia," issued to Augustine, et al., on April 5, 1994.

The '400 device disclosed by Berke is a U-shaped device having two substantially parallel legs positioned adjacent to and extending a substantial length of a patient's body, and the device directs heated air to the body. The '400 device has a crosspiece connecting the two legs. The ' 101 device disclosed by Augustine is a device similar to that disclosed in the '400 patent, except that it fits an infant or small child and includes positionable covering sheets.

It is an objective of this invention to provide a heat therapy device for a patient who is off-pump. It is a further objective to provide a therapy device for the upper body, specifically the head and upper shoulders.

BRIEF SUMMARY OF THE INVENTION According to one embodiment of the present invention, an upper body convective heat therapy device is provided. The heat therapy device is a light weight disposable convective hypothermia article that provides warm air to a patient's upper body. It is suitable for use in off-pump situations; that is, when the patient is not on life-support, but requires a source of heat.

In one embodiment, the therapy device is a U-shaped tube that is inflated with a heated air supply. The heated air escapes through slits or an air permeable portion of the tube and is directed towards the patient's head and shoulders. The tube is attached to a flat sheet, upon which the patient lies. Attached to the tube is a flat covering sheet that can be positioned over the patient's upper body without restricting access to the patient. The covering sheet forms a tent over the patient and serves to prevent the heated air from escaping. The covering sheet is fabricated of a clear material that permits viewing the face of the patient.

A method of making the therapy device includes cutting or forming tube sheets, gluing or welding them together, forming exhaust ports in the resulting tube, attaching the tube to a base sheet and a cover sheet. A method for selectively warming a patient's upper body is disclosed and includes arranging a therapy device around the patient's head and shoulders, forcing heated air into the device, exhausting air from the device and directing the air to the patient. A cover sheet is used to prevent the heated air from immediately escaping.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS The above-mentioned features of the invention will become more clearly understood from the following detailed description of the invention read together with the drawings in which:

Figure 1 is a top view of a patient with the therapy device inflated and in place;

Figure 2 is a perspective view of the therapy device;

Figure 3 is a top view of the therapy device;

Figure 4 is a top view of another embodiment of the therapy device;

Figure 5 is an exploded view of the therapy device;

Figure 6 is a perspective view of one panel of one embodiment the device; and

Figure 7 is a perspective view of the embodiment illustrated in Figure 6.

DETAILED DESCRIPTION OF THE INVENTION An apparatus for an upper body convective heat therapy device 10 and a method of making and using the device 10 is disclosed. Referring to Figure 1, the therapy device 10 provides warm air to the upper portion of a patient's body 110. A base sheet 104 is placed under the head and shoulders of the patient 110, who is lying on a table or bed 114. The therapy device 10 is connected to a supply hose 112 from a heated air supply (not illustrated). When air is pumped into the therapy device 10, the tube 102 inflates, and heated air is exhausted in a thermal warming zone surrounding a portion of the patient's body 110. A cover sheet 106 prevents the heated air from immediately escaping and is attached 107 to one leg 85 110 and placed on top of the tube 102.

86 Figure 2 illustrates a perspective view of an inflated therapy device 10. A

87 first securing strap 206 extending from the seam 222 on the inside of the tube 102

88 is attached to the base sheet 104. A second securing strap 306 (not illustrated in

89 Figure 2) extends similarly from the seam opposite that of the first securing strap

90 206. The securing straps 206, 306 are attached to the base sheet 104 by any of

91 various methods known by those skilled in the art, including welding, double-sided

92 tape, or hot-glue.

93 The cover sheet 106 is a clear plastic material that forms a tent over the

94 head of the patient 110 and serves to direct the escaping air over a greater portion

95 of the body of the patient 110 by preventing the immediate escape of the heated

96 air. A portion of one end 107 of the cover sheet 106 is attached 107 to one leg of

97 the tube 102 using means known to those skilled in the art, for example, welding,

98 double-sided tape, or hot-glue.

99 Also shown in Figure 2 are the exhaust ports or slits 212a, 212b, 212c,

100 212d through which the heated air forced into the therapy device 10 escapes. The

101 slits 212 are substantially parallel to a line tangent to the nearest seam edge of the

102 tube 102. Alternatively, the slits 212 are substantially perpendicular to the

103 tangent of a circumference of the tube 102 defined by a radius perpendicular to

104 the axis of the tube 102. In another embodiment, the exhaust ports 212 are V-

105 shaped slits; that is, each exhaust port 212 is formed of two slits that are

106 connected at one end and separated at the other end. In still another embodiment,

107 the exhaust ports 212 are holes cut or punched into the tube 102.

108 In yet another embodiment, the exhaust ports 212 are an integral part of

109 the fabric of the tube 102. That is, the tube 102 is fabricated with material that is

110 air impermeable in all areas except where the exhaust ports 212 are located. For

111 example, the tube 102 is fabricated out of air permeable fabric that is coated with

112 a thin sheet of plastic or other air impermeable material, The coating completely

113 coats the tube 102 material except in the areas in which heated air is to be

114 exhausted. The uncoated areas form the exhaust ports 212 because air escapes

115 from the tube 102 in those areas. Those skilled in the art will recognize that size, 116 number, and location of the exhaust ports 212 can vary depending on the available

117 air flow without departing from the spirit and scope of the present invention.

118 . The exhaust ports 212 cover the surface of the tube 102 in the area in

119 which heated air is desired to be exhausted. In the illustrated embodiment, the

120 tube 102 does not discharge heated air in the area where the patient's ears would

121 be located. The area between exhaust ports 212a and 212b, 212c and 212d is the

122 area of the tube 102 that is adjacent to the ears of the patient 110.

123 Figure 3 shows a therapy device 10 in a deflated state. The legs 302, 304 of

124 the therapy device 10 are splayed out because, when the tube 102 is inflated, the

125 end of the legs 302, 304 draw towards each other. In the illustrated embodiment,

126 the legs 302, 304 are substantially parallel to each other when the therapy device

127 10 is inflated.

128 Figure 4 shows another embodiment of a therapy device 10' in a deflated

129 state. In this embodiment, the legs 402, 404 of the therapy device 10' have a foot-

130 shaped end portion opposite their connection to the crosspiece 308. The shape of

131 the legs 402, 404 permits the heated air exhausted from the therapy device 10' to

132 be directed across the top of the full width of the shoulders of the patient 110.

133 Figure 5 is an exploded view of the therapy device 10, showing the base

134 sheet 104, two tube sheets 502, 504, the cover sheet 106, and the inlet collar

135 108. The base sheet 104 is fabricated of the same material as the tube sheets 502,

136 504, although those skilled in the art will recognize that other material can be

137 used without departing from the spirit and scope of the present invention. The

138 cover sheet 106 is fabricated of a thin-gauge clear plastic that is impermeable to

139 air, for example, 10 gauge clear PVC sheeting.

140 The tube 102 is made of two tube sheets 502, 504, one on top of the other.

141 The tube sheets 502, 504 are fabricated of a material that is not permeable to air,

142 such as a fabric coated with a plastic. Those skilled in the art will recognize that

143 any of various materials can be used without departing from the spirit and scope of

144 the present invention. Common materials include woven and non-woven fabrics

145 and cellulosics. Material that is air permeable can be coated on at least one side 146 with a thin film of plastic or other air impermeable material. The material is

147 waterproof and impermeable to air.

148 In the illustrated embodiment, at least one of the tube sheets 502, 504 has

149 two securing straps 206, 306, each extending from a leg 206, 306 towards the

150 other. In another embodiment, the securing straps 206, 306 are separate pieces of

151 material placed between and secured to the tube sheets 502, 504. The two tube

152 sheets 504, 504 are sealed together at their common edges 222. The sheets 502,

153 504 can be sealed by gluing the opposing surfaces or by welding the plastic coated

154 surfaces. The sealed edge 222 extends into the tube sheet 502, 504 a distance

155 sufficient to provide an air tight seal and provide mechanical strength when the

156 tube 102 is inflated. For fabric with a plastic film, the sealed distance is

157 approximately one-quarter inch.

158 In the illustrated embodiment, the tube 102 is secured to the base sheet

159 104 in four places. The tube 102 is attached by securing the seam 222 on both

160 sides of the inlet collar 108 to the base sheet 104. The tube 102 can be glued or

161 welded to the base sheet 104. The tube 102 is secured to the base sheet 104 by

162 the two securing tabs 206, 306 protruding from the tube 102. Each securing tab

163 206, 306 is folded under its respective tube leg 302, 304 and secured to the base

164 sheet 104.

165 The inlet collar 108 is secured to the cross-piece of the tube 102. The inlet

166 collar 108 is a section of stiff material, such as paper or cardboard, with a hole in

167 the center sized to accept the nozzle of the heated air supply hose 112. The inlet

168 collar 108 is attached to the tube sheets 502, 504 by gluing it to the fabric. Slits

169 512, 514 are cut into the tube sheets 502, 504 and provide clearance for the

170 nozzle of the heated air supply hose 112. In the illustrated embodiment, the inlet

171 collar 108 is not secured to the base sheet 104.

172 Figure 6 illustrates a tube sheet 602 for another embodiment of the present

173 invention, which is illustrated in Figure 7. The tube sheet 602, instead of being

174 laid flat during fabrication, has excess material 604, 606 which is folded over

175 along the length of each leg 302, 304. After the tube sheet 602 is attached to its

176 mating tube sheet 504, the tube legs 702, 704 have a greater height than without

177 using the excess material 604, 606. The excess material 604, 606 at the end of 178 the tube legs 702, 704 can be seen in Figure 7 as a puckered area 712, 714 at the

179 seam 222. As can be seen in Figure 7, with the upper tube sheet 602 having

180 excess material 604, 606, the seam 222 on the outside of the tube legs 702, 704

181 is positioned closer to the base sheet 104 at the end of the tube leg 702, 704

182 opposite the connection to the crosspiece 708. In another embodiment, both the

183 top and bottom tube sheets 502, 504 are similar to the tube sheet 602 with excess

184 material 604, 606. A tube fabricated with excess material 604, 606 on both the

185 top and bottom tube sheet 502, 504 has legs 702, 704 with a greater height,

186 which results in the cover sheet 106 being supported more by the tube legs 702,

187 704 than the face of the patient 110.

188 Figure 8 is a flow diagram showing the steps of fabricating the therapy

189 device 10. The first step is to cut the material 802. Once the material is cut, the

190 tube sheets 502, 504 can be sealed at their common edges 222 by welding 804 or

191 other means for making an air tight seal.

192 In the illustrated embodiment, the exhaust ports 212 are slits cut parallel to

193 a tangent line of the tube sheet 502, 504 edge 222. Once the two tube sheets

194 502, 504 are fastened together, the exhaust ports 212 are formed 806 by cutting

195 into the material of the tube 102. The exhaust ports 212 can be cut 806 by

196 lancing slits or punching holes in the tube sheets 502, 504. In another

197 embodiment, the exhaust ports 212 are uncoated areas of an air permeable

198 material that is partially coated with a thin film of plastic or other air impermeable

199 material. For this embodiment, when the tube sheet 502, 504 material is coated

200 before cutting, the exhaust ports 212 can be formed 806 before the material is cut.

201 Those skilled in the art will recognize that the number of exhaust ports 212 can

202 vary based on their size and the available air supply flow without departing from

203 the spirit and scope of the present invention.

204 After the tube sheets 502, 504 are mated 804, the tube 102 is secured to

205 the base sheet 104 by attaching the crosspiece 308 of the tube 102 to the base

206 sheet 104 and by attaching the securing straps 206, 306 to the base sheet 104.

207 The inlet collar 108 is secured 810 to the tube 102 and the cover sheet 106 is

208 attached 812 to the tube 102. Lastly, the assembled therapy device is folded and

209 packed 814, and otherwise made ready for shipment, storage, and use. 210 In the illustrated embodiment, the patient 110 is positioned on the base

211 sheet 104 with the head of the patient 110 between the legs 302, 304 of the

212 therapy device 10. Heated air is pumped into the therapy device 10 and is

213 exhausted from the exhaust ports 212, which are of a size and number to maintain

214 a back pressure in the therapy device 10, which serves to keep the tube 102

215 inflated. The cover sheet 106 is extended from one tube leg 302, over the face of

216 the patient 110, and to the other tube leg 304. The therapy device 10 disclosed is

217 suitable for use with a patient 110 off-pump.

218 From the forgoing description, it will be recognized by those skilled in the art

219 that a therapy device for providing heated air to the upper body of a patient and a

220 method of making the therapy device have been provided. The therapy device is an

221 inflatable U-shaped tube mounted on a base sheet and having a cover sheet. The

222 patient is placed on the base sheet with the patient's head between the legs of the

223 tube. The cover sheet is placed over the patient's face. A heated air supply tube is

224 connected to the tube and the heated air both inflates the tube and is forced out of

225 the exhaust ports of the tube, thereby providing an environment in which a portion

226 of the patient's body is heated.

227 While the present invention has been illustrated by description of several

228 embodiments and while the illustrative embodiments have been described in

229 considerable detail, it is not the intention of the applicant to restrict or in any way

230 limit the scope of the appended claims to such detail. Additional advantages and

231 modifications will readily appear to those skilled in the art. The invention in its

232 broader aspects is therefore not limited to the specific details, representative

233 apparatus and methods, and illustrative examples shown and described.

234 Accordingly, departures may be made from such details without departing from the

235 spirit or scope of applicant's general inventive concept.

Claims

CLAIMS Having thus described the aforementioned invention, we claim:

1. A therapy device for providing air to a patient's upper body, said device comprising: a tube having a first leg, a second leg, and a crosspiece, said tube having an orifice for an air supply hose, said tube having a plurality of exhaust ports; a base sheet attached to said crosspiece; and a cover sheet attached to said first leg and extending to said second leg.

2. The device of Claim 1 further comprising at least one securing tab extending from said first leg and attached to said base sheet.

3. The device of Claim 1 wherein said first leg, said second leg, and said crosspiece define a U-shaped opening sized to accommodate a head of a patient between said first leg and said second leg, and said first leg and said second leg having a length sufficient to extend from a shoulder of said patient to a crown of said head of said patient.

4. The device of Claim 1 wherein said first leg, said second leg, and said crosspiece define a U-shaped opening having a width and a length, said width is defined by a distance between said first leg and said second leg, said width being greater than 6 inches and said width being less than 12 inches.

5. The device of Claim 4 wherein said first leg and said second leg each have a leg length, said leg length defining said length of said U-shaped opening, said length greater than 10 inches and said length less than 18 inches.

6. The device of Claim 1 wherein said tube further includes a first tube sheet and a second tube sheet, said tube formed by overlaying said first tube sheet and said second tube sheet and joining said first tube sheet and said second tube sheet at a common outside edge.

7. The device of Claim 6 wherein said plurality of exhaust ports are a plurality of openings formed in said tube.

8. The device of Clai 6 wherein said plurality of exhaust ports are a plurality of slits formed in said tube, each of said plurality of slits positioned substantially parallel to a line tangent to said common outside edge.

9. The device of Claim 6 wherein said plurality of exhaust ports includes an air permeable portion of said first tube sheet.

10. The device of Claim 9 wherein said air permeable portion is formed by applying a coating of an air impermeable material to said first tube sheet, said coating covering at least one complete side of said first tube sheet except for an area bounded by said air permeable portion.

11. The device of Claim 6 wherein said plurality of exhaust ports are located adjacent to said common outside edge.

12. The device of Claim 6 wherein said first tube sheet has an amount of excess material that is folded parallel to an axis of said first leg, said fold being joined with said second tube sheet at said common outside edge.

13. The device of Claim 1 wherein said tube further includes a first appendage and a second appendage, said first appendage connected to and extending substantially perpendicular to said first leg at a first leg end distal to connection of said first leg to said crosspiece, said second appendage connected to and extending substantially perpendicular said second leg at a second leg end distal to connection of said second leg to said crosspiece.

14. A therapy device for providing air to a patient's upper body, said device comprising: a tube having a first leg, a second leg, and a crosspiece, wherein said first leg, said second leg, and said crosspiece defining a U-shaped opening, said tube having an orifice for an air supply hose, said tube formed by overlaying a first tube sheet and a second tube sheet and joining said first tube sheet and said second tube sheet at a common outside edge; a plurality of exhaust ports formed in said tube; a base sheet attached to said crosspiece; and at least one securing tab extending from said common outside edge and attached to said base sheet; a cover sheet attached to said first leg, said cover sheet being transparent and extending to said second leg.

15. The device of Claim 14 wherein said U-shaped opening is sized to accommodate a head of a patient between said first leg and said second leg, and said U-shaped opening has a length sufficient to extend from a shoulder of said patient to a crown of said head of said patient.

16. The device of Claim 14 wherein said first tube sheet has an amount of excess material that is folded parallel to an axis of said first leg, said fold being joined with said second tube sheet at said common outside edge.

17. The device of Claim 14 wherein said plurality of exhaust ports include a means for exhausting a medium from said tube into said U-shaped opening.

18. The device of Claim 14 wherein said plurality of exhaust ports include a plurality of openings in said tube.

19. The device of Claim 14 wherein said plurality of exhaust ports include a plurality of slits formed in said tube, each of said plurality of slits positioned substantially parallel to a line tangent to said common outside edge and adjacent to said common outside edge.

20. The device of Claim 14 wherein said plurality of exhaust ports includes an air permeable portion of said first tube sheet, wherein said air permeable portion is formed by applying a coating of an air impermeable material to said first tube sheet, said coating covering at least one complete side of said first tube sheet except for an area bounded by said air permeable portion.

21. A therapy device for providing heated air to a patient's upper body, said device comprising: a means for releasably containing a first quantity of a medium; a means for connecting a source of said first quantity of said medium to said means for containing; a means for exhausting a second quantity of said medium from said means for containing; a means for securing said means for containing in a fixed position adjacent to an upper body member; and a means for directing said second quantity of said medium over said upper body member.

22. A method for fabricating a therapy device for providing heated air to a patient's upper body, said method comprising the steps of: (a) forming a first tube sheet and a second tube sheet with a complementary shape; (b) attaching said first tube sheet to said second tube sheet; (c) forming exhaust ports in said first tube sheet and said second tube sheet (d) attaching said first tube sheet and said second tube sheet to a base sheet; (e) attaching a cover sheet to said first tube sheet.

23. The method of Claim 22 a therapy device wherein said step of forming exhaust ports includes cutting slits in said first tube sheet and said second tube sheet.

24. The method of Claim 22 a therapy device wherein said step of forming exhaust ports includes cutting apertures in said first tube sheet and said second tube sheet.

25. The method of Claim 22 a therapy device wherein said step of forming exhaust ports includes selectively coating said first tube sheet and said second tube sheet with an air impervious material except in an area bounded by said exhaust ports.

26. A method for selectively warming a patient's upper body, said method comprising the steps of: (a) arranging a therapy device to form a thermal warming zone around an upper body portion of a patient, said therapy device including an inflatable tube having an inlet connection for receiving a thermally controlled medium and a plurality of exhaust ports for directing said thermally controlled medium into said thermal warming zone; (b) securing said therapy device to said patient; (c) inflating said therapy device with said thermally controlled medium; (d) exhausting said thermally controlled medium from said therapy device; and (e) releasably covering said upper body portion to direct said exhausted medium to said upper body portion.

27. The method of Claim 26 wherein each one of said plurality of exhaust ports is a slit cut into said therapy device, said slit oriented perpendicular to a tangent of a circumference defined by a radius perpendicular to an axis of said inflatable tube.